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目的:观察硫酸长春新碱脂质体在肿瘤患者中单次静脉给药的安全性和耐受性,获得注射用硫酸长春新碱脂质体单次给药的最大耐受剂量(MTD)和剂量限制性毒性(DLT)。方法:采用单次给药,先低剂量后高剂量的逐渐递增的探索性研究方法。试验共入组20例恶性肿瘤患者,分别给予1.0,1.5,2.0,2.3 mg.m-2,电子输液泵维持静脉滴注1 h。观察患者的耐受性及用药后d 7,d 14,d 21的血尿常规、便常规+潜血、生化指标、心电图等检查。结果:患者单次静脉应用长春新碱脂质体的最高剂量为2.3 mg.m-2。不良反应主要表现为神经性疼痛及肢端麻木,其他不良反应有便秘、发热、乏力、腹痛腹胀、恶心呕吐、脱发等,而血液学毒性轻微。结论:长春新碱脂质体的剂量限制性毒性为神经毒性,其单次静脉给药的最大耐受剂量为2.0 mg.m-2。
OBJECTIVE: To observe the safety and tolerability of single-dose administration of vincristine sulfate liposomes in cancer patients and obtain the maximum tolerated dose (MTD) of single injection of vincristine sulfate for injection and Dose-limiting toxicity (DLT). Methods: A single dose, the first low-dose high-dose gradually increasing exploratory research methods. A total of 20 patients with malignant tumor were enrolled in this study. The patients were treated with 1.0, 1.5, 2.0 and 2.3 mg.m-2 respectively. The IV infusion pump was maintained for 1 hour. Observe the patient’s tolerance and medication d 7, d 14, d 21 of hematuria routine, routine occult blood, biochemical indicators, ECG and other tests. RESULTS: The highest single-dose intravenous vincristine liposomal vehicle was 2.3 mg.m-2. Adverse reactions mainly manifested as neuropathic pain and limb numbness, other adverse reactions are constipation, fever, fatigue, abdominal pain, abdominal distension, nausea and vomiting, hair loss, etc., and hematologic toxicity. CONCLUSION: The dose-limiting toxicity of vincristine liposomes is neurotoxic, with a maximum tolerated dose of 2.0 mg.m-2 for single intravenous administration.