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背景与目的:亚叶酸钙(calciumfolinate,CF)作为5-氟尿嘧啶(5-fluorouracil,5-FU)的生化反应调节剂,能提高5-FU的抗肿瘤效应,已被国内外研究证实,但在用量、用法等方面还有待进一步探讨。本研究目的是探讨同时持续静脉滴注CF与5-FU,人体对5-FU的最大耐受剂量(maximumtolerateddose,MTD)及剂量限制性不良反应。方法:符合入选标准的病例,使用顺铂(cisplatin,DDP)+CF/5-FU方案,5-FU初始剂量为500mg·(m2·d)-1,如未观察到严重不良反应,以50mg·(m2·d)-1逐渐递增,每个剂量级3～6例,直到最大耐受剂量。CF、DDP每疗程剂量固定不变。结果:全组32例进入临床试验,共化疗64疗程,总缓解率为84.4%,5-FU最大耐受剂量为800mg·(m2·d)-1,口腔粘膜炎与腹泻为剂量限制性不良反应。结论:CF与5-FU同时静脉滴注可提高5-FU给药剂量,且对晚期消化系统肿瘤及头颈部癌有较高疗效,推荐Ⅱ期临床试验5-FU剂量为700mg·(m2·d)-1,连用5天,每3周为1个疗程。
BACKGROUND & AIM: Calcium folinate (CF), as a biochemical response regulator of 5-fluorouracil (5-FU), has been shown to enhance the anti-tumor effects of 5-FU by domestic and foreign studies. However, Dosage, usage and other aspects have yet to be further explored. The purpose of this study was to investigate the maximum dose (MTD) and dose-limiting adverse effects of 5-FU on human 5-FU with continuous continuous infusion of CF and 5-FU. Methods: The initial dose of 5-FU was 500 mg · (m2 · d) -1. The patients were treated with cisplatin (DDP) + CF / 5-FU and no serious adverse reactions were observed. · (M2 · d) -1 gradually increase, each dose level 3-6 cases, until the maximum tolerated dose. CF, DDP each dose fixed. Results: The whole group of 32 patients were enrolled in the clinical trial. The total remission rate was 84.4% and the maximum tolerated dose of 5-FU was 800 mg · (m2 · d) -1. Oral mucositis and diarrhea were dose-limiting reaction. Conclusions: The combination of CF and 5-FU at the same time can increase the dosage of 5-FU, and have a higher efficacy on advanced digestive system tumors and head and neck cancer. The dose of 5-FU in Phase II clinical trial is 700 mg · (m2) · D) -1, once every 5 days, every 3 weeks for a course of treatment.