【作者】 周洁；

【导师】 吴敏；

【作者基本信息】 南京中医药大学 ， 中医学（专业学位）， 2014， 硕士

【摘要】 目的：评价改良二至丸治疗围绝经期伴女性性功能障碍证属肾阴虚证的临床疗效。方法：观察围绝经期伴女性性功能障碍证属肾阴虚证的妇女30例,随机分为治疗组15例(改良二至丸)和对照组(坤泰胶囊)。观察患者治疗前后围绝经期症状及实验室指标的变化、性功能评估及安全性评估。结果：1.治疗前后两组患者围绝经期症状的疗效比较：治疗组：痊愈率6.7%,显效率26.7%,有效率66.6%,无效率0%,总有效率100%。对照组：痊愈率0%,显效率13.3%,有效率73.3%,无效率13.3%,总有效率86.7%。治疗后两组总有效率相比,有统计学意义(P<0.05),提示改良二至丸对于围绝经期症状改善的疗效要优于坤泰胶囊。2.治疗前后两组患者中医证候的疗效比较：治疗组痊愈率6.7%,显效率13.3%,有效率80%,无效率0%,总有效率100%。对照组：痊愈率0%,显效率6.7%,有效率86.6%,无效率6.7%,总有效率93.3%。治疗后两组总有效率相比,有统计学意义(P<0.05),提示改良二至丸对于围绝经期伴女性性功能障碍的中医证候改善的疗效要优于坤泰胶囊。3.治疗前后两组患者中医证候的总积分比较：两组患者治疗后中医症状积分均明显下降(P<0.05),说明两种治疗方法对围绝经期综合征均有疗效。治疗后两组组间比较,有统计学意义(P<0.05),提示改良二至丸在改善该病的中医症状总积分方面要优于坤泰胶囊。4.治疗前后两组患者围绝经期改良Kupperman的总积分比较：两组患者治疗后Kupperman积分均有明显的下降(P<0.05),提示改良二至丸与坤泰胶囊对围绝经期伴女性性能障碍证属肾阴虚证女性的围绝经期症状的改善均具有较好的疗效。5.治疗前后两组患者中医证候中单项症状的积分比较：治疗组患者与对照组患者在腰膝酸软、五心烦热、潮热盗汗、口干咽燥、头晕、潮热盗汗、骨蒸潮热、失眠等症状积分有明显下降,P<0.05,有显著性差异,有统计学意义。治疗组与对照组相比,在腰膝酸软、头晕、潮热盗汗、骨蒸潮热等方面,有统计学意义(P<0.05),提示改良二至丸在治疗围绝经期的腰膝酸软、头晕、潮热盗汗、骨蒸潮热等方面的疗效优于坤泰胶囊。6.治疗前后两组患者血清性激素水平变化比较：治疗组与对照组的血清E2、FSH、LH水平均比治疗前明显改善,即血清E2水平升高,FSH、LH水平降低(P<0.05),说明中药改良二至丸与坤泰胶囊均能显著改善血清E2、FSH、LH水平。治疗后两组组间对比,在E2水平的改变具有显著性差异(P<0.05),提示改良二至丸在提高血清E2水平方面优于坤泰胶囊。7.治疗前后两组患者性功能指数量表(FSFI)的总积分比较：两组患者治疗后FSFI总积分均有明显的下降(P<0.05),提示两种治疗方法对围绝经期综合征的性功能障碍均有改善作用。8.治疗前后两组患者性功能各指标变化的比较：两组治疗前后性欲、性唤起功能、阴道润滑、性交满意度、性交时疼痛均较治疗前有显著的提高(P<0.05)；治疗后两组组间比较,治疗组的性欲、性唤起功能、阴道润滑、性交时疼痛改善更为明显(P<0.05)。结论：改良二至丸治疗围绝经期伴女性性功能障碍,可明显改善患者的围绝经期症状及性功能障碍,改善血清激素水平；对性功能的改善主要表现为性欲、性唤起功能、阴道润滑度、性交时满意度、性交痛等方面的改变；故提示改良二至丸治疗围绝经期伴女性性功能障碍具有良好的疗效。更多还原

