| Research purpose:Menopausal symptoms(MPS),also known as the climacteric syndrome,refers to appear before and after menopause hormones fluctuations or reduce be caused by a series of physical and mental symptoms.Modern medicine believes that the occurrence of MPS is closely related to the increase of age,the decrease of ovarian function and the imbalance of hypothalamic-pituitary-ovarian axis in perimenopausal women.In the treatment with postmenopausal hormone therapy(Menopausal hormone therapy,MHT),also called hormone replacement therapy(Hormonereplacement therapy,HRT).Professor li yunbo studied under professor jin zhe from dongfang hospital of Beijing university of traditional Chinese medicine.The team reviewed ancient books,combined with clinical research and modern women's life characteristics,and gradually concluded that:women's whole life of menstruation,pregnancy,birth,lactation,often more consumption of Yin blood,so women's physiological characteristics are often liver qi surplus and Yin blood deficiency;Camp dark consumption accelerated,kidney Yin more deficiency,the normal ovarian function of faster and earlier consumption.Under normal conditions,heart fire should be under the temperature of kidney water,kidney water when on the heart Yang,that is,both water and fire,heart and kidney intersection.If the heart and kidney two dirty can not better temperature,moisture,it is easy to appear heart and kidney do not hand over the symptoms.The incidence of MPS patients with cardiorenal nondelivery syndrome is increasing year by year,which is a common clinical disease in gynecology.Therefore,MPS patients with cardiorenal nondelivery syndrome are selected for research.In this paper,we treat Xin-Shen incoordination MPS by applying the ZhenKun-HeHuan-Yin.From the clinical symptoms,anxiety,depression,changes in sleep and sex hormones FSH(Follicle stimulating hormone),LH(Luteinizing hormone)and estradiol changes in these aspects,we observe the curative effect of ZhenKun-HeHuan-Yin.Research methods:In this paper,the cases we studied come from the third affiliated hospital of Beijing University of Chinese Medicine,Oriental hospital of Beijing university of Chinese medicine Xin-Shen incoordination MPS patients and network propaganda recruiting MPS patients from March 2017 to January 2019.A total of 60 cases were screened in strict accordance with the inclusion and exclusion criteria,and informed consent was signed by the subjects.According to the principle of randomization and control,the cases were divided into ZhenKun-HeHuan-Yin treatment group(n=30)and KunTai capsule control group(n=30).Both medicines are Oral medicine,8 weeks as a course of treatment.And the case observation table(CRF)was filled in before and after treatment.With that we observed the two groups of patients before and after the treatment of TCM symptom rating scale,improved Kupperman scale score,anxiety and depression scale score and Pittsburgh(PSQI)sleep quality scale of change and the change of sex hormones FSH,LH,E2 levels.Research results:1.Comprehensive therapeutic effect:ZhenKun-HeHuan-Yin treatment group:30 cases,cured 2 cases(6.67%),significantly effective 7 cases(23.33%),effective 20 cases(66.67%),invalid 1(3.33%),total effective rate 96.67%;KunTai capsule control group:30 cases,cured 0 cases(0.00%),significantly effective 6 cases(20.00%),effective 18 cases(60.00%),ineffective 6 cases(20.00%),total effective rate of 80.00%;The therapeutic effect of the treatment group was better than that of the control group(p<0.05).2.Scoring of TCM symptom scale:Compared with the two groups,the mean standard deviation of the score in the treatment group decreased from 33.73±4.96 to 11.67±3.58,and the mean standard deviation of the control group decreased from 32.70±5.98 to 19.13±5.87.In addition,the treatment group was better than the control group in improving the individual symptoms of upset and restless,hot flashes and sweating,irritability,dizziness and tinnitus,and memory loss.The difference was statistically significant(p<0.05).3.Improved Kupperman scale scores:The scores of the modified Kupperman scale were compared between the two groups.The mean standard deviation of the treatment group decreased from 29.80±5.36 to 10.00±3.81,and the mean standard deviation of the control group decreased from 32.40±5.08 to 20.00±5.17.Both groups of patients had better curative effect after treatment than before treatment.In addition,the treatment group had better efficacy than the control group in the five single items of hot flashes,sweating,paresthesia,insomnia,fatigue and fatigue,and urinary symptoms.And the difference was statistically significant(p<0.05).4.Anxiety and depression scale score:Intra-group and inter-group comparisons were performed for the two scales,and the intra-group comparison showed statistically significant differences(p<0.05),while the inter-group comparison showed no statistical significance(p>0.05),indicating that the anxiety and depression of the two groups were relieved after treatment,but there was no significant difference between the two groups.5.Pittsburgh(PSQI)sleep quality scale score:Statistically,both groups had improved sleep quality after treatment(p<0.05).There was no significant difference(p>0.05).In the comparison of PSQI between the two groups,the treatment group had better efficacy in sleep time and sleep quality(p<0.05).6.Serum sexual hormone levels:After treatment,the levels of FSH and LH in the two groups both decreased.After statistical analysis,the levels of FSH and LH in the two groups both decreased before and after treatment(p<0.05),and the levels of FSH and LH in the treatment group were significantly lower than those in the control group(p<0.05).The mean standard deviation of the treatment group increased from 20.66±6.73 to 38.78±8.66,and the mean standard deviation of the control group increased from 19.69±6.40 to 28.06±6.65.The increase of E2 before and after treatment in the two groups was statistically significant(p<0.05),indicating that both the treatment group and the control group could increase the E2 level.After treatment,there was no significant difference in E2 level between the two groups(p>0.05).It indicates that ZhenKun-HeHuan-Yin can promote the function of hypothalamic-pituitary-ovarian axis,has a certain effect on the increase of estrogen level in the body,and reduce the levels of FSH and LH,which plays an active role in protecting ovaries and slowing down aging.7.Safety observation:Before and after treatment,patients in the two groups had no significant abnormalities in body temperature,heart rate,respiration,blood pressure,blood routine,urine routine,liver and kidney function,and endometrial thickness(p>0.05),no breast distension and pain,no breast mass and other breast discomfort,and no adverse reactions such as drug allergy.Research conclusions:Zhenkun hehuan decoction in the treatment of MPS has a significant clinical effect,which can significantly reduce the TCM syndrome scale score and the modified Kupperman score,especially in improving hot flashes,sweating,upset,dizziness,tinnitus,memory loss,fatigue and paresthesia.It can also improve the anxiety and depression of patients,improve the quality of sleep,shorten the time to fall asleep,reduce the level of FSH and improve the level of E2,which is conducive to protecting the ovarian function of patients,improving the quality of life of patients,with high safety,and has good clinical application value. |
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