沙美特罗替卡松与噻托溴铵联合吸入对稳定期中重度慢性阻塞性肺疾病患者疗效的系统评价

摘要

Objective To systematically evaluate the efficacy of Salmeterol/Fluticasone Propionate combined with Tiotropium Bromide in the treatment of patients with stable moderate to severe chronic obstructive pulmonary disease (COPD). Methods The Cochrane Library, Pubmed, CNKI and Wanfang Data were searched in English and Chinese from the date of establishment of databases to November 2014. Randomized controlled trials (RCTs) were chosen ac-cording to criteria, in which Salmeterol/Fluticasone Propionate plus Tiotropium Bromide was taken as observation group, while single Salmeterol/Fluticasone Propionate therapy was taken as control group. The effect of the two groups was e-valuated, the data was extracted by two independent researchers. Meta-analysis was performed with RevMan 5.1 soft-ware. Results 12 RCTs of 878 patients with stable moderate to severe COPD were included, Meta-analysis showed that, compared with control group, the observation group could statistically improve the FEV1/FVC (W MD=8.86, 95%CI:6.64-11.08, P<0.000 01), FEV1%predicted (W MD=7.77, 95%CI:5.31-10.24, P<0.000 01), PaO2 (W MD=9.97, 95%CI: 7.08-12.86, P< 0.000 01) and PaCO2 (W MD = 7.69, 95%CI: 5.67-9.71, P< 0.000 01). Descriptive analysis for secondary indexes showed that combined therapy could statistically relieve patients' clinical symptoms than control group, and improve patients' quality of life. Conclusion This meta-analysis suggests that the combined therapy of Sal-meterol/Fluticasone Propionate and Tiotropium Bromide can obviously improve clinical symptoms, lung function and arterial blood gases of patients with stable moderate and severe COPD. However, due to the poor quality of the origi-nal studies and the small sample size of included stud-ies, more high-quality, large-sample studies are re-quired.%目的：系统评价沙美特罗替卡松与噻托溴铵联合吸入治疗稳定期中重度慢性阻塞性肺疾病患者的效果。方法计算机检索Cochrane图书馆、Pubmed、CNKI、万方数据库,检索时限为建库至2014年11月。根据纳入/排除标准选择研究对象为稳定期中重度慢性阻塞性肺疾病患者,以沙美特罗替卡松联合噻托溴铵吸入治疗为观察组,单用沙美特罗替卡松粉吸入剂治疗为对照组,比较两组治疗效果。由2名研究者对文献质量进行评价和资料提取,采用RevMan 5.1进行Meta分析。结果共纳入12个RCT的稳定期中重度慢性阻塞性肺疾病患者878例,其中观察组447例,对照组431例。 Meta分析结果显示：观察组患者第1秒用力呼气量(FEV1)/用力肺活量(FVC)(W MD =8.86,95%CI：6.64~11.08,P <0.00001)、FEV1占预计值的百分比(W MD =7.77,95%CI：5.31~10.24,P<0.00001)、动脉血氧分压(PaO2)(W MD =9.97,95%CI：7.08~12.86,P<0.00001)和二氧化碳分压(Pa-CO2)(W MD=7.69,95%CI：5.67~9.71,P<0.00001)改变较对照组显著,差异均有统计学意义。对临床症状等进行描述性分析,结果显示观察组能明显改善患者的症状与体征,提高患者生活质量。结论沙美特罗替卡松与噻托溴铵联合吸入治疗稳定期中重度慢性阻塞性肺疾病可以更显著地改善患者临床症状、肺功能及动脉血气。但鉴于原始研究的质量均不高,且样本量少,故需要更多方法科学规范的高质量、大样本的RCT进一步论证。