喜炎平注射液不良反应的Meta分析  

The adverse reaction of Xiyanping injection: a systematic review and meta-analysis

作　　者：王青宇[1,2] 曹珍[1] 高钟丽 刘伟[1] 杜娟[1] 

机构地区：[1]郑州大学药学院,郑州450001 [2]沈阳药科大学工商管理学院,沈阳110016

出　　处：《中药药理与临床》2016年第4期141-147,共7页Pharmacology and Clinics of Chinese Materia Medica

摘　　要：目的:采用Meta分析的方法,对喜炎平注射液临床使用中不良反应的发生率进行研究,以评价其在临床应用中的安全性和疗效。方法:由2位研究者分别独立检索中国知网、万方数据库、维普数据库、Web of Knowledge、Pub Med、Elsevier Science Direct电子期刊等数据库(1950年1月至2016年4月)中与喜炎平注射液不良反应有关的临床研究文献。根据制定的纳入标准以及排除标准收集数据,提取信息并交叉核对筛选。用Rev Man5.3软件对筛选后数据进行Meta分析。结果:共有73篇文献共8485例患者纳入研究,喜炎平注射液组不良反应发生率(4.3%)低于对照组(8.9%)。喜炎平注射液组与对照组不良反应发生率的比值比OR值为0.46,95%CI[0.38,0.55],P<0.00001,结果呈显著性差异。在疗效的考察上,除热毒宁外,有效率均高于对照组。结论:喜炎平注射液的有效性和安全性相对较好,但临床使用中应密切注视其引发的严重过敏反应。不排除失访偏倚和发表偏倚对结果的影响。喜炎平注射液不良反应研究的文献质量有待进一步提高,确保是随机双盲临床对照研究。Objective： To systematically review the incidence rate of adverse drug reaction for xiyanping injection and assess the safety and effect ofthe drug using Meta analysis. Methods： Two researchers independently searched and screened literature from the databases as CNKI, Wan- fang, VIP, Web of Knowledge, PubMed and Elsevier science Direct electronic journals （between January, 1950 and April, 2016）. Ran- domized controlled trims （RCTs） related to Xiyanping injection according to the inclusion and exclusion criteria were included. Data was ex- tracted and crosschecked. RevMan 5.3 software was used to conduct recta-analysis for the rate of adverse reaction of Xiyanping injection. Re- suits： A total of 73 articles, 8485 patients complied with inclusion criteria were included in the study. The result of meta-analyses showed that the incidence rate of adverse reaction in Xiyanping injection group was 4.3%, which was significant lower than that of 8.9% in the con- trol group （OR = 0.46, 95% CI 0. 38to 0. 55, P 〈 0.00001 ）. And the significant differences were found between xiyanping injection group and the control group. The rate of effect on xiyanping injection group is higher than control group except for Reduning group. Conclusion： The safety and effect of Xiyanping injection was higher than that of the control group, but more attention should be paid to relating its sever anaphylactic reaction to ensure the rational use of drug. However,lost to follow-up bias and publication bias may exist in the research. More high-quality clinical randomized , double-blinded control studies were needed to assess the safety of Xiyanping injection.

关 键 词：喜炎平注射液 不良反应 META分析 

分 类 号：R286[医药卫生—中药学]