摘要
目的:系统评价噻托溴铵治疗慢性阻塞性肺疾病(COPD)的有效性和安全性,以为临床治疗提供循证参考。方法:计算机检索Pub Med、EMBase、Medline、Cochrane图书馆、中国期刊全文数据库、万方数据库和中文科技期刊数据库,收集噻托溴铵(试验组)对比安慰剂(对照组)治疗COPD的随机对照试验(RCT),提取资料并评价质量后,采用Rev Man 5.0统计软件进行分析。结果:共纳入19项RCT,合计16 318例患者。Meta分析结果显示,试验组患者第1秒用力呼气容积(FEV1)[MD=0.13,95%CI(0.12,0.14),P<0.001]、用力肺活量(FVC)[MD=0.20,95%CI(0.20,0.25),P<0.001]显著高于对照组,圣乔治呼吸问卷得分(SGRQ)[MD=-2.94,95%CI(-3.38,-2.49),P<0.001]和COPD急性加重率[RR=0.83,95%CI(0.77,0.90),P<0.001]显著低于对照组,口干发生率亦显著高于对照组[RR=2.07,95%CI(1.34,3.20),P<0.001],差异均有统计学意义。结论:噻托溴铵治疗COPD疗效较好,但易引起口干的不良反应。受纳入研究方法学的限制,该结论有待大样本、高质量的RCT进一步验证。
OBJECTIVE：To evaluate the efficacy and safety of tiotropium bromide in the treatment of COPD patients and provide evidence-based reference for the clinical treatment. METHODS：Pub Med,EMBase,Medline,Cochrane Library,CJFD,WanFang and VIP database were retrieved to collect the randomized controlled trial（RCT）of tiotropium bromide（test group）vs. placebo（control group）in the treatment of COPD. The data was extracted and the quality was evaluated by Rev Man 5.0 software. RESULTS：A total of 19 studies were included,involving 16 318 patients. Meta-analysis shows that the FEV1[MD=0.13,95% CI（0.12,0.14）,P〈0.001],FVC[MD=0.20,95%CI（0.20,0.25）,P〈0.001] in test group were higher than control group,SGRQ score[MD=-2.94,95%CI（-3.38,-2.49）,P〈0.001] and COPD exacerbation rate[RR=0.83,95%CI（0.77,0.90）,P〈0.001] in test group were lower than those in control group,but the dry mouth rate was higher than that of control group[RR=2.07,95%CI（1.34,3.20）,P〈0.001],there were significant differences in 2 groups. CONCLUSIONS：Tiotropium bromide has good efficacy in the treatment of COPD. However,it may cause dry mouth. Due to the methodological limitations of included studies,it remians to be further verified by large-sample and high-quality RCT.
出处
《中国药房》
CAS
北大核心
2015年第21期2947-2949,共3页
China Pharmacy
基金
国家科技支撑计划子课题(No.2013BAI06B04Y023054)
