盐酸曲马多联合行为疗法治疗早泄的安全性、有效性临床观察

Safety and efficacy of tramadol hydrochloride with behavioral modification in the treatment of premature ejaculation

目的:评价盐酸曲马多联合行为疗法治疗早泄的安全性、有效性。方法:按随机原则将72例早泄患者分为治疗组和对照组,治疗组(n=36)性生活前2 h口服盐酸曲马多50 mg联合行为疗法,对照组(n=36)予以单纯行为疗法,两组疗程均为8周,记录治疗前后阴道内射精潜伏期(IELT)、配偶性生活满意度评分、临床总有效率、不良反应和肝、肾功能。结果:两组治疗前后在IELT和改善配偶性交满意度评分方面有显著性差异(P<0.01),两组治疗效果的总有效率,治疗组为72.2%,对照组为47.2%,治疗组较对照组治疗后IELT、改善配偶性交满意度评分和临床总有效率方面有显著性差异(P<0.05),10例(27.8%)患者出现不良反应,治疗组治疗前后肝肾功能无统计学差异(P>0.05)。结论:盐酸曲马多联合行为疗法在延长IELT及改善配偶性交满意度评分、临床总有效率和肝、肾功能方面,其安全性和有效性值得肯定。但盐酸曲马多为阿片类药物,成瘾性还有待评估,是否作为国内治疗早泄的常规治疗药物尚需进行多中心、双盲临床安全性及有效性的进一步研究。

Objective： To evaluate the efficacy and safety of tramadol hydrochloride with behavioral modification in delaying ejaculation in patients with premature ejaculation. Methods： Seventy-two potent men with premature ejaculation were equally and randomly assigned to a treatment group and control group,the former received 50 mg tramadol hydrochloride with behavioral modification approximately 2 hours before planned sexual activity,while the latter underwent behavioral therapy only,both treated for 8 weeks.Intravaginal ejaculatory latency time（IELT）,intercourse satisfaction of the partners,total therapeutic effectiveness,adverse reactions,and hepatic and renal function of the patients were recorded and compared before and after the treatment.Results： Both the treatment and the control groups showed significant differences from pretreatment in the mean IELT and intercourse satisfaction domain values（P0.01）.The total rate of effectiveness was 72.2% in the treatment group and 47.2% in the control.The former exhibited even more significant improvement than the latter in the mean IELT,intercourse satisfaction domain values and total rate of effectiveness（P0.05）.Adverse reactions occurred in 10 cases（27.8%）,and no statistically significant differences were found in hepatic and renal function before and after treatment（P0.05）. Conclusion： Tramadol hydrochloride with behavioral modification showed positive effects in prolonging IELT and improving partners＇ intercourse satisfaction.Yet more multicenter and double-blind studies are required to evaluate its efficacy and safety as a routine therapy for premature ejaculation.