Clinical Observation On Perimenopausal Period Syndrome (Kidney Deficiency Of Both Yin And Yang) With GengnianAnshen Capsules

Objection:Perimenopausal period syndrome (PPS) is a common and frequently occurring gynecological disease. The main purpose of this project is.to observe the clinical efficacy and safty on perimenopausal Anshen Capsules treating PPS (deficiency of both Kidney yin and yang syndrome) and evaluate it systemly in order to provide a scientific basis for its clinical application.Method:This experiment used a randomized, double-blind double-dummy, positive control research method.All the patients were selected from Hubei traditional Chinese medicine hospital outpatient department of gynecology during November 2005 to February 2007, with the diagnosis of deficiency of both Kidney Yin and Yang syndrome, which has a total number of 60, aged 45-55 years old. They were randomly divided into the treatment group (GNC tranquilizer capsules)and the control group (GNC Ning capsule) with the ratio of 1:1,and both group had 30 patients.Scoring according to the Chinese Symptom standards, and individual Chinese standards. After taking medication for 8 weeks, patients were observed the changes of traditional Chinese symptoms, hormone level, tongue and pulse, and three conventional test, liver and kidney function and other safety indicators before and after the treatment. Then use the statistical analysis to determine its clinical efficacy.Result:1. Comprehensive Clinical Comparison:8 weeks after the treatment, the treatment group of 27 patients, has a recovery rate of 7.41%, effective rate of 14.81%, total efficiency rate of 96.29%; the control group of 25 cases, has a recovery rate of 8%, effective rate of 20%, the total efficiency rate of 96%. According to the statistical analysis, P> 0.05, the difference has no statistical significant.2. Comparative efficacy of the main symptoms:After 8 weeks of treatment, there were 5 cases cured and 3 cases invalid, significantly more was 18.52%, total effective rate was 88.89% in the treatment group; there were 5 patients cured and 3 cases invalid, significantly more was 20%,the total effective rate was 88% in the control group. Between the two groups, the difference showed no statistical significance (P> 0.05). The main symptoms points of the two groups were significantly decreased compared before and after the treatment (P<0.05), showing that both of the two groups can improve the main symptoms of hot flashes, sweating. Difference between the two groups was not significant (P> 0.05), showing that the two groups had the similar effect on hot flashes, sweating.3. Comparative efficacy of secondary symptoms:After 8 weeks of treatment,In the heart palpitations Zheng Zhong, insomnia and other minor clinical symptoms, before and after treatment, symptom scores were significantly decreased (p<0.01). Treatment group and control group after treatment compared with all the secondary symptoms, p> 0.05, the difference was not statistically significant.4. Hormone levels:After 8 weeks treatment, the treatment group and control group before and after treatment, serum FSH levels were inspected p> 0.05, the difference was not statistically significant; serum LH, E2 side was statistically significant by both tests (p <0.05); treatment control group and treatment group for statistical analysis, the serum E2, FSH no significant areas (p> 0.05), serum LH have statistical significance (p<0.05)5. Safety:There were no significant adverse reactions and side effects found during the medication observation period in both groups. After treatment, the blood and urine routine test, ECG, liver and kidney function, breast had no obvious abnormalities,compared with them before the treatment. All these showed that the medication of the treatment group had no toxic side effects,and was safe and reliable.Conclusion:The test drugs (GNC Anshen Capsules) can effectively treat both kidney yin and yang deficiency syndrome type women,which has PPS. It can not only significantly improve women's hot flashes and sweating and other menopause symptoms,but also have a certain degree effect in sex hormone levels, which can improve the life quality of patients. It is effective, reliable, good safety, and no obvious side effects in clinical application, and it worths the further research and has a promoted clinical use.