Abstract: Safety and prognostic survival analysis of raltitrexed in patients with colorectal cancer during perioperative period        XUE Wei-nan*，SONG Li-qiang，LI Bing-yun，et al. *Department of Colorectal Surgery, Harbin Medical University Cancer Hospital, Harbin 150081，China
Corresponding author： CUI Bin-bin，E-mail：cuibinbinhrb@163.com
XUE Wei-nan and SONG Li-qiang are the first authors who contributed equally to the article.
Abstract    Objective     To explore the safety and prognosis of different application of raltitrexed in perioperative period. Methods    Patients undergone colorectal cancer surgery at Department of Colorectal Surgery, Harbin Medical University Cancer Hospital between June 2015 and December 2015 were randomly divided into four groups according to the different ways of administration of raltitrexed. Group A: intraperitoneal perfusion of raltitrexed during surgery. Group B: intravenous drip raltitrexed during surgery. Group C: intraperitoneal perfusion of raltitrexed during surgery and intravenous drip raltitrexed after the operation. Group D（negative control group）:intraoperative normal saline infusion and intravenous drip normal saline after the operation. Safety and prognosis of patients treated by raltitrexed in four groups were analyzed. Results    There was no significant statistical difference in clinical events and systemic toxicity. There was no significant difference in overall survival（OS）and disease-free survival（DFS）of 3 years among the groups. However, in stage Ⅲ colorectal cancer patients, the overall survival of group C was significantly higher than that of the control group. Conclusion    Application of raltitrexed for colorectal cancer in perioperative period is tolerated and safe. Meanwhile, for patients with stage Ⅲ colorectal cancer，using raltitrexed during perioperative period, especially intraoperative intraperitoneal perfusion combined with postoperative intravenous drip of raltitrexed can significantly improve OS for 3 years.

Key words: colorectal cancer, raltitrexed, survival analysis

摘要： 目的    探讨雷替曲塞在围手术期不同应用方式的安全性及对预后的影响。方法    哈尔滨医科大学附属肿瘤医院结直肠外科将2015年6月至2015年12月确诊为大肠癌并拟行大肠癌手术的病人按照雷替曲塞不同的给药方式随机分为4组：A组，术中腹腔灌注雷替曲塞；B组，术中静脉滴注雷替曲塞；C组，术中腹腔灌注+术后静脉滴注雷替曲塞；D组（对照组），术中生理盐水灌注+术后生理盐水静脉滴注。随后研究4组病人经雷替曲塞治疗后的安全性及预后情况。结果    在术后各临床并发症、系统毒性等方面的分析中，未见差异有统计学意义。各个组间的3年总存活率及无病生存未见明显统计学差异，但在TNM分期为Ⅲ期的结直肠癌病人中C组的3年总存活率明显优于对照组。结论    结直肠癌围手术期应用雷替曲塞化疗具有良好的耐受性和安全性。同时，对于TNM分期为Ⅲ期大肠癌的病人，围手术期应用雷替曲塞，特别是术中腹腔灌注联合术后静脉输注雷替曲塞可以显著改善3年总存活率。

关键词: 结直肠癌, 雷替曲塞, 生存分析