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口服西地那非治疗重度肺动脉高压的一年疗效与安全性

One year efficacy and safety of oral sildenafil treatment in severe pulmonary hypertension.

作者信息

Samarzija Miroslav, Zuljević Ervin, Jakopović Marko, Sever Branko, Knezević Aleksandar, Dumija Zeljko, Vidjak Vinko, Samija Mirko

机构信息

Post-Intensive Care Unit, University Hospital for Lung Diseases "Jordanovac", Zagreb, Croatia.

出版信息

Coll Antropol. 2009 Sep;33(3):799-803.

PMID:19860106
Abstract

Severe pulmonary hypertension is a progressive disease which leads to limitations of functional status and poor survival. We evaluated efficacy and safety of a short (3 months) and a long term (12 months) sildenafil treatment in patients with severe pulmonary hypertension. We treated 12 patients with pulmonary hypertension with oral sildenafil. Patients were followed at three time points, at baseline, and after 3 and 12 months of treatment. Primary end point was improvement in functional exercise capacity assesed by 6-minute walk test, and secondary end points were changes in right ventricle hemodynamics. We found significant improvement in 6-minute walk test distance from 357 +/- 193 m at baseline to 431 +/- 179 m after three months and further improvement to 501 +/- 159 m after 12 months (p < 0.01); decrease in right ventricule pressure from 107 +/- 42 mmHg at baseline to 87 +/- 32 mmHg after 12 months (p < 0.01); and, decrease in right ventricule diameter from 3.2 +/- 1.1 cm to 2.76 +/- 0.86 cm after twelve months (p < 0.01). Drug-related adverse events were mild and transient in our group of patients. Long-term (12 months) sildenafil treatment is effective and safe in our patients with idiopathic and chronic thrombo-embolic pulmonary hypertension.

摘要

重度肺动脉高压是一种进行性疾病,会导致功能状态受限和生存率低下。我们评估了短期(3个月)和长期(12个月)西地那非治疗重度肺动脉高压患者的疗效和安全性。我们对12例肺动脉高压患者口服西地那非进行治疗。在基线、治疗3个月和12个月后这三个时间点对患者进行随访。主要终点是通过6分钟步行试验评估的功能运动能力的改善,次要终点是右心室血流动力学的变化。我们发现6分钟步行试验距离从基线时的357±193米显著改善至3个月后的431±179米,并在12个月后进一步改善至501±159米(p<0.01);右心室压力从基线时的107±42毫米汞柱降至12个月后的87±32毫米汞柱(p<0.01);并且,右心室直径在12个月后从3.2±1.1厘米降至2.76±0.86厘米(p<0.01)。在我们的患者组中,与药物相关的不良事件轻微且短暂。长期(12个月)西地那非治疗对我们的特发性和慢性血栓栓塞性肺动脉高压患者有效且安全。

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One year efficacy and safety of oral sildenafil treatment in severe pulmonary hypertension.口服西地那非治疗重度肺动脉高压的一年疗效与安全性
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Long-term treatment with oral sildenafil is safe and improves functional capacity and hemodynamics in patients with pulmonary arterial hypertension.口服西地那非长期治疗对肺动脉高压患者是安全的,并能改善其功能容量和血流动力学。
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A randomized, placebo-controlled, double-blind, crossover study to evaluate the efficacy of oral sildenafil therapy in severe pulmonary artery hypertension.一项随机、安慰剂对照、双盲、交叉研究,以评估口服西地那非治疗重度肺动脉高压的疗效。
Am Heart J. 2006 Apr;151(4):851.e1-5. doi: 10.1016/j.ahj.2005.09.006.

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Rheumatol Int. 2013 Apr;33(4):1047-52. doi: 10.1007/s00296-012-2466-5. Epub 2012 Jul 26.