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目的采用多中心、随机对照的原则,研究长春瑞宾(盖诺)治疗晚期消化道肿瘤的作用及地位、临床疗效和安全性。方法来源于7家医院肿瘤科51例晚期消化道肿瘤,随机分成2组,盖诺组在FP方案(5-FU、DDP)基础上加盖诺25 mg/m2第1天、第5天静脉推注;对照组在FP方案基础上加VP-16 0.1第1~5天静滴。结果盖诺组总有效率RR 54.2%(13/24),CR率4.2%,PD率16.7%;对照组总有效率RR 40.7%(11/27),无CR,PD率29.6%。2组无统计学意义(P>0.05)。近期综合疗效盖诺组好转率高于对照组,进展率低于对照组,亦有显著意义(P<0.05)。结论长春瑞宾治疗晚期消化道肿瘤总有效率较高,近期综合疗效较好,长春瑞宾在消化道肿瘤上的作用及地位值得进一步研究。
Objective To investigate the role and status, clinical efficacy and safety of vinorelbine in the treatment of advanced gastrointestinal tumors by the principle of multi-center and randomized control. Methods Fifty-one patients with advanced gastrointestinal tumors from 7 oncology departments of 7 hospitals were randomly divided into 2 groups. On the basis of FP protocol (5-FU, DDP) Bolus; the control group on the basis of the FP program plus VP-16 0.1 intravenous infusion 1 to 5 days. Results The total effective rate was 54.2% (13/24) in the Gereno group, 4.2% in the CR rate and 16.7% in the PD group. The total effective rate in the control group was 40.7% (RR), with no CR and the PD rate was 29.6%. There was no significant difference between the two groups (P> 0.05). The recent comprehensive improvement of the rate of improvement in the Gano group was higher than that of the control group, the rate of progress was lower than that of the control group, which was also significant (P <0.05). Conclusion Vinorelbine treatment of advanced digestive tract tumors have a higher total effective rate, the recent comprehensive effect is good, the role of vinorelbine in gastrointestinal tumors and status worthy of further study.