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Long-term incobotulinumtoxinA treatment for chronic sialorrhea: Efficacy and safety over 64 weeks.
Parkinsonism & Related Disorders ( IF 4.1 ) Pub Date : 2019-11-26 , DOI: 10.1016/j.parkreldis.2019.11.024
Wolfgang H Jost 1 , Andrzej Friedman 2 , Olaf Michel 3 , Christian Oehlwein 4 , Jaroslaw Slawek 5 , Andrzej Bogucki 6 , Stanislaw Ochudlo 7 , Marta Banach 8 , Fernando Pagan 9 , Birgit Flatau-Baqué 10 , Ulrike Dorsch 10 , János Csikós 11 , Andrew Blitzer 12
Affiliation  

BACKGROUND Botulinum neurotoxin (BoNT) is an effective treatment for chronic sialorrhea; however, reliable and robust evidence supporting long-term efficacy and safety is lacking. This study investigated the efficacy and safety of repeated incobotulinumtoxinA injections for chronic sialorrhea over 64 weeks. METHODS Adults with sialorrhea were randomized (2:2:1) to incobotulinumtoxinA 75 U, incobotulinumtoxinA 100 U (n = 74 each), or placebo (n = 36) in the double-blind, placebo-controlled main period (NCT02091739). Eligible subjects entered the extension period and received dose-blinded incobotulinumtoxinA 75 or 100 U in three further 16±2-week injection cycles. Efficacy and safety assessments in subjects who received incobotulinumtoxinA throughout the study included unstimulated salivary flow rate (uSFR), subjects' Global Impression of Change Scale (GICS), Drooling Severity and Frequency Scale (DSFS), modified Radboud Oral Motor Inventory for Parkinson's Disease (mROMP) drooling, speech, and swallowing symptom scores, and incidence of adverse events (AEs). RESULTS In total, 173/184 subjects (94%) completed the main period and entered the extension period; 141 subjects received incobotulinumtoxinA 75 U (n = 69) or 100 U (n = 72) in both periods. Mean uSFR decreased consistently with repeated incobotulinumtoxinA 75 and 100 U treatment and by -0.16 and -0.17, respectively, at the end-of-study visit. Subjects' GICS, DSFS, and mROMP drooling scores also improved at all assessments. mROMP speech and swallowing scores remained stable. The most common treatment-related AEs during the extension period were dry mouth (4.4% and 11.1%) and dysphagia (1.5% and 4.2%). CONCLUSIONS Data support long-term efficacy and safety of repeated incobotulinumtoxinA treatment for sialorrhea, with no additional safety concerns reported over 64 weeks.

中文翻译:

长期用incobotulinumtoxinA治疗慢性腹泻:64周以上的疗效和安全性。

背景技术肉毒杆菌神经毒素(BoNT)是治疗慢性腹泻的有效方法。但是,缺乏支持长期疗效和安全性的可靠且有力的证据。这项研究调查了反复注射incobotulinumtoxinA对64周内慢性腹泻的疗效和安全性。方法在双盲,安慰剂对照的主要治疗期(NCT02091739)中,将成年腹泻的成人随机(2:2:1)分配给incobotulinumtoxinA 75 U,incobotulinumtoxinA 100 U(每个n = 74)或安慰剂(n = 36)。符合条件的受试者进入延长期,并在另外三个16±2周的注射周期中接受了剂量盲的IncobotulinumumxinA 75或100U。在整个研究中接受incobotulinumtoxinA的受试者的功效和安全性评估包括未刺激的唾液流速(uSFR),受试者的 全球印象变化量表(GICS),流口水严重度和频率量表(DSFS),帕金森氏病(MROMP)流口水,言语和吞咽症状评分的改良Radboud口腔运动量表以及不良事件(AEs)发生率。结果总共有173/184名受试者(占94%)完成了主要阶段并进入了延长阶段。在这两个时期中,有141名受试者接受了IncobotulinumtoxinA 75 U(n = 69)或100 U(n = 72)。在研究结束后,反复进行incobotulinumtoxinA 75和100 U治疗后,平均uSFR持续下降,分别下降-0.16和-0.17。在所有评估中,受试者的GICS,DSFS和mROMP流口水分数也有所提高。mROMP语音和吞咽分数保持稳定。延长期最常见的与治疗有关的AE是口干(4.4%和11.1%)和吞咽困难(1。5%和4.2%)。结论数据支持反复使用incobotulinumtoxinA治疗腹泻的长期疗效和安全性,在64周内未报告其他安全性问题。
更新日期:2019-11-26
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