Dermatologikum Hamburg, Hamburg, Germany.
Dermatol Surg. 2010 Dec;36 Suppl 4:2155-60. doi: 10.1111/j.1524-4725.2010.01798.x.
This is the first double-blind, randomized, proof-of-concept study to compare the clinical effectiveness of botulinum toxin type A (BoNTA) free of complexing proteins with a BoNTA complex (BTXCo) in the treatment of crow's feet.
Twelve U of each product were compared in an intra-individual study in 21 participants with a facial wrinkle scale (FWS) score of 2 to 3. Evaluations were done for up to 4 months. Subjects with an improvement of at least 1 point on the FWS were considered responders.
One month after treatment, the percentage of responders was slightly higher for the BoNTA side (95%) than the BTXCo side (90%). After 4 months, both sides still showed good efficacy, with an 84% response rate and greater than 30% FWS reduction (no statistically significant difference between the products). After 1 month, FWS score at rest was approximately 66% lower for BoNTA, versus 63% lower for BTXCo. After 4 months, FWS reduction was approximately 50%.
Both botulinum toxin A products displayed high efficacy and good tolerability at a dose ratio of 1:1, with no statistically significant differences between them. The high response rates observed after 4 months suggest a good effectiveness beyond this observation period.
这是第一项比较不含复合蛋白的肉毒毒素 A 型（BoNTA）与 BoNTA 复合物（BTXCo）在鱼尾纹治疗中的临床疗效的双盲、随机、概念验证研究。
在 21 名面部皱纹量表（FWS）评分为 2 至 3 的患者中进行了一项个体内研究，比较了每种产品 12U。评估时间长达 4 个月。FWS 评分至少提高 1 分的患者被认为是有应答者。
治疗后 1 个月，BoNTA 组的应答者比例（95%）略高于 BTXCo 组（90%）。4 个月后，两侧仍显示出良好的疗效，应答率为 84%，FWS 评分降低超过 30%（产品之间无统计学差异）。治疗后 1 个月，BoNTA 组静息时 FWS 评分降低约 66%，BTXCo 组降低约 63%。治疗 4 个月后，FWS 评分降低约 50%。
两种肉毒毒素 A 产品在 1:1 的剂量比下均显示出高疗效和良好的耐受性，两者之间无统计学差异。4 个月后观察到的高应答率表明，在此观察期后，其疗效良好。
