Clinical Study on Yangxue Sanhan Tongmai Prescription for the Treatment of Endometriosis of Blood Deficiency and Cold Coagulation Type / 广州中医药大学学报

ABSTRACT

Objective To observe the clinical efficacy of Yangxue Sanhan Tongmai Prescription(derived from the modification of Danggui Sini plus Wuzhuyu Shengjiang Decoction,i.e.,Danggui Sini Decoction with Euodiae Fructus and Zingiberis Rhizoma Recens added)for the treatment of endometriosis(EMS)of blood deficiency and cold coagulation type.Methods A total of 120 cases of EMS with blood deficiency and cold coagulation syndrome were randomly divided into the study group and the control group,with 60 cases in each group.The study group was treated with Yangxue Sanhan Tongmai Prescription,and the control group was treated with Shaofu Zhuyu Granules.Both groups were treated for a period of 3 months,and were followed up for one year after the completion of the treatment.The two groups were observed in the changes of the visual analogue scale(VAS)scores of menstrual abdominal pain,the grading scores of dysmenorrhea,non-menstrual pelvic pain,pain during sexual intercourse,pelvic pressure pain and sacral ligament tenderness,the size of ovarian endometriosis cysts,and the serum levels of carbohydrate antigen 125(CA125),vascular endothelial growth factor(VEGF),soluble intercellular adhesion molecule 1(SICAM-1),matrix metalloproteinase 9(MMP-9)and tissue inhibitor of metalloproteinase 2(TIMP-2).After treatment,the clinical efficacy and safety,recurrence and pregnancy in the two groups were evaluated.Results(1)In the course of the trial,3 cases fell off in the study group and 5 cases fell off in the control group,and a total of 112 patients were eventually included in the statistical analysis,including 57 cases in the study group and 55 cases in the control group.(2)After 3 months of treatment,the total effective rate in the study group was 92.98%(53/57)and that in the control group was 85.45%(47/55),and the intergroup comparison showed that the efficacy of the study group was significantly superior to that of the control group(P＜0.05).(3)After treatment,VAS scores of menstrual abdominal pain and the grading scores of dysmenorrhea,non-menstrual pelvic pain,pain during sexual intercourse,pelvic pressure pain and sacral ligament tenderness in the two groups were significantly reduced compared with those before treatment(P＜0.05),and the reduction in the study group was significantly superior to that in the control group(P＜0.05).(4)After treatment,the ovarian endometriosis cysts of the two groups were slightly reduced,but the intragroup pre-and post-treatment differences and the intergroup post-treatment differences were not statistically significant(P＞0.05).(5)After treatment,the levels of serum CA125,VEGF,SICAM-1 and MMP-9 were decreased and the serum TIMP-2 level was increased in both groups compared with those before treatment(P＜0.05).And the decrease of serum CA125,VEGF,SICAM-1 and MMP-9 as well as the increase of serum TIMP-2 in the study group were significantly superior to those in the control group(P＜0.05).(6)The results of one-year follow-up showed that the recurrence rate of the study group was 30.19%(16/53),which was significantly lower than that of the control group(68.09%,32/47),and the difference was statistically significant between the two groups(P＜0.05).In the study group,there were 21 patients having the fertility desire,and then 14 cases of them were pregnant after treatment,with a pregnancy rate of 66.67%(14/21);in the control group,there were 20 cases having fertility desire,and then 4 cases of them were pregnant after treatment,with a pregnancy rate of 20.00%(4/20).The intergroup comparison showed that the pregnancy rate of the study group was significantly higher than that of the control group,and the difference was statistically significant(P＜0.05).(7)During the treatment period,there were no obvious adverse reactions in the two groups,and there were no abnormal changes in the safety indexes of blood,urine,and stool routine test,electrocardiogram,and liver and kidney function.Conclusion Yangxue Sanhan Tongmai Prescription exerts certain effect in treating patients with endometriosis of blood deficiency and cold coagulation type,which can significantly alleviate various pain symptoms,improve pregnancy outcomes,and effectively regulate the levels of serum CA125,VEGF,SICAM-1,MMP-9 and TIMP-2 of the patients.