贝伐单抗联合吉非替尼片治疗非小细胞肺癌的临床研究

Clinical trial of bevacizumab combined with gefitinib tablets in the treatment of non-small cell lung adenocarcinoma

目的观察贝伐单抗联合吉非替尼片治疗非小细胞肺癌的临床疗效和安全性。方法将90例非小细胞肺癌患者随机分为对照组45例和试验组45例。对照组予以吉非替尼250 mg,qd,口服;试验组在对照组治疗的基础上,予以贝伐单抗7.5 mg·kg^(-1),qd,静脉滴注。2组患者一个疗程均为21 d,共治疗3个疗程。观察2组患者的临床疗效、血管内皮细胞生长因子(VEGF)及其受体(KDR)、基质金属蛋白酶-9(MMP-9)、上皮型黏附素(E-cad)水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为77.78%(35/45例)和57.78%(26/45例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的VEGF分别为(0.76±0.08),(1.47±0.11);KDR分别为(0.65±0.13),(0.81±0.14);MMP-9分别为(0.87±0.15),(1.11±0.15);E-cad分别为(1.58±0.16),(1.32±0.14),差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要为皮疹、腹泻、头痛,对照组的药物不良反应主要为皮疹、腹泻,试验组和对照组的药物不良反应发生率分别为22.22%和15.56%,差异无统计学意义(P>0.05)。结论贝伐单抗联合吉非替尼片治疗非小细胞肺癌具有较好的临床疗效,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of bevacizumab combined with gefitinib tablets in the treatment of non - small cell lung adenocarcinoma. Methods Ninety patients with non -small cell lung adenocarcinoma were divided into control group （n = 45 cases） and treatment group（n =45 cases） according to random method. Control group was given oral gefitinib, 250 mg qd. Treatment group was given intravenous drip of bevacizumab 7.5 mg · kg^-1, qd, on the basis of control group. Two groups were treated for 3 cycles with 21 days per cycle. The clinical efficacy, the levels of vascular endothelial growth factor（VEGF） and its receptor（ KDR）, matrix metalloproteinase 9 （ MMP - 9 ） and epithelial type adhesive（ E - cad）, and the occurrence of adverse drug reactions were observed. Results After treatment, the total effective rates in treatment and control groups were 77.78% （ 35/45 cases） and 57.78% （26/45 cases） with statistically significant difference （ P 〈 0. 05 ）. Alter treatment, the main indexes in the treatment and control groups were compared ： the levels of VEGF were （ 0. 76 ± 0. 08 ） and （ 1.47 ± 0. 11 ）,KDR were （ 0. 65 ± 0.13 ） and（0.81 ±0.14）, MMP-9 were（0.87 ±0.15） and（1.11 ±0.15）, E-cad were （1.58 ±0. 16） and（ 1.32 ±0. 14） ,the differences were statistically signifieant（P 〈0. 05）. The adverse drug reactions were mainly skin rashes, diarrhea and headache in treatment group, which in control group were skin rashes and diarrhea. The incidences of adverse drug reactions were 22. 22% and 15.56% in treatment and control groups without significant difference（P 〉0. 05）. Conclusion Bevacizumab combined with gefitinib tablets has a definitive clinical efficacy in the treatment of non - small cell lung adenoearcinoma, without increasing the incidence of adverse drug reactions.