Maria Vittoria Hospital and Ospedale degli Infermi, Torino, Ospedali Riuniti, Bergamo, San Maurizio Regional Hospital, Bolzano, Italy.
Ann Intern Med. 2011 Oct 4;155(7):409-14. doi: 10.7326/0003-4819-155-7-201110040-00359. Epub 2011 Aug 28.
Recurrence is the most common complication of pericarditis, affecting 10% to 50% of patients.
To evaluate the efficacy and safety of colchicine for the secondary prevention of recurrent pericarditis.
Prospective, randomized, double-blind, placebo-controlled multicenter trial. (ClinicalTrials.gov registration number: NCT00128414) SETTING: 4 general hospitals in urban areas of Italy.
120 patients with a first recurrence of pericarditis.
In addition to conventional treatment, patients were randomly assigned to receive either placebo or colchicine, 1.0 to 2.0 mg on the first day followed by a maintenance dose of 0.5 to 1.0 mg/d, for 6 months.
The primary study end point was the recurrence rate at 18 months. Secondary end points were symptom persistence at 72 hours, remission rate at 1 week, number of recurrences, time to first recurrence, disease-related hospitalization, cardiac tamponade, and rate of constrictive pericarditis.
At 18 months, the recurrence rate was 24% in the colchicine group and 55% in the placebo group (absolute risk reduction, 0.31 [95% CI, 0.13 to 0.46]; relative risk reduction, 0.56 [CI, 0.27 to 0.73]; number needed to treat, 3 [CI, 2 to 7]). Colchicine reduced the persistence of symptoms at 72 hours (absolute risk reduction, 0.30 [CI, 0.13 to 0.45]; relative risk reduction, 0.56 [CI, 0.27 to 0.74]) and mean number of recurrences, increased the remission rate at 1 week, and prolonged the time to subsequent recurrence. The study groups had similar rates of side effects and drug withdrawal.
Multiple recurrences and neoplastic or bacterial causes were excluded.
Colchicine is safe and effective for secondary prevention of recurrent pericarditis.
复发是心包炎最常见的并发症，影响 10%至 50%的患者。
评估秋水仙碱预防复发性心包炎的疗效和安全性。
前瞻性、随机、双盲、安慰剂对照多中心试验。（临床试验.gov 注册号：NCT00128414）
意大利城市地区的 4 所综合医院。
120 例首次复发心包炎患者。
除常规治疗外，患者随机分为安慰剂组或秋水仙碱组，首日剂量为 1.0 至 2.0mg，随后维持剂量为 0.5 至 1.0mg/d，治疗 6 个月。
主要研究终点为 18 个月时的复发率。次要终点为 72 小时时症状持续时间、1 周时缓解率、复发次数、首次复发时间、与疾病相关的住院治疗、心脏压塞以及缩窄性心包炎发生率。
18 个月时，秋水仙碱组的复发率为 24%，安慰剂组为 55%（绝对风险降低率，0.31[95%CI，0.13 至 0.46]；相对风险降低率，0.56[CI，0.27 至 0.73]；需要治疗的人数，3[CI，2 至 7]）。秋水仙碱降低了 72 小时时症状持续时间（绝对风险降低率，0.30[CI，0.13 至 0.45]；相对风险降低率，0.56[CI，0.27 至 0.74]）和平均复发次数，提高了 1 周时的缓解率，并延长了随后复发的时间。两组的不良反应和停药率相似。
排除了多发性复发、肿瘤或细菌性病因。
秋水仙碱安全有效，可用于预防复发性心包炎。
