【 文献重点摘要 】

Objective

To measure and compare the duration of action of abobotulinumtoxinA and onabotulinumtoxinA.

Design

Randomized, double-blind, contralateral (split-face) study.

Setting

Two United States clinical sites.

Participants

Twenty subjects with severe frontalis lines at maximum elevation.

Measurements

Subjects randomly received equal volumes of abobotulinumtoxinA or onabotulinumtoxinA (0.2mL) in five injection points on contralateral sides of the frontalis (N=40) using a dose ratio of 2.5:1.0 (total 25U abobotulinumtoxinA:10U onabotulinumtoxinA), respectively. Subjects were evaluated using a 4-point Frontalis Rating Scale and a new objective Frontalis Activity Measurement Standard for 210 days using predefined endpoints for efficacy.

Results

Using the Frontalis Activity Measurement Standard, the median duration of “complete efficacy” was 72 days for abobotulinumtoxinA and 56 days for onabotulinumtoxinA (p=0.01), “full efficacy” was 103 days for abobotulinumtoxinA and 87 days for onabotulinumtoxinA (p<0.003), and “partial efficacy” was 105 days for abobotulinumtoxinA and 99 days for onabotulinumtoxinA (p=0.006). Using the Frontalis Rating Scale, the median duration of “complete efficacy” was 63 days for abobotulinumtoxinA and 44 days for onabotulinumtoxinA (p=0.006), “full efficacy” was 119 days for abobotulinumtoxinA and 77 days for onabotulinumtoxinA (p=0.005), and “partial efficacy” was 160 days for abobotulinumtoxinA and 145 days for onabotulinumtoxinA (p=NS). Adverse events included local bruising and occasional headache, but no significant intergroup differences.

Conclusion

The contralateral Frontalis Activity Measurement Standard is well-suited for assessing the pharmacodynamic and clinical attributes of botulinum toxin type A and can be used to measure differences in the clinical properties of abobotulinumtoxinA and onabotulinumtoxinA. Using a dose ratio of 2.5:1.0, abobotulinumtoxinA displayed significantly longer duration of action than onabotulinumtoxinA.

目的

测定并比较A型肉毒毒素与A型肉毒毒素的作用时间。

设计

随机、双盲、对侧(双面)研究。

环境

两个美国临床地点。

研究对象

20名最高海拔严重额肌线的受试者。

测量

受试者分别在对侧额肌5个注射点(n=40)随机注射A型或A型肉毒毒素0.2mL等体积，剂量比2.5：1.0(A型肉毒毒素A总量25U：A型肉毒毒素A 10U)。受试者使用4点额肌评定量表和新的客观额肌活动测量标准进行评估，为期210天，使用预先定义的疗效终点。

结果

按额肌活动度评定标准，A型肉毒毒素“完全有效”的中位数为72d，A型肉毒毒素为56d(P=0.006)；A型肉毒毒素“完全有效”的中位数为103d，A型肉毒毒素为87d(P<0.006)；A型肉毒毒素为105d，A型肉毒毒素为99d(P=0.006)，A型肉毒毒素的“完全有效”中位数为105d，A型肉毒毒素的中位数为56d(P=0.006)；A型肉毒毒素的“完全有效”中位数为103d，A型肉毒毒素的中位有效时间为87d(P=0.006)。A型肉毒毒素A和A型肉毒毒素A“完全有效”的中位数分别为63天和44天(p=0.006)，“完全有效”的中位数分别为119d和77天(p=0.005)，“部分有效”的中位数分别为160d和145d(p=NS)。不良事件包括局部瘀伤和偶尔头痛，但组间没有显著差异。

结论

对侧额肌活性测定标准适用于评价A型肉毒毒素的药效学和临床属性，可用于衡量A型肉毒毒素和A型肉毒毒素临床性质的差异。在剂量比为2.5：1.0的情况下，A型肉毒毒素A的作用持续时间明显长于A型肉毒毒素A。