乳腺癌术中植入缓释氟尿嘧啶间质化疗的研究

Interstitial Chemotherapy with Sustained Release Fluorouracil in Breast Cancer Surgery

目的探讨在乳腺癌改良根治术中植入缓释氟尿嘧啶的临床安全性及疗效。方法乳腺癌改良根治术患者187例,其中浸润性导管癌155例,髓样癌24例,原位癌8例;TNM分期Ⅰ-Ⅱ期134例,Ⅲ期53例。按随机数字表法分为植入剂组95例和对照组92例。植入剂组在肿瘤下方、腋窝、锁骨下血管区域、胸大小肌之间多点撒入氟尿嘧啶植入剂,总剂量为600mg。对照组无植入。术后常规化疗。观察术后切口感染、渗液或裂开,患肢水肿、组织溃烂情况及局部疼痛、皮瓣坏死、皮下积液等局部不良反应情况;观察手术前后患者的血红细胞、白细胞计数及谷丙转氨酶、血肌酐水平;观察患者肿瘤局部复发情况和3年生存率。结果植入剂组和对照组均未发生切口感染、渗液或裂开及患肢水肿、组织溃烂情况;局部疼痛、皮下积液、皮瓣坏死发生率植入组分别为8.42%、15.79%、10.53%,对照组分别为6.52%、11.96%、11.96%,2组比较差异无统计学意义(P>0.05)。2组术后全身不良反应比较差异均无统计学意义(均P>0.05)。植入剂组术后局部复发6例(6.3%),对照组术后局部复发15例(16.3%),2组间差异有统计学意义(P=0.031);植入剂组死亡6例(3年生存率为93.7%),对照组死亡16例(3年生存率为82.6%),2组比较差异有统计学意义(P=0.019)。结论乳腺癌改良根治术的患者术中植入缓释氟尿嘧啶是安全、有效的,是乳腺癌术后局部化疗的有效途径,可减少乳腺癌术后局部复发,提高远期生存率。

Objective To explore the clinical safety and efficacy of sustained-release fluorouracil implant in modified radical mastectomy.Methods A total of 187 patients（95 patients with infitrating ductal carcinoma,24 patients with medullary carcinoma and 8 patients with preinvasive carcinoma;134 patients with TNM stage Ⅰ-Ⅱ and 53 patients with TNM stage Ⅲ） were randomly divided into implant group（n=95） and control group（n=92）.The fluorouracil（600 mg） was administered to implant group in the tumor,axillary and subclavian vascular region and between pectoralis major muscle and pectoralis minor muscle.Control group was not given fluorouracil implant.All patients received postoperative conventional chemotherapy.Wound infection,effusion,dehiscence,limb edema,tissue ulceration,local pain,skin flap necrosis,local tumor recurrence and 3-year survival rate were observed after operation.Red and white blood cell count and alanine aminotransferase and creatinine levels were measured before and after operation.Results All patients have no incision infection,effusion,dehiscence,limb edema and tissue ulceration.The incidences of local pain,seroma and flap necrosis were 8.42%,15.79% and 10.53% in implant group and 6.52%,11.96% and 11.96% in control group,with no significant differences between the two groups（P0.05）.Moreover,postoperative systemic adverse reactions were not statistically different between the two group（all P0.05）.Compared with control group,fluorouracil implant significantly decreased local recurrence rate（6.3% vs 16.3%,P=0.031）,and obviously increased 3-year survival rate（93.7% vs 82.6%,P=0.019）.Conclusion Sustained-release fluorouracil implant is safe and effective in modified radical mastectomy,and can reduce local recurrence and improve long-term survival in patients with breast cancer.