摘要
目的 比较阿扎胞苷集采中选仿制药与原研药的疗效与安全性。方法 通过医院电子病历系统调取数据,收集2019年1月1日至2022年3月31日首都医科大学宣武医院、皖南医学院弋矶山医院和云南省肿瘤医院使用阿扎胞苷的住院患者信息,包括基本信息、疾病信息和用药信息。将患者分为原研药组和仿制药组,比较2组患者的基本情况,使用含阿扎胞苷化疗方案的治疗缓解情况及不良反应发生情况。结果 纳入阿扎胞苷仿制药(厂家1)组(仿制药1组)55例患者,原研药组53例患者。2组患者性别、年龄、身高、体质量、医保类型、吸烟史、饮酒史、肿瘤家族史、治疗疾病、疾病分型及合并慢性病情况比较差异均无统计学意义(P>0.05)。纳入阿扎胞苷仿制药(厂家2)组(仿制药2组)38例患者,与原研药组经倾向性评分匹配后基线情况差异均无统计学意义(P>0.05)。仿制药组与原研药组含阿扎胞苷治疗方案的骨髓抑制、继发感染、胃肠道反应、肝功能损伤、发热、乏力不良反应发生率差异均无统计学意义(P>0.05)。仿制药组与原研药组2个疗程内治疗缓解率相比差异无统计学意义(P>0.05)。结论 阿扎胞苷集采中选仿制药与原研药的疗效与安全性没有明显差异。
Objective To compare the efficacy and safety between generic in volume-based procurementand and original drug.Methods Data were collected from the hospital electronic medical record system,and the information of inpatients using azacitidine in Xuanwu Hospital of Capital Medical University,Yijishan Hospital of Wannan Medical College and Yunnan Cancer Hospital from January 1,2019 to March 31,2022 were collected,including basic information,disease and medication information.The patients were divided into the original drug group and the generic drug group.The basic information,treatment remission and adverse reactions of patients using azacitidine-containing chemotherapy regimen were compared.Results There were 55 patients in the generic drug(manufacturer 1)group and 53 patients in the original drug group.There were no significant differences in gender,age,height,weight,type of medical insurance,smoking,drinking,family history of cancer,treated diseases,disease classification and chronic diseases between the two groups(P>0.05).A total of 38 patients in the generic drug(manufacturer 2)group were included,and there was no significant difference in the baseline between the two groups after propensity score matching (P>0.05).There was no significant difference in the incidence of myelosuppression, secondary infection, gastrointestinal reaction, liver function injury, fever and fatigue between the original drug groupand the generic drug group (P>0.05).There was no significant difference in the response rate within 2 courses of treatment between the generic drug group and the original drug group (all P>0.05).Conclusion There is no significant difference in efficacy and safety between the selected generic azacitidine and the original azacitidine.
作者
王可
董宪喆
冯英楠
王之舟
庄伟
栾家杰
孔树佳
岳小林
张兰
WANG Ke;DONG Xian-zhe;FENG Ying-nan;WANG Zhi-zhou;ZHUANG Wei;LUAN Jia-jie;KONG Shu-jia;YUE Xiao-lin;ZHANG Lan(Department of Pharmacy,Xuanwu Hospital,Capital Medical University,National Clinical Research Center for Geriatric Diseases,Beijing 100053,China;Department of Pharmacy,Yijishan Hospital,Wannan Medical College,Anhui Wuhu 241001,China;Department of Pharmacy,Yunnan Cancer Hospital(the Third Affiliated Hospital of Kunming Medical University),Kunming 650118,China)
出处
《临床药物治疗杂志》
2023年第3期28-33,共6页
Clinical Medication Journal
基金
国家医疗保障局委托项目(JCS-ZCHT-2021-007)
2022年度科技智库青年人才计划(20220615ZZ07110070)
北京市医院管理中心“登峰”计划专项项目(DFL20190803)。
关键词
阿扎胞苷
仿制药
原研药
疗效
安全性
集中带量采购
azacitidine
generic drug
original drug
efficacy
safety
volume-based procurement
