摘要
目的:了解喜炎平注射液上市后研究中不良反应(ADR)发生水平及分布特征。方法:以"喜炎平"或"Xiyanping"为检索词,检索Cochrane图书馆、Medline、EMbase、Sino Med、CNKI、VIP和Wan Fang Data,由两位研究者独立筛选和提取资料,分析采用Stata 14.0软件。结果:共纳入1 587项研究,其中随机对照试验、队列研究和无对照随访研究分别占90.2%,6.8%和3.0%。共涉及1 778个喜炎平注射液用药组,其中823组报告了ADR发生信息(46.3%),共涉及患者62 464例,报道ADR 1 244例,整体发生率为1.8%(95%可信区间:1.7%~2.1%)。前三位构成为消化系统损害(40.7%)、皮肤及附件损害(23.6%)和用药部位疼痛(8.4%),但涉及药品及对应处理的报告比例较低(低于30%)。Meta回归调整协变量后,无对照随访研究、≤1岁年龄组的ADR发生率相对较低,而每日用药≥2次时、疗程≥1周时、合并抗菌药用药或其他中成药用药时,发生率相对较高。结论:鉴于用药频率越高、服药时间越长、合并用药时,ADR发生率相对较高,建议尽量避免过于频繁或长期使用喜炎平注射液,并谨慎联合用药。同时,建议充分利用医疗大数据开展更多关于儿童的足够规模的主动监测。此外,现有文献质量堪忧的问题,也急需研究者、企业、期刊和政府充分重视,各司其职营造高质量证据诞生的必要氛围。
Objective： To understand the current level and characteristics of adverse drug reaction in Post-marketing study of Xiyanping injection. Methods： The Cochrane library,Medline and Embase with four Chinese databases including Sino Med,CNKI,VIP and Wan Fang Data were systematically seolrched,with the keywords ＂Xiyanping＂. The relevant information was extracted by two researchers independently and the data were analyzed using Stata 14. 0. Results： A total of 1 587 studies were included,90. 2% of which were claimed as randomized controlled trial. There were 1 778 patient groups medicated with Xiyanping injection,46. 3% of which reported information about adverse drug reaction. About1 244 patients with adverse drug reaction were extracted from above studies,which concluded with digestive system damage（ 40. 7%）,skin and its accessories damage（ 23. 6%）,pain at the application site（ 8. 4%）. However,little information was reported about the related drugs and treatment measures. The overall incidence rate of adverse drug reaction for Xiyanping injection was 1. 8%（ 95% confidence interval： 1. 7%-2. 1%） based on a total of 62 464 patients. After Meta regression,the incidence rates for the follow-up studies without control group and for the infants aged less than one year-old were significantly lower,whereas the incidence rates for the patients medicated with Xiyanping injection at least twice a day or at least seven days and for patients treated together with anti-biotics or other Chinese patent drugs were significantly higher.Conclusion： Given that it might increase the risk of adverse drug reaction while using Xiyanping injection with higher frequency,longer duration,or together with other medications,we suggested that the clinicians should try their best to avoid above conditions. Meanwhile,it＇s highly recommended to make the best use of electronic health records to conduct more big scale active surveillance targeted for children. In addition,the issue of poor quality for the Post-marketing s
作者
陈茹
卓琳
潘昱廷
蔡婷
曹宇
王胜锋
Chen Ru1 , Zhuo Lin2, Pan Yuting2, Cai Ting2, Cao Yu2, Wang Shengfeng2(1. National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China; 2. Department of Epidemiology, School of Public Health, Peking University Health Science Cente)
出处
《药物流行病学杂志》
CAS
2018年第5期317-323,共7页
Chinese Journal of Pharmacoepidemiology
关键词
喜炎平注射液
药品不良反应
上市后再研究
分布特征
Xiyanping Injection
Adverse drug reaction
Post-marketing study
Distribution feature
