双盲临床试验：沙巴棕治疗BPH及炎症的药理作用.pdfVIP

European Urology European Urology 44 (2003) 549–555 BPH and Inflammation: Pharmacological Effects of Permixon on Histological and Molecular Inflammatory Markers. Results of a Double Blind Pilot Clinical Assay a,* a b b ´ ´c R. Vela Navarrete , J.V. Garcia Cardoso , A. Barat , F. Manzarbeitia , A. Lopez Farre a ´ ´ ´ ´ Department of Urology, Fundacion Jimenez Dıaz, Universidad Autonoma, 6 Avda. Reyes Catolicos, 2, 28040 Madrid, Spain b ´ ´ ´ ´ Department of Pathology, Fundacion Jimenez Dıaz, Universidad Autonoma, Madrid, Spain c ´ ´ ´ ´ Department of Molecular Biology, Fundacion Jimenez Dıaz, Universidad Autonoma, Madrid, Spain First published online 29 July 2003 Abstract Introduction: The role of infiltrating cells (I.C.), commonly observed in the adenoma interstitial tissue, is unknown. We tested the hypothesis that I.C. are related with BPH progression by: phenotypically characterising these cells; quantifying the expression of lymphokines and growth factors; investigating the response to Permixon (P) in a clinical study. Permixon is a Lipido Sterolic Extract of Serenoa repens possessing pharmacological activities and widely used in the treatment of men with BPH. Material and Methods: A multicenter open pilot study of two parallel groups on BPH patients was carried out. They were randomized to receive either oral Permixon (P) 160 mg bid for three months or to be followed for 3 weeks without any treatment before surgery (control group C). Strict inclusion and exclusion criteria were applied to conform homogeneous groups, avoiding interferences of inflammatory drugs or others. Baseline clini