大株红景天注射液的安全性系统评价  

Systematic review on safety of sofren injection

作　　者：阙翼 谢雁鸣[1] 廖星[1] 章轶立[1] 

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]中国中医科学院中医基础理论研究所,北京100700

出　　处：《中国中药杂志》2016年第20期3866-3874,共9页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(81202776);国家"重大新药创制"科技重大专项(2015ZX09501004-001-002);中央级公益性科研院所基本业务费项目(Z0406);2014年第七批博士后特别项目(2014T70202)

摘　　要：该研究旨在系统评价大株红景天注射液的用药安全性。通过检索国内外7个数据库,由2位研究者按纳入和排除标准提取文献,并按照国际公认的方法学评价标准和报告标准评价文献质量和提取信息。最终纳入研究63篇,包括随机对照研究58篇、非随机对照研究3篇、病例报告研究2篇,共涉及5 872例患者。试验组发生不良反应23例,占纳入研究人群的0.39%。出现较多的不良反应是头痛、心悸、头晕,分别是6,4,4例,其中头疼出现的例数最多。不良反应主要涉及神经系统、心血管系统、消化系统等。该研究尚未发现大株红景天注射液严重的不良事件,但仍需在临床应用中谨慎。且由于该研究是基于既往研究的二次分析,因此仍需加强其长时期的安全性监测,同时规范其临床使用。This systematic review aims to evaluate the drug safety of sofren injection in clinical studies. Seven databases were retrieved,and the articles were extracted by 2 researchers according to inclusion and exclusion criteria. Then the quality of all studies and extracted information was evaluated. Sixty three articles were finally included in our study,including 58 randomized controlled trials,3 non randomized controlled trials,and 2 case reports. All studies included 5 872 patients. Intervention group had a total of 23 cases of adverse drug reaction（ ADR）,accounting for 0. 39% of the total number of patients. ADRs mainly included headache（ 6 cases）,palpitations（ 4 cases） and dizziness（ 4 cases）. ADRs mainly occurred in the nervous system,cardiovascular system,digestive system and so on. Serious adverse events about sofren injection have not been found in the study,but it is still needed to be cautious in clinical applications. As the current systematic review is based on the previous studies,it is necessary to strengthen the safety monitoring in a long period,and regulate its clinical use as well.

关 键 词：大株红景天注射液 安全性评价 系统综述 中药注射剂 

分 类 号：R286[医药卫生—中药学]