注射用头孢曲松钠集采中选仿制药与原研药有效性、安全性的真实世界研究  

Real-world study of effectiveness and safety between generic involume-based purchasing and patent drug ceftriaxone sodium for injection

作　　者：马雯雯 杨蕊[2] 杨依磊 衣巧艳 劳家辉 曹佳 黄欣 MA Wenwen;YANG Rui;YANG Yilei;YI Qiaoyan;LAO Jiahui;CAO Jia;HUANG Xin(School of Pharmacy,Shandong University of Traditional Chinese Medicine,Shandong Jinan 250355,China;Department of Clinical Pharmacy,First Affiliated Hospital,Shandong First Medical University&Shandong Provincial Qianfoshan Hospital,Shandong Engineering and Technology Research Center for Pediatric Drug Development,Shandong Medicine and Health Key Laboratory of Clinical Pharmacy,Shandong Jinan 250014,China;Center for Big Data Research in Health and Medicine,First Affiliated Hospital,Shandong First Medical University,Shandong Jinan 250014,China)

机构地区：[1]山东中医药大学药学院,山东济南250355 [2]山东第一医科大学第一附属医院/山东省千佛山医院临床药学,山东省儿童药物临床评价与研发工程技术研究中心,山东省医药卫生临床药学重点实验室,山东济南250014 [3]山东第一医科大学第一附属医院健康医疗大数据研究中心,山东济南250014

出　　处：《中国医院药学杂志》2024年第24期2892-2898,共7页Chinese Journal of Hospital Pharmacy

基　　金：山东省药品临床综合评价项目(编号:2022YZ030)。

摘　　要：目的:比较注射用头孢曲松钠集采中选仿制药与原研药的有效性和安全性,为临床实践提供参考。方法:将使用注射用头孢曲松钠的住院感染患者纳入回顾性队列研究,考察仿制药组和原研药组在安全性(肝功能异常、肾功能异常、血常规异常、过敏反应、胃肠道不适)和有效性(临床有效率、死亡率、放弃治疗率和细菌清除率)方面的差异,其中有效性考察分肺部感染、腹腔感染和中枢感染3个亚组,并采用单因素分析和多因素logistic回归模型分析其安全性、有效性的影响因素。结果:与原研药组相比,仿制药组患者同时发生肝功能、肾功能和血常规异常的比例、合用平衡肠道菌群药物比例更低(P<0.05),合用抗过敏药物比例更高(P<0.05);有效性方面,仿制药组患者3种感染的细菌清除率低于原研药组(P<0.05),而临床有效率、死亡率和放弃治疗率两组间差异均无统计学意义(P>0.05)。单因素与多因素logistic回归分析结果显示,年龄(OR=1.010,P=0.014)、住院时间(OR=1.020,P=0.024)、头孢曲松钠用药时间(OR=1.104,P<0.01)、伴随恶性肿瘤(OR=1.470,P=0.023)、伴随慢性肝病(OR=2.581,P<0.01)、使用原研品种(OR=1.595,P=0.011)是不良反应发生的风险因素;头孢曲松钠用药时间与临床有效独立相关。结论:使用头孢曲松钠仿制药患者同时发生肝功能、肾功能和血常规异常的比例低于使用原研药的患者,3种感染的细菌清除率低于原研药,临床有效率、死亡率和放弃治疗率方面两者相当;保证充足的抗感染疗程、腹腔感染时联合抗厌氧菌药物是临床有效的有利因素。OBJECTIVE To compare the effectiveness and safety between generic in volume-based purchasing and patent drug ceftriaxone sodium for injection and provide references for clinical practices.METHODS Inpatients with infections using ceftriaxone sodium for injection were included into this retrospective cohort study.The differences of safety(abnormalities in liver function,abnormalities in renal function,abnormalities in blood routine examination,allergic reactions&gastrointestinal disturbances)and effectiveness(clinical efficacy rate,mortality rate,treatment abandonment rate&bacterial clearance rate)were compared between generic drug and patent drug groups.There were three subgroups of lung infection,abdominal infection and central infection for effectiveness.Univariate and multi-factor COX regression analyses were utilized for examining the influencing factors on safety and effectiveness.RESULTS As compared with patent drug group,the proportion of simultaneous abnormalities for liver function,renal function and blood routine,the proportion of co-administered drugs for balancing intestinal flora were lower in generic group(P<0.05)and the proportion of co-administered anti-allergic drugs was higher(P<0.05);in terms of effectiveness,bacterial clearance rate of three infections types were lower in generic drug group than that in patent drug group(P<0.05).Clinical effectiveness rate,mortality rate and treatment abandonment rate were not statistically different between two groups(P>0.05).The results of univariate and multivariate Logistic regression analysis indicated that age(OR=1.010,P=0.014),length of stay(OR=1.020,P=0.024),duration of ceftriaxone sodium(OR=1.104,P<0.01),concurrent malignant tumors(OR=1.470,P=0.023),concurrent chronic liver disease(OR=2.581,P<0.01)and use of patent drug(OR=1.595,P=0.011)were risk factors for the occurrence of adverse reactions.Duration of ceftriaxone sodium was independently associated with clinical effectiveness.CONCLUSION Generic drug of ceftriaxone sodium has a lower incidence for s

关 键 词：仿制药 原研药 注射用头孢曲松钠 有效性 安全性 

分 类 号：R969[医药卫生—药理学]