The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).
N Engl J Med. 2020 Nov 12;383(20):1907-1919. doi: 10.1056/NEJMoa2014320. Epub 2020 Oct 5.
Antibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis.
We conducted a pragmatic, nonblinded, noninferiority, randomized trial comparing antibiotic therapy (10-day course) with appendectomy in patients with appendicitis at 25 U.S. centers. The primary outcome was 30-day health status, as assessed with the European Quality of Life-5 Dimensions (EQ-5D) questionnaire (scores range from 0 to 1, with higher scores indicating better health status; noninferiority margin, 0.05 points). Secondary outcomes included appendectomy in the antibiotics group and complications through 90 days; analyses were prespecified in subgroups defined according to the presence or absence of an appendicolith.
In total, 1552 adults (414 with an appendicolith) underwent randomization; 776 were assigned to receive antibiotics (47% of whom were not hospitalized for the index treatment) and 776 to undergo appendectomy (96% of whom underwent a laparoscopic procedure). Antibiotics were noninferior to appendectomy on the basis of 30-day EQ-5D scores (mean difference, 0.01 points; 95% confidence interval [CI], -0.001 to 0.03). In the antibiotics group, 29% had undergone appendectomy by 90 days, including 41% of those with an appendicolith and 25% of those without an appendicolith. Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43). The rate of serious adverse events was 4.0 per 100 participants in the antibiotics group and 3.0 per 100 participants in the appendectomy group (rate ratio, 1.29; 95% CI, 0.67 to 2.50).
For the treatment of appendicitis, antibiotics were noninferior to appendectomy on the basis of results of a standard health-status measure. In the antibiotics group, nearly 3 in 10 participants had undergone appendectomy by 90 days. Participants with an appendicolith were at a higher risk for appendectomy and for complications than those without an appendicolith. (Funded by the Patient-Centered Outcomes Research Institute; CODA ClinicalTrials.gov number, NCT02800785.).
抗生素治疗已被提议作为治疗阑尾炎的替代方法。
我们在美国 25 个中心进行了一项实用、非盲、非劣效、随机试验，比较了抗生素治疗（10 天疗程）与阑尾切除术在阑尾炎患者中的疗效。主要结局是采用欧洲生活质量 5 维度（EQ-5D）问卷评估的 30 天健康状况（评分范围为 0 至 1，分数越高表示健康状况越好；非劣效性边界为 0.05 分）。次要结局包括抗生素组中转行阑尾切除术以及 90 天内的并发症；分析预先根据有无阑尾结石进行了亚组定义。
共有 1552 名成年人（414 名有阑尾结石）接受了随机分组；776 名被分配接受抗生素治疗（其中 47%未住院接受指数治疗），776 名接受阑尾切除术（其中 96%接受腹腔镜手术）。基于 30 天 EQ-5D 评分，抗生素治疗不劣于阑尾切除术（平均差值，0.01 分；95%置信区间 [CI]，-0.001 至 0.03）。在抗生素组中，90 天内有 29%的患者接受了阑尾切除术，其中有阑尾结石的患者占 41%，无阑尾结石的患者占 25%。抗生素组的并发症发生率高于阑尾切除术组（每 100 名参与者分别为 8.1 例和 3.5 例；发生率比，2.28；95%CI，1.30 至 3.98）；抗生素组的高发生率归因于有阑尾结石的患者（每 100 名参与者分别为 20.2 例和 3.6 例；发生率比，5.69；95%CI，2.11 至 15.38），而不是无阑尾结石的患者（每 100 名参与者分别为 3.7 例和 3.5 例；发生率比，1.05；95%CI，0.45 至 2.43）。抗生素组的严重不良事件发生率为每 100 名参与者 4.0 例，阑尾切除术组为每 100 名参与者 3.0 例（发生率比，1.29；95%CI，0.67 至 2.50）。
基于标准健康状况测量结果，抗生素治疗在治疗阑尾炎方面不劣于阑尾切除术。在抗生素组中，近 10 名参与者中有 3 名在 90 天内接受了阑尾切除术。有阑尾结石的参与者发生阑尾切除术和并发症的风险高于无阑尾结石的参与者。（由患者为中心的成果研究所资助；CODA ClinicalTrials.gov 编号，NCT02800785。）
