Jacoby Ann, Sudell Maria, Tudur Smith Catrin, Crossley Joanne, Marson Anthony G, Baker Gus A
Department of Public Health &Policy, University of Liverpool, Liverpool, United Kingdom.
Epilepsia. 2015 Mar;56(3):460-72. doi: 10.1111/epi.12913. Epub 2015 Jan 29.
To compare quality-of-life (QoL) outcomes over 2 years following initiation of treatment with a standard or newer antiepileptic drug (AED) in adults with new-onset epilepsy. To examine the impact of seizure remission and failure of initial treatment on QoL outcomes measured over 2 years.
We conducted a pragmatic, randomized, unblinded, multicenter, parallel-group clinical trial (the Standard and New Antiepileptic Drugs [SANAD] trial) comparing clinical and cost effectiveness of initiating treatment with carbamazepine versus lamotrigine, gabapentin, oxcarbazepine and topiramate, and valproate versus lamotrigine and topiramate. QoL data were collected by mail at baseline, 3 months, and at 1 and 2 years using validated measures. These data were analyzed using longitudinal data models. Continuous QoL measures, time to 12-month remission and time to treatment withdrawal were explored using joint models.
Baseline questionnaires were returned by 1,575 adults; 1,439 returned the 3-month questionnaire, 1,274 returned the 1-year questionnaire, and 1,121 returned the 2-year questionnaire. There were few statistically significant differences between drugs over 2 years in QoL outcomes. Significant association was identified between QoL scores over the 2-year time frame and the risk of experiencing a 12-month remission or treatment withdrawal over that period.
The choice of initial treatment had no significant effect on QoL by 2-year follow-up. However, overall QoL was reduced with continued seizures, adverse events, and failure of the initial treatment.
比较新诊断癫痫的成人患者开始使用标准或新型抗癫痫药物(AED)治疗2年后的生活质量(QoL)结果。研究发作缓解和初始治疗失败对2年期间所测量的QoL结果的影响。
我们进行了一项实用、随机、非盲、多中心、平行组临床试验(标准与新型抗癫痫药物[SANAD]试验),比较卡马西平与拉莫三嗪、加巴喷丁、奥卡西平、托吡酯起始治疗的临床和成本效益,以及丙戊酸盐与拉莫三嗪和托吡酯起始治疗的临床和成本效益。使用经过验证的测量方法,在基线、3个月、1年和2年时通过邮件收集QoL数据。使用纵向数据模型对这些数据进行分析。使用联合模型探索连续QoL测量、12个月缓解时间和治疗停药时间。
1575名成年人返回了基线问卷;1439人返回了3个月问卷,1274人返回了1年问卷,1121人返回了2年问卷。2年期间,不同药物在QoL结果方面几乎没有统计学上的显著差异。在2年时间框架内的QoL评分与该期间经历12个月缓解或治疗停药的风险之间存在显著关联。
到2年随访时,初始治疗的选择对QoL没有显著影响。然而,持续发作、不良事件和初始治疗失败会降低总体QoL。