| Objective: In this study,the patients with uterine leiomyoma who were diagnosed as qi stagnation and blood stasis were followed up by random double-blind method after applying Xiaoliu I prescription and placebo,and the curative effect of uterine leiomyoma volume difference and TCM syndrome was analyzed.It provides more and more useful research basis for the diagnosis and treatment of uterine leiomyoma.Methods: From January 2018 to June 2018,120 patients with uterine leiomyoma diagnosed in outpatient department and ward of our hospital who met the diagnostic criteria and inclusion criteria were selected as the subjects of the study.The random number was simulated by SAS statistical software,and the experimental group and the control group were allocated according to 2:1,according to which the drugs in the study were blinded.By this clinical observation,monitoring and statistics and other unrelated personnel,according to the formed processing code will be the corresponding drug number affixed to the drug packaging.Designate a trial drug manager.After the researchers screened the qualified subjects and wrote the research medical records with informed consent,the trial drug administrator distributed the drugs on a case-by-case basis according to the order in which the subjects were enrolled and the drug code from small to large.The experimental group was treated with Xiaoliu I recipe 5 tablets per time,3 times a day for 75 days,25 days as a cycle,and the curative effect was judged by 3 menstrual cycles.Control group: placebo(made into Xiaoliu I recipe simulation agent,its appearance,color,shape is basically consistent with the original drug)5 tablets,3 times a day,75 days,25 days for 1 cycle,continuous administration of 3 menstrual cycles to judge the efficacy of the placebo(made into Xiaoliu I recipe,its appearance,color and shape are basically consistent with the original drug)5 tablets per time,3 times a day,75 days,25 days as a cycle.To observe the volume difference of uterine leiomyoma in patients treated with Xiaoliu I prescription.To observe the curative effect of TCM syndromes of oral Xiaoliu I recipe.Results: According to the standard of drug clinical trial management,at least 60 cases were completed in the preparation test group of medical institutions,and the shedding rate should not exceed 20%.Therefore,80 cases were planned to complete the study in the experimental group and 40 cases in the control group.In this clinical trial,69 patients were followed up by randomized double-blind method,including 49 patients in the treatment group and 20 patients in the control group.The standard treatment rate of the main curative effect in the treatment group was 47%.The treatment rate of the control group was 25%.The difference between the two groups was statistically significant,indicating that the efficacy of Xiaoliu I recipe in the treatment of uterine leiomyoma was better than that of the control group.The total effective rate of TCM syndromes was79.59% in the treatment group and 60% in the control group.After statistical analysis,the difference between the two groups was statistically significant.It shows that Xiaoliu I recipe is better than the control group in the treatment of uterine leiomyoma of qi stagnation and blood stasis type.The average tumor size in the treatment group was19.698cm3.The average tumor size of the control group was 18.891cm3.There was no significant difference in tumor size between the two groups after treatment,indicating that there was no significant difference in tumor size between the two groups after treatment.In the comparison of the curative effect of various TCM syndromes,there was significant difference between Xiaoliu I recipe and control group in menstrual volume and TCM syndrome of small abdominal prick / distension pain,which indicated that Xiaoliu I recipe had significant effect on improving menstrual volume and small abdominal prick /distension pain.Conclusion:1.Xiaoliu I recipe is an effective prescription for the treatment of uterine leiomyoma with qi stagnation and blood stasis syndrome.it can alleviate the clinical symptoms such as abdominal distension,tingling,breast distension and depression,and improve menstrual conditions such as menstrual blood.the improvement effect of TCM symptoms is better than that of the control group.2.According to the criteria for judging the curative effect of uterine leiomyoma,the curative effect of Xiaoliu I recipe in the treatment of uterine leiomyoma is better than that of the control group,suggesting that Xiaoliu I recipe is effective in the treatment of uterine leiomyoma.3.Xiaoliu I prescription has no side effects and adverse reactions and can be taken for a long time. |
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