噻托溴铵治疗重度持续哮喘疗效及安全性Meta分析

Efficacy and Safety of Tiotropium in the Treatment of Severe Persistent Asthma: Meta-analysis

目的对噻托溴铵治疗重度持续哮喘的疗效及安全性进行系统评价与分析。方法计算机检索Cochrane Library、Clinical Trials.gov、Pub Med、Ovid Medline、中国期刊全文数据库（CNKI）、维普中文科技期刊全文数据（CSJD）,检索时间为1946年1月至2015年2月,查找关于噻托溴铵治疗重度持续哮喘的随机对照试验（RCT）;对于符合纳入标准、排除标准的RCT进行资料提取及质量评价;采用Revman5.3软件对纳入文献行进Meta分析。结果共纳入5项RCTs共计1433名患者,结果显示,与安慰剂组相比,噻托溴铵组第1秒用力呼气容积（FEV1）峰值[加权均数差（WMD）：0.13L,95%置信区间（CI）：0.10-0.16 L,P〈0.00001]、FEV1谷值（WMD：0.09 L,95%CI：0.06-0.12 L,P〈0.00001]、用力肺活量（FVC）峰值（WMD：0.10 L,95%CI：0.06-0.14 L,P〈0.00001）、FVC谷值（WMD：0.12 L,95%CI：0.08-0.17 L,P〈0.00001）、晨起呼气峰值流速（PEF）（WMD：9.21 L/min,95%CI：4.2-14.23 L/min,P=0.0003）、夜间PEF（WMD：22.06 L/min,95%CI：13.05-31.08 L/min,P〈0.00001）等均有显著改善;哮喘控制问卷评分（WMD：0.01,95%CI：-0.07-0.09,P=0.86）及哮喘生活质量问卷调查评分（WMD：0.06,95%CI：-0.18-0.06,P=0.33）未见统计学差异;噻托溴铵组与安慰剂组不良反应发生率未见统计学差异（P〉0.05）。结论噻托溴铵可改善重度持续哮喘患者的FEV1、FVC和PEF,但对于生活质量无明显改善作用,服用耐受性良好,可在糖皮质激素和长效β2受体激动剂基础上使用。

Objective To evaluate the efficacy and safety of tiotropium in treatment of severe persistent asthma. Methods Reports of randomized controlled trials（ RCTs） describing tiotropium for treatment of severe persistent asthma published from January 1946 to February 2015 were searched in Cochrane Library,Clinical Trials. gov,Pub Med,Ovid Medline,CNKI,and CSJD. The data of the included RCTs were extracted and the data quality was evaluated. Meta-analyses were performed with Revman 5. 3 software. Results Five RCTs including 1433 patients were analyzed. Meta-analysis of the data showed that compared with the placebo group,tiotropium treatment significantly improved the patients＇ peak forced expiratory volume in one second（ FEV1）[weighted mean difference（ WMD） ： 0. 13 L,95% confidence interval（ CI） ： 0. 10-0. 16 L,P〈0. 00001],trough FEV1（ WMD： 0. 09 L,95% CI： 0. 06-0. 12 L,P〈0. 00001）,peak forced vital capacity（ FVC）（ WMD： 0. 10 L,95% CI： 0. 06-0. 14 L,P〈0. 00001）,trough FVC（ WMD： 0. 12 L,95% CI： 0. 08-0. 17 L,P〈0. 00001）,morning peak expiratory flow（ PEF）（ WMD： 9. 21 L / min,95% CI： 4. 2-14. 23 L / min,P =0. 0003）,evening PEF（ WMD： 22. 06 L / min,95% CI 13. 05-31. 08 L / min,P〈0. 00001）. The scores of asthma control questionnaire（ ACQ）（ WMD： 0. 01,95% CI：- 0. 07-0. 09,P = 0. 86） or asthma quality of life questionnaire（ AQLQ）（ WMD： 0. 06,95% CI：- 0. 18-0. 06,P = 0. 33） were not affected by tiotropium. No significant difference with adverse events between tiotropium group and placebo group were reported in these included studies（ P〉0. 05）. Conclusions Tiotropium for severe persistent asthma treatment can improve FEV1,FVC,and PEF but may not improve the quality of life of the patients. Tiotropium is well tolerated and can be an add-on therapy for severe persistent asthma.