Antibiotic Therapy for Uncomplicated Acute Appendicitis: Ten-Year Follow-Up of the APPAC Randomized Clinical Trial.

Background

To determine the 10-year appendicitis recurrence and appendectomy rate in patients with uncomplicated appendicitis treated with antibiotics.

确定了用抗生素治疗的非复杂性阑尾炎患者在10年内的阑尾炎复发率和阑尾切除率。

DESIGN, SETTING, AND PARTICIPANTS: Ten-year observational follow-up of patients in the Appendicitis Acuta (APPAC) multicenter randomized clinical trial comparing appendectomy with antibiotics at 6 Finnish hospitals from November 2009 to June 2012, where 530 patients (aged 18-60 years) with uncomplicated acute appendicitis diagnosed by computed tomography were randomly assigned to appendectomy (n = 273) or antibiotics (n = 257).

设计、设置和参与者：对2009年11月至2012年6月在芬兰6家医院进行的急性阑尾炎（APPAC）多中心随机临床试验的患者进行了10年的观察性随访，该试验比较了阑尾切除术与抗生素治疗。共有530名（年龄18-60岁）通过计算机断层扫描诊断为非复杂性急性阑尾炎的患者被随机分配到阑尾切除组（n = 273）或抗生素组（n = 257）。

Last follow-up was April 29, 2024.

最后的随访日期为2024年4月29日。

This current analysis focused on assessing the 10-year appendicitis recurrence rate among patients assigned to antibiotics.

本次分析专注于评估被分配至抗生素治疗的患者中10年阑尾炎复发率。

Methods

Open appendectomy vs antibiotics with intravenous ertapenem sodium (1 g/d) for 3 days followed by 7 days of oral levofloxacin (500 mg once daily) and metronidazole (500 mg 3 times/d).

开放性阑尾切除术与抗生素治疗比较，抗生素治疗包括静脉注射厄他培南钠（每日1克）3天，随后口服左氧氟沙星（每日一次500毫克）和甲硝唑（每日三次500毫克）7天。

main_outcomes_and_measures

Prespecified 10-year secondary end points included late (after 1 year) appendectomy and appendicitis recurrence rate after antibiotics and complications.

预设的次要终点包括10年内的晚期（1年后）阑尾切除术和抗生素治疗后的阑尾炎复发率以及并发症。

Post hoc outcomes included the detection of possible appendiceal tumors among patients in the antibiotic group undergoing appendectomy or with an intact appendix using magnetic resonance imaging.

事后分析的终点包括在抗生素组中接受阑尾切除术或阑尾完整的患者中，使用磁共振成像检测可能的阑尾肿瘤。

Additional post hoc outcomes were quality of life and patient satisfaction.

额外的事后分析结果包括生活质量评估和患者满意度。

Results

At 10-year follow-up, 253/257 patients (98.4%) randomized to receive antibiotics (median age, 33 years; 102 [40.3%] female) were assessed for appendicitis recurrence, with a true appendicitis recurrence rate (appendicitis at histopathology) of 37.8% (95% CI, 31.6%-44.1% [87/230]) and a cumulative appendectomy rate of 44.3% (95% CI, 38.2%-50.4% [112/253]).

在10年的随访中，257名随机接受抗生素治疗的患者中有253名（98.4%）（中位年龄33岁；102名女性，占40.3%）接受了阑尾炎复发的评估，真正的阑尾炎复发率（组织病理学上的阑尾炎）为37.8%（95%置信区间，31.6%-44.1% [87/230]），累积阑尾切除术的比率为44.3%（95%置信区间，38.2%-50.4% [112/253]）。

Overall, the 10-year cumulative complication rate in the group randomized to appendectomy was 27.4% (95% CI, 21.6%-33.3% [62/226]) and 8.5% (95% CI, 4.8%-12.1% [19/224]) in the group randomized to receive antibiotics (P < .001).

总体而言，随机接受阑尾切除术的组别中，10年累积并发症发生率为27.4%（95%置信区间，21.6%-33.3% [62/226]），而随机接受抗生素治疗的组别为8.5%（95%置信区间，4.8%-12.1% [19/224]）（P < .001）。

There was no observed significant difference in quality of life between antibiotics and appendectomy (387/530; median health index value, 1.0 [95% CI, 1.0-1.0] for both groups; P = .18).

在抗生素治疗组和阑尾切除术组之间，生活质量没有观察到显著差异（387/530；中位健康指数值，两组均为1.0 [95%置信区间，1.0-1.0]；P = .18）。

conclusions_and_relevance

Among patients initially treated with antibiotics for uncomplicated acute appendicitis, the rate of recurrence and appendectomy at 10-year follow-up supports the use of antibiotics as an option for uncomplicated acute appendicitis in adult patients.

在最初接受抗生素治疗的非复杂性急性阑尾炎患者中，10年随访期间的复发率和阑尾切除率支持将抗生素作为成人非复杂性急性阑尾炎的一个治疗选项。

trial_registration

ClinicalTrials.gov Identifier: NCT01022567.

ClinicalTrials.gov 注册号：NCT01022567。