Stone N N
Department of Urology, Mt. Sinai Medical Center, New York, New York.
Urology. 1989 Oct;34(4 Suppl):64-8; discussion 87-96. doi: 10.1016/0090-4295(89)90236-7.
A multicenter, randomized, double-blind study was undertaken to evaluate the efficacy of the antiandrogen flutamide in treating patients with urinary obstruction caused by benign prostatic hypertrophy (BPH). Patients were randomized to either flutamide (750 mg/d) or a placebo. Prostate size (measured by ultrasound), uroflow, and symptomatology were assessed in all patients. Of the 84 patients entered in the study, 30 receiving placebo have, to date, reached twelve weeks and 4 have reached twenty-four weeks. Twenty-eight patients receiving flutamide have reached twelve weeks, while 8 have reached twenty-four weeks. At twenty-four weeks, a 41 percent median decrease in prostate volume and a 46 percent increase in full-bladder uroflow was observed in patients receiving flutamide; no significant changes in prostate volume or uroflow occurred in patients receiving placebo. However, significant symptomatic improvements were noted in both groups. Only 4 patients (11%) had significant adverse reactions to flutamide; these reactions included breast pain and diarrhea. No cases of impotence occurred. It was concluded that flutamide may be a safe and effective drug for the treatment of symptomatic BPH.
开展了一项多中心、随机、双盲研究，以评估抗雄激素药物氟他胺治疗良性前列腺增生（BPH）所致尿路梗阻患者的疗效。患者被随机分为氟他胺组（750毫克/天）或安慰剂组。对所有患者评估前列腺大小（通过超声测量）、尿流率和症状。在纳入研究的84例患者中，30例接受安慰剂治疗的患者迄今已达12周，4例已达24周。28例接受氟他胺治疗的患者已达12周，8例已达24周。在24周时，接受氟他胺治疗的患者前列腺体积中位数下降41%，膀胱充盈时尿流率增加46%；接受安慰剂治疗的患者前列腺体积或尿流率无显著变化。然而，两组患者症状均有显著改善。仅4例患者（11%）对氟他胺有显著不良反应；这些反应包括乳房疼痛和腹泻。未发生阳痿病例。结论是氟他胺可能是治疗有症状BPH的一种安全有效的药物。
