METHODS: 106 patients aged ≥ 16 years were recruited consecutively in this single-center prospective observational study. All patients received LCM as an add-on treatment on the basis of clinical judgement. Seizure frequency, adverse events (AEs) and retention rates were obtained at 3 and 6 months after LCM introduction.
RESULTS: The overall response rates were 53.3 and 70.4% after 3 and 6 months, respectively, and the freedom of seizures at the same points was reached at 19 and 26.5%. The retention rates were 99.1% at the 3-month follow-up and 93.3% at the 6-month follow-up. The overall incidence of adverse events was 35.8%. The leading AEs were dizziness (16.98%) and sedation (6.6%).
CONCLUSIONS: Our study confirmed the efficacy and tolerability of adjunctive LCM in Chinese patients in real-life conditions. Based on our treatment experience, a universal maintenance dose of LCM would be needed in Chinese patients.
方法:在这项单中心前瞻性观察研究中,连续招募了106名年龄≥16岁的患者。所有患者均根据临床判断接受LCM作为附加治疗。癫痫发作频率,在引入LCM后3个月和6个月获得了不良事件(AE)和保留率.
结果:3个月和6个月后的总有效率分别为53.3和70.4%,分别,相同时间点的癫痫发作自由度分别为19%和26.5%。随访3个月时保留率为99.1%,随访6个月时保留率为93.3%。不良事件的总发生率为35.8%。主要的不良事件是头晕(16.98%)和镇静(6.6%)。
结论:我们的研究证实了辅助性LCM在中国患者现实生活中的疗效和耐受性。根据我们的治疗经验,中国患者需要普遍维持剂量的LCM。