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目的:观察沙尔威辛治疗恶性肿瘤的安全性,毒副反应与剂量的关系,确定推荐Ⅱ期临床研究的剂量。方法:共入选29例患者,沙尔威辛分为9个剂量组,由初始剂量15 mg.m-2.d-1开始逐渐增加至30,45,60,75,90,105 mg.m-2.d-1,加入生理氯化钠溶液500 mL静脉点滴2 h,连续3 d,其中第7剂量组为90 mg.m-2.d-1连续4 d,第8剂量组为90 mg.m-2.d-1连续5 d,第9剂量组为105 mg.m-2.d-1连续5 d,21 d为一周期,每剂量组3或4例。观察药物对人体各系统的影响及毒性反应。结果:沙尔威辛的毒副反应比较轻微,除了血管刺激疼痛外主要还包括Ⅰ/Ⅱ度的骨髓抑制、消化道反应、发热及皮肤潮红等,所有的毒副反应均在停药2周内恢复。没有出现剂量限制性毒性。爬坡最高剂量为105 mg.m-2.d-1连续5 d。结论:沙尔威辛对恶性肿瘤患者的耐受性良好,建议Ⅱ期临床研究推荐剂量为90 mg.m-2.d-1连续5 d,21 d为一周期。
OBJECTIVE: To observe the safety of Shar-Waxin in the treatment of malignant tumors, the relationship between toxicities and dose, and to determine the recommended dose of Phase II clinical study. Methods: A total of 29 patients were enrolled in this study. Shar-Waxin was divided into 9 dosage groups, which were gradually increased from the initial dose of 15 mg.m-2.d-1 to 30, 45, 60, 75, 90 and 105 mg.m- .d-1, adding 500 mL of physiological sodium chloride solution intravenously for 2 h for 3 d, wherein the seventh dose group was 90 mg.m-2.d-1 for 4 d, and the eighth dose group was 90 mg. m-2.d-1 for 5 consecutive days. The 9th dose group was 105 mg.m-2.d-1 for 5 consecutive days and 21 days for one cycle with 3 or 4 doses for each dose group. Observe the impact of drugs on various systems and toxic reactions in humans. Results: The side effects of Salbutamol were mild, except for the pain of vascular stimulation, including Ⅰ / Ⅱ degrees of myelosuppression, gastrointestinal reactions, fever and skin flushing. All the side effects were discontinued for 2 weeks Within the recovery. No dose-limiting toxicity was observed. The highest dose of climbing was 105 mg.m-2.d-1 for 5 days. Conclusions: Salbutamol is well tolerated in patients with malignant tumors. It is recommended that the recommended dose of 90 mg.m-2.d-1 in Phase II clinical study be continuous for 5 days and 21 days for one cycle.