Analysis On The Clinical Use Of Levonorgestrel-Releasing Intrauterine System And Its Clinical Effects And Safety Used Alone Or Combined With Mifepristone On Peri-Menopausal Dysfunctional Uterine Bleeding

objective:1.To investigate a using situation of levonorgestrel-releasing intrauterine system(Mirena)and its off-label drug use in clinic,and to evaluate the rationality of its medication so as to provide reference for guiding clinical rational use of drug.2.To compare and analyze the clinical effect and safety of levonorgestrel-releasing intrauterine system(Mirena)and mifepristone on peri-menopausal dysfunctional uterine bleeding patients so as to provide the theoretical basis for clinical medication.3.To evaluate the clinical effects and safety of mifepristone combined with levonorgestrel-releasing intrauterine system(Mirena)to provide an optimal treatment plan for peri-menopausal dysfunctional uterine bleeding.Methods:1.The use of levonorgestrel-releasing intrauterine system monotherapy or combined with gonadotropin releasing hormone agonist(GnRHa)in the whole hospital clinic was retrospectively analyzed from November 2011 to June 2015,and to determine whether it is an off-label drug use in accordance with the instructions of the levonorgestrel-releasing intrauterine system(date of approval:September 04,2006)strictly.The use of rationality was judged on the basis of its instruction,related clinical guidelines and literature,etc.and the situation of the levonorgestrel-releasing intrauterine system shedding was analyzed statistically according to the patient follow-up visit within six months after treatment.2.One hundred and six patients with peri-menopausal dysfunctional uterine bleeding.were divided into experiment group(n = 53)and control group(n =53),and patients in experiment group received levonorgestrel drug delivery system treatment 5 days after curettage,while patients in the control group were given mifepristone 5 days after curettage,10 mg a day,for 3 months as a course of treatment.The data of effect,the adverse reactions,endometrial thickness,volume of menstruation and hemoglobin concentration of the two groups were compared.3.Eighty-two perimenopausal patients with dysfunctional uterine bleeding were randomly divided into two groups,with 41 cases in each group.The patients in the treatment group were treated with mifepristone combined with levonorgestrel-releasing intrauterine system(patients were given mifepristone 100 mg at the time of levonorgestrel-releasing intrauterine system insertion and then at 30-day intervals for 3 months with a total dose of 400mg).The patients in the control group were treated with levonorgestrel-releasing intrauterine system alone.The number of irregular vaginal bleeding,menstrual blood volume,patient satisfaction,adverse reactions and so on were observed and compared between the two groups by follow-up in 1,3 and 6 months after treatment.Results:1.There were 395 patients using levonorgestrel-releasing intrauterine system(Mirena),and 328(83.04%,328/395)patients in the outpatient department,and the off-label drug use was identified in 269(68.10%,269/395)patients,and 210(53.16%,210/395)patients with adenomyosis;There were 43 patients(10.89%,43/395)combined with gonadotropin releasing hormone agonist(GnRHa);A total of 7 levonorgestrel-releasing intrauterine system were shifted after placement.2.The drug efficiency of experiment group(94.34%)was significantly higher than that of control group(67.92%,P<0.05),and the incidence of adverse reactions in experi ment group(7.55%)was significantly lower than that in control group(33.96%,P<0.05).The data of endometrial thickness and the a mount of menstrual of experiment group were significantly lower than that of control group,hemoglobin concentration was significantly higher than that of control group.3.Compared with the control group,the irregular vaginal bleeding cases,menstrual volume pictorial blood loss assessment chart(PBAC)score and endometrial thickness were significantly lower in the treatment group(P<0.05),respectively in 1 and 3 months after treatment.There were no significant differences in above indexes between the two groups(P>0.05)in 6 months after treatment.The incidence of adverse reactions in the treatment group was 12%(5/41),which was not significantly different from that in the control group(17%,7/41,P>0.05).However,the patient satisfaction rate was significantly higher in the treatment group compared with control group(93%vs.71%,P<0.05).Conclusion:1.The levonorgestrel-releasing intrauterine system(Mirena)is widely used in gynecology clinic.The off-label drug use of levonorgestrel-releasing intrauterine system was basically reasonable.In order to guarantee the safety of patients in medication,reinforced follow-ups are required after inserting levonorgestrel-releasing intrauterine system.2.The levonorgestrel-releasing intrauterine system(Mirena)has good effect on peri-menopausal dysfunctional uterine bleeding,with less adverse reactions.So it is worth promoting in clinical.3.Mifepristone combined with levonorgestrel-releasing intrauterine system(Mirena)in treatment of peri-menopausal dysfunctional uterine bleeding is safe and effective with higher compliance,which is worth to be spread.