PDF(Pubmed)
Abstract：
UNASSIGNED: Excipient allergy is a rare, but potentially lethal, form of drug allergy. Diagnosing excipient allergy remains difficult in regions without mandatory drug ingredient disclosure and is a significant barrier to drug safety.
UNASSIGNED: To investigate the feasibility of a drug allergy registry-based excipient database to identify potential excipient culprits in patients with history of drug allergy, using polyethylene glycol (PEG) as an example.
UNASSIGNED: An excipient registry was created by compiling the excipient lists pertaining to all available formulations of the top 50 most reported drug allergy culprits in Hong Kong. Availability of excipient information, and its relationship with total number of formulations of individual drugs were analysed. All formulations were checked for the presence or absence of PEG.
UNASSIGNED: Complete excipient information was available for 36.5% (729/2,000) of all formulations of the top 50 reported drug allergy culprits in Hong Kong. The number of formulations for each drug was associated with proportion of available excipient information (ρ = 0.466, p = 0.001). Out of 729 formulations, 109 (15.0%) and 620 (85.0%) were confirmed to contain and not contain PEG, respectively. Excipient information was not available for the other 1,271 (63.6%) formulations. We were unable to confirm the presence or absence of PEG in any of the top 50 drug allergy culprits in Hong Kong.
UNASSIGNED: In countries without mandatory drug ingredient disclosure, excipient databases are unlikely able to identify potential excipient allergy in drug allergy patients. Legislations to enforce mandatory and universal ingredient disclosure are urgently needed.
UNASSIGNED: To investigate the feasibility of a drug allergy registry-based excipient database to identify potential excipient culprits in patients with history of drug allergy, using polyethylene glycol (PEG) as an example.
UNASSIGNED: An excipient registry was created by compiling the excipient lists pertaining to all available formulations of the top 50 most reported drug allergy culprits in Hong Kong. Availability of excipient information, and its relationship with total number of formulations of individual drugs were analysed. All formulations were checked for the presence or absence of PEG.
UNASSIGNED: Complete excipient information was available for 36.5% (729/2,000) of all formulations of the top 50 reported drug allergy culprits in Hong Kong. The number of formulations for each drug was associated with proportion of available excipient information (ρ = 0.466, p = 0.001). Out of 729 formulations, 109 (15.0%) and 620 (85.0%) were confirmed to contain and not contain PEG, respectively. Excipient information was not available for the other 1,271 (63.6%) formulations. We were unable to confirm the presence or absence of PEG in any of the top 50 drug allergy culprits in Hong Kong.
UNASSIGNED: In countries without mandatory drug ingredient disclosure, excipient databases are unlikely able to identify potential excipient allergy in drug allergy patients. Legislations to enforce mandatory and universal ingredient disclosure are urgently needed.
摘要：
■赋形剂过敏是一种罕见的，但可能是致命的,药物过敏的形式。在没有强制性药物成分披露的地区，诊断赋形剂过敏仍然很困难，并且是药物安全性的重要障碍。
■为了研究基于药物过敏登记的赋形剂数据库的可行性，以确定有药物过敏史的患者中潜在的赋形剂罪魁祸首，以聚乙二醇(PEG)为例。
通过编制与香港报告最多的50种药物过敏罪魁祸首的所有可用配方有关的赋形剂清单，创建了赋形剂注册表。赋形剂信息的可用性，并分析了其与单个药物配方总数的关系。检查所有制剂是否存在PEG。
在香港报告的前50名药物过敏罪魁祸首的所有配方中，有36.5％（729/2,000）的完整赋形剂信息可用。每种药物的制剂数量与可用赋形剂信息的比例相关(ρ=0.466,p=0.001)。在729种配方中，109（15.0％）和620（85.0％）被确认含有和不含有PEG，分别。其他1,271（63.6％）制剂的赋形剂信息不可用。我们无法确认香港前50名药物过敏罪魁祸首中是否存在PEG。
■在没有强制性药物成分披露的国家，赋形剂数据库不太可能识别药物过敏患者中潜在的赋形剂过敏.迫切需要立法强制实施强制性和普遍的成分披露。
■为了研究基于药物过敏登记的赋形剂数据库的可行性，以确定有药物过敏史的患者中潜在的赋形剂罪魁祸首，以聚乙二醇(PEG)为例。
通过编制与香港报告最多的50种药物过敏罪魁祸首的所有可用配方有关的赋形剂清单，创建了赋形剂注册表。赋形剂信息的可用性，并分析了其与单个药物配方总数的关系。检查所有制剂是否存在PEG。
在香港报告的前50名药物过敏罪魁祸首的所有配方中，有36.5％（729/2,000）的完整赋形剂信息可用。每种药物的制剂数量与可用赋形剂信息的比例相关(ρ=0.466,p=0.001)。在729种配方中，109（15.0％）和620（85.0％）被确认含有和不含有PEG，分别。其他1,271（63.6％）制剂的赋形剂信息不可用。我们无法确认香港前50名药物过敏罪魁祸首中是否存在PEG。
■在没有强制性药物成分披露的国家，赋形剂数据库不太可能识别药物过敏患者中潜在的赋形剂过敏.迫切需要立法强制实施强制性和普遍的成分披露。
