摘要
目的探索Ａ型肉毒毒素（ＢＴＸＡ）在神经肌肉疾病中的治疗应用，证实和比较国产ＢＴＸＡ（ＣＢＴＸＡ）与美国产ＢＴＸＡ（ｂｏｔｏｘ）治疗局限性肌张力障碍和肌肉痉挛等的疗效和不良反应。方法４年间用ｂｏｔｏｘ和ＣＢＴＸＡ分别注射治疗１９２和５９３例局限性肌张力障碍和肌肉痉挛等运动障碍性疾病，共计７８５例，注射１３９３次。随访３～４８个月，分析前瞻性、开放性临床研究的结果。结果ｂｏｔｏｘ或ＣＢＴＸＡ的疗效没有明显差别，症状完全缓解占３０．４％，明显改善占５７．８％，部分改善８．９％，无效１．４％（１１例资料不全）。疗效平均持续约３～５个月。最引人关注的并发症是眼睑下垂和吞咽困难，一般程度不重，约数周内自行好转。ｂｏｔｏｘ与ＣＢＴＸＡ治疗的反应潜伏期、疗效持续时间、综合治疗和患者的主观改善差异均无显著性意义，但治疗达到相似疗效所需ＣＢＴＸＡ的剂量较大，且ＣＢＴＸＡ组有５例注射后数天内出现皮疹，其余不良反应两组之间差异无显著性意义。绝大多数患者需重复注射维持疗效。肌肉痉挛复发多为部分复发，重复注射的疗效没有下降，反应潜伏期和疗效持续时间保持不变，所用剂量也相对稳定或略有减小。结论局部注射ｂｏｔｏｘ或ＣＢＴ?
Objective To
confirm and compare the therapeutic efficacies of CBTXA (made by Lanzhou Biological Products
Institute, China) and botox ( from Allergan Inc.,US) for focal dystonia and other neurological
disorders characterized by involuntary or abnormal muscle contractions. Methods We treated
785 patients with medically intractable focal dystonia and muscle spasm in two groups, 192
cases with botox and 593 cases with CBTXA. A total of 1 393 treatments were given over a
4year period. The results of a prospective open study were analyzed. Results Considerable
improvement of the symptoms was observed in all patients but 11 (1.4%) with either botox or
CBTXA, 30.4% were rated as excellent, 57.8% as marked improvement, and 8.9% as moderate
improvement. The side effects were usually minor and transient. The most concerned
complications after injections were ptosis and dysphagia. There was no significant difference in
the clinical effects between these two kinds of preparations, including the latency of response,
the maximal benefit and the duration of improvement. The patients subjective assessments
were similar too. But the requested dose of Chinese preparation which produced the similar
effects was statistically higher than that of botox; and skin rash appeared within a few days
after injections in 5 cases of the CBTXA group, but none occurred in the botox group. There were
no statistical differences in the other adverse reactions between them. The treatment was
needed to repeat in most patients to maintain the effects. The pretreatment scores of the
reinjection were slightly lower. Moreover, a progressive reduction in posttreatment scores was
observed in HFS and CD, with the latency of response, the duration of improvement and doses
unchanged or lower than the initial one. Conclusion The injections
出处
《中华神经科杂志》
CAS
CSCD
1999年第3期135-138,共4页
Chinese Journal of Neurology
