注射用益气复脉(冻干)不良反应文献研究与分析  

Literature-based study of adverse effects of Yi-Qi-Fu-Mai sterile powder

作　　者：马宁[1] 侯雅竹[2] 王贤良[2] 毛静远[2] 

机构地区：[1]天津中医药大学,天津300193 [2]天津中医药大学第一附属医院,天津300193

出　　处：《中国新药杂志》2015年第10期1197-1200,共4页Chinese Journal of New Drugs

基　　金："十二五"国家科技支撑计划课题(2013BAI02B02);教育部"创新团队发展计划"--中医药防治心血管疾病研究(IRT1276)

摘　　要：目的:研究注射用益气复脉(冻干)临床应用中不良反应的分布及影响因素,为注射用益气复脉(冻干)上市后再评价以及临床合理使用提供参考。方法:以"益气复脉"为检索词,检索中国期刊全文数据库(CNKI,2007-2014年6月)、中文科技期刊全文数据库(VIP,2007-2014年6月)、万方数据库(2007-2014年6月),中国生物医学文献数据库(CBM,2007-2014年6月),纳入注射用益气复脉(冻干)的临床研究文献,提取文献资料中不良反应的信息并进行描述性分析。结果:注射用益气复脉(冻干)主要不良反应表现在心血管系统占28.6%,神经系统占20.4%,皮肤及其附件占22.5%,消化系统占20.3%。临床症状表现轻微,大多能够痊愈,无严重不良事件报道。结论:在所研究的文献范畴内,注射用益气复脉(冻干)上市后未见与药物相关严重不良反应报道,可在临床应用和研究中进一步关注。Objective： To analyze the adverse effect distribution and influential factors of Yi-Qi-Fu-Mai ster- ile powder on clinical application, and provide a reference for post-marketing re-evaluation and rational administration of Yi-Qi-Fu-Mai sterile powder. Methods： China National knowledge Infrastructure （CNKI, 2007 -2014. 06）, Chinese Scientific Journals Database （VIP, 2007 -2014.06）, Chinese Biomedical Literature Database （CBM, 2007 -2014.06） , and Wanfang database （2007 -2014.06） were searched to collect the studies about clinical ap- plication of Yi-Qi-Fu-Mai sterile powder with the term ＂Yi-Qi-Fu-Mai＂. Then the information was extracted and analyzed. Results： The main adverse effects of Yi-Qi-Fu-Mai sterile powder were those on cardiovascular system （2g.6%）, nervous system （20.4%）, skin and its appendages （22.5%）, and alimentary system （20.3%）. The symptoms were generally mild and most of them could be recovered. No severe adverse effect was reported. Conclusion： No severe adverse effect of Yi-Qi-Fn-Mai sterile powder has been reported on post-marking clinical application, but should be monitored in the further studies.

关 键 词：注射用益气复脉(冻干) 不良反应 文献研究 

分 类 号：R969[医药卫生—药理学]