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阑尾切除术与抗生素治疗急性阑尾炎的比较。

Appendectomy versus antibiotic treatment for acute appendicitis.

机构信息

Department of Surgery and Anaesthesia, Division of Medical Sciences and Graduate Entry Medicine, School of Medicine, University of Nottingham, Derby, UK.

Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, Herlev, Denmark.

出版信息

Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD015038. doi: 10.1002/14651858.CD015038.pub2.

Abstract

BACKGROUND

Acute appendicitis is one of the most common emergency general surgical conditions worldwide. Uncomplicated/simple appendicitis can be treated with appendectomy or antibiotics. Some studies have suggested possible benefits with antibiotics with reduced complications, length of hospital stay, and the number of days off work. However, surgery may improve success of treatment as antibiotic treatment is associated with recurrence and future need for surgery.

OBJECTIVES

To assess the effects of antibiotic treatment for uncomplicated/simple acute appendicitis compared with appendectomy for resolution of symptoms and complications.

SEARCH METHODS

We searched CENTRAL, MEDLINE, Embase, and two trial registers (World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov) on 19 July 2022. We also searched for unpublished studies in conference proceedings together with reference checking and citation search. There were no restrictions on date, publication status, or language of publication.

SELECTION CRITERIA

We included parallel-group randomised controlled trials (RCTs) only. We included studies where most participants were adults with uncomplicated/simple appendicitis. Interventions included antibiotics (by any route) compared with appendectomy (open or laparoscopic).

DATA COLLECTION AND ANALYSIS

We used standard methodology expected by Cochrane. We used GRADE to assess the certainty of evidence for each outcome. Primary outcomes included mortality and success of treatment, and secondary outcomes included number of participants requiring appendectomy in the antibiotic group, complications, pain, length of hospital stay, sick leave, malignancy in the antibiotic group, negative appendectomy rate, and quality of life. Success of treatment definitions were heterogeneous although mainly based on resolution of symptoms rather than incorporation of long-term recurrence or need for surgery in the antibiotic group.

MAIN RESULTS

We included 13 studies in the review covering 1675 participants randomised to antibiotics and 1683 participants randomised to appendectomy. One study was unpublished. All were conducted in secondary care and two studies received pharmaceutical funding. All studies used broad-spectrum antibiotic regimens expected to cover gastrointestinal bacteria. Most studies used predominantly laparoscopic surgery, but some included mainly open procedures. Six studies included adults and children. Almost all studies aimed to exclude participants with complicated appendicitis prior to randomisation, although one study included 12% with perforation. The diagnostic technique was clinical assessment and imaging in most studies. Only one study limited inclusion by sex (male only). Follow-up ranged from hospital admission only to seven years. Certainty of evidence was mainly affected by risk of bias (due to lack of blinding and loss to follow-up) and imprecision. Primary outcomes It is uncertain whether there was any difference in mortality due to the very low-certainty evidence (Peto odds ratio (OR) 0.51, 95% confidence interval (CI) 0.05 to 4.95; 1 study, 492 participants). There may be 76 more people per 1000 having unsuccessful treatment in the antibiotic group compared with surgery, which did not reach our predefined level for clinical significance (risk ratio (RR) 0.91, 95% CI 0.87 to 0.96; I = 69%; 7 studies, 2471 participants; low-certainty evidence). Secondary outcomes At one year, 30.7% (95% CI 24.0 to 37.8; I = 80%; 9 studies, 1396 participants) of participants in the antibiotic group required appendectomy or, alternatively, more than two-thirds of antibiotic-treated participants avoided surgery in the first year, but the evidence is very uncertain. Regarding complications, it is uncertain whether there is any difference in episodes of Clostridium difficile diarrhoea due to very low-certainty evidence (Peto OR 0.97, 95% CI 0.24 to 3.89; 1 study, 1332 participants). There may be a clinically significant reduction in wound infections with antibiotics (RR 0.25, 95% CI 0.09 to 0.68; I = 16%; 9 studies, 2606 participants; low-certainty evidence). It is uncertain whether antibiotics affect the incidence of intra-abdominal abscess or collection (RR 1.58, 95% CI 0.61 to 4.07; I = 19%; 6 studies, 1831 participants), or reoperation (Peto OR 0.13, 95% CI 0.01 to 2.16; 1 study, 492 participants) due to very low-certainty evidence, mainly due to rare events causing imprecision and risk of bias. It is uncertain if antibiotics prolonged length of hospital stay by half a day due to the very low-certainty evidence (MD 0.54, 95% CI 0.06 to 1.01; I = 97%; 11 studies, 3192 participants). The incidence of malignancy was 0.3% (95% CI 0 to 1.5; 5 studies, 403 participants) in the antibiotic group although follow-up was variable. Antibiotics probably increased the number of negative appendectomies at surgery (RR 3.16, 95% CI 1.54 to 6.49; I = 17%; 5 studies, 707 participants; moderate-certainty evidence).

AUTHORS' CONCLUSIONS: Antibiotics may be associated with higher rates of unsuccessful treatment for 76 per 1000 people, although differences may not be clinically significant. It is uncertain if antibiotics increase length of hospital stay by half a day. Antibiotics may reduce wound infections. A third of the participants initially treated with antibiotics required subsequent appendectomy or two-thirds avoided surgery within one year, but the evidence is very uncertain. There were too few data from the included studies to comment on major complications.

