Reboxetine Plus Oxybutynin for OSA Treatment: A 1-Week, Randomized, Placebo-Controlled, Double-Blind Crossover Trial.

Reboxetine Plus Oxybutynin for OSA Treatment: A 1-Week, Randomized, Placebo-Controlled, Double-Blind Crossover Trial.
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DOI:
10.1016/j.chest.2021.08.080
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发表时间:
2022-01
期刊:
影响因子:
9.6
通讯作者:
Parati, Gianfranco
Parati, Gianfranco
中科院分区:
医学1区
文献类型:
--
作者:
Perger, Elisa;Montemurro, Luigi Taranto;Rosa, Debora;Vicini, Stefano;Marconi, Mariapaola;Zanotti, Lucia;Meriggi, Paolo;Azarbarzin, Ali;Sands, Scott A.;Wellman, Andrew;Lombardi, Carolina;Parati, Gianfranco

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最近发现,去甲肾上腺素能和抗毒蕈碱药物联合使用可改善睡眠时上呼吸道肌肉功能并降低OSA严重程度,这重新引起了对OSA药物治疗的兴趣。1周的瑞波西汀加奥昔布宁(Reb-Oxy)是否对OSA严重程度有效?进行了一项随机、安慰剂对照、双盲、交叉试验,比较4mg瑞博西汀加5mg奥昔布宁(Reb-Oxy)与安慰剂在OSA患者中的作用。在基线实验室多导睡眠图(PSG)后,患者在服用Reb-Oxy 7晚和安慰剂7晚后进行PSG,以比较呼吸暂停低通气指数(AHI),这是主要结局。缓解率基于AHI较基线降低≥50%的受试者百分比。次要结果包括Epworth嗜睡量表(ESS)评分和精神运动警觉性测试(PVT)值。家庭血氧仪在整个治疗过程中评估过夜氧去饱和指数(ODI)。16名年龄为57[51-61]岁(中位数[四分位数间距])、体重指数为30 [26-36]kg/m2的受试者完成了研究。Reb-Oxy将AHI从基线时的49[35-57]事件/小时降低至18[13-21]事件/小时(中位降低59%),而安慰剂组为39[29-48]事件/小时(中位降低6%)(P < 0.001)。Reb-Oxy组的有效率为81%,安慰剂组为13% (P < 0.001)。虽然ESS评分没有显著降低,但Reb-Oxy组PVT中位反应时间从基线时的250 [239-312]ms降至223 [172-244]ms,而安慰剂组为264 [217-284]ms (P < 0.001)。家庭血氧测量显示,与安慰剂相比,Reb-Oxy组的氧去饱和指数有急性和持续的改善。Reb-Oxy的使用大大降低了OSA的严重程度并提高了警惕性。这些结果突出了OSA药物治疗的潜在可能性。ClinicalTrials.gov;否。: NCT04449133;URL: www.clinicaltrials.gov
The recent discovery that a combination of noradrenergic and antimuscarinic drugs improved upper airway muscle function during sleep and reduced OSA severity has revitalized interest in pharmacologic therapies for OSA. Would 1 week of reboxetine plus oxybutynin (Reb-Oxy) be effective on OSA severity? A randomized, placebo-controlled, double-blind, crossover trial was performed comparing 4 mg reboxetine plus 5 mg oxybutynin (Reb-Oxy) vs placebo in patients with OSA. After a baseline in-laboratory polysomnogram (PSG), patients underwent PSGs after 7 nights of Reb-Oxy and 7 nights of placebo to compare apnea-hypopnea index (AHI), which was the primary outcome. Response rate was based on the percentage of subjects with a ≥ 50% reduction in AHI from baseline. Secondary outcomes included Epworth Sleepiness Scale (ESS) score and psychomotor vigilance test (PVT) values. Home oximetry evaluated overnight oxygen desaturation index (ODI) throughout treatment. Sixteen subjects aged 57 [51-61] years (median [interquartile range]) with a BMI of 30 [26-36] kg/m2 completed the study. Reb-Oxy lowered AHI from 49 [35-57] events per hour at baseline to 18 [13-21] events per hour (59% median reduction) compared with 39 [29-48] events per hour (6% median reduction) with placebo (P < .001). Response rate for Reb-Oxy was 81% vs 13% for placebo (P < .001). Although ESS scores were not significantly lowered, PVT median reaction time decreased from 250 [239-312] ms at baseline to 223 [172-244] ms on Reb-Oxy vs 264 [217-284] ms on placebo (P < .001). Home oximetry illustrated acute and sustained improvement in the oxygen desaturation index on Reb-Oxy vs placebo. The administration of Reb-Oxy greatly decreased OSA severity and increased vigilance. These results highlight potential possibilities for pharmacologic treatment of OSA. ClinicalTrials.gov; No.: NCT04449133; URL: www.clinicaltrials.gov
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