美国华盛顿大学David R. Flum团队比较了抗生素和阑尾切除术治疗阑尾炎的疗效。2020年10月5日，《新英格兰医学杂志》发表了该成果。

目前已有人提出抗生素疗法可作为手术治疗阑尾炎的替代方法。

研究组在美国25个中心进行了一项实用、非盲、非劣效性、随机对照试验，比较了抗生素（10天疗程）和阑尾切除术治疗阑尾炎患者的疗效。主要结局为30天健康状况，根据《欧洲生活质量5维》（EQ-5D）问卷进行评估，评分范围从0到1，得分越高表明健康状况越好；非劣效性阈值为0.05分。

共有1552名成人（414名有阑尾粪石）进行了随机分组，其中776名接受抗生素治疗（其中47％的人因指数治疗未住院），776名接受阑尾切除术（其中96％接受了腹腔镜手术）。

根据30天EQ-5D评分（平均差异0.01分），抗生素治疗不逊于阑尾切除术。抗生素组中有29％的患者在90天后接受了阑尾切除术，其中41％的患者有阑尾粪石，而25％的患者没有阑尾粪石。

抗生素组的并发症发生率为每100名参与者中8.1例，显著高于阑尾切除术组（3.5例），抗生素组中较高的发生率可归因于有阑尾粪石的患者。抗生素组中严重不良事件的发生率为每100名参与者中4.0例，在阑尾切除术组为3.0例，差异不显著。

研究结果表明，抗生素治疗阑尾炎不逊于阑尾切除术。在抗生素组中，有阑尾粪石的参与者发生阑尾切除术和并发症的风险更高。

附：英文原文

Title: A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis | NEJM

Author: The CODA Collaborative

Issue&Volume: 2020-10-05

Abstract:

Background

Antibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis.

Methods

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.

Results

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).

Conclusions

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.

DOI: 10.1056/NEJMoa2014320

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2014320