Page 69 - 《中国药房》2024年7期

伏立康唑原研药与仿制药的有效性、安全性及经济性评价
Δ

＊
唐甘翎 ，谢祥威，罗鲜丹，陆艳丽，蒋慧娴，李静怡，黄肖曼，张宏亮（广西医科大学第一附属医院药学部，南宁
#
530021）

中图分类号 R978.5 文献标志码 A 文章编号 1001-0408（2024）07-0831-06
DOI 10.6039/j.issn.1001-0408.2024.07.11

摘 要 目的 评价伏立康唑仿制药与原研药的有效性、安全性和经济性。方法 收集本院使用集采中选伏立康唑仿制药（仿制药
组）或非中选原研药（原研药组）治疗真菌感染的患者信息。采用倾向性得分匹配消除偏倚。通过临床疗效、影像学表现和微生物
试验评估综合疗效，根据感染真菌菌种、基础疾病等对不同人群进行分层并评估不同分层的疗效；使用药物不良反应发生情况评
价安全性；采用总费用和药品的用药频度、日均费用等评估经济性。结果 有436例患者被纳入，经匹配后，两组各有190例。在有
效性方面，伏立康唑仿制药和原研药的有效率分别为62.63%和59.47%（P＝0.528）。在安全性方面，伏立康唑仿制药和原研药的不
良反应发生率分别为 13.68% 和 7.89%（P＝0.069）。在经济性方面，伏立康唑仿制药平均总费用 4 636.26 元，原研药平均总费用
8 613.20元（P＜0.001）；仿制药在集采实施后药品替换率上升至87.30%，日均费用下降59.08%。结论 伏立康唑仿制药在治疗真
菌感染的有效性和安全性与原研药相似，且在治疗成本方面经济性更佳。
关键词 伏立康唑；国家药品集中采购；倾向性得分匹配；真实世界

Efficacy， safety and cost-effectiveness evaluation of voriconazole original and generic drugs
TANG Ganling，XIE Xiangwei，LUO Xiandan，LU Yanli，JIANG Huixian，LI Jingyi，HUANG Xiaoman，ZHANG
Hongliang（Dept. of Pharmacy， the First Affiliated Hospital of Guangxi Medical University， Nanning 530021，
China）

ABSTRACT OBJECTIVE To evaluate the efficacy， safety and cost-effectiveness of generic drugs and original drugs of
voriconazole. METHODS The information of patients who used voriconazole generic drugs selected in National Centralized Drug
Procurement （generic drug group） or non-selected original drugs （original drug group） in the treatment of fungal infection was
collected from the our hospital. The propensity score matching was carried out to eliminate bias. The comprehensive efficacy was
evaluated according to clinical efficacy， image findings and microbiological test， and stratified analysis of different populations was
conducted based on fungal species， underlying diseases， etc.， the efficacy of different stratifications was evaluated. Evaluation of
safety was performed by using the incidence of adverse reactions. The total cost， defined daily doses （DDDs） and defined daily
dose cost （DDDc） were used to evaluate the cost-effectiveness. RESULTS A total of 436 patients were included， and there were
190 patients in each group after matching. In terms of efficacy， the effective rates of voriconazole generic drugs and original drugs
were 62.63% and 59.47% （P＝0.528）； in terms of safety， the incidence of adverse reactions caused by generic drugs and original
drugs of voriconazole was 13.68% and 7.89%， respectively（P＝0.069）. In terms of cost-effectiveness， the average total cost of
generic drugs was 4 636.26 yuan， and that of original drugs was 8 613.20 yuan （P＜0.001）. After the implementation of National
Centralized Drug Procurement， replacement rate of generic drugs increased to 87.30%， and DDDc decreased by 59.08%.
CONCLUSIONS The efficacy and safety of voriconazole generic drugs are similar to those of original drugs in the treatment of
fungal infection， and it is more cost-effective in terms of treatment cost.
KEYWORDS voriconazole； National Centralized Drug Procurement； propensity score matching； real-world

2019年初，“4+7”城市根据国务院办公厅印发的《国
Δ 基金项目 国家卫生健康委医院管理研究所医疗质量（循证）管
家组织药品集中采购和使用试点方案》开展了药品采购
理研究项目（No.YLZLXZ23K004）；广西壮族自治区卫生健康委自筹
经费科研课题（No.Z-A20230477） 试点工作。政府通过“以量换价”为人民群众减轻经济
＊ 第一作者 硕 士 研 究 生 。 研 究 方 向 ：临 床 药 学 。 E-mail： 负担，制药企业借此政策获取大量市场份额提升了市场
18211392699@163.com [1]
影响力，二者实现双赢的局面 。
# 通信作者 副主任药师，硕士生导师，博士。研究方向：临床药
学、循证药学。E-mail：277749097@qq.com 药品在参加国家集中带量采购（后简称“集采”）前

中国药房 2024年第35卷第7期 China Pharmacy 2024 Vol. 35 No. 7 · 831 ·