Henrie Adam M, Nawarskas James J, Anderson Joe R
College of Pharmacy, University of New Mexico, Albuquerque, NM, USA.
Core Evid. 2015 Nov 2;10:99-109. doi: 10.2147/CE.S58457. eCollection 2015.
Pulmonary arterial hypertension (PAH) is a chronic and disabling condition characterized by an elevated pulmonary vascular resistance and an elevated mean pulmonary arterial pressure. Despite recent improvements in treatment availability, PAH remains challenging to treat, burdensome for patients, and ultimately incurable. Tadalafil is a phos-phodiesterase-5 inhibitor that is administered once daily by mouth for the treatment of PAH. Current treatment guidelines recommend tadalafil as an option for patients with World Health Organization functional class II or III PAH. In a placebo-controlled clinical trial, patients taking tadalafil demonstrated significantly improved exercise capacity as measured by the 6-minute walk distance. Patients also experienced decreased incidence of clinical worsening, increased quality of life, and improved cardiopulmonary hemodynamics. Uncontrolled studies and smaller trials have indicated a possible role for tadalafil as a suitable alternative to sildenafil and as a beneficial add-on option when used in combination with other treatments for PAH. Tadalafil is generally safe and well tolerated. Adverse events are typically mild-to-moderate in intensity, and discontinuation rates are usually low. The purpose of this review is to provide an evidence-based evaluation of the clinical utility of tadalafil in the treatment of PAH.
肺动脉高压(PAH)是一种慢性致残性疾病,其特征为肺血管阻力升高和平均肺动脉压升高。尽管近期在治疗可及性方面有所改善,但PAH的治疗仍然具有挑战性,给患者带来沉重负担,且最终无法治愈。他达拉非是一种磷酸二酯酶-5抑制剂,每日口服一次用于治疗PAH。当前的治疗指南推荐他达拉非作为世界卫生组织功能分级为II级或III级PAH患者的一种治疗选择。在一项安慰剂对照临床试验中,服用他达拉非的患者经6分钟步行距离测量显示运动能力显著改善。患者还经历了临床恶化发生率降低、生活质量提高以及心肺血流动力学改善。非对照研究和较小规模试验表明,他达拉非可能作为西地那非的合适替代药物,以及与其他PAH治疗药物联合使用时作为有益的附加治疗选择。他达拉非总体上安全且耐受性良好。不良事件的强度通常为轻至中度,停药率通常较低。本综述的目的是对他达拉非治疗PAH的临床效用进行基于证据的评估。