国产与进口盐酸吉西他滨的疗效对比研究  

Comparative study on the curative effect and adverse reaction between domestic and imported gemcitabine hydrochloride

作　　者：吴伟文[1] 陈友华[1] 余伟标[1] 

机构地区：[1]佛山市顺德区第一人民医院,广东佛山528300

出　　处：《现代医药卫生》2005年第13期1641-1643,共3页Journal of Modern Medicine & Health

摘　　要：目的:评价国产药与进口药盐酸吉西他滨治疗非小细胞肺癌(NSCLC)的疗效、安全性及不良反应。方法:我院肿瘤内科住院患者有明确组织学或细胞学证实的,不能手术切除的晚期NSCLC患者中,选择无化疗禁忌证,预计生存3个月以上,并同意全身化疗及随访的70例患者,随机分为两组,A组用国产吉西他滨联合顺铂或卡铂化疗,B组用进口吉西他滨联合顺铂或卡铂化疗,每例患者化疗2～4周期,定期复查血象、肝肾功能、影象学检查等指标,并进行临床观察与随访。结果:入组70例中,可评价的66例,A组34例中,9例(26.5%)达到PR;B组32例中,8例(25.0%)达到PR,两组间疗效差异无显著性。第二周期后,有66例参与不良反应评估,两组之间不良反应的发生率差异无显著性。结论:国产盐酸吉他西滨是治疗晚期NSCLC的有效药物,使用安全,联合顺铂的疗效及不良反应与进口盐酸吉西他滨联合顺铂用药相近。Objective:To evaluate the curative effect,safety and adverse reaction of domestic and imported gemcitabine hydrochloride in non-small cell lung cancer(NSCLC).Methods:70patients with advanced NSCLC documented by histology and cytology in our department were unable to receive operative treatment,expected to survive for over3months and willing to accept chemical therapy and follow-up without chemotherapeutic contraindication,and divided into two groups randomly.Group A was used with domestic gemcitabine combined with cisplatin or carboplatin,while group B with imported gemcitabine combined with cisplatin or carboplatin,while group B with imported gemcitabine combined with cisplatin or carboplatin,Each patient was performed chemical therapy for2～4weeks.The blood picture,liver and kidney functions and raˉdiology were examined periodicly.The clinical observation and follow-up were performed.Results:Of70patients with advanced NSCLC,66could be evaluated,9of34patients in group A obtained partial remission(PR),occupying26.5%,8of32patients in group B abtained PR,occupying25%,with a significant difference between two group.The adverse reaction was evaluated in66cases after the second period,without significant difference between two group.Conclusion:Domestic gemcitabine hydrochloride is a kind of effective and safe medicine for advanced NSCLC,the curative effect and adverse reaction of domestic gemcitabine hydromchloride combined with cisplatin are similar to those of imported one combined with cisplatin.

关 键 词：抗肿瘤药 脱氧胞苷 肺肿瘤 国产药物 进口药物 盐酸吉西他滨 

分 类 号：R979.1[医药卫生—药品]