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左乙拉西坦口服溶液治疗部分性发作癫痫的可接受性和耐受性:SOLUCIÓN研究

Acceptability and tolerability of levetiracetam oral solution for the treatment of partial-onset seizures: the SOLUCIÓN study.

作者信息

Matías-Guíu J, Molins A, Mauri J A, Villar E

机构信息

Hospital Universitario Clínico San Carlos, Madrid, Spain.

出版信息

Methods Find Exp Clin Pharmacol. 2010 Sep;32(7):507-16. doi: 10.1358/mf.2010.32.7.1472183.

DOI:10.1358/mf.2010.32.7.1472183
PMID:21069102
Abstract

This cross-sectional, observational study evaluated the use of levetiracetam oral solution in usual clinical practice. Patients ≥ 16 years with partial-onset seizures (had received levetiracetam oral solution for ≥ 28 days) completed a study questionnaire assessing overall acceptability of levetiracetam oral solution, specific organoleptic characteristics (taste, taste intensity, aftertaste), ease of use and convenience. Tolerability was assessed by evaluating adverse events. Of 389 patients, 92.8% (361/389) were evaluable for acceptability, all (389) for tolerability; 65.3% (236/361) rated levetiracetam oral solution very acceptable or acceptable, 41.5% (150/361) pleasant or very pleasant, 54.3% (196/361) neither strong nor mild taste intensity and indicated the drug left an aftertaste (most stated aftertaste did not bother them), 75.3% very easy or easy to use and 61.8% very convenient or convenient to use. There was a positive relationship between overall acceptability of levetiracetam oral solution and favorable responses for organoleptic characteristics, ease of use, convenience and patients' evaluation of treatment compliance (P < 0.0001 for each). Of the 176/353 who previously received another antiepileptic drug and reported preference for a medication, 72.2% (127/176) preferred levetiracetam oral solution and 39/389 (10%) reported adverse events. Levetiracetam oral solution demonstrated a high degree of patient acceptability in adult patients with partial-onset seizures and was well tolerated.

摘要

这项横断面观察性研究评估了左乙拉西坦口服溶液在常规临床实践中的使用情况。年龄≥16岁的部分性发作患者(已接受左乙拉西坦口服溶液治疗≥28天)完成了一份研究问卷,该问卷评估了左乙拉西坦口服溶液的总体可接受性、特定感官特性(味道、味道强度、余味)、易用性和便利性。通过评估不良事件来评估耐受性。在389例患者中,92.8%(361/389)可评估可接受性,全部389例可评估耐受性;65.3%(236/361)将左乙拉西坦口服溶液评为非常可接受或可接受,41.5%(150/361)评为愉快或非常愉快,54.3%(196/361)评为味道强度既不强烈也不轻微,并表示药物有后味(大多数表示后味不困扰他们),75.3%评为非常容易或容易使用,61.8%评为非常方便或方便使用。左乙拉西坦口服溶液的总体可接受性与对感官特性、易用性、便利性的良好反应以及患者对治疗依从性的评估之间存在正相关关系(每项P<0.0001)。在之前接受过另一种抗癫痫药物并报告对某种药物有偏好的176/353例患者中,72.2%(127/176)更喜欢左乙拉西坦口服溶液,39/389(10%)报告了不良事件。左乙拉西坦口服溶液在成年部分性发作患者中显示出高度的患者可接受性,并且耐受性良好。

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