沙美特罗替卡松干粉剂单用和联合孟鲁司特应用对成人中重度哮喘疗效的系统评价  

Efficacy of Salmeterol/Fluticasone Propionate Only or Combined with Montelukast in the Treatment of Moderate and Severe Degree Asthma in Adults:A Systematic Review

作　　者：陈毅斐[1] 李平[1] 陈凡[1] 曹洁[1] 杨炯[1] 

机构地区：[1]武汉大学中南医院呼吸内科,湖北武汉430071

出　　处：《中国呼吸与危重监护杂志》2013年第6期605-612,共8页Chinese Journal of Respiratory and Critical Care Medicine

摘　　要：目的 系统评价单独使用沙美特罗替卡松干粉剂与沙美特罗替卡松干粉剂联合孟鲁司特治疗成人中重度哮喘的疗效。方法 计算机检索Pubmed、CNKI、维普数据库、万方数据库、CBM中关于联合应用沙美特罗替卡松干粉剂与孟鲁司特治疗成人中重度哮喘的随机对照试验（ RCT） 。检索时限从建库至2013 年3 月。由2 名研究者对符合条件的RCT 独立进行资料提取与评价, 采用RevMan 5. 1 软件进行Meta 分析, 采用GRADE 指南对证据质量和推荐等级进行分级。结果 共纳入7 个RCT（ n =507） 的中重度哮喘成人患者。Meta 分析结果显示, 与对照组相比, 沙美特罗替卡松干粉剂联合孟鲁司特治疗8 周能更有效地改善患者的FEV1%pred（ WMD =5. 81[ 2. 79, 8. 84] , P =0. 000 2） 。治疗12 周后, 观察组FEV1% pred（ WMD=4. 57[ 1. 98, 7. 15] , P =0. 000 5） 和PEF% pred（ WMD = 6. 09[ 3. 75, 8. 44] , P 〈0. 000 01） 改变也较对照组显著, 组间差异均具有统计学意义。对临床症状、不良反应等次要指标进行描述性分析, 结果表明联合治疗能更快缓解患者的症状与体征, 且安全性较高。GRADE 证据质量评价显示, 肺功能三项结局的证据水平为极低级～低级, 推荐分级均为弱推荐。结论 现有研究显示, 沙美特罗替卡松干粉剂联合孟鲁司特治疗成人中重度哮喘能快速有效地缓解患者的临床症状, 改善肺功能。但鉴于纳入研究的样本量少, 且质量不高, 故仍需开展大样本、多中心、方法科学和规范的高质量RCT。Objective To systematically evaluate the efficacy of salmeterol / fluticasone propionate（ seretide） plus montelukast versus seretide only in the treatment of moderate and severe asthma in adults.Methods Randomized controlled trials （ RCTs） of seretide plus montelukast in the treatment of moderateand severe asthma in adults were searched in Pubmed, CNKI, VIP,Wanfang Data and CBM fromthe date ofestablishment of databases to March 2013. The quality of included RCTs was evaluated and the data wereextracted by two independent researchers. Meta-analyses were performed with RevMan 5.1 software, and theGRADE system was applied to rate the level of evidence and strength of recommendation.？Results SevenRCTs （ n = 507） were included. Meta-analyses showed that, compared with control groups, the combinedtherapy of seretide and montelukast could statistically improve FEV1% pred after 8 weeks （ WMD = 5. 81[ 2. 79, 8. 84] , P = 0. 000 2） and 12 weeks （ WMD = 4. 57 [ 1. 98, 7. 15] , P = 0. 000 5） and PEF% predafter 12 weeks （ WMD = 6. 09[ 3. 75, 8. 44] , P 〈 0. 000 01） . Descriptive analysis for secondary indexesshowed that combined therapy could statistically relieve patients’ clinical symptoms more quickly thancontrol groups with higher safety. Based on the GRADE system, three outcomes of lung function were verylow to low quality and the strength of recommendation was weak.？Conclusions This meta-analysis suggeststhat the combined therapy of seretide and montelukast could relieve patients’clinical symptoms and improve the lung function effectively and quickly. However, due to the limitations of the included studies,more largesample,high-quality RCTs are required.

关 键 词：沙美特罗替卡松干粉剂 孟鲁司特 中重度哮喘 系统评价 META 分析 

分 类 号：R562.25[医药卫生—呼吸系统]