小牛脾提取物注射液联合吉非替尼治疗晚期非小细胞肺癌的临床研究

Clinical study on Calf Spleen Extractive Injection combined with gefitinib in treatment of advanced non-small cell lung cancer

目的探讨小牛脾提取物注射液联合吉非替尼片治疗晚期非小细胞肺癌(NSCLC)的临床疗效。方法选取2014年1月—2017年12月在焦作市第二人民医院治疗的晚期NSCLC患者368例,随机分为治疗组(184例)和对照组(184例)。对照组患者口服吉非替尼片,250 mg/次,1次/d;治疗组在对照组基础上静脉滴注小牛脾提取物注射液,10 m L加入5%葡萄糖注射液500 m L,1次/d。两组均经过12周治疗。观察两组患者临床疗效,同时比较治疗前后两组患者肿瘤标志物、血清学指标、T淋巴细胞亚群水平和QLQ-C30评分。结果治疗后,对照组客观缓解率(ORR)和临床获益率(CBR)分别为22.28%、47.86%,均分别明显低于治疗组的45.11%、66.85%,两组比较差异具有统计学意义(P<0.05)。治疗后,两组血清糖抗原153(CA153)、角蛋白19可溶片段(Cy-fra21-1)、鳞状细胞癌抗原(SCCAg)、热休克蛋白90α(HSP90α)、钙结合蛋白A4(S100A4)、肿瘤坏死因子-α(TNF-α)、白细胞介素-17(IL-17)、CD3+、CD4+、CD4+/CD8+水平均显著降低,IL-2和CD8+水平显著升高,同组比较差异具有统计学意义(P<0.05);且治疗后治疗组上述指标水平明显优于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组QLQ-C30功能领域评分显著升高(P<0.05),且治疗组QLQ-C30各评分明显高于对照组(P<0.05)。结论小牛脾提取物注射液联合吉非替尼片治疗晚期NSCLC能够有效降低机体肿瘤标志物水平,提高机体免疫能力,提高患者生活质量,具有一定的临床推广应用价值。

Objective To explore the clinical efficacy of Calf Spleen Extractive Injection combined with gefitinib in treatment of advanced non-small cell lung cancer. Methods Patients（368 cases） with advanced non-small cell lung cancer in Jiaozuo Second People＇s Hospital from January 2014 to December 2017 were randomly divided into control（184 cases） and treatment（184 cases） groups. Patients in the control group were po administered with Gefitinib Tablets, 250 mg/time, once daily. Patients in the treatment group were iv administered with Calf Spleen Extractive Injection on the basis of the control group, 10 m L added into 5% glucose injection 500 m L, once daily. Patients in two groups were treated for 12 weeks. After treatment, the clinical efficacy was evaluated, and the tumor markers, the serological indexes, the T lymphocyte subsets levels and the QLQ-C30 scores in two groups before and after treatment were compared. Results After treatment, the objective reaction rate（ORR） and clinical benefit rate（CBR） in the control group were 22.28% and 47.86%, which were significantly lower than 45.11% and 66.85% in the treatment group, respectively, and there were differences between two groups（P〈 0.05）. After treatment, the CA153, Cy-fra21-1, SCCAg, HSP90α, S100 A4, TNF-α, IL-17, CD3＋, CD4＋ and CD4＋/CD8＋ levels in two groups were significantly decreased, IL-2 and CD8＋ levels were significantly increased, and the difference was statistically significant in the same group（P〈 0.05）. And these indexes in the treatment group after treatment were significantly better than those in the control group, with significant difference between two groups（P〈 0.05）. After treatment, the QLQ-C30 scores in two groups were significantly increased（P〈 0.05）, and the QLQ-C30 scores in the treatment group after treatment were significantly higher than that in the control group（P〈 0.05）. Conclusion Calf Spleen Extractive Injection combined with gefitinib in treatment of advanced non-small cell lung cancer can reduce the level of tumor markers, improve immune function and the quality of life, which has a certain clinical application value.