左卡尼汀联合他达拉非治疗ED为主症的LOH安全性有效性的随机对照多中心临床研究

Safety and efficacy of L-carnitine and tadalafil for late-onset hypogonadism with ED:A randomized controlled multicenter clinical trial

目的:评价左卡尼汀联合他达拉非治疗迟发性性腺功能低下(LOH)合并勃功能起障碍(ED)的安全性和有效性。方法:140例性腺功能低下合并ED患者随机分为治疗组和对照组,治疗组给予左卡尼汀联合他达拉非治疗,对照组给予十一酸睾酮联合他达拉非治疗,8周后分别评价治疗前后IIEF-5和老年男子症状测评表(AMS)评分、生殖激素水平等有效性指标变化以及血常规、PSA、前列腺指检或体积等安全性指标变化。结果:最终有效病例110例,治疗组60例,对照组50例;治疗8周后IIEF-5评分治疗组为(17.7±3.5)分,对照组为(16.7±2.6)分,均较治疗前[(10.2±2.7)分和(9.3±2.4)分]明显改善(P<0.05);两组AMS评分治疗后8周较治疗前亦有明显改善[(36.2±6.5)vs(48.8±5.8)分;(35.8±6.6)vs(50.7±5.0)分](P<0.05),但两组之间疗效无显著性差异(P>0.05)。两组治疗前后及两组之间,安全性比较无明显差异(P>0.05),但对照组有2例患者PSA﹥4μg/L,进一步随访确定因前列腺炎症导致。结论:左卡尼汀联合他达拉非治疗LOH合并ED安全、有效。

Objective ： To evaluate the safety and effect of L-carnitine combined with tadalafil in the treatment of late-onset hy- pogonadism （LOH） with erectile dysfunction （ED）. Methods ： We randomly divided 140 cases of LOH with ED aged 40 - 70 years into a treatment and a control group to receive L-carnitine ＋ tadalafil and testosterone undecanoate ＋ tadalafil, respectively. After 8 weeks of treatment, we obtained the scores on IIEF-5 and Aging Male Symptoms （ AMS）, observed changes in the levels of sex hormones, analyzed the results of the routine blood test and PSA level, and evaluated the safety of medication. Results： Finally, 110 cases were included, 60 in the treatment group and 50 in the control. After 8 weeks of medication, the IIEF-5 and AMS scores were significantly improved as compared with the baseline both in the treatment group （ 17.7 ±3.5 vs 10.2 ± 2.7 and 36.2 ± 6.5 vs 48.8 ± 5.8 ） and in the control group （ 16.7 ± 2.6 vs 9.3 ± 2.4 and 35.8 ± 6.6 vs 50.7 ± 5.0） （ both P 〈 0.05 ）, with no significant differences between the two groups （ P 〉 0.05 ）. As for the safety of medication, there were no significant differences between the two groups before and after treatment （P 〉 0.05）. Two patients in the control group showed a PSA level 〉 4 ixg/L, which was confirmed to be caused by prostatitis during follow-up. Conclusion ： L-carnitine combined with tadalafil is safe and effective for the treatment of LOH with ED.