Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.
Department of Surgery, University of Turku, Turku, Finland.
JAMA. 2021 Jan 26;325(4):353-362. doi: 10.1001/jama.2020.23525.
Antibiotics are an effective and safe alternative to appendectomy for managing uncomplicated acute appendicitis, but the optimal antibiotic regimen is not known.
To compare oral antibiotics with combined intravenous followed by oral antibiotics in the management of computed tomography-confirmed uncomplicated acute appendicitis.
DESIGN, SETTING, AND PARTICIPANTS: The Appendicitis Acuta (APPAC) II multicenter, open-label, noninferiority randomized clinical trial was conducted from April 2017 until November 2018 in 9 Finnish hospitals. A total of 599 patients aged 18 to 60 years with computed tomography-confirmed uncomplicated acute appendicitis were enrolled in the trial. The last date of follow-up was November 29, 2019.
Patients randomized to receive oral monotherapy (n = 295) received oral moxifloxacin (400 mg/d) for 7 days. Patients randomized to receive intravenous antibiotics followed by oral antibiotics (n = 288) received intravenous ertapenem (1 g/d) for 2 days followed by oral levofloxacin (500 mg/d) and metronidazole (500 mg 3 times/d) for 5 days.
The primary end point was treatment success (≥65%) for both groups, defined as discharge from hospital without surgery and no recurrent appendicitis during 1-year follow-up, and to determine whether oral antibiotics alone were noninferior to intravenous and oral antibiotics, with a margin of 6% for difference.
Among 599 patients who were randomized (mean [SD] age, 36 [12] years; 263 [44%] women), 581 (99.7%) were available for the 1-year follow-up. The treatment success rate at 1 year was 70.2% (1-sided 95% CI, 65.8% to ∞) for patients treated with oral antibiotics and 73.8% (1-sided 95% CI, 69.5% to ∞) for patients treated with intravenous followed by oral antibiotics. The difference was -3.6% ([1-sided 95% CI, -9.7% to ∞]; P = .26 for noninferiority), with the confidence limit exceeding the noninferiority margin.
Among adults with uncomplicated acute appendicitis, treatment with 7 days of oral moxifloxacin compared with 2 days of intravenous ertapenem followed by 5 days of levofloxacin and metronidazole resulted in treatment success rates greater than 65% in both groups, but failed to demonstrate noninferiority for treatment success of oral antibiotics compared with intravenous followed by oral antibiotics.
ClinicalTrials.gov Identifier: NCT03236961; EudraCT Identifier: 2015-003633-10.
抗生素是治疗单纯性急性阑尾炎的有效且安全的替代方案，但最佳抗生素方案尚不清楚。
比较口服抗生素与静脉联合口服抗生素在计算机断层扫描（CT）确诊的单纯性急性阑尾炎治疗中的作用。
设计、地点和参与者：这项多中心、开放性、非劣效性 APPAC II 随机临床试验于 2017 年 4 月至 2018 年 11 月在芬兰的 9 家医院进行。共有 599 名年龄在 18 至 60 岁之间的 CT 确诊为单纯性急性阑尾炎的患者参与了该试验。最后随访日期为 2019 年 11 月 29 日。
接受口服单药治疗的患者（n=295）接受口服莫西沙星（400mg/d）治疗 7 天。接受静脉抗生素联合口服抗生素治疗的患者（n=288）接受静脉注射厄他培南（1g/d）治疗 2 天，然后口服左氧氟沙星（500mg/d）和甲硝唑（500mg，每日 3 次）治疗 5 天。
主要终点为两组的治疗成功率（≥65%），定义为无手术出院且 1 年随访期间无复发性阑尾炎，以确定口服抗生素是否不劣于静脉和口服抗生素，差异幅度为 6%。
在 599 名接受随机分组的患者中（平均[SD]年龄为 36[12]岁；263[44%]为女性），581 名（99.7%）患者完成了 1 年随访。接受口服抗生素治疗的患者 1 年治疗成功率为 70.2%（单侧 95%CI，65.8%至∞），接受静脉联合口服抗生素治疗的患者为 73.8%（单侧 95%CI，69.5%至∞）。差异为-3.6%（单侧 95%CI，-9.7%至∞）；P=0.26 表示非劣效性），置信限超过非劣效性边界。
在单纯性急性阑尾炎的成年患者中，与静脉注射 2 天厄他培南后再口服 5 天左氧氟沙星和甲硝唑相比，7 天口服莫西沙星治疗可使两组的治疗成功率均大于 65%，但未能证明口服抗生素治疗与静脉联合口服抗生素治疗相比不劣效。
ClinicalTrials.gov 标识符：NCT03236961；EudraCT 标识符：2015-003633-10。
