溶栓与抗凝治疗急性次大面积肺血栓栓塞症的疗效和安全性比较

Comparative Study on the Efficacy and Safety of Thrombolysis and Anticoagulation Therapy for Patients with Acute Sub-Massive Pulmonary Thromboembolism

目的探讨溶栓与抗凝治疗对急性次大面积肺血栓栓塞症(PTE)患者的疗效与安全性。方法回顾分析符合入选标准的84例次大面积PTE患者的临床资料,溶栓组49例,单纯肝素抗凝组(抗凝组)35例,以治愈、显效、进步、无效、恶化和死亡6级判断标准进行疗效评价,以治愈+显效+进步为有效,计算有效率,以恶化+死亡计算严重事件发生率,统计出血并发症。结果溶栓组临床有效率为81.6%,显著高于抗凝组的54.3%(P=0.007)。溶栓组恶化1例,无死亡病例;抗凝组恶化4例,死亡1例,两组严重事件发生率分别为2.0%和14.3%,差异有统计学意义(P=0.032);溶栓组和抗凝组出血发生率分别为20.4%和14.3%,差异无统计学意义(P>0.05),且主要为皮下或穿刺点出血,两组均未出现严重出血病例。结论急性次大面积PTE患者,在无溶栓绝对禁忌证的情况下,可首选溶栓治疗,以迅速逆转右心功能不全,改善患者临床症状和近期预后。

Objective To compare the clinical efficacy and safety of thrombolysis with anticoagulation therapy for patients with acute sub-massive pulmonary thromboembolism. Methods The clinical data of 84 patients with acute sub-massive pulmonary thromboembolism were analyzed retrospectively, mainly focusing on the in-hospital efficacy and safety of thrombolysis and/or anticoagulation. The efficacy was evaluated based on 6 grades：cured,markedly improved,improved,not changed,deteriorated and died. Results Among the 84 patients, 49 patients received thrombolysis and sequential anticoagulation therapy（ thrombolysis group） ,35 patients received anticoagulation therapy alone（ antieoagulation group）. As compared with the anticoagulation group, the thrombolysis group had higher effective rate（ defined as patients who were cured, markedly improved or improved,81.6% versus 54. 3% ,P = 0.007）, lower critical event occurrence（defined as clinical condition deteriorated or died,2.0% versus 14. 3%, P = 0. 032 ） . There was no significant difference in bleeding rates between the two groups （thrombolysis group 20.4% versus anticoagulation group 14. 3%, P 〉 0. 05 ）. No major bleeding or intracranial hemorrhage occurred in any of the patients. Conclusions Thrombolysis therapy may be more effective than anticoagulation therapy alone in patients with acute sub-massive pulmonary thromboembolism, and thus warrants further prospective randomized control study in large population.