长期小剂量罗红霉素对稳定期慢性阻塞性肺疾病疗效作用的Meta分析

Effects of low-dose roxithromycin on patients with stable COPD:A Meta-analysis

目的系统评价长期小剂量罗红霉素对稳定期慢性阻塞性肺疾病(COPD)的临床疗效。方法通过检索PubMed、CNKI、维普期刊和中华医学会期刊库等数据库,检索已公开发表的小剂量罗红霉素对稳定期慢性阻塞性肺疾病疗效作用的随机对照试验,检索时限均从建库至2017年10月,使用RevMan 5.3软件对研究结果进行Meta分析。结果共纳入11篇研究文献,共925例稳定期COPD患者,试验组462例,对照组463例。Meta分析结果显示:与对照组相比,长期小剂量应用罗红霉素可以改善稳定期COPD患者的肺功能(MD=0.81, 95%CI:0.45~1.17, P<0.0001)、生活质量;延长患者6min步行距离(MD=37.08,95%CI:13.83~60.33, P=0.002);缓解呼吸困难(MD=-1.22, 95%CI:-1.89^-0.55, P=0.00004);减少急性发作人数(OR=0.23, 95%CI:0.15~0.36, P<0.00001)、炎症因子和炎症细胞,两组的不良反应发生率无显著差异(OR=2.75, 95%CI:0.94~8.06, P=0.06)。结论长期小剂量罗红霉素对稳定期COPD患者有显著疗效,可有效改善患者生活质量,安全性较高,值得临床推广应用。但受纳入研究质量和数量的限制,上述结论尚有待于进一步开展更多大样本、多中心、高质量的随机对照试验加以验证。

Objective To systematically evaluate the clinical efficacy and safety of low-dose roxithromycin in patients with stable chronic obstructive pulmonary disease （COPD）. Methods We searched randomized controlled trials （RCTs） of low-dose roxithromycin in patients with stable chronic obstructive pulmonary disease from the pubmed, CNKI, VIP Database, Wanfang Database from their establishment dates to Oct 2017. The meta-analysis was performed by RevMan 5.3. Results A total of 925 participants were enrolled in the 11 RCTs, with 462 patients in the trial group and 463 in the control group. The meta-analysis showed that low-dose roxithromycin could significantly improve pulmonary function （MD = 0.81, 95% CI： 0.45~ 1.17, e〈0.0001） and the quality of life, prolong six-minute walk distance（MD = 37.08, 95%CI： 13.83-60.33, P=0.002）, ease the breathing （MD=-l.22, 95%CI： -1.89--0.55, P=0.00004）, reduced the amount of acute exacerbation （OR=0.23, 95%CI： 0.15~0.36, P〈0.00001）, inflammatory cytokines and cells. There was no significant difference in adverse reactions between the two groups（OR=2.75, 95%CI： 0.94-8.06, P=0.06）. Conclusions Low-dose roxithromycin could effectively improve the quality of life of patients with stable COPD, and there was no serious adverse reactions. Therefore, we recommend focusing on the clinical application of roxithromycin. Due to limited quantity and quality of the included studies, larger scale, multicenter, high quality RCTs are needed to verify the aforementioned conclusion.