Department of Psychology, Martin Luther University Halle-Wittenberg, D-06120 Halle, Germany.
MEU-Study Center of DIPLOMA University of Applied Science, D-39114 Magdeburg, Germany.
Toxins (Basel). 2022 Jul 24;14(8):508. doi: 10.3390/toxins14080508.
On a group level, satisfaction with botulinum neurotoxin (BoNT) treatment in neurological indications is high. However, it is well known that a relevant amount of patients may not respond as expected. The aim of this study is to evaluate the BoNT treatment outcome on an individual level using a statistical single-case analysis as an adjunct to traditional group statistics. The course of the daily perceived severity of symptoms across a BoNT cycle was analyzed in 20 cervical dystonia (CD) and 15 hemifacial spasm (HFS) patients. A parametric single-case autoregressive integrated moving average (ARIMA) time series analysis was used to detect individual responsiveness to BoNT treatment. Overall, both CD and HFS patients significantly responded to BoNT treatment with a gradual worsening of symptom intensities towards BoNT reinjection. However, only 8/20 CD patients (40%) and 5/15 HFS patients (33.3%) displayed the expected U-shaped curve of BoNT efficacy across a single treatment cycle. CD (but not HFS) patients who followed the expected outcome course had longer BoNT injection intervals, showed a better match to objective symptom assessments, and were characterized by a stronger certainty to control their somatic symptoms (i.e., internal medical locus of control). In addition to standard evaluation procedures, patients should be identified who do not follow the mean course-of-treatment effect. Thus, the ARIMA single-case time series analysis seems to be an appropriate addition to clinical treatment studies in order to detect individual courses of subjective symptom intensities.
在群体层面上，神经学适应证中肉毒毒素（BoNT）治疗的满意度很高。然而，众所周知，相当一部分患者的反应可能不如预期。本研究旨在使用统计单项案例分析作为传统群体统计的补充，在个体层面上评估 BoNT 治疗的结果。分析了 20 例颈部肌张力障碍（CD）和 15 例半面痉挛（HFS）患者在一个 BoNT 周期内每天感知到的症状严重程度的变化过程。采用参数单项自回归综合移动平均（ARIMA）时间序列分析来检测对 BoNT 治疗的个体反应性。总体而言，CD 和 HFS 患者对 BoNT 治疗均有明显反应，随着 BoNT 再注射，症状强度逐渐加重。然而，只有 20 例 CD 患者中的 8 例（40%）和 15 例 HFS 患者中的 5 例（33.3%）在单个治疗周期中显示出预期的 BoNT 疗效 U 形曲线。遵循预期结果过程的 CD（但不是 HFS）患者 BoNT 注射间隔更长，与客观症状评估更匹配，并且具有更强的控制躯体症状的确定性（即内部医学控制源）。除了标准评估程序外，还应识别出不符合平均治疗效果的患者。因此，ARIMA 单项时间序列分析似乎是临床治疗研究的一个合适补充，可以检测个体主观症状强度的变化过程。
