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目的探讨小剂量睾酮补充治疗(TST)对男性迟发性性腺功能减退症(LOH)合并代谢综合征(MS)的有效性和安全性。方法选取80例合并有男性LOH和MS的患者,以3∶1的比例随机分为实验组和对照组:实验组给予口服十一酸睾酮(每次40 mg,每日2次,餐后服用);对照组不做任何治疗。随访12个月,比较各项指标水平差异,分析TST的有效性及安全性。结果与对照组相比,实验组采用TST3个月后中老年男性症状问卷(AMS)评分、睾酮水平、空腹胰岛素(FINS)及胰岛素敏感指数(ISI)变化差异有统计学意义(P<0.05),其他MS指标及国际勃起功能指数表(IIEF-5)评分变化差异均无统计学意义;12个月后AMS评分为(23.5±2.7)分,睾酮水平为(18.2±5.3)nmol/L,均达到正常范围,IIEF-5评分、腰围(WC)、高密度脂蛋白胆固醇(HDL-C)、三酰甘油(TG)、空腹血糖(FBG)、FINS及ISI变化差异均有统计学意义(P<0.05)。治疗期间,对照组各指标变化差异均无统计学意义,实验组未出现明显不良反应,前列腺特异性抗原(PSA)、血红细胞计数(RBC)、血红蛋白(Hb)及红细胞压积(HCT)变化差异均无统计学意义。结论小剂量TST对LOH合并MS安全有效。
Objective To investigate the efficacy and safety of low-dose testosterone replacement therapy (TST) on men with delayed hypogonadism (LOH) and metabolic syndrome (MS). Methods Totally 80 patients with male LOH and MS were selected and randomly divided into experimental group and control group with the ratio of 3: 1. The experimental group was given oral testosterone undecanoate (40 mg twice daily, after meals ); Control group without any treatment. The patients were followed up for 12 months. The differences of the indexes were compared, and the validity and safety of TST were analyzed. Results Compared with the control group, there was significant difference in AMS score, testosterone level, FINS and ISI between the experimental group and the control group after 3 months of TST (P <0.05) , Other MS indexes and IIEF-5 scores had no significant difference. After 12 months, AMS score was (23.5 ± 2.7) and testosterone level was (18.2 ± 5.3) nmol / L, All reached the normal range. The differences of IIEF-5, WC, HDL-C, TG, FBG, FINS and ISI were all statistically significant ( P <0.05). There was no significant difference in every index of the control group during the treatment period, and no significant adverse reactions, PSA, RBC, Hb and HCT in the experimental group were observed The difference was not statistically significant. Conclusion Low-dose TST is safe and effective for LOH combined with MS.