地黄叶总苷胶囊治疗糖尿病女性性功能障碍的临床研究
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摘要
目的评价地黄叶总苷胶囊治疗糖尿病女性性功能障碍的有效性及安全性。方法选取2011年5月~2014年12月在我院治疗的糖尿病患者中存在女性性功能障碍者54例,随机分成观察组和对照组,各27例。观察组给予地黄叶总苷胶囊联合西地那非片治疗,对照组给予西地那非片治疗,比较两组患者中医证候积分、治疗前后体内性激素水平变化、女性性功能量表(FSFI)六大维度变化、不良反应发生率等。结果治疗后治疗组总有效率90.30%,高于对照组的70.37%,统计学意义显著(P<0.01);两组较治疗前在中医证候积分改善方面均不同程度得到了改善,但是观察组较对照组改善更明显(P<0.05);对照组在性唤起、性欲方面有改善,在阴道湿润度、性交痛、性交满意度方面落后观察组,差异有统计学意义(P<0.05);观察组治疗后的雌二醇(E2)、睾酮(T)、孕酮(P)水平较治疗前升高(P<0.05),对照组治疗前后无明显变化(P>0.05);治疗组不良反应发生率为0,低于对照组的7.41%,差异具有统计学意义(P<0.05)。结论地黄叶总苷胶囊可有效改善糖尿病女性性功能障碍患者的幸福指数,在阴道湿润度和性交痛方面的效果优于单纯西药,能够降低西地那非片副作用,值得临床推广。
Objective To evaluate the efficacy and safety of Rehmannia total glycoside capsule for the treatment of sexual dysfunction in diabetic women.Methods From May 2011 to December 2014,54 diabetic patients with female sexual dysfunction were randomly divided into observation group and control group,27 cases in each group.The observation group was given the Rehmannia total glycoside capsule combined with sildenafil tablet, and the control group was treated with sildenafil tablet.The TCM syndrome scores,the change of sex hormone levels in the body before and after treatment,and the female sexual function scale(FSFI)were compared between the two groups.Six major dimensions of change,the incidence of adverse reactions and so on. Results After treatment,the total effective rate of the treatment group was 90.30%,which was higher than that of the control group 70.37%.The statistical significance was significant(P<0.01).Both groups improved in different degrees before the treatment to improve the TCM syndrome scores,but the observation group compared with the control group,the improvement was more obvious(P<0.05).The control group was improved in sexual arousal and sexual desire,and lagged behind the observation group in terms of vaginal wetness,intercourse pain and sexual intercourse satisfaction,the difference was significant(P<0.05),The levels of estradiol(E2),testosterone(T)and progesterone(P)in the observation group were higher than those before treatment(P<0.05),but there was no significant change before and after treatment in the control group(P>0.05);The response rate was 0,which was lower than that of the control group 7.41%,the difference was statistically significant(P <0.05).Conclusion Rehmannia total glycoside capsule can effectively improve the happiness index of women with diabetic sexual dysfunction.It is better than western medicine in the aspects of vaginal wetness and sexual pain. It can reduce the side effects of sildenafil,and it is worthy of clinical promotion.
Objective To evaluate the efficacy and safety of Rehmannia total glycoside capsule for the treatment of sexual dysfunction in diabetic women.Methods From May 2011 to December 2014,54 diabetic patients with female sexual dysfunction were randomly divided into observation group and control group,27 cases in each group.The observation group was given the Rehmannia total glycoside capsule combined with sildenafil tablet, and the control group was treated with sildenafil tablet.The TCM syndrome scores,the change of sex hormone levels in the body before and after treatment,and the female sexual function scale(FSFI)were compared between the two groups.Six major dimensions of change,the incidence of adverse reactions and so on. Results After treatment,the total effective rate of the treatment group was 90.30%,which was higher than that of the control group 70.37%.The statistical significance was significant(P<0.01).Both groups improved in different degrees before the treatment to improve the TCM syndrome scores,but the observation group compared with the control group,the improvement was more obvious(P<0.05).The control group was improved in sexual arousal and sexual desire,and lagged behind the observation group in terms of vaginal wetness,intercourse pain and sexual intercourse satisfaction,the difference was significant(P<0.05),The levels of estradiol(E2),testosterone(T)and progesterone(P)in the observation group were higher than those before treatment(P<0.05),but there was no significant change before and after treatment in the control group(P>0.05);The response rate was 0,which was lower than that of the control group 7.41%,the difference was statistically significant(P <0.05).Conclusion Rehmannia total glycoside capsule can effectively improve the happiness index of women with diabetic sexual dysfunction.It is better than western medicine in the aspects of vaginal wetness and sexual pain. It can reduce the side effects of sildenafil,and it is worthy of clinical promotion.
引文
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[8]Abu Ali RM,AL Hajeri RM,Khader YS,et al.Sexual Dysfunction in Jordanian Diabetic Women[J].Diabetes Care,2008,31(8):1580-1581.
[9]张友杰.西地那非联合疏肝益坎汤治疗糖尿病男性患者性功能障碍的疗效观察[J].现代中西医结合杂志,2016,25(23):3708-3710.
[10]邵淑玲.中国女性糖尿病患者性功能障碍的研究进展[J].中国性科学,2015,24(5):35-37.
[2]World Health organization.Definition,diagnosis and classification of diabetes mellitus and its complications:report of a World Health Organisation Collaborations[J].Diabet Med,1999,15(7):539-553.
[3]Shi YF,Shao XY,Lou QQ,et al.Study on female sexual dysfunction in Type 2 Diabetic Chinese women[J].Biomed Environ SCi,2012,25(5):557-561.
[4]国家中医药管理局.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002:10.
[5]Rosen R,Brown C,Heiman J,et al.The Female Sexual Function Index(FSFI):a mulidimensional self reported instrument for the assessment of female sexual dysfunction[J].J Sex Marital Ther,2000,26(2):191-208.
[6]Verit FF,Veri A.Validation of the female sexual function index in women with chronic pelvic pain[J].Sex Med,2007,4(6):1635-1641.
[7]Shi YF,Shao XY,Lou QQ,et al.Study on female sexual dysfunction in Type 2 Diabetic Chinese women[J].Biomed Environ SCi,2012,25(5):557-561.
[8]Abu Ali RM,AL Hajeri RM,Khader YS,et al.Sexual Dysfunction in Jordanian Diabetic Women[J].Diabetes Care,2008,31(8):1580-1581.
[9]张友杰.西地那非联合疏肝益坎汤治疗糖尿病男性患者性功能障碍的疗效观察[J].现代中西医结合杂志,2016,25(23):3708-3710.
[10]邵淑玲.中国女性糖尿病患者性功能障碍的研究进展[J].中国性科学,2015,24(5):35-37.