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长期度他雄胺治疗对良性前列腺增生有所帮助
“有症状的BPH病人治疗48个月，度他雄胺对5-α-还原酶的双重抑制对病人持续有效”，美国德州大学西南医学中心的罗尔伯恩（Claus G. Roehrborn）和同事写道，“两年内对双氢睾酮的近乎安全、长期抑制没有导致副作用增多”。这些研究者汇集了多中心、随机、对照试验的两阶段资料，病人治疗2年，再进入2年的开放性延伸期。参试标准是至少50岁，有BPH的临床诊断，前列腺至少30 cm3，美国泌尿外科学会症状指数分至少12，最大排尿速度等于小于15 mL/秒，前列腺特异性抗原至少1.5 ng/mL，但不到10 ng/mL。
共2,802人参加了研究的双盲阶段，1,908人(68%)完成了试验，在进入开放期的1,570人中，569人用度他雄胺治疗48个月。在最后访视时发现，两阶段都用了度他雄胺的人前列腺大小 (−26.2%)、美国泌尿协会症状分（−6.1）、最大排尿速度（+2.8 mL/秒）改善。安慰剂/度他雄胺组的男性在前列腺大小（−20.7%）、美国泌尿协会症状分（−5.3）、最大排尿速度(+1.8 mL/秒)上的改善小些。在开放阶段，有急性尿潴留的男性不到2%，手术的不到1%。
“度他雄胺的耐受性很好，开放阶段在药物引起的副作用上没有统计学意义的显著增多，实验室检查没有不利倾向”，作者写道，“一直用度他雄胺治疗48个月的病人症状及尿速的改善与用а受体阻滞剂者相似”。
Efficacy and safety of dutasteride in the four-year treatment of men with benign prostatic hyperplasia.
Roehrborn CG, Marks LS, Fenter T, Freedman S, Tuttle J, Gittleman M, Morrill B, Wolford ET.
Department of Urology, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75390-9110, USA.
OBJECTIVES: To assess the long-term safety and efficacy of dutasteride, a dual type 1 and type 2 5-alpha-reductase inhibitor, in the treatment of symptomatic benign prostatic hyperplasia and associated lower urinary tract symptoms. METHODS: Data from two Phase IIIa multicenter, randomized, placebo-controlled trials of 2-year duration plus a 2-year open-label extension were pooled and analyzed. The entry criteria included age 50 years old or older, clinical diagnosis of benign prostatic hyperplasia, prostate volume of 30 cm3 or greater, American Urological Association symptom score of 12 or greater, peak urinary flow rate of 15 mL/s or less, and prostate-specific antigen level of 1.5 ng/mL or greater but less than 10 ng/mL. RESULTS: A total of 2802 men were randomized into the double-blind phase of the two studies with 1908 patients (68%) completing the study. Of these, 1570 subjects were enrolled in the open-label phase, and 569 subjects received dutasteride for 48 months. Changes at the 48-month visit for dutasteride/dutasteride-treated subjects included improvement in prostate volume (-26.2%), American Urological Association Symptom Index (-6.1 points), and peak urinary flow rate (+2.8 mL/s). Changes for the placebo/dutasteride group included prostate volume (-20.7%), American Urological Association Symptom Index (-5.3 points), and peak urinary flow rate (+1.8 mL/s). Acute urinary retention and surgery occurred in a small percentage of subjects (less than 2% and less than 1%) in the open-label extension phase. Dutasteride was well tolerated with no statistically significant increase in drug-related adverse events during the open-label extension and no adverse laboratory trends. CONCLUSIONS: Dual inhibition of 5-alpha-reductase with dutasteride provided sustained efficacy in subjects with symptomatic benign prostatic hyperplasia treated for 48 months. Near-complete, long-term suppression of dihydrotestosterone (93% at 48 months) with dutasteride did not lead to an increase in adverse events compared with that reported in the 2-year period. [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-05-24 17:17
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