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目的观察长春新碱脂质体在肿瘤患者中多次静脉给药的耐受性、不良反应及与剂量的关系,并初步观察该药的抗肿瘤作用。方法根据该剂型单次静脉给药的试验结果,设置低(1.5 mg.m-2)、中(1.8 mg.m-2)、高(2.0 mg.m-2)3个剂量组,进行剂量爬坡。每剂量组至少6例受试者,每名受试者仅接受1个剂量,长春新碱脂质体加入5%葡萄糖注射液100 mL,静脉滴注1 h。每周静脉滴注1次,1 wk为一个周期,连用4个周期,进行疗程耐受性试验。结果 19例肿瘤患者进入试验,共进行了1.5、1.8 mg.m-2两个剂量组的研究(n=7和n=12),分别有6例和7例完成4周期给药。1.5 mg.m-2剂量组1例患者用药2周期后,因出现肺部真菌感染合并应用吡咯系列抗真菌药而出组;1.8 mg.m-2剂量组3例患者用药3周期、1例用药1周期因出现不可耐受的神经毒性而出组,另1例用药2周期后患者放弃治疗而出组。主要不良反应为神经毒性,表现为神经性疼痛及肢端麻木;其次有便秘、发热、乏力、腹痛腹胀、恶心呕吐、食欲减退。血液学毒性轻微。结论长春新碱脂质体通过每周1次连续4次静脉给药,最大耐受性剂量为1.5 mg.m-2,剂量限制性毒性为神经毒性。
OBJECTIVE To observe the tolerance, adverse reactions and dose-related relationship of vincristine liposomes in patients with multiple intravenous tumors and to observe the anti-tumor effect of this drug. Methods According to the results of a single intravenous administration of this dosage form, three doses (1.5 mg.m-2), medium (1.8 mg.m-2) and high (2.0 mg.m-2) Climbing. Each dose group of at least 6 subjects, each subject received only one dose, vincristine liposomes added 5% glucose injection 100 mL, intravenous infusion of 1 h. Weekly intravenous infusion of 1 wk for a cycle, once every 4 cycles, the course of tolerance test. RESULTS: Nineteen cancer patients were enrolled in the study. A total of 1.5 and 1.8 mg.m-2 dose groups (n = 7 and n = 12) were enrolled in this study. Six and seven patients, respectively, completed the 4-week regimen. 1.5 mg.m-2 dose group 1 patient after 2 cycles of medication, due to the emergence of pulmonary fungal infection combined with pyrrole-based antifungal drugs out of the group; 1.8 mg.m-2 dose group 3 patients treated 3 cycles, 1 case 1 cycle because of the emergence of intolerable neurotoxicity out of the group, the other 1 case of medication 2 cycles after the patient gave up treatment out of the group. The main adverse reactions were neurotoxicity manifested as neuropathic pain and limb numbness; followed by constipation, fever, fatigue, abdominal distension, nausea and vomiting, loss of appetite. Hematologic toxicity is mild. CONCLUSION Vincristine liposomes are administered intravenously four times weekly once a week with the maximum tolerated dose being 1.5 mg.m-2 and the dose-limiting toxicity being neurotoxic.