中标与原研盐酸莫西沙星片治疗门诊社区获得性肺炎的有效性、安全性与经济性比较  

Comparison of efficacy,safety and economics of bid-winning and original Moxifloxacin hydrochloride tablets in the treatment of outpatient community-acquired pneumonia

作　　者：庞婕[1,2] 吴晓雯 李春华 金泰宇[4] 游维丽[1] PANG Jie;WU Xiaowen;LI Chunhua;JIN Taiyu;YOU Weili(Dept.of Pharmacy,Lianyungang First People’s Hospital,Jiangsu Lianyungang 222023,China;Dept.of Pharmacy,the First Affiliated Hospital of Kangda College of Nanjing Medical University,Jiangsu Lianyungang 222023,China;Dept.of Respiratory and Critical Care Medicine,Lianyungang First People’s Hospital,Jiangsu Lianyungang 222023,China;Dept.of Pharmacy,Lianyungang Second People’s Hospital,Jiangsu Lianyungang 222023,China)

机构地区：[1]连云港市第一人民医院药学部,江苏连云港222023 [2]南京医科大学康达学院第一附属医院药学部,江苏连云港222023 [3]连云港市第一人民医院呼吸与危重症医学科,江苏连云港222023 [4]连云港市第二人民医院药学部,江苏连云港222023

出　　处：《中国药房》2023年第2期200-204,共5页China Pharmacy

基　　金：江苏省药学会-天晴医院药学研究项目(No.Q202047)。

摘　　要：目的比较中标和原研盐酸莫西沙星片治疗门诊社区获得性肺炎(CAP)的有效性、安全性和经济性。方法采用回顾性队列研究,筛选并纳入2021年1-12月在江苏省连云港市第一人民医院门诊治疗的CAP患者,根据其所用药品来源分为原研药组(1058例)和中标药组(1121例)。2组患者分别口服原研盐酸莫西沙星片和中标盐酸莫西沙星片,每次0.4 g,每天1次。比较2组患者的有效性指标(临床治疗有效率、缓解时间、用药疗程、再次就诊率)和安全性指标(变态反应、神经系统反应等不良反应发生情况),并采用多因素修正Poisson回归模型分析临床治疗失败的影响因素;比较2种药物的经济性指标[使用数量、销售金额、用药频度(DDDs)、日均费用(DDDc)、价格比、中标药替代率]。结果2组患者的临床治疗有效率、用药疗程、再次就诊率和神经系统反应、Q-T间期延长的发生率比较差异均无统计学意义(P>0.05);原研药组患者的缓解时间显著短于中标药组,其总药品不良反应、变态反应、消化系统反应和血糖异常的发生率均显著低于中标药组(P<0.05)。多因素Poisson回归分析显示,使用中标药不会增加门诊CAP患者临床治疗失败风险[风险比=1.132,95%置信区间(0.883,1.542),P=0.327],但有抗菌药物暴露史、临床表现异常项目或辅助检查异常项目≥2项均会增加临床治疗失败风险(P<0.05)。与实施集中带量采购政策前比较,实施集中带量采购政策后,盐酸莫西沙星片的使用数量和DDDs明显增加,销售金额明显下降;中标药的DDDc明显下降,与原研药的价格比降至0.117,替代率升至69.44%。结论与原研药物相比,中标盐酸莫西沙星片治疗门诊CAP的临床疗效可靠,且具有明显的价格优势,但不良反应发生率较高。OBJECTIVE To compare the efficacy,safety and economics of bid-winning and original Moxifloxacin hydrochloride tablets in the treatment of outpatient community-acquired pneumonia(CAP).METHODS A retrospective cohort study was conducted to screen and include CAP outpatients during the period of January to December 2021 in Lianyungang First People’s Hospital.They were divided into generic drug group(1058 cases)and bid-winning drug group(1121 cases)according to the drug source.Two groups were respectively given original and bid-winning Moxifloxacin hydrochloride tablets,0.4 g each time,once a day.The efficacy indexes(clinical effective rate,remission time,treatment course,revisiting rate)and safety indexes(allergy,nervous system symptoms,etc.)were compared between the two groups;and the influence factors of clinical treatment failure were analyzed with multi-factor modified Poisson regression model.The economic indicators of the two drugs[quantity,consumption sum,defined daily doses(DDDs),defined daily dose cost(DDDc),price ratio,replacement rate]were compared.RESULTS There were no significant differences in the clinical effective rate,treatment course,revisiting rate,the incidence of nervous system symptoms and Q-T interval prolongation between the two groups(P>0.05).The remission time of original drug group was significantly shorter than that of bid-winning drug group,and the incidence of total adverse drug reaction,allergy reaction,gastrointestinal symptom reaction and hyperglycemia were significantly lower than those in bid-winning drug group(P<0.05).Multivariate Poisson regression analysis showed that bid-winning drug did not increase the risk of clinical treatment failure in CAP outpatients[RR=1.132,95%CI(0.883,1.542),P=0.327].However,antibiotic exposure history,more than 2 items of abnormal clinical manifestations and auxiliary examination all increased the risk of clinical treatment failure(P<0.05).Compared with before the implementation of centralized volume-based procurement policy,the quantity and DDDs of

关 键 词：社区获得性肺炎 门诊 盐酸莫西沙星片 仿制药 原研药 药品集中带量采购 

分 类 号：R978.1[医药卫生—药品] R563.1[医药卫生—药学]