国产与进口奥沙利铂在直肠癌术后化疗中的安全性与有效性的比较研究

Efficacy and Safety of Domestic vs. Imported Oxaliplatin Used in the Postoperative Chemotherapy for Rectal Cancer

目的:探讨国产与进口奥沙利铂在直肠癌术后化疗中的安全性与有效性,指导临床用药。方法:对同期收治的TNMⅡ和Ⅲ期直肠癌患者共97例,随机分为国产奥沙利铂(奥沙利铂注射液)组52例,和进口奥沙利铂(乐沙定)组45例,进行术后辅助化疗,采用FOLFOX4方案,观察、记录患者的不良反应及术后局部复发、远处转移及生存情况,进行统计学分析。结果:两组患者化疗不良反应的差异无显著性意义(P>0.05),3年后的局部复发及存活率存在一定的差异。结论:国产奥沙利铂使用仍然是安全、有效的,其3年生存率较高;对有经济条件的患者,可以考虑使用进口奥沙利铂,对患者整体术后治疗是有益的。

OBJECTIVE：To study the efficacy and safety of the domestic vs.imported oxaliplatin applied in postoperative chemotherapy for rectal cancer so as to offer references for clinical medication.METHODS：A total of 97 concurrently admitted patients with TNM Ⅱ and Ⅲ rectal cancer were randomly assigned to either domestic oxaliplatin group（Oxaliplatin Injection,n = 52） or imported oxaliplatin group（Eloxatin,n = 45）.Postoperative adjuvant chemotherapy with FOLFOX4 program was adopted.The adverse reactions,postoperative local recurrence,metastasis and survival rates were observed and recorded and a statistical analysis was conducted.RESULTS：There were no significant differences between the two groups with regard to the adverse reactions（P 0.05） whereas there were some certain differences in local recurrence at 3 years and survival rates.CONCLUSION：Domestic oxaliplatin is safe and effective with high three-year survival rates.However,the imported Oxaliplatin can be considered for those patients with good economic conditions for its beneficial efficacy for patient＇s postoperative holistic treatment.