A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis
A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis
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DOI：
10.1056/nejmoa2014320
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发表时间：
2020-11-12
影响因子：
158.5
通讯作者：
Talan, David A.
中科院分区：
文献类型：
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作者：
Flum, David R.;Davidson, Giana H.;Talan, David A.
已提出抗生素治疗作为手术治疗阑尾炎的替代方法，我们进行了一项务实的，非盲的，非劣效性，随机试验比较抗生素治疗（10天的课程）与阑尾切除术在25个美国中心的阑尾炎患者。主要结局为30天健康状况，采用欧洲五维生活质量（EQ-5D）问卷进行评估（评分范围为0 - 1，评分越高表示健康状况越好;非劣效性界值为0.05分）。次要结果包括抗生素组的阑尾切除术和90天内的并发症;分析是根据是否存在阑尾结石预先规定的亚组。（414例有结石）接受随机化; 776人被分配接受抗生素（其中47%未住院接受首次治疗），776例接受阑尾切除术（其中96%接受腹腔镜手术）。根据30天EQ-5D评分，抗生素非劣效于阑尾切除术（平均差异，0.01分; 95%置信区间[CI]，-0.001至0.03）。在抗生素组中，29%的人在90天内接受了阑尾切除术，包括41%的阑尾结石患者和25%的无阑尾结石患者。并发症在抗生素组比阑尾切除术组更常见（每100名受试者中8.1 vs. 3.5;率比，2.28; 95% CI，1.30 - 3.98）;抗生素组的较高发生率可归因于有结石的受试者（每100名参与者20.2 vs. 3.6;率比，5.69; 95%CI，2.11至15.38），而不包括无结石的患者（每100名参与者3.7 vs. 3.5;率比，1.05; 95%CI，0.45至2.43）。严重不良事件的发生率为4.0每100名参与者在抗生素组和3.0每100名参与者在阑尾切除术组（率比，1.29; 95%CI，0.67至2.50）。在抗生素组中，近十分之三的参与者在90天内接受了阑尾切除术。有阑尾结石的参与者比没有阑尾结石的参与者有更高的阑尾切除术和并发症风险。
BACKGROUNDAntibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis.METHODSWe 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.RESULTSIn 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).CONCLUSIONSFor 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.