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左乙拉西坦在伴有和不伴有智力障碍人群中的疗效和耐受性:一项自然病例对照研究。

Efficacy and tolerability of levetiracetam in people with and without intellectual disabilities: A naturalistic case control study.

机构信息

Cornwall Intellectual Disability Equitable Research (CIDER) Cornwall Partnership NHS Foundation Trust, United Kingdom; CIDER, Peninsula School of medicine, University of Plymouth, United Kingdom.

Cornwall Intellectual Disability Equitable Research (CIDER) Cornwall Partnership NHS Foundation Trust, United Kingdom.

出版信息

Seizure. 2024 Aug;120:25-32. doi: 10.1016/j.seizure.2024.05.010. Epub 2024 May 16.

Abstract

INTRODUCTION

People with Intellectual Disabilities (PwID) are twenty times more likely than general population to have epilepsy. Guidance for prescribing antiseizure medication (ASM) to PwID is driven by trials excluding them. Levetiracetam (LEV) is a first-line ASM in the UK. Concerns exist regarding LEV's behavioural and psychological adverse effects, particularly in PwID. There is no high-quality evidence comparing effectiveness and adverse effects in PwID to those without, prescribed LEV.

METHODS

Pooled casenote data for patients prescribed LEV (2000-2020) at 18 UK NHS Trusts were analysed. Demographics, starting and maximum dose, adverse effects, dropouts and seizure frequency between ID (mild vs. moderate-profound (M/P)) and general population for a 12-month period were compared. Descriptive analysis, Mann-Whitney, Fisher's exact and logistic regression methods were employed.

RESULTS

173 PwID (mild 53 M/P 120) were compared to 200 without ID. Mean start and maximum dose were similar across all groups. PwID (Mild & M/P) were less likely to withdraw from treatment (P = 0.036). No difference was found between ID and non-ID or between ID groups (Mild vs M/P) in LEV's efficacy i.e. >50 % seizure reduction. Significant association emerged between ID severity and psychiatric adverse effects (P = 0.035). More irritability (14.2 %) and aggression (10.8 %) were reported in M/P PwID.

CONCLUSION

PwID and epilepsy have high rates of premature mortality, comorbidities, treatment resistance and polypharmacy but remain poorly researched for ASM use. This is the largest studied cohort of PwID trialled on LEV compared to general population controls. Findings support prescribing of LEV for PwID as a first-line ASM.

摘要

简介

智障人士(PwID)患癫痫的可能性是普通人群的二十倍。为 PwID 开具抗癫痫药物(ASM)的指南是基于排除他们的临床试验制定的。左乙拉西坦(LEV)是英国的一线 ASM。人们对 LEV 的行为和心理不良反应存在担忧,尤其是在 PwID 中。没有高质量的证据表明 PwID 与非 PwID 患者在 LEV 治疗的有效性和不良反应方面存在差异。

方法

对 18 家英国 NHS 信托机构在 2000 年至 2020 年期间为接受 LEV 治疗的患者(173 名 PwID(轻度 53 名 M/P 120 名)和 200 名非 PwID)的 pooled casenote 数据进行了分析。比较了 ID(轻度 vs. 中度-重度(M/P))和普通人群在 12 个月期间的人口统计学特征、起始剂量和最大剂量、不良反应、停药率和癫痫发作频率。采用描述性分析、Mann-Whitney、Fisher 精确检验和逻辑回归方法。

结果

173 名 PwID(轻度 53 名 M/P 120 名)与 200 名非 PwID 进行了比较。所有组的起始剂量和最大剂量相似。PwID(轻度和 M/P)停药的可能性较小(P = 0.036)。在 LEV 的疗效方面,ID 和非 ID 之间或 ID 组(轻度 vs M/P)之间没有差异,即>50%的癫痫发作减少。ID 严重程度与精神不良反应之间存在显著关联(P = 0.035)。M/P PwID 中报告了更多的烦躁(14.2%)和攻击行为(10.8%)。

结论

智障人士和癫痫患者的死亡率、合并症、治疗抵抗和药物滥用率都很高,但针对 ASM 使用的研究仍然很少。这是迄今为止针对 LEV 对 PwID 进行的最大规模研究,与普通人群对照。研究结果支持将 LEV 作为一线 ASM 用于 PwID。

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