Kumamoto Y, Tsukamoto T, Aoki M, Sato Y, Umehara T, Yoshida O, Arai Y, Kubo T, Aoki H, Komatsu Y
Department of Urology, Sapporo Medical College.
Hinyokika Kiyo. 1994 Aug;40(8):745-59.
Using chlormadinone acetate (CMA) as the control drug, a double-blind study was carried out to examine not only the effects of 17 alpha-acetoxy-6-chloro-2-oxa-4,6-pregnadiene-3,20-dione (TZP-4238;) on subjective urinary symptoms but also, especially, that on the sexual function in patients with benign prostatic hypertrophy (BPH). The clinical efficacy rate in relation to the subjective urinary symptoms was about the same in the two treatment groups; 45.9% in the TZP-4238 group and 50.0% in the CMA group. However, the incidence of adverse effects on the sexual function showed a marked difference between the two groups. The TZP-4238 group revealed a lower suppressive effect on the function than the CMA group (45.1% vs. 71.4%). In relation to their causation of other adverse effects, there were no differences between the two drugs. Accordingly, in consideration of the facts that TZP-4238 with less influence on the sexual function affords a superior quality of life to elderly patients, while achieving effective treatment by means of a convenient single daily administration, TZP-4238 was surmised to be a more useful drug than CMA as an antiandrogen for the treatment of BPH.
以醋酸氯地孕酮(CMA)作为对照药物,开展了一项双盲研究,不仅旨在考察17α-乙酰氧基-6-氯-2-氧杂-4,6-孕二烯-3,20-二酮(TZP-4238)对主观尿路症状的影响,更特别地,考察其对良性前列腺增生(BPH)患者性功能的影响。两个治疗组在主观尿路症状方面的临床有效率大致相同;TZP-4238组为45.9%,CMA组为50.0%。然而,两组在性功能不良反应发生率上存在显著差异。TZP-4238组对性功能的抑制作用低于CMA组(45.1%对71.4%)。在其他不良反应的发生原因方面,两种药物之间没有差异。因此,考虑到TZP-4238对性功能影响较小,能为老年患者带来更高的生活质量,同时通过方便的每日一次给药实现有效治疗,推测TZP-4238作为抗雄激素药物治疗BPH比CMA更有用。