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目的:评价抗肿瘤新药人参三醇-3,6-二琥珀酸酯钠的人体安全性,观察毒副反应并确定人体安全耐受剂量。方法:采用改良的Fibonacci方法进行剂量递增。选择30例健康受试者和9例肿瘤患者。21例健康受试者进行7个剂量组单次给药试验(20,40,70,100,140,190,240 mg);9例健康受试者进行3个剂量组(70,100,140 mg)连续给药30 d的试验,9例肿瘤患者进行100 mg连续给药30 d试验。结果:21例健康受试者单次给药试验未观察到不良反应;9例健康受试者和9例肿瘤患者连续给药30 d试验主要的不良反应为乏力、体内热感、咽痛和大便干燥等。结论:人参三醇-3,6-二琥珀酸酯钠毒性反应轻,患者耐受性好。推荐Ⅱ期临床使用剂量及方法为70~100 mg.d-1,静脉滴注,连用30 d。
OBJECTIVE: To evaluate the human safety of the new antitumor drug, ginsenoside 3,6-disuccinate, observe the side effects and determine the safe tolerated dose. Methods: Dose escalation was performed using a modified Fibonacci method. Thirty healthy subjects and nine tumor patients were selected. Twenty-one healthy volunteers were given a single dose of 7 doses (20, 40, 70, 100, 140, 190, 240 mg); 9 healthy subjects were treated with 3 doses (70, 100, 140 mg) for 30 consecutive days, and 9 patients Tumor patients were treated with 100 mg for 30 days. Results: No adverse reactions were observed in the single dose trials of 21 healthy subjects. The main adverse reactions in 9 healthy subjects and 9 tumor patients were continuous administration for 30 days. The main adverse reactions were fatigue, thermal sensation, sore throat and Dry stools and so on. CONCLUSIONS: Panaxtriol-3,6-disuccinate sodium has a mild toxicity and is well tolerated by patients. The recommended phase II clinical dose and method for the 70 ~ 100 mg. D-1, intravenous infusion for 30 days.