Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT Africa), College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Department of Pharmacology and Clinical Pharmacy, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Ann Clin Microbiol Antimicrob. 2021 Apr 24;20(1):28. doi: 10.1186/s12941-021-00434-x.
Resistance, prolonged therapy, and more adverse reactions made amoxicillin less preferred for treating otitis media. This study aimed to compare the efficacy and safety of azithromycin and amoxicillin/clavulanate for the treatment of otitis media in children.
This study was a systematic review and meta-analysis. PubMed, Cochrane library, and Google scholar databases were searched. Comparative randomized clinical trial studies between azithromycin and amoxicillin/clavulanate to treat otitis media in children published up to 30 September 2019 were included. The risk of bias was assessed and Data was extracted by the first author and checked by the second author. Meta-analysis was performed by STATA software version 16, and Mantel-Haenszel statistical method with effect measure odds ratio was employed for analysis.
751 records were identified and 14 studies were eligible for analysis. In 12 studies azithromycin had equivalent clinical efficacy and 2 had less to amoxicillin/clavulanate. Meta-analysis results showed no statistically significant difference in efficacy in favor of amoxicillin/clavulanate after completion of treatment OR 0.75, 95% CI (0.62-0.91). On subgroup analysis for children less than 2 years (OR 0.96 95% CI (0.49-2.29), and greater than 2 years (OR 1.40 95% CI (0.93-2.11) and also efficacy on follow up (OR 0.97 95% CI (0.83-1.15) there is no statistically significant difference. The clinical adverse events are more in the amoxicillin/clavulanate group than in the azithromycin with a statistical significant difference OR 0.46 95% CI (0.43-0.56).
Azithromycin is comparable to amoxicillin/clavulanate to treat otitis media in children, and it is safer and more tolerable.
由于耐药性、治疗时间延长和更多不良反应，阿莫西林不太适合治疗中耳炎。本研究旨在比较阿奇霉素和阿莫西林/克拉维酸治疗儿童中耳炎的疗效和安全性。
本研究为系统评价和荟萃分析。检索了 PubMed、Cochrane 图书馆和 Google 学者数据库。纳入了截至 2019 年 9 月 30 日发表的比较阿奇霉素和阿莫西林/克拉维酸治疗儿童中耳炎的随机对照临床试验研究。由第一作者进行风险偏倚评估和数据提取，第二作者进行核对。采用 STATA 软件版本 16 进行荟萃分析，采用 Mantel-Haenszel 统计方法，效应量为比值比进行分析。
共检索到 751 条记录，有 14 项研究符合分析条件。在 12 项研究中，阿奇霉素的临床疗效与阿莫西林/克拉维酸相当，而有 2 项研究的疗效不如阿莫西林/克拉维酸。荟萃分析结果显示，治疗完成后，阿奇霉素在疗效上没有明显优于阿莫西林/克拉维酸的优势，OR 值为 0.75，95%CI（0.62-0.91）。亚组分析结果显示，对于 2 岁以下儿童（OR 0.96，95%CI（0.49-2.29）和 2 岁以上儿童（OR 1.40，95%CI（0.93-2.11），以及随访时的疗效（OR 0.97，95%CI（0.83-1.15），差异均无统计学意义。阿莫西林/克拉维酸组的临床不良反应明显多于阿奇霉素组，差异有统计学意义，OR 值为 0.46，95%CI（0.43-0.56）。
阿奇霉素治疗儿童中耳炎与阿莫西林/克拉维酸相当，且安全性更高，耐受性更好。
