Kessler K R, Skutta M, Benecke R
Neurologische Klinik und Poliklinik, Heinrich-Heine-Universität, Düsseldorf, Germany.
J Neurol. 1999 Apr;246(4):265-74. doi: 10.1007/s004150050345.
Data from 616 patients suffering from idiopathic cervical dystonia were analyzed to determine the efficacy and safety of treatment with botulinum neurotoxin type A (BoNT/A). Since the specific purpose of this study was to determine the long-term effects of this treatment, the analysis focused specifically on the patients (n = 303) having received six or more injections. Statistical analysis of a standardized documentation showed sustained significant benefit as measured by a disease severity score independent of the type of cervical dystonia. Furthermore, pronounced individual differences were found in response to this treatment although initial clinical scores and doses of BoNT/A were similar. There was no indication of previously unknown adverse events, the only risk being the development of serum antibodies against the toxin. As in previous studies on short-term effects of BoNT/A treatment, the most frequent adverse event was dysphagia, which occurred on average 9.7 days after injection and lasted on average 3.5 weeks. While secondary nonresponse was seen in approx. 5% of patients, antibody tests revealed neutralizing serum antibodies in only 2%. On the basis of the present data, therapy of cervical dystonia with BoNT/A seems to be safe and yields good stable results even after 5 years of treatment.
对616例特发性颈部肌张力障碍患者的数据进行分析,以确定A型肉毒杆菌神经毒素(BoNT/A)治疗的有效性和安全性。由于本研究的特定目的是确定该治疗的长期效果,分析特别关注接受过6次或更多次注射的患者(n = 303)。对标准化记录的统计分析表明,通过疾病严重程度评分衡量,无论颈部肌张力障碍的类型如何,均持续存在显著益处。此外,尽管初始临床评分和BoNT/A剂量相似,但发现患者对该治疗的反应存在明显个体差异。没有迹象表明存在先前未知的不良事件,唯一的风险是产生抗毒素血清抗体。与先前关于BoNT/A治疗短期效果的研究一样,最常见的不良事件是吞咽困难,平均在注射后9.7天出现,平均持续3.5周。虽然约5%的患者出现继发性无反应,但抗体检测仅在2%的患者中发现中和血清抗体。根据目前的数据,BoNT/A治疗颈部肌张力障碍似乎是安全的,即使在治疗5年后也能产生良好的稳定效果。