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A Randomized Trial of Colchicine for Acute Pericarditis

医学 秋水仙碱 中止 安慰剂 不利影响 心包炎 内科学 急性心包炎 外科 相对风险 置信区间 随机对照试验 阿司匹林 意向治疗分析 替代医学 病理
作者
Massimo Imazio,Antonio Brucato,Roberto Cemin,Stefania Ferrua,Stefano Maggiolini,Federico Beqaraj,Daniela Demarie,Davide Forno,Silvia Ferro,Silvia Maestroni,Riccardo Belli,Rita Trinchero,David H. Spodick,Yehuda Adler
出处
期刊:The New England Journal of Medicine [Massachusetts Medical Society]
卷期号:369 (16): 1522-1528 被引量:520
标识
DOI:10.1056/nejmoa1208536
摘要

Colchicine is effective for the treatment of recurrent pericarditis. However, conclusive data are lacking regarding the use of colchicine during a first attack of acute pericarditis and in the prevention of recurrent symptoms.In a multicenter, double-blind trial, eligible adults with acute pericarditis were randomly assigned to receive either colchicine (at a dose of 0.5 mg twice daily for 3 months for patients weighing >70 kg or 0.5 mg once daily for patients weighing ≤70 kg) or placebo in addition to conventional antiinflammatory therapy with aspirin or ibuprofen. The primary study outcome was incessant or recurrent pericarditis.A total of 240 patients were enrolled, and 120 were randomly assigned to each of the two study groups. The primary outcome occurred in 20 patients (16.7%) in the colchicine group and 45 patients (37.5%) in the placebo group (relative risk reduction in the colchicine group, 0.56; 95% confidence interval, 0.30 to 0.72; number needed to treat, 4; P<0.001). Colchicine reduced the rate of symptom persistence at 72 hours (19.2% vs. 40.0%, P=0.001), the number of recurrences per patient (0.21 vs. 0.52, P=0.001), and the hospitalization rate (5.0% vs. 14.2%, P=0.02). Colchicine also improved the remission rate at 1 week (85.0% vs. 58.3%, P<0.001). Overall adverse effects and rates of study-drug discontinuation were similar in the two study groups. No serious adverse events were observed.In patients with acute pericarditis, colchicine, when added to conventional antiinflammatory therapy, significantly reduced the rate of incessant or recurrent pericarditis. (Funded by former Azienda Sanitaria Locale 3 of Turin [now Azienda Sanitaria Locale 2] and Acarpia; ICAP ClinicalTrials.gov number, NCT00128453.).

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