MCNU（雷莫司汀）片剂口服给药的II期研究。阪神血液系统疾病合作研究组
[Phase II study on oral administration of MCNU (ranomustine) tablet. Hanshin Cooperative Study Group on Hematological Disorders].
作者信息
Kanamaru A, Nagai K, Masaoka T, Shibata H, Kitani T, Taniguchi N, Horiuchi A, Tsubaki K, Kawagoe H, Hirata M
出版信息
Gan To Kagaku Ryoho. 1986 May;13(5):1915-20.
A phase II study of MCNU tablet has been performed on 70 patients with hematological disorders including mostly myeloproliferative disorders. MCNU tablet was given p.o. at a dose of 50 mg daily for 2-6 days (total 100-300mg) as one course with average intervals of 3 to 5 months or more for patients responding to this drug. The effective rates were 72% in 18 patients with chronic myelogenous leukemia, 88% in 25 patients with polycythemia vera and 68.5% in 19 patients with essential thrombocythemia. Side effects of MCNU tablet were nausea and vomiting (31%) which had a dose-dependent relationship, mild liver dysfunction (5%) and elevation of BUN and creatinine (2%) which were not serious. The results were almost comparable to those of the phase II study of MCNU given intravenously.
对70例血液系统疾病患者开展了甲环亚硝脲片的II期研究，这些患者大多患有骨髓增殖性疾病。甲环亚硝脲片口服给药，剂量为每日50mg，服用2 - 6天（总计100 - 300mg）作为一个疗程，对该药物有反应的患者平均间隔3至5个月或更长时间进行下一疗程。18例慢性粒细胞白血病患者的有效率为72%，25例真性红细胞增多症患者的有效率为88%，19例原发性血小板增多症患者的有效率为68.5%。甲环亚硝脲片的副作用包括恶心和呕吐（31%），呈剂量依赖性关系，轻度肝功能障碍（5%）以及血尿素氮和肌酐升高（2%），但均不严重。结果与静脉注射甲环亚硝脲的II期研究结果几乎相当。
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