十一酸睾酮改善慢性疾病晚期老年男性患者生存质量的随机对照试验

A Randomized Controlled Trial of Testosterone Undecanoate for Improving Quality of Life of the Elderly Male Patients with Chronic Disease in Advanced Stage

目的了解十一酸睾酮在改善老年男性慢性疾病晚期患者生存质量和体力改善方面的作用及其安全性和耐受性。方法采用前瞻性随机对照设计方案,将2003年6月至2005年3月在四川大学华西医院老年科住院的80名慢性疾病晚期伴衰竭的老年男性患者随机(采用简单随机法)分成两组。试验组在常规临床支持治疗基础上加服十一酸睾酮;对照组仅采用常规临床治疗。观察各项相关指标的变化。结果①两组基线情况有可比性;②治疗组较对照组更年期相关症状评分下降,生活质量评分增加(P<0.05);③与对照组相比,试验组血清总睾酮水平明显增加,上臂周径及右手握力增加(P<0.05);体重、BMI及左手握力虽有增加,但与对照组比较无明显差异(P>0.05);④治疗后尿路症状、下肢水肿、血前列腺特异抗原、肝功、血糖及血色素水平,两组无明显差异。结论十一酸睾酮能明显改善老年男性慢性疾病衰竭患者整体临床状况,使患者血清睾酮水平增加,并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 exhaustion and quality of life （QOL） of the elderly male patients with chronic disease in advanced stage. Methods Using a simple randomized controlled trial design, eighty patients were randomized into two groups. The treatment group took routine therapy and TU and the control group with routine therapy alone. Results 1. Baseline characteristics in both groups were similar. 2. The PADAM grade decreased, and the QOL scale increased in the treatment group （P 〈0.05 ）. 3. Serum total testosterone in the treatment group rose, upper arm circumference and right hand grip improved （ P 〈0.05 ）. 4. There were no significant differences in adverse effects between both groups. Conclusions TU can improve the clinical health status in the elderly male patients with chronic disease in advanced stage and increase serum testosterone level, there is a satisfactory tolerances and few adverse reactions.