目的 探究尼妥珠單抗注射液聯(lián)合PF方案治療舌鱗狀細(xì)胞癌的臨床研究。方法 選取2010年3月-2017年4月鄭州大學(xué)附屬鄭州中心醫(yī)院口腔頜面科收治的舌鱗狀細(xì)胞癌患者60例為研究對(duì)象，根據(jù)其自愿選擇的術(shù)后化療方法不同分為對(duì)照組和治療組，每組各30例。對(duì)照組采用PF化療方案，第1天靜脈滴注注射用順鉑20 mg/m²；第1~5天靜脈滴注復(fù)方氟尿嘧啶注射液750 mg/m²。治療組在對(duì)照組治療基礎(chǔ)上第1天靜脈滴注尼妥珠單抗注射液400 mg。3周為1個(gè)療程，兩組患者均連續(xù)治療2個(gè)療程。觀察兩組的臨床療效，比較兩組的生存質(zhì)量和血清因子水平。結(jié)果 治療后，對(duì)照組和治療組的總緩解率分別為63.33%、86.67%，兩組比較差異有統(tǒng)計(jì)學(xué)意義（P<0.05）。治療后，對(duì)照組和治療組的生存質(zhì)量改善率分別為63.33%、80.00%，兩組比較差異有統(tǒng)計(jì)學(xué)意義（P<0.05）。治療后，兩組血清細(xì)胞周期蛋白D1（CyclinD1）、血管內(nèi)皮生長(zhǎng)因子（VEGF）、B淋巴細(xì)胞瘤-2（BCL-2）水平均明顯下降，同組治療前后比較差異有統(tǒng)計(jì)學(xué)意義（P<0.05）；且治療組血清因子水平明顯低于對(duì)照組，兩組比較差異具有統(tǒng)計(jì)學(xué)意義（P<0.05）。結(jié)論 尼妥珠單抗注射液聯(lián)合PF方案治療舌鱗狀細(xì)胞癌具有較好的臨床療效，可改善患者生活質(zhì)量，降低外周血中CyclinD1、VEGF、BCL-2水平，安全性較好，具有一定的臨床推廣應(yīng)用價(jià)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.

國(guó)家自然科學(xué)基金資助項(xiàng)目（81402231）