Botto Henry, Lan Olivier, Poulain Jean-Eudes, Comenducci Andrea
Service d'Urologie, Hôpital Foch, Suresnes, France.
Prog Urol. 2005 Dec;15(6):1090-5.
Dihydrotestosterone (DHT) is a steroid hormone derived from testosterone, by the action of two distinct isoenzymes (type 1 and 2) of 5-alpha-reductase. Dutasteride is a specific selective inhibitor of the two isoenzymes, while finasteride is a selective inhibitor of type 2 -alpha-reductase. The working hypothesis is that the double 5-alpha-reductase inhibition induced by dutasteride therapy for 6 weeks should induce a supplementary reduction of plasma DHT levels compared to a parallel patient group continuing finasteride therapy over the same period.
In this prospective, two-centre, double-blind study, 21 patients previously treated by finasteride 5 mg for benign prostatic hyperplasia (BPH) for at least 6 months were randomized to receive either dutasteride 0.5 mg, or finasteride 5 mg daily for 6 weeks.
The mean relative variation of plasma DHT was 67.3% +/- 16.16% in the dutasteride group and 30.3% +/- 59.8% in the finasteride group. The reduction of DHT was numerically greater and more constant in the dutasteride group than in the finasteride group at 6 weeks; such a tendency was already observed after two weeks of treatment with dutasteride. Nevertheless, these differences were not statistically significant. Both medications were well tolerated and the only treatment-related adverse event (epigastric pain) was reported in the finasteride group.
The working hypothesis was therefore not statistically confirmed. It is difficult to conclude whether this reflects poor patient compliance with long-term finasteride for BPH or variability of response in patients with good compliance with treatment.
双氢睾酮(DHT)是一种由睾酮经5-α-还原酶的两种不同同工酶(1型和2型)作用而衍生的甾体激素。度他雄胺是这两种同工酶的特异性选择性抑制剂,而非那雄胺是2型α-还原酶的选择性抑制剂。工作假设是,与在同一时期继续使用非那雄胺治疗的平行患者组相比,度他雄胺治疗6周所诱导的双重5-α-还原酶抑制应能使血浆DHT水平进一步降低。
在这项前瞻性、双中心、双盲研究中,21例先前接受5mg非那雄胺治疗良性前列腺增生(BPH)至少6个月的患者被随机分为两组,一组每日服用0.5mg度他雄胺,另一组每日服用5mg非那雄胺,为期6周。
度他雄胺组血浆DHT的平均相对变化为67.3%±16.16%,非那雄胺组为30.3%±59.8%。在第6周时,度他雄胺组DHT的降低在数值上比非那雄胺组更大且更稳定;在度他雄胺治疗两周后就已观察到这种趋势。然而,这些差异无统计学意义。两种药物耐受性均良好,仅在非那雄胺组报告了唯一与治疗相关的不良事件(上腹部疼痛)。
因此,工作假设未得到统计学证实。很难确定这是反映了患者对用于BPH的长期非那雄胺治疗依从性差,还是反映了依从性良好的患者反应的变异性。