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目的：根据５ＦＵ、ＣＦ药代动力学特点，设计５ＦＵ连续８小时静滴，ＣＦ１００ｍｇ，在５ＦＵ静滴第０、４、８小时３次静推的ＣＦ／５ＦＵ给药方案，联合卡铂对晚期鼻咽癌患者进行临床研究，重点摸索该联合化疗方案的剂量限制性毒性及５ＦＵ的最大耐受剂量（ＭＴＤ）。方法：将符合入选条件的病例分组，每组３５例。５ＦＵ剂量从５００ｍｇ／（ｍ２·ｄ）开始，以１２５ｍｇ／（ｍ２·ｄ）逐渐递增，直至最大耐受剂量，ＣＦ３００ｍｇ、卡铂３００～３５０ｍｇ／ｍ２剂量固定不变。结果：共２１例晚期鼻咽癌患者进入该临床试验，５ＦＵ的最大耐受剂量为１０００ｍｇ／（ｍ２·ｄ），口腔粘膜炎是该联合化疗方案的主要剂量限制性毒性。初步观察该方案有较率为７６２％。结论：５ＦＵ连续８小时静滴与ＣＦ、卡铂联合化疗可提高５ＦＵ剂量强度，推荐Ⅱ期临床试用时５ＦＵ剂量为７５０～８７５ｍｇ／（ｍ２·ｄ），共５天，３～４周重复一次。该方案对晚期鼻咽癌有较高缓解率，但确切疗效尚待进一步证实。
OBJECTIVE: According to the pharmacokinetics characteristics of 5FU and CF, we designed 5FU continuous 8-hour intravenous drip, CF100mg, CF / 5FU dosing regimen with 5FU intravenous infusion for 0, 4 and 8 hours, The clinical study of patients with nasopharyngeal carcinoma focused on exploring the dose-limiting toxicity of the combination chemotherapy regimen and the maximum tolerated dose (MTD) of 5FU. Methods: The cases that meet the inclusion criteria were divided into groups of 3 to 5 cases. The dosage of 5FU was gradually increased from 500mg / (m2 · d) to 125mg / (m2 · d) until the maximum tolerated dosage was 300mg / kg and 300-350mg / m2 of carboplatin was fixed. RESULTS: A total of 21 patients with advanced NPC were enrolled in this trial. The maximum tolerated dose of 5FU was 1000 mg / (m2 · d). Oral mucositis was the main dose-limiting toxicity of this combined chemotherapy regimen. The preliminary observation of the program has a rate of 76 2%. CONCLUSION: The 5FU dose of 5FU can be increased by 750F-875mg / (m2 · d) for 5 days and 3 to 4 weeks . The program has a high remission rate of advanced nasopharyngeal carcinoma, but the exact effect remains to be confirmed.