Meneveau N, Schiele F, Metz D, Valette B, Attali P, Vuillemenot A, Grollier G, Elaerts J, Mossard J M, Viel J F, Bassand J P
Département de Cardiologie, Hôpital Universitaire Saint-Jacques, Besançon, France.
J Am Coll Cardiol. 1998 Apr;31(5):1057-63. doi: 10.1016/s0735-1097(98)00068-0.
This study sought to compare the efficacy of 2-h regimens of alteplase and streptokinase in acute massive pulmonary embolism. The primary end point was immediate hemodynamic improvement, and secondary end points included early clinical efficacy and safety, as well as 1-year clinical outcome.
Several thrombolytic regimens have been compared for the past 10 years in randomized studies, showing that 2-h infusion regimens of alteplase or urokinase lead to faster hemodynamic improvement than former 12- to 24-h administration protocols in acute massive pulmonary embolism. Many trials have focused on immediate hemodynamic and angiographic outcomes, but none has addressed long-term follow-up after thrombolysis.
Sixty-six patients with acute massive pulmonary embolism (Miller score > 17 and mean pulmonary artery pressure >20 mm Hg) were randomly assigned to receive either a 100-mg 2-h infusion of alteplase (n = 23) or 1.5 million IU of streptokinase over 2 h (n = 43). In both groups, heparin infusion was started at the end of thrombolytic infusion and adapted thereafter. Total pulmonary resistance was monitored over a 12-h period. Pulmonary vascular obstruction was assessed 36 to 48 h after thrombolytic therapy. One-year follow-up information included death, cause of death, recurrent pulmonary embolism, chronic thromboembolic pulmonary hypertension, stroke and bleeding.
Both groups had similar baseline angiographic and hemodynamic characteristics of severity, with maintained cardiac output in 64 (97%) of 66 patients. The results (mean +/- SD) demonstrated that despite a faster total pulmonary resistance improvement observed at 1 h in the alteplase group compared with the streptokinase group (33+/-16% vs. 19 16%, p = 0.006), a similar hemodynamic efficacy was obtained at 2 h when both thrombolytic regimens were completed (38+/-18% vs. 31+/-19%). There was no significant difference in either pulmonary vascular obstruction at 36 to 48 h or bleeding complication rates. One-year event-free survival was similar in both groups, as most events were related to concomitant diseases.
These results suggest that a 2-h regimen of streptokinase can be routinely used in patients with massive pulmonary embolism and maintained cardiac output without obviously compromising efficacy or safety.
本研究旨在比较阿替普酶和链激酶2小时给药方案治疗急性大面积肺栓塞的疗效。主要终点是即刻血流动力学改善，次要终点包括早期临床疗效和安全性以及1年临床结局。
在过去10年的随机研究中对几种溶栓方案进行了比较，结果显示在急性大面积肺栓塞中，阿替普酶或尿激酶2小时输注方案比以前12至24小时给药方案能更快改善血流动力学。许多试验关注即刻血流动力学和血管造影结局，但没有一项涉及溶栓后的长期随访。
66例急性大面积肺栓塞患者（米勒评分>17且平均肺动脉压>20 mmHg）被随机分配接受100 mg阿替普酶2小时输注（n = 23）或2小时内输注150万国际单位链激酶（n = 43）。两组均在溶栓输注结束时开始输注肝素并随后调整剂量。在12小时内监测总肺阻力。溶栓治疗后36至48小时评估肺血管阻塞情况。1年随访信息包括死亡、死亡原因、复发性肺栓塞、慢性血栓栓塞性肺动脉高压、中风和出血。
两组在严重程度的基线血管造影和血流动力学特征相似，66例患者中有64例（97%）心输出量维持正常。结果（均值±标准差）表明，尽管与链激酶组相比，阿替普酶组在1小时时观察到总肺阻力改善更快（33±16%对19±16%，p = 0.006），但在2小时完成两种溶栓方案时获得了相似的血流动力学疗效（38±18%对31±19%）。在36至48小时时肺血管阻塞或出血并发症发生率均无显著差异。两组1年无事件生存率相似，因为大多数事件与合并疾病有关。
这些结果表明，链激酶2小时给药方案可常规用于大面积肺栓塞且心输出量维持正常的患者，而不会明显影响疗效或安全性。
