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背景与目的:奥沙利铂是治疗晚期结直肠癌有效的二线药物,但是由我国开发的奥沙利铂疗效及毒副作用如何,有待于临床试验研究。本试验目的是观察国产奥沙利铂单药治疗复治晚期结直肠癌患者的疗效及不良反应。方法:对复治的结直肠癌患者(既往化疗无效的晚期患者)进行奥沙利铂单药治疗。奥沙利铂130mg/m2,静脉滴注2h,第1天,每3周重复。结果:共31例患者进入临床试验,可评价疗效者28例。1例CR,3例PR,总有效率为14.3%(按照ITT计算为12.9%)。主要的不良反应为轻度的感觉神经毒性、轻中度的骨髓抑制及恶心呕吐。结论:国产奥沙利铂治疗复治晚期结直肠癌患者有一定的疗效,不良反应较轻。
BACKGROUND & OBJECTIVE: Oxaliplatin is an effective second-line drug for the treatment of advanced colorectal cancer. However, the efficacy and toxic side effects of oxaliplatin developed in our country need to be studied in clinical trials. The purpose of this experiment is to observe the efficacy and adverse reactions of domestic oxaliplatin monotherapy in patients with advanced colorectal cancer. METHODS: Oxaliplatin monotherapy was given to refractory patients with colorectal cancer, a late-stage patient who had previously failed chemotherapy. Oxaliplatin 130mg / m2, intravenous infusion 2h, the first day, repeated every 3 weeks. Results: A total of 31 patients entered the clinical trial, 28 patients could evaluate the efficacy. 1 CR, and 3 PR, with a total effective rate of 14.3% (calculated as ITT 12.9%). The main adverse reactions were mild sensory neurotoxicity, mild to moderate myelosuppression and nausea and vomiting. Conclusion: Domestic oxaliplatin treatment of patients with advanced colorectal cancer have a certain effect, mild adverse reactions.