Hepatocellular carcinoma is a common malignancy in Asia. It is associated with chronic hepatitis B virus or hepatitis C virus infection and alcoholic hepatitis. Commonly, the tumor metastasizes to the lungs, r...
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Σάββατο 29 Σεπτεμβρίου 2018
Hepatocellular carcinoma presenting as spinal cord compression in Native Americans with controlled hepatitis C: two case reports
Gute Arzthelferinnen an die Praxis binden
Qualifizierte Medizinische Fachangestellte zu finden, wird in vielen Regionen zunehmend schwieriger. Es gilt daher, gute Arzthelferinnen möglichst an die Praxis zu binden. Neben einer übertariflichen Entlohnung können steuerbegünstigte Zusatzleistungen infrage kommen.
https://ift.tt/2xJiCfm
Der akute Schiefhals: Wann rasches Handeln gefragt ist
Zusammenfassung
Eine Schiefhaltung des Kopfes kann viele, zum Teil auch banale Ursachen haben. Ein plötzlich auftretender Torticollis sollte aber stets als Alarmzeichen gewertet werden, da er Ausdruck verschiedener bedrohlicher Erkrankungen sein kann, die einer raschen Therapie bedürfen.
https://ift.tt/2DH44T2
Von Malchus zum Schlitzohr
In zahlreichen mittelalterlichen Altären und Bildern ist die Szene von der Gefangennahme Jesu im Garten Gethsemane dargestellt. Dem armen Herrn Malchus wurde dabei von Petrus das rechte Ohr mit einem Schwertschlag abgetrennt. Aber Jesus heilte die Amputation der Ohrmuschel sofort. Anders erging es jenen Straftätern, bei denen bis zum 18. Jahrhundert Verstümmelungsstrafen gerichtlich angeordnet wurden.
https://ift.tt/2DH42KU
Qualitätsmanagement — zu oft noch Mauerblümchen im Praxisalltag
Die sektorenübergreifende Richtlinie zum Qualitätsmanagement des Gemeinsamen Bundesausschusses ist seit rund einem Jahr in Kraft. In vielen Praxen schlummert aber noch großes Optimierungspotenzial, sind sich Experten einig.
https://ift.tt/2xNUB74
Naturheilverfahren bei Infekten der oberen Atemwege
Behandlungen nach naturheilkundlichen Prinzipien erfreuen sich zunehmender Beliebtheit — aber erfüllt Naturheilkunde auch die Standards der modernen Medizin? Was sagen die Leitlinien und Cochrane Reviews zu Naturheilverfahren bei Infektionen der oberen Atemwege?
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Antirefluxtherapie schützt vor Ösophaguskarzinom
Die Behandlung der gastroösophagealen Refluxkrankheit kann die Patienten vor Krebs der Speiseröhre bewahren. Allerdings dauert es einige Jahre, bis das Inzidenzniveau der Allgemeinpopulation erreicht ist.
https://ift.tt/2xPwB3h
Rechtsprobleme bei der Praxisverlegung
Der Vertragsarztsitz ist für den niedergelassenen Arzt von großer Bedeutung. Dieser, als konkreter, durch die Anschrift gekennzeichnete Ort der Praxis, hat Einfluss auf deren Frequentierung, die Zusammensetzung des Patientenstamms und die Erreichbarkeit der Praxis für den Arzt selbst.
https://ift.tt/2DRU0H1
70 Jahre WHO — Kampf mit Höhen und Tiefen
Seit nunmehr sieben Dekaden setzt sich die Weltgesundheitsorganisation (WHO) mit ihren 194 Mitgliedstaaten dafür ein, dass allen Menschen das höchstmögliche Gesundheitsniveau zuteil wird. Der wohl größte Erfolg in diesen Jahren ist die Ausrottung der Pocken. Als nächstes Ziel soll die Welt poliofrei werden.
https://ift.tt/2DH3Pr6
SCIT auch bei Kindern sicher
Die subkutane Immuntherapie ist eine gut verträgliche Option mit vor allem lokalen Nebenwirkungen. Ob diese meist in Erwachsenenstudien gewonnenen Ergebnisse auch für Kinder gelten, wurde jetzt prospektiv untersucht.
https://ift.tt/2xNtMQl
Blutungskomplikationen nach Tonsillektomie
Dass sich Operationsrisiken tatsächlich verwirklichen, ist gemessen an der Gesamtzahl von Eingriffen in Deutschland selten. Wenn es dazu kommt und die betroffenen Patienten Behandlungsfehler vermuten, können langjährige Auseinandersetzungen die Folge sein.
https://ift.tt/2DH3Kni
Hartnäckige Epistaxis: uni- oder bilaterale Ligatur der A. sphenopalatina?
Gegen behandlungsresistentes Nasenbluten kann eine Ligatur der Arteria sphenopalatina helfen. Dabei sind die Erfolgsraten offenbar höher, wenn dies bilateral geschieht.
https://ift.tt/2xJiBbi
Leukoplakie an den Stimmlippen — Dysplasie oder Biofilm?
Als Leukoplakie (wörtlich „weiße Fläche") gelten alle weißen, nicht abwischbaren Effloreszenzen der Schleimhaut. Traditionell hat dieser Begriff eine gewisse Alarmwirkung. Eine Leukoplakie wird reflexhaft oft gleichgesetzt mit dem Vorliegen einer Dysplasie, die histologisch abgeklärt oder zumindest engmaschig kontrolliert werden muss. Andererseits zeigen viele Studien, dass sich bei Leukoplakien der Stimmlippen nur in etwa der Hälfte der Fälle Dysplasien nachweisen lassen. Differenzialdiagnostische Überlegungen sind deshalb besonders wichtig.
https://ift.tt/2DH3F2Y
Immunmarker für klinische Insektengifttoleranz gesucht
Noch ist es schwierig, den Therapieerfolg einer insektengiftspezifischen Immuntherapie oder die klinische Relevanz einer Insektengiftsensibilisierung auf serologischer Ebene zu verifizieren. Eine Studie nahm IgE, IgG und Basophile ins Visier.
https://ift.tt/2xNkxQ1
Hält das „tailor-made notched music training“, was es verspricht?
Bis heute existiert keine wirksame Standardbehandlung für Tinnitus. Von sich reden machte in den letzten Jahren das sogenannte „tailor-made notched music training" (TMNMT), bei dem der Patient Musik hört, die im Bereich seiner individuellen Tinnitus-Frequenz so gefiltert ist, dass sie keine Signalanteile mehr enthält. Doch wie wirksam ist diese Methode wirklich?
https://ift.tt/2DH3C7i
Effect of different sizes of bioactive glass-coated mesoporous silica nanoparticles on dentinal tubule occlusion and mineralization
Abstract
Objectives
To synthesize two different sizes of bioactive glass-coated mesoporous silica nanoparticles (BGN@MSNs) and to investigate their effects on dentinal tubule occlusion and remineralization.
