Sildenafil in severe pulmonary hypertension associated with chronic obstructive pulmonary disease: A randomized controlled multicenter clinical trial
Sildenafil in severe pulmonary hypertension associated with chronic obstructive pulmonary disease: A randomized controlled multicenter clinical trial
复制标题
DOI：
10.1016/j.healun.2016.04.010
复制
发表时间：
2017-02-01
影响因子：
8.9
通讯作者：
Vizza, Carmine Dario
中科院分区：
文献类型：
--
作者：
Vita, Patrizio;Stanziola, Anna;Vizza, Carmine Dario
背景技术背景：肺动脉高压（pH）是众所周知的慢性阻塞性肺疾病（COPD）的独立预后因素，也是肺移植候选人的充分标准。目前关于磷酸二酯酶5抑制剂在COPD相关重度PH患者中的血流动力学和临床作用的数据有限。本研究评估了西地那非对重度PH伴COPD.METHODS肺血流动力学和气体交换的影响：筛选后，这个多中心，随机，安慰剂对照的双盲试验随机患者接受20 mg西地那非或安慰剂，每天3次（比例2：1），为期16周。主要终点是肺血管阻力降低。次要终点包括BODE（体重指数、气流阻塞、呼吸困难和运动能力）指数、6分钟步行试验和生活质量问卷。动脉血氧分压的变化进行了评价作为一个安全性parameter.Results：最终的人口包括28例患者，18在西地那非组和10在安慰剂组。在16周时，用西地那非治疗的患者肺血管阻力降低（与安慰剂的平均差异为-1.4WU; 95%置信区间，
BACKGROUND: Pulmonary hypertension (pH) is a well-known independent prognostic factor in chronic obstructive pulmonary disease (COPD) and a sufficient criterion for lung transplant candidacy. Limited data are currently available on the hemodynamic and clinical effect of phosphodiesterase 5 inhibitors in patients with severe PH associated with COPD. This study assessed the effect of sildenafil on pulmonary hemodynamics and gas exchange in severe PH associated with COPD.METHODS: After screening, this multicenter, randomized, placebo-controlled double-blind trial randomized patients to receive 20 mg sildenafil or placebo 3 times a day (ratio 2:1) for 16 weeks. The primary end point was the reduction in pulmonary vascular resistance. Secondary end points included BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index, 6-minute walk test, and quality of life questionnaire. Changes in the partial pressure of arterial oxygen were evaluated as a safety parameter.RESULTS: The final population included 28 patients, 18 in the sildenafil group and 10 in the placebo group. At 16 week, patients treated with sildenafil had a decrease in pulmonary vascular resistance (mean difference with placebo -1.4 WU; 95% confidence interval,