中低位直肠癌根治手术中置入氟尿嘧啶缓释剂的临床研究

目的观察并探讨中低位直肠癌根治术中置入氟尿嘧啶缓释剂行局部化疗的临床疗效和安全性。方法2008年4月至2010年4月间，入选的中低位直肠癌根治术患者74例，随机分为治疗组（39例）和对照组（35例），对照组患者直肠癌根治术后行奥利沙铂联合亚叶酸钙化疗，治疗组患者根治术中局部置入氟尿嘧啶缓释剂1000mg，术后化疗方案同对照组。随访观察两组患者术后肿瘤复发、转移及24个月内生存率和平均生存时间。结果（1）治疗组与对照组术后手术相关并发症发生率相近（23．1％和20．0％），差异无统计学意义（P〉0．05）；（2）治疗组患者术后12个月内局部复发率（2．6％）和远处转移率（2．6％）均低于对照组（17．1％和8．6％），两组复发率差异有统计学意义（P〈0．05）；（3）治疗组和对照组患者术后24个月内分别死亡5例（12．8％）和8例（22．9％），两组患者24个月总生存率分别为（90．2±5．7）％和（83．7±6．8）％，死亡者术后平均生存时间分别为（19．3±2．9）个月和（16．7±3．4）个月，差异均有统计学意义（P〈0．05）。结论中低位直肠癌根治术中置入氟尿嘧啶缓释剂行区域性缓释化疗能有效控制肿瘤局部复发、延长患者生存时间，且具备较高的安全性。

Clinical research on efficacy of implantation of sustained-release fluorouracil in radical operation of middle and low rectal cancer

Objective To observe and evaluate clinical efficacy and safety of local chemotherapy with implantation of fluorouracil sustained release agent in radical resection of middle and low rectal cancer. Methods 74 admitted patients with middle and low rectal cancer undergone radical surgery from April 2008 to April 2010 were randomly divided into treatment group （n = 39 ） and control group （n = 35 ）, the control group was given oxaliplatin combined with calcium folinate chemotherapy after radical operation, treatment group was implanted with 5-fluorouracil sustained release particles 1000 mg during radical surgery, post- operative chemotherapy was same as control group, and postoperative tumor recurrence, metastasis and 24 months survival rate and mean survival months were noted and compared between two groups. Results （ 1 ） Incidences of operation related complications of 2 groups were similar （ 23.1% vs 20.0% ） , there was no statistical difference （ P 〉 0. 05 ）. （ 2 ） Local recurrence rate （2. 6% ） and distant metastasis rate （ 2. 6% ） of treatment group were both lower than those of control group （ 17.1% and 8.6% ） within 12 months of postoperation, the recurrence rates of two groups were significant differences （ P 〈 0.05 ） ; （ 3 ） Treatment group and control group after 24 months of postoperation 5 cases （ 12. 8% ）, 8 cases （22. 9% ） of deaths were seen respectively. Overall survival rate of 24 months was （ 90. 2 ± 5.7 ） % , （ 82. 7 ± 6. 8 ） % , deaths postoperative mean survival months were （ 19. 3 ± 2. 9 ） , （ 16. 7 ± 3.4） respectively, the differences were both statistically significant （ P 〈 0. 05 ）. Conclusions Implantation of sustained-release fluorouracil inradical operation of rectal cancer undergoing regional chemotherapy can effectively control incidence of local recurrence, prolong survival time, and obtain high security.