Clinical Valuation Of Observe Add-back Therapy In Patients Treated With Leuprolide For Symptomatic Endometriosis

Objective:This study is to compare the effect of combined therapy Leuprolide acetate(LA)plus add-back tibolone on endocrine hormone levels and bone loss of endometriosis patients.Methods:Totally 148 endometriosis patients were enrolled.They were randomly divided into blank control group,1.25 mg tibolone group and 2.5 mg tibolone group,with 48 patients in blank control group,50 patients in other two groups.The levels of and endocrine hormone levels were measured before treatment and at 24 weeks of treatment.The levels of bone gla-protein(BGP)and endocrine hormone levels were measured before treatment and at 24 weeks of treatment.Bone mineral density(BMD)was measured before treatment,at 24 weeks of treatment,at 6 months and 12 months after drug withdrawal.Results:In the three groups,the serum endocrine hormone levels of estradiol(E2),follicle stimulating hormone(FSH),and luteinizing hormone(LH)at 24 weeks of treatment were significantly lower than those before treatment(P<0.05).Compared before treatment,BGP or BMD of lumbar vertebra was significantly lower than at 24 weeks of treatment in the blank control group(P<0.05),6 months and 12 months after drug withdrawal,BMD of lumbar vertebra was still lower than before treatment(P<0.05),BGP was higher than before treatment(P>0.05).BMD of lumbar vertebra and femoral intertrochanteric in 1.25mg tibolone group and 2.5mg tibolone group at 24 weeks of treatment,at 6 months and 12 months after drug withdrawal were lower than those before treatment,but without significant difference.Furthermore,there were no significant differences in endocrine hormone levels and BMD or BGP between the 1.25mg tibolone group and 2.5mg tibolone group at all the time points.Conclusions:Combined therapy Leuprolide acetate plus add-back tibolone can reduce bone loss and low dose tibolone can maintain bone density.