本文由小咖机器人翻译整理

期刊来源：JAMA

文献发表时间：2023-09-19

原文链接：https://jamanetwork.com/journals/jama/article-abstract/2809688

关键点内容如下：

问题

对于儿童急性鼻窦炎，与阿莫西林相比，阿莫西林-克拉维酸是否与不同的治疗失败率或不良事件发生率相关？

调查结果

在320141名儿童的队列研究中，治疗失败是罕见的（总体1.7%），严重的治疗失败是非常罕见的（0.01%）。两组之间的治疗失败没有差异，而不良事件，特别是胃肠道症状和酵母菌感染，在接受阿莫西林-克拉维酸治疗的患者中更为常见。

意义

在门诊治疗的急性鼻窦炎患儿中，与阿莫西林相比，阿莫西林-克拉维酸与更多的不良事件相关，且治疗失败风险无差异。

摘要内容如下：

重要性

急性鼻窦炎是儿童抗生素处方最常见的适应症之一，据估计，美国每年有490万例此类处方。关于最佳经验性抗生素尚无共识。

目的

比较阿莫西林-克拉维酸与阿莫西林治疗门诊儿童急性鼻窦炎的疗效。

研究设计和参与者

在全国卫生保健利用数据库中，对17岁或以下的儿童和青少年进行队列研究，这些儿童和青少年新的门诊诊断为急性鼻窦炎，并在同一天获得阿莫西林-克拉维酸或阿莫西林的新处方。倾向评分匹配用于减轻混淆。

暴露

阿莫西林-克拉维酸或阿莫西林的新处方配方。

主要结局和措施

治疗失败（定义为新抗生素分配、急诊或住院治疗急性鼻窦炎或住院治疗鼻窦炎并发症的总和）在队列入组后1至14天进行评估。不良反应包括胃肠道症状、超敏反应、皮肤反应、急性肾损伤和继发感染。

结果

该队列包括320141名患者。倾向评分匹配后，共有198942例患者（每组99471例），其中100340例（50.4%）为女性，101726例（51.1%）为12~17岁青少年，52149例（26.2%）为6~11岁儿童，45067例（22.7%）为0~5岁儿童。治疗失败率为1.7%；0.01%有严重的失败（急诊科或住院病人）。阿莫西林-克拉维酸组和阿莫西林组之间治疗失败的风险没有差异（相对风险[RR]，0.98[95%CI，0.92-1.05]）。阿莫西林-克拉维酸组胃肠道症状（RR，1.15[95%CI，1.05-1.25]）和酵母菌感染（RR，1.33[95%CI，1.16-1.54]）的风险更高。按年龄对患者进行分层后，阿莫西林-克拉维酸治疗失败的风险在0至5岁时为0.98（95%CI，0.86-1.12）；6~11年的RR为1.06（95%CI，0.92~1.21）；12~17年的RR为0.87（95%CI，0.79~0.95）。阿莫西林-克拉维酸治疗后不良事件的年龄分层风险为:0至5岁的RR为1.23（95%CI，1.10-1.37）；6~11年的RR为1.19（95%CI，1.04~1.35）；12~17年的相对危险度（RR）为1.04（95%CI，0.95~1.14）。

结论和相关性

在接受门诊治疗的急性鼻窦炎患儿中，接受阿莫西林-克拉维酸治疗的患儿与接受阿莫西林治疗的患儿相比，治疗失败的风险没有差异，但阿莫西林-克拉维酸与胃肠道症状和酵母菌感染的风险较高相关。这些发现可能有助于急性鼻窦炎患者的经验性抗生素选择。

英文原文如下：

Key Points

Question  For pediatric acute sinusitis, is amoxicillin-clavulanate associated with different rates of treatment failure or adverse events compared with amoxicillin?

Findings  In this cohort study of 320 141 children, treatment failure was rare (1.7% overall) and serious treatment failure was very rare (0.01%). There was no difference in treatment failure between groups while adverse events, specifically gastrointestinal symptoms and yeast infections, were more frequent among patients treated with amoxicillin-clavulanate.

Meaning  Among children with acute sinusitis treated in the outpatient setting, amoxicillin-clavulanate was associated with more adverse events and no difference in treatment failure risk compared to amoxicillin.

Abstract

Importance  Acute sinusitis is one of the most common indications for antibiotic prescribing in children, with an estimated 4.9 million such prescriptions in the US annually. Consensus does not exist regarding the optimal empirical antibiotic.

Objective  To compare amoxicillin-clavulanate vs amoxicillin for the treatment of acute sinusitis in outpatient children.

Design, Setting, and Participants  Cohort study of children and adolescents aged 17 years or younger with a new outpatient diagnosis of acute sinusitis and a same-day new prescription dispensation of amoxicillin-clavulanate or amoxicillin in a nationwide health care utilization database. Propensity score matching was used to mitigate confounding.

Exposure  A new prescription dispensation of amoxicillin-clavulanate or amoxicillin.

Main Outcomes and Measures  Treatment failure, defined as an aggregate of a new antibiotic dispensation, emergency department or inpatient encounter for acute sinusitis, or inpatient encounter for a sinusitis complication, was assessed 1 to 14 days after cohort enrollment. Adverse events were evaluated, including gastrointestinal symptoms, hypersensitivity and skin reactions, acute kidney injury, and secondary infections.

Results  The cohort included 320 141 patients. After propensity score matching, there were 198 942 patients (99 471 patients per group), including 100 340 (50.4%) who were female, 101 726 (51.1%) adolescents aged 12 to 17 years, 52 149 (26.2%) children aged 6 to 11 years, and 45 067 (22.7%) children aged 0 to 5 years. Treatment failure occurred in 1.7% overall; 0.01% had serious failure (an emergency department or inpatient encounter). There was no difference in the risk of treatment failure between the amoxicillin-clavulanate and amoxicillin groups (relative risk [RR], 0.98 [95% CI, 0.92-1.05]). The risk of gastrointestinal symptoms (RR, 1.15 [95% CI, 1.05-1.25]) and yeast infections (RR, 1.33 [95% CI, 1.16-1.54]) was higher with amoxicillin-clavulanate. After patients were stratified by age, the risk of treatment failure after amoxicillin-clavulanate was an RR of 0.98 (95% CI, 0.86-1.12) for ages 0 to 5 years; RR was 1.06 (95% CI, 0.92-1.21) for 6 to 11 years; and RR was 0.87 (95% CI, 0.79-0.95) for 12 to 17 years. The age-stratified risk of adverse events after amoxicillin-clavulanate was an RR of 1.23 (95% CI, 1.10-1.37) for ages 0 to 5 years; RR was 1.19 (95% CI, 1.04-1.35) for 6 to 11 years; and RR was 1.04 (95% CI, 0.95-1.14) for 12 to 17 years.

Conclusions and Relevance  In children with acute sinusitis who were treated as outpatients, there was no difference in the risk of treatment failure between those who received amoxicillin-clavulanate compared with amoxicillin, but amoxicillin-clavulanate was associated with a higher risk of gastrointestinal symptoms and yeast infections. These findings may help inform decisions for empirical antibiotic selection in acute sinusitis.

医咖会员已正式上线，点击链接https://new.mediecogroup.com/user/vip/categories/，查看会员12项权益！