Cardiology Department, Maria Vittoria Hospital, Torino, Italy.
Am Heart J. 2011 Sep;162(3):527-32.e1. doi: 10.1016/j.ahj.2011.05.017. Epub 2011 Jul 18.
No preventive pharmacologic strategies have been proven efficacious for the prevention of postoperative effusions after cardiac surgery. Colchicine is safe and efficacious for the prevention of pericarditis. On this basis, we realized a substudy of the COPPS trial to assess the efficacy and safety of colchicine for the prevention of postoperative pericardial and pleural effusions.
The COPPS is a multicenter, double-blind, randomized trial, where 360 consecutive patients (mean age 65.7 ± 12.3 years, 66% men), 180 in each treatment arm, were randomized on the third postoperative day to receive placebo or colchicine for 1 month (1.0 mg twice daily for the first day, followed by a maintenance dose of 0.5 mg twice daily in patients ≥70 kg, and halved doses for patients <70 kg). The incidence of postoperative effusions was evaluated in each study group.
Despite similar baseline features, colchicine significantly reduced the incidence of postoperative pericardial (12.8% vs 22.8%, P = .019, relative risk reduction 43.9%, no. of patients needed to treat 10) and pleural effusions (12.2% vs 25.6%, P = .002, relative risk reduction 52.3%, no. of patients needed to treat 8). The rate of side effects (only gastrointestinal intolerance) and drug withdrawal was similar in the study groups with a trend toward an increased rate of both events for colchicine. In multivariable analysis, female gender (hazard ratio 1.76, 95% CI 1.03-3.03, P = .040) and pleura incision (hazard ratio 2.58, 95% CI 1.53-4.53, P < .001) were risk factors for postoperative effusions.
Colchicine is safe and efficacious for the primary prevention of postoperative effusions after cardiac surgery.
尚无预防药物策略被证明可有效预防心脏手术后的术后积液。秋水仙碱可安全有效地预防心包炎。在此基础上，我们对 COPPS 试验进行了一项亚研究，以评估秋水仙碱预防术后心包和胸腔积液的疗效和安全性。
COPPS 是一项多中心、双盲、随机试验，360 例连续患者（平均年龄 65.7 ± 12.3 岁，66%为男性），每组 180 例，在术后第 3 天随机分为安慰剂或秋水仙碱治疗组，为期 1 个月（第 1 天给予 1.0 mg 每日 2 次，然后在 ≥70 kg 的患者中维持剂量为 0.5 mg 每日 2 次，在 <70 kg 的患者中减半剂量）。评估每组患者术后积液的发生率。
尽管基线特征相似，但秋水仙碱显著降低了术后心包积液的发生率（12.8%比 22.8%，P =.019，相对风险降低 43.9%，需要治疗的患者数为 10）和胸腔积液（12.2%比 25.6%，P =.002，相对风险降低 52.3%，需要治疗的患者数为 8）。两组不良反应（仅胃肠道不耐受）和停药率相似，但秋水仙碱组这两种事件的发生率呈上升趋势。多变量分析显示，女性（危险比 1.76，95%可信区间 1.03-3.03，P =.040）和胸膜切开术（危险比 2.58，95%可信区间 1.53-4.53，P <.001）是术后积液的危险因素。
秋水仙碱安全有效，可预防心脏手术后术后积液的发生。
