[Efficacy and safety of tiotropium Respimat in the treatment of chronic obstructive pulmonary disease: systematic review].

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. Methods: 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. Results: 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[ MD =0.12, 95% CI (0.10-0.14), P <0.000 01], while FEV(1) 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]. C(max, ss) and AUC(0-6 h, ss) were also similar between the tiotropium Respimat group and the HandiHaler group[ MD =0.2, 95% CI (-5.1-5.5), P =0.94]; MD =-1.01, 95% CI (-11.78-9.77), P =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[ RR =0.95, 95% CI (0.89-1.00), P =0.05], [ OR =1.07, 95% CI (1.00-1.16), P =0.06]. Conclusions: 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.