Materials and methods
Two different sizes of mesoporous silica nanoparticles (MSNs) were synthesized using the Stöber method (368A, 1840A) and coated with bioactive glass nanoparticles (BGNs) using a modified quick alkali-mediated sol-gel method (368B, 1840B). Sensitive tooth disc models were prepared and divided into six groups and the following treatments were applied: group 1—no treatment, group 2—bioglass, group 3—368A, group 4—368B, group 5—1840A, and group 6—1840B. Then, five discs were selected from each group and soaked in 6 wt% citric acid to test acid resistance. Dentinal tubule occlusion and occlusion ratio were observed using field-emission scanning electron microscopy. In vitro mineralization tests using simulated body fluid solution were performed to evaluate the remineralization effect of the treatment.
Results
All samples effectively occluded the dentinal tubule and formed a membrane-like layer. After acid treatment, 1840B (group 6) exhibited the highest rate of dentinal tubule occlusion. Remineralization was observed in 368B and 1840B, and 1840B exhibited the fastest remineralization.
Conclusions
Dentinal tubule remineralization induced by the BGN@MSN biocomposite can be used to stabilize long-term prognosis in dentin hypersensitivity. The 1840B induced the most efficient remineralization, and its smaller size and larger surface area were effective for remineralization.
Clinical relevance
The BGN@MSN biocomposite with its smaller size and larger surface area was more effective for remineralization and dentinal tubule sealing.
https://ift.tt/2N9CjBT
Patient Safety and Quality Improvement: Driving to New Frontiers
Patient safety and quality improvement in health care, and specifically, in surgical specialties, is at a crossroads; the last decade has seen a myriad of initiatives resulting in order of magnitude improvements. The next decade will be challenging. Providers, hospitals, and organizations will need to "think differently" to drive toward zero harm.
https://ift.tt/2N9eIRP
Self-report oral health and disease experience among adults in China and NZ
Abstract
Objectives
Differences in oral health perceptions complicate comparisons of self-reported oral health in countries with considerably different cultures, traditions, and dental care. We compared it in China and New Zealand (NZ), to determine whether adults in those countries differ in how self-report oral health item responses distinguish those with different clinical oral disease states.
Materials and methods
Analysis of representative data on dentate 35–44-year-olds and 65–74-year-olds from the 3rd National Oral Health Survey of China in 2005 (for Sichuan province) and the NZ Oral Health Survey in 2009. Self-rated oral health in the Chinese survey was assessed by asking "Overall, how would you rate your oral health?"(responses: "Very poor," "Poor," "Fair," "Good," and "Very good"). The NZ survey asked "How would you describe the health of your teeth or mouth?" (responses: "Excellent," "Very good," "Good," "Fair," or "Poor"). To enable comparability, these were combined to create a four-category ordinal measure of self-reported oral health. The slope index of inequality (SII) and the relative index of inequality (RII) determined the extent to which the four-category self-report item distinguished those with better or poorer oral status.
Results
A higher proportion of Chinese than NZ 35–44-year-olds rated their oral health as poor or fair, and the NZ proportion rating their oral health as very good was four times that observed among Chinese. The 65–74-year-olds differed even more in their overall responses. For most aspects of clinical disease experience, the two populations were responding similarly to the self-reported oral health item, although the SII and RII values were more pronounced among 35–44-year-olds in NZ than in China; among 65–74-year-olds, both countries were more similar.
Conclusions
Chinese and NZ adults' self-ratings reflect their oral disease experience in largely similar ways, despite considerable absolute differences.
Clinical relevance
These findings support the cross-cultural applicability of self-report oral health measures.
https://ift.tt/2RaLzZB
Relationship between folate concentration and expression of folate-associated genes in tissue and plasma after intraoperative administration of leucovorin in patients with colorectal cancer
Abstract
Purpose
The aim of study was to investigate the relationship between folate concentration and expression of folate-associated genes in tumour, mucosa and plasma of patients with colorectal cancer, after intraoperative administration of bolus leucovorin (LV).
Methods
Eighty patients were randomized into four groups to receive 0, 60, 200, or 500 mg/m2 LV, respectively. Tissue and plasma folate concentrations were assessed by LC–MS/MS. Gene expression of ABCC3/MRP3, FPGS, GGH, MTHFD1L, SLC46A1/PCFT, and SLC19A1/RFC-1 was determined using quantitative PCR.
Results
The folate concentration in tumour increased with increasing dosage of LV. Half of the patients treated with 60 mg/m2 did not reach a level above the levels of untreated patients. A significant correlation between folate concentration in tumour and mucosa was found in untreated patients, and in the group treated with 60 mg/m2 LV. The 5-MTHF/LV ratio correlated negatively with folate concentration in mucosa, whereas a positive correlation was found in tumour of patients who received 200 or 500 mg/m2 LV. A positive correlation was found between folate concentration and expression of all genes, except MTHFD1L, in patients who received LV. There was a negative correlation between 5-MTHF concentration in plasma of untreated patients and expression of GGH and SLC46A1/PCFT in tumour.
Conclusions
The results indicate the possibility of using the individual plasma 5-MTHF/LV ratio after LV injection as a surrogate marker for tissue folate concentration. Expression of several folate-associated genes is associated with folate concentration in tissue and plasma and may become useful when predicting response to LV treatment.
