G.F. Ingrassia Hospital, Palermo, Italy.
Am J Med Sci. 2011 Jan;341(1):33-9. doi: 10.1097/MAJ.0b013e3181f1fc3e.
The aim of this study was to assess the effect of thrombolysis versus heparin treatment on echocardiographic parameters and clinical outcome, during hospitalization and within the first 180 days after admission, in patients with first episode of submassive pulmonary embolism (SPE) and right ventricle dysfunction (RVD).
Consecutive patients (age, 18-75 years) with a first episode of SPE, symptoms onset since no more than 6 hours, normal blood pressure (>100 mm Hg), echocardiographic evidence of RVD and positive lung spiral computed tomography were double-blind randomized: 1 group received 100 mg of alteplase (10-mg bolus, followed by a 90-mg intravenous infusion over a period of 2 hours), while the other group received matching placebo. In addition to alteplase or placebo, both groups received an unfractionated heparin treatment. Echocardiogram was performed at admission, at 24, 48 and 72 hours, at discharge and at 3 and at 6 months after randomization.
Seventy-two patients were included into the study; 37 were assigned to thrombolysis and 35 to placebo. Both groups were well matched with regard to features and clinical presentation. Thrombolysis group showed a significant early improvement of RV function compared with heparin group, and this improvement was observed also during the follow-up (180 days). The same group also showed significant reduction in clinical events during the hospitalization and follow-up.
Our data suggest that, in hemodynamically stable patients with SPE, thrombolysis shows an earliest reduction of RVD and a more favorable trend in clinical outcome, so, it could merit consideration in SPE.
本研究旨在评估溶栓治疗与肝素治疗对首次次大面积肺栓塞(SPE)合并右心室功能障碍(RVD)患者住院期间和入院后 180 天内超声心动图参数和临床结局的影响。
连续入选年龄在 18-75 岁之间、首次发生 SPE、症状发作时间不超过 6 小时、血压正常(>100mmHg)、超声心动图证实 RVD 且肺部螺旋 CT 阳性的患者,进行双盲随机分组:一组接受 100mg 阿替普酶(10mg 推注,随后 2 小时内静脉滴注 90mg),另一组接受匹配的安慰剂。除了阿替普酶或安慰剂外,两组均接受普通肝素治疗。入院时、24 小时、48 小时、72 小时、出院时以及随机分组后 3 个月和 6 个月时进行超声心动图检查。
72 例患者入选本研究;37 例患者被分配至溶栓组,35 例患者被分配至安慰剂组。两组在特征和临床表现方面均匹配良好。溶栓组与肝素组相比,RV 功能早期改善明显,且在随访期间(180 天)也观察到改善。该组在住院和随访期间的临床事件也明显减少。
我们的数据表明,在血流动力学稳定的 SPE 患者中,溶栓治疗可更早地减轻 RVD,并对临床结局产生更有利的趋势,因此,在 SPE 中值得考虑。