| Endometriosis is a chronic and refractory gynecological disease.Conservative surgery is an important treatment for endometriosis,which is aimed at definite diagnosis,excision and dissection.Postoperative recurrence is one of the three major problems in the field of endometriosis.Endometriosis takes "blood stasis" as the basic pathogenesis,and is complicated by qi stagnation,qi deficiency,cold coagulation,kidney deficiency,dampness-heat,etc.The TCM syndrome types of postoperative patients are not only similar to those before surgery,but also have their own unique characteristics.Our research on the recurrence syndrome types of endometriosis after surgery is still insufficient.Traditional Chinese medicine is effective in inhibiting the recurrence of endometriosis after conservative operation,and has good clinical effect with less adverse reactions.Granule formulation has been used more and more because of its advantages of convenient taking method and stable property.The purpose of this study was to summarize the syndrome type characteristics of patients with postoperative recurrence of endometriosis,evaluate the intervention effect of Huoxue Xiaoyi granules on postoperative recurrence,and provide theoretical basis for the inhibition of traditional Chinese medicine on postoperative recurrence of endometriosis.Objectives:(1)To explore the distribution of TCM syndromes and the characteristics of different syndromes in patients with postoperative recurrence of endometriosis.(2)To evaluate the effectiveness and safety of Huoxue Xiaoyi granules in inhibiting the recurrence of endometriosis after conservative surgery.Methods:Questionnaire surveyPatients with postoperative recurrence of endometriosis were invited to Guang ’anmen Hospital,China Academy of Chinese Medical Sciences from December 2020 to December 2022 to fill in the questionnaire to summarize the distribution of TCM syndrome types and characteristics of different syndrome types in patients with postoperative recurrence of endometriosis.Clinical researchA prospective,two-center,randomized controlled study was used to select patients with endometriosis with qi stagnation and blood stasis who underwent conservative surgery in Guang ’anmen Hospital of China Academy of Chinese Medical Sciences and Beijing Maternity Hospital Affiliated to Capital Medical University from October 2020 to October 2021,and they were divided into Chinese medicine group and Western medicine group by block randomized method.The traditional Chinese medicine group took Huoxue Xiaoyi granules orally,and GnRH-a was injected subcutaneously or intramuscular as the control.The course of treatment was 6 months,and the follow-up was up to 1 year after the operation.By observing postoperative recurrence rate,CA125 level,dysmenorrhea score,pelvic pain score,menstruation score,TCM symptom efficacy evaluation,pregnancy rate,ovarian function and other indicators to evaluate the effectiveness and safety of Huoxue Xiaoyi granules in inhibiting postoperative endometriosis recurrence.Results:Questionnaire surveyA total of 369 valid questionnaires were included.(1)The syndrome of qi stagnation and blood stasis was the main syndrome type in patients with postoperative recurrence of endometriosis,accounting for 41.19%.(2)There was no significant difference in the distribution of TCM syndrome types at different ages(P>0.05),and Qi-stagnation and blood-stasis were the main factors.Most of them are sitting workers.(3)Patients with postoperative recurrence of endometriosis often complicated with uterine fibroids,breast nodules,and thyroid nodules,and the distribution of TCM syndrome types varied significantly under different types of complicated diseases(P<0.05).The distribution of TCM syndrome types in patients with pelvic inflammatory disease and uterine fibroids,pelvic inflammatory disease and breast nodules,and pelvic inflammatory disease and thyroid nodules showed statistical significance(P<0.003).The patients with Qi stagnation and blood stasis syndrome were mainly complicated with uterine fibroids,breast nodules and thyroid nodules.Clinical researchA total of 64 patients were included,including 30 in the Chinese medicine group and 34 in the western medicine group.(1)There was no significant difference in the recurrence rate 1 year after surgery between the TCM group and the western medicine group(P>0.05).(2)The level of CA125 in the Chinese medicine group decreased at 3,9 and 12 months after operation compared with before treatment(P<0.001),and at 6 months after operation compared with before treatment(P<0.05);In the western medicine group,CA125 level was decreased 3 and 6 months after surgery(P<0.001),and 9 and 12 months after surgery(P<0.05).There was no significant difference in CA125 level between the two groups 12 months after surgery(P>0.05).(3)There were no significant differences in VAS score,COX score,pelvic pain score and menstrual status score between TCM group and western medicine group after treatment(P>0.05).The VAS scores of dysmenorrhea in 2 groups were decreased 12 months after operation compared with before treatment(P<0.05).COX severity scores of patients in the Chinese medicine group at 3,6,9 and 12 months after surgery were lower than those before treatment(P<0.05),while those in the western medicine group at 9 and 12 months after surgery were lower than those before treatment(P<0.001).COX duration score of TCM group was decreased 12 months after operation compared with before treatment(P<0.05).The pelvic pain score of the Chinese medicine group was decreased 3,6 and 9 months after operation compared with that before treatment(P<0.05),and the pelvic pain score of the western medicine group was decreased 3 and 9 months after operation compared with that before treatment(P<0.05).(4)12 months after operation,TCM symptom score in TCM group was significantly lower than that in western medicine group(P<0.05).TCM symptom score of patients in TCM group was decreased 3 months after surgery compared with before treatment(P<0.05),and TCM symptom score was decreased 6,9 and 12 months after surgery compared with before treatment(P<0.001).The TCM symptom score of the western medicine group was decreased 9 months after surgery compared with before treatment(P<0.001),and the TCM symptom score was decreased 12 months after surgery compared with before treatment(P<0.05).The total effective rate of TCM symptoms was 77.78%in the TCM group and 50%in the western medicine group,and the difference between the two groups was statistically significant(P<0.05).(5)Among the patients with fertility needs,the pregnancy rate within 1 year after surgery was 21.43%in the Chinese medicine group and 23.53%in the western medicine group,the difference was not statistically significant(P>0.05).(6)There were no significant differences in serum E2,LH and FSH levels between TCM group and western medicine group 12 months after operation(P>0.05).(7)During the treatment period,6 cases of adverse reactions occurred in the Chinese medicine group and 19 cases in the western medicine group,the difference was statistically significant(P<0.05).The incidence of ADR in TCM group(20%)was lower than that in western medicine group(55.88%).Conclusions:(1)The syndrome of qi stagnation and blood stasis is the main syndrome type in patients with postoperative recurrence of endometriosis.(2)The syndrome of Qi stagnation and blood stasis is most common in patients of all ages with postoperative recurrence of endometriosis,which is often combined with uterine fibroids,breast nodules and thyroid nodules.(3)Huoxue Xiaoyi Granules and GnRH-α have the same efficacy in preventing EMs recurrence after operation,and Huoxue Xiaoyi Granules can effectively improve TCM symptoms,with advantages of better safety and less adverse reactions. |
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