https://ift.tt/2NNAgJ0
Endogenous IL-10 maintains immune tolerance but IL-10 gene transfer exacerbates autoimmune cholangitis
Publication date: Available online 28 September 2018
Source: Journal of Autoimmunity
Author(s): Yu-Hsin Hsueh, Hung-Wen Chen, Bi-Jhen Syu, Chia-I. Lin, Patrick S.C. Leung, M. Eric Gershwin, Ya-Hui Chuang
Abstract
The immunomodulatory effect of IL-10 as an immunosuppressive and anti-inflammatory cytokine is well known. Taking advantage of our established mouse model of autoimmune cholangitis using 2-octynoic acid conjugated ovalbumin (2-OA-OVA) induction, we compared liver pathology, immune cell populations and antimitochondrial antibodies between IL-10 knockout and wild type mice immunized with 2-OA-OVA. At 10 weeks post immunization, portal inflammation and fibrosis were more severe in 2-OA-OVA immunized IL-10 knockout mice than in wild type mice. This was accompanied by significant higher levels of collagen I and III expression, T, NK and NKT subsets in liver and IgG anti-mitochondrial autoantibodies (AMAs) compared to 2-OA-OVA immunized wild type mice, suggesting that endogenous IL-10 is necessary for the maintenance of immune tolerance in primary biliary cholangitis (PBC). Further, we investigated whether administration of exogenous IL-10 could prevent PBC by administration of IL-10 expressing recombinant adeno-associated virus (AAV-IL-10) either 3 days before or 3 weeks after the establishment of liver pathology. Interestingly, administration of AAV-IL-10 resulted in increased liver inflammation and fibrosis, accompanied by increases in IFN-γ in liver CD4+ T cell, granzyme B, FasL, and CD107a in liver CD8+ T and NKT cells, and granzyme B and FasL in liver NK cells of AAV-IL-10 administered mice compared with control mice. Furthermore, administration of AAV-IL-10 significantly increased levels of proinflammatory cytokines and chemokines (IFN-γ, TNF-α, CXCL9 and CXCL10) and collagen I and III production in naïve mice, together with increase in immune cell infiltration and collagen deposition in the liver, suggesting a role of IL-10 in fibrosis. In conclusion, our data demonstrate that endogenous IL-10 is critical in the maintenance of immune tolerance but exogenous administration of IL-10 exacerbates liver inflammation and fibrosis. Furthermore, the distinctive presence of inflammatory immune cell populations and collagen expression in AAV-IL-10 treated naïve mice cautions against the clinical use of exogenous IL-10 in patients with autoimmune cholangitis.
https://ift.tt/2OiGnVf
Japan Singapore Skin Conference 2019
Publication date: October 2018
Source: Journal of Dermatological Science, Volume 92, Issue 1
Author(s):
https://ift.tt/2NTv72h
The Editor's Choice
Publication date: October 2018
Source: Journal of Dermatological Science, Volume 92, Issue 1
Author(s):
https://ift.tt/2N95ODV
Editorial board
Publication date: October 2018
Source: Journal of Dermatological Science, Volume 92, Issue 1
Author(s):
https://ift.tt/2NOOJEH
Pathological risk factors stratification in pN3b oral cavity squamous cell carcinoma: Focus on the number of positive nodes and extranodal extension
Publication date: November 2018
Source: Oral Oncology, Volume 86
Author(s): Chun-Ta Liao, Li-Yu Lee, Chuen Hsueh, Chien-Yu Lin, Kang-Hsing Fan, Hung-Ming Wang, Chia-Hsun Hsieh, Shu-Hang Ng, Chih-Hung Lin, Chung-Kan Tsao, Chung-Jan Kang, Tuan-Jen Fang, Shiang-Fu Huang, Kai-Ping Chang, Lan Yan Yang, Tzu-Chen Yen
Abstract
Objective
According to the AJCC 2017 Staging Manual, oral cavity squamous cell carcinoma (OCSCC) with pN2 disease (based on the AJCC 2010 criteria) and extra-nodal extension (ENE) should be classified as pN3b. We performed a detailed outcome analyses in this patient subgroup.
Material and methods
We retrospectively reviewed the clinical records of consecutive OCSCC patients who underwent radical surgery between 1996 and 2017. Patients with pN3b disease (n = 365) were divided into a pN+ ≥8/ENE ≥5 subgroup (defined by the presence of pN+ ≥8 nodes or ENE ≥5 nodes, n = 77) and a pN+ ≤7/ENE ≤4 subgroup (defined by the presence of pN+ ≤7 nodes and ENE ≤4 nodes, n = 288). Patients with pN0/pN1/pN2 (n = 1192/179/197) disease were included for comparison purposes.
Results
Patients in the pN+ ≥8/ENE ≥5 subgroup had less favorable 5-year outcomes than those in the pN+ ≤7/ENE ≤4/pN2/pN1/pN0 groups (local control, 64%/79%/86%/83%/88%, p < 0.001; neck control, 55%/75%/80%/86%/93%, p < 0.001; distant metastases, 67%/28%/20%/12%/3%, p < 0.001; disease-free survival, 21%/51%/64%/72%/82%, p < 0.001; disease-specific survival, 25%/55%/71%/82%/92%, p < 0.001; overall survival, 19%/40%/54%/64%/82%, p < 0.001; respectively). Among patients with pN3b disease, multivariable analysis identified the pN+ ≥8/ENE ≥5 subgroup, lower neck (level IV/V) metastases, and depth of invasion ≥25 mm as independent adverse prognostic factors for 5-year distant metastases and survival rates.
Conclusions
Patients in the pN+ ≥8/ENE ≥5 subgroup have an unfavorable prognosis and their classification as pN3b is advisable. In contrast, patients in the pN+ ≤7/ENE ≤4 subgroup should be classified as pN3a.
https://ift.tt/2y1P8bS
18F-Choline-PET in parathyroid carcinoma
Publication date: Available online 28 September 2018
Source: Oral Oncology
Author(s): Grégoire B. Morand, Birgit M. Helmchen, Hans C. Steinert, Christoph Schmid, Martina A. Broglie
https://ift.tt/2NQtOkA
CDKN2A germline mutations are not associated with poor survival in an Italian cohort of melanoma patients
Publication date: Available online 28 September 2018
Source: Journal of the American Academy of Dermatology
Author(s): Bruna Dalmasso, Lorenza Pastorino, Giulia Ciccarese, Virginia Andreotti, Federica Grillo, Luca Mastracci, Francesco Spagnolo, Alberto Ballestrero, Paola Queirolo, William Bruno, Paola Ghiorzo
Background
Cyclin dependent kinase inhibitor 2A gene (CDKN2A) germline mutations have recently been associated with poor survival in patients with melanoma. Despite the high mutation rate in our cohort (up to 10% in patients with apparently sporadic melanoma), information on the impact of CDKN2A on survival in this cohort is lacking.
Objective
To investigate whether poor survival associated with CDKN2A germline mutations was confirmed in a high mutation–prevalence cohort of Italian patients with melanoma undergoing a mutation-based follow-up.
Methods
A total of 1239 patients with cutaneous melanoma were tested for CDKN2A mutational status and then assigned to a follow-up scheme according not only to family history but also to CDKN2A mutational status, as follow-up intervals were more frequent for CDKN2A germline mutation–positive (MUT+) patients. From this cohort, we selected 106 MUT+ patients (with familial melanoma or apparently sporadic melanoma) and 199 CDKN2A germline mutation–negative (MUT–) patients with sporadic melanoma who were matched by age and sex and had a similar tumor stage distribution.
