阿奇霉素治疗支气管哮喘疗效及安全性的系统评价

Effectiveness and safety of azithromycin in the treatment of bronchial asthma: a meta-analysis

目的系统评价阿奇霉素治疗支气管哮喘(以下简称哮喘)的疗效及安全性。方法计算机检索中国知网、万方数据库、Pub Med、Medline电子数据库,检索时间从建库至2013年12月,查找公开发表的关于阿奇霉素治疗哮喘的随机对照试验(randomized controlled trial,RCT);对符合条件的RCT,由两位评价员独立进行资料提取及质量评价,并交叉核对;采用Revman5.1软件对纳入文献行进Meta分析。结果共纳入8项RCTs,分析结果显示,与对照组相比,阿奇霉素组呼气峰值流速(peak expiratory flow,PEF)[加权均数差(weighted mean difference,WMD)=0.15,95%CI=0.06—0.24,P=0.001]、哮喘控制测试(asthma control test,ACT)评分[WMD=1.59,95%CI=0.95—2.23,P<0.00001]、第1秒用力呼气容积(forced expiratory volume in one second,FEV1)占预计值百分比(FEV1%)水平改善[WMD=1.44,95%CI=0.40—2.49,P=0.007],但后者的改善作用仅见于中文研究[WMD=1.48,95%CI=0.40—2.57,P=0.007];哮喘控制问卷(asthma control questionnaire,ACQ)评分[WMD=0.07,95%CI=-0.11—0.25,P=0.45]及哮喘生活质量问卷调查(asthma quality of life questionnaire,AQLQ)评分[WMD=-0.06,95%CI=-0.42—0.31,P=0.77]无统计学差异(P>0.05);无明显不良反应。结论阿奇霉素可改善哮喘患者PEF、ACT,以及中国人种的FEV1%水平,但对于生活质量无明显作用,长期服用耐受性良好,有可能成为哮喘治疗的辅助用药。

Objective To evaluate the effectiveness and safety of azithromycin in treatment of bronchial asthma. Methods Reports of randomized controlled trials（RCTs） describing azithromycin for treatment of asthma published before December2013 were searched in CNKI, WANFANG, Pub Med and Medline databases. The data of the included RCTs were extracted and the data quality was evaluated by two assessors independently. Meta- analyses were performed with Revman 5.1 software.Results Eight RCTs were identified. Meta- analysis of the data showed that compared with the control group, azithromycin treatment significantly improved the patients＇ PEF（WMD=0.15, 95%CI=0.06-0.24, P=0.001）, scores of asthma control test（ACT）（WMD=1.59, 95%CI=0.95-2.23, P0.00001）, and FEV1%（WMD=1.44, 95%CI=0.40-2.49, P=0.007）, but the improvement of FEV1%was observed only in Chinese patients（WMD=1.48, 95% CI=0.40- 2.57, P=0.007）. The scores of asthma control questionnaire（WMD=0.07, 95%CI=-0.11-0.25, P=0.45） or asthma quality of life questionnaire（WMD=-0.06, 95%CI=-0.42-0.31, P=0.77） were not affected by azithromycin. No severe adverse events were reported in these included studies. Conclusion Azithromycin for asthma treatment can improve PEF, ACT and FEV1%（in Chinese patients only） but shows no significant effect on the quality of life of the patients. Azithromycin is well tolerated and may therefore be beneficial as adjuvant therapy for asthma.