Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT-proven uncomplicated acute diverticulitis
Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT-proven uncomplicated acute diverticulitis
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DOI：
10.1002/bjs.10309
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发表时间：
2017-01-01
影响因子：
9.6
通讯作者：
Boermeester, M. A.
中科院分区：
文献类型：
--
作者：
Daniels, L.;Unlu, C.;Boermeester, M. A.
背景：尽管缺乏证据支持抗生素的常规使用，但大多数急性憩室炎指南都建议使用抗生素。本试验比较了一个战略的有效性，或没有抗生素的首次发作的单纯性急性憩室炎。方法：CT证实，原发性，左侧，单纯性，急性憩室炎患者被列入在22个临床网站在荷兰，并随机分配到一个观察或抗生素治疗策略。主要终点是6个月随访期间的恢复时间。主要次要终点为再入院率、并发、持续和复发性憩室炎、乙状结肠切除术和死亡率。进行意向治疗和符合方案分析。结果：共纳入528例患者。中位恢复时间为14（i.q.r. 6-35）天，抗生素治疗策略为12（7-30）天，恢复的风险比为0.91（单侧95%置信区间下限）。0.78; P = 0.151）。观察组和抗生素治疗组的次要终点：并发性憩室炎无显著差异（分别为3.8%和2.6%; P = 0.377），正在进行的憩室炎（7.3%对4.1%; P = 0.183），复发性憩室炎（3.4%对3.0%; P = 0.494），乙状结肠切除术（3.8%对2.3%; P = 0.323），再入院（17.6对12.0%; P = 0.148），不良事件（48.5对54.5%; P = 0.221）和死亡率（1.1对0.4%; P = 0.432）。观察组的住院时间明显较短（2 vs 3天; P = 0.006）。符合协议的分析是一致的意向治疗analysis.Conclusion：观察治疗无抗生素并没有延长恢复，可以被认为是适当的，在单纯性憩室炎的患者。注册号：NCT 01111253（http：www.clinicaltrials.gov）。
Background: Antibiotics are advised in most guidelines on acute diverticulitis, despite a lack of evidence to support their routine use. This trial compared the effectiveness of a strategy with or without antibiotics for a first episode of uncomplicated acute diverticulitis.Methods: Patients with CT-proven, primary, left-sided, uncomplicated, acute diverticulitis were included at 22 clinical sites in the Netherlands, and assigned randomly to an observational or antibiotic treatment strategy. The primary endpoint was time to recovery during 6 months of follow-up. Main secondary endpoints were readmission rate, complicated, ongoing and recurrent diverticulitis, sigmoid resection and mortality. Intention-to-treat and per-protocol analyses were done.Results: A total of 528 patients were included. Median time to recovery was 14 (i.q.r. 6-35) days for the observational and 12 (7-30) days for the antibiotic treatment strategy, with a hazard ratio for recovery of 0.91 (lower limit of 1-sided 95 per cent c.i. 0.78; P = 0.151). No significant differences between the observation and antibiotic treatment groups were found for secondary endpoints: complicated diverticulitis (3.8 versus 2.6 per cent respectively; P = 0.377), ongoing diverticulitis (7.3 versus 4.1 per cent; P = 0.183), recurrent diverticulitis (3.4 versus 3.0 per cent; P = 0.494), sigmoid resection (3.8 versus 2.3 per cent; P = 0.323), readmission (17.6 versus 12.0 per cent; P = 0.148), adverse events (48.5 versus 54.5 per cent; P = 0.221) and mortality (1.1 versus 0.4 per cent; P = 0.432). Hospital stay was significantly shorter in the observation group (2 versus 3 days; P = 0.006). Per-protocol analyses were concordant with the intention-to-treat analyses.Conclusion: Observational treatment without antibiotics did not prolong recovery and can be considered appropriate in patients with uncomplicated diverticulitis. Registration number: NCT01111253 (http://www.clinicaltrials.gov).