The clinical study of leuprorelin acetate microspheres for injection combined with remifemin tablets on endometriosis
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Leuprolide acetate combined with remifemin tablets for endometriosis showed reduced menopausal symptoms and bone metabolism markers compared to leuprolide alone, without significantly impacting remission or recurrence rates.
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Abstract
Objective To evaluate effects and safety of Leuprolide acetate combined with remifemin tablets in the treatment of endometriosis. Methods Sixty endometriosis patients underwent laporoscopic surgery in the second people's hospital of Fuxin City were selected from December 1st, 2009 to December 1st, 2010, they were randomly divided into group A and group B, 30 cases in each group, the group A received 3.75 mg leuprolide acetate once 4 weeks, 24 weeks in all. The group B received leuprolide acetate and added oral Remifemin tablets. The serum hormones, menopause symptom severity, biochemical markers of bone metabolism and clinical effect in the two groups of patients before and after treatment were compared. Results (1)After treatment, FSH, LH and E2 were lower than before treatment, the differences between before and after treatment were statistical significance; After treatment, the E2 level of group B was slightly higher than which of group B, the levels of FSH and LH of group B were lower than which of group A, but the diffrences were not statistics significance (P 0.05). (2) After treatment, the average Kupperman scoring of group A and group B was (19±5) and (12±2), respectively, there were significant differences between the two groups; The incidence of Hot flashes, insomnia and muscle and joint pain between the two groups were statistically significant (P 0.05); Comparison between the two groups in the incidence of paresthesia, the differences were not statistically significant (P 0.05). (3)After treatment, calcium and phosphorus levels were significantly elevated, the differences between before and after treatment were statistically significant (P 0.05); After treatment, the indexes of group B with less elevated than group A, the difference was statistical significant (P 0.05); Patients of two groups before and after treatment had significant differences in bone mineral density of lumbar vertebrae, patients in group A after the Administration compared with group B vary, group B before and after drug was not significantly different. (4)Complete remission rate and partial response rate in patients of two groups with no differences, the recurrence rate for group A was little more than group B, speculation may be related to small sample size, samples need to be expanded further. Conclusion Subcutaneous injection of leuprolide acetate for EM conservative operation to consolidation treatment is precise and assist with oral remifemin tablets was able to mitigate its adverse effects, enhanced patient compliance, as well as safe and effective.
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