Les Grands Prés, 27 rue Sainte Christine, 77174 Villeneuve Saint Denis, France.
Ann Intern Med. 2010 Feb 2;152(3):137-43. doi: 10.7326/0003-4819-152-3-201002020-00004.
The incidence of asymptomatic pericardial effusion is high after cardiac surgery. Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely prescribed in this setting, but no study has assessed their efficacy.
To assess whether the NSAID diclofenac is effective in reducing postoperative pericardial effusion volume.
Multicenter randomized, double-blind, placebo-controlled study. (Clinical trials.gov registration number: NCT00247052)
5 postoperative cardiac rehabilitation centers.
196 patients at high risk for tamponade because of moderate to large persistent pericardial effusion (grade 2, 3, or 4 on a scale of 0 to 4, as measured by echocardiography) more than 7 days after cardiac surgery.
Random assignment at each site in blocks of 4 to diclofenac, 50 mg, or placebo twice daily for 14 days.
The main end point was change in effusion grade after 14 days of treatment. Secondary end points included frequency of late cardiac tamponade.
The initial mean pericardial effusion grade was 2.58 (SD, 0.73) for the placebo group and 2.75 (SD, 0.81) for the diclofenac group. The 2 groups showed similar mean decreases from baseline after treatment (-1.08 grades [SD, 1.20] for the placebo group vs. -1.36 (SD, 1.25) for the diclofenac group). The mean difference between groups was -0.28 grade (95% CI, -0.63 to 0.06 grade; P = 0.105). Eleven cases of late cardiac tamponade occurred in the placebo group and 9 in the diclofenac group (P = 0.64). These differences persisted after adjustment for grade of pericardial effusion at baseline, treatment site, and type of surgery.
The sample was not large enough to find small beneficial effects of diclofenac or assess the cardiovascular tolerance of diclofenac.
In patients with pericardial effusion after cardiac surgery, diclofenac neither reduced the size of the effusions nor prevented late cardiac tamponade.
French Society of Cardiology.
心脏手术后无症状性心包积液的发生率较高。非甾体抗炎药（NSAIDs）在这种情况下广泛应用，但尚无研究评估其疗效。
评估 NSAID 双氯芬酸是否可有效减少术后心包积液量。
多中心、随机、双盲、安慰剂对照研究。（临床试验.gov 注册号：NCT00247052）
5 个心脏术后康复中心。
196 例因中等至大量持续性心包积液（超声心动图测量为 0 至 4 级，2、3 或 4 级）而有填塞风险的患者，且心包积液于心脏手术后 7 天以上仍持续存在。
在各中心以 4 例为一组进行随机分组，接受双氯芬酸 50 mg 或安慰剂，每日 2 次，共 14 天。
主要终点为治疗 14 天后积液分级的变化。次要终点包括迟发性心脏填塞的发生率。
安慰剂组和双氯芬酸组的初始平均心包积液分级分别为 2.58（SD，0.73）和 2.75（SD，0.81）。两组在治疗后从基线的平均下降值相似（安慰剂组-1.08 级[SD，1.20] vs. 双氯芬酸组-1.36[SD，1.25]）。组间平均差异为-0.28 级（95%CI，-0.63 至 0.06 级；P=0.105）。安慰剂组发生 11 例迟发性心脏填塞，双氯芬酸组发生 9 例（P=0.64）。这些差异在调整基线心包积液分级、治疗地点和手术类型后仍持续存在。
样本量不足以发现双氯芬酸的小获益效应，也不足以评估双氯芬酸的心血管耐受性。
对于心脏手术后有心包积液的患者，双氯芬酸既不能减少积液量，也不能预防迟发性心脏填塞。
法国心脏病学会。
