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

发布时间：2018-07-07 14:32

本文选题：康莱特注射液 + 注射用盐酸吉西他滨　；参考：《中国临床药理学杂志》2017年23期

【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(P0.05)。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(P0.05)。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P0.05)。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(P0.05)。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。
[Abstract]:Objective to observe the efficacy and safety of Kanglaite injection in the treatment of advanced non-small cell lung cancer (NSCLC) with gemcitabine cisplatin (GP) regimen. Methods 72 patients with advanced NSCLC were randomly divided into trial group and control group with 36 cases in each group. The control group was treated with GP regimen (gemcitabine 1250 mg m-2, cisplatin 75 mg m-2), and the experimental group was treated with Kanglaite injection 60 mL. Double antibody sandwich enzyme linked immunosorbent assay (Elisa) was used to detect vascular endothelial growth factor (VEGF), tumor suppressor gene p53 (p53) and anti-survivin antibody. The quality of life (QOL) was evaluated according to Karnofsky score. The clinical efficacy and adverse drug reaction (ADR) were observed. Results after treatment, the total effective rate of the trial group was 91.67% (33 / 36 cases), which was significantly higher than that of the control group (69.44%) (25 / 36 cases). The difference was statistically significant (P0.05). The improvement rate of quality of life in the trial group was significantly higher than that in the control group [63.89% (23 / 36 cases) vs 19.44% (7 / 36 cases)], the difference was statistically significant (P0.05). After treatment, the levels of anti-survivin antibody and anti-survivin antibody were (112.57 卤10.84), (, 143.60 卤10.90) ng L-1 and (2.82 卤0.25), (, 3.31 卤0.24) U mL ~ (-1), respectively (P0.05). The total ADR of experimental group and control group were 11.11% (4 / 36 cases) and 36.11% (13 / 36 cases) respectively, which were significantly lower than that of control group (P0.05). Conclusion Kanglaite injection can effectively reduce the serum levels of VEGF p53 and anti survivin antibody in patients with advanced NSCLC treated with GP regimen. The clinical efficacy of Kanglaite injection is better than that of GP regimen.
【作者单位】：南阳市中心医院肿瘤科;南阳市中心医院药学室;
【基金】：国家自然科学基金资助项目(81172217)
【分类号】：R734.2

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