血栓通(注射剂型)不良反应文献分析及其与兰州地区药物不良反应类比

Literature Analysis on Adverse Drug Reactions of Xueshuantong Injection and Analogous Analysis of Adverse Drug Reactions in Lanzhou Region

目的评价血栓通(注射剂型,以下简称"血栓通")不良反应(ADR)发生情况及其相关因素。方法计算机检索中国知识资源总库(CNKI)、中文科技期刊全文数据库(VIP)和中国生物医学文献数据库(CBM),检索日期2014年6月,按纳入与排除标准选择文献、提取资料,分析纳入研究血栓通的用药剂量、适应病证、给药途径、溶媒、疗程及ADR;并检索国家药品不良反应监测系统兰州地区(2004年9月-2014年9月)上报血栓通的ADR报告,分析案例并与文献分析结果进行类比。结果最终纳入文献66篇,共4686例(不包括对照组病例),发生ADR 778例,ADR类型包括皮肤及附件损害(402例)、全身性损害(221例)、胃肠系统损害(75例)等,均经治疗好转。兰州地区上报国家药品不良反应监测系统血栓通病例11例。结论血栓通在临床使用中ADR发生率较高,并有严重ADR事件发生。

Objective To review the occurrence and relevant factors of adverse drug reactions （ADR） of Xueshuantong Injection. Methods Articles and documents in CNKI, VIP, and CBM were searched in June 2014 according to incorporation and exclusion standard. The dose, indication, medicating path and method, solvent, as well as the duration of treatment course and adverse reaction of Xueshuantong Injection were analyzed. The national information system for monitoring ADR was searched to collect adverse reaction cases of Xueshuantong Injection （2004.9-2014.9） reported in Lanzhou region. Cases were analyzed and under analogy with literature results. Results Totally 66 articles involving 4686 patients were included （except for patients of control group）. Adverse reactions occurred in 767 patients, including skin damage （402 cases）, systemic damage （221 cases）, gastrointestinal system damage （75 cases）. All of these were relieved after treatment. There were 11 adverse reaction cases of Xueshuantong Injection fromLanzhou region reported in the national information system for monitoring ADR. Conclusion There is a high incidence of adverse reactions in the clinical application of Xueshuantong Injection and ratio of serious adverse events report.