Department of Surgery, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
BJU Int. 2012 Jul;110(2):260-5. doi: 10.1111/j.1464-410X.2011.10755.x. Epub 2011 Nov 17.
Study Type - Therapy (RCT). Level of Evidence 1b. What's known on the subject? and What does the study add? Testosterone deficiency syndrome can be treated with testosterone replacement in the form of injectable, transdermal, buccal and oral preparations. Long-acting i.m. testosterone undecanoate 1000 mg, which is given at 10-14 week intervals, has been shown to be adequate for sustaining normal testosterone levels in hypogonadal men. This study confirms that long-acting i.m. testosterone undecanoate is effective in improving the health-related quality of life in men with testosterone deficiency syndrome as assessed by the improvement in the Aging Male Symptoms scale. Testosterone treatment can be indicated in men who have poor health-related quality of life resulting from testosterone deficiency syndrome.
• To evaluate the effect of i.m. injection of testosterone undecanoate 1000 mg over 12 months on the Aging Male Symptom (AMS) scale scores in men with testosterone deficiency syndrome (TDS).
• A total of 120 men >40 years old with TDS (total testosterone < 12 nmol/L and total AMS scores ≥ 27) were randomized into i.m. injection of either placebo or testosterone undecanoate 1000 mg. • In all, 56 and 58 participants from the active treatment and placebo groups, respectively completed the study. • An i.m. injection of either placebo or testosterone undecanoate 1000 mg was given at weeks 0, 6, 18, 30 and 48. • Self-administered AMS questionnaires were completed at weeks 0, week 18 and week 48.
• Improvement in the total AMS score was significantly greater in the treatment group than in the placebo group (F: 4.576, P= 0.017) over the 48-week period. • The mean (sd) total AMS score was 38.46 (11.85) at baseline and 33.59 (1.69) at 48 weeks for the placebo group, and 41.73 (12.73) at baseline and 32.61 (9.67) at 48 weeks for the treatment group. • The mean change in the total AMS score was -12.6% in the placebo group and -21.9% in the treatment group. • The mean psychological and somatovegetative domain scores decreased significantly more in the treatment group than in the placebo group (-2.8 vs -1.2, P= 0.03; and -3.2 vs -1.8, P= 0.016). • The difference in change between the randomized groups for the sexual domain scores followed the same trend, though the difference was not significant.
• Long-acting testosterone is effective in improving health-related quality of life as assessed by the AMS scale in men with TDS.
评估肌内注射十一酸睾酮 1000mg 治疗 12 个月对睾酮缺乏综合征（TDS）男性患者衰老男性症状（AMS）量表评分的影响。
共 120 名年龄>40 岁的 TDS 患者（总睾酮<12nmol/L，总 AMS 评分≥27）被随机分为肌内注射安慰剂或十一酸睾酮 1000mg 组。共有 56 名和 58 名来自活性治疗组和安慰剂组的参与者分别完成了研究。每周 0、6、18、30 和 48 时分别给予肌内注射安慰剂或十一酸睾酮 1000mg。在第 0 周、第 18 周和第 48 周时完成自我管理的 AMS 问卷。
在 48 周期间，治疗组的总 AMS 评分改善明显大于安慰剂组（F：4.576，P=0.017）。安慰剂组的平均（标准差）总 AMS 评分在基线时为 38.46（11.85），在第 48 周时为 33.59（1.69），治疗组在基线时为 41.73（12.73），在第 48 周时为 32.61（9.67）。安慰剂组的总 AMS 评分平均变化为-12.6%，治疗组为-21.9%。治疗组的心理和躯体植物神经域评分较安慰剂组显著下降（-2.8 比-1.2，P=0.03；-3.2 比-1.8，P=0.016）。随机分组间性域评分的变化差异也呈现相同趋势，尽管差异无统计学意义。
长效睾酮可有效改善 TDS 男性患者的健康相关生活质量，评估指标为 AMS 量表。
