在一项实用双盲随机试验中，抗生素并不能缩短单纯性憩室炎患者的住院时间。

Antibiotics Do Not Reduce Length of Hospital Stay for Uncomplicated Diverticulitis in a Pragmatic Double-Blind Randomized Trial.

作者信息

Jaung Rebekah, Nisbet Sherry, Gosselink Martijn Pieter, Di Re Angelina, Keane Celia, Lin Anthony, Milne Tony, Su'a Bruce, Rajaratnam Siraj, Ctercteko Grahame, Hsee Li, Rowbotham David, Hill Andrew, Bissett Ian

机构信息

Department of Surgery, University of Auckland, Auckland, New Zealand.

Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.

出版信息

Clin Gastroenterol Hepatol. 2021 Mar;19(3):503-510.e1. doi: 10.1016/j.cgh.2020.03.049. Epub 2020 Mar 30.

DOI:10.1016/j.cgh.2020.03.049

PMID:32240832

Abstract

BACKGROUND & AIMS: Antibiotic treatment is the standard care for patients with uncomplicated acute diverticulitis. However, this practice is based on low-level evidence and has been challenged by findings from 2 randomized trials, which did not include a placebo group. We investigated the non-inferiority of placebo vs antibiotic treatment for the management of uncomplicated acute diverticulitis.

METHODS

In the selective treatment with antibiotics for non-complicated diverticulitis study, 180 patients hospitalized for uncomplicated acute diverticulitis (determined by computed tomography, Hinchey 1a grade) from New Zealand and Australia were randomly assigned to groups given antibiotics (n = 85) or placebo (n = 95) for 7 days. We collected demographic, clinical, and laboratory data and answers to questionnaires completed every 12 hrs for the first 48 hrs and then daily until hospital discharge. The primary endpoint was length of hospital stay; secondary endpoints included occurrence of adverse events, readmission to the hospital, procedural intervention, change in serum markers of inflammation, and patient-reported pain scores at 12 and 24 hrs.

RESULTS

There was no significant difference in median time of hospital stay between the antibiotic group (40.0 hrs; 95% CI, 24.4-57.6 hrs) and the placebo group (45.8 hrs; 95% CI, 26.5-60.2 hrs) (P = .2). There were no significant differences between groups in adverse events (12% for both groups; P = 1.0), readmission to the hospital within 1 week (1% for the placebo group vs 6% for the antibiotic group; P = .1), and readmission to the hospital within 30 days (11% for the placebo group vs 6% for the antibiotic group; P = .3).

CONCLUSIONS

Foregoing antibiotic treatment did not prolong length of hospital admission. This result provides strong evidence for omission of antibiotics for selected patients with uncomplicated acute diverticulitis.

ACTRN

12615000249550.

摘要

背景与目的

抗生素治疗是单纯性急性憩室炎患者的标准治疗方法。然而，这种做法基于低质量证据，且受到两项随机试验结果的挑战，这两项试验未设安慰剂组。我们研究了安慰剂与抗生素治疗单纯性急性憩室炎的非劣效性。

方法

在非复杂性憩室炎抗生素选择性治疗研究中，180例因单纯性急性憩室炎（通过计算机断层扫描确定为欣奇1a级）住院的新西兰和澳大利亚患者被随机分为接受抗生素治疗组（n = 85）或安慰剂组（n = 95），为期7天。我们收集了人口统计学、临床和实验室数据，以及在前48小时每12小时填写一次、之后直至出院每天填写一次的问卷答案。主要终点是住院时间；次要终点包括不良事件的发生、再次入院、手术干预、炎症血清标志物的变化以及患者报告的12小时和24小时疼痛评分。

结果

抗生素组的中位住院时间（40.0小时；95%CI，24.4 - 57.6小时）与安慰剂组（45.8小时；95%CI，26.5 - 60.2小时）之间无显著差异（P = 0.2）。两组在不良事件（两组均为12%；P = 1.0）、1周内再次入院（安慰剂组为1%，抗生素组为6%；P = 0.1）和30天内再次入院（安慰剂组为11%，抗生素组为6%；P = 0.3）方面无显著差异。