目的 探究尼妥珠单抗注射液联合PF方案治疗舌鳞状细胞癌的临床研究。方法 选取2010年3月-2017年4月郑州大学附属郑州中心医院口腔颌面科收治的舌鳞状细胞癌患者60例为研究对象，根据其自愿选择的术后化疗方法不同分为对照组和治疗组，每组各30例。对照组采用PF化疗方案，第1天静脉滴注注射用顺铂20 mg/m²；第1~5天静脉滴注复方氟尿嘧啶注射液750 mg/m²。治疗组在对照组治疗基础上第1天静脉滴注尼妥珠单抗注射液400 mg。3周为1个疗程，两组患者均连续治疗2个疗程。观察两组的临床疗效，比较两组的生存质量和血清因子水平。结果 治疗后，对照组和治疗组的总缓解率分别为63.33%、86.67%，两组比较差异有统计学意义（P<0.05）。治疗后，对照组和治疗组的生存质量改善率分别为63.33%、80.00%，两组比较差异有统计学意义（P<0.05）。治疗后，两组血清细胞周期蛋白D1（CyclinD1）、血管内皮生长因子（VEGF）、B淋巴细胞瘤-2（BCL-2）水平均明显下降，同组治疗前后比较差异有统计学意义（P<0.05）；且治疗组血清因子水平明显低于对照组，两组比较差异具有统计学意义（P<0.05）。结论 尼妥珠单抗注射液联合PF方案治疗舌鳞状细胞癌具有较好的临床疗效，可改善患者生活质量，降低外周血中CyclinD1、VEGF、BCL-2水平，安全性较好，具有一定的临床推广应用价值。

Objective To explore the effects of Nimotuzumab Injection combined with PF regimen in treatment of tongue squamous cell carcinomas. Methods Patients (60 cases) with tongue squamous cell carcinomas in Zhengzhou Central Hospital Affiliated to Zhengzhou University from March 2010 to April 2015 were randomly divided into control and treatment groups, and each group had 30 cases. Patients in the control group were given PF regimen, and patients were iv administered with Cisplatin for injection (20 mg/m²) at the first day, and were iv administered with Compound Fluorouracil Injection (750 mg/m²) at the first to fifth day. Patients in the treatment group were iv administered with Nimotuzumab Injection (400 mg) on the basis of the control group, 0.3 g/time, three times daily. Patients in two groups were treated for 2 courses (3 weeks for 1 course). After treatment, the clinical efficacies were evaluated, and quality of life and levels of serum factors in two groups were compared. Results After treatment, the remission rate in the control and treatment groups were 63.33% and 86.67%, respectively, and there was difference between two groups (P<0.05). After treatment, the improvement rates of quality of life in the control and treatment groups were 63.33% and 80.00%, respectively, and there was difference between two groups (P<0.05). After treatment, the levels of CyclinD1, VEGF, and BCL-2 in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the levels of serum factors in the treatment group were significantly better than those in the control group, with significant difference between two groups (P<0.05). Conclusion Nimotuzumab Injection combined with PF regimen has clinical curative effect in treatment of tongue squamous cell carcinomas, can improve the quality of life of patients, reduce the levels of CyclinD1, VEGF, and BCL-2 in peripheral blood, with good safety, which has a certain clinical application value.

国家自然科学基金资助项目（81402231）