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Abstract：
Despite more than 80 years of use in a number of conditions, including in critically ill patients, comments have recently arisen regarding the safety and efficacy of human serum albumin (HSA) as a therapeutic product and stabilizer/excipient in botulinum neurotoxins. This review summarizes the literature on the safety of HSA. Beyond decades of safe use, the largest clinical dataset of HSA safety is a large meta-analysis of HSA supplier data, which found only an extremely remote risk of serious adverse events across millions of doses of therapeutic concentrations of HSA. There is a paucity of literature identifying HSA-specific adverse events when used as a stabilizer/excipient; however, studies of HSA-containing botulinum neurotoxins (BoNTs) suggest that adverse events are not related to HSA. Polysorbates, which are synthetically produced and not physiologically inert, are contained in pending or new-to-market BoNT formulations. In contrast to HSA, evidence exists to suggest that polysorbates (particularly PS20/PS80) can cause serious adverse events (e.g., hypersensitivity, anaphylaxis, and immunogenicity).
摘要：
尽管在许多条件下使用了80多年，包括危重病人,最近出现了关于人血清白蛋白（HSA）作为肉毒杆菌神经毒素的治疗产品和稳定剂/赋形剂的安全性和有效性的评论。本文综述了有关HSA安全性的文献。除了几十年的安全使用，HSA安全性的最大临床数据集是对HSA供应商数据的大型荟萃分析，该研究发现，在数百万剂量的治疗浓度的HSA中，严重不良事件的风险极小。当用作稳定剂/赋形剂时，缺乏鉴定HSA特异性不良事件的文献;然而，对含HSA的肉毒杆菌神经毒素(BoNTs)的研究表明,不良事件与HSA无关.聚山梨醇酯,它们是合成生产的，不是生理惰性的，包含在待定或新上市的BoNT配方中。与HSA相比,有证据表明聚山梨醇酯(特别是PS20/PS80)可引起严重的不良事件(例如，超敏反应，过敏反应，和免疫原性）。
