From the Department of Plastic and Reconstructive Surgery, Royal Free Hospital, University College London; Samarpit Hospital; and Faculty of Pharmaceutical and Allied Health Sciences, Institute of Pharmacy, Lahore College for Women University.
Plast Reconstr Surg. 2022 Apr 1;149(4):837-848. doi: 10.1097/PRS.0000000000008904.
Botulinum toxin type A has been used to treat a wide array of neurologic, medical, and aesthetic indications. Several factors contribute to the formation of neutralizing antibodies, such as shorter intervals of treatment, higher dosage, amounts of antigenic proteins, serotypes, and storage of formulations.
This overview followed the Cochrane guideline for overview reviews. The AMSTAR-2 (revised version of A Measurement Tool to Assess Systematic Reviews) tool was used for the critical appraisal of the selected systematic reviews.
Five systematic reviews consisting of 203 studies (17,815 patients) were included, and their AMSTAR-2 scores were low to critically poor. There was high heterogeneity between the studies. Across the clinical indications, neutralizing antibody prevalence was significantly higher in dystonia, spasticity, and urologic conditions, and nil to insignificant in hyperhidrosis and aesthetic indications. The overall rate for the neutralizing antibody formation across three different formulations, abobotulinumtoxinA, incobotulinumtoxinA, and onabotulinumtoxinA, was 1 to 2.1 percent, with no significant difference between them.
Although there is debate on the prevalence rate across the different botulinum toxin type A formulations in individual systematic reviews, the overall frequency of the development of neutralizing antibodies and the immunogenicity of abobotulinumtoxinA, incobotulinumtoxinA, and onabotulinumtoxinA remain low to insignificant.
Properly designed comparative trials are required to explore the difference in the prevalence of neutralizing antibodies across the commercially available botulinum toxin type A products. Such studies should also examine the relevance of neutralizing antibody titer to clinical responsiveness and nonresponse.
肉毒毒素 A 已被用于治疗广泛的神经、医学和美容适应症。形成中和抗体的几个因素包括治疗间隔较短、剂量较高、抗原蛋白量、血清型和制剂储存等。
本综述遵循 Cochrane 综述指南。使用 AMSTAR-2（系统评价测量工具的修订版）工具对选定的系统评价进行批判性评估。
纳入了 5 项系统评价，共包含 203 项研究（17815 名患者），其 AMSTAR-2 评分较低至极差。研究之间存在高度异质性。在各种临床适应症中，中和抗体的患病率在肌张力障碍、痉挛和泌尿科疾病中显著较高，在多汗症和美容适应症中则为零或无显著意义。三种不同制剂（阿博特毒素 A、依诺特毒素 A 和奥博特毒素 A）的中和抗体形成的总体发生率为 1%至 2.1%，它们之间无显著差异。
尽管在不同的肉毒毒素 A 制剂中存在关于中和抗体患病率的争议，但总体而言，中和抗体的产生频率以及阿博特毒素 A、依诺特毒素 A 和奥博特毒素 A 的免疫原性仍然较低或无显著意义。
需要进行适当设计的比较试验，以探索市售肉毒毒素 A 产品中中和抗体的患病率差异。这些研究还应检查中和抗体滴度与临床反应性和无反应性的相关性。
