A Cohort Study Of The Efficacy And Safety Of The Dienogest And The Gonadotropi-releasing Hormone Agonist In Women With Adenomyosis

BackgroundAdenomyosis is a common gynecological disease,its main manifestations are dysmenorrhea,menorrhagia,and infertility,which seriously affect women’s physical and mental health.At present,the treatment of adenomyosis is still controversial,and the current treatment mainly includes drugs,surgery or a combination of the two.The complete treatment of adenomyosis is hysterectomy,but it is not suitable for patients who have fertility requirements or who desperately want to preserve the uterus although they do not have fertility requirements.The cause of adenomyosis is unknown,but it is well known that adenomyosis and endometriosis are both hormone-dependent diseases.Therefore,the drugs used to treat adenomyosis are roughly the same as those used to treat endometriosis,and most of them are hormone drugs.Dienogest has been on the market abroad for many years.It is safe and effective to treat endometriosis pain at 2mg per day,which is comparable to GnRH-a(gonadotropin-releasing hormone agonist).The clinical trial completed in China has also verified its efficacy and safety.In December 2018,it was approved by the State Food and Drug Administration for listing in our country.Dienogest can also be used to treat adenomyosis and taken for a long time.There is not much experience in the treatment of adenomyosis in China with dienogest.This project is trying to observe the efficacy and safety of dienogest on dysmenorrhea and heavy menstrual flow in patients with adenomyosis,which provides a new option for the long-term treatment of adenomyosis.Objective1.Observe the effect of dienogest on dysmenorrhea and hypermenorrhea in patients with adenomyosis;2.Observe the safety and side effects of dienogest and GnRH-a;Materials and MethodsWe collected the data of patients with adenomyosis.They were admitted to Qilu Hospital of Shandong University from September 2019 to August 2020.A total of 127 women with adenomyosis were collected and they were divided into two groups alternately:63 people in the dienogest group received 2 mg of dienogest orally daily for 12 weeks;64 people in the GnRH-a group received 3.6 mg of Goserelin Acetate Sustained-ReleseDopot subcutaneously in the lower abdomen every 28 days,a total of 3 injections.Questionnaire surveys were conducted on the patients before treatment and at 12 weeks of treatment,and general characteristics and clinical information were collected when the patients were enrolled.The visual analog scale(VAS)is used to evaluate the treatment effect on dysmenorrhea,the hemoglobin(Hgb)level is used to evaluate the effect on menorrhagia,the patient’s uterus size is assessed by ultrasound,and the patient’s CA125(carcinoma antigen 125)is detected.At 12 weeks of treatment,patients were asked about adverse reactions during treatment to assess the safety of the treatment.Results56/63(88.9%)women with adenomyosis in the dienogest group finished the treatment,and 62/64(96.9%)patients in the GnRH-a group completed the treatment.After 12 weeks of treatment,the VAS score and CA125 in both groups were reduced considerably.After 12 weeks of treatment,the Hgb of the anemia patients in the dienogest group was not significantly improved(P=0.21),while the Hgb of the anemia patients in the GnRH-a group was significantly improved(P<0.001).The uterine volume in the dienogest group increased slightly,but the difference was not statistically significant(P=0.10),while the uterine volume in the GnRH-a group decreased considerably(P<0.05).The most common side effect of patients taking dienogest is breast discomfort,and the most common side effect of patients receiving GnRH-a treatment is hot flashes.Conclusion1.Dienogest can virtually soften the symptoms of pain in women with adenomyosis,but it cannot improve the symptoms of anemia and shrink the uterus in reality.GnRH-a can effectively improves anaemia symptoms and reduce the uterine volume in effect while lightening the symptoms of pain in women with adenomyosis.2.Compared with GnRH-a,patients who took dienogest experienced fewer side effects related to low levels of estrogen.However,it should be noted that there is a risk of genital bleeding during the treatment of adenomyosis with dienogest.