| Endometriosis(EMT)is a common gynaecological disease,which has attracted wide attention in recent years.EMT occurs mostly among reproductive aged women,and its incidence has increased significantly in recent years.High cesarean section rate,induced abortion and laparoscopic hysteroscopy are considered to be the causes of the increased incidence.Pain and infertility are the main manifestations of EMT.Pain mainly manifests as secondary dysmenorrhea,pelvic pain and pain at the lesion site,and the pain aggravates over time.About 30% of infertility patients are associated with EMT.The treatment of EMT is constantly evolving with the increasing understanding of the disease.However,there is no standardized protocol for the treatment of EMT currently.Surgical treatment and drug treatment are the main treatment methods in Western medicine.Surgical treatment is mainly used for cysts and adhesions formed by endometriosis,while drug treatment aims at inhibiting ovarian function and preventing disease development.In traditional Chinese medicine(TCM),the treatment of EMT is mainly based on syndrome differentiation,and sometimes combined with external treatment of TCM.Huayuningkun Formula is made by Professor Guo Zhiqiang,a well-known expert in gynaecology of TCM.The Formula has helped many patients with tubal infertility to get relief from symptoms and even to get fertility opportunities in some patients.Common factors of tubal infertility include sequelae of pelvic inflammatory diseases,EMT and pelvic injury caused by pelvic manipulation.In our team's previous researches,we have confirmed the clinical efficacy of Huayuningkun Formula on the sequela of chronic pelvic inflammatory disease.In this study,we also retrospectively explored the clinical basis of Professor Guo's use of Huayuningkun Formula.Among the cases we have collected which have usedHuayuningkun Formula,some patients were clearly diagnosed with EMT.However,the efficacy of Huayuningkun Formula for EMT has not been clearly confirmed.In order to clarify and evaluate the efficacy and safety of Huayuningkun Formula on endometriosis,we conducted this study.Objective: The main objective of this study is to explore and evaluate the clinical efficacy and safety of Huayuningkun Formula in the treatment of endometriosis.Methods: 31 patients were selected according to the proposed diagnostic criteria for endometriosis((1)progressive dysmenorrhea;(2)chronic pelvic pain;(3)algopareunia;(4)Anal pain;(5)tender nodules located in the posterior fornix,Jarjavay's ligaments or Isthmus uteri;(6)cystic or solid cystic masses may be palpable on one or both sides of the uterus and may adhere to surrounding tissues to form masses;(7)infertility;(8)serum CA125 above normal range;(9)Ultrasounddetected specific signs.Diagnosis can be given when meet one of(1)-(4)and two of(5)-(9).Laparoscopic examination,pathological examination to confirm the diagnosis can be directly diagnosed),were treated with Huayuningkun Formula granule(By retaining the enema)for 3 months,and the changes of dysmenorrhea,gynecological examination,ultrasonography and serum CA125 were evaluated before and after treatment and 1 month after treatment(follow-up).And adverse reactions during treatment were recorded.Results:(1)Changes of dysmenorrhea observation table before and after treatment: Compared with before treatment,the scores of dysmenorrhea observation table after treatment and follow-up were significantly lower(P<0.05);there was no significant difference between after treatment and followup(P>0.05).(2)Changes of COX Menstrual Symptom Scale(CMSS)scores before and after treatment: Compared with before treatment,the scores of duration and degree of symptoms after treatment and followup were significantly lower than before treatment(P<0.05),and there was no significant difference between after treatment and followup(P>0.05).(3)Changes of McGill Pain Questionnaire scores before and after treatment: Compared with before treatment,the McGill Pain Questionnaire scores after treatment and followup were significantly lower than before treatment(P<0.05);there was no significant difference between after treatment and followup(P>0.05).(4)Changes in scores of Gynecological Examination Record before and after treatment: Compared with before treatment,the scores after treatment and followup were significantly lower than before treatment,the difference was statistically significant(P<0.05);there was no significant difference between after treatment and followup(P>0.05).(5)Before and after treatment,the score changes of the Ultrasound Examination Record: Compared with before treatment,the scores of the ultrasound record table after treatment and followup were lower than that before treatment,with statistical significance(P<0.05);there was no significant difference between after treatment and followup(P>0.05).(6)Changes in serum CA125 before and after treatment: Serum CA125 in the normal range of patients with serum CA125 before treatment was in the normal range throughout the treatment.In the cases of patients with abnormal CA125,after treatment and followup CA125 levels were significantly lower than before treatment(P<0.05),and there was no significant difference between after treatment and follow-up(P>0.05)(7)After treatment,0 cases were cured;6 cases(19.35%)were markedly effective,including 3 cases of pregnancy;25 cases(80.65%)were effective;0 cases were ineffective,and the total effective rate was 100%.In the course of treatment,allergy occurred in 1 case(eyelid edema,without other discomfort),which did not recur after stopping the drug,and no adverse reactions occurred in other patients,Conclusions: Huayuningkun Formula granule can significantly alleviate dysmenorrhea in patients with endometriosis and improve the signs of gynecological examination and ultrasonography.For patients with abnormal serum CA125,it can significantly reduce the level of serum CA125.During the whole treatment process,there was only 1 case of allergy,and the symptoms were mild and totally relieved after drug withdrawal.Huayuningkun Formula is effective and safe in the treatment of endometriosis. |
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