裂面双盲研究比较单肉毒杆菌毒素和肉毒杆菌毒素的起始作用。

Kenneth C Y Yu, Kartik D Nettar, Sumit Bapna, W John Boscardin, Corey S Maas
{"title":"裂面双盲研究比较单肉毒杆菌毒素和肉毒杆菌毒素的起始作用。","authors":"Kenneth C Y Yu,&nbsp;Kartik D Nettar,&nbsp;Sumit Bapna,&nbsp;W John Boscardin,&nbsp;Corey S Maas","doi":"10.1001/archfacial.2011.1142","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To report and discuss the outcome of a prospective, internally controlled, randomized, double-blind, split-face study comparing the onset of action of 2 commercially available botulinum neuromodulators.</p><p><strong>Methods: </strong>Ninety individuals with moderate-to-severe lateral orbital rhytids were treated with onabotulinumtoxinA, 10 U, and abobotulinumtoxinA, 30 U, for the treatment of lateral orbital rhytids. Participants were assessed live with a validated 5-point photographic scale before treatment and on days 2, 4, and 6 after treatment. Photographs were taken at each encounter. Statistical analysis was applied to evaluate for any significant difference in onset of action between the 2 products.</p><p><strong>Results: </strong>AbobotulinumtoxinA and onabotulinumtoxinA demonstrated statistically significant change from baseline at day 2 in the treatment of lateral orbital rhytids at maximal contraction and rest when evaluated independently by investigator and participant (P.001). Also at day 2, the improvement with abobotulinumtoxinA was better than that with onabotulinumtoxinA for the primary end point of maximal contraction graded by the investigator, although this did not reach statistical significance (P=.21); by day 4, the greater improvement achieved with abobotulinumtoxinA reached statistical significance (P=.02) and remained superior at day 6 (P=.02). The primary findings were strengthened by similar results in the secondary end points of patient self-grade at maximal contraction and at rest and of investigator grade at rest.</p><p><strong>Conclusions: </strong>In conclusion, both abobotulinumtoxinA and onabotulinumtoxinA achieved statistically significant onset of action at day 2. This improvement was seen in all end points, with abobotulinumtoxinA demonstrating a trend toward greater improvement than onabotulinumtoxinA at day 2 and a statistically significant greater improvement at days 4 and 6 when looking at maximal contraction.</p>","PeriodicalId":55470,"journal":{"name":"Archives of Facial Plastic Surgery","volume":"14 3","pages":"198-204"},"PeriodicalIF":0.0000,"publicationDate":"2012-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1001/archfacial.2011.1142","citationCount":"27","resultStr":"{\"title\":\"Split-face double-blind study comparing the onset of action of onabotulinumtoxinA and abobotulinumtoxinA.\",\"authors\":\"Kenneth C Y Yu,&nbsp;Kartik D Nettar,&nbsp;Sumit Bapna,&nbsp;W John Boscardin,&nbsp;Corey S Maas\",\"doi\":\"10.1001/archfacial.2011.1142\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To report and discuss the outcome of a prospective, internally controlled, randomized, double-blind, split-face study comparing the onset of action of 2 commercially available botulinum neuromodulators.</p><p><strong>Methods: </strong>Ninety individuals with moderate-to-severe lateral orbital rhytids were treated with onabotulinumtoxinA, 10 U, and abobotulinumtoxinA, 30 U, for the treatment of lateral orbital rhytids. Participants were assessed live with a validated 5-point photographic scale before treatment and on days 2, 4, and 6 after treatment. Photographs were taken at each encounter. Statistical analysis was applied to evaluate for any significant difference in onset of action between the 2 products.</p><p><strong>Results: </strong>AbobotulinumtoxinA and onabotulinumtoxinA demonstrated statistically significant change from baseline at day 2 in the treatment of lateral orbital rhytids at maximal contraction and rest when evaluated independently by investigator and participant (P.001). Also at day 2, the improvement with abobotulinumtoxinA was better than that with onabotulinumtoxinA for the primary end point of maximal contraction graded by the investigator, although this did not reach statistical significance (P=.21); by day 4, the greater improvement achieved with abobotulinumtoxinA reached statistical significance (P=.02) and remained superior at day 6 (P=.02). The primary findings were strengthened by similar results in the secondary end points of patient self-grade at maximal contraction and at rest and of investigator grade at rest.</p><p><strong>Conclusions: </strong>In conclusion, both abobotulinumtoxinA and onabotulinumtoxinA achieved statistically significant onset of action at day 2. This improvement was seen in all end points, with abobotulinumtoxinA demonstrating a trend toward greater improvement than onabotulinumtoxinA at day 2 and a statistically significant greater improvement at days 4 and 6 when looking at maximal contraction.</p>\",\"PeriodicalId\":55470,\"journal\":{\"name\":\"Archives of Facial Plastic Surgery\",\"volume\":\"14 3\",\"pages\":\"198-204\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2012-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1001/archfacial.2011.1142\",\"citationCount\":\"27\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Archives of Facial Plastic Surgery\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1001/archfacial.2011.1142\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Archives of Facial Plastic Surgery","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1001/archfacial.2011.1142","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 27

