Avilés A, Rubio M E, Gómez J, Medina M L, González-Llaven J
Arch Invest Med (Mex). 1989 Apr-Jun;20(2):183-8.
A double-blind, placebo-controlled randomized study of danazol was performed to determine if the drug has a therapeutic effect in patients with myelodysplastic syndromes (MDS). Fifty evaluable patients with MDS were randomized to receive, a single daily oral dose of either danazol (600 mg/day) or matching placebo. Treatment was continued, when possible, for a period of 6 months. Response was based on clinical course, peripheral blood counts with white blood cells differential, platelet, reticulocyte at specified intervals. Repeat bone marrow aspirates and biopsy were also done. Significant differences was observed between the treatment groups in response to test drug. Increase in hemoglobin, granulocytes, platelets and improvement in survival was noted in danazol group. Side effects were minimal. Our study suggests that danazol exerts a beneficial therapeutic effect in patients with MDS.
进行了一项关于达那唑的双盲、安慰剂对照随机研究，以确定该药物对骨髓增生异常综合征（MDS）患者是否具有治疗作用。50例可评估的MDS患者被随机分为两组，分别每日口服一次达那唑（600毫克/天）或匹配的安慰剂。在可能的情况下，治疗持续6个月。疗效基于临床病程、特定间隔时间的外周血细胞计数（包括白细胞分类、血小板、网织红细胞）。还进行了重复骨髓穿刺和活检。在对受试药物的反应方面，治疗组之间观察到显著差异。达那唑组血红蛋白、粒细胞、血小板增加，生存情况改善。副作用极小。我们的研究表明，达那唑对MDS患者具有有益的治疗作用。
