Neurology:助慢性偏瘫患者恢复行走 注射A型肉毒素可行吗?

2017-12-05 王淳 环球医学资讯

2017年11月,发表在《Neurology》的一项由法国、波兰、意大利、智利等国科学家进行的研究,考察了A型肉毒素注射治疗慢性偏瘫成年患者下肢的安全性和有效性。

肌内注射A型肉毒素可使肌肉放松12~16周或更长时间,是面瘫的有效治疗方法,但尚未探索A型肉毒素重复下肢注射的长期安全性及其对偏瘫步行速度的影响。2017年11月,发表在《Neurology》的一项由法国、波兰、意大利、智利等国科学家进行的研究,考察了A型肉毒素注射治疗慢性偏瘫成年患者下肢的安全性和有效性。

方法:在一项多中心、双盲、随机、安慰剂对照、单周期研究及随后的1年的开放性多周期扩展研究中,卒中/脑损伤后≥6个月的成人接受了1次的下肢注射(A型肉毒素,1000U; A型肉毒素,1500U;安慰剂),之后在≥12周的间隔接受了≤4次开放性的A型肉毒素注射(1000、1500U)。有效性测量指标包括腓肠肌-比目鱼肌组织(GSC;双盲首要终点指标)的改良Ashworth量表(MAS)、医生总体评估(PGA)和舒适的赤脚行走速度。安全性为开放性阶段的首要终点指标。

结果:单次注射后,平均MAS GCS自基线到4周时(双盲,381例)的改变如下:-0.5(95% CI,-0.7~-0.4)(安慰剂,128例)、-0.6(-0.8~-0.5)(1000U,125例;P=0.28)、-0.8(-0.9~-0.7)(1500U,128例,P=0.009)。平均4周的PGA评分如下:0.7(0.5~0.9)(安慰剂)、0.9(0.7~1.1)(1000U,P=0.067)和0.9(0.7~1.1)(1500U,P=0.067);与安慰剂相比,步行速度未显着改善。4次注射,4周时(开放性),平均MAS GSC改变达到-1.0。PGA和步行速度的增量改善在各开放性注射中发生:4次注射,4周时,平均PGA为1.9,步行速度增加+25.3%(17.5~33.2),16%的参与者步行速度>0.8m/s(与社区流动性相关,基线时为0%)。耐受性良好,与已知的A型肉毒素安全性特征一致。

结论:慢性偏瘫患者中,单次A型肉毒素给药会降低肌肉张力。重复给药超过1年的耐受性良好,并改善步行速度和提高实现社区行动的可能性。

证据分类:该双盲阶段的研究提供的I类证据显示,对于慢性偏瘫患者,单次A型肉毒素注射会降低下肢肌肉张力。

原始出处:

Gracies JM,et al.,Efficacy and safety of abobotulinumtoxinA in spastic lower limb: Randomized trial and extension.Neurology. 2017 Nov 28;89(22):2245-2253.

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