Results
We found no difference in overall survival (hazard ratio, 0.85; 95% confidence interval, 0.48-1.52; P = .592,) or melanoma-specific survival (hazard ratio, 0.86; 95% confidence interval, 0.38-1.95; P = .718,) between MUT+ and MUT– patients. MUT+ patients were more likely to develop multiple melanomas and to undergo surgical excision of dysplastic nevi than were MUT– patients.
Limitations
Retrospective study.
Conclusion
CDKN2A mutations were not associated with survival in our cohort.
https://ift.tt/2OZ0d50
Nasal function before and after rapid maxillary expansion in children: A randomized, prospective, controlled study
Publication date: Available online 28 September 2018
Source: International Journal of Pediatric Otorhinolaryngology
Author(s): G. Ottaviano, P. Maculan, G. Borghetto, V. Favero, B. Galletti, E. Savietto, B. Scarpa, A. Martini, E. Stellini, C. De Filippis, L. Favero
Abstract
Objectives
Children can well detect and respond to odours in order to have information about food and environment.
Rapid Maxillary Expansion seems to improve dental and skeletal crossbite and increase nasal patency correcting oral respiration in children. A previous pilot study suggested that Rapid Maxillary Expansion may lead to improved N-Butanol olfactory thresholds, and peak nasal inspiratory flow values (PNIF). The aim of the present study was to prospectively evaluate olfactory threshold, nasal flows and nasal resistances in children aged from 6 to 11 years before and after Rapid Maxillary Expansion, comparing treated children with a control group of similar age, growth stage (prepubertal) and transversal skeletal deficiency.
Methods
N-butanol olfactory thresholds, anterior active rhinomanometry (AAR) and PNIF were measured in 11 children (6-11 years) before (T0), immediately and 6 months after Rapid Maxillary Expansion application (T1 and T2 respectively), and in a control group of 11 children (6-11 years) whose members remained under observation for the period of the study.
Results
Considering the study group, PNIF values improved at T1 respect to the T0 values (p=0.003), while T2 values were significantly higher than T0 ones (p=0.0002). N-Butanol Olfactory Threshold significantly improved at each control (p=0.01, p=0,01 and p=0.0003, for T1 vs T0, T2 vs T1, T2 vs T0 respectively). No differences on AAR values were found during the six months follow-up in this group.
Considering the control group, no significant differences were found for any of the considered variables during the time of the study.
Comparing the two groups, there was a significant increase of PNIF values in the study group compared to the control group (p=0.003) at T1, which was even more evident six months after Rapid Maxillary Expansion (p=0.0005). This improvement was not shown by AAR values. N-Butanol Olfactory Threshold showed a significant improvement at T2 respect to T1 (p=0.002) and T0 (p=0.0005).
Conclusion
Rapid Maxillary Expansion seems to significantly improve the respiratory capacity of treated patients, at least in terms of PNIF, and their olfactory function, measured by N-Butanol Olfactory Threshold Test. Further studies should be performed to evaluate if also changes in nasal resistances, measured by AAR, could occur, maybe considering a larger group of subjects and possibly using 4-phase rhinomanometry in order to evaluate the effective resistances during the entire breath.
https://ift.tt/2ItE5xa
Chemical composition of Pistacia vera L. oleoresin and its antibacterial, anti-virulence and anti-biofilm activities against oral streptococci, including Streptococcus mutans
Publication date: Available online 28 September 2018
Source: Archives of Oral Biology
Author(s): Gloria Magi, Emanuela Marini, Andrea Brenciani, Silvia Di Lodovico, Davide Gentile, Giuseppe Ruberto, Luigina Cellini, Antonia Nostro, Bruna Facinelli, Edoardo Napoli
Abstract
Objective
The aim of this study was to characterise the chemical composition of oleoresin of Pistacia vera L. and to determine its antimicrobial and anti-virulence activity versus selected oral streptococci.
Design
A gaschromatografic analysis of the oleoresin was performed. The antimicrobial and anti-virulence activity of the oleoresin and its fractions was evaluated by the Minimum Inhibitory Concentration (MIC) and/or Minimum Bactericidal Concentration (MBC), biofilm production and haemolytic activity inhibition experiments.
Results
The oleoresin MBCs were ≥1024 μg/mL for all tested strains; the neutral and acidic fraction MBCs ranged from 128 to 2048 μg/mL. Essential oil's MBCs (from 256 to 2048 μg/mL) were almost identical to MICs, suggesting a bactericidal effect.P. vera oleoresin at sub-lethal concentrations significantly reduced biofilm production by Streptococcus mutans (up to 49.4%) and by Streptococcus sanguinis (up to 71.2%). In addition, the acidic fraction showed a specific anti-biofilm activity against S. mutans (up to 41.3% reduction). A significant dose-dependent reduction in the haemolytic activity of S. mutans (up to 65.9%) and of S. anginosus (up to 78.3%) was observed after growth in the presence of oleoresin at sub-lethal concentrations. The acidic fraction reduced haemolytic activity (up to 54.3% at 64 µg/mL) of S. mutans only.
Conclusions
Given the anti-virulence activity of theP. vera oleoresin and its acidic fraction against S. mutans, our findings suggest their potential use in oral hygiene. These data represent the first step in the exploitation of P. vera L. oleoresin.
https://ift.tt/2NQ6q6D
The rise and fall of the alveolar process: Dependency of teeth and metabolic aspects
Publication date: Available online 28 September 2018
Source: Archives of Oral Biology
Author(s): Grethe Jonasson, Ingmarie Skoglund, Marianne Rythén
Abstract
The alveolar bone has a unique capacity to follow the teeth's movements. It is formed around erupting teeth and their periodontal ligaments: the more the teeth have erupted, the larger the alveolar process. Throughout life the teeth erupt and migrate in an occlusal and mesial direction to compensate for attrition, an evolutionary trait. After tooth extraction, the alveolar process is resorbed to varying degrees. The mandibular alveolar bone mirrors skeletal bone condition. Due to fast bone turnover (which is the fastest in the whole skeleton), low bone mass and increased fracture risk may first be seen here. If a periapical radiograph of the mandibular premolars shows a dense trabeculation with well-mineralized trabeculae and small intertrabecular spaces, it is a reliable sign of normal skeletal bone density (BMD) and low skeletal fracture risk, whereas a sparse trabecular pattern indicates osteopenia and high fracture risk. The bone turnover rate in the mandible is twice that of the maxilla, and may, hypothetically, play a role in the development of osteonecrosis of the jaw (ONJ), which has been found mainly in the mandibular alveolar process?
