Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, Florida.
Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Otol Neurotol. 2018 Sep;39(8):957-963. doi: 10.1097/MAO.0000000000001887.
To examine whether short-term use of azithromycin increases the risk of sensorineural hearing loss (SNHL) in adults with uncomplicated infections.
A retrospective cohort study using Medicaid claims data, 1999 to 2010.
Adults (18-64 years old) who had continuous enrollment in Medicaid for the 12 months (baseline) before the date of first dispensation (index date) of oral azithromycin or amoxicillin ± clavulanate for uncomplicated infections.
We operationalized sensorineural hearing loss (SNHL) by a charge for audiometry and followed by a diagnosis of SNHL within 30 days.
We adjusted for the baseline covariates through propensity score matching. Adults were followed for up to 120 days after the index date. The hazard of SNHL in azithromycin-exposed adults was compared with those who had amoxicillin ± clavulanate using a Cox proportional hazard model. We performed several sensitivity analyses by varying the follow-up time, SNHL definition, adjusting for cumulative antibiotic use, and switching exposure status during the follow-up period.
A total of 493,774 patients entered the study cohort. The unadjusted incidence rates of SNHL were 38 and 41 cases per 10,000 patient-years following exposure to azithromycin and amoxicillin ± clavulanate, respectively. The adjusted (matched) hazard ratio (HR) of SNHL for azithromycin versus amoxicillin ± clavulanate was 0.91 (95% confidence interval [CI], 0.77-1.07). The sensitivity analyses findings were consistent with the primary analysis.
Azithromycin short-term use was not associated with an increased risk of SNHL in comparison to amoxicillin ± clavulanate.
研究短期使用阿奇霉素是否会增加无并发症感染成人的感音神经性听力损失（SNHL）风险。
使用医疗补助索赔数据进行的回顾性队列研究，时间为 1999 年至 2010 年。
在口服阿奇霉素或阿莫西林-克拉维酸用于无并发症感染的首次配药（索引日期）前 12 个月（基线）内持续参加医疗补助的成年人（18-64 岁）。
我们通过听力计收费来操作感音神经性听力损失（SNHL），并在 30 天内对 SNHL 进行诊断。
我们通过倾向评分匹配调整了基线协变量。成年人在索引日期后最多随访 120 天。使用 Cox 比例风险模型比较了暴露于阿奇霉素的成年人与接受阿莫西林-克拉维酸的成年人的 SNHL 风险。我们通过改变随访时间、SNHL 定义、调整累积抗生素使用以及在随访期间切换暴露状态进行了几次敏感性分析。
共有 493774 名患者进入研究队列。在未调整的情况下，暴露于阿奇霉素和阿莫西林-克拉维酸后，SNHL 的发生率分别为每 10000 患者年 38 例和 41 例。与阿莫西林-克拉维酸相比，阿奇霉素的 SNHL 调整（匹配）风险比（HR）为 0.91（95%置信区间[CI]，0.77-1.07）。敏感性分析结果与主要分析一致。
与阿莫西林-克拉维酸相比，短期使用阿奇霉素与 SNHL 风险增加无关。
