Department of Respiratory Diseases, Tongji Hospital, Key Lab of Pulmonary Diseases of Health Ministry, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Respirology. 2011 Feb;16(2):350-8. doi: 10.1111/j.1440-1843.2010.01912.x.
It is not clear whether combination therapy with tiotropium plus formoterol has greater efficacy, without increasing the burden of adverse events, compared with tiotropium alone. This meta-analysis was performed to evaluate the differences in efficacy and adverse events associated with combination therapy compared with tiotropium alone, in patients with stable COPD.
MEDLINE, EMBASE, CINAHL and the Cochrane trials database were searched for this analysis. Randomized controlled trials of 2 or more weeks of treatment with tiotropium plus formoterol or arformoterol, compared with tiotropium alone, were reviewed. Studies were pooled to yield odds ratio (OR) or weighted mean differences (WMD), with 95% confidence interval (CI).
Eight trials, involving 1868 randomized patients, met the inclusion criteria. Treatment with tiotropium plus formoterol significantly improved the average FEV(1) (WMD 105 mL, 95% CI: 69-142), average FVC (WMD 135 mL, 95% CI: 96-174) and trough FEV(1) (WMD 53 mL, 95% CI: 30-76), compared with tiotropium alone, although the difference was not statistically significant for trough FVC. The mean change in transitional dyspnoea index (TDI) was markedly greater with tiotropium plus formoterol (WMD 1.50, 95% CI: 1.01-1.99) than with tiotropium alone, and there was a similar difference in the proportion of patients with a clinically significant change in TDI (OR 2.34, 95% CI: 1.58-3.46). There tended to be fewer adverse events and COPD exacerbations with tiotropium plus formoterol, compared with tiotropium alone, but the differences were not statistically significant.
Tiotropium plus formoterol significantly improved lung function and symptom scores compared with tiotropium alone. There was a trend towards a reduction in adverse events, although the difference was not statistically significant. Long-term trials are necessary to evaluate the effects of tiotropium plus formoterol and to clarify the role of combination therapy, compared with tiotropium alone.
噻托溴铵联合福莫特罗治疗与单独使用噻托溴铵相比，在不增加不良反应负担的情况下，是否具有更好的疗效尚不清楚。本荟萃分析旨在评估噻托溴铵联合福莫特罗或阿福特罗治疗与单独使用噻托溴铵相比，在稳定期 COPD 患者中的疗效和不良反应差异。
对 MEDLINE、EMBASE、CINAHL 和 Cochrane 临床试验数据库进行了检索。纳入噻托溴铵联合福莫特罗或阿福特罗治疗 2 周或以上与单独使用噻托溴铵治疗的随机对照试验。对研究进行汇总，得出比值比（OR）或加权均数差（WMD），置信区间（CI）为 95%。
纳入 8 项试验，共 1868 例随机患者。与单独使用噻托溴铵相比，噻托溴铵联合福莫特罗治疗显著改善了平均 FEV1（WMD 105 mL，95% CI：69-142）、平均 FVC（WMD 135 mL，95% CI：96-174）和谷值 FEV1（WMD 53 mL，95% CI：30-76），但谷值 FVC 的差异无统计学意义。噻托溴铵联合福莫特罗治疗组的过渡性呼吸困难指数（TDI）平均变化明显大于单独使用噻托溴铵组（WMD 1.50，95% CI：1.01-1.99），且 TDI 有临床意义变化的患者比例也有类似差异（OR 2.34，95% CI：1.58-3.46）。与单独使用噻托溴铵相比，噻托溴铵联合福莫特罗治疗组不良反应和 COPD 加重的发生率较低，但差异无统计学意义。
与单独使用噻托溴铵相比，噻托溴铵联合福莫特罗显著改善了肺功能和症状评分。虽然不良反应的减少趋势，但差异无统计学意义。需要进行长期试验来评估噻托溴铵联合福莫特罗的疗效，并阐明与单独使用噻托溴铵相比，联合治疗的作用。