https://ift.tt/2xV7RWC
Unexpected Relevant Role of Gene Mosaicism in Primary Immunodeficiency Diseases
Publication date: Available online 29 September 2018
Source: Journal of Allergy and Clinical Immunology
Author(s): Anna Mensa-Vilaró, María Bravo García-Morato, Oscar de la Calle-Martin, Clara Franco-Jarava, María Teresa Martínez-Saavedra, Luis I. González-Granado, Eva González-Roca, Jose Luis Fuster, Laia Alsina, Osvaldo M. Mutchinick, Angélica Balderrama-Rodríguez, Eduardo Ramos, Consuelo Modesto, Pablo Mesa-del-Castillo, Norberto Ortego-Centeno, Daniel Clemente, Alejandro Souto, Natalia Palmou, Agustín Remesal, Kieron S. Leslie
Abstract
Background
Post-zygotic de novo mutations lead to the phenomenon of gene mosaicism. The three main types are called somatic, gonadal and gonosomal mosaicism, which differ on the body distribution of post-zygotic mutations. Mosaicism has been occasionally reported in primary immunodeficiency diseases (PID) since early 90s, but its real involvement has not been systematically addressed.
Objective
To investigate the incidence of gene mosaicism in PID.
Methods
The amplicon-based deep sequencing method was employed in the three parts of the study that establish the allele frequency of germline variants (n:100), the incidence of parental gonosomal mosaicism in PID families with de novo mutations (n:92) and the incidence of mosaicism in PID families with moderate-to-high suspicious (n:36), respectively. Additional investigations evaluated body distribution of post-zygotic mutations, their stability over time and their characteristics.
Results
The range of allele frequency 44.1-55.6% was established for germline variants. Those with minor allele frequency (MAF) <44.1% were assumed as post-zygotic. Mosaicism was detected in 30/128 (23.4%) PID families, with variable MAF (0.8-40.5%). Parental gonosomal mosaicism was detected in 6/92 (6.5%) families with de novo mutations, whereas a high incidence of mosaicism (63.9%) was detected among families with moderate-to-high suspicious. In most analyzed cases, mosaicism was found both uniformly distributed and stable over time.
Conclusion
This study represents the largest one performed to date to investigate mosaicism in PID, revealing that it affects ≈25% of enrolled families. Our results may have serious consequences regarding patients' treatment and genetic counseling, and reinforce the use of NGS-based methods in the routine analyses of PID.
Graphical abstract
https://ift.tt/2Qi5VPt
ARIA Phase 4 (2018): Change management in allergic rhinitis and asthma multimorbidity using mobile technology
Publication date: Available online 29 September 2018
Source: Journal of Allergy and Clinical Immunology
Author(s): Jean Bousquet, Peter W. Hellings, Ioana Agache, Flore Amat, Isabella Annesi-Maesano, Ignacio J. Ansotegui, Josep M. Anto, Claus Bachert, Eric D. Bateman, Anna Bedbrook, Kazi Bennoor, Mickael Bewick, Carsten Bindslev-Jensen, Sinthia Bosnic-Anticevich, Isabelle Bosse, Jan Brozek, Luisa Brussino, Giorgio W. Canonica, Victoria Cardona, Thomas Casale
Abstract
Allergic Rhinitis and its Impact on Asthma (ARIA) has evolved from a guideline using the best approach to integrated care pathways (ICPs) using mobile technology in AR and asthma multimorbidity. The proposed next phase of ARIA is Change Management (CM) with the aim of providing an active and healthy life to rhinitis sufferers and to those with asthma multimorbidity across the life cycle whatever their gender or socio-economic status in order to reduce health and social inequities incurred by the disease. ARIA has followed the 8-step model of Kotter to assess and implement the impact of rhinitis on asthma multimorbidity and to propose multimorbid guidelines. A second change management strategy is proposed by ARIA Phase 4 to increase self-medication and shared decision making in rhinitis and asthma multimorbidity. An innovation of ARIA has been the development and validation of IT evidence-based tools (MASK: Mobile Airways Sentinel Network) that can inform patient decisions on the basis of a self-care plan proposed by the health care professional.
https://ift.tt/2xL1Xbd
Oral microbiota maturation during the first 7 years of life in relation to allergy development
Allergy, EarlyView.
https://ift.tt/2xLZ6yV
Diagnosing microscopic pancreatic neuroendocrine tumor using 68-Ga-DOTATATE PET/CT: case series
Abstract
Neuroendocrine tumors (NETs) are an uncommon diagnosis which often present asymptomatically or with vague symptoms. They can originate from many different organs such as the GI tract, lungs, pancreas and others. 68Gallium DOTATATE positron emission topography/computed topography has been shown to be an effective imaging modality for diagnosing NET and evaluating management options for patients. Here, we present two cases of positive findings in the distal pancreas on the DOTATATE PET/CT scans without any morphological lesion found to be NET in a healthy 48-year-old male and 68-year-old male.https://ift.tt/2DEGiHd
Adult ileocecal intussusception induced by adenomatous ileal polyp: case report and literature review
Abstract
Intussusception is a rare cause of bowel obstruction in adults, and has generally an organic etiology. However, adenomatous polyp of the small bowel is an uncommon etiology. Moreover, there's a great difference with childhood intussusception in its presentation, etiology and management. We describe herein a case of adult ileocecal intussusception due to an adenomatous ileal polyp with a preoperative diagnosis made on computed tomography. We performed a right hemicolectomy, without attempting to reduce the intussusception, and an end-to-end ileotransverse anastomosis. The pathological examination of the surgical specimen revealed an adenomatous polyp with a high grade dysplasia on the terminal ileum, being the cause of the ileocecal intussusception.https://ift.tt/2Ooe4oa
Biliary obstruction secondary to migrated intra-duodenal gastric band: a case report
Abstract
Adjustable gastric banding (AGB) was a previously popular bariatric procedure, but adverse events such as erosion have surfaced as common complications. We present an interesting case of an AGB causing biliary obstruction after eroding into the stomach.https://ift.tt/2DFYsZa
Spontaneous rupture of the urinary bladder due to bacterial cystitis
Abstract
We report a case of spontaneous rupture of the urinary bladder (SRUB) due to bacterial cystitis in a 76-year-old woman with chief complaint of abdominal pain a day before presentation. She had fever (38.0°C), and her systolic blood pressure dropped to 70 mmHg; she was referred to our hospital, where she was admitted with a diagnosis of ileus. However, her abdominal pain worsened the following day, and abdominal CT showed free air. Emergency laparotomy was performed for suspicion of digestive tract perforation, which revealed a small hole at the dome of the urinary bladder and another at the peritoneum. Suture repair was performed. We reviewed the abdominal CT on admission and noted that the perforation of the urinary bladder was present during admission, whereas that of the peritoneum occurred the following day. SRUB is rare, and bacterial cystitis rarely causes it; thus, accurate diagnosis and proper treatment are essential.https://ift.tt/2OodVkC
Enlarging plaque on the sole
Clinical and Experimental Dermatology, EarlyView.