【Abstract】 Objective:To evaluate the impact of Gai Liang Er Zhi Wan on Sexual Dysfunction in climacteric women with kidney-yin dyficiency.Methods:Thirty patients were randomized to treatment group(n=15,treated with Jia Jian Er Zhi Wan) and control group(n=15,treated with Kun Tai capsule). Changes of symptoms of climacteric syndrome, laboratory indexes, sexual function,and the safety were observed.Results:(1) The effective comparisons of climacteric syndrome for the two groups are as follows. The treatment group:the full recovery rate is6.7%,the excellence rate is26.7%,the effective rate is66.6%, and the inefficacy rate is0%,and the total effective rate is100%.The control group:the full recovery rate is0%, the excellence rate is13.3%,the effective rate is73.3%, and the inefficacy rate is13.3%, and the total effective rate is86.7%. Two groups’total curative effect comparison shows significant difference, and the treatment group is more effective than the control group.(2) The effective comparisons of syndrome in Chinese Medicine for the two groups’are as follows. The treatment group:the full recovery rate is6.7%,the excellence rate is13.3%,the effective rate is80%, and the inefficacy rate is0%, and the total effective rate is100%.The control group:the full recovery rate is0%, the excellence rate is6.7%, the effective rate is86.6%, and the inefficacy rate is6.7%, and the total effective rate is93.3%. Two groups’total curative effect comparison shows significant difference, and the treatment group is more effective than the control group.(3) The comparisons of clinical symptom integrals in Chinese Medicine for the two groups’are as follows. The clinical symptom integrals in Chinese Medicine of the two group are declined (P<0.05),which means both of the two treatments are effective to climacteric syndrome. Comparison between groups shows that the treatment group is more effective than the control group in the promotion of clinical symptom integrals in Chinese Medicine.(4) The integrals comparisons of improved Kupperman for the two groups are as follows. The integrals of improved Kupperman for the two groups’are declined (P<0.05),which means both of the two treatments are effective to climacteric syndrome. Comparison between groups shows that the treatment group is more effective than the control group in the promotion of clinical symptom integrals for the promotion of improved Kupperman..(5) The comparisons of TCM symptoms before and after the treatment of two groups are as follows:Symptoms score of relative weakness in the loins and knees,burning sensation of five centres, night sweats and progressive emaciation, dry mouth and throat, dizziness, tinnitus, osteopyrexia and fever, insomnia, tongue decreased significantly (P<0.05). Comparison between groups shows that the treatment group is more effective in the aspects of relative weakness in the loins and knees, dizziness and tinnitus.(6) The comparisons of serum sex hormone levels before and after the treatment of two groups are as follows:serum E2, FSH, LH levels were significantly improved than that of before treatment for the both two groups. That is to say the serum level of E2improves, and FSH, LH levels decreased (P<0.05),which means both of the two treatments are effective to the promotion of sex hormone levels. Comparison between groups shows that the treatment group is more effective in the promotion of level of E2.(7) The comparisons of FSFI scores before and after the treatment of two groups are as follows: FSFI score were significantly reduced (P<0.05), which means both of the two treatments are effective to the promotion of Sexual Dysfunction in climacteric women.(8) The comparisons of FSFI scores before and after the treatment of two groups are as follows:the indexs including sexual desire, sexual arousal, vaginal lubrication,sexual satisfaction and sexual pain were significantly improved than that of before treatment for the both two groups(P<0.05). Comparison between groups shows that the treatment group is more effective for Sexual Dysfunction in climacteric women.Conclusion:Gai Liang Er Zhi Wan plays an important role in improving symptoms of climacteric syndrome and kidney-yin deficiency syndrome, female sexual dysfunction, and the level of serum E2. It can improve exual desire,vaginal lubrication, orgasm and sexual pain, which shows that Jia Jian Er Zhi Wan is effective for Sexual Dysfunction in climacteric women with Kidney-Yin dyficiency.更多还原