Mesh : Acute Disease Anti-Bacterial Agents / therapeutic use Delphi Technique Disease Progression Diverticulitis, Colonic / drug therapy Equivalence Trials as Topic Humans Treatment Outcome Watchful Waiting

来  源:   DOI:10.1016/j.surg.2021.07.012   PDF(Sci-hub)

Abstract:
The purpose of this study was to determine if observational therapy is noninferior to antibiotics for acute uncomplicated diverticulitis according to clinically relevant margins.
MEDLINE, EMBASE, and Cochrane were systematically searched by 2 independent reviewers to identify comparative studies of observational therapy versus antibiotics for acute uncomplicated diverticulitis. Non-inferiority margins (ΔNI) for each outcome were based on Delphi consensus including 50 patients and 55 physicians: persistent diverticulitis (ΔNI = 4.0%), progression to complicated diverticulitis (ΔNI = 3.0%), and time to recovery (ΔNI = 5 days). Risk differences and mean differences were pooled using random-effects meta-analysis. One-sided 90% confidence intervals and Z-tests were used to determine non-inferiority. A sensitivity analysis was performed, excluding patients post hoc determined to have complicated diverticulitis.
Nine studies (3 randomized controlled trials, 6 observational studies) met inclusion criteria: observational therapy (n = 2,011) versus antibiotics (n = 1,144). Observational therapy was noninferior to antibiotics regarding the risk of persistent diverticulitis (pooled risk differences: -0.39%, 90% CI -3.22 to 2.44%, ΔNI: 4.0%, PNI < 0.001; I2 = 66%) and progression to complicated diverticulitis (pooled risk differences: -0.030%, 90% CI -0.99 to 0.92%, ΔNI: 3.0%, PNI < 0.001; I2 = 0%). On sensitivity analysis, observational therapy remained noninferior for both outcomes. When stratified by study design, observational therapy also remained noninferior for both outcomes among randomized controlled trials only. Only 1 study reported on time to recovery as a continuous outcome, with no statistical difference between antibiotics and observational therapy.
According to clinically relevant ΔNIs, observational therapy was noninferior to antibiotics for the treatment of acute uncomplicated diverticulitis with regard to persistent diverticulitis and progression to complicated diverticulitis.
摘要:
这项研究的目的是根据临床相关的切缘,确定观察性治疗是否不劣于抗生素治疗急性单纯性憩室炎。
MEDLINE,EMBASE,和Cochrane由2名独立审核员进行系统搜索,以确定急性非复杂性憩室炎的观察性治疗与抗生素的比较研究.每个结果的非劣效性(ΔNI)基于Delphi共识,包括50名患者和55名医生:持续性憩室炎(ΔNI=4.0%),进展为复杂性憩室炎(ΔNI=3.0%),和恢复时间(ΔNI=5天)。使用随机效应荟萃分析汇总风险差异和平均差异。单侧90%置信区间和Z检验用于确定非劣效性。进行了敏感性分析,排除事后确定患有复杂憩室炎的患者。
九项研究(3项随机对照试验,6项观察性研究)符合纳入标准:观察性治疗(n=2,011)与抗生素(n=1,144)。关于持续性憩室炎的风险,观察性治疗不劣于抗生素(合并风险差异:-0.39%,90%CI-3.22至2.44%,ΔNI:4.0%,PNI<0.001;I2=66%)和进展为复杂性憩室炎(合并风险差异:-0.030%,90%CI-0.99至0.92%,ΔNI:3.0%,PNI<0.001;I2=0%)。关于敏感性分析,两种结局的观察性治疗均不逊色.当按研究设计分层时,仅在随机对照试验中,观察性治疗在两种结局方面均未逊色.只有一项研究报告说,恢复时间是连续的结果,抗生素和观察性治疗之间没有统计学差异。
根据临床相关ΔNI,对于持续性憩室炎和进展为复杂性憩室炎的急性非复杂性憩室炎,观察性治疗不劣于抗生素。
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