The Clinical Observation Of Menopausal Syndrome Of Heart-kidney Imbalance Treated With Zishen Yuyin Prescription

Objective: Patients suffering from menopausal syndrome(MS)of heartkidney imbalance were treated with Zishen Yuyin prescription.The total TCM symptom scores,Single TCM symptom scores,Menstrual disorder symptoms,KI scores,PSQI scores,HAMA scores,MENQOL scores and the level of sex hormones,blood lipids were compared before and after the treatment to study the effectiveness and safety of Zishen Yuyin prescription for the treatment of MS.Method: The research objects were selected from the first affiliated hospital of yunnan university of traditional Chinese medicine(Yunnan Provincial Hospital of Traditional Chinese Medicine)gynecology outpatient and the inpatient who visits gynecologist during December 1,2018 to November 30,2019.The subjects needs to accord with the standard of heart-kidney imbalance of Yin and Yang and the diagnostic criteria of menopausal syndrome.Eventually 72 patients selected to be randomly divided into the observation group and the control group,the cases were treated with Zishen Yuyin prescription(n=32)and Tianwang Buxin Dan prescription(n=32),and treated for 3 consecutive courses,2 weeks for a course of treatment.After the treatment course,the total TCM symptom scores,Single TCM symptom scores,Menstrual disorder symptoms,KI scores,PSQI scores,HAMA scores,MENQOL scores and the level of sex hormones,blood lipids,liver and kidney function were statistically analyzed before and after the treatment to evaluate the clinical curative effect and security of Zishen Yuyin prescription for the treatment of MS.Result1.In this study,a total of 72 cases were enrolled.64 cases of effective clinical observation were completed,which 3 cases were lost in the observation group,1 casewas removed,and 4 cases were lost in the control group.2.There was no significant difference in age,weight,height,BMI,course of disease,the total TCM symptom scores,Single TCM symptom scores,the number of menses and menopause,Menstrual disorder symptoms,KI scores,PSQI scores,HAMA scores,MENQOL scores,the level of sex hormones(FSH,LH,E2),blood lipids(TC,TG,HDL-C,LDL-C),liver and kidney function between the observation group and the control group before treatment(P >0.05).3.After the treatment course,the total clinical efficacy was analyzed: the total effective rate of the observation group was 84.38%,and that of the control group was75.00%.The total clinical efficacy of the treatment group was better than that of the control group,with statistically significant difference(P < 0.05).4.After the treatment course,body weight and BMI were analyzed: the body weight and BMI were compared,both groups had decreased after treatment than before treatment,but the difference was not statistically significant(P>0.05).There was no statistically significant difference in BMI decrease between the observation group and the control group(P >0.05).5.After the course of treatment,the total TCM symptoms scores,Single TCM symptom scores,Menstrual disorder symptoms,Kupperman scores,HAMA score s and PSQI scores were analyzed:(1)The total TCM symptoms scores and KI scores were compared within the group,both groups had decreased after treatment than before treatment,the difference was statistically significantly(P < 0.01);(2)After treatment,single TCM symptom scores and Menstrual disorder symptoms in the group were compared:(1)The single TCM symptom scores except Menstrual disorder symptoms have been improved between the both groups,the difference was statistically significant(P < 0.01,P< 0.05).(2)The Menstrual disorder symptoms were compared within the group,both groups had improved after treatment than before treatment,the difference was not statistically significantly(P > 0.05);the observation group have been improved better than that in control group in terms of menstrual disorder symptoms,but the difference between the two groups was not statistically significant(P> 0.05).(3)The PSQI scores and KI scores of the two groups were compared within thegroup,both groups had decreased after treatment than before treatment,the difference was statistically significantly(P < 0.05);(4)Compared with the control group,the observation group showed more significant decreases in the total TCM symptoms scores,KI scores,HAMA scores(P<0.05),the observation group in the Single TCM symptom scores such as the hot flushes and night sweating,the Menstrual disorder symptoms,lumbar debility,dizziness tinnitus,dry throat dry mouth symptoms have been improved better than that in control group,the difference is statistically significant(P < 0.05),while the control group has been improved in terms of insomnia forgetful better than the observation group(P<0.05),and the decrease of PSQI in the control group was more significant than that in the observation group(P< 0.05);Although both groups had different degrees of improvement in single symptom of Menstrual disorder symptoms dreaminess,palpitation and irritability,the difference between the two groups was not statistically significant(P> 0.05).6.After the treatment course,MENQOL scores was analyzed: intra-group comparison showed that MENQOL scores in vasomotor symptoms,somatic symptoms,psychological symptoms and sex in the two groups have been decreased(P< 0.01,P<0.05).Comparison between groups,the observation group had better than the control group in the areas of somatic symptoms,vasomotor and psychological symptoms(P < 0.05),while there was no significant difference in the improvement of sexually related quality of life(P > 0.05).7.After the treatment course,the level of sex hormones(FSH,LH and E2)was analyzed:the results showed that the level of sex hormones in the two groups have been improved,but the improvement was not statistically significant(P>0.05).There was no significant difference in the improvement of the level of sex hormones(FSH?LH?E2)between the two groups(P > 0.05).8.After the treatment course,the blood lipids(TC,TG,HDL-C,LDL-C)were analyzed:the blood lipids were compared within the group,both groups had improved before and after treatment,but the improvement was not statistically significant(P>0.05);There was no significant difference between the observation group and the control group(P >0.05).9.After the treatment course,liver and kidney functions were analyzed:there wasno significant difference in liver function(ALT,AST)and kidney function(Cr,BUN,UA)before and after treatment between the two groups(P> 0.05).10.Three months after the end of the course of treatment,telephone follow-up was conducted for those who were effective in the treatment to understand the recurrence situation:32 patients in the observation group have been followed up,including 5patients with recurrence and 27 patients without recurrence,with the recurrence rate of15.6%;32 patients in the control group have been followed up,including 8 patients with recurrence and 24 patients without recurrence,with the recurrence rate of25.0%,the difference between the two groups was statistically insignificant(P> 0.05).Conclusion: The Zishen Yuyin prescription in the treatment of heart-kidney imbalance of Menopausal Syndrome can effectively improve the clinical symptoms such as the hot flushes and night sweating,lumbar debility and other clinical symptoms,and can also effectively improve the quality of life of the menopausal patients.The level of sex hormones,blood lipids have different degrees of improvement.It is no obvious adverse reactions and better safety,which is a method worthy of clinical application.