Objective:Hysteromyoma,as the most common benign tumor of the female reproductive system,accounts for about 52%of the total number.Hysteromyoma is one of the main causes of hysterectomy in clinical patients,which has a great impact on women’s physical and mental health.At present,the treatment of hysteromyoma in western medicine is mainly traditional invasive surgery.However,with the change of treatment concept from invasive to minimally invasive or non-invasive,more and more women are willing to choose high intensity focused ultrasound(HIFU),an almost non-invasive treatment of hysteromyoma.However,there is no effective treatment for the absorption of myoma necrosis after HIFU in western medicine.The traditional Chinese medicine has the advantages of good curative effect,small side effects and low price,which is an ideal intervention method.Ranjiansanjie(Ranjian)capsule developed by our hospital has the effects of activating blood circulation,removing blood stasis,resolving phlegm,resolving phlegm and dispersing knot.Ranjiansanjie capsule has been used in the treatment of benign and malignant tumor for many years.The preliminary experiment and clinical research have also confirmed the therapeutic effect of Ranjiansanjie capsule on phlegm and blood stasis syndrome hysteromyoma.Hysteromyomas were divided into 0-8 types based on FIGO classification.The study evaluated the effect difference of HIFU combined with Ranjiansanjie capsule in the treatment of different types of hysteromyoma with phlegm and blood stasis syndrome,and provided a more personalized treatment scheme of integrated traditional Chinese and Western medicine for hysteromyoma.Methods:Based on the inclusion and exclusion criteria,a total of 235 hysteromyoma patients(296 hysteromyomas)with phlegm and blood stasis syndrome who were treated in the HIFU treatment center of Shanxi Provincial Hospital of Traditional Chinese Medicine and Shanghai First Maternity and Infant Hospital from September 2017 to September 2020 were retrospectively selected and analyzed.According to the regional differences,the patients were divided into two groups,125 patients in Shanxi Province were HIFU+Ruanjian group,a total of 158 leiomyomas,including 6 type 0,24 type 1,23 type 2,26 type 3,28 type 4,26 type 5,20 type 6,4 type 7 and 1 type 8.110 patients in Shanghai were HIFU group,a total of 138 leiomyomas,including 5 type 0,21 type 1,19 type 2,18 type 3 and 21 type 4 20 of type 5,26 of type 6,6 of type 7 and 2 of type 8.The patients in the HIFU+Ruanjian group took Capsule of Ranjiansanjie orally from 1 day after operation to 3 months after operation.The patients in the HIFU group did not receive any drug intervention related to uterine fibroids.All patients were followed up 1 day,1 month and 3 months after operation.In the study,we collected the general information of the patients,compared the ablation rate,reduction rate,curative effect judgment and postoperative symptom score of the patients,and evaluated the occurrence of surgical complications between the two groups.Result:(1)One day after operation,the total myoma ablation rate of all patients was 85.57%There was no significant difference in the ablation rate between HIFU group and HIFU+Ruanjian group.There was no significant difference in the ablation rate of type 1-6 myoma between the two groups.Because the sample size of type 0,7 and 8 myoma was too small,there was no significant difference compared with other groups,so no comparison was made.(2)The reduction rate of myoma in HIFU+Ruanjian group was higher than that in HIFU group at 1 month and 3 months after operation.And in different time windows,the shrinkage rate of type 1-6 myoma in the two groups was 1>2>3=4>5=6.There was no statistically significant difference in the effect of Capsule of Ranjiansanjie on the reduction rate of type 1~6 myoma after HIFU by the least square method.(3)There was no significant difference between HIFU group and HIFU+Ruanjian group in judging the curative effect of myoma 3 months after operation,and the total effective rate was 98.28%.There was no significant difference in the total effective rate of type 1-6 myoma between the two groups after analysis of variance,and there was no significant difference in judging the curative effect of type 1-6 myoma between the two groups after chi square test.(4)One month after operation,the total symptom score of the two groups was lower than that before operation,and the HIFU+Ruanjian group was lower than that of the HIFU group.One month after operation,the symptom scores of HIFU group were significantly lower than those before operation in terms of dysmenorrhea and lower abdominal discomfort,while those of HIFU+Ruanjian group were significantly lower than those before operation in terms of increased blood clot,dysmenorrhea,fatigue,lower abdominal discomfort and lumbar acid.The total symptom score of the two groups at 3 months after operation was lower than that at 1 month before operation,and that of the HIFU+Ruanjian group was lower than that of the HIFU group.At 3 months after operation,the symptom scores of the two groups were lower than those at 1 month after operation,and the scores of 5 symptoms,such as increased blood clot,dysmenorrhea,fatigue,lower abdominal discomfort and lumbar acid,were lower in the HIFU+Ruanjian group than those in the HIFU group.All patients successfully completed the operation,intraoperative and postoperative follow-up,some patients had different degrees of treatment area pain,hip and sacrococcygeal pain,low fever and other complications.After grading according to Sir standard,there was no sir C~F patients in the two groups.T test was used to compare the incidence of complications between the two groups,and there was no statistical difference.The safety of the two groups was high.Conclusion:All patients in the study can successfully and safely complete HIFU surgery,and the postoperative myoma ablation rate is high,and the postoperative myoma gradually shrinks.The total average ablation rate of myoma in the two groups was 85.39%,and there is no significant difference in the myoma ablation rate,curative effect judgment and complications among the groups.As for the reduction rate of myoma,there was no significant difference compared with other groups due to the small number of myoma types 0,7 and 8.However,the reduction rate of myoma types 1-6 in different time windows after HIFU was type 1>type 2>type 3=type 4>type 5=type 6.Capsule of Ranjiansanjie can improve the reduction rate of myoma after operation,but there is no significant difference in the reduction rate of type 1~6 myoma.In terms of symptom score,HIFU can significantly improve the total symptom score of patients,especially for dysmenorrhea and lower abdominal discomfort,while Capsule of Ranjiansanjie can further improve the increase of blood clot,fatigue and lumbar acid on the basis of HIFU.One month after the operation,the patients may still have symptoms such as excessive menstrual volume,menstrual cycle disorder,and large amount of blood clots.However,all symptoms can be basically improved three months after the operation.The patients can be informed in advance after the operation to reduce the psychological burden of the patients. |