https://ift.tt/2zDwARt
Bullous pemphigoid in a 3‐month‐old infant after vaccination
Clinical and Experimental Dermatology, EarlyView.
https://ift.tt/2IoBg0d
Neutrophilic dermatosis associated with an NFKB2 mutation
Clinical and Experimental Dermatology, EarlyView.
https://ift.tt/2zEyfpN
Cutaneous features of Zika virus infection: a clinicopathological overview
Clinical and Experimental Dermatology, EarlyView.
https://ift.tt/2ItmlC4
First reported case of dermatofibrosarcoma in siblings
Clinical and Experimental Dermatology, EarlyView.
https://ift.tt/2zEcx57
Description of a new pigmentary demarcation line (Type I)
Clinical and Experimental Dermatology, EarlyView.
https://ift.tt/2IqfYPR
Enlarging plaque on the sole
Clinical and Experimental Dermatology, EarlyView.
https://ift.tt/2zDwARt
Bullous pemphigoid in a 3‐month‐old infant after vaccination
Clinical and Experimental Dermatology, EarlyView.
https://ift.tt/2IoBg0d
Neutrophilic dermatosis associated with an NFKB2 mutation
Clinical and Experimental Dermatology, EarlyView.
https://ift.tt/2zEyfpN
Cutaneous features of Zika virus infection: a clinicopathological overview
Clinical and Experimental Dermatology, EarlyView.
https://ift.tt/2ItmlC4
First reported case of dermatofibrosarcoma in siblings
Clinical and Experimental Dermatology, EarlyView.
https://ift.tt/2zEcx57
Description of a new pigmentary demarcation line (Type I)
Clinical and Experimental Dermatology, EarlyView.
https://ift.tt/2IqfYPR
A Retrospective Study to Assess the Role of Using Fine Needle Aspiration Cytology and Frozen Section in the Diagnosis of Thyroid Swelling
Abstract
The most cost-effective test is fine needle aspiration cytology (FNAC). Many surgeons use intraoperative frozen section to confirm the FNAC findings and to guide the extent of thyroid surgery. Though it is a valuable tool in the diagnosis of the thyroid lesion and determining the extent of thyroid surgery, still in certain cases diagnosis can be incorrect or inconclusive, so histopathology of the excised specimen remains the most reliable test. The purpose of this study will be to compare the result attained by FNAC and frozen section of the thyroid to the final histopathological diagnosis, in order to establish their role in thyroid surgery today. A retrospective study with a total of 140 patients who underwent thyroid surgery at the ENT department, of a tertiary hospital in coastal Karnataka. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were calculated for FNAC and frozen section. The sensitivity, specificity, positive predictive rate, and negative predictive rate of frozen section was found to be 66.7%, 88.4%,76.6%, 82.4% respectively for detecting malignancy. This was found to be higher than the results of FNAC for the same which were 64.4%, 77.8%, 64.4%, 77.8% respectively. As the sensitivity of FNAC is similar to frozen section in detecting malignant cases, FNAC is a good tool for screening the patient for determining malignancy in thyroid, but frozen section is more specific in confirming the malignancy.
https://ift.tt/2R7wDvk
Two Cases of Lingual Arteriovenous Malformations with Comorbidities Treated by Glue Embolization: A Report with Review of Literature
Abstract
Arteriovenous malformations (AVMs) involving the tongue are uncommon lesions in the head and neck region. They present with bleeding that can be massive and life-threatening apart from debilitating symptoms of pain, ulcers, difficulty in phonation or swallowing. Various therapeutic approaches have been used in their management—surgery, endovascular embolization, radiation and ablation procedures like laser ablation. We report two patients—a 34 year-old man and 56 year-old female who presented with massive bleeding due to lingual AVM and had comorbidities as liver cirrhosis and chronic medical renal disease respectively, and treated with glue embolization, with a review of the literature.
https://ift.tt/2OYHjv5
Long Term Oncological Results of Transoral Laser Microsurgery for Early and Moderately Advanced Glottic Carcinoma in Primary and Salvage Settings
Abstract
The aim of the study is to document the long term oncological results of trans-oral laser microsurgery (TLM) for early and moderately advanced glottic cancer in primary and salvage settings. In this prospective cohort study 43 consecutive patients of glottic cancer (T1–30, T2–7, and selected T3 with mobile cords-6) were recruited. TLM was performed in these 35 primary and 8 previously treated cases. In our series, the local disease control rate with TLM was 90% (27/30) for T1 disease, 71.4% (5/7) for T2 cancer and 66.6% (4/6) for T3 lesions. The overall disease control rates after subsequent treatment for locoregional recurrences were 100% (30/30), 85.7% (6/7) and 83.3% (5/6) for T1, T2, and T3 glottic cancers respectively. The 5-years disease free survival rate for primary cases was 100% and 50% for salvage cases. The 5-years local disease control rate was 96.4% and 41.67% in primary and salvage TLM settings respectively. The 5-years laryngectomy free rates were 96.3% and 18.75% for primary and salvage cases respectively. TLM offers a minimally invasive and oncologically robust treatment option for early glottic cancer with an overall disease free survival of 100% at 5 years noted for primary untreated cases in this experience. TLM for post radiation salvage cases has however been disappointing and alternate larynx preserving option of open partial laryngectomy needs to be considered in this setting.
https://ift.tt/2R7hDO9
Adenoma mimicking hyponatremia of SIAD
Hyponatremia is a common electrolyte disorder, with prevalence as high as 20% in inpatient settings. It is classified based on volume status, urine sodium and osmolality results. While this approach might help narrow down the differential diagnoses, it can leave other diagnoses unentertained. In this case, we report recurrent and refractory hyponatremia secondary to hypocortisolism due to non-functioning pituitary macroadenoma. Interestingly, urine studies mimicked syndrome of inappropriate antidiuresis, but exclusively responded to hydrocortisone replacement. Hospital course was also complicated by hyponatremia-induced rhabdomyolysis, which is a rare complication of severe hyponatremia. We also discuss the role of anchoring heuristics and how they influence the physician's decision leading to possible diagnostic errors. One way to minimise the effect of anchoring bias on physicians is their cognitive awareness of such bias. In addition, discussing complicated cases with all members of medical team can highlight the clinician's thought processes, share uncertainty and help broaden differential diagnoses.
