Thrombolysis vs heparin in the treatment of pulmonary embolism - A clinical outcome-based meta-analysis
Thrombolysis vs heparin in the treatment of pulmonary embolism - A clinical outcome-based meta-analysis
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DOI：
10.1001/archinte.162.22.2537
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发表时间：
2002-12-09
影响因子：
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通讯作者：
Kirschstein, T
中科院分区：
文献类型：
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作者：
Agnelli, G;Becattini, C;Kirschstein, T
背景：在急性肺栓塞患者中，溶栓比肝素治疗能更快地消除肺栓塞。这种优势是否会改善临床结局尚不清楚。我们试图对比较肺栓塞患者溶栓和肝素治疗的研究进行基于临床结果的荟萃分析。方法：有关不良结果事件的数据（死亡、复发性肺栓塞和大出血事件）从确定的随机研究中提取。共有56在9项随机试验中，241例接受溶栓药物治疗的患者中有23.2%发生了不良结局事件，（25.9%）（相对风险[RR]，0.9; 95%置信区间[CI]，0.57-1.32）。溶栓组有11例（4.6%）患者死亡，肝素组有17例（7.7%）患者死亡（RR，0.59; 95% CI，0.27-1.25）。31例接受溶栓治疗的患者（12.9%）发生了大出血事件，而19例接受肝素治疗的患者（8.6%）发生了大出血事件（RR，1.49; 95% CI，0.85-2.81）。溶栓组发生5例致死性出血事件（2.1%），肝素组无。6项研究提供了复发性肺栓塞的数据。214例接受溶栓药物治疗的患者中有14例（6.6%）复发，201例接受肝素治疗的患者中有22例（10.9%）复发（RR，0.60; 95% CI，0.29-1.15）。溶栓和肝素治疗的241例患者中有25例（10.4%）和220例患者中有38例（17.3%）发生复发和/或死亡（RR，0.55; 95%CI，0.33-0.96; P= 0.03）。结论：在肺栓塞患者中，溶栓治疗的死亡/复发复合终点低于肝素治疗。出血过多是提高疗效的代价。在肺栓塞患者中进行溶栓和肝素治疗的比较临床结局试验是必要的，并且选择了高死亡和/或复发风险和低出血风险的患者。
Background: In patients with acute pulmonary embolism, thrombolysis results in a more rapid resolution of pulmonary emboli than heparin treatment. Whether this advantage results in an improved clinical outcome is unclear. We sought to perform a clinical outcome-based meta-analysis of studies comparing thrombolytic and heparin treatment in patients with pulmonary embolism.Methods: Data concerning adverse outcome events (death, recurrent pulmonary embolism, and major bleeding events) were extracted from the identified randomized studies.Results: A total of 56 (23.2%) of 241 patients treated with thrombolytic agents in 9 randomized trials experienced an adverse outcome event compared with 57 (25.9%) of 220 patients treated with heparin (relative risk [RR], 0.9; 95% confidence interval [CI], 0.57-1.32). In the thrombolysis group, 11 patients (4.6%) died compared with 17 (7.7%) in the heparin group (RR, 0.59; 95% CI, 0.27-1.25). Thirty-one patients (12.9%) undergoing thrombolysis had a major bleeding episode compared with 19 patients (8.6%) treated with heparin (RR, 1.49; 95% CI, 0.85-2.81). Five fatal bleeding episodes (2.1%) occurred in the thrombolysis group and none in the heparin group. Six studies provided data on recurrent pulmonary embolism. A recurrence occurred in 14 (6.6%) of 214 patients treated with thrombolytic agents and in 22 (10.9%) of 201 patients treated with heparin (RR, 0.60; 95% CI, 0.29-1.15). Recurrence and/or death occurred in 25 (10.4%) of 241 and in 38 (17.3%) of 220 patients treated with thrombolytic agents and heparin, respectively (RR, 0.55; 95% CI, 0.33-0.96; P=.03).Conclusions: In patients with pulmonary embolism, thrombolysis had a lower composite end point of death/recurrence than heparin treatment. Excessive bleeding is the trade-off for improved efficacy. A comparative clinical outcome trial of thrombolysis and heparin treatment is warranted in patients with pulmonary embolism and selected for high risk of death and/or recurrence and low risk of bleeding.