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盐酸曲马多联合行为疗法治疗早泄的安全性与有效性

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

作者信息

Xiong Guo-Gen, Wu Fei-Hua, Chen Sheng-Hui, Yao Wen-Liang

机构信息

Nanchang Institute of Medical Sciences, Nanchang Andrology Hospital, Nangchang, Jiangxi 330001, China.

出版信息

Zhonghua Nan Ke Xue. 2011 Jun;17(6):538-41.

PMID:21735655
Abstract

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 (P < 0.01). 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 (P < 0.05). Adverse reactions occurred in 10 cases (27.8%), and no statistically significant differences were found in hepatic and renal function before and after treatment (P > 0.05).

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.

摘要

目的

评估盐酸曲马多联合行为疗法延迟早泄患者射精的疗效及安全性。

方法

72例有早泄问题的性功能正常男性被平均随机分为治疗组和对照组,治疗组在计划性行为前约2小时服用50毫克盐酸曲马多并结合行为疗法,对照组仅接受行为疗法,两组均治疗8周。记录并比较治疗前后患者的阴道内射精潜伏期(IELT)、性伴侣的性交满意度、总治疗效果、不良反应以及肝肾功能。

结果

治疗组和对照组的平均IELT及性交满意度领域值与治疗前相比均有显著差异(P < 0.01)。治疗组总有效率为72.2%,对照组为47.2%。治疗组在平均IELT、性交满意度领域值及总有效率方面的改善比对照组更显著(P < 0.05)。10例(27.8%)出现不良反应,治疗前后肝肾功能无统计学显著差异(P > 0.05)。

结论

盐酸曲马多联合行为疗法在延长IELT及提高性伴侣性交满意度方面显示出积极效果。然而,需要更多多中心双盲研究来评估其作为早泄常规治疗方法的疗效和安全性。

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