轻度急性憩室炎非抗生素门诊治疗的疗效与安全性（DINAMO研究）：一项多中心、随机、开放标签、非劣效性试验

Efficacy and Safety of Nonantibiotic Outpatient Treatment in Mild Acute Diverticulitis (DINAMO-study): A Multicentre, Randomised, Open-label, Noninferiority Trial.

作者信息

Mora-López Laura, Ruiz-Edo Neus, Estrada-Ferrer Oscar, Piñana-Campón Maria Luisa, Labró-Ciurans Meritxell, Escuder-Perez Jordi, Sales-Mallafré Ricard, Rebasa-Cladera Pere, Navarro-Soto Salvador, Serra-Aracil Xavier

机构信息

Coloproctology Unit. Parc Tauli University Hospital, Sabadell. Institut d'investigació i innovació Parc Tauli I3PT. Despartment of Surgery, Universitat Autonoma de Barcelona, Spain.

Coloproctology Unit, Mataro Hospital.

出版信息

Ann Surg. 2021 Nov 1;274(5):e435-e442. doi: 10.1097/SLA.0000000000005031.

DOI:10.1097/SLA.0000000000005031

PMID:34183510

Abstract

OBJECTIVE

Mild AD can be treated safely and effectively on an outpatient basis without antibiotics.

SUMMARY OF BACKGROUND DATA

In recent years, it has shown no benefit of antibiotics in the treatment of uncomplicated AD in hospitalized patients. Also, outpatient treatment of uncomplicated AD has been shown to be safe and effective.

METHODS

A Prospective, multicentre, open-label, noninferiority, randomized controlled trial, in 15 hospitals of patients consulting the emergency department with symptoms compatible with AD.The Participants were patients with mild AD diagnosed by Computed Tomography meeting the inclusion criteria were randomly assigned to control arm (ATB-Group): classical treatment (875/125 mg/8 h amoxicillin/clavulanic acid apart from anti-inflammatory and symptomatic treatment) or experimental arm (Non-ATB-Group): experimental treatment (antiinflammatory and symptomatic treatment). Clinical controls were performed at 2, 7, 30, and 90 days.The primary endpoint was hospital admission. Secondary endpoints included number of emergency department revisits, pain control and emergency surgery in the different arms.

RESULTS

Four hundred and eighty patients meeting the inclusion criteria were randomly assigned to Non-ATB-Group (n = 242) or ATB-Group (n = 238). Hospitalization rates were: ATB-Group 14/238 (5.8%) and Non-ATB-Group 8/242 (3.3%) [mean difference 2.58%, 95% confidence interval (CI) 6.32 to -1.17], confirming noninferiority margin. Revisits: ATB-Group 16/238 (6.7%) and Non-ATB-Group 17/242 (7%) (mean difference -0.3, 95% CI 4.22 to -4.83). Poor pain control at 2 days follow up: ATB-Group 13/230 (5.7%), Non-ATB-Group 5/221 (2.3%) (mean difference 3.39, 95% CI 6.96 to -0.18).

CONCLUSIONS

Nonantibiotic outpatient treatment of mild AD is safe and effective and is not inferior to current standard treatment.

TRIAL REGISTRATION

ClinicalTrials.gov (NCT02785549); EU Clinical Trials Register (2016-001596-75).

摘要

目的

轻度急性腹泻病（AD）无需使用抗生素即可在门诊安全有效地治疗。

背景资料总结

近年来，已表明抗生素对住院患者单纯性AD的治疗无益处。此外，单纯性AD的门诊治疗已被证明是安全有效的。

方法

一项前瞻性、多中心、开放标签、非劣效性随机对照试验，在15家医院中对因AD症状到急诊科就诊的患者进行。参与者为经计算机断层扫描诊断为轻度AD且符合纳入标准的患者，随机分配至对照组（抗生素组）：采用经典治疗（除抗炎和对症治疗外，每8小时服用875/125毫克阿莫西林/克拉维酸）或试验组（非抗生素组）：采用试验性治疗（抗炎和对症治疗）。在第2、7、30和90天进行临床对照。主要终点是住院情况。次要终点包括不同组别的急诊科复诊次数、疼痛控制情况和急诊手术情况。

结果

480名符合纳入标准的患者被随机分配至非抗生素组（n = 242）或抗生素组（n = 238）。住院率分别为：抗生素组14/238（5.8%），非抗生素组8/242（3.3%）[平均差异2.58%，95%置信区间（CI）6.32至 -1.17]，证实了非劣效性界限。复诊情况：抗生素组16/238（6.7%），非抗生素组17/242（7%）（平均差异 -0.3，95% CI 4.22至 -4.83）。随访2天时疼痛控制不佳的情况：抗生素组13/230（5.7%），非抗生素组5/221（2.3%）（平均差异3.39，95% CI 6.96至 -0.18）。