芬兰图尔库大学Paulina Salminen团队比较了口服莫西沙星与静脉注射厄他培南联合口服左氧氟沙星治疗单纯性急性阑尾炎的疗效。2021年1月11日，该研究发表在《美国医学会杂志》上。

抗生素是治疗单纯性急性阑尾炎的有效方法，可替代阑尾切除术，但尚无最佳抗生素治疗方案。

为了比较口服抗生素与静脉注射联合口服抗生素治疗经CT扫描证实无并发症的急性阑尾炎的疗效，2017年4月至2018年11月，研究组在芬兰的9家医院进行了一项多中心、开放标签、非劣效性随机临床试验。共招募了599名年龄为18至60岁、CT确诊的无并发症急性阑尾炎患者，最后随访日期为2019年11月29日。

将其随机分组，其中295例接受口服莫西沙星（400mg/d）7天，288例接受静脉注射厄他培南（1g/d）2天+口服左氧氟沙星（500mg/d）和甲硝唑（500mg/d）5天。两组的主要终点均为治疗成功率（≥65%），定义为出院后无手术，随访1年无阑尾炎复发。599例患者的平均年龄为36岁，其中44%为女性，581例（99.7％）接受了1年随访。口服抗生素组1年治疗成功率为70.2%，静脉滴注联合口服抗生素组为73.8%，组间差异不显著。

研究结果表明，对于没有并发症的成人急性阑尾炎，口服莫西沙星7天，与静脉注射厄他培南2天、左氧氟沙星和甲硝唑口服5天相比，两组的治疗成功率均超过65％，但差异不显著。

附：英文原文

Title: Effect of Oral Moxifloxacin vs Intravenous Ertapenem Plus Oral Levofloxacin for Treatment of Uncomplicated Acute Appendicitis: The APPAC II Randomized Clinical Trial

Author: Suvi Sippola, Jussi Haijanen, Juha Grnroos, Tero Rautio, Pia Nordstrm, Tuomo Rantanen, Tarja Pinta, Imre Ilves, Anne Mattila, Jukka Rintala, Eliisa Lyttyniemi, Saija Hurme, Ville Tammilehto, Harri Marttila, Sanna Merilinen, Johanna Laukkarinen, Eeva-Liisa Svel, Heini Savolainen, Tomi Sippola, Markku Aarnio, Hannu Paajanen, Paulina Salminen

Issue&Volume: 2021-01-11

Abstract:

Importance  Antibiotics are an effective and safe alternative to appendectomy for managing uncomplicated acute appendicitis, but the optimal antibiotic regimen is not known.

Objective  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.

Interventions  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.

Main Outcomes and Measures  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.

Results  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.

Conclusion and Relevance  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.

DOI: 10.1001/jama.2020.23525

Source: https://jamanetwork.com/journals/jama/fullarticle/2775227