Ventetuolo Corey E, Benza Raymond L, Peacock Andrew J, Zamanian Roham T, Badesch David B, Kawut Steven M
Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA.
Proc Am Thorac Soc. 2008 Jul 15;5(5):617-22. doi: 10.1513/pats.200803-029SK.
Pulmonary arterial hypertension is a rare and often devastating disease, although various effective therapies are now available. Clinical trials have used hemodynamic, cardiac imaging, laboratory, and exercise measurements as surrogate and intermediate end points in pulmonary arterial hypertension. Yet, based on the current literature, it is difficult to surmise which of these (if any) have been definitively validated. In addition, investigators have advocated the use of combined clinical end points in future clinical trials. The dependence of clinical trials and clinical management on such end points warrants a review of their use.
肺动脉高压是一种罕见且往往具有毁灭性的疾病,尽管目前已有多种有效疗法。在肺动脉高压的临床试验中,血流动力学、心脏成像、实验室检查和运动测量等指标被用作替代终点和中间终点。然而,根据目前的文献,很难推测这些指标(如果有的话)中哪些已得到明确验证。此外,研究人员主张在未来的临床试验中使用综合临床终点。临床试验和临床管理对这些终点的依赖使得有必要对其使用情况进行审查。