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作者用持续静脉滴注的方法进行第Ⅰ期临床试验,研究PALA(N-(Phosphonacetyl)-L-aspartate)和氟尿嘧啶(5-FU)的合并应用,以提高其抗肿瘤活性,以及探讨了合并应用后的毒性和PALA的血药浓度。在临床试用中,共观察42例病人,其中可供评价的34例,年龄在21～78岁。这34例病人总共经受105个疗程,平均每人约3个疗程。临床试用PALA剂量为850mg/m~2天×5;5-FU的剂量开始为300mg/m~2/天,以后增加到450、500、560和630mg/m~2/天,采取持续静脉滴注,连续给药5天。先输入PALA,24小时后再给5-FU。
The authors performed a phase I clinical trial with continuous intravenous infusions to study the combined use of PALA (N-(Phosphonacetyl)-L-aspartate) and fluorouracil (5-FU) to increase their anti-tumor activity and explore the possibility of merger. Post-application toxicity and plasma concentrations of PALA. In clinical trials, a total of 42 patients were observed, of which 34 were available for evaluation, aged 21 to 78 years. The 34 patients received a total of 105 courses, with an average of about 3 courses each. The dose of clinically tested PALA is 850 mg/m~2 days x 5; the dose of 5-FU starts at 300 mg/m~2/day, then increases to 450, 500, 560, and 630 mg/m~2/day, and continuous intravenous drip is taken. Note, continuous dosing for 5 days. Enter PALA first and give 5-FU after 24 hours.