血塞通注射液不良反应的Meta分析  

Meta-analysis of adverse reaction induced by Xuesaitong Injection

作　　者：陈华英[1] 张立波[1] 金若敏[1] 

机构地区：[1]上海中医药大学药物安全评价研究中心,上海201203

出　　处：《中药药理与临床》2012年第2期163-168,共6页Pharmacology and Clinics of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项项目(2009ZX0902-002)

摘　　要：目的:根据临床研究文献,采用Meta分析法评价血塞通注射液临床应用的安全性。方法:计算机检索CNKI、VIP、万方数据库1995年至2011年期间发表的有关血塞通注射液的临床随机对照研究,采用RevMan5.1软件,对血塞通注射液的不良反应发生率进行Meta分析。同时对不同适应症(脑梗死、心绞痛、椎-基底动脉缺血)、不同剂量(100mg～300mg/d、400mg/d、500mg～600mg/d)、不同对照措施(常规治疗、其它药物)的不良反应发生率进行亚组分析。结果:符合标准的36篇文献纳入研究。Meta分析结果显示,血塞通注射液组的不良反应发生率[OR=1.88,95%CI(1.34,2.65),P<0.01]明显高于对照组。在脑梗死亚组[OR=1.76,95%CI(1.13,2.72),P<0.05]、心绞痛亚组[OR=2.50,95%CI(1.19,5.25),P<0.05]、500mg～600mg/d亚组[OR=3.44,95%CI(1.52,7.81),P<0.01]、其它药物亚组[OR=1.88,95%CI(1.34,2.65),P<0.01]中,血塞通注射液组的不良反应发生率均明显高于对照组。而在椎-基底动脉缺血亚组[OR=2.92,95%CI(0.77,11.04),P=0.88]、100mg～300mg/d亚组[OR=3.02,95%CI(0.96,9.52),P=0.06]、400mg/d亚组[OR=1.48,95%CI(0.99,2.22),P=0.06]、常规治疗亚组[OR=1.91,95%CI(0.96,4.23),P=0.11]中,治疗组和对照组不良反应发生率的差异无统计学意义。结论:血塞通注射液的安全性低于对照组,临床应用时需加以关注,但血塞通注射液的安全性尚需要更多高质量的临床随机对照研究进行证实。To assess the safety of Xuesaitong injection in clinical practice by applying Meta analysis on the basis of available statistic data of clinical research. Methods： Such databases as CNKI, VIP and Wanfang were searched for randomized controlled trials（RCTs） relat- ed to Xuesaitong injection, which were published officially between 1995 and 2011. RevMan 5.1 software was used to conduct meta-analysis for the rate of adverse reaction of Xuesaitong injection. Meanwhile, subgroup analysis was conducted to the safety of different indications（ cer- abral infarction, anginal and ventebro basilar ischemia）, doses （100mg-300mg/d, 400mg/d and 500mg-600mg/d） and control measures （conventional treatment and other medicine）. Results： A total of 36 articles complied with inclusion criteria were included in the study. The result of meta-analyses showed that the rate of adverse reaction in Xuesaitong injection group was significant higher than that in the control group（ OR = 1.88,95% CI 1.34 to 2.65 ,P 〈 0.01 ）. The rate of adverse reaction in Xuesaitong injection group in the cerabral infarction sub- group （ OR = 1.76,95% CI 1.13 to 2.72, P 〈 0.05 ）, the anginal subgroup （ OR = 2.50,95% CI 1.19 to 5.25, P 〈 0.05 ）, the 500mg- 600mg/d subgroup （ OR = 3.44,95% CI 1.52 to 7.81, P 〈 0.01 ） and the other medicine subgroup （ OR = I. 88,95% CI 1.34 to 2.65, P 〈 0.01 ） were also significant higher than that in the control group. Whereas, no significant differences were found between Xuesaitong injection group and the control group in the vertebrobasilar ischemia subgroup （ OR = 2.92,95% CI 0.77 to 11.04, P = 0.88）, 100mg-300mg/d sub- group （ OR = 3.02,95 % CI 0.96 to 9.52, P = 0.06）, 400mg/d subgroup （ OR = 1.48,95 % CI 0.99 to 2.22, P = 0.06 ） and the conventional treatment subgroup（ OR = 1.91,95% CI 0.96 to 4.23, P = 0.11 ）. Conclusion： The safety of Xuesaitong injection was lower than that of the control group, which needed to be paid attention to in clinical applicat

关 键 词：血塞通注射液 不良反应 META分析 亚组分析 

分 类 号：R286[医药卫生—中药学]