Clinical trial of gefitinib tablets combination with Aidi injection in the treatment of non-small cell lung cancer in elderly patients
10.13699/j.cnki.1001-6821.2017.20.005
- VernacularTitle:吉非替尼片联合艾迪注射液治疗老年非小细胞肺癌的临床研究
- Author:
Jin-Lan HOU
1
;
Wen-Yan ZHANG
;
Ying-Yu LIU
Author Information
1. 唐山市工人医院呼吸内科
- Keywords:
gefitinib;
Aidi injection;
non-small cell lung cancer
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(20):2013-2015,2019
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of gefitinib tablets combined with Aidi injection in the treatment of non-small cell lung cancer in the elderly patients.Methods A total of 108 elderly patients with non-small cell lung cancer were randamly divided into the control group and the treatment group,with 54 cases in each group.Patients in the both groups were given regular treatment and limited lung resection.Before operation,patients in the control group were given 250 mg gefitinib once daily.On the basis of control group,patients in the treatment group were given additional 60 mL Aidi injection + 450 mL 0.9％ sodium chloride injection once daily.Both groups were treated for 10 d.After operation,patients in the two groups were treated with 500 mL 5％ glucose injection + 60 mg · m-2 paclitaxel injection via intravenous drip at the first day of every cycle,a week as a course treatment,all the patients were treated for 4 cycle.The clinical efficacy,levels of serum tumor antigen (CEA),cell keratin 21 fragment (CYFRA21-1),neuron specific enzyme (NSE),vascular endothelial growth factor (VEGF),and phosphorylated extracellular signal regulated kinase (P-ERK) and adverse drug reactions were compared between the two groups.Results After treatment the clinical efficacy in treatment group and control group were 64.82％ (21 cases/54 cases) and 38.89％ (35 cases/54 cases),respectively,and there was statistically significant difference (P ＜ 0.05).After treatment,the serum level of CEA in treatment group and control group were (97.37 ± 10.05),(120.58 ± 12.96) ng·mL-1,CYFRA21-1 were (90.37±10.47),(107.58 ± 12.11) ng · mL-1;NSE were (7.02 ±0.81),(8.55±1.13)ng · mL-1;p-ERK were (0.95 ±0.11),(1.73 ±0.15)1μg · mL-1,respectively,VEGF were (5.77 ± 0.72),(15.47 ± 1.86) ng · mL-1,respectively,there were statistically significant differences (P ＜ 0.05).The adverse drug reactions in treatment group were rash (1 case),dry skin (1 case),acne(1 case) and diarrhea (1 case);the adverse drug reactions in control group were rash (2 cases),acne(2 cases),dry skin (1 case) and diarrhea(1 case),the adverse drug reaction rates in the treatment and the control group were 7.41％ (4 cases/54 cases) and 11.11％ (6 cases/54 cases),respectively,there was no statistically significant different between the two groups (P ＞ 0.05).Conclusion Gefitinib in combination with Aidi injection exerted high efficacy in the treatment of non small cell lung cancer in elderly patients and with high safety.