https://ift.tt/2xKftfw
Pneumatosis cystoides intestinalis (PCI) in a patient with undiagnosed systemic sclerosis
Pneumatosis cystoides intestinalis (PCI) refers to the presence of gas within the wall of the small or large intestine. The pathophysiology is incompletely understood and is probably multifactorial in nature. PCI is a known but rare complication of systemic scleroderma, and the aetiology of PCI in patients with scleroderma is not fully understood. We present the case of a patient who was referred to gastroenterology clinic by her general practitioner for investigation of 8 months of weight loss, urgency, diarrhoea, bloating and crampy abdominal pain. Extensive investigations were performed to exclude infective, inflammatory or malignant aetiologies for these symptoms. She was diagnosed with PCI on her colonoscopy and was subsequently screened for secondary causes. Our patient was diagnosed with the limited cutaneous (CREST) variant of systemic scleroderma. This case report illustrates that PCI could be an uncommon presentation of systemic sclerosis, therefore clinicians should be aware of the association between these conditions.
https://ift.tt/2DDZfKb
Correction: Non-operative management, supported by self-monitoring using web-based patient reported outcome measures (PROMs), in knee osteoarthritis
Webb E, Parkes RJ, Gough AT, et al. Non-operative management, supported by self-monitoring using web-based patient reported outcome measures (PROMs), in knee osteoarthritis. BMJ Case Rep 2018. doi:10.1136/bcr-2017-223560.
This article was published with an error in the funding statement. The correct funding statement should read: 'the authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors'.
https://ift.tt/2xKCVJx
Perianeurysmal vasogenic oedema (PAVO) following aneurysm embolisation: a unique case of asymptomatic long-term progression and review of the literature
Perianeurysmal vasogenic oedema is a recognised although rare phenomenon following endovascular treatment of certain intracranial aneurysms. We present a unique case of asymptomatic perianeurysmal vasogenic oedema following bare platinum coil embolisation of an incidentally discovered right middle cerebral artery aneurysm that slowly increased over a period of 6 years before stabilising and regressing. During this time, the coiled aneurysm per se remained completely stable on serial magnetic resonance angiography.
https://ift.tt/2DGrjg1
Pneumopericardium due to bronchopericardial fistula in a patient with lung cancer
Description
Documented cases of pneumopericardium in patients with lung cancer are extremely rare.
We report the case of a 66-year-old man with a 45 pack-year smoking history and an Eastern Cooperative Oncology Group performance status 4. He presented with dyspnoea and chest pain in the last 2 hours. There were no signs of cardiac tamponade present.
CT angiography of the chest revealed a 78 mm right pulmonary mass containing small areas with gas density and a pneumopericardium of 28 mm in maximum thickness (figure 1). Transthoracic echocardiography showed the air gap sign, identified as the loss of signal during the systolic phase presented in patients with pneumopericardium. Bronchofibroscopy showed extensive infiltration and destruction of the carina bronchial wall and of the main bronchi by malignancy and endobronchial disease (figure 2). Endobronchial biopsies revealed an invasive squamous cell carcinoma.
Figure 1
CT angiography of the chest...
https://ift.tt/2xLV2yF
Unusual case of primary pulmonary Hodgkins lymphoma presenting with a continuous murmur
Systemic to pulmonary fistulas are an unusual entity, even more so in association with Hodgkin's lymphoma. We herein report a case of a 33-year-old woman that presented with an incidental lung lesion on a chest radiograph with an associated high-frequency continuous murmur over the lesion. The diagnosis of primary pulmonary Hodgkin's lymphoma, nodular sclerosis type, was obtained by a CT transthoracic biopsy. We achieved an excellent response after polychemotherapy with near-complete disappearance of the mass and a residual faint systolic murmur over the lesion.
https://ift.tt/2DHk4Er
Gardener-associated fibroma: an unusual cause of upper airway obstruction
We present the first case of upper airway obstruction secondary to a retropharyngeal Gardner-associated fibroma (GAF). A 16-month-old infant presented with a 3-month history of worsening dyspnoea and apnoeic episodes. Examination revealed stridor and left-sided retropharyngeal asymmetry. MRI demonstrated a mass in the retropharynx. Tracheostomy and pharyngeal biopsy under anaesthesia were performed, and histology confirmed a diagnosis of GAF. The mass was excised using a transcervical approach, and postoperative recovery was unremarkable. GAF is associated with Gardner's syndrome (GS) and familial adenomatous polyposis (FAP), both of which are associated with multiple colonic polyps and increased risk of colorectal malignancy. Subsequent testing for an APC mutation seen in GS and FAP was negative in our patient. The details of this unusual presentation of a rare disease are given in addition to a review of the literature.
https://ift.tt/2xKCQpd
Liver transplantation for inferior vena cava leiomyosarcoma: from a Maslows hammer to the Occams razor
Leiomyosarcoma (LMS) of primary vascular origin is a rare entity with only potentially curative option being complete surgical resection; despite which the prognosis remains dismal. Tumour recurrence is very common, and the benefits of adjuvant therapy are undefined. A 39-year-old woman presented with 6 months' history of abdominal pain, abdominal distension and pedal oedema. On evaluation, she was diagnosed to have chronic Budd-Chiari syndrome (BCS) secondary to a tumour arising from the inferior vena cava (IVC) on evaluation. Her liver decompensation included jaundice, gastrointestinal bleed and ascites. Following a detailed multidisciplinary team discussion, she underwent complete excision of the tumour along with a segment of the IVC with living donor liver transplantation. She remains disease-free 24 months following surgery. This is the first reported case of liver transplantation for IVC LMS causing chronic BCS.
https://ift.tt/2DCzrhC
Kiloh-Nevin syndrome associated with humeral shaft fracture
Fracture humerus may be associated with nerve injuries. However, among them median nerve is uncommonly involved and clinical affection of the anterior branch of median nerve is rare which can be easily missed and could be under-reported. A 42-year-old man presented with closed fracture of shaft of humerus right sided following fall. He had isolated weakness of flexor pollicis longus and flexor digitorum profundus of index finger without any other sensorimotor dysfunction. The findings were consistent with isolated palsy of anterior interosseous nerve (AIN). The patient was operated with fixation of humerus without exploring the AIN. At 6-month follow-up, the patient had complete recovery of both the muscles. This case highlights the classical clinical presentation of a rare injury associated with humerus fracture. Awareness and knowledge of this entity is of paramount importance for the practitioners.
https://ift.tt/2xKCKOn
Neuromyelitis optica with unilateral diaphragmatic paralysis
In this case report, we describe the course of a female patient who is known to have neuromyelitis optica (NMO) and developed left hemiparesis and unilateral diaphragmatic paralysis. She was initially treated with intravenous methylprednisolone 1 g daily for 5 days without improvement. Subsequently, she received five sessions of a plasmapheresis. Her hemiparesis had improved after few days. however, the phrenic nerve palsy remained.
https://ift.tt/2DNUuOm
Leptomeningeal dissemination of spinal pilocytic astrocytoma: a rare entity
Description
A currently 12-year-old boy presented at the age of 8 months with sleepiness, irritability and a tense fontanelle with upgaze palsy on a background of a 2-month history of vomiting, difficulty feeding and weight loss. Acute communicating hydrocephalus was diagnosed using ultrasonography and CT and treated with Ventriculo-Peritoneal shunt insertion. Further investigation with MRI (2006) found a thoracic intramedullary mass with further intracranial and spinal leptomeningeal dissemination (LD) (figures 1 and 2). A biopsy of the thoracic intramedullary mass showed pilocytic astrocytoma (PA) (figure 3).
