Randomized, blind, parallel-controlled and multiple-centre clinical trial on the efficacy and safety of sustained-released leuprolide acetate in the treatment of endometriosis

摘要

Objective:To evaluate the efficacy and safety of leuprolide acetate in the treatment of endometriosis.Methods:The patients with endometriosis were randomly divided into leuprolide (n=75) and control (n=74)groups.They were treated with either sustained-release injection of leuprolide acetate or Enatntone injection (control) for 3 times totally.After treatment,the ovarian mass volume was measured under B ultrasound.The changes in hormone levels of estrodial (E2),FSH and LH,the pelvic signs,the scores of the patient's subjective symptoms during menstruation and non-menstrual days were observed.Results:The rate of changes in ovarian mass volume had no statistically significant difference between the two groups (P=0.495-0.965).The average reduction of ovarian mass volume was 47.91％ in leuprolide group,and 53.51％ in the control group 12 weeks after first medication.The distinct improvement rate and improvement rate of total symptom scores during menstruation and non-menstrual days had no significant difference between the two groups.The hormone levels of E2,FSH and LH were not significantly different between the two groups.The differences in the incidence of adverse reactions were not significant between the two groups.Conclusion:Leuprolide acetate produced by Livzon China is effective and safe in the treatment of endometriosis.