加拿大多伦多大学Agostino Pierro团队比较了非穿孔阑尾炎的抗生素治疗与阑尾切除术的疗效。相关论文发表在2025年1月18日出版的《柳叶刀》杂志上。

目前文献中对非手术治疗无并发症阑尾炎的支持越来越多。该研究旨在通过比较两种治疗方法的失败率，研究儿童无并发症阑尾炎的抗生素治疗是否不如阑尾切除术。

在这项实用、多中心、平行组、非盲、随机、非劣效性试验中，研究组从加拿大、美国、芬兰、瑞典和新加坡的11家儿童医院招募了5-16岁疑似非穿孔阑尾炎的儿童（基于有或没有放射学诊断的临床诊断）。使用在线分层随机工具将患者随机分配（1:1）到抗生素组或阑尾切除术组，按性别、机构和症状持续时间分层（≥48小时vs<48小时）。主要结局是随机分配后1年内治疗失败。在抗生素组中，失败被定义为切除阑尾，在阑尾切除术组中，根据病理学，失败被界定为正常阑尾。在两组中，失败也被定义为与需要全身麻醉的阑尾炎相关的额外手术。研究组进行了中期分析，以确定是否在中途宣布非劣效。非劣效性界限为20%。所有结果均在参与者中进行了为期12个月的随访数据评估。

2016年1月20日至2021年12月3日，936名患者被纳入研究，并随机分配到阑尾切除术组（n=459）或抗生素组（n=477）。在12个月的随访中，846名（90%）患者的主要结局数据可用。抗生素组452名患者中有153名（34%）出现治疗失败，而阑尾切除术组394名患者中只有28名（7%）出现失败（差异26.7%，90%置信区间22.4-30.9）。除一名患者外，所有符合阑尾切除术治疗失败定义的患者均为阴性阑尾切除术患者。在抗生素组接受阑尾切除术的患者中，13人（8%）的病理正常。两组均无死亡或严重不良事件。与阑尾切除术组相比，抗生素组发生轻度至中度不良事件的相对风险为4.3（95%CI 2.1-8.7；p<0.0001）。

研究结果表明，根据累积失败率和20%的非劣效性界限，非穿孔阑尾炎的抗生素治疗不如阑尾切除术。

附：英文原文

Title: Appendicectomy versus antibiotics for acute uncomplicated appendicitis in children: an open-label, international, multicentre, randomised, non-inferiority trial

Author: Shawn D St Peter, Janelle R Noel-MacDonnell, Nigel J Hall, Simon Eaton, Janne S Suominen, Tomas Wester, Jan F Svensson, Markus Almstrm, E Pete Muenks, Marianne Beaudin, Nelson Piché, Mary Brindle, Ali MacRobie, Richard Keijzer, Helene Engstrand Lilja, Ann-Marie Kassa, Tim Jancelewicz, Andreana Butter, Jacob Davidson, Erik Skarsgard, Yap Te-Lu, Shireen Nah, Andrew R Willan, Agostino Pierro

Issue&Volume: 2025/01/18

Abstract:

Background

Support for the treatment of uncomplicated appendicitis with non-operative management rather than surgery has been increasing in the literature. We aimed to investigate whether treatment of uncomplicated appendicitis with antibiotics in children is inferior to appendicectomy by comparing failure rates for the two treatments.

Methods

In this pragmatic, multicentre, parallel-group, unmasked, randomised, non-inferiority trial, children aged 5–16 years with suspected non-perforated appendicitis (based on clinical diagnosis with or without radiological diagnosis) were recruited from 11 children's hospitals in Canada, the USA, Finland, Sweden, and Singapore. Patients were randomly assigned (1:1) to the antibiotic or the appendicectomy group with an online stratified randomisation tool, with stratification by sex, institution, and duration of symptoms (≥48 h vs <48 h). The primary outcome was treatment failure within 1 year of random assignment. In the antibiotic group, failure was defined as removal of the appendix, and in the appendicectomy group, failure was defined as a normal appendix based on pathology. In both groups, failure was also defined as additional procedures related to appendicitis requiring general anaesthesia. Interim analysis was done to determine whether inferiority was to be declared at the halfway point. We used a non-inferiority design with a margin of 20%. All outcomes were assessed in participants with 12-month follow-up data. The trial was registered at ClinicalTrials.gov (NCT02687464).

Findings

Between Jan 20, 2016, and Dec 3, 2021, 936 patients were enrolled and randomly assigned to appendicectomy (n=459) or antibiotics (n=477). At 12-month follow-up, primary outcome data were available for 846 (90%) patients. Treatment failure occurred in 153 (34%) of 452 patients in the antibiotic group, compared with 28 (7%) of 394 in the appendicectomy group (difference 26·7%, 90% CI 22·4–30·9). All but one patient meeting the definition for treatment failure with appendicectomy were those with negative appendicectomies. Of those who underwent appendicectomy in the antibiotic group, 13 (8%) had normal pathology. There were no deaths or serious adverse events in either group. The relative risk of having a mild-to-moderate adverse event in the antibiotic group compared with the appendicectomy group was 4·3 (95% CI 2·1–8·7; p<0·0001).

Interpretation

Based on cumulative failure rates and a 20% non-inferiority margin, antibiotic management of non-perforated appendicitis was inferior to appendicectomy.

DOI: 10.1016/S0140-6736(24)02420-6

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02420-6/abstract