大剂量醛氢叶酸加氟尿嘧啶持续滴注联合顺铂治疗晚期食管癌临床研究

Clinical study on the effect of the high-dose leucovorin plus fluorouracil in combination with cisplatin in the treatment of advanced esophageal cancer

目的观察大剂量醛氢叶酸（Leucovonn，LV）加氟尿嘧啶（5-Fluorouracil，5-Fu）持续48h滴注联合顺铂（Cisplantin，DDP）治疗晚期食管癌与传统DF方案疗效及其不良反应的差别。方法病理确诊的食管癌60例，随机分成治疗组30例，采用DDP25mg／m2静脉滴注30min，第1—3天；LV200mg／m2静脉滴注2h，5-Fu0．5静脉注射10min，然后5-Fu2．5／m2，用输液泵连续输注48h，每21天重复，2个周期以上评定疗效。对照组30例，采用DDP25mg／m2静脉滴注30min，第1—3天；LV60mg／m2静脉滴注2h，第1～5天，5-Fu500mg／m2静脉滴注8h，每21天重复，2个周期以上评定疗效。结果近期疗效，治疗组，完全缓解（CR）1例，部分缓解（PR）15例，稳定（SD）9例，进展（PD）5例，总有效率CR＋PR53．3％（16／30）。对照组，PR11例，SD11例，PD8例，无PR病例，总有效率36．7％（11／30）。恶心、呕吐、口腔粘膜炎、骨髓抑制、腹泻及脱发为主要不良反应。两组均能耐受，未发生IV度毒性，骨髓抑制对照组比治疗组明显。结论大剂量LV＋5-Fu48h滴注联合铂治疗晚期食管癌近期疗效较传统DF方案好，不良反应较小，值得进一步扩大研究。

Objective To observe the effect of high-dose leucovorin （LV） plus 5-fluorouracil （5-Fu） for 48 hours infusion in combination with eisplatin（DDP） in treatment of advanced esophageal cancer. Methods Pathological diagnosis of esophageal cancer 60 eases were randomly divided into treatment group of 30 patients, using DDP 25mg/m2 intravenous infusion 30 minutes,dl - 3 ,LV 200mg/m2 intravenous infusion 2 hours,5-Fu 0. 5 intravenous injection 10 minutes,and 5-Fu 2.5/m2 ,continuous infusion with the infusion pump for 48 hours every 21 days,2 cycles of assessment of efficacy. Control group of 30 patients, using DDP 25mg/m2 intravenous infusion 30 minutes, d1 - 3, LV 60mg/m2 intravenously two hours, d1- 5,5-Fu 500mg/m2 intravenously 8 hours every 21 days,2 cycles of assessment of efficacy. Results Short-term effect, treatment group, complete remission （CR） 1 patient and partial remission（PR） 15 cases, stable （SD） 9 cases, progress （PD） 5 cases, the total effective rate of CR ＋ PR53.3% （ 16/ 30）. Control group, PR 11 patients, SD 11 cases, PD 8 cases, no cases of PR, the total effective rate 36.7% （11/30）. Nausea, vomiting, oral mucositis, bone marrow suppression, diarrhea and hair loss were the main adverse reactions. Two groups are able to withstand, without any IV toxicities, myelosuppression was significant in control group than the treat- ment group. Conclusion High-dose LV ＋ 5-Fu 48 hours infusion combined platinum-term efficacy in treatment of advanced esophageal cancer compared with conventional DF program is good, less adverse reactions, should further expand the study.