摘要

目的:报告并讨论一项前瞻性、内部对照、随机、双盲、裂面研究的结果,该研究比较了两种市售肉毒杆菌神经调节剂的起效。方法:90例中重度眼眶外侧曲痛患者分别应用肉毒杆菌毒素a (10 U)和肉毒杆菌毒素a (30 U)治疗眼眶外侧曲痛。在治疗前和治疗后的第2、4和6天,用有效的5点摄影量表对参与者进行现场评估。每次相遇都拍了照片。应用统计分析来评估两种产品在起效方面的任何显著差异。结果:当研究者和参与者独立评估时,AbobotulinumtoxinA和onabobotulinumtoxina在治疗最大收缩和休息时的第2天显示具有统计学意义的基线变化(P.001)。同样在第2天,对于研究者分级的最大收缩的主要终点,肉毒杆菌毒素a的改善优于肉毒杆菌毒素a,尽管这没有达到统计学意义(P= 0.21);到第4天,肉毒杆菌毒素a取得了更大的改善,达到统计学意义(P= 0.02),并在第6天保持优势(P= 0.02)。在最大收缩和休息时患者自我评分和休息时研究者评分的次要终点中,类似的结果加强了主要研究结果。结论:总之,abobotulinumtoxinA和onabobotulinumtoxina在第2天起效具有统计学意义。这种改善在所有终点都可以看到,在第2天,肉毒杆菌毒素a比肉毒杆菌毒素a显示出更大的改善趋势,在第4天和第6天,当观察最大收缩时,有统计学意义上的更大改善。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Split-face double-blind study comparing the onset of action of onabotulinumtoxinA and abobotulinumtoxinA.

Objective: To report and discuss the outcome of a prospective, internally controlled, randomized, double-blind, split-face study comparing the onset of action of 2 commercially available botulinum neuromodulators.

Methods: Ninety individuals with moderate-to-severe lateral orbital rhytids were treated with onabotulinumtoxinA, 10 U, and abobotulinumtoxinA, 30 U, for the treatment of lateral orbital rhytids. Participants were assessed live with a validated 5-point photographic scale before treatment and on days 2, 4, and 6 after treatment. Photographs were taken at each encounter. Statistical analysis was applied to evaluate for any significant difference in onset of action between the 2 products.

Results: AbobotulinumtoxinA and onabotulinumtoxinA demonstrated statistically significant change from baseline at day 2 in the treatment of lateral orbital rhytids at maximal contraction and rest when evaluated independently by investigator and participant (P.001). Also at day 2, the improvement with abobotulinumtoxinA was better than that with onabotulinumtoxinA for the primary end point of maximal contraction graded by the investigator, although this did not reach statistical significance (P=.21); by day 4, the greater improvement achieved with abobotulinumtoxinA reached statistical significance (P=.02) and remained superior at day 6 (P=.02). The primary findings were strengthened by similar results in the secondary end points of patient self-grade at maximal contraction and at rest and of investigator grade at rest.

Conclusions: In conclusion, both abobotulinumtoxinA and onabotulinumtoxinA achieved statistically significant onset of action at day 2. This improvement was seen in all end points, with abobotulinumtoxinA demonstrating a trend toward greater improvement than onabotulinumtoxinA at day 2 and a statistically significant greater improvement at days 4 and 6 when looking at maximal contraction.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
审稿时长
2 months
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信