Levin R M, Das A K
Division of Basic and Pharmaceutical Sciences, Albany College of Pharmacy, NY 12208, USA.
Urol Res. 2000 Jun;28(3):201-9. doi: 10.1007/s002409900098.
In Europe, phytotherapeutic preparations have been prescribed for the treatment of symptomatic benign prostatic hyperplasia (BPH) for over 20 years [1-4]. In these countries, phytotherapeutic preparations represent approximately 1/3 of total sales of all therapeutic agents sold for the treatment of BPH. In France, and other countries, phytotherapeutic preparations are the most widely used drugs for the treatment of BPH. In Asia, Africa, and India, phytotherapy is considered a first-line treatment for BPH and has been utilized effectively for centuries. In the United States, the multimillion dollar sales of phytotherapeutic preparations for "the health of the prostate and bladder" attests to the widespread utilization of these agents [3, 4]. Two of the most popular phytotherapeutic agents that have undergone both clinical studies to determine their efficacy, and have been the subject of basic science studies to identify the mechanism(s) of action are Pygeum africanum (Tadenan), an extract from the bark of the African plum tree, and Serenoa repens (Permixon), a lipido-sterol extract of dwarf palm. Tadenan and Permixon are registered therapeutic agents of Debat Pharmaceuticals, and Pierre Fabre Medicament, respectively. Manufacture of both preparations are tightly controlled and subjected to strict quality control for stability of component composition. In regard to phytotherapeutic agents, each individual preparation (even from the same plant source) must be considered individually because of differences in the extraction techniques, preparation of products, composition, and biological activities. Thus, the clinical and biological activities of one preparation cannot be extrapolated to other preparations of the same plant source. Thus, studies described in this review which utilize the preparations that are manufactured by DEBAT (Pygeum africanum) or Pierre Fabre Medicament (Serenoa repens) are referred to by their trade names, Tadenan and Permixon, to differentiate them from other nonstandardized preparations of the same plants.
在欧洲，植物疗法制剂已被用于治疗有症状的良性前列腺增生（BPH）达20多年之久[1 - 4]。在这些国家，植物疗法制剂约占所有用于治疗BPH的治疗药物总销售额的三分之一。在法国和其他国家，植物疗法制剂是治疗BPH最广泛使用的药物。在亚洲、非洲和印度，植物疗法被视为BPH的一线治疗方法，并且已经有效使用了几个世纪。在美国，用于“前列腺和膀胱健康”的植物疗法制剂数百万美元的销售额证明了这些药物的广泛使用[3, 4]。两种最受欢迎的植物疗法药物，既进行了临床研究以确定其疗效，也成为基础科学研究以确定其作用机制的对象，它们是非洲臀果木提取物（Tadenan），一种从非洲李树树皮中提取的物质，以及锯叶棕脂甾醇提取物（Permixon），一种矮棕榈的脂甾醇提取物。Tadenan和Permixon分别是Debat制药公司和Pierre Fabre Medicament公司的注册治疗药物。两种制剂的生产都受到严格控制，并对成分组成的稳定性进行严格的质量控制。对于植物疗法药物，由于提取技术、产品制备、成分和生物活性的差异，每种单独的制剂（即使来自同一植物来源）都必须单独考虑。因此，一种制剂的临床和生物活性不能外推到同一植物来源的其他制剂。因此，本综述中描述的使用DEBAT（非洲臀果木）或Pierre Fabre Medicament（锯叶棕）生产的制剂的研究，将以其商品名Tadenan和Permixon提及，以将它们与同一植物的其他非标准化制剂区分开来。
