| Research objective:To explore the clinical efficacy and safety of Wenyang Huoxue Chinese medicine in treating dysmenorrhea of adenomyosis of cold coagulation and blood stasis type.Research methods:In this study,a prospective cohort study was conducted with GnRH-a as a control.Patients who met the western medicine diagnosis standard of adenomyosis,syndrome differentiation standard of cold coagulation and blood stasis of traditional Chinese medicine and inclusion standard were collected from the outpatient department of Guang'anmen Hospital,Chinese Academy of traditional Chinese Medicine from April 2018 to June 2019.According to the different treatment methods,they were divided into Chinese medicine group and Western medicine group.The Chinese medicine group was treated with Wenyang Huoxue Decoction and the western medicine group was treated with GnRH-a drugs.Then according to the different treatment course,it is divided into Chinese medicine group a,Chinese medicine group b,western medicine group a,western medicine group b.Chinese medicine group a,western medicine group a for 3 months,Chinese medicine group b,western medicine group b for 6 months.All patients were followed up for 6 menstrual cycles.The general information,dysmenorrhea,TCM syndromes,uterine volume,serum CA125,E2,FSH,LH of the patients were analyzed and evaluated.Research results:1.General situation:In this study,108 patients were collected and 89 patients were included,Among them,there were a25 cases in traditional Chinese medicine group,b26 cases in traditional Chinese medicine group,a24 cases in western medicine group and b14 cases in western medicine group.The age,body mass index(BMI),menarche age,occupation,education background,adenomyosis course,dysmenorrhea course,previous uterine cavity operation history and combined diseases of each group were compared,The difference was not statistically significant(P>0.05).The degree of dysmenorrhea in each group was mainly severe.2.Total effective rate:The total effective rate of traditional Chinese medicine group in treating dysmenorrhea of adenomyosis of cold coagulation and blood stasis type was similar to that of Western medicine group,but there was no significant difference(P>0.05);There was no significant difference in the total effective rate of different courses(P>0.05).3.Relapse of dysmenorrhea after drug withdrawal:The recurrence rate of dysmenorrhea in traditional Chinese medicine group was significantly lower than that in western medicine group(P<0.05);The recurrence rate of dysmenorrhea in different courses of treatment has little difference(P>0.05).There was no significant difference in the recurrence time of dysmenorrhea between the traditional Chinese medicine group and the western medicine group(P>0.05);The recurrence time of Western medicine group was later than that of Western medicine group in 6 months(P<0.05).4.Dysmenorrhea VAS score:There was no significant difference in VAS score of dysmenorrhea between Chinese and Western medicine groups before and after treatment(P>0.05),But they were significantly lower than before treatment(P<0.05).During the follow-up-period,the trend of traditional Chinese medicine group was stable and lower than that before treatment,the difference was statistically significant(P<0.05);The first to fourth menstrual cycle of Western medicine group was lower than that before treatment(P<0.05);Since the 5th menstrual cycle,the VAS score of dysmenorrhea in western medicine group was significantly higher than that in traditional Chinese medicine group(P<0.05).Different courses of treatment can reduce VAS score of dysmenorrhea equally(P>0.05).5.Duration of dysmenorrhea:There was no significant difference in the duration of dysmenorrhea between Chinese and Western medicine groups before and after treatment(P>0.05),But they were significantly lower than before treatment(P<0.05).During the follow-up period,from the fourth menstrual cycle to the level before treatment,there was no significant difference between the two groups(P>0.05);Western medicine group returned to the level before treatment from the second menstrual cycle(P>0.05).Different courses of treatment have the same effect on reducing the duration of dysmenorrhea(P>0.05).6.Dysmenorrhea Cox score:There was no significant difference in Cox score of dysmenorrhea between Chinese and Western medicine groups before and after treatment(P>0.05),But they were significantly lower than before treatment(P<0.05).During the follow-up period,the trend of traditional Chinese medicine group was stable and lower than the level before treatment,the difference was statistically significant(P<0.05);The first to fourth menstrual cycle of Western medicine group was lower than that before treatment(P<0.05);Since the 5th menstrual cycle of follow-up,the Cox score of dysmenorrhea in western medicine group was significantly higher than that in traditional Chinese medicine group(P<0.05).Different courses of treatment can reduce the Cox score of dysmenorrhea(P>0.05).7.Combined use of painkillers:A total of 17 patients were given painkillers before treatment,Before and after treatment and during follow-up,There was no significant difference in the number of cases of painkillers between Chinese and Western medicine groups and between different treatment groups(P>0.05).The painkillers used in combination were all non steroidal anti-inflammatory drugs,including ibuprofen,indomethacin,aspirin and paracetamol.8.TCM syndrome score:(1)The total effective rate of traditional Chinese medicine group in improving dysmenorrhea of adenomyosis of cold coagulation stasis type was significantly higher than that of Western medicine group,the difference was statistically significant(P<0.01).