碱性成纤维细胞生长因子抑制剂太得恩治疗良性前列腺增生  

Efficacy and safety of a bFGF inhibitor,tadenan in the treatment of benign prostatic hyperplasia:a multicenter trial in China

作　　者：金杰[1] 郭应禄[1] 梅骅[2] 张元芳[3] 

机构地区：[1]北京大学第一医院北京大学泌尿外科研究所,100034 [2]广州中山大学附属第一医院泌尿外科 [3]复旦大学附属华山医院复旦大学泌尿外科研究所

出　　处：《中华泌尿外科杂志》2003年第1期55-57,共3页Chinese Journal of Urology

摘　　要：目的　探讨碱性成纤维细胞生长因子 (bFGF)抑制剂太得恩 (tadenan ,通尿灵 )治疗良性前列腺增生 (BPH)的有效性及安全性。　方法　多中心开放性临床研究 ,BPH患者 3 50 8例口服太得恩 50mg,每日 2次 ,共 8周。　结果　患者治疗前、治疗后 4周和 8周IPSS评分平均值分别为2 2 .61± 6 .66、1 9.57± 1 4 .93和 1 3 .31± 1 1 .86 ,差别均有显著性意义 (P <0 .0 0 0 1 ) ;最大尿流率(MFR)分别为 (1 1 .1 6± 4 .88)ml/s、(1 3 .52± 5 .36)ml/s和 (1 5 .58± 5 .98)ml/s ,用药后 4周和 8周比用药前均有明显提高 ,差别有显著性意义 (P <0 .0 0 0 1 ) ;治疗前、治疗后 4周和 8周剩余尿量分别为(57.30± 39.91 )ml,(44.58± 30 .95)ml和 (32 .64± 2 4 .2 3)ml,治疗 4周和 8周后均较治疗前明显减少 ;治疗后 8周较治疗后 4周明显减少 ,差别均有显著性意义 (P =0 .0 0 0 1 )。 2 4 4例患者行经腹B超前列腺体积监测 ,治疗前及治疗 8周后前列腺体积分别为 (67.33± 2 7.88)ml和 (64 .2 7± 2 7.54)ml,差别有显著性意义 (P =0 .0 0 0 1 ) ;总的不良反应发生率 1 .7% ,多为头晕、上腹不适、恶心、浮肿等 ,均自行缓解。治疗过程中尿常规、肝肾功能均未见异常。　结论　太得恩治疗BPH疗效显著 ,副作用少。Objective To further confirm the Efficacy and safety of tadenan (Pygeum africunum extract) in the treatment of benign prostatic hyperplasia (BPH) in larger population in China. Methods In this open multicenter study,a total of 3 508 patients with symptomatic BPH received oral tadenan of 50 mg twice daily for 8 weeks. Results IPSS,maximum urinary flow and post voiding volume were 19.57± 14.93 ,(13.52±5.36)ml/s and (44.58±30.95)ml four weeks after the treatment of tadenan and were 13.31±11.86,(15.58±5.98)ml/s and (32.64±24.23)ml eight weeks after the treatment,both improved significantly comparing to those before the treatment ( P <0.0001).The volumes of the prostates were reduced.The differences between pre and post treatment were statistically.Adverse events were 1.7% in frequency and generally mild in nature.They could be relieved automatically.No abnormality in routine urine and liver and renal function examinations were found. Conclusions Tadenan offers an alternative for the treatment of patients with BPH.It has satisfactory efficacy and safety profile.

关 键 词：前列腺增生 成纤维细胞生长因子 碱性 太得恩 

分 类 号：R697.3[医药卫生—泌尿科学]