| Objective:To observe the clinical efficacy of Gengnian Ⅰ Hao decoction in the treatment of hepatic and renal Yin deficiency syndrome of menopausal syndrome,provideing reference for clinical treatment,so as to provide appropriate drug selection for patients.Method:A total of 64 cases were included in this study,The 64 patients were randomly divided into experimental group and control group,with 32 patients in each group.During the observation period,2 patients were removed from each group,and a total of 60 patients were actually completed.The experimental group was given Gengnian Ⅰ Hao decoction and the control group was given Kuntai capsule for 3 consecutive courses of treatment.Comparing the TCM syndrome score,modified Kupperman score,MENQOL score,luteinizing hormone(LH),follicle stimulating hormone(FSH),estradiol(E2)levels and safety indexes in the two groups of patients before and after treatment.SPSS 26.0statistical software was used to analyze the two groups of data.Finally,its efficacy and safety were evaluated.Result:1.The basic situation of the two groups of patients before treatment was statistically analyzed,and the results showed that there were no statistically significant differences between the two groups in age,course of disease,severity of disease,TCM syndrome score,modified Kupperman score,scores of various dimensions of menopausal quality of life,and sex hormones(FSH,LH,E2)(P>0.05),which were comparable between the two groups.2.Comparison of single scores of TCM Syndrome:The single scores of TCM syndrome were decreased after treatment in both groups,the experimental group was better than the control group in improving the sweating,waist and knee pain,vertigo and tinnitus,menstrual disorder,irritability and irritability,five upset heat,vaginal dryness,dry mouth and throat,binocular dryness,yellow urine,constipation(P<0.05);and there was no statistical significance in comparing the syndrome of insomnia and multi-dream between the two groups(P>0.05),the result indicates that Gengnian Ⅰ Hao decoction has the same efficacy as Kuntai capsule in improving insomnia and multi-dream.Comparison of the total score of TCM syndrome:The total score of TCM syndrome of Gengnian Ⅰ Hao decoction and Kuntai capsule decreased after treatment(P<0.05),and the difference of the total score of TCM syndrome of the two groups after treatment was statistically significant(P<0.05),indicating that Gengnian Ⅰ Hao decoction was better than Kuntai capsule in improving TCM syndrome.3.The modified Kupperman score and all dimensions of menopausal quality of life(vasomotor,psychological,physiological and sexual)were decreased after treatment,with statistical significance(P<0.05);After treatment,there were statistically significant differences in modified Kupperman scores and scores of various dimensions of menopausal quality of life(namely vasomotor,psychological,physiological and sexual life)between the two groups(P<0.05).The results showed that both Gengnian Ⅰ Hao decoction and Kuntai capsule could improve patients’clinical symptoms,and Gengnian Ⅰ Hao decoction was superior to Kuntai capsule.4.Comparison of the three items of sex hormones(FSH、LH、E2)showed that FSH and LH levels were decreased and E2levels were increased in 2 groups after treatment,with statistical significance(P<0.05);After treatment,both Gengnian Ⅰ Hao decoction and Kuntai capsule could improve the levels of FSH,LH and E2,the difference was not statistically significant(P>0.05).The effect of Gengnian Ⅰ Hao decoction was comparable to Kuntai capsule.5.In terms of the efficacy of TCM syndroms,the efficacy of experimental group were93.33%and control group was 86.67%,respectively,with statistical significance(P<0.05).The efficacy of experimental group was higher than that of control group,indicating that Gengnian Ⅰ Hao decoction was better than Kuntai capsule in improving TCM syndroms.6.In terms of clinical efficacy,the clinical efficacy of the two groups were respectively(93.33%and 83.33%),the difference was statistically significant(P<0.05).Gengnian Ⅰ Hao decoction was better than Kuntai capsule in improving clinical efficacy.7.Comparison of safety indicators:Vital signs,blood routine,the liver and kidney function and other indicators of all patients were not abnormal after treatment,and no reactions were found,it is absolutely safe.Conclusion:1.Gengnian Ⅰ Hao decoction has obvious curative effect on the syndrome of liver-kidney Yin deficiency of menopausal syndrome,which can effectively relieve clinical symptoms.2.Gengnian Ⅰ Hao decoction can reduce FSH and LH levels,increase E2levels,and improve the quality of life of patients.3.Gengnian Ⅰ Hao decoction is safe and effective in the treatment of menopausal syndrome without adverse reactions,and it is worthy of clinical promotion and application. |