Ahmad Naveed, Keith-Ferris Jeanne, Gooden Elizabeth, Abell Thomas
Department of Medicine and Division of Digestive Disease, University of Mississippi Medical Center, Jackson, Mississippi 39216, USA.
Curr Opin Pharmacol. 2006 Dec;6(6):571-6. doi: 10.1016/j.coph.2006.07.004. Epub 2006 Sep 25.
There are very few treatment options currently available for patients with gastrointestinal motility disorders, especially patients with gastroparesis. Domperidone, a peripheral dopamine receptor antagonist, has been successfully used for decades in the US and marketed in many countries for the treatment of gastroparesis. Its use, however, has recently become controversial owing to safety concerns, and it has never been approved for marketing by the FDA. During the 1990s, domperidone was available to US gastroenterologists under a compassionate-use program by Janssen Pharmaceutica, as the manufacturer worked towards, and fell short of, full US market approval. Medical studies, trials and case reports demonstrate the superior efficacy of domperidone when compared with placebo and other pharmaceutical therapies available. Data on the cardiac toxicity associated with oral use of domperidone fail to be convincing.
目前,针对胃肠动力障碍患者,尤其是胃轻瘫患者,可供选择的治疗方案非常有限。多潘立酮,一种外周多巴胺受体拮抗剂,在美国已成功使用数十年,并在许多国家上市用于治疗胃轻瘫。然而,由于安全问题,其使用最近引发了争议,并且从未获得美国食品药品监督管理局(FDA)的上市批准。在20世纪90年代,扬森制药公司通过一项同情用药计划,将多潘立酮提供给美国胃肠病学家,因为该制造商努力争取获得美国市场的全面批准,但未成功。医学研究、试验和病例报告表明,与安慰剂和其他可用药物疗法相比,多潘立酮具有卓越的疗效。关于口服多潘立酮相关心脏毒性的数据并不令人信服。