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基于文献的喜炎平注射液不良反应分布特征探索

Features of Adverse Drug Reaction in Post marketing Study about Xiyanping Injection Based on Literature

DOI：

中文关键词: 喜炎平注射液药品不良反应上市后再研究分布特征

英文关键词:Xiyanping Injection Adverse drug reaction Post marketing study Distribution feature

基金项目:

作者	单位
陈茹¹ 卓琳²潘昱廷²蔡婷²曹宇²王胜锋²	1.国家癌症中心/中国医学科学院北京协和医学院肿瘤医院北京100021；2.北京大学公共卫生学院流行病与卫生统计学系

摘要点击次数: 1908

全文下载次数: 1244

中文摘要:

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、SinoMed、CNKI、VIP和WanFang 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。

英文摘要:

ABSTRACT 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 SinoMed, CNKI, VIP and WanFang 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. About 1 244 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 studies of Xiyanping injection should receive adequate attention from the related researchers, industry, periodical association, and government, whom are responsible for creating a positive atmosphere for high quality studies.

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