目的 探讨替吉奥胶囊联合尼妥珠单抗治疗晚期头颈部鳞状细胞癌的临床疗效。方法 收集2012年5月-2015年5月在郑州大学附属肿瘤医院治疗的晚期头颈部鳞状细胞癌患者78例，随机分为对照组（39例）和治疗组（39例）。对照组静脉滴注尼妥珠单抗注射液，100 mg加入5%葡萄糖注射液250 mL，1次/周，治疗8周；治疗组在对照组的基础上口服替吉奥胶囊，第1周25 mg/次，2次/d，若可耐受则增至50 mg/次，2次/d，服用3周停1周，再服用3周。评价两组患者临床疗效，同时比较治疗前后两组患者生活质量调查表（QLQ-C30）评分和两年生存率差异。结果 治疗后，对照组总有效率为38.46%，疾病控制率为74.36%，分别显著低于治疗组患者的61.54%和92.31%，两组比较差异具有统计学意义（P<0.05）。治疗后，两组患者各项QLQ-C30评分均显著升高，同组比较差异具有统计学意义（P<0.05）；且治疗组患者各项QLQ-C30评分显著高于对照组，两组比较差异具有统计学意义（P<0.05）。治疗两年后，治疗组总生存率为89.74%，显著高于对照组的71.79%，两组两年生存率比较差异具有统计学意义（P<0.05）。结论 替吉奥胶囊联合尼妥珠单抗注射液治疗晚期头颈部鳞状细胞癌疾病具有较高的控制率和生存率，可有效改善患者生活质量，具有一定的临床推广应用价值。

Objective To evaluate the clinical efficacy of Tegafur Gimeracil Oteracil Potassium Capsules combined with nimotuzumab in treatment of advanced head and neck squamous cell carcinoma. Methods Patients (78 cases) with advanced head and neck squamous cell carcinoma in Zhengzhou University Cancer Hospital from May 2012 to May 2015 were randomly divided into control (39 cases) and treatment (39 cases) groups. Patients in the control group were iv administered with Nimotuzumab Injection for 8 weeks, 100 mg added into 5% glucose injection 250 mL, once weekly. Patients in the treatment group were po administered with Tegafur Gimeracil Oteracil Potassium Capsules on the basis of the control group, 25 mg/time for the first week, then 50 mg/time for the tolerable patient, withdraw 1 week after taking 3 weeks, then they were treated for another 3 weeks, twice daily. After treatment, the clinical efficacy was evaluated, and the difference of QLQ-C30 scores and two-year survival rate in two groups before and after treatment was compared. Results After treatment, clinical efficacy and disease control rate in the control group were 38.46% and 74.36%, which were significantly lower than 61.54% and 92.31% in the treatment group, respectively, and there were differences between two groups (P<0.05). After treatment, the QLQ-C30 scores in two groups were significantly increased and there were differences in the same group (P<0.05). And the QLQ-C30 scores in the treatment group were significantly higher than that in the control group, with significant difference between two groups (P<0.05). After treatment for two years, the overall survival rate in the treatment group was 89.74%, which was significantly higher than 71.79% in the control group, and there were differences between two groups (P<0.05). Conclusion Tegafur Gimeracil Oteracil Potassium Capsules combined with nimotuzumab has high control rate and survival rate in treatment of advanced head and neck squamous cell carcinoma, and can effectively improve the quality of life, which has a certain clinical application value.