UK controlled trial of intrapleural streptokinase for pleural infection
UK controlled trial of intrapleural streptokinase for pleural infection
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DOI：
10.1056/nejmoa042473
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发表时间：
2005-03-03
影响因子：
158.5
通讯作者：
Davies, RJO
中科院分区：
文献类型：
--
作者：
Maskell, NA;Davies, CWH;Davies, RJO
背景：胸膜纤溶剂用于感染胸腔积液的引流。这种使用是基于小型试验，这些试验没有统计能力来准确评估重要的临床结果，包括安全性。我们进行了一项试验，以阐明胸膜内链激酶的治疗作用。方法：在这项双盲试验中，454例胸膜感染患者（定义为脓性胸膜液或pH值低于7.2且有感染迹象的胸膜液或证实有细菌侵入胸膜间隙）被随机分配接受胸膜内注射链激酶（250,000 IU，每日两次，连续3天）或安慰剂。作为常规护理的一部分，患者接受抗生素治疗并接受胸腔引流、手术和其他治疗。比较两组患者在3个月内死亡或需要手术引流的人数（主要终点）；次要终点是死亡率和手术率（单独分析）、放射学结果和住院时间。结果两组在基线时匹配良好。在427例接受链激酶或安慰剂治疗的患者中，两组之间死亡或需要手术的患者比例无显著差异（链激酶组：206例患者中有64例[31%]；安慰剂组：221例患者中有60例[27%]；相对风险为1.14[95%置信区间，0.85 ~ 1.54；P=0.43]），这一结果排除了链激酶的临床显著获益。在死亡率、手术率、放射学结果或住院时间方面，链激酶没有任何益处。链激酶组的严重不良事件（胸痛、发热或过敏）更为常见（7%，安慰剂组为3%；相对危险度为2.49[95%可信区间，0.98至6.36]；P=0.08）。结论胸膜内注射链激酶不能提高胸膜感染患者的死亡率、手术率或住院时间。
BACKGROUNDIntrapleural fibrinolytic agents are used in the drainage of infected pleural-fluid collections. This use is based on small trials that did not have the statistical power to evaluate accurately important clinical outcomes, including safety. We conducted a trial to clarify the therapeutic role of intrapleural streptokinase.METHODSIn this double-blind trial, 454 patients with pleural infection (defined by the presence of purulent pleural fluid or pleural fluid with a pH below 7.2 with signs of infection or by proven bacterial invasion of the pleural space) were randomly assigned to receive either intrapleural streptokinase (250,000 IU twice daily for three days) or placebo. Patients received antibiotics and underwent chest-tube drainage, surgery, and other treatment as part of routine care. The number of patients in the two groups who had died or needed surgical drainage at three months was compared (the primary end point); secondary end points were the rates of death and of surgery (analyzed separately), the radiographic outcome, and the length of the hospital stay.RESULTSThe groups were well matched at baseline. Among the 427 patients who received streptokinase or placebo, there was no significant difference between the groups in the proportion of patients who died or needed surgery (with streptokinase: 64 of 206 patients [31 percent]; with placebo: 60 of 221 [27 percent]; relative risk, 1.14 [95 percent confidence interval, 0.85 to 1.54; P=0.43), a result that excluded a clinically significant benefit of streptokinase. There was no benefit to streptokinase in terms of mortality, rate of surgery, radiographic outcomes, or length of the hospital stay. Serious adverse events (chest pain, fever, or allergy) were more common with streptokinase (7 percent, vs. 3 percent with placebo; relative risk, 2.49 [95 percent confidence interval, 0.98 to 6.36]; P=0.08).CONCLUSIONSThe intrapleural administration of streptokinase does not improve mortality, the rate of surgery, or the length of the hospital stay among patients with pleural infection.