Department of Rehabilitation Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul 03080, Korea.
Department of Rehabilitation Medicine, Incheon St. Mary's Hospital, Incheon 22711, Korea.
Toxins (Basel). 2018 May 16;10(5):203. doi: 10.3390/toxins10050203.
We aimed to evaluate the efficacy and safety of injecting botulinum toxin A (BoNT-A) into the neck muscles to treat cervical dystonia (CD) in patients with dyskinetic cerebral palsy (CP). This was a randomized, double-blinded, placebo-controlled trial with cross-over design. We prospectively enrolled adults with dyskinetic CP who were over 20 years old and had been clinically diagnosed with CD for more than one year. The primary outcome measure was the change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) at four weeks from the baseline TWSTRS. Seventeen patients were initially enrolled, but one patient was excluded after the final evaluation because of a violation of the study protocol. At four weeks, the BoNT-A injections showed significant improvement in TWSTRS total scores compared to the saline injections ( = 0.0286 for ANCOVA). At 12 weeks, the BoNT-A injections resulted in greater improvements in TWSTRS total scores than the saline injections without statistical significance ( = 0.0783 for ANCOVA). Dysphagia occurred in three out of 16 patients: two after BoNT-A and one after saline. The dysphagia was transient and improved naturally within two weeks without any special treatment. BoNT-A injection for CD in adults with dyskinetic CP is relatively safe and improves pain and disability.
我们旨在评估向颈部肌肉注射肉毒毒素 A (BoNT-A) 治疗运动障碍型脑瘫 (CP) 患者的颈肌张力障碍 (CD) 的疗效和安全性。这是一项随机、双盲、安慰剂对照的交叉设计试验。我们前瞻性地招募了年龄超过 20 岁且已被临床诊断为 CD 超过一年的运动障碍型 CP 成人患者。主要结局指标是从基线 TWSTRS 开始四周时多伦多西部痉挛性斜颈评定量表 (TWSTRS) 的变化。最初有 17 名患者入组,但在最终评估后,由于违反研究方案,有 1 名患者被排除。四周时,肉毒毒素 A 注射与盐水注射相比,TWSTRS 总分有显著改善(ANCOVA = 0.0286)。12 周时,肉毒毒素 A 注射在 TWSTRS 总分方面的改善大于盐水注射,但无统计学意义(ANCOVA = 0.0783)。16 名患者中有 3 名出现吞咽困难:2 名在肉毒毒素 A 后,1 名在盐水后。吞咽困难是短暂的,在没有任何特殊治疗的情况下,两周内自然改善。对于运动障碍型 CP 成人的 CD,肉毒毒素 A 注射相对安全,并可改善疼痛和残疾。