Cardiology Department, Maria Vittoria Hospital, Turin, Italy.
Cardiology Department, Maria Vittoria Hospital, Turin, Italy.
Lancet. 2014 Jun 28;383(9936):2232-7. doi: 10.1016/S0140-6736(13)62709-9. Epub 2014 Mar 30.
Colchicine is effective for the treatment of acute pericarditis and first recurrences. However, conclusive data are lacking for the efficacy and safety of colchicine for treatment of multiple recurrences of pericarditis.
We did this multicentre, double-blind trial at four general hospitals in northern Italy. Adult patients with multiple recurrences of pericarditis (≥two) were randomly assigned (1:1) to placebo or colchicine (0·5 mg twice daily for 6 months for patients weighing more than 70 kg or 0·5 mg once daily for patients weighing 70 kg or less) in addition to conventional anti-inflammatory treatment with aspirin, ibuprofen, or indometacin. Permuted block randomisation (size four) was done with a central computer-based automated sequence. Patients and all investigators were masked to treatment allocation. The primary outcome was recurrent pericarditis in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT00235079.
240 patients were enrolled and 120 were assigned to each group. The proportion of patients who had recurrent pericarditis was 26 (21·6%) of 120 in the colchicine group and 51 (42·5%) of 120 in the placebo group (relative risk 0·49; 95% CI 0·24-0·65; p=0·0009; number needed to treat 5). Adverse effects and discontinuation of study drug occurred in much the same proportions in each group. The most common adverse events were gastrointestinal intolerance (nine patients in the colchicine group vs nine in the placebo group) and hepatotoxicity (three vs one). No serious adverse events were reported.
Colchicine added to conventional anti-inflammatory treatment significantly reduced the rate of subsequent recurrences of pericarditis in patients with multiple recurrences. Taken together with results from other randomised controlled trials, these findings suggest that colchicine should be probably regarded as a first-line treatment for either acute or recurrent pericarditis in the absence of contraindications or specific indications.
Azienda Sanitaria 3 of Torino (now ASLTO2).
秋水仙碱对急性心包炎和首次复发的疗效确切。然而，秋水仙碱治疗多次复发的心包炎的疗效和安全性的相关数据还不够充分。
我们在意大利北部的 4 家综合医院进行了这项多中心、双盲试验。患有多次复发的心包炎（≥2 次）的成年患者被随机分为安慰剂组或秋水仙碱组（体重＞70kg 的患者每日 2 次服用 0.5mg，体重≤70kg 的患者每日 1 次服用 0.5mg），同时给予常规抗炎治疗，包括阿司匹林、布洛芬或吲哚美辛。采用中央计算机化的随机序列（区组大小为 4）进行区组随机化。患者和所有研究者对治疗分配均不知情。主要结局是意向治疗人群中复发性心包炎的发生情况。本试验已在 ClinicalTrials.gov 注册，编号为 NCT00235079。
共纳入 240 例患者，每组 120 例。秋水仙碱组 120 例患者中，有 26 例（21.6%）发生复发性心包炎；安慰剂组 120 例患者中，有 51 例（42.5%）发生复发性心包炎（相对风险 0.49；95%CI 0.24-0.65；p=0.0009；需要治疗的人数为 5）。两组不良反应和研究药物停药的发生比例大致相同。最常见的不良反应是胃肠道不耐受（秋水仙碱组 9 例，安慰剂组 9 例）和肝毒性（秋水仙碱组 3 例，安慰剂组 1 例）。无严重不良事件报告。
在常规抗炎治疗的基础上加用心秋水仙碱可显著降低多发性心包炎患者后续复发的发生率。结合其他随机对照试验的结果，这些发现表明，在没有禁忌证或特殊适应证的情况下，秋水仙碱可能应被视为急性或复发性心包炎的一线治疗药物。
都灵 3 区卫生局（现更名为 ASLTO2）。