Figure 1
Initial MRI whole spine (2006). (A) T2 sagittal, (B) T1 sagittal and (C) postcontrast T1 sagittal. Black arrows in (A) and (B) show upper thoracic intramedullary mass. The white arrow in (C) shows no significant enhancement. Thick white arrows in (C) show leptomeningeal enhancement.
Figure 2
Initial MRI brain...
https://ift.tt/2xKCDlV
Severe calcium pyrophosphate dihydrate deposition disease of the metacarpophalangeal joints
We report a case of calcium pyrophosphate deposition disease (CPPD) with an unusual presentation of severe chondrocalcinosis with atypical large burden deposited in the metacarpophalangeal joints as well as more typical deposition in wrists and knees as demonstrated on plain radiographs. A 77-year-old African-American woman 1-year status post parathyroidectomy for hyperparathyroidism initially presented to the rheumatology clinic to treat suspected rheumatoid arthritis given her pattern of joint involvement but was found to have CPPD. The patient's history is notable for end-stage renal disease which complicates medical management. This case illustrates radiographic findings of CPPD and explores the challenges of treating CPPD in the setting of comorbid conditions.
https://ift.tt/2DNUqhA
Quality of Life in Hand Eczema Questionnaire: Validation of the Japanese version of a disease‐specific measure of quality of life for hand eczema patients
The Journal of Dermatology, EarlyView.
https://ift.tt/2IrhfpN
Epidemiology and bone‐related comorbidities of ingrown nail: A nationwide population‐based study
The Journal of Dermatology, EarlyView.
https://ift.tt/2NRJBPW
Psoriasiform keratosis shows abnormal keratinization and increased number of T‐helper 17 cells in psoriasiform keratosis implying a pathogenic link to psoriasis
The Journal of Dermatology, EarlyView.
https://ift.tt/2IoCxED
Malassezia infections with systemic involvement: Figures and facts
The Journal of Dermatology, EarlyView.
https://ift.tt/2NMTluI
Familial or sporadic porokeratosis as an autoinflammatory keratinization disease
The Journal of Dermatology, EarlyView.
https://ift.tt/2IoCskj
Anterolateral leg alopecia: unknown entity or yet underreported?
International Journal of Dermatology, EarlyView.
https://ift.tt/2RbVXRd
Cervical lymphadenopathy from PRP treatment with microneedling therapy
Journal of Cosmetic Dermatology, EarlyView.
https://ift.tt/2zDZDo3
Should we provide anti‐HPV vaccination for patients with genital hidradenitis suppurativa?
British Journal of Dermatology, Volume 0, Issue ja, -Not available-.
https://ift.tt/2y02Ax7
Novel therapeutic approaches to xeroderma pigmentosum
British Journal of Dermatology, Volume 0, Issue ja, -Not available-.
https://ift.tt/2xKao6U
Cervical lymphadenopathy from PRP treatment with microneedling therapy
Journal of Cosmetic Dermatology, EarlyView.
https://ift.tt/2zDZDo3
Effect of high-flow high-volume-intermittent hemodiafiltration on metformin-associated lactic acidosis with circulatory failure: a case report
Metformin-associated lactic acidosis is a well-known life-threatening complication of metformin. We here report the case of a patient who developed metformin-associated lactic acidosis without organ manifestat...
https://ift.tt/2xYyH00
Should we provide anti‐HPV vaccination for patients with genital hidradenitis suppurativa?
British Journal of Dermatology, Volume 0, Issue ja, -Not available-.
https://ift.tt/2y02Ax7
Novel therapeutic approaches to xeroderma pigmentosum
British Journal of Dermatology, Volume 0, Issue ja, -Not available-.
https://ift.tt/2xKao6U
A randomized, single-blind, single-dose study to assess the pharmacokinetic equivalence of the biosimilar ABP 215 and bevacizumab in healthy Japanese male subjects
Abstract
Purpose
Analytic, pharmacokinetic (PK), and clinical similarity between the biosimilar ABP 215 and bevacizumab has previously been demonstrated in global studies. Here we present a phase 1 study in healthy adult Japanese men.
Methods
This study was a randomized, single-blind, single-dose, parallel-group study comparing PK parameters of ABP 215 versus EU-authorized bevacizumab in healthy Japanese men. Primary endpoints were maximum observed serum concentration (Cmax) and area under the serum concentration—time curve from time 0 to infinity (AUCinf). Secondary endpoints included AUC from time 0 to time of last quantifiable concentration (AUClast), safety, tolerability, and immunogenicity.
Results
Baseline characteristics were similar among study subjects (n = 24/group). After a 3-mg/kg intravenous infusion, the geometric means (GMs) of Cmax, AUCinf, and AUClast were 71.2 µg/mL, 25,259 µg h/mL, and 22,499.3 µg h/mL, respectively, for ABP 215 and 70.16 µg/mL, 25,801 µg h/mL, and 22,604.6 µg h/mL, respectively, for bevacizumab. The GM ratios (90% confidence interval; CI) for Cmax, AUCinf, and AUClast were 1.015 (0.946–1.088), 0.979 (0.914–1.049), and 0.995 (0.941–1.053) for ABP 215 versus bevacizumab. All CIs fell within the prespecified bioequivalence margin (0.80–1.25). Adverse events (AEs) occurred in 2/24 subjects receiving ABP 215 and 1/24 receiving bevacizumab. There were no deaths or AEs leading to study discontinuation; no subject was positive for binding anti-drug antibodies (ADAs).
Conclusions
ABP 215 and bevacizumab showed PK similarity in Japanese men. Safety profiles were comparable between the two groups. The pharmacokinetics in Japanese subjects were consistent with those in a previous global PK equivalence study.
https://ift.tt/2xOuKf2
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