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1.
ABSTRACT
Introduction
Acne is a chronic, inflammatory, and immune mediated disease of pilosebaceous unit, highly prevalent in adolescents. It involves face, trunk, and back; may leave scars and affect quality of life. Early, effective, and safe treatment is the key for disease resolution. Oral isotretinoin is the unique treatment for cure or prolonged remission for moderate and severe acne, preventing psychosocial impact and scars. It inhibits sebaceous glands activity and has anti-inflammatory and immunoregulatory properties. 相似文献2.
药品上市后临床安全性研究应开展真实世界的多维度设计,充分考虑多种来源的数据、证据及证据的整合。论文以仙灵骨葆制剂的上市后临床安全性研究设计为例,报告了国家不良反应监测中心自发呈报系统数据、医院信息系统数据、文献数据的统计分析以及数据、分析结果和证据的整合,通过证据整合发现:仙灵骨葆制剂的一般ADR主要是胃肠系统损害,表现为恶心、呕吐、口干、便秘、腹泻等;严重ADR主要表现为肝胆系统损害,表现为肝功能异常、肝酶升高、肝细胞损害等;过敏反应有时候表现为一般ADR,有时候表现为严重ADR;肝功能异常具有性别差异,女性比例偏高;肝功能异常出现3~7 d和15 d及以2个发病高峰,提示可能存在不同的发病机制;恶心、呕吐和胃功能紊乱是仙灵骨葆制剂的ADR预警信号。论文进一步讨论了回顾性数据对于前瞻性研究设计的支撑,初步明确了安全性真实世界多维度研究设计中主要数据源的优势和不足,从安全性证据的角度分析了数据之间的互补性和相应研究的时序性。 相似文献
3.
Tomotaka Shingaki Kentaro Taki Momoha Koyanagi Soshi Nagaoka Kenichi Yoshizawa Norika Oki 《Current medical research and opinion》2020,36(6):947-958
AbstractObjective: To evaluate the long-term safety and effectiveness of biosimilar insulin glargine (GLY) in real-world clinical practice.Methods: This prospective, non-interventional, multicenter, observational, post-marketing safety study (PMSS) enrolled Japanese patients with type 1 or 2 diabetes mellitus (T1DM or T2DM) starting GLY therapy, and was required by Japanese Pharmaceutical Affairs Law mandating post-marketing safety surveillance to acquire safety and effectiveness data of biosimilar products. Data collected from the 12-month observation included patient characteristics, adverse events, and blood glucose control.Results: The study enrolled 141 patients with T1DM and 1104 patients with T2DM. Pre-study insulin was used by 94.1% of patients with T1DM and 75.0% with T2DM. 65.4% of patients with T1DM and 64.3% with T2DM switched from the reference product (GLY-switched), while 25.0% with T2DM were insulin-naive. Adverse events were reported by 5.7% and 8.5% in T1DM and T2DM, respectively. Similar incidences were reported in GLY-switched. Adverse events were reported by 10.7% in insulin-naive T2DM. Baseline mean hypoglycemic events/month were 1.8 and 0.1 in T1DM and T2DM, respectively: the mean change from baseline (CFB) was –1.2 (p?=?.066) and 0.0 (p?=?.915), respectively. Baseline mean HbA1c was 8.4% and 8.7% in T1DM and T2DM, respectively; the mean CFB was –0.5% (p?<?.001) and –0.9% (p?<?.001), respectively, and –1.5% (p?<?.001) in insulin-naive T2DM.Conclusions: This first long-term Japanese PMSS of GLY demonstrated adverse events, hypoglycemia, and glycemic control consistent with the known GLY profile for T1DM and T2DM patients, in routine clinical practice. 相似文献
4.
中药安全性问题已经成为社会关注的热点,中成药上市后临床安全性评价亟需开展。然而,关于如何开展相关研究,具体操作步骤尚无标准可循,故此,急需建立一种临床安全性评价研究模式和方法以指导实践。笔者根据课题组前期开展的一系列研究,提出在中成药上市后临床安全性评价工作中的几点看法,包括明确临床安全性评价的目的与内容,确定评价工作的流程,制定安全性评估项目清单,并提出三级风险分类控制,最终探索性的形成临床安全性评价研究模式。该评价模式根据前期研究基础,通过项目清单评估的方式对中成药目标品种进行风险分级,并分别针对不同风险级别的品种采取相应措施,目的是使药品从高风险级别降到低风险级别,最后进入五步骤循环无端的常态化风险管理,即广泛收集风险信号,通过数据挖掘等技术对风险进行识别,以过程质量控制进行风险评估,采取风险最小化措施的风险管理,再次应用于临床进行后效评估。希望该文提出的评价模式和方法能够为将来开展的研究提供参考。 相似文献
5.
《Vaccine》2020,38(40):6215-6223
BackgroundVaccination of pregnant women against hepatitis A virus (HAV) or hepatitis B virus (HBV) may benefit the mother and the fetus but is not routinely recommended. However, the risk associated with vaccination should be weighed against the risk of HAV or HBV infection. Data on safety profiles after hepatitis A, B or combined AB immunization during pregnancy are limited.MethodsWe searched the GSK Worldwide Safety Database for adverse events (AEs) following immunization of pregnant women with HAV (Havrix, GSK), HBV (Engerix-B, GSK) or the combined hepatitis AB (Twinrix, GSK) vaccine since market authorization through 31 January 2018, covering at least 25 years. AE reports (spontaneous, post-marketing surveillance and clinical trial cases) in the GSK Worldwide Safety Database were identified using a systematic search and were reviewed by clinicians to ascertain pregnancy status at time of vaccination and characterize adverse pregnancy outcomes, including pregnancy-related AEs and AEs in infants regardless of the causality assessment.ResultsOverall, 613, 700 and 363 pregnancies with exposure to Havrix, Engerix-B and Twinrix, respectively, were reported. Of these, 378, 339 and 194 were analyzed. The most frequently identified pregnancy outcomes were live infants (288, 223 and 151), spontaneous abortions (43, 57 and 26) and elective terminations (25, 24 and 9). A total of 19, 29 and 10 cases of congenital anomalies were reported. Of these, 17, 20 and 7 were major birth defects. The most commonly reported pregnancy-related AE and AE in infants were premature delivery (28) and jaundice (11), respectively. No maternal deaths were reported. Congenital anomalies were reported in all recorded infant deaths.ConclusionsThis review did not indicate any concerning pattern of adverse pregnancy outcomes following exposure to any of the 3 vaccines during pregnancy. 相似文献
6.
临床试验注册制度与循证医学 总被引:5,自引:3,他引:5
本文介绍了当前新药临床试验、院内制剂、上市后药物临床试验及其他类型临床试验的管理情况,世界卫生组织临床试验注册平台(WHO ICTRP)的结构和运作机制和全球临床试验注册制度建立概况,中国临床试验注册中心和中国临床试验注册与发表协作网及其运作机制;提出用循证医学基本哲学思想作为临床试验研究者的思想和行为准则,是临床试验真实性的内部保障系统。 相似文献
7.
结合国外药品上市后风险管理经验,浅析我国药品上市后风险管理工作中存在的不足,提出相关建议,为完善我国药品上市后风险管理工作提供参考。 相似文献
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10.
医疗器械不良事件监测-现状与展望 总被引:23,自引:0,他引:23
王兰明 《中国医疗器械杂志》2004,28(4):282-289
介绍医疗器械不良事件的基本概念,论述美国、欧盟、日本和有关国际组织关于医疗器械不良事件监测的管理规定,并回顾和展望我国在该领域的相关工作. 相似文献