作　　者： (蔡华丹）; (侯均）; (吕永宁）; (熊亮）; (路明忠）; (伍三兰）;

机构地区： 黄石市第二医院药剂科

出　　处： 《中华结核和呼吸杂志》 2017年第8期596-603,共8页

摘　　要： 目的 系统评价噻托溴铵喷雾剂治疗慢性阻塞性肺疾病（慢阻肺）的疗效和安全性.方法 以＂tiotropium respimat＂、＂tiotropium bromide spray＂、＂chronic obstructive pulmonary disease＂、＂COPD＂、＂randomized＂、＂controlled＂、＂randomly＂为英文检索词,＂噻托溴铵喷雾剂＂、＂慢阻肺＂、＂慢性阻塞性肺疾病＂、＂随机对照＂为中文检索词,分别检索Cochrane Library、PubMed、EMbase、中国知网、维普数据、中国生物医学文献数据库和万方数据,各数据库检索时间均从建库至2016年10月.按照 Cochrane 系统评价方法检索噻托溴铵喷雾剂治疗慢阻肺的所有随机对照试验（RCT）,2名研究者按照纳入排除标准进行数据提取和质量评价,采用RevMan 5.3软件进行统计分析. 结果 共纳入11个RCT研究,对文献进行不同指标分析：在改善患者FEV1水平方面,噻托溴铵喷雾剂组（5 μg/吸）优于安慰剂组[MD=0.12,95%CI（0.10~0.14）,P〈0.01].不同剂量噻托溴铵喷雾剂组均与粉吸入剂组疗效相似[5 μg： MD=0.00,95%CI（-0.04~0.04）,P=0.94;2.5 μg：MD=-0.04,95%CI（-0.10~0.01）,P=0.12;10 μg：MD=0.02,95%CI（-0.06~0.09）,P=0.66].在改善患者FVC水平方面,噻托溴铵喷雾剂组（5 μg/吸）优于安慰剂组[MD=0.18,95%CI（0.09~0.28）,P〈〈0.01].不同剂量噻托溴铵喷雾剂组与粉吸入剂组疗效相似[2.5 μg：MD=-0.06,95%CI（-0.16~0.04）,P=0.24;5 μg：MD=-0.00, 95%CI（-0.08~0.08）,P=1.00;10 μg：MD=0.02,95%CI（-0.14~0.19）,P=0.78].在急性加重风险方面,噻托溴铵喷雾剂组（5 μg/吸）发生急性加重的风险较安慰剂组低 [OR=0.72, 95%CI（0.60~0.86）,P〈0.01].噻托溴铵喷雾剂组（5 μg/吸）和粉吸入剂组发生急性加重风险相似[OR=1.01, 95%CI（0.94~1.09）,P=0.71].圣乔治呼吸问卷评分上,噻托溴铵喷雾剂组（5 μg/吸）优于安慰剂组[MD=-3.6, 95%CI（-3.88^-3.32）,P〈0.01].噻托溴铵喷雾剂组（5 μg/吸）和粉吸入剂组� Objective To evaluate the efficacy and safety of tiotropium Respimat in the treatment of chronic obstructive pulmonary disease （COPD） according to the Cochrane systematic evaluation.MethodsThe Cochrane Library, PubMed, EMbase, CNKI, VIP and CBM, Wanfang Data were searched（from the foundation date to Jan.2016） for the randomized controlled trials （RCTs） of tiotropium Respimat in the treatment of patients with COPD.Two reviewers independently retrieved the RCTs according to the inclusion and exclusion criteria,assessed the methodological quality of the included trials.and performed statistical analysis on the data using RevMan 5.3 software. Results Totally 11 RCTs on efficacy were finally included.The results of the combined analysis showed that FEV1 was significantly improved in the tiotropium Respimat group than that in the placebo group[MD=0.12,95%CI（0.10-0.14）,P〈0.000 01],while FEV1 was similar between the tiotropium Respimat group and the tiotropium HandiHaler group[5 μg： MD=0.00, 95%CI（-0.04-0.04）, P=0.94;2.5 μg： MD=-0.04, 95%CI（-0.10-0.01）, P=0.12;10 μg：MD=0.02, 95%CI（-0.06-0.09）, P=0.66].FVC was significantly improved in the tiotropium Respimat group than that in the placebo group[MD=0.18, 95%CI（0.09-0.28）, P=0.0002], while FVC was similar between the tiotropium Respimat group and the HandiHaler group[2.5 μg： MD=-0.06, 95%CI（-0.16-0.04）, P=0.24;5 μg： MD=-0.00, 95%CI（-0.08-0.08）, P=1.00;10 μg： MD=0.02, 95%CI（-0.14-0.19）, P=0.78].The risk of acute exacerbations was lower in the tiotropium Respimat group （5 μg / kg） than in the placebo group [OR=0.72, 95%CI（0.60-0.86）, P=0.000 3].It was similar in the tiotropium Respimat group （5 μg） and the HandiHaler group[OR=1.01, 95%CI（0.94-1.09）, P=0.71].The SGRQ total score of the tiotropium Respimat group （5 μg） was significantly different from that of the placebo group[MD=-3.6, 95%CI（-3.88——3.32）, P〈0.000 01].Cmax,ss and AUC0-6 h,ss were also similar between the tiotropium

关 键 词： 噻托溴铵 肺疾病 慢性阻塞性 系统评价 随机对照试验