Objects:We are conducting a clinical observation of the clinical curative effect of tong luo xi feng qi wei soup in treating blood stasis and kidney deficiency type impotence.Statistical analysis was carried out on the score of the subjects before and after treatment of international index of erectile function-5 (IIEF-5) score,9 items patient health questionnaire (PHQ-9) score and TCM syndrome score (blood stasis and kidney deficiency type) to evaluate the clinical curative effect. Through the clinical observation of impotence, we expect to find impotence (blood stasis and kidney deficiency type) standardization of diagnosis and treatment plan, popularization and application in clinical practice.Methods:The study is a randomized controlled clinical study.By using statistical methods to estimate sample size,controling the loss rate at 10%, we finally calculate the sample size,106 cases. All male impotence cases to be included in the standard of patients come from dongzhimen hospital andrology, divide into two groups by using the random number table:treatment group and control group,53 cases in treatment group given tong luo xi feng qi wei soup (avoid Fried grain, in the morning and a bag) and the control group given cong rong yi shen granules(a bag at a time, twice a day). Boil-free granule of traditional Chinese medicine each 200ml with the warm boiled water, twice daily, in the morning and evening before meals 40 min. During treatment the subjects are not given other drugs for the treatment of impotence. We ask before treatment and record the subjects’ age, course of diseases, medical history, etc. Observation period is 4 weeks.Before and after 4 weeks treatment we respectively record the subjects’IIEF-5 score, primary symptom score of traditional Chinese medicine, Chinese medicine syndrome score and PHQ-9 scores all the time, to observe the adverse reaction of two groups before and after treatment. The two groups data before and after treatment of measurement are used statistical description of average number and standard deviation.All statistical data are used SPSS 20.0 statistical software, with double side test, P< 0.05 represents the difference was statistically significant. Two sets of data before and after treatment in the two groups data are used independent sample t test respectively or nonparametric test comparison, the treatment group and control group before and after medication score respectively use the paired t test or nonparametric test compared in the group.Results:There are 3 cases of loss in treatment group and control group and the final effective cases is 100 cases.Loss cases will not affect the results. Treatment group cure 5 cases,10 cases were markedly effective, effective 23 cases,12 cases ineffective, IIEF-5 points total effective rate was 76.0%;The control group,3 were cured,4 cases were markedly effective, effective 22 cases,21 cases, IIEF-5 points total effective rate is 58.0%. Tong luo xi feng qi wei soup with desert cistanche kidney particles can improve clinical symptoms, blood stasis and kidney deficiency type impotence in IIEF-5,PHQ-9,TCM syndrome score (blood stasis and kidney deficiency type), the two groups before treatment after treatment were statistically significant (P<0.05). The IIEF-5 score, primary symptom score of traditional Chinese medicine and the improvement of PHQ-9 score is better than that of control group, with statistical difference (P<0.05). Treatment group in improving the chest, a sting ling, arrested, lower abdomen perineum soreness, scrotal pain more than cold, and cold limbs, tinnitus secondary symptoms of traditional Chinese medicine is better than that in control group (P<0.05), two groups of lumbar debility, fatigue strength evaluation of similar god, after treatment no statistical difference (P>0.05). After 4 weeks 3 cases of treatment group appear dizziness, diarrhea, significantly reduce symptoms after resting, consideration and ferrite deficiency of qi and blood, and blood activating drugs take gas, no any adverse reactions are found in control group.Conclusion:Tong luo xi feng qi wei soup and cong rong yi shen granules are effective on blood stasis and kidney deficiency type impotence, the two groups after treatment IIEF-5, PHQ-9, primary symptom score of traditional Chinese medicine, and most of the secondary symptom scores were significantly different. It is better than for tong luo xi feng method kidney method, can further promote in clinic. |