十一酸睾酮改善维持性血液透析男性患者性生活质量的随机对照试验

A randomized controlled trial of testosterone undecanoate for improving quality of sex life of the male continuous hemodialysis patients

目的了解十一酸睾酮(TU)在改善维持性血液透析男性患者性生活质量方面的作用及其安全性和耐受性。方法 70例血清睾酮低于260 ng/dl的维持性血透男性患者随机(随机数字表法)分为观察组和对照组,观察组除了常规血透外加用口服TU(安特尔)80 mg/早、40 mg/晚,2周后改为40 mg早晚两次,疗程6个月;对照组仅常规血透,检测血清性激素水平(FSH、LH、E2、PRL、P、T)变化及IIEF-5评分变化。结果观察组经TU治疗后T(273.72±86.52)ng/dl高于对照组(212.36±69.10)ng/dl(P<0.05),IIEF评分优于对照组,雌性激素水平、排尿困难、下肢水肿、血PSA两组均无差异(P>0.05)。结论 TU能明显改善维持性血液透析男性患者性生活质量,具有良好的安全性和耐受性。

Objective To study the effectiveness, safety and tolerance of testosterone undecanoate （TU） in improving quality of sex life of the male continuous hemodialysis patients. Methods Seventy male continuous hemodialysis patients whose serum total testosterone（T） level was lower than 260ng/dl were randomized into two groups. The treatment group was treated with routine hemodialysis and TU （80 mg/morning and 40 mg/night, after two weeks it was changed to 40 mg/morning and 40 mg/night） and the control group with routine hemodialysis alone. The study was continued for six months. Serum sex hormone of the patients was examined and the international index of erectile function （IIEF） was assessed. Results The T of the treatment group （273.72 ± 86. 52）ng/dl was significantly higher than those of the control group （212. 36 ±69. 10）ng/dl （ P 〈 0. 05 ）, and the IIEF scores was also significantly higher than those of the control group. FSH,LH,E2,PRL.P level were no significant differences between both groups. There were no significant differences in adverse effects between both groups. Conclusion TU can improve the quality of sex life of the male continuous hemedialysis patients. There is a satisfactory tolerances and few adverse reactions.