Department of Cardio-Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine, China.
Heart. 2011 Nov;97(22):1876-81. doi: 10.1136/heartjnl-2011-300344. Epub 2011 Sep 21.
Although sildenafil has been shown to be safe and effective in idiopathic pulmonary arterial hypertension (PAH) and PAH related to connective tissue disease, its effects in Eisenmenger syndrome are less clear.
To investigate whether long-term treatment (12 months) with the phosphodiesterase type 5 inhibitor sildenafil improves clinical and haemodynamic parameters in patients with Eisenmenger syndrome.
Prospective, open-label, multicentre study.
Four pulmonary hypertension centres in China.
84 Eisenmenger syndrome functional class II-IV patients.
Oral sildenafil 20 mg orally three times a day.
6-min walk distance (6MWD) test, resting systemic arterial blood oxygen saturation (SaO(2)) in room air, haemodynamic parameters assessed by right heart catheterisation, safety and tolerability.
The overall treatment effects at 12 months versus baseline (mean changes with 95% CIs) were 56 m increase (42 to 69, p<0.0001) in 6MWD, and 2.4% increase (1.8% to 2.9%, p<0.0001) in resting room air SaO(2). Improvements were also seen in mean pulmonary arterial pressure and pulmonary vascular resistance index (-4.7 mm Hg (-7.5 to -1.9), p=0.001; and -474 dyn×s×cm(-5)×m(2) (-634 to -314), p<0.0001, respectively). Sildenafil was well tolerated. Most adverse events were mild and transient, and occurred in the first 2 weeks of treatment.
Twelve months of oral sildenafil treatment was well tolerated and appeared to improve exercise capacity, systemic arterial oxygen saturation and haemodynamic parameters in patients with Eisenmenger syndrome.
西地那非已被证实对特发性肺动脉高压（PAH）和与结缔组织病相关的 PAH 安全且有效，但在艾森曼格综合征中的作用尚不清楚。
研究磷酸二酯酶 5 抑制剂西地那非长期（12 个月）治疗能否改善艾森曼格综合征患者的临床和血液动力学参数。
前瞻性、开放标签、多中心研究。
中国的 4 个肺动脉高压中心。
84 例艾森曼格综合征功能分级 II-IV 级患者。
西地那非 20 mg，口服，每日 3 次。
6 分钟步行距离（6MWD）试验、静息室内空气下的体循环动脉血氧饱和度（SaO2）、右心导管评估的血液动力学参数、安全性和耐受性。
与基线相比，治疗 12 个月时的总体治疗效果（平均变化及 95%CI）为 6MWD 增加 56 m（42 至 69，p<0.0001），静息室内空气 SaO2 增加 2.4%（1.8%至 2.9%，p<0.0001）。平均肺动脉压和肺血管阻力指数也有改善（-4.7mmHg[-7.5 至-1.9]，p=0.001；-474dyn×s×cm-5×m-2[-634 至-314]，p<0.0001）。西地那非耐受性良好。大多数不良反应为轻度和短暂性，发生在治疗的前 2 周。
口服西地那非治疗 12 个月耐受性良好，似乎能改善艾森曼格综合征患者的运动能力、体循环动脉血氧饱和度和血液动力学参数。
