Cai H D, Hou J, Lyu Y N, Xiong L, Lu M Z, Wu S L
Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.
Zhonghua Jie He He Hu Xi Za Zhi. 2017 Aug 12;40(8):596-603. doi: 10.3760/cma.j.issn.1001-0939.2017.08.011.
To evaluate the efficacy and safety of tiotropium Respimat in the treatment of chronic obstructive pulmonary disease (COPD) according to the Cochrane systematic evaluation. The 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. Totally 11 RCTs on efficacy were finally included.The results of the combined analysis showed that FEV(1) was significantly improved in the tiotropium Respimat group than that in the placebo group[=0.12, 95%(0.10-0.14), <0.000 01], while FEV(1) was similar between the tiotropium Respimat group and the tiotropium HandiHaler group[5 μg: =0.00, 95%(-0.04-0.04), =0.94; 2.5 μg: =-0.04, 95%(-0.10-0.01), =0.12; 10 μg: =0.02, 95%(-0.06-0.09), =0.66]. FVC was significantly improved in the tiotropium Respimat group than that in the placebo group[=0.18, 95%(0.09-0.28), =0.0002], while FVC was similar between the tiotropium Respimat group and the HandiHaler group[2.5 μg: =-0.06, 95%(-0.16-0.04), =0.24; 5 μg: =-0.00, 95%(-0.08-0.08), =1.00; 10 μg: =0.02, 95%(-0.14-0.19), =0.78]. The risk of acute exacerbations was lower in the tiotropium Respimat group (5 μg / kg) than in the placebo group [=0.72, 95%(0.60-0.86), =0.000 3]. It was similar in the tiotropium Respimat group (5 μg) and the HandiHaler group[=1.01, 95%(0.94-1.09), =0.71]. The SGRQ total score of the tiotropium Respimat group (5 μg) was significantly different from that of the placebo group[=-3.6, 95%(-3.88--3.32), <0.000 01]. C(max, ss) and AUC(0-6 h, ss) were also similar between the tiotropium Respimat group and the HandiHaler group[=0.2, 95%(-5.1-5.5), =0.94]; =-1.01, 95%(-11.78-9.77), =0.85]. Nine RCTs were included in the evaluation of the incident rates of adverse drug reactions(ADR). There was no significant difference between the tiotropium Respimat group HandiHaler group and the placebo group[=0.95, 95%(0.89-1.00), =0.05], [=1.07, 95%(1.00-1.16), =0.06]. The efficacy and safety of tiotropium Respimat was similar to tiotropium HandiHaler in the treatment of COPD. They can effectively improve the pulmonary function and clinical symptoms of patients. But the long-term efficacy and safety of tiotropium Respimat still need to be confirmed by higher quality and larger RCTs with long-term follow-up.
根据Cochrane系统评价评估噻托溴铵Respimat治疗慢性阻塞性肺疾病（COPD）的疗效和安全性。检索Cochrane图书馆、PubMed、EMbase、中国知网、维普资讯、中国生物医学文献数据库、万方数据（从建库至2016年1月）中噻托溴铵Respimat治疗COPD患者的随机对照试验（RCT）。两名评价员根据纳入和排除标准独立检索RCT，评估纳入试验的方法学质量，并使用RevMan 5.3软件对数据进行统计分析。最终共纳入11项关于疗效的RCT。合并分析结果显示，噻托溴铵Respimat组的第1秒用力呼气容积（FEV₁）较安慰剂组显著改善[平均差值（MD）=0.12，95%可信区间（CI）（0.10 - 0.14），P<0.000 01]，而噻托溴铵Respimat组与噻托溴铵HandiHaler组之间的FEV₁相似[5μg：MD =0.00，95%CI（-0.04 - 0.04），P =0.94；2.5μg：MD = -0.04，95%CI（-0.10 - 0.01），P =0.12；10μg：MD =0.02，95%CI（-0.06 - 0.09），P =0.66]。噻托溴铵Respimat组的用力肺活量（FVC）较安慰剂组显著改善[MD =0.18，95%CI（0.09 - 0.28），P =0.0002]，而噻托溴铵Respimat组与HandiHaler组之间的FVC相似[2.5μg：MD = -0.06，95%CI（-0.16 - 0.04），P =0.24；5μg：MD = -0.00，95%CI（-0.08 - 0.08），P =1.00；10μg：MD =0.02，95%CI（-0.14 - 0.19），P =0.78]。噻托溴铵Respimat组（5μg/kg）急性加重的风险低于安慰剂组[MD =0.72，95%CI（0.60 - 0.86），P =0.000 3]。噻托溴铵Respimat组（5μg）与HandiHaler组相似[MD =1.01，95%CI（0.94 - 1.09），P =0.71]。噻托溴铵Respimat组（5μg）的圣乔治呼吸问卷（SGRQ）总分与安慰剂组有显著差异[MD = -3.6，95%CI（-3.88 - -3.32），P<0.000 01]。噻托溴铵Respimat组与HandiHaler组之间的血药峰浓度（Cmax,ss）和0至6小时血药浓度时间曲线下面积（AUC(0 - 6 h,ss)）也相似[MD =0.2，95%CI（-5.1 - 5.5），P =0.94]；[MD = -1.01，95%CI（-11.78 - 9.77），P =0.85]。9项RCT纳入了药物不良反应（ADR）发生率的评价。噻托溴铵Respimat组、HandiHaler组与安慰剂组之间无显著差异[MD =0.95，95%CI（0.89 - 1.00），P =0.05]，[MD =1.07，95%CI（1.00 - 1.16），P =0.06]。噻托溴铵Respimat在治疗COPD方面的疗效和安全性与噻托溴铵HandiHaler相似。它们均可有效改善患者的肺功能和临床症状。但噻托溴铵Respimat的长期疗效和安全性仍需通过更高质量、更大规模且长期随访的RCT来证实。
