含药用辅料右旋糖酐40的注射剂临床用药安全风险  

Clinical safety risks of the injections containing the pharmaceutical excipient dextran 40

作　　者：张泰 吴强[1] 王锦 张云丽 Zhang Tai;Wu Qiang;Wang Jin;Zhang Yunli(Department of Pharmacy,Women and Children’s Hospital,Qingdao University,Shandong Province,Qingdao 266034,China;Department of Pharmacy,Qingdao Hospital of Traditional Chinese Medicine,Shandong Province,Qingdao 266033,China)

机构地区：[1]青岛大学附属妇女儿童医院药学部,青岛266034 [2]青岛市中医医院药学部,青岛266033

出　　处：《药物不良反应杂志》2024年第4期234-237,共4页Adverse Drug Reactions Journal

摘　　要：右旋糖酐40是一种常用的药用辅料,可作为粉针类注射剂的赋形剂,但具有抗原性,可引发严重过敏反应。含辅料右旋糖酐40的注射剂可能具有更多的安全性风险,临床不易识别。右旋糖酐40引发过敏反应会对某些疾病的诊断造成干扰,治疗药物的选择范围受到限制。修订相关药品说明书、完善临床用药流程等有助于降低含辅料右旋糖酐40的注射剂临床用药风险。医师和药师应拓宽临床和药学思维,将辅料右旋糖酐40的抗原性作为一个独立影响因素纳入合理和安全用药范畴进行评估。既应识别由该辅料导致的不良事件个案,也应采取措施减少因该辅料导致的不同药品的一系列不良事件,切实降低相关制剂的用药安全风险。Dextran 40 is a commonly used pharmaceutical excipient and can be used as formulations of dry powder for injection.But it has antigenic properties that can trigger severe allergic reactions.Therefore,injections containing the excipient dextran 40 may have additional safety risks that are not easily recognized in the clinic.Dextran 40-associated allergic reactions may also interfere with the diagnosis of certain diseases and limit the choice of therapeutic drugs.Revision of the relevant instructions and improvement of the clinical dosing process can help reduce the risk of injections containing the excipient dextran 40 in clinical use.Physicians and pharmacists should expand their clinical and pharmacological thinking to evaluate the antigenicity of the excipient dextran 40 as an independent influence factor in the rational and safe use of medication.Identification individual cases of adverse events caused by this excipient and taking measures to minimize adverse events caused by this excipient in different drugs can help effectively reduce the risk of drug safety of the relevant formulations.

关 键 词：注射 药用辅料 葡聚糖类 右旋糖酐类 右旋糖酐40 用药安全 

分 类 号：R969.3[医药卫生—药理学]