| Backgrounds:In recent years,the incidence of endometriosis(Endometriosis)increased year by year,and increasingly become a common disease of women of childbearing age.Endometriosis refers to the endometrial tissue(glands and stroma)appear in site outside the uterus.Endometriosis is characterized with sex hormone-dependent,occurred in women of childbearing age,the main symptoms are the pain of pelvic,the symptoms associated with special organs suffering from endometrial ectopia,infertility,pelvic nodules and mass.The lesion of the disease is various,extensive,invasive and easy to relapse after treatment.The most common symptom of endometriosis is pelvic pain,including secondary dysmenorrhea,progressive increase,chronic pelvic pain,dyspareunia,anal sank pain and so on.Most of the patients with endometriosis had a decline in quality of life due to severe symptoms of dysmenorrhea,and dysmenorrhea caused by endometriosis has not have regular and effective drug treatment,and the current drug treatment have adverse reactions in some aspect.So it is a valuable clinical study,it is expected to provide a better drug to endometriosis patients with dysmenorrhea.In traditional Chinese medicine,there is no diease of endometriosis,but according to the clinical symptoms,it can be found in " dysmenorrhea ","Zheng Jia"," menstrual irregularities","infertility" and other diseases.Traditional Chinese medicine think that its pathogenesis is mainly "blood stasis in Chong Ren and Uterus",and blood stasis as a pathological product,can be caused by a variety of causes.Mentor Professor Wang,in his long-term clinical experience,found that endometriosis patients with dysmenorrhea are most belonging to cold coagulation type.The treatment to this type is warming channel and activating blood circulation.And Professor Wang always use Dahuang Fuzi Decoction and Hupo Decoction as the elemental prescription,at the same time,plus and minus some herbs,and the effect is significant.Purpose:The aim of this study was to study the effect of prescription,that is Efu granules,to cure the endometriosis patients with dysmenorrhea in cold blood stasis by the method of clinical observation.The composition of the prescription include Sanleng 10g,Ezhu10g,Rougui 5g,Xixin 3g,Dahuang 6g,Fuzi 9g,Liujinu 20g,Biejia 10g.It is expected to receive a better clinical efficacy for endometriosis patients with dysmenorrhea and to provide better relief of symptoms and treatment of disease.Methods:In this study,60 cases of endometriosis dysmenorrhea patients with cold blood stasis type were observed by randomized controlled study.The patients were randomly divided into treatment group and control group.The treatment group was treated with the Efu granules(selected Dongfang Hospital of Beijing University of Chinise Medicine,two times a day,a bag each time,after meals).The control group took Guizhi Fuling Capsule(selected Jiangsu Kangyuan Guizhi Fuling Capsule,two times a day,each five tablets,after meals).Two groups of patients were taking three menstrual cycle,from the first day of the menstrual cycle began to take medicine,menstrual period can take medicine.If the menstrual volume increased significantly,the drugs should be stopped.And the time of pain onset,the average severity of pain,the severity of dysmenorrhea,the score of TCM syndromes were evaluated after each menstrual cycle,and serum CA125 levels and gynecological ultrasonography were examined before and after continuous treatment to help assess the condition.After the treatment period,clinical data were collected and SPSS 21.0 was used to analyze the data.Results:A total of 57 qualified subjects were enrolled in the study group,29 patients in the treatment group,28 patients in the control group.There were no significant difference in age,course of disease,medical history,obsterical history,the time of pain onset COX score,the average severity of pain COX score,the severity of dysmenorrhea VAS score,and the score of TCM syndromes,serum CA125 level and the size of ovarian chocolate cysts measuring by gynecological B-ultrasonography.(P>0.05)After treatment for three menstrual cycles Time of pain onset COX score:After treatment for three menstrual cycle,the sympotom related to dysmenorrhea including abdominal pain,nausea,loss of appetite,depression,irritability,neurotic,the treatment group was better than the control group,P<0.05,with statistical differences.Average severity of pain COX score:After treatment for three menstrual cycles,the average severity of pain in the treatment group and the control group was significantly better than that before treatment.After treatment of the first menstrual cycle,there was no significant difference between the treatment group and the control group in improving the average severity of pain(P>0.05).After treatment of the second menstrual cycle,there was significant difference between two groups,and statistically significant,After treatment for three menstrual cycles,the treatment group in improving the average severity of pain was significantly better than the control group,P<0.05,was statistically significant.Dysmenorrhea severity VAS score:the treatment group in improving the severity of dysmenorrhea VAS score,cured 7 cases,markedly effective in 12 cases,effective in 6 cases,4 cases were ineffective,the cure rate of 24.13%,markedly effective rate of 41.38%,the effective rate of 20.69%,inefficiency was 13.79%,the total effective rate was 86.21%.In the control group,3 cases were cured,7 cases were markedly effective,12 cases were effective,6 cases were ineffective,the cure rate was 10.71%,the effective rate was 25%,the effective rate was 42.86%,inefficiency was 21.43%,the total effective rate of 78.57%.The curative effect between the treatment group and the control group in the severity of dysmenorrhea VAS score,the treatment group was better than the control group,with statistical differences.P<0.05.The score of TCM syndromes:In the improvement of TCM syndromes,the treatment group had no cure cases,5 cases were markedly effective,21 cases were effective,3 cases were ineffective,the markedly effective rate was 17.24%,the effective rate was 72.41%,the inefficiency was 10.34%,the total effective rate was 89.66%.The control group had no cure and markedly effective patients,22 cases were effective,6 cases were ineffective,the effective rate was 78.57%,the inefficiency rate was 21.43%,the total effective rate was 78.57%.The curative effect between the treatment group and the control group in TCM syndromes,the treatment group was better than that in the control group,P<0.05,which was statistically significant.Gynecological B-ultrasound:After treatment,the treatment group and the control group all have therapeutic effect in reducing the size of ovarian chocolate cysts.Compared with before the treatment,two groups after treatment are better,P<0.05,with statistical differences.However,there was no significant difference between the treatment group and the control group in reducing the size of ovarian chocolate cysts,P>0.05,no significant difference.CA125:After treatment,the treatment group and the control group in the reduction of serum CA125 no significant effect.Safety:This drug during the medication did not appear obvious adverse reactions,the drug was safe.Conclusion:Efu granules in the treatment of endometriosis dysmenorrhea(cold coagulation and blood stasis)has the effect of reducing the time of pain onset,reducing the average severity of pain,and easing the severity of dysmenorrhea,and reducing the size of ovarian chocolate cysts.And during the clinical efficacy of the time of pain onset COX score in the nausea,loss of appetite and emotional indicators related to dymenorrhea significantly decreased,suggesting that the drug can not only in the relief of dysmenorrhea symptoms,but also ease the symptoms caused by dysmenorrhea including nausea,loss of appetite,depression,irritability,neuroticism and other issues.And it can indirectly improve the quality of life of patients.The efficacy of this drug is stable,no side effects and adverse reactions.It is worth to further study and exploration. |
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