Chen Yuncan, Wang Qinyue, Xu Ye, Wu Dongyan, Xu Lan, Zhu Guoxing, Wu Xunyi
Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
National Center for Neurological Disorders, Shanghai, China.
Front Neurol. 2022 Jun 10;13:855498. doi: 10.3389/fneur.2022.855498. eCollection 2022.
We performed a prospective cohort study to compare the efficacy, safety, effect on mood, and quality of life between lamotrigine (LTG) and oxcarbazepine (OXC) monotherapy among Chinese adult patients with newly-diagnosed focal-onset epilepsy (FOE) with or without secondarily generalized tonic-clonic seizures.
We enrolled 106 adult patients with new-onset FOE, of whom 56 were in the OXC group and 50 in the LTG group. Their clinical characteristics were detailly recorded especially basic seizure frequency, seizure types, and drug-related adverse events. Efficacy was evaluated as seizure-free (no seizure for 6 months), effective (seizure reduction by more than 50%), and ineffective (seizure reduction by less than 50%). Both intention-to-treat and per-protocol analyses were performed. We also assessed their mood state with the Zung Self-rating Scale for anxiety (Z-SAS) and Zung Self-rating Scale for Depression (Z-SDS) and quality of life (QOL) with Quality of Life in Epilepsy (QOLIE-31) at their baseline visit, 3-month visits, and 6-month visit. Intra-group comparisons in each group and inter-group comparisons between the two groups were made. Correlation analysis and multiple regression analysis were also conducted.
Except for gender, the two groups were well matched in any other characteristics such as primary seizure frequency and seizure types. In terms of efficacy, 33 patients in the OXC group were evaluated as seizure-free and 15 as effective, while in the LTG group, 31 were seizure-free, and nine were effective. No significant differences could be observed in efficacy between the two groups ( = 0.429). Through multiple logistic regression analysis, we found that OXC monotherapy was more likely to predict a seizure-free state (OR = 1.76) than LTG, but the difference didn't reach statistical significance ( = 0.322) after correcting for other clinical variables. Both groups had adverse events such as fatigue, drowsiness, dizziness, rash, and gastrointestinal discomfort, most of which were mild and transient. In the OXC group, the scores of SAS ( = 0.067) and SDS ( = 0.004) reduced at the 6-month visit, while the score of QOLIE-31 significantly increased ( = 0.001). In the LTG group, a significant decrease in SAS and SDS scores and an increase in QOLIE-31 scores could be witnessed (All < 0.001). The inter-group comparison showed that improvement of SAS and SDS in the LTG group was more evident than that in the OXC group, which was of statistical significance. Correlational analysis indicated that the improvement of mood and life quality scales in both groups was independent of baseline seizure frequency and treatment efficacy. Multiple linear regression analysis indicated that LTG monotherapy was the only independent factor that could predict a better SAS ( = 0.01) and SDS ( = 0.019) outcome.
OXC and LTG are effective as monotherapy and can be considered first-line selection among adult patients with new-onset FOE. Most adverse events are mild, transient, and tolerable. The two drugs improve the mood state of patients, though LTG is superior to OXC in this respect. OXC and LTG have great power in enhancing patients' quality of life. The positive effect on the psychosocial well-being of epilepsy patients may be one of the intrinsic pharmacological properties of LTG and OXC.
我们进行了一项前瞻性队列研究,以比较拉莫三嗪(LTG)和奥卡西平(OXC)单药治疗对中国新诊断的局灶性发作癫痫(FOE)成年患者(伴或不伴继发全面性强直阵挛发作)的疗效、安全性、情绪影响及生活质量。
我们纳入了106例新发FOE成年患者,其中56例在OXC组,50例在LTG组。详细记录他们的临床特征,尤其是基本发作频率、发作类型及药物相关不良事件。疗效评估为无发作(6个月无发作)、有效(发作减少超过50%)及无效(发作减少少于50%)。进行了意向性分析和符合方案分析。我们还在基线访视、3个月访视和6个月访视时,用焦虑自评量表(Z-SAS)和抑郁自评量表(Z-SDS)评估他们的情绪状态,并用癫痫生活质量量表(QOLIE-31)评估生活质量。进行了每组内的组内比较及两组间的组间比较。还进行了相关性分析和多元回归分析。
除性别外,两组在其他特征如初始发作频率和发作类型方面匹配良好。在疗效方面,OXC组33例患者评估为无发作,15例有效,而LTG组31例无发作,9例有效。两组疗效无显著差异(=0.429)。通过多元逻辑回归分析,我们发现OXC单药治疗比LTG更有可能预测无发作状态(OR=1.76),但校正其他临床变量后差异未达到统计学意义(=0.322)。两组均有疲劳、嗜睡、头晕、皮疹和胃肠道不适等不良事件,大多为轻度且短暂。在OXC组,6个月访视时SAS(=0.067)和SDS(=0.004)评分降低,而QOLIE-31评分显著升高(=0.001)。在LTG组,可观察到SAS和SDS评分显著降低,QOLIE-31评分升高(均<0.001)。组间比较显示,LTG组SAS和SDS的改善比OXC组更明显,具有统计学意义。相关性分析表明,两组情绪和生活质量量表的改善与基线发作频率和治疗疗效无关。多元线性回归分析表明,LTG单药治疗是唯一能预测更好的SAS(=0.01)和SDS(=0.019)结果的独立因素。
OXC和LTG作为单药治疗有效,可被视为新诊断FOE成年患者的一线选择。大多数不良事件为轻度、短暂且可耐受。两种药物均改善患者情绪状态,尽管LTG在这方面优于OXC。OXC和LTG在提高患者生活质量方面有很大作用。对癫痫患者心理社会福祉的积极影响可能是LTG和OXC的内在药理学特性之一。