中国中西医结合杂志2017，Vol.37Issue(3)：283-290,8.DOI:10.7661/CJIM.2017.03.0283
舒血宁注射液治疗心血管疾病安全性的系统评价
A Systematic Review on Safety Evaluation of Treating Cardiovascular Diseases by Shuxuening Injection
摘要
Abstract
Objective To systematically evaluate the safety of Shuxuening Injection (SI) for treating cardiovascular disease in line with indications.Methods Ten databases such as Cochrane Library,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 systematic 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 reactions (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 gastrointestinal 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 between 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.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Key words
Shuxuening Injection/cardiovascular disease/safety/adverse reaction/event/systematic review引用本文复制引用
陈红玉,谢雁鸣,廖星,陈媛媛..舒血宁注射液治疗心血管疾病安全性的系统评价[J].中国中西医结合杂志,2017,37(3):283-290,8.基金项目
国家“重大新药创制”科技重大专项(No.2009ZX09502-030) （No.2009ZX09502-030）
2014年第七批博士后特别资助项目(No.2014T70202) （No.2014T70202）
中央级公益性科研院所基本业务费项目(No.Z0406) （No.Z0406）
北京中医药科技资金发展项目(No.JJ2016-79) （No.JJ2016-79）