摘要

背景

急性阑尾炎是全球最常见的普通外科急症之一。单纯性/简单性阑尾炎可以采用阑尾切除术或抗生素治疗。一些研究表明,抗生素治疗可能具有减少并发症、住院时间和缺勤天数的益处。然而,手术可能会提高治疗成功率,因为抗生素治疗与复发和未来需要手术有关。

目的

评估单纯性/简单性急性阑尾炎的抗生素治疗与阑尾切除术在缓解症状和并发症方面的效果。

检索方法

我们于 2022 年 7 月 19 日在 CENTRAL、MEDLINE、Embase 和两个试验注册库(世界卫生组织国际临床试验注册平台和 ClinicalTrials.gov)上进行了检索。我们还检索了会议记录中的未发表研究以及参考文献和引文检索。没有对日期、出版状态或语言出版进行限制。

选择标准

我们仅纳入了平行组随机对照试验(RCT)。我们纳入的研究对象主要为成人,患有单纯性/简单性阑尾炎。干预措施包括抗生素(任何途径)与阑尾切除术(开放或腹腔镜)。

数据收集和分析

我们使用了 Cochrane 预期的标准方法。我们使用 GRADE 评估了每个结局的证据确定性。主要结局包括死亡率和治疗成功率,次要结局包括抗生素组中需要行阑尾切除术的参与者人数、并发症、疼痛、住院时间、病假、抗生素组中的恶性肿瘤、阴性阑尾切除率和生活质量。尽管治疗成功的定义主要基于症状缓解,而不是纳入抗生素组的长期复发或需要手术,但这些定义存在很大差异。

主要结果

我们纳入了 13 项研究,共纳入了 1675 名接受抗生素治疗的参与者和 1683 名接受阑尾切除术的参与者。其中一项研究未发表。所有研究均在二级保健机构进行,两项研究获得了制药公司的资助。所有研究均使用广谱抗生素方案,预计可覆盖胃肠道细菌。大多数研究使用的是腹腔镜手术,但也有一些研究主要采用开放手术。六项研究纳入了成人和儿童。几乎所有研究都旨在在随机分组前排除患有复杂性阑尾炎的患者,尽管一项研究纳入了 12%的穿孔患者。诊断技术主要是临床评估和影像学检查。仅有一项研究限制了性别纳入(仅限男性)。随访时间从住院到七年不等。证据的确定性主要受到偏倚风险(由于缺乏盲法和失访)和不精确性的影响。主要结局由于极低确定性证据(Peto 比值比(OR)0.51,95%置信区间(CI)0.05 至 4.95;1 项研究,492 名参与者),我们不确定抗生素治疗是否会导致死亡率的任何差异。与手术相比,抗生素组中可能有 76 人以上的人治疗不成功,这没有达到我们预定的临床意义水平(风险比(RR)0.91,95%CI 0.87 至 0.96;I = 69%;7 项研究,2471 名参与者;低确定性证据)。次要结局在一年时,抗生素组中 30.7%(95%CI 24.0 至 37.8;I = 80%;9 项研究,1396 名参与者)的参与者需要行阑尾切除术,或者在第一年,超过三分之二的接受抗生素治疗的参与者避免了手术,但证据非常不确定。关于并发症,由于极低确定性证据(Peto OR 0.97,95%CI 0.24 至 3.89;1 项研究,1332 名参与者),我们不确定是否会因抗生素治疗而出现更多的艰难梭菌腹泻病例。抗生素可能会显著降低伤口感染的发生率(RR 0.25,95%CI 0.09 至 0.68;I = 16%;9 项研究,2606 名参与者;低确定性证据)。由于极低确定性证据,我们不确定抗生素是否会影响腹腔脓肿或积液(RR 1.58,95%CI 0.61 至 4.07;I = 19%;6 项研究,1831 名参与者)或再次手术(Peto OR 0.13,95%CI 0.01 至 2.16;1 项研究,492 名参与者)的发生率,这主要是由于罕见事件导致的不精确性和偏倚风险。由于极低确定性证据,我们不确定抗生素是否会使住院时间延长半天(MD 0.54,95%CI 0.06 至 1.01;I = 97%;11 项研究,3192 名参与者)。抗生素组的恶性肿瘤发病率为 0.3%(95%CI 0 至 1.5;5 项研究,403 名参与者),但随访时间不同。抗生素治疗可能会增加手术时的阴性阑尾切除率(RR 3.16,95%CI 1.54 至 6.49;I = 17%;5 项研究,707 名参与者;中等确定性证据)。

作者结论

抗生素治疗可能与 76 人以上的人治疗不成功有关,尽管差异可能没有临床意义。抗生素治疗可能会使住院时间延长半天。抗生素可能会降低伤口感染的风险。最初接受抗生素治疗的三分之一参与者需要随后进行阑尾切除术,或者三分之二的人在一年内避免了手术,但证据非常不确定。纳入研究的数据太少,无法对主要并发症发表意见。

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