文献类型：期刊文献

中文题名：基于文献的红花注射液安全性研究

英文题名：A Safety Study on Honghua Injection Based on Literature

作者：别磊[1];柴乃俊[1];常成[1];田金徽[2];顾静[3];汪小刚[1]

第一作者：别磊

机构：[1]兰州大学基础医学院,甘肃兰州730000;[2]兰州大学循证医学中心,甘肃兰州730000;[3]甘肃中医学院,甘肃兰州730000

第一机构：兰州大学基础医学院,甘肃兰州730000

年份：2014

卷号：21

期号：11

起止页码：37

中文期刊名：中国中医药信息杂志

外文期刊名：Chinese Journal of Information on Traditional Chinese Medicine

收录：CSTPCD;;CSCD:【CSCD_E2013_2014】；

语种：中文

中文关键词：红花注射液;系统评价;不良反应;心血管用药;中药注射剂

外文关键词：Honghua Injection;system evaluation;adverse reactions;cardiovascular drug;traditional Chinese medicine injection

摘要：目的采用上市后药物循证评价方法对红花注射液的安全性进行全面系统的评价,为临床合理应用红花注射液提供参考。方法计算机检索中国生物医学文献数据库、中国期刊全文数据库、万方数据库、中文科技期刊数据库等中文数据库,同时辅助其他检索,检索时间为2013年7月。纳入有关红花注射液的所有研究类型,对已发表的文献中报道的不良反应情况进行描述和统计分析。结果共纳入红花注射液相关研究69篇。文献报告的合计药物不良反应(ADR)病例为1111例,男性568例(51%),女性543例(49%)。36篇(52%)文献详细描述了红花注射液的ADR,33篇(48%)文献仅提及或未详细描述ADR。ADR主要为皮肤及其附件的损伤和循环系统的病变。原患疾病以循环系统病变为主。溶媒介质以及剂量基本符合其产品说明书中的要求。大多数ADR在首次用药后出现,出现时间5 min^5 d不等。结论现已发表文献数据表明红花注射液未发现有严重ADR的发生。
Objective To conduct a comprehensive evaluation on safety of Honghua Injection through adopting the method of the evidence-based method;To provide reference for clinical reasonable application of Honghua Injection. Methods Computers were used to retrieve some Chinese databases, such as China Biology Medicine, China National Knowledge Infrastructure, Wangfang Database and VIP database. At the same time, other search methods were employed, up to July 2013, including all research types about Honghua Injection. The adverse reactions in the reports of published literature were analyzed by description and statistical analysis. Results Sixty-nine researches on Honghua Injection were included. The total cases of adverse drug reaction （ADR） were 1111, among which male cases were 568 （51%）, and female cases were 543 （49%）. Thirty-six （52%） papers described ADR of Honghua Injection in detail, and thirty-three （48%） papers just mentioned ADR or did not describe ADR in detail. Skin, skin accessories damage and pathological changes in circulatory system were main contents of ADR. In terms of original diseases, diseases of circulatory system play an important role. Solvent medium was largely in line with its product specification requirements. Most ADR appeared when the drug was used for the first time, from 5 minutes to 5 days. Conclusion The current published literature data show that severe ADR does not happen after the intervention of Honghua Injection.