阿奇霉素对比阿莫西林/克拉维酸治疗儿童急性中耳炎疗效和安全性的Meta分析

Efficacy and safety of azithromycin vs. amoxicillin/clavulanic in the treatment of children with acute otitis media:a meta-analysis

目的采用Meta分析方法比较阿奇霉素与阿莫西林／克拉维酸治疗儿童急性中耳炎疗效和安全性。方法电子检索中国生物医学文献数据库、中文科技期刊数据库、中国知网、万方数据库、中国医学会数字化期刊、PubMed、Cochrane Library和EMBASE数据库，检索起止时间均从建库至2013年8月。纳入阿奇霉素对比阿莫西林／克拉维酸治疗儿童急性中耳炎的RCT文献，对文献进行质量评价。评估临床治愈率、治疗失败率和不良反应。采用RevMan5．0软件进行数据分析，二分类变量采用OR及其95％CI表示。结果共纳入13篇RCT文献（5081例患儿）。Meta分析结果显示，阿奇霉素组与阿莫西St,／克拉维酸组在〈10d临床治愈率（OR=0．69，95％CI：0．46～1．02）、-19d临床治愈率（OR=0．88，95％CI：0．68～1．13）、～29d临床治愈率（OR=0．99，95％CI：0．83—1．19）、t〉30d临床治愈率（OR=1．00，95％CI：0．72～1．39）和治疗失败率（OR=0．87，95％CI：0．65～1．17）差异均无统计学意义。阿奇霉素组恶心（OR=0．44，95％CI：0．20～0．97）、皮疹（OR=0．48，95％CI：0．31～0．75）、腹泻（OR=0．38，95％CI：0．25～0．57）和稀便（OR=0．41，95％CI：0．20—0．81）的发生率显著低于阿莫西林／克拉维酸组。结论阿奇霉素与阿莫西林／克拉维酸治疗儿童中耳炎疗效相当且不良反应少。

Objective To compare the efficacy and safety of azithromycin with amoxicillin/clavulanic acid in the treatment of acute otitis media using meta-analysis methods. Methods The Wanfang, VIP, CNKI, PubMed, Coehrance library and EMBASE database establishment were selected to search the randomized controlled studies that compared azithromycin with amoxicillin/ clavulanic acid in the treatment of acute otitis media from initiation establishment of database to August, 2013. Outcomes included clinical cure, treatment failure rates and adverse events. RevMan 5.0 software was used for data analysis. Categorical variables were expressed using the odds ratio （OR） and 95% confidence intervals （95% CI）. Heterogeneity was analyzed using I2 test. Results A total of 13 randomized controlled trials （5 081 patients） were included. Meta-analysis showed that there were no significant differences of clinical cure rate within 10 days （ OR =0.69, 95% CI： 0.46 - 1.02） ,clinical cure rate within 10 - 19 days （ OR = 0.88, 95% CI ： 0.68 - 1.13 ） , clinical cure rate within 20 - 29 days （ OR = 0.99, 95% C1：0.83 - 1.19）, clinical cure rate after 30 days （ OR = 1.00, 95% CI ： 0.72 - 1.39） and cure failure rate （ OR = 0.87, 95% CI ： 0.65 - 1.17） was not statistically significant. There were less patients with nausea （ OR = 0.44, 95% CI：0.20 - 0.97）, rash （ OR = 0.48, 95% CI： 0.31-0.75）, diarrhea （OR =0.38, 95%CI： 0.25 -0.57） and loose stools （OR =0.41, 95%CI： 0.20-0.81） in azithromycin group than that in amoxicillin clavulanic acid group. Conclusion Compared with amoxicillin/clavulanate treatment of children with otitis media, the meta-analysis showed that azithromycin had non-inferior efficacy, but less adverse events such as nausea, rash, or diarrheaand loose stools.