AIM To assess the efficacy and safety of repeat abobotulinumtoxinA injections in reducing upper limb spasticity in children with cerebral palsy (CP). METHOD This was a double-blind, repeat-cycle study (NCT02106351) in children with CP (2-17y). Children were randomized to receive 2U/kg (control), 8U/kg, or 16U/kg abobotulinumtoxinA injections into the target muscle group (wrist or elbow flexors) and additional muscles alongside occupational therapy via a home-exercise therapy program (HETP; minimum five 15min sessions/wk). Children received 8U/kg or 16U/kg plus HETP in cycles 2 to 4. RESULTS During cycle 1, 210 children (126 males, 84 females; mean age [SD] 9y [4y 5mo], range 2-17y; n=70/group) had at least one upper limb abobotulinumtoxinA injection and 209 complied with the HETP. At week 6 of cycle 1, children in the 8U/kg or 16U/kg groups had significantly lower Modified Ashworth scale scores versus the 2U/kg group (primary outcome: treatment differences of -0.4 [p=0.012] and -0.7 [p<0.001] respectively). All groups improved on Physician Global Assessment and children in all groups achieved their treatment goals at least as expected. Therapeutic benefits were sustained during cycles 2 to 4; muscular weakness was the only treatment-related adverse event reported in at least one child/group (4.3% and 5.7% vs 1.4% respectively). INTERPRETATION Treatment with 8U/kg or 16U/kg abobotulinumtoxinA significantly reduced upper limb spasticity versus the 2U/kg control dose. Therapeutic benefits of abobotulinumtoxinA plus HETP were sustained with repeat treatment cycles.

中文翻译：

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肉毒杆菌毒素 A 治疗脑瘫患儿上肢痉挛的疗效和安全性：一项随机重复治疗研究

目的评价反复注射abobotulinumtoxinA减少脑瘫（CP）患儿上肢痉挛的有效性和安全性。方法 这是一项针对 CP 儿童（2-17 岁）的双盲、重复周期研究 (NCT02106351)。儿童随机接受 2U/kg（对照）、8U/kg 或 16U/kg abobotulinumtoxinA 注射到目标肌肉群（腕或肘屈肌）和额外肌肉，同时通过家庭锻炼治疗计划（HETP；最低五个 15 分钟的疗程/周）。儿童在第 2 至第 4 周期接受 8U/kg 或 16U/kg 加 HETP。 结果 在第 1 周期，210 名儿童（126 名男性，84 名女性；平均年龄 [SD] 9 岁 [4 岁 5 个月]，范围 2-17 岁；n=70 /组）至少注射了一次上肢肉毒杆菌毒素 A 并且 209 符合 HETP。在第 1 周期的第 6 周，与 2U/kg 组相比，8U/kg 或 16U/kg 组儿童的改良 Ashworth 量表评分显着降低（主要结果：治疗差异分别为 -0.4 [p=0.012] 和 -0.7 [p<0.001]）。所有组的医师总体评估均有所改善，所有组中的儿童都至少按预期实现了治疗目标。在第 2 至第 4 个周期期间治疗效果持续；肌肉无力是至少在一个儿童/组中报告的唯一与治疗相关的不良事件（分别为 4.3% 和 5.7% 对 1.4%）。解释 与 2U/kg 对照剂量相比，8U/kg 或 16U/kg abobotulinumtoxinA 治疗显着降低了上肢痉挛。通过重复治疗周期，abobotulinumtoxinA 加 HETP 的治疗效果得以持续。