波生坦治疗肺动脉高压患者的初步结果

目的 观察内皮素受体拮抗剂波生坦对中国肺动脉高压患者的初步疗效和安全性.方法 入选特发性肺动脉高压(9例)、先天性心脏病相关性肺动脉高压(7例)及结缔组织病相关性肺动脉高压患者(5例)共21例,应用波生坦治疗前4周用量为62.5 mg,1日2次,如无明显不良反应则于4周结束后增加到125 mg,1日2次至12周结束.分别于波生坦治疗前及治疗12周时进行6min步行距离、血流动力学参数评价.结果 波生坦治疗12周,肺动脉高压患者的6 min步行距离由(375±113)m增加至(461±85)m(P<0.001),肺血管阻力由(1441±766)dyn·s-1·cm-5下降至(1236±729)dyn·s-1·cm-5(P=0.007),心指数由(2.35±1.20)L·min-1·m2增加至(3.02±1.71)L·min-1·m2(P=0.002).无一例患者因发生严重不良反应退出研究.结论 波生坦可有效改善肺动脉高压患者的运动耐量和血流动力学参数,并且安全性耐受性良好.

Effects of bosentan in treatment of pulmonary arterial hypertension: a pilot study of 21 patients

Objective To investigate the preliminary efficacy and safety of bosentan, a dual endothelin-receptor antagonist, in Chinese pulmonary arterial hypertension (PAH) patients. Methods 21 patients with PAH, idiopathic or associated with congenital heart disease or connective-tissue disease received 62.5 mg of bosentan twice daily for 4 weeks, and then 125 mg twice daily for 8 weeks if without serious side effects. At week 12, the patients underwent 6 min walk test, hemodynamic variables examination, right heart catheterization, ultrasound cardiography, and electrocardiography. Results The six-minute walking distance 12 weeks after bosentan treatment was 461 m ± 84 m, significantly longer than that before the therapy ( 374 m ± 113 m, P < 0.001 ). The pulmonary vascular resistance 12 weeks after the bosentan treatment was (1236±729) dyn · s-1· cm-5, significantly lower than that before [(1440±766) dyn·s-1· cm-5, P = 0.007]. The cardiac index 12 weeks after the bosentan treatment was ( 3.02 ±1. 71 ) L·min-1· m2, significantly higher than that before treatment [(2.35 ± 1.20) L·min-1·m2 , P = 0. 002]. No patient was withdrawn from this study for safety reason. Conclusion Improves the exercise capacity and hemodynamic parameters in Chinese PAH patients; bosentan is safe in treating PAH and can be well tolerated.