基于药品说明书的单克隆抗体药物输液器具的选择分析与建议 点击下载
| 论文标题： | 基于药品说明书的单克隆抗体药物输液器具的选择分析与建议 |
| 英文标题： | |
| 中文摘要： | 目的 调查国内在售临床常用静脉输注用单克隆抗体（单抗）药物说明书对输液器具的要求，为临床合理选择该类药物的输液器具提供参考。方法检索国家药品监督管理局官网“药品查询”中“境内生产药品“”境外生产药品”及丁香园“用药助手”数据库，收集截至2025年11月国内在售且具有静脉输注器具要求的单抗药物说明书，提取输液器具材质、过滤器孔径与材质等相关要求，进行分类统计并分析。结果纳入了55种静脉输注用单抗药物，包括抗肿瘤药物45种（81.82%）、免疫调节药物5种（9.09%）、其他疾病治疗药物5种（9.09%）。44种药物（80.00%）说明书对输液器具的过滤器孔径有明确要求，其中36种（65.45%）要求孔径为0.2μm或0.22μm；16种药物（29.09%）说明书明确了过滤器材质，均推荐聚醚砜；25种药物（45.45%）明确了输液器具材质，主要为聚氯乙烯、聚乙烯或聚丙烯。结论不同单抗药物对输液器具的要求差异集中于材质相容性与过滤器孔径两个方面，临床选择时应以药品说明书为依据，遵循“相容性优先、过滤器适度、系统整合”的原则，并通过有关输液器具要求的速查手册制定与审方调配系统嵌入实现标准化管理。 |
| 英文摘要： | OBJECTIVE To investigate the requirements for infusion sets specified in the package inserts of monoclonal antibody drugs commonly used for intravenous infusion in China， and to provide a reference for the rational selection of infusion sets for this class of drugs in clinical practice. METHODS The “Drug Query” section of the official website of the National Medical Products Administration， including the “Domestically Manufactured Drugs” and “Overseas Manufactured Drugs” databases， as well as the DXY “Yongyao Zhushou” database， were searched to collect the package inserts of monoclonal antibody drugs available on the domestic market as of November 2025 that had requirements for intravenous infusion sets. Relevant requirements for infusion set materials， filter pore size， and filter materials were extracted， classified， and analyzed. RESULTS A total of 55 monoclonal antibody drugs for intravenous infusion were included， comprising 45 anticancer drugs （81.82%）， 5 immunomodulatory drugs （9.09%）， and 5 drugs for other diseases （9.09%）. The package inserts of 44 drugs （80.00%） had clear requirements for the filter pore size of infusion sets， of which 36 drugs （65.45%） required a pore size of 0.2 μm or 0.22 μm. The package inserts of 16 drugs （29.09%） specified the filter material， all of which recommended polyethersulfone. The package inserts of 25 drugs （45.45%） specified the infusion set material， primarily polyvinyl chloride， polyethylene， or polypropylene. CONCLUSIONS The requirements for infusion sets vary among different monoclonal antibody drugs， with differences mainly concentrated in two aspects： material compatibility and filter pore size. In clinical practice， the selection should be based on the drug package inserts， following the principles of “compatibility first， appropriate filtration， and system integration”， and standardized management should be achieved through the development of quick-reference manuals specifically addressing the requirements for infusion sets and the integration of relevant requirements into the prescription review and dispensing systems. |
| 期刊： | 2026年第37卷第15期 |
| 作者： | 王竹青；武丹威；任爽；杨雅麟；张威 |
| 英文作者： | WANG Zhuqing，WU Danwei，REN Shuang，YANG Yalin，ZHANG Wei |
| 关键字： | 单克隆抗体；输液器具；过滤器；材质；孔径；药品说明书 |
| KEYWORDS： | monoclonal antibody； infusion set； filter； material； pore size； package insert |
| 总下载数： | 81次 |
| 本日下载数： | 2次 |
| 本月下载数： | 81次 |
| 文件大小： | 619.60Kb |
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