摘要
目的初步观察安立生坦治疗肺动脉高压患者的有效性和安全性。方法采用多中心前瞻性开放性研究，入选2012年8月至2013年2月上海市东方医院、复旦大学附属中山医院、上海市第五人民医院28例肺动脉高压患者（肺动脉高压分类第1和第4大类），给予安立生坦2．5～5．0mg／次、1次／d口服治疗，治疗12周研究结束。分别记录基线资料和治疗12周时的6min步行距离（6MWD）、世界卫生组织心功能分级（WHO—FC分级），检测氨基末端脑钠肽前体（NT—proBNP）、肝功能等。对治疗前后6MWD、WHO—FC分级、NT—proBNP、肝功能变化进行分析。结果入选28例患者，男9例，女19例，平均年龄（35±17）岁。基线6MWD为（372±86）m，WHO—FC分级Ⅱ级11例、Ⅲ级15例、Ⅳ级2例，肝功能均正常。治疗12周后，患者6MWD增至（443±96）m（P=0．000）；WHO—FC分级明显改善为I级4例、Ⅱ级18例、Ⅲ级6例（P=0．000）；中位NT—proBNP值由基线时的732ng／L降至329ng／L（P=0．046）。治疗后患者肝功能未见明显异常变化。结论安立生坦能明显改善肺动脉高压患者的心功能和运动耐力，安全性和耐受性良好。
Objective To explore the efficacy, safety and tolerance of ambrisentan, a high- selective endothelin receptor antagonist, in Chinese patients with pulmonary hypertension （PH）. Methods Twenty-eight PH patients （ Group 1 ＋ Group 4 ） came from Shanghai East Hospital, Zhongshan Hospital of Fudan University and Fifth People＇s Hospital of Shanghai were recruited into this open-label, prospective multi-center trial between August 2012 and February 2013. They received 2. 5 - 5.0 mg ambrisentan once daily for 12 weeks. The primary endpoint was the change in exercise capacity showed by six-minute walk distance （6MWD） from baseline to 12 weeks. Secondary endpoints included the changes in World Health Organization （WHO） function class, N-terminal brain natriuretic peptide （NT-proBNP） and liver function test results. Results There were 9 males and 19 females with an average age of （ 35 ± 17 ） years. The value of 6MWD increased from （ 372 ±86） m at baseline to （ 443 ±96 ） m （ P =0. 000 ） after 12 weeks. WHO functional class improved after a 12-week therapy compared to the baseline level （P = 0. 000 ）. NT-proBNP decreased from a median of 732 ng/L at baseline to 329 ng/L after 12 weeks （ P = 0. 046 ）. The baseline liver function test was normal. And liver function test didn＇t significantly change after a 12-week therapy. Conclusion Ambrisentan therapy is well-tolerated and it improves the exercise capacity and WHO function class in Chinese PH patients.
出处
《中华医学杂志》
CAS
CSCD
北大核心
2013年第34期2736-2738,共3页
National Medical Journal of China
关键词
高血压
肺性
治疗结果
安立生坦
Hypertension, pulmonary
Treatment outcomes
Ambrisentan
