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目的:探讨乳腺癌术中植入缓释氟尿嘧啶进行区域性化疗的安全性及疗效。方法:采用随机对照方法,周一、周三就诊的患者设为对照组(n=26例),周二、周五就诊的患者设为植入组(n=28例),植入组患者在术中植入缓释氟尿嘧啶,比较2组患者术后毒副反应(toxic and side effect)、无病生存率(Disease-free survival rate,DFSR)及总生存率(overall survival rate,OSR)差异。结果:2组患者术后恶心呕吐、脱发、发热等临床毒性反应、血常规、肝肾功能等实验室检查及切口愈合等级比较,差异无统计学意义(P>0.05);2组病例3～12个月DFSR、OSR差异无统计学意义(P>0.05)。结论:2组患者的药物毒副反应、DFSR及OSR无统计学差异,说明乳腺癌术中植入缓释氟尿嘧啶安全可靠,是否可以预防乳腺癌术后局部转移复发、提高无病生存率及总生存率,还有待长期随访。
Objective: To investigate the safety and efficacy of regional chemotherapy for sustained-release fluorouracil implantation during breast cancer surgery. Methods: A randomized controlled trial was performed on Monday and Wednesday as control group (n = 26). Patients on weekdays and Fridays were enrolled as the implantation group (n = 28). Patients in the implantation group underwent surgery The sustained-release fluorouracil was implanted to compare the differences of toxic and side effects, disease-free survival rate (DFSR) and overall survival rate (OSR) between the two groups. Results: There were no significant differences in laboratory tests and incision healing between the two groups (P> 0.05). The incidences of postoperative nausea and vomiting, alopecia, fever and other clinical toxic reactions in the two groups were not significantly different (P> 0.05) There was no significant difference in DFSR and OSR at 12 months (P> 0.05). Conclusion: The drug toxicity, DFSR and OSR of two groups of patients have no statistical difference, which shows that the intraoperative implantation of sustained-release fluorouracil in breast cancer is safe and reliable, whether it can prevent the local recurrence and metastasis of post-operative breast cancer, improve the disease-free survival rate and total Survival rate, yet to be long-term follow-up.