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1.
Thomas Felix John B. Jordan Catherine Akers Bina Patel Daniela Drago 《Expert opinion on drug safety》2019,18(3):231-240
Introduction: Pharmacovigilance is essential to monitoring the safety profiles of authorized medicines. Compared with small-molecule drugs, biological drugs are more complex, more susceptible to structural variability due to manufacturing processes, and have the potential to induce immune-related reactions, underscoring the importance of safety monitoring for these products. Although highly similar to reference products, biosimilars are not expected to be structurally identical. For these reasons, proper reporting of potential adverse drug reactions (ADRs) using distinguishable names and batch numbers is essential for accurate tracing of all biological drugs. To address the need for robust pharmacovigilance, the European Parliament and Council of the European Union provided legislation regarding pharmacovigilance of biologics in 2010.
Areas covered: This narrative review examines the current state of pharmacovigilance for biologics in the European Union (EU) and discusses relevant information on pharmacovigilance of biosimilars, the current EU pharmacovigilance system, and areas that could be improved.
Expert opinion: Although steps have been taken to improve pharmacovigilance of biologics in the EU, several enhancements can still be made, including additional training for healthcare professionals on ADR reporting, the use of 2D barcodes that enhance traceability, and an open discussion of potentially missed opportunities in the pharmacovigilance of biosimilars. 相似文献
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Ragnhild B. Wijma Marloes Emous Merel van den Broek Anke Laskewitz Anneke C. Muller Kobold André P. van Beek 《Surgery for obesity and related diseases》2019,15(1):73-81
Background
Early dumping is a poorly defined and incompletely understood complication after Roux-en-Y gastric (RYGB).Objective
We performed a mixed-meal tolerance test in patients after RYGB to address the prevalence of early dumping and to gain further insight into its pathophysiology.Setting
The study was conducted in a regional hospital in the northern part of the Netherlands.Methods
From a random sample of patients who underwent primary RYGB between 2008 and 2011, 46 patients completed the mixed-meal tolerance test. The dumping severity score for early dumping was assessed every 30 minutes. A sum score at 30 or 60 minutes of ≥5 and an incremental score of ≥3 points were defined as indicating a high suspicion of early dumping. Blood samples were collected at baseline, every 10 minutes during the first half hour, and at 60 minutes after the start.Results
The prevalence of a high suspicion of early dumping was 26%. No differences were seen for absolute hematocrit value, inactive glucagon-like peptide-1, and vasoactive intestinal peptide between patients with or without early dumping. Patients at high suspicion of early dumping had higher levels of active glucagon-like peptide-1 and peptide YY.Conclusion
The prevalence of complaints at high suspicion of early dumping in a random population of patients after RYGB is 26% in response to a mixed-meal tolerance test. Postprandial increases in both glucagon-like peptide-1 and peptide YY are associated with symptoms of early dumping, suggesting gut L-cell overactivity in this syndrome. 相似文献8.
Angela J. Jacques-Tiura Deborah A. Ellis April Idalski Carcone Sylvie Naar Kathryn Brogan Hartlieb Elizabeth K. Towner Thomas N. Templin K.-L. Catherine Jen 《The Journal of adolescent health》2019,64(3):355-361
Objective
Successful weight loss interventions for African-Americans adolescents are lacking. Cognitive-behavioral interventions seek to develop weight loss skills (e.g., counting calories, goal setting, managing one's environment). Little is known about how well adolescents implement such skills in their daily lives. Study aims were to (1) examine weight loss skills utilization at midpoint and end of a 6-month cognitive-behavioral/motivational interviewing weight loss sequential multiple assignment randomized trial (SMART), and (2) determine if greater skill utilization predicted weight loss at treatment end and 3 months post-treatment.Method
One hundred and eighty six African-Americans adolescents with obesity and their caregiver were first randomly assigned to complete 3 months of cognitive-behavioral and motivational interviewing family-based weight loss treatment in their home or in the research office (Phase 1). Nonresponders (i.e., those who lost < 3% of initial weight, n?=?161) were rerandomized to 3 months of continued skills training (n?=?83) or contingency management (n?=?78) for Phase 2; responders were allocated to 3 months of relapse prevention (n?=?20). Adolescents’ frequency of weight loss skills utilization was assessed via questionnaire at treatment midpoint and end.Results
Higher treatment attendance was associated with better skill utilization. Higher skill utilization was associated with more weight loss at treatment end, whereas higher baseline confidence was associated with more weight loss at follow-up.Conclusions
This study indicates the importance of attending weight loss intervention sessions to develop and strengthen weight loss skills in African-American adolescents with obesity, and strengthening confidence to use such skills for continued weight loss. 相似文献9.
Paola Gilsanz Maria M. Corrada Claudia H. Kawas Elizabeth Rose Mayeda M. Maria Glymour Charles P. Quesenberry Catherine Lee Rachel A. Whitmer 《Alzheimer's & dementia》2019,15(4):497-505
Introduction
Little is known about dementia incidence in diverse populations of oldest-old, the age group with highest dementia incidence.Methods
Incident dementia diagnoses from 1/1/2010 to 9/30/2015 were abstracted from medical records for 2350 members of an integrated health care system in California (n = 1702 whites, n = 375 blacks, n = 105 Latinos, n = 168 Asians) aged ≥90 in 2010. We estimated race/ethnicity-specific age-adjusted dementia incidence rates and implemented Cox proportional hazards models and Fine and Gray competing risk of death models adjusted for demographics and comorbidities in midlife and late-life.Results
Dementia incidence rates (n = 771 cases) were lowest among Asians (89.9/1000 person-years), followed by whites (96.9/1000 person-years), Latinos (105.8/1000 person-years), and blacks (121.5/1000 person-years). Cox regression and competing risk models estimated 28% and 36% higher dementia risk for blacks versus whites adjusting for demographics and comorbidities.Discussion
Patterns of racial/ethnic disparities in dementia seen in younger older adults continue after the age of 90 years, though smaller in magnitude. 相似文献10.