口腔癌术区植入缓释氟脲嘧啶的临床研究

Treatment of oral squamous carcinoma by surgery combined with sustained release fluorouracil interstitial chemotherapy

目的:探讨外科手术+全身化疗结合局部植入缓释5-氟脲嘧啶间质化疗药物治疗口腔鳞癌(OSCC)的疗效及安全性。方法:实验组(间质化疗组):33例实施OSCC根治手术及全身静脉化疗,术中植入中人氟安缓释氟尿嘧啶间质化疗药,平均用药剂量为200～400mg;对照组(静脉化疗组)30例OSCC手术结合全身静脉化疗。两组均随访36个月,比较其术后复发率、死亡率以及毒副反应。SPSS统计软件进行统计学分析。结果:随访观察的患者中,实验组术后12、24个月的复发率(6.06%,15.2%)、术后12、24、36个月的死亡率(6.06%,12.1%,24.2%)优于对照组(P<0.05),且其毒副反应与对照组无显著性差异(P>0.05)。结论:手术切除+全身化疗结合局部术区植入缓释氟尿嘧啶间质化疗药物,可以提高肿瘤局部化疗药物的浓度,延长作用时间,在不增加毒副反应的同时提高疗效及生存质量。

Objective：To investigate the therapeutic effect and safety of additional interstitial chemotherapy by biodegradable polymers coated 5-FU after surgery in combination with systemic chemotherapy in oral squamous carcinoma. Method：The patients diagnosed with advanced squamous carcinoma were randomly divided into two groups：the control group and the group with interstitial chemotherapy. 30 patients in the control group were treated by surgery and venous chemotherapy. In the interstitial chemotherapy group,in addition to the same treatment as the control,5-fluorouracil sustained release capsule was additionally planted in tumor bed at a dose range from 200 to 400mg.The patients were followed up for 36 months. The data were processed by SPSS statistical software. Result：After additional treatment with interstitial chemotherapy,the 12-month recurrence rate and 24-month recurrence rate were 6.06 % and 15.2 %. And the 6,24,36 month-mortality rate in the interstitial chemotherapy group were 6.06 %,12.1 %,24.2 %. They were significantly lower than the control group （recurrence rate 13.3 %,23.3 %;and mortality 10 %,20 %,36.7 % respectively）（P〈0.05）. In addition, there is no more serious syndrome in the additional interstitial chemotherapy group,when compared with the control. Conclusion：Oral squamous carcinoma with additional interstitial chemotherapy by Fluorouracil sustained release would prolong the survival without significant side-effects,which might act through increase local drug concentration and extend action time.