PDF(Pubmed)
Abstract：
The use of lactose and cow milk protein (CMP) as potential allergens in pharmaceuticals and their ability to cause allergic reactions remains a significant concern in medicine. Lactose, a common pharmaceutical excipient due to its inert, inexpensive, and stable properties, is found in many prescription-only and over-the-counter medications. However, despite their widespread use, individuals with lactose intolerance (LI) or cow milk protein allergy (CMPA) may experience adverse reactions to these excipients. This study investigated the prevalence of lactose and other dairy-derived ingredients in pharmaceuticals marketed in Portugal. Using the Summary of Product Characteristics (SmPC) from the INFOMED database, various medications, including analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), and antiasthmatics, were analyzed. Results showed a high prevalence of dairy-derived excipients, particularly in antiasthmatic drugs (62.6%) and NSAIDs (39%). Although CMP are not explicitly mentioned in SmPCs, the presence of lactose as an ingredient poses a risk of cross-contamination. The findings emphasize the need for healthcare professionals to be aware of potential allergens in medications and the importance of developing lactose-free alternatives to ensure the safety of patients with LI and CMPA. Further research is required to assess the safety and implications of lactose in medicines for these populations.
摘要：
乳糖和牛乳蛋白(CMP)作为药物中的潜在过敏原的用途及其引起过敏反应的能力仍然是医学中的重要问题。乳糖,一种常见的药物赋形剂，由于其惰性，便宜,和稳定的性能，在许多处方药和非处方药中都有发现。然而,尽管它们被广泛使用，患有乳糖不耐受(LI)或牛奶蛋白过敏(CMPA)的个体可能会出现这些赋形剂的不良反应.这项研究调查了在葡萄牙销售的药品中乳糖和其他乳制品衍生成分的患病率。使用INFOMED数据库中的产品特性摘要(SmPC)，各种药物,包括镇痛药,退烧药,非甾体抗炎药（NSAIDs），和抗哮喘药，进行了分析。结果显示，乳制品衍生赋形剂的患病率很高，特别是在平喘药物（62.6％）和NSAIDs（39％）中。虽然在SmPC中没有明确提到CMP，乳糖作为成分的存在会带来交叉污染的风险。研究结果强调，医疗保健专业人员需要意识到药物中潜在的过敏原，以及开发无乳糖替代品以确保LI和CMPA患者安全的重要性。需要进一步的研究来评估这些人群药物中乳糖的安全性和影响。
