| OBJECTIVE:This subject is based on clinical observations,based on years of cli nical experience of the tutor Zhang Taojing,chief physician,in treating the disease,a nd research on the treatment of menopausal patients with Shuangqingguben Decoction.Oserve the changes of menopausal symptoms and the levels of sex hormone in men opausal patients after taking Shuangqingguben Decoction.After the treatment,we discus sed the clinical effect of the treatment of menopause,By comparingShuangqing Guben Decoction with Kuntai Capsule Group,the feasibility,safety and effectiveness of Shu angqing Guben Decoction in the treatment of menopause syndrome were verified,pro viding a clinical evidence.And the New methods and ideas for the clinical applicatio n of traditional Chinese medicine in the treatment of menopause syndrome will be pr ovide.METHODS:The patients in this study were all 72 patients with menopausal syn drome from the outpatient clinic of Dongfang Hospital of Beijing University of Chine se Medicine who met the inclusion criteria.According to the order of visit time,the patients were randomly divided into Shuangqingguben decoction group and Kuntai gro up,with 36 cases in each group.After 8 weeks of treatment with Shuangqing Guben Decoction and Kuntai Capsules,the domesticmodified Kuppenman score,Chinese me dicine syndrome score,perimenopausal qualityof life scale,HAMA score and sex hor mone(E2,FSH,LH)levels of the two groupswere compared before and after treatmen t.The scale scores and hormone levels were compared within and between groups,an d statistical analysis was performed to determine the effectiveness of Shuangqingguben Decoction in the treatment of menopausal syndrome.RESULTS:(1)72 patients were enrolled in this subject,and 7 cases were dropped(3 cases i n the experimental group and 4 cases in the control group).A total of 65 patients co mpleted the entire study process,and the total drop-out rate was 9.72%.(2)Before treatment,the patient's age,illness time,Kupperman score,TCM synd rome score,HAMA score,MEN-QOL dimension score,Kupperman symptom score,TCM single symptom score and sex hormone level(E2,FSH,LH)The comparisons bet ween groups were not statistically significant(P> 0.05),and they were comparable.(3)Overall clinical efficacy:33 cases in Shuangqing Guben Decoction group wer e cured in 3 cases,significantly effective in 22 cases,effective in 6 cases and ineffec tive in 2 cases.The total effective rate was 93.94%.In the control group,1 case was cured,4 cases showed obvious effect,18 cases were effective,9 cases were ineffectiv e,and the total effective rate was 71.87%.Shuangqingguben decoction group and Kunt ai capsule group were compared between groups,x2=5.626,P=0.018 <0.05,indicating that the total effective rate of Shuangqingguben decoction group was better than the c ontrol group.(4)After treatment,Kupperman score,TCM syndrome score,MEN-QOL score an d HAMA score were compared within the two groups,and the differences were statist ically significant(P<0.01),indicating that the two groups had certain efficacy in imp roving the above scores.Moreover,the reduction degree of the Shuangqingguben deco ction group is better than that of the Kuntai capsule group(P <0.01),the results sho wed significant differences indicating,this conclusion show that there was a significan t difference.This conclusion indicated that the experimental group was better than the control group in improving the symptoms,TCM syndromes,quality of life,anxiety a nd other aspects of menopausal patients.(5)The modified Kupperman symptom score before and after treatment was com pared between the two groups.The results showed that symptom scores in 2 groups were lower than before treatment(P <0.05);Shuangqing after treatment Compared wit h the Kuntai capsule group,the Shuangqinggubentang group had symptoms of hot fla shes and sweating,paresthesia,insomnia,dreaminess,agitation,irritability,dyspareunia,urinary system symptoms,dizziness,fatigue,joint muscles and limbs Pain and palpit ations were superior to the Kuntai capsule group in terms of symptoms,and the diffe rences were statistically significant(P <0.05).However,the symptoms of depression,headache and skin ant walking were not significantly improved(P> 0.05).(6)Single symptom of TCM syndrome:Compared with the control group,the sy mptoms of palpitation,dry mouth and throat in Shuangqing Guben Decoction groupwere significantly improved(P <0.01).Compared with the control group,irritability,c onstipation and other symptoms were significantly improved(P <0.05);There were no statistically significant differences in other symptoms among the groups(P> 0.05).(7)After treatment,the two groups can significantly improve the levels of E2,F SH,and LH after treatment with the group before treatment.The difference is statistic ally significant(P <0.01);after treatment,the Shuangqingguben decoction group is co mpared with Kun Compared with the Tai capsule group,it was found that the E2 lev el of the Shuangqingguben decoction group was significantly higher than that of the Kuntai capsule group(P <0.05),and FSH and LH were significantly reduced(P <0.01).(8)There were no recurrent cases in 31 patients of Shuangqing Guben Decoction group,and the recurrence rate was 0%.Among the 23 cases in the Kuntai capsule gr oup,5 cases had recurrence,and the recurrence rate was 21.74%,showing a significa nt difference(P <0.05),indicating that Shuangqing Guben Decoction has an advantage over Kuntai Capsule in reducing the recurrence rate in the treatment of menopause.(9)The two groups of patients had no obvious abnormalities in general condition s(respiration,blood pressure,body temperature,heart rate)during the entire study proc ess,no physical or psychological symptoms,no drug-related allergic reactions and side effects.CONCLUSIONS:Shuangqing Guben Decoction has a significant improvement eff ect on menstruation disorders,heart palpitations,insomnia,irritability,waist and leg so reness and other clinical symptoms of menopausal syndrome patients with hot heart a nd liver and deficiency of kidney Yin,and alleviates the discomfort caused by menop ausal symptoms,and the clinical effect is obvious.It has more advantages than Kuntai Capsules in improving the TCM symptom score,HAMA score,domestic modified Ku pperman score and sex hormones(E2,FSH,LH),and improves the sex hormone level of patients;There are no obvious drug-related adverse reactions,good safety,and lo w recurrence rate.It is clinically worthy of further promotion to treat more patients. |
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