Tadalafil as monotherapy and in combination regimens for the treatment of pulmonary arterial hypertension

Tadalafil as monotherapy and in combination regimens for the treatment of pulmonary arterial hypertension
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DOI:
10.1177/1753465812463627
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发表时间:
2013-02
影响因子:
4.3
通讯作者:
Dioma U. Udeoji;E. Schwarz
Dioma U. Udeoji;E. Schwarz
中科院分区:
医学3区
文献类型:
--
作者:
Dioma U. Udeoji;E. Schwarz

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本综述的目的是评估他达拉非作为单一疗法和联合疗法治疗肺动脉高压(PAH)的用途。 1960 年 1 月至 2012 年 5 月期间,使用 PubMed 对医学文献进行了系统的英语检索,检索词为“他达拉非”、“治疗”、“肺(动脉)高血压”和“联合治疗”。特别强调与他达拉非治疗肺动脉高压相关的对照临床试验和案例研究。检索发现了 113 篇相关出版物,其中 31 篇为临床试验,52 篇为综述,12 篇为病例报告。其中,12 项是在人类 PAH 患者中单独使用他达拉非治疗的临床研究,7 项是在人类 PAH 患者中使用他达拉非与其他药物联合治疗的临床研究。仅纳入人类患者的临床研究。排除标准是除使用他达拉非之外的单一疗法以及排除他达拉非作为治疗方案一部分的任何联合疗法。总共对 1353 名人类受试者进行了研究; 896 名受试者单独接受他达拉非治疗,而 457 名受试者接受他达拉非联合治疗。对于 PAH 患者来说,他达拉非似乎是一种有效且安全的治疗选择。它可以改善临床状态、运动能力、血流动力学参数、依从性问题和生活质量,并减少临床恶化的发生。联合治疗中的他达拉非似乎在松弛肺血管肌细胞方面具有相加和协同作用,但需要对人体进行更多的临床试验。
The purpose of this review is to evaluate the use of tadalafil as monotherapy and in combination regimens for the treatment of pulmonary arterial hypertension (PAH). A systematic English language search of the medical literature using PubMed was conducted between January 1960 and May 2012 using the search terms ‘tadalafil’, ‘therapy’, ‘pulmonary (arterial) hypertension’ and ‘combination therapy’. Special emphasis was given to controlled clinical trials and case studies relevant for the use of tadalafil in PAH. The search revealed 113 relevant publications, 31 of which were clinical trials, 52 were reviews and 12 were case reports. Of these, 12 were clinical studies in human patients with PAH who were treated with tadalafil alone, and seven were clinical studies in human patients with PAH who were treated with tadalafil in combination with other agents. Only clinical studies in human patients were included. Exclusion criteria were monotherapy other than using tadalafil and any combination therapy that excluded tadalafil as part of the treatment regimen. Overall, 1353 human subjects were studied; 896 were treated with tadalafil alone while 457 subjects were treated with tadalafil in coadministration. Tadalafil appears to be an effective and a safe treatment option for patients with PAH. It improves clinical status, exercise capacity, hemodynamic parameters, compliance issues and quality of life and reduces the occurrence of clinical worsening. Tadalafil in combination therapy seems to be additive and synergistic in relaxing pulmonary vascular muscle cells but more clinical trials on human subjects are warranted.