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将激素疗法优先于氨己烯酸作为婴儿痉挛症的首选治疗方法:一项质量改进计划。

Prioritizing Hormone Therapy Over Vigabatrin as the First Treatment for Infantile Spasms: A Quality Improvement Initiative.

作者信息

Mytinger John R, Parker William, Rust Steven W, Ahrens Stephanie M, Albert Dara V F, Beatty Christopher W, Chrisman Julie, Clark Daniel J, Debs Andrea, Denney Danielle, Karn Mary, Herbst James, Ostendorf Adam P, Taylor Mary C, Twanow Jaime D E, Vidaurre Jorge, Patel Anup D

机构信息

From the Division of Pediatric Neurology (J.R.M., S.M.A., D.V.F.A., C.W.B., A.P.O., J.D.E.T., J.V., A.D.P.), Department of Pediatrics, Nationwide Children's Hospital, and The Ohio State University; The Center for Clinical Excellence (W.P., A.D.P.) ; Information Technology Research & Innovation (S.W.R.), and Division of Pediatric Neurology (J.C., D.J.C., A.D., D.D., M.K., J.H., M.C.T.), Department of Pediatrics, Nationwide Children's Hospital, Columbus, OH.

出版信息

Neurology. 2022 Nov 8;99(19):e2171-e2180. doi: 10.1212/WNL.0000000000201113. Epub 2022 Aug 29.

DOI:10.1212/WNL.0000000000201113
PMID:36038276
Abstract

BACKGROUND AND OBJECTIVES

Infantile spasms (IS) are early childhood seizures with potentially devastating consequences. Standard therapies (adrenocorticotropic hormone [ACTH], high-dose prednisolone, and vigabatrin) are strongly recommended as the first treatment for IS. Although this recommendation comes without preference for one standard therapy over another, early remission rates are higher with hormone therapy (ACTH and high-dose prednisolone) when compared with vigabatrin. Using quality improvement (QI) methodology that included hormone therapy as the first treatment, we sought to increase the percentage of children with new-onset nontuberous sclerosis complex (TSC)-associated IS achieving 3-month electroclinical remission from a mean of 53.8% to ≥70%.

METHODS

This was an observational consecutive sample cohort study at a single academic tertiary care hospital that compared a prospective intervention cohort (May 2019-January 2022, N = 57) with a retrospective baseline cohort (November 2015-April 2019, N = 67). Our initiative addressed key drivers such as the routine use of vigabatrin over hormone therapy as first treatment and the common initiation of a second treatment after 14 days for initial nonresponders. We included consecutive children without TSC presenting with new-onset IS diagnosed and treated between ages 2 and 24 months. We displayed our primary outcome and process measures as control charts in which the centerline is the quarterly (previous 3 months) mean based on statistical process control methodology.

RESULTS

QI interventions that included the standardization of hormone therapy as the first treatment resulted in higher rates of 3-month remission, rising from 53.8% (baseline cohort) to 75.9% (intervention cohort). Process measure results included an increased rate of children receiving hormone therapy as first treatment (mean, 44.6%-100%) and a decreased number of days to both clinical follow-up after first treatment (mean, of 16.3-12.6 days) and starting a second treatment within 14 days for initial nonresponders (mean, 36.3-17.2 days).

DISCUSSION

For children with IS, improved rates of 3-month electroclinical remission can be achieved with QI methodology. Implementation of similar QI initiatives at other centers may likewise improve local remission rates.

摘要

背景与目的

婴儿痉挛症(IS)是一种发生于幼儿期的癫痫发作,可能会带来严重后果。强烈推荐将标准疗法(促肾上腺皮质激素[ACTH]、大剂量泼尼松龙和氨己烯酸)作为IS的首选治疗方法。尽管该推荐并未表明对某一种标准疗法更青睐,但与氨己烯酸相比,激素疗法(ACTH和大剂量泼尼松龙)的早期缓解率更高。我们采用包括激素疗法作为首选治疗方法的质量改进(QI)方法,试图将新发性非结节性硬化症(TSC)相关IS患儿3个月实现电临床缓解的比例从平均53.8%提高到≥70%。

方法

这是一项在一家单一的学术三级护理医院进行的观察性连续样本队列研究,将一个前瞻性干预队列(2019年5月至2022年1月,N = 57)与一个回顾性基线队列(2015年11月至2019年4月,N = 67)进行比较。我们的举措解决了一些关键驱动因素,比如常规将氨己烯酸而非激素疗法作为首选治疗方法,以及对于初始无反应者在14天后通常开始第二种治疗。我们纳入了年龄在2至24个月之间、无TSC且新发性IS确诊并接受治疗的连续患儿。我们将主要结局和过程指标以控制图的形式展示,其中中心线是基于统计过程控制方法得出的季度(前3个月)平均值。

结果

包括将激素疗法标准化作为首选治疗方法的QI干预措施使3个月缓解率更高,从53.8%(基线队列)升至75.9%(干预队列)。过程指标结果包括接受激素疗法作为首选治疗的患儿比例增加(平均值,从44.6%至100%),首次治疗后至临床随访的天数减少(平均值,从16.3天至12.6天),以及对于初始无反应者在14天内开始第二种治疗的天数减少(平均值,从36.3天至17.2天)。

讨论

对于IS患儿,采用QI方法可提高3个月电临床缓解率。在其他中心实施类似的QI举措同样可能提高当地的缓解率。

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