阿奇霉素对比阿莫西林-克拉维酸治疗儿童部分急性呼吸道感染临床疗效与安全性的系统评价  

Clinical efficacy and safety of azithromycin versus amoxicillin-clavulanic acid in the treatment of some acute respiratory infections in children:systematic evaluation

作　　者：王培香[1] 印亚双 陈月[2] 李文静[1] 张啸[3] 冯婉玉[2] 

机构地区：[1]北京大学国际医院,北京102206 [2]北京大学人民医院,北京100044 [3]北京生物医药研究所,北京100000

出　　处：《国际药学研究杂志》2016年第4期646-651,共6页Journal of International Pharmaceutical Research

摘　　要：目的系统评价阿奇霉素对比阿莫西林-克拉维酸治疗儿童部分急性呼吸道感染临床疗效与安全性。方法计算机检索Pub Med、EMBase、Medline、Cochrane图书馆、中国期刊全文数据库,检索起止时间均从建库至2016年2月,收集阿奇霉素与阿莫西林-克拉维酸治疗儿童急性呼吸道感染临床疗效与安全性的随机对照试验(RCT),提取资料并对文献进行质量评价,采用Rev Man5.2统计软件进行Meta分析。结果临床疗效评价共纳入20项RCT,合计4980例儿童患者。Meta分析结果显示,两组临床治愈率比较差异有统计学意义[OR=0.78,95%CI(0.65,0.93),P=0.007],阿奇霉素在治疗部分小儿细菌性呼吸道感染方面的疗效显著优于阿莫西林-克拉维酸。其中在治疗急性中耳炎等上呼吸道感染方面,两组临床治愈率比较差异有统计学意义[OR=0.75,95%C(I0.62,0.91),P=0.003],阿奇霉素疗效显著优于阿莫西林-克拉维酸;在治疗社区获得性肺炎等下呼吸道感染方面,两组临床治愈率比较差异无统计学意义[OR=1.20,95%CI(0.62,2.33),P=0.58],两药疗效相当。安全性评价共纳入13项RCT,合计3474例儿童患者。Meta分析结果显示,两组不良反应发生率比较差异有统计学意义[OR=0.49,95%CI(0.40,0.60),P<0.000 01]。结论 Meta分析结果显示,整体上,阿奇霉素在治疗部分儿童细菌性呼吸道感染方面疗效和安全性优于阿莫西林-克拉维酸。Objective To systematically evaluate the clinical efficacy and safety of azithromycin（Az）versus amoxicillin-clavulanic acid（A-Cva）in the treatment of some acute respiratory infections in children. Methods Pubmed,EMBase,Medline,Cochrane Library and CJFD were retrieved to collect the randomized controlled trial（RCT）of their clinical efficacy and safety in the treatment of acute respiratory infections in children. The methodological quality of included studies was evaluated.The Rev Man5.2 software was chosen for data analysis. Results Twenty RCTs involving 4980 pediatric patients were included for assessment of the clinical efficacy. Meta-analysis showed that Az had more significant effect on the treatment of some bacterial repiratory infections in children〔OR=0.78,95%CI（0.65,0.93）,P=0.007〕than A-Cva. In the treatment of upper respiratory infections,acute otitis media and so on,Az had more significant effect〔OR=0.75,95%CI（0.62,0.91）,P=0.003〕;in the treatment of lower respiratory infections,such as community acquired pneumonia and so on,Az and A-Cva acid had the similar effect〔OR=1.20,95%CI（0.62,2.33）,P=0.58〕. Thirteen RCT involving 3474 pediatric patients were included for assessment of the clinical safety. Meta-analysis shows that the difference between Az and A-Cva is statistic significant in the treatment of some bacterial repiratory infections in children〔OR=0.49,95%CI（0.40,0.60）,P〈0.000 01〕. Conclusion Overall,Meta-analysis shows that Az is more effective and safer in the treatment of some bacterial repiratory infections in children than A-Cva.

关 键 词：阿奇霉素 阿莫西林-克拉维酸 儿童急性呼吸道感染 临床疗效与安全性 Meta分析 

分 类 号：R725.6[医药卫生—儿科]