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薬理と治療
Abstract
Objective To compare the efficacy and safety of dienogest(DNG)over intranasal buserelin acetate(BA)in endometriosis. Design PhaseIII, multicenter, randomized, double−blind, active−controlled trial. Setting Twenty−four clinical trial sites in Japan. Patient(s) Two hundred seventy−one patients with endometriosis. Intervention(s) DNG(2 mg/day, oral)or BA(900μg/day, intranasal)for 24 weeks. Main outcome measure(s) Global improvement based on the change of subjective symptoms during non−menstruation(lower abdominal pain, lumbago, defecation pain, dyspareunia and pain on internal examination)and objective findings(induration of the pouch of Douglas and limited uterine mobility)from baseline to the end of treatment;adverse drug reactions; bone mineral density(BMD)measured by dual−energy X−ray absorptiometry. Result(s) Two hundred fifty−three patients were evaluable for efficacy and 255 for safety. The proportion of patients with marked or moderate global improvement was 78.1%(100/128)with DNG and 80.8%(101/125)with BA. Genital bleeding and hot flushes were the most common adverse drug reactions occurring in 95% versus 67% and 50% versus 67% (DNG versus BA)of patients respectively. The reduction in BMD was−1.0% with DNG and−2.6% with BA. Conclusion(s) DNG was at least as effective as BA in alleviating endometriosis, with less BMD loss than BA.(Jpn Pharmacol Ther 2008;36:129−40)KEY WORDS Dienogest, Buserelin acetate, Progestin, Endometriosis, Bone mineral density
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