| Objective:The purpose of this study was to compare the efficacy of Self-made Tong Zhi Fang of dysmenorrhea and Ibuprofen Sustained Release Capsules in treating moderate and severe primary dysmenorrhea and investigate the mechanism and advantages of Self-made Tong Zhi Fang of dysmenorrhea in treating moderate and severe primary dysmenorrhea.The results will provide practical solutions for the treatment of this disease.Methods:From March 2019 to October 2019,112 patients with primary moderate and severe primary dysmenorrhea were enrolled.These patients were from the department of the integrated traditional Chinese and Western medicine clinic of the North Hospital affiliated to Hebei University Hospital in Baoding.General information and menstruation situations were collected.112 patients were randomly divided into 2 groups,treatment group(self-made Tong Zhi Fang group)and control group(Ibuprofen Sustained Release Capsules group).There were32 cases lost.At last,totally 80 patients,either group of 40 patients were recorded and analyzed.Both groups were treated for 3 menstrual cycles and followed up for 2 menstrual cycles after withdrawal.The dysmenorrhea symptom score,visual analogue scale(VAS),traditional Chinese medicine(TCM)symptom and sign score and the COX menstrual symptom(CMSS)severity score were used to observe the therapeutic efficacy before and after treatment.Results:1.In each course of treatment,the dysmenorrhea symptom scores,VAS scores and TCM symptom and sign scores in the both groups were significantly decreased than before treatment,and there were no statistical significant differences between the two groups.During the first and second follow-up periods,the scores of the three observation indexes mentioned above of the treatment group were significantly decreased than before treatment,and therewere statistical significant differences compared with the control group.2.In each course of treatment and during the first and second follow-up periods,the CMSS severity scores of the treatment group were significantly decreased than before treatment.Compared with the control group,there were statistical significant difference in each course of treatment and the first and second follow-up periods.3.With the increase of treatment time,the TCM symptom and sign scores of pain intensity,pain duration,dark purple menstrual flow,scant menstrual flow,swollen breasts,chills or cold hands and feet,delayed menorrhea,lumbago in the treatment group decreased gradually,and the differences were statistical significant than before treatment.During the first and second follow-up periods of the treatment group,the scores of pain intensity,pain duration,chills or cold hands and feet,lumbago were statistical significant than before treatment.In the control group,the scores of pain intensity and duration decreased gradually,and the differences were statistical significant than before treatment,but there was no statistically significant difference between the two groups.4.With the increase of treatment time,the the CMSS severity scores of abdominal pain,lumbago,changes in facial expression,depression,irritability,nervousness,nausea and vomiting,anorexia,stomachache,diarrhea,fatigue,in the treatment group decreased gradually,and the differences were statistical significant than before treatment.During the first and second follow-up periods of the treatment group,the scores of abdominal pain,lumbago,changes in facial expression,irritability,nervousness,nausea and vomiting,anorexia,diarrhea,fatigue were statistical significant than before treatment.In the control group,the scores of abdominal pain decreased gradually,and the difference was statistical significant than before treatment,but there were no statistically significant difference between the two groups.5.The clinical efficacy of dysmenorrhea symptom score in the two groups showed no significant difference.During the first and second follow-up periods,the clinical efficacy in the two groups showed statistical significant difference,and the effect of the treatment group was better than that of the control group.Conclusion:Self-made Tong Zhi Fang of dysmenorrhea has remarkable clinical effect on moderate and severe primary dysmenorrhea.Self-made Tong Zhi Fang of dysmenorrhea can significantly improve the degree and duration of abdominal pain and associated with dysmenorrhea,and also has a definite long-term effect,which can be used and promoted in clinical practice. |