目的: 比较集采与原研替加环素治疗细菌性感染患者的有效性、安全性和经济性,为临床药物选择提供依据。方法: 回顾性收集三家医疗机构2019年7月—2023年7月使用集采与原研替加环素治疗的318例患者资料,其中原研组109例、集采组209例,采用倾向性评分匹配获得组间协变量均衡的2组样本,以临床有效率、28d死亡率、细菌学清除率和感染相关指标评估疗效,以不良反应发生率和不良事件异常率评估安全性,以最小成本分析法评价经济性。结果: 经过倾向性评分匹配后,集采与原研组各86例。集采与原研组的临床有效率、28d死亡率、细菌学清除率、WBC、NEUT、NEUT%、hsCRP/CRP、IL-6、PCT恢复效果无统计学差异(P>0.05);原研组体温恢复至正常范围的患者比例较集采组高(P<0.05)。集采与原研组不良反应发生率组间无统计学差异(P>0.05)。集采组凝血酶原时间延长的发生率高于原研组(P<0.05),其余不良事件相关指标异常发生率组间均无统计学意义(P>0.05)。最小成本法显示,集采组的替加环素费用、住院期间总抗菌药物费用、住院期间总药品费用及住院总费用低于原研组(P<0.01);且在敏感性分析的参数浮动范围内,与最小成本法分析结果一致。结论: 集采与原研替加环素抗细菌感染的疗效和安全性总体相似,集采较原研替加环素更具经济学优势。
Abstract
Objective: The paper compares the efficacy, safety and economics of centralized procurement and original tigecycline in the treatment of patients with bacterial infection to provide evidence for clinical drug selection. Methods: Data of 318 patients treated with centralized procurement (209 cases) and original (109 cases) tigacycline from 3 hospitals from July 2019 to July 2023 were retrospectively collected. The two groups of samples with balanced covariates were obtained by propensity score matching (PSM). The efficacy was evaluated by clinical effective rate, 28d mortality rate, bacteriological clearance rate and infection-related indicators, the safety was evaluated by the incidence of adverse reactions and abnormal rate of adverse events, and the economics was evaluated by the cost-minimization analysis. Results: After PSM, the centralized procurement group and the original group included 86 patients respectively. There was no significant difference in clinical effective rate, 28d mortality rate, bacteriological clearance rate, WBC, NEUT, NEUT%, hsCRP/CRP, IL-6 and PCT recovery between the two groups (P > 0.05). The proportion of patients whose body temperature returned to the normal range in the original group was higher than that in the centralized procurement group (P < 0.05). There was no statistically significant difference in the incidence of adverse reactions between the centralized procurement and original research groups (P>0.05). The incidence of PT extension in the centralized procurement group was higher than that in the original group (P<0.05), and there was no significant difference in the abnormal rate of other adverse event-related indicators between the groups (P>0.05). The cost-minimization analysis showed that the cost of tigacycline, total antibacterial drug cost, total drug cost and total hospitalization cost in the centralized procurement group were lower than those in the original group (P<0.01). Moreover, within the range of parameters for sensitivity analysis, the results were consistent with those of cost-minimization analysis. Conclusions: Centralized procurement and original tigecycline have similar efficacy and safety in the treatment of bacterial infection, and centralized procurement tigecycline has an economic advantage than original tigecycline.
关键词
替加环素 /
集中采购 /
真实世界数据
Key words
tigecycline /
centralized procurement /
real-world data
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参考文献
[1] 肖婷婷,肖永红.替加环素临床应用剖析[J].医药导报,2019,38(5):544-550.
[2] MEAGHER A K, AMBROSE P G, GRASELA T H,et al.The parmacokinetic and parmacodynamic pofile of tgecycline[J].Clinical infectious diseases,2005,41(Suppl 5):S333-S340.
[3] 冀希炜,马序竹,董晶,等.替加环素的药代动力学/药效学研究与临床应用[J].中国临床药理学杂志,2023,39(24):3674-3676.
[4] 朱曼,田小燕,郭代红,等.替加环素药源性肝损伤与胰腺炎的主动监测研究[J].中华医院感染学杂志,2017,27(20):4581-4583+4603.
[5] 邵华,吴鑫,陈浩,等.集中采购仿制药说明书一致性评价与风险评估[J].中国药学杂志,2022,57(20):1771-1775.
[6] 张焕,徐诺,徐敢,等.药品可及性视角下415种过评仿制药与基药、医保、集采目录的联动情况分析[J].中国药房,2022,33(6):661-665+705.
[7] 嵇金如,沈萍,魏泽庆,等.国产和进口替加环素体外抗菌活性比较[J].中国感染与化疗杂志,2015,15(4):330-334.
[8] 邱波,田延猛.进口与国产替加环素临床抗菌疗效对比[J].中国抗生素杂志,2022,47(12):1280-1284.
[9] 刘雨蒙,熊堉,胡琪,等.替加环素原研药和仿制药的有效性和安全性评价[J].中国医院药学杂志,2022,42(22):2378-2382.
[10] 《抗菌药物临床试验技术指导原则》写作组.抗菌药物临床试验技术指导原则[J].中国临床药理学杂志,2014,30(9):844-856.
[11] 梁虹艺,叶嘉盛,万宁,等.真实世界中国产与进口替加环素治疗泛耐药鲍曼不动杆菌感染的有效性、安全性、经济性研究[J].中国新药与临床杂志,2022,41(1):28-33.
[12] 周峰,吴小燕,郭晓辉.替加环素不良反应分析[J].医药导报,2019,38(6):807-810.
[13] 周煊平,任俊丽,鲁汝淇,等.替加环素致不良反应的国内外文献分析[J].中国医院用药评价与分析,2023,23(2):241-244.
[14] 徐银丽,祁慧,江翊国,等.替加环素治疗对重症患者凝血功能的影响[J].中国药物应用与监测,2020,17(1):6-9.
[15] 王敏,杨娜,罗雪梅,等.重症患者替加环素血药浓度与凝血指标相关性研究[J].中国药师,2021,24(11):2058-2061.
[16] 孙哲,杨文娟,王瑞麟,等.基于回顾性队列的阿托伐他汀钙仿制药与原研药安全性和经济性评价及危险因素评估[J].中国医院药学杂志,2022,42(14):1447-1451.
[17] 边妍,潘芸芸,陈吉生.硫酸氢氯吡格雷片仿制药对比原研药治疗冠心病的疗效、安全性与经济性的系统评价[J].中国药房,2018,29(21):2980-2984.
[18] 宋沧桑,邓雨琴,刘璐,等.基于多中心真实世界数据的集采注射用头孢曲松治疗细菌性感染的临床综合评价[J].中国医院药学志,2024,44(5):585-590+597.
基金
云南省卫生健康委员会“临床药学中心建设项目” 云南省卫生健康委员会“医学领军人才培养计划项目”(L-2018012); 昆明市卫生健康委员会卫生科研课题项目“基于多中心真实世界数据的原研药与仿制药注射用替加环素临床综合评价” (2022-13-01-013)