康莱特注射液用于吉西他滨联合顺铂方案化疗晚期非小细胞肺癌的临床研究  

Clinical trial of Kanglaite injection in gemcitabine combined cisplatin regimen chemotherapy for advanced non-small cell lung cancer

作　　者：王媛[1] 惠双[1] 李敏[2] 张成辉[1] 

机构地区：[1]南阳市中心医院肿瘤科,河南南阳473009 [2]南阳市中心医院药学室,河南南阳473009

出　　处：《中国临床药理学杂志》2017年第23期2354-2356,2360,共4页The Chinese Journal of Clinical Pharmacology

基　　金：国家自然科学基金资助项目(81172217)

摘　　要：目的观察康莱特注射液用于吉西他滨+顺铂(GP)方案化疗晚期非小细胞肺癌(NSCLC)的临床疗效与安全性。方法将72例晚期NSCLC患者随机分为试验组和对照组,每组36例。对照组用GP方案(吉西他滨1250 mg·m-2+顺铂75 mg·m-2)完成化疗,试验组在此基础上加康莱特注射液60 m L完成治疗。以双抗体夹心酶联免疫吸附法检测血管内皮生长因子(VEGF)、抑癌基因p53(P53)与抗Survivin抗体,根据Karnofsky评分评价患者生活质量。观察2组的临床疗效与药物不良反应(ADR)。结果治疗后,试验组的总有效率为91.67%(33例/36例),显著高于对照组的69.44%(25例/36例),差异有统计学意义(P<0.05)。试验组的生活质量好转率显著高于对照组[63.89%(23例/36例)比19.44%(7例/36例)],差异有统计学意义(P<0.05)。治疗后,试验组和对照组患者的VEGF分别为(112.57±10.84),(143.60±10.90)ng·L^(-1);P53分别为(2.82±0.25),(3.31±0.24)U·m L^(-1);抗Survivin抗体水平分别为(2.17±0.19),(3.15±0.30)U·m L^(-1),差异均有统计学意义(均P<0.05)。试验组和对照组的总ADR分别为11.11%(4例/36例)和36.11%(13例/36例),试验组明显低于对照组,组间比较差异有统计学意义(P<0.05)。结论康莱特注射液用于GP方案化疗晚期NSCLC患者中,能有效降低患者血清VEGF、P53与抗Survivin抗体水平,临床疗效良好,安全性较优于GP方案。Objective To observe the clinical efficacy and safety of Kanglaite injection with gemcitabine combined cisplatin（ GP） regimen in the treatment of advanced non-small cell carcinoma（ NSCLC）.Methods A total of 72 patients with NSCLC enrolled in our hospital from January 2013 to January 2015,were divided into treatment group and control group according to the order of admission. The control group was treated with GP regimen（ 1250 mg·m-2 gemcitabine ＋ 75 mg·m-2 cisplatin）,the treatment group was treated with Kanglaite injection 60 m L on the basis of control group. The levels of vascular endothelial growth factor（ VEGF）,tumor suppressor gene p53（ P53） antibody,anti-survivin antibody were determined by double antibody sandwich enzyme-linked immunosorbent assay. The quality life of patients wasevaluated by the Karnofsky score. The clinical efficacy and adverse drugs reaction were investigated. Results After treatment,the total effective rate of the treatment group was significantly higher than that of control group [91. 67%（ 33 cases/36 cases） vs 69. 44%（ 25 cases/36 cases）,P〈0. 05]. The improvement rate of quality of life in the treatment group was higher than the control group [63. 89%（ 23 cases/36 cases） vs 19. 44%（ 7 cases/36 cases） ],significantly（ P〈0. 05）. The levels of VEGF,P53 and anti-Survivin in the treatment group were significantly lower than those of control group [（ 112. 57 ± 10. 84）,（ 143. 60 ± 10. 90） ng · L-1;（ 2. 82 ± 0. 25）,（ 3. 31 ± 0. 24）U·m L-1;（ 2. 17 ± 0. 19）,（ 3. 15 ± 0. 30） U·m L-1]（ all P〈0. 05）. The toxicity rate of the treatment group was lower than that of control group [11. 11%（ 4 cases/36 cases） vs 36. 11%（ 13 cases/36 cases） ] with significant difference（ P〈0. 05）. Conclusion Kanglaite injection can decrease the serum levels of VEGF, P53 and anti-Survivin antibody in patients with advanced NSCLC,which has good clinical curative effect and safety.

关 键 词：康莱特注射液 注射用盐酸吉西他滨 吉西他滨+顺铂方案 非小细胞肺癌 

分 类 号：R979.1[医药卫生—药品]