Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial
Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial
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DOI：
10.1016/s0140-6736(11)60410-8
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发表时间：
2011-05-07
期刊：
影响因子：
168.9
通讯作者：
Franco, Dominique
中科院分区：
文献类型：
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作者：
Vons, Corinne;Barry, Caroline;Franco, Dominique
研究人员认为抗生素可以治疗急性阑尾炎。我们评估了阿莫西林加克拉维酸的疗效比较与紧急阑尾切除术治疗患者无并发症的急性appendicitis.Methods在这个开放标签，非劣效性，随机试验，成人患者（年龄18-68岁）与无并发症的急性阑尾炎，CT扫描评估，在法国的6所大学医院。使用计算机生成的随机序列，以1：1的比例将患者随机分配至接受阿莫西林+克拉维酸（每天3 g）治疗8-15天或紧急阑尾切除术。主要终点是治疗开始后30天内发生干预后腹膜炎。如果发生率差异的双侧95% CI上限低于10个百分点，则显示非劣效性。进行了意向治疗分析和符合方案分析。该试验在ClinicalTrials.gov注册，编号NCT 00135603。结果在随机分配的243名患者中，123名被分配到抗生素组，120名被分配到阑尾切除术组。4例患者因在接受干预前提前退出而被排除在分析之外，剩下239例患者（抗生素组，120例;阑尾切除术组，119例）进行意向治疗分析。30-抗生素组（8%，n=9）干预后1天腹膜炎的发生率显著高于阑尾切除术组（2%，n=2;治疗差异5.8; 95% CI 0.3-12.1）。在阑尾切除术组中，尽管进行了CT扫描评估，但119名患者中有21名（18%）在手术时意外发现患有并发性阑尾炎伴腹膜炎。在抗生素组，14（12% [7.1-18.6]）在前30天和30天内接受了阑尾切除术。（29% [21.4-38.9]）的102例患者在1个月至1年内接受了阑尾切除术，其中26例患有急性阑尾炎（复发率26%; 18.0-34.7）。解释阿莫西林加克拉维酸治疗急性阑尾炎并非非劣效于急诊阑尾切除术。在CT扫描上识别预测标志物可能有助于改善抗生素治疗的靶向。
Background Researchers have suggested that antibiotics could cure acute appendicitis. We assessed the efficacy of amoxicillin plus clavulanic acid by comparison with emergency appendicectomy for treatment of patients with uncomplicated acute appendicitis.Methods In this open-label, non-inferiority, randomised trial, adult patients (aged 18-68 years) with uncomplicated acute appendicitis, as assessed by CT scan, were enrolled at six university hospitals in France. A computer-generated randomisation sequence was used to allocate patients randomly in a 1:1 ratio to receive amoxicillin plus clavulanic acid (3 g per day) for 8-15 days or emergency appendicectomy. The primary endpoint was occurrence of postintervention peritonitis within 30 days of treatment initiation. Non-inferiority was shown if the upper limit of the two-sided 95% CI for the difference in rates was lower than 10 percentage points. Both intention-to-treat and per-protocol analyses were done. This trial is registered with ClinicalTrials.gov, number NCT00135603.Findings Of 243 patients randomised, 123 were allocated to the antibiotic group and 120 to the appendicectomy group. Four were excluded from analysis because of early dropout before receiving the intervention, leaving 239 (antibiotic group, 120; appendicectomy group, 119) patients for intention-to-treat analysis. 30-day postintervention peritonitis was significantly more frequent in the antibiotic group (8%, n=9) than in the appendicectomy group (2%, n=2; treatment difference 5.8; 95% CI 0.3-12.1). In the appendicectomy group, despite CT-scan assessment, 21 (18%) of 119 patients were unexpectedly identified at surgery to have complicated appendicitis with peritonitis. In the antibiotic group, 14 (12% [7.1-18.6]) of 120 underwent an appendicectomy during the first 30 days and 30 (29% [21.4-38.9]) of 102 underwent appendicectomy between 1 month and 1 year, 26 of whom had acute appendicitis (recurrence rate 26%; 18.0-34.7).Interpretation Amoxicillin plus clavulanic acid was not non-inferior to emergency appendicectomy for treatment of acute appendicitis. Identification of predictive markers on CT scans might enable improved targeting of antibiotic treatment.