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目的:进一步考察甲异靛的疗效及副作用。方法:1994年3月~1995年7月中华医学会组织全国甲异靛治疗慢性粒细胞白血病(CML)Ⅲ期临床试验协作组,包括36个省级以上医疗单位,有402例CML患者进入临床观察,可评价疗效的有374例。结果:单一用药,每日75~150mg,总有效率为90.1%,缓解率为81.3%。初治患者疗效优于复治患者,缩脾效果好。获最佳疗效的时间平均为73.3天。副作用主要为不同程度的骨、关节、肌肉的疼痛,消化道反应轻微,近期与长期观察无心、肝、肾功能的损害,所有患者均未发生骨髓抑制。结论:甲异靛是一种新型的治疗CML的药物。
Objective: To further investigate the efficacy and side effects of meglumine. METHODS: From March 1994 to July 1995, the Chinese Medical Association organized a national phase III clinical trial collaboration group for treatment of chronic myelogenous leukemia (CML) with 36 patients at or above the provincial level. 402 CML patients entered the clinic. Observed, 374 cases can evaluate the efficacy. Results: Single use, daily 75 ~ 150mg, the total effective rate was 90.1%, the remission rate was 81.3%. The curative effect of the initial treatment is better than that of the retreatment patients, and the effect of reducing the spleen is good. The average time to get the best results was 73.3 days. The main side effects were bone, joint, and muscle pains of different degrees, and the digestive tract reactions were mild. There was no heart, liver, or kidney damage in recent and long-term observations. No bone marrow suppression occurred in all patients. Conclusion: Meisoindigo is a novel drug for the treatment of CML.