PDF(Pubmed)
Abstract：
The growing use of botulinum neurotoxins (BoNTs) for medical and aesthetic purposes has led to the development and marketing of an increasing number of BoNT products. Given that BoNTs are biological medications, their characteristics are heavily influenced by their manufacturing methods, leading to unique products with distinct clinical characteristics. The manufacturing and formulation processes for each BoNT are proprietary, including the potency determination of reference standards and other features of the assays used to measure unit potency. As a result of these differences, units of BoNT products are not interchangeable or convertible using dose ratios. The intrinsic, product-level differences among BoNTs are compounded by differences in the injected tissues, which are innervated by different nerve fiber types (e.g., motor, sensory, and/or autonomic nerves) and require unique dosing and injection sites that are particularly evident when treating complex therapeutic and aesthetic conditions. It is also difficult to compare across studies due to inherent differences in patient populations and trial methods, necessitating attention to study details underlying each outcome reported. Ultimately, each BoNT possesses a unique clinical profile for which unit doses and injection paradigms must be determined individually for each indication. This practice will help minimize unexpected adverse events and maximize efficacy, duration, and patient satisfaction. With this approach, BoNT is poised to continue as a unique tool for achieving individual goals for an increasing number of medical and aesthetic indications.
摘要：
用于医学和美学目的的肉毒杆菌神经毒素(BoNT)的不断增长的使用导致了越来越多的BoNT产品的开发和销售。鉴于BoNT是生物药物，它们的特性受到其制造方法的严重影响，导致具有独特临床特征的独特产品。每个BoNT的制造和配方过程都是专有的，包括参考标准的效力测定和用于测量单位效力的测定的其他特征。由于这些差异，使用剂量比，BoNT产品的单位不可互换或转换。内在的，BoNT之间的产品水平差异因注射组织的差异而加剧，由不同的神经纤维类型支配(例如，电机,感官,和/或自主神经），并且需要独特的给药和注射部位，这在治疗复杂的治疗和美学状况时特别明显。由于患者人群和试验方法的固有差异，很难在不同的研究中进行比较。需要注意报告的每个结果背后的研究细节。最终,每种BoNT都具有独特的临床特征,必须针对每种适应症分别确定单位剂量和注射范例.这种做法将有助于最大限度地减少意外的不良事件，并最大限度地提高疗效。持续时间,患者满意度。通过这种方法，BoNT将继续作为实现越来越多的医学和美学适应症的个人目标的独特工具。
