Lu Xian-ling, Xiong Chang-ming, Shan Guang-liang, Liu Zhi-hong, Ni Xin-hai, Cheng Xian-sheng, Gu Qing, Zhao Zhi-hui, Zeng Wei-jie, Zhu Feng, He Jian-Guo
Center for Diagnosis and Management of Pulmonary Vascular Diseases, Cardiovascular Institute and Fu Wai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.
Zhonghua Jie He He Hu Xi Za Zhi. 2011 Jun;34(6):419-23.
To explore the safety and efficacy of oral sildenafil therapy for pulmonary arterial hypertension (PAH), and to provide evidence for sildenafil treatment for Chinese patients with PAH.
In this 12-week, prospective, open-label, uncontrolled study, 56 patients with PAH were given oral sildenafil (25 mg, tid). The primary end point was change from baseline to 12 weeks in exercise capacity assessed by 6 min walk (6MW) test. Secondary end points included changes in WHO class and cardiopulmonary hemodynamics. Clinical worsening was defined as death, transplantation, hospitalization for PAH, or initiation of additional therapies for PAH, such as intravenous epoprostenol or oral bosentan.
After 12 weeks, the compliance was good in 56 patients. Significant improvement was seen in NYHA heart function class and WHO class as compared to baseline (P < 0.01): from class IV to class III in 2, from class III to class II in 8 and to class I in 2 cases, and from class II to class I in 5 cases. No NYHA heart function class and WHO PAH function class deterioration were observed. Oral sildenafil increased 6MW distance, from (352 ± 80) m to (396 ± 78) m, with a change of (44 ± 70) m (P < 0.01). Significant improvement was seen in hemodynamics (mean pulmonary artery pressure, P < 0.01; cardiac index, P < 0.01; pulmonary vascular resistance, P < 0.01) at week 12 as compared with baseline. Mean right atrial pressure decreased (3 ± 11) mm Hg (1 mm Hg = 0.133 kPa), mean pulmonary arterial pressure decreased (6 ± 14) mm Hg, cardiac output increased (1.1 ± 2.0) L/min, cardiac index increased (0.7 ± 1.1) L×min(-1)×m(-2), and total pulmonary resistance decreased (490 ± 831) Dys×s×cm(-5). Side effects were mild and consistent with those reported with sildenafil treatment. No statistically significant clinical worsening was observed with sildenafil therapy for PAH patients.
Sildenafil improves exercise capacity, WHO functional class, and hemodynamics in patients with pulmonary arterial hypertension.
探讨口服西地那非治疗肺动脉高压（PAH）的安全性和有效性，为中国PAH患者的西地那非治疗提供依据。
在这项为期12周的前瞻性、开放标签、非对照研究中，56例PAH患者口服西地那非（25 mg，每日三次）。主要终点是通过6分钟步行（6MW）试验评估的运动能力从基线到12周的变化。次要终点包括世界卫生组织（WHO）心功能分级和心肺血流动力学的变化。临床恶化定义为死亡、移植、因PAH住院或开始使用其他PAH治疗，如静脉注射依前列醇或口服波生坦。
12周后，56例患者依从性良好。与基线相比，纽约心脏协会（NYHA）心功能分级和WHO心功能分级有显著改善（P<0.01）：2例从IV级改善至III级，8例从III级改善至II级，2例改善至I级，5例从II级改善至I级。未观察到NYHA心功能分级和WHO PAH功能分级恶化。口服西地那非使6MW距离从（352±80）m增加至（396±78）m，变化为（44±70）m（P<0.01）。与基线相比，第12周时血流动力学有显著改善（平均肺动脉压，P<0.01；心指数，P<0.01；肺血管阻力，P<0.01）。平均右心房压下降（3±11）mmHg（1 mmHg = 0.133 kPa），平均肺动脉压下降（6±14）mmHg，心输出量增加（1.1±2.0）L/min，心指数增加（0.7±1.1）L×min⁻¹×m⁻²，总肺阻力下降（490±831）Dys×s×cm⁻⁵。副作用轻微，与西地那非治疗报道的一致。西地那非治疗PAH患者未观察到有统计学意义的临床恶化。
西地那非可改善肺动脉高压患者的运动能力、WHO功能分级和血流动力学。
