Antibiotic treatment versus appendicectomy for acute appendicitis in adults: an individual patient data meta-analysis.

However, patient inclusion criteria and outcome definitions vary greatly between RCTs.

然而，不同RCTs在患者纳入标准和结果定义方面存在很大差异。

We aimed to compare antibiotics with appendicectomy for the treatment of acute appendicitis using individual patient data and uniform outcome definitions.

我们旨在通过使用个别患者数据和统一的结果定义，比较抗生素与阑尾切除术治疗急性阑尾炎的效果。

Methods

In this individual patient data meta-analysis, we searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials without language restrictions between database inception and June 6, 2023, for RCTs comparing appendicectomy with antibiotics for the treatment of adults (≥18 years) with imaging-confirmed acute appendicitis.

在这项个别患者数据的荟萃分析中，我们在没有任何语言限制的情况下，从数据库创建开始至2023年6月6日，通过检索PubMed、Embase和Cochrane中央对照试验登记处，寻找比较阑尾切除术与抗生素治疗成年（≥18岁）急性阑尾炎的随机对照试验（RCTs），这些成年患者的急性阑尾炎通过影像学确认。

Studies without 1-year follow-up data on complications were excluded, as were patients.

没有1年随访数据关于并发症的研究被排除，患者亦然。

Corresponding authors of eligible studies were contacted and invited to share data; individual patient data were merged after validation.

联系了符合条件研究的通讯作者，并邀请他们分享数据；在验证后合并了个体患者数据。

One-stage meta-analyses were conducted using a generalised, mixed-effects linear regression model, accounting for clustering of patients within studies.

使用广义混合效应线性回归模型进行了一阶段荟萃分析，考虑了研究中患者聚集的情况。

The primary outcome was the complication rate at 1-year follow-up, uniformly harmonised across trials using the Clavien-Dindo classification.

主要结果是1年随访期间的并发症发生率，通过Clavien-Dindo分类在试验中统一协调。

Complications were further divided into minor (grade 1-2 or equivalent) and major (grade 3-5 or equivalent) complications.

并发症进一步细分为轻微（1-2级或相当）和重大（3-5级或相当）并发症。

Appendicectomy rate during 1 year was a key secondary outcome but not considered a complication for the antibiotics group.

一年内的阑尾切除率是一个关键的次要结果，但对抗生素组来说不被视为并发症。

Outcomes were described separately for patients with and without an appendicolith.

分别描述了有无阑尾石患者的临床结果。

This study is registered with PROSPERO, CRD42023391676.

本研究已在PROSPERO注册，注册号为CRD42023391676。

Results

Of 887 potentially relevant articles, eight were eligible for inclusion, of which six RCTs could provide data for 2101 eligible patients (1050 assigned to antibiotics and 1051 assigned to appendicectomy; 830 [39·5%] women and 1271 [60·5%] men).

在887篇可能相关的文章中，有八篇符合纳入标准，其中六项随机对照试验（RCTs）为2101名符合条件的患者提供了数据（1050名被分配到抗生素组，1051名被分配到阑尾切除术组；830名[39.5%]女性和1271名[60.5%]男性）。

All studies raised some bias concerns due to absence of blinding.

所有研究都因缺乏盲法而引发了一些偏倚问题。

One study was judged to have a high risk of bias due to the exclusion of eligible patients after randomisation, but these patients were eligible for inclusion in our meta-analysis.

一项研究因随机化后排除符合条件的患者而被判定为存在较高的偏倚风险，但这些患者符合我们荟萃分析的纳入标准。

At 1 year, 57 (5·4%) of 1050 patients randomly assigned to antibiotics had a complication compared with 87 (8·3%) of 1051 patients randomly assigned to appendicectomy (odds ratio [OR] 0·49 [95% CI 0·20 to 1·20]; risk difference -4·5 percentage points [95% CI -11·6 to 2·6]).

在1年时，随机分配至抗生素治疗的1050名患者中有57名（5.4%）出现并发症，而随机分配至阑尾切除术的1051名患者中有87名（8.3%）出现并发症（比值比[OR] 0.49 [95% 置信区间 0.20 至 1.20]；风险差异为-4.5个百分点 [95% 置信区间 -11.6 至 2.6]）。

At 1 year, 1025 (97·5%) patients in the appendicectomy group had undergone appendicectomy compared with 356 (33·9%) patients in the antibiotics group.

在1年时，阑尾切除组有1025名（97.5%）患者接受了阑尾切除术，而抗生素组有356名（33.9%）患者接受了抗生素治疗。

In patients with an appendicolith at pre-interventional imaging, there were more complications at 1 year among patients who received antibiotic treatment than among those who underwent appendicectomy (29 [15·0%] of 193 patients vs 12 [6·3%] of 190 patients; OR 2·82 [95% CI 1·11 to 7·18]; risk difference 13·2 percentage points [95% CI 2·3 to 24·2]).

在术前影像学检查发现阑尾石的患者中，接受抗生素治疗的患者在1年时的并发症比接受阑尾切除术的患者多（193名患者中有29名[15.0%]，而190名患者中有12名[6.3%]；比值比为2.82[95%置信区间1.11至7.18]；风险差异为13.2个百分点[95%置信区间2.3至24.2]）。

In the antibiotics group, 94 (48·7%) of 193 patients with an appendicolith underwent appendicectomy within 1 year versus 262 (30·6%) of 857 patients without an appendicolith.

在抗生素组中，193名有阑尾石的患者中有94名（48.7%）在一年内接受了阑尾切除术，而在857名没有阑尾石的患者中，有262名（30.6%）接受了阑尾切除术。

interpretation

This meta-analysisshowed that antibiotic treatment in adults with imaging-confirmed acute appendicitis was a safe alternative to surgery and resulted in around two-thirds of patients avoiding appendicectomy during the first year.

这项荟萃分析显示，在成像确诊的急性阑尾炎患者中，抗生素治疗是手术的安全替代方案，并且在第一年内约有三分之二的患者避免了阑尾切除术。

In patients with an appendicolith, initial antibiotic treatment increased the risk of complications compared with appendicectomy, and around half of these patients assigned to antibiotics underwent step-up appendicectomy within 1 year.

在阑尾结石患者中，初始抗生素治疗相较于阑尾切除术增加了并发症的风险，约有一半被分配至抗生素治疗的患者在1年内接受了升级的阑尾切除术。

These data should be key components in shared decision making.

这些数据应成为共享决策制定的关键要素。

funding

None.

无。