美国布列根和妇女医院Krista F. Huybrechts团队比较了阿莫西林-克拉维酸与阿莫西林治疗小儿急性鼻窦炎后的治疗失败和不良事件。相关论文发表在2023年9月19日出版的《美国医学会杂志》上。

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490万张此类处方。关于最佳经验性抗生素，目前尚未达成共识。

为了比较阿莫西林-克拉维酸与阿莫西林治疗门诊儿童急性鼻窦炎的疗效，研究组在全国卫生保健数据库中对17岁或以下的儿童和青少年进行了一项队列研究，这些儿童和青少年在门诊新诊断为急性鼻窦炎，并在同一天新开阿莫西林-克拉维酸盐或阿莫西林处方。倾向性评分匹配用于缓解混淆。曝光因素为阿莫西林克拉维酸盐或阿莫西林的新处方。在队列登记后1至14天，对治疗失败进行评估，治疗失败被定义为新的抗生素分配、急性鼻窦炎的急诊科或住院治疗，或鼻窦炎并发症的住院治疗。评估不良事件，包括胃肠道症状、超敏反应和皮肤反应、急性肾损伤和继发感染。

该队列包括320141名患者。在倾向评分匹配后，共有198942名患者（每组99471名患者），其中100340名（50.4%）为女性，101726名（51.1%）为12至17岁的青少年，52149名（26.2%）为6至11岁的儿童，45067名（22.7%）为0至5岁的幼儿。治疗失败发生率为1.7%；0.01%的患者严重失败（急诊科或住院）。阿莫西林-克拉维酸和阿莫西林组治疗失败的风险没有差异（相对风险[RR]为0.98）。

阿莫西林-克拉维酸的胃肠道症状（RR为1.15）和酵母感染（RR为1.33）的风险更高。按年龄对患者进行分层后，0至5岁的阿莫西林-克拉维酸盐治疗失败的风险比为0.98；6至11岁的RR为1.06；12至17岁RR为0.87。阿莫西林-克拉维酸盐治疗后不良事件的年龄分层风险，0至5岁的RR为1.23；6至11岁的RR为1.19；12至17岁的RR为1.04。

研究结果表明，在门诊治疗的急性鼻窦炎儿童中，接受阿莫西林-克拉维酸盐治疗的儿童与阿莫西林相比，治疗失败的风险没有差异，但阿莫西林-克拉维酸盐与更高的胃肠道症状和酵母感染风险相关。这些发现可能有助于为急性鼻窦炎的经验性抗生素选择提供决策依据。

附：英文原文

Title: Treatment Failure and Adverse Events After Amoxicillin-Clavulanate vs Amoxicillin for Pediatric Acute Sinusitis

Author: Timothy J. Savage, Matthew P. Kronman, Sushama Kattinakere Sreedhara, Su Been Lee, Theresa Oduol, Krista F. Huybrechts

Issue&Volume: 2023/09/19

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 320141 patients. After propensity score matching, there were 198942 patients (99471 patients per group), including 100340 (50.4%) who were female, 101726 (51.1%) adolescents aged 12 to 17 years, 52149 (26.2%) children aged 6 to 11 years, and 45067 (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.

DOI: 10.1001/jama.2023.15503

Source: https://jamanetwork.com/journals/jama/fullarticle/2809688