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研究称西地那非对原发性肺动脉高压治疗有效
主要用于治疗勃起障碍的西地那非“对PPH病人也很有效”，研究负责人、印度海德拉巴市护理医疗中心的卡斯崔（B. K. S. Sastry）告诉路透社记者，“与以前的药物相比，它能缓解病人的症状和改善运动力，是一种没有许多副作用的单纯药物”。他和同事随机分配22名PPH病人或用西地那非（根据体重25-100mg，每天三次）或用安慰剂。6周后，两组病人均交换到另一组，再治疗6周。
在4月7日的《美国心脏病学会杂志》（J Am Coll Cardiol 2004;43:1149-1153）上作者报告，用完安慰剂后的踏车运动时间为475秒，用西地那非后增加到686秒（p < 0.0001），而且心排血指数显著改善（p < 0.0001），肺动脉收缩压下降，但没有统计学意义。另外，生活品质调查问卷表明呼吸困难和疲劳部分也显著改善。
未没参加此研究的加州大学的拉宾（Lewis J. Rubin）说，“这是一个令人鼓舞的研究，但是初步的”，尽管交叉设计加强了它的说服力，但它只是个短时期的小型研究。一项纳入数百名病人、为期几个月的跨国、安慰剂对照试验“应能清楚阐释西地那非对肺动脉高压的作用”。
Clinical efficacy of sildenafil in primary pulmonary hypertension: a randomized, placebo-controlled, double-blind, crossover study.
Sastry BK, Narasimhan C, Reddy NK, Raju BS.
Department of Cardiology, CARE Hospital, Hyderabad, India. bkssastry@hotmail.com
OBJECTIVES: In a randomized, double-blind, crossover design, we compared the efficacy of sildenafil with placebo in patients with primary pulmonary hypertension (PPH). The primary end point was the change in exercise time on treadmill using the Naughton protocol. Secondary end points were change in cardiac index and pulmonary artery systolic pressure as assessed by Doppler echocardiography and quality of life (QOL) as assessed by a questionnaire. BACKGROUND: Primary pulmonary hypertension is a disorder with limited treatment options. Uncontrolled studies had shown sildenafil to be beneficial in the treatment of PPH. METHODS: After initial clinical evaluation, including Doppler echocardiography and treadmill exercise test, patients were randomized to placebo or sildenafil with dosages ranging from 25 to 100 mg thrice daily on the basis of body weight. The evaluation was repeated after six weeks. Then patients were crossed over to alternate therapy. Final evaluation was performed after another six weeks of treatment. RESULTS: Twenty-two patients completed the study. Exercise time increased by 44% from 475 +/- 168 s at the end of placebo phase to 686 +/- 224 s at the end of sildenafil phase (p < 0.0001). With sildenafil, cardiac index improved from 2.80 +/- 0.9 l/m2 to 3.45 +/- 1.1 l/m(2) (p < 0.0001), whereas pulmonary artery systolic pressure decreased insignificantly from 105.23 +/- 17.82 mm Hg to 98.50 +/- 24.38 mm Hg. There was significant improvement in the dyspnea and fatigue components of the QOL questionnaire. During the placebo phase, one patient died and another had syncope. There were no serious side effects with sildenafil. CONCLUSIONS: Sildenafil significantly improves exercise tolerance, cardiac index, and QOL in patients with PPH.
J Am Coll Cardiol. 2004 Apr 7;43(7):1149-53. [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-04-01 17:14
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