摘要
目的系统评价舒血宁注射液治疗符合适应症的心血管疾病的安全性。方法 2015年10月通过计算机检索Cochrane图书馆、Medline、EMBase、Web of Science、Clinical Trials、中国生物医学文献数据库(CBM)、中国知网(CNKI)、维普(VIP)、万方数据库和中国临床试验注册中心数据库,收集关于应用舒血宁注射液治疗心血管疾病用药安全性的所有研究类型文献。根据纳入、排除标准筛选并提取资料。所纳入研究包括随机对照试验、非随机对照试验、观察性研究(病例对照、队列研究、病例系列、病例报告等),分别采用Cochrane系统评价员手册5.1.0偏倚风险评估工具、TREND非随机对照研究报告规范、SUMARI进行方法学质量评价。结果共纳入185篇文献,其中随机对照试验155篇,非随机对照试验6篇,病例系列11篇,病例报告13篇。纳入13篇病例报告中,出现不良反应15例。在155篇RCT研究中,使用舒血宁注射液患者共8 553例,出现不良反应162例,4例发生不良事件;不良反应结局主要是对胃肠系统、中枢及外周神经系统、皮肤及其附件损害等,损害程度多为轻度;不能明确舒血宁注射液不良反应发生与用药剂量、方式、溶媒、联合用药的关系。结论舒血宁注射液治疗心血管疾病总体安全性可接受,现虽系统分析了关于舒血宁注射液安全性病例报告的直接证据,但缺少针对该药安全性的机理研究或临床观察性研究。
Objective To systematically evaluate the safety of Shuxuening Injection （SI） for treating cardiovascular disease in line with indications. Methods Ten databases such as Cochrane Li- brary, Medline, EMBase, Web of Science, Clinical Trials, CBM, CNKI, VIP, Wangfang Data, and Chinese Clinical Trial Registry Database were retrieved in October 2015 for collecting literatures on use of SI. Data were screened by inclusion and exclusion criteria. Literatures retrieved included randomized controlled trials, non-randomized controlled trials, observational research （case control, cohort studies, case series, case reports, and so on）, and were methodologically evaluated by Cochrane Systematic Risk of Bias Manual, TREND, and SUMARI. Results A total of 185 literatures were retrieved in this sys- tematic review. Of them, 155 randomized controlled trials （RCT）, 6 non-randomized controlled trials, 11 case series, and 13 case reports were finally identified. Among the 13 case reports, adverse drug reac- tions （ADRs） occurred in 15 cases. Of the 155 RCT studies, Xl was used in 8 553 patients, with ADRs in 162 cases and adverse events （AEs） in 4 cases. The outcomes of ADRs mainly covered the gastrointes- tinal system damage, central/peripheral nervous system damage, skin and appendages injury, and so on. The degree of damage was mostly mild. It is difficult to get a clear judgment on the relationship be-tween the occurrence of these ADRs and drug dosage, drug administration, drug solvents, and combination medications. Conclusions The general safety of using Xl for treating cardiovascular diseases was acceptable in this systematic review. Although Xl was systematically analyzed to be safely used in case reports, mechanism studies or large sample observational studies are lack.
作者
陈红玉
谢雁鸣
廖星
陈媛媛
CHEN Hong-yu XIE Yan-ming LIAO Xing CHEN Yuan-yuan(Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing （100700 In- formation Center, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing （100102 Department of Radiology, Guang＇anmen Hospital, China Academy of Chinese Medical Sciences, Beijing （100053)
出处
《中国中西医结合杂志》
CAS
CSCD
北大核心
2017年第3期283-290,共8页
Chinese Journal of Integrated Traditional and Western Medicine
基金
国家"重大新药创制"科技重大专项(No.2009ZX09502-030)
2014年第七批博士后特别资助项目(No.2014T70202)
中央级公益性科研院所基本业务费项目(No.Z0406)
北京中医药科技资金发展项目(No.JJ2016-79)
关键词
舒血宁注射液
心血管疾病
安全性
不良反应/事件
系统评价
Shuxuening Injection
cardiovascular disease
safety
adverse reaction/event
sys- tematic review
