Department of Neurology, IRCCS Humanitas Research Hospital, 20089 Rozzano, MI, Italy.
Department of Neurorehabilitation and Physical Therapy, Vivantes Hospital Spandau, 13585 Berlin, Germany.
Toxins (Basel). 2023 May 12;15(5):333. doi: 10.3390/toxins15050333.
This analysis pooled pain severity data from four phase 3 and 4 studies of incobotulinumtoxinA (incoBoNT-A) for the treatment of cervical dystonia (CD) in adults. CD-related pain severity was assessed at baseline, each injection visit, and 4 weeks after each injection of incoBoNT-A using the Toronto Western Spasmodic Torticollis Rating Scale pain severity subscale or a pain visual analog scale. Both were analyzed using a score range of 0-10 and pain was categorized as mild, moderate, or severe. Data for 678 patients with pain at baseline were assessed and sensitivity analyses evaluated pain responses in the subgroup not taking concomitant pain medication ( = 384 at baseline). At Week 4 after the first injection, there was a mean change of -1.25 (standard deviation 2.04) points from baseline pain severity ( < 0.0001), with 48.1% showing ≥ 30% pain reduction from baseline, 34.4% showing ≥50% pain reduction from baseline, and 10.3% becoming pain free. Pain responses were sustained over five injection cycles with a trend to incremental improvements with each successive cycle. Pain responses in the subgroup not taking concomitant pain medication demonstrated the lack of confounding effects of pain medications. These results confirmed the pain relief benefits of long-term treatment with incoBoNT-A.
本分析汇总了四项关于成人颈部肌张力障碍(CD)治疗的 incobotulinumtoxinA(incoBoNT-A)的 3 期和 4 期研究中的疼痛严重程度数据。使用多伦多西部痉挛性斜颈严重程度评定量表疼痛严重程度子量表或疼痛视觉模拟量表,在基线、每次注射就诊时以及每次注射 incoBoNT-A 后 4 周评估与 CD 相关的疼痛严重程度。两者均采用 0-10 的评分范围进行分析,疼痛分为轻度、中度或重度。对 678 名基线有疼痛的患者进行了数据评估,敏感性分析评估了未服用伴随性疼痛药物的亚组(基线时为 384 名)的疼痛反应。第一次注射后第 4 周,与基线疼痛严重程度相比,疼痛平均变化为-1.25 分(标准差 2.04)(<0.0001),48.1%的患者疼痛减轻≥30%,34.4%的患者疼痛减轻≥50%,10.3%的患者无疼痛。疼痛反应在五个注射周期中持续存在,每个连续周期都有逐渐改善的趋势。未服用伴随性疼痛药物的亚组的疼痛反应表明疼痛药物没有混杂作用。这些结果证实了 incoBoNT-A 长期治疗的疼痛缓解益处。