注射用灯盏花素临床不良反应的Meta分析

目的:采用Meta分析法对注射用灯盏花素的不良反应进行回顾性分析,以评价其临床应用的安全性。方法:检索CNKI、VIP、万方数据库1995年1月至2015年12月期间发表的有关注射用灯盏花素静脉给药的临床随机对照研究文献,采用Rev Man 5.3软件对其不良反应发生率进行Meta分析。同时对不同适应证、不同剂量、不同疗程、联合用药情况、使用年限等方面的不良反应发生率进行亚组分析。结果:符合标准的33篇文献纳入研究。Meta分析结果显示,注射用灯盏花素组的不良反应发生率与对照组比较无明显差异[OR=1.17,95%CI(0.83,1.64),P=0.37]。亚组分析显示,在不同适应证、不同剂量、联合用药情况、不同使用年份等相关亚组中,治疗组不良反应发生率与对照组比较均无显著性差异(P0.05);不同疗程亚组中,10 d疗程中治疗组的不良反应发生率明显低于对照组(P=0.03),14~15 d疗程治疗组的不良反应发生率高于对照组(P=0.01)。结论:注射用灯盏花素临床不良反应发生率与对照用药比较无明显差异,用药时间控制在15 d内表现出较好的安全性。

Meta-analysis of Clinical Adverse Reactions Induced by Breviscapine Injection

  Objective:To conduct retrospective analysis for the adverse reactions of Breviscapine Injection by Meta-analysis, in an attempt to evaluate its safety in clinical application.   Methods: Databases, including CNKI, VIP and Wanfang, were retrieved for randomized controlled trials related to the administration of Breviscapine Injection, which were published between 1995 and 2015. Data was screened according to inclusion and exclusion criteria and RevMan 5.3 software was used to conduct Meta-analysis for the rate of adverse reaction of Breviscapine injection. Meanwhile, subgroup analysis was conducted for the rate of adverse reaction of different indications, different doses of Breviscapine, different courses, drug combination and publish years.   Results: A total of 33 articles were included in this study. The results of Meta-analysis showed that there were no significant differences on the rate of adverse reactions between the Breviscapine Injection group and the control group . Subgroup analysis showed no significant differences on the rate of adverse reactions between two groups in subgroups with different indications, subgroups with different doses, subgroups with or without drug combination, subgroups with different year published (P>0.05). Among subgroups with different courses, the rate of adverse reactions in 10-day treatment group was significantly lower than that of the control group(P=0.03); the rate of adverse reactions in 14~15-day treatment group was significantly higher than that of the control group(P=0.01).   Conclusion: There were no significant differences on the adverse reactions of Breviscapine Injection compared with counterpart medications, especially within 15 days.