Siatkowski R M, Tyutyunikov A, Biglan A W, Scalise D, Genovese C, Raikow R B, Kennerdell J S, Feuer W J
Bascom Palmer Eye Institute, University of Miami, FL 33101.
Ophthalmology. 1993 Dec;100(12):1861-6. doi: 10.1016/s0161-6420(93)31384-9.
Conflicting data have been reported regarding development of serum antibodies to botulinum A toxin. The purpose of this study is to determine conclusively whether antibody production to this toxin occurs in humans, and, if so, to determine its relationship, if any, to length of treatment, total cumulative dose, and clinical response to treatment.
Sixty-five sera samples from 42 adults treated with botulinum A toxin for essential blepharospasm, hemifacial spasm, or spasmodic torticollis were analyzed via a sphere-linked immunodiagnostic assay for antibody production. Results were plotted against length of treatment, number of injections, cumulative dose, and treatment effect produced.
Twenty-four (57%) of the 42 patients produced antibodies in all three diagnostic groups. No significant differences were found between antibody producers and nonproducers with respect to age (P = 0.216), length of treatment (P = 0.586), number of injections (P = 0.619), or total cumulative dose (P = 0.286). Within the antibody-producing group, there was no significant correlation between amount of antibody and length of treatment (P = 0.081), number of injections (P = 0.134), or cumulative dose (P = 0.250). The presence of demonstrable antibodies in serum did not affect the clinical responsiveness to injection.
Antibody production is present in a majority of patients treated with botulinum A toxin. The sphere-linked immunodiagnostic assay is a reliable and reproducible method for detecting and quantifying these antibodies. When antibody production occurs, it is likely due to variations in individual immune responsiveness and appears to have no direct effect on the patient's clinical response to treatment.
关于肉毒杆菌A毒素血清抗体的产生，已有相互矛盾的数据报道。本研究的目的是最终确定人类是否会产生针对这种毒素的抗体，如果会产生，则确定其与治疗时长、总累积剂量以及治疗临床反应之间的关系（若存在关系的话）。
通过一种基于微球的免疫诊断测定法分析了42例接受肉毒杆菌A毒素治疗特发性睑痉挛、半面痉挛或痉挛性斜颈的成人的65份血清样本，以检测抗体产生情况。将结果与治疗时长、注射次数、累积剂量以及产生的治疗效果进行了绘图分析。
42例患者中有24例（57%）在所有三个诊断组中均产生了抗体。在抗体产生者和非产生者之间，在年龄（P = 0.216）、治疗时长（P = 0.586）、注射次数（P = 0.619）或总累积剂量（P = 0.286）方面未发现显著差异。在抗体产生组内，抗体量与治疗时长（P = 0.081）、注射次数（P = 0.134）或累积剂量（P = 0.250）之间均无显著相关性。血清中可检测到的抗体的存在并不影响对注射的临床反应性。
大多数接受肉毒杆菌A毒素治疗的患者会产生抗体。基于微球的免疫诊断测定法是检测和定量这些抗体的可靠且可重复的方法。当产生抗体时，可能是由于个体免疫反应性的差异，并且似乎对患者的治疗临床反应没有直接影响。