(2)After treatment,the scores of abdominal pain and non menstrual abdominal pain in the Chinese and Western medicine groups were significantly lower than those before treatment(P<0.05);But there was no significant difference between Chinese and Western medicine groups(P>0.05).(3)The scores of menstrual volume in Chinese and Western medicine group were significantly lower than that before treatment(P<0.05),And Western medicine group was significantly lower than Chinese medicine group,the difference was statistically significant(P<0.05).(4)The improvement of Western medicine group was not obvious in the aspects of dark purple or blood clots,cold limbs and loose stools(P>0.05),After treatment,the score of traditional Chinese medicine group was significantly lower than that of Western medicine group,and the difference was statistically significant(P<0.05).(5)The score of sexual desire decline in western medicine group after treatment was significantly higher than that before treatment,and significantly higher than that in traditional Chinese medicine group,the difference was statistically significant(P<0.05).(6)There was no significant difference between Chinese and Western medicine groups in the amount of leucorrhea under the belt and the length of clear urine(P>0.05).(7)In terms of treatment course,the total effective rate of different treatment courses is the same,and the difference is not statistically significant(P>0.05);Traditional Chinese medicine treatment for 6 months can relieve the symptoms of cold limbs and loose stools more effectively than that for 3 months(P<0.05),However,there was no significant difference between the three-month and six-month courses of Western medicine(P>0.05).9.Menopause and menorrhagia:The western medicine group began to stop menstruation at the first two injections on average.The menstruation of the western medicine group was later than that of the western medicine group for 6 months(P<0.01).There was no amenorrhea in the traditional Chinese medicine group.10.Serum CA125 level:The serum CA125 of Chinese and Western medicine group was significantly lower than that before treatment(P<0.05),Compared with the traditional Chinese medicine group,the effect of serum CA125 in the western medicine group was significantly lower after 6 months of treatment(P<0.05).During the follow-up period,the third menstrual cycle of TCM group was still significantly lower than that before treatment(P<0.05),Up to the 6th menstrual cycle,it was still lower than the level before treatment,but the difference was not statistically significant(P>0.05);The serum CA125 level of Western medicine group in the third menstrual cycle was slightly lower than that before treatment,but the difference was not statistically significant(P>0.05),And it is much higher than that of traditional Chinese medicine group(P<0.05),To the sixth menstrual cycle,the difference was statistically significant,which was significantly higher than the level before treatment and the traditional Chinese medicine group(P<0.01).The effect of reducing serum CA125 in different courses of treatment is similar(P>0.05).11.Uterine volume:The volume of uterus in traditional Chinese medicine group was slightly smaller than that before treatment,but the difference was not statistically significant(P>0.05),The volume of uterus in western medicine group was significantly smaller than that in traditional Chinese medicine group(P<0.05),It was significantly smaller than that before treatment(P<0.05).During the follow-up period,there was no significant change in the volume of uterus(P>0.05),The difference between western medicine group and Chinese medicine group was statistically significant(P<0.05).The effect of reducing uterine volume in different treatment courses was similar(P>0.05).12.Ovarian function E2,FSH,LH:The levels of E2,FSH and LH in western medicine group were significantly lower than those before treatment(P<0.05),and lower than those in traditional Chinese medicine group(P<0.05);The level of E2 hormone in traditional Chinese medicine group was also significantly lower than that before treatment(P<0.05),while the level of FSH and LH in serum was slightly lower than that before treatment,but the difference was not statistically significant(P>0.05).The level of FSH and LH in western medicine treatment for 6 months was higher than that for 3 months(P<0.05).13.Safety evaluation:Before and after treatment,blood routine,urine routine,liver function,renal function and ECG were examined in each group,and no abnormality was found.During the treatment of group a,one patient suffered from interphase hemorrhage,while in group b,two patients suffered from slight heartburn;38 cases in western medicine group all had slight adverse reactions,the frequency of hot flashes and sweating was the highest,followed by emotional abnormality,joint pain and insomnia.Research conclusion:The clinical effect of Wenyang Huoxue Chinese medicine on dysmenorrhea of adenomyosis of cold coagulation and blood stasis type is significant,which can effectively improve the symptoms of traditional Chinese medicine,It can reduce the recurrence rate of dysmenorrhea,control the volume of uterus,regulate the expression of CA125,reduce the expression of E2,FSH and LH,and has a certain long-term effect,less adverse reactions and good safety. |
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