Iyer Sunil R, Annex Brian H
Division of Cardiovascular Medicine, University of Virginia School of Medicine, Charlottesville, Virginia.
Robert Bernie Cardiovascular Research Center, University of Virginia School of Medicine, Charlottesville, Virginia.
JACC Basic Transl Sci. 2017 Oct;2(5):503-512. doi: 10.1016/j.jacbts.2017.07.012. Epub 2017 Oct 30.
Peripheral arterial disease (PAD) is a major health care problem. There have been limited advances in medical therapies, and a huge burden of symptomatic patients with intermittent claudication and critical limb ischemia who have limited treatment options. Angiogenesis is the growth and proliferation of blood vessels from existing vasculature. For approximately 2 decades, "therapeutic angiogenesis" has been studied as an investigational approach to treat patients with symptomatic PAD. Despite literally hundreds of positive preclinical studies, results from human clinical studies thus far have been disappointing. Here we present an overview of where the field of therapeutic angiogenesis stands today and examine lessons learned from previously conducted clinical trials. The objective is not to second-guess past efforts but to place the lessons in perspective to allow for trial success in the future to improve agent development, trial design, and ultimately, clinical outcomes for new therapeutics for PAD.
外周动脉疾病（PAD）是一个重大的医疗保健问题。医学治疗方面进展有限，有症状的间歇性跛行和严重肢体缺血患者负担沉重，且治疗选择有限。血管生成是指从现有脉管系统中生长和增殖血管。大约20年来，“治疗性血管生成”一直作为一种治疗有症状PAD患者的研究方法进行研究。尽管有数百项临床前研究结果呈阳性，但迄今为止人类临床研究的结果却令人失望。在此，我们概述了治疗性血管生成领域目前的状况，并审视从先前进行的临床试验中吸取的经验教训。目的不是对过去的努力进行事后评判，而是正确看待这些经验教训，以便未来的试验能够成功，从而改进药物研发、试验设计，并最终改善PAD新疗法的临床疗效。
