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奥卡西平、拉莫三嗪和左乙拉西坦治疗新诊断局灶性癫痫患者的长期疗效、耐受性及安全性比较:一项真实世界中的观察性研究

Comparison of long-term efficacy, tolerability, and safety of oxcarbazepine, lamotrigine, and levetiracetam in patients with newly diagnosed focal epilepsy: An observational study in the real world.

作者信息

Li Rong, Zhou Qin, Ou Shuchun, Wang Yuxuan, Li Yudan, Xia Li, Pan Songqing

机构信息

Department of Neurology, Renmin Hospital of Wuhan University, Wuhan, Hubei Province, China.

出版信息

Epilepsy Res. 2020 Oct;166:106408. doi: 10.1016/j.eplepsyres.2020.106408. Epub 2020 Jun 26.

Abstract

OBJECTIVE

We performed observational cohort study to compare the long-term efficacy, tolerability, and safety of oxcarbazepine (OXC), lamotrigine (LTG), and levetiracetam (LEV) monotherapy for newly diagnosed focal epilepsy patients.

METHODS

Three hundred and eighty eight newly diagnosed focal epilepsy patients aged 1-70 years were enrolled in this study between June 2009 and March 2016. Among the patients, 191 were treated with OXC, 98 were treated with LTG, and 99 were treated with LEV monotherapy. The study was performed in a real-world setting and the primary outcomes were the one-year and three-year seizure-free rates. The secondary outcomes were the one-year and three-year withdrawal rates, the time to treatment withdrawal, the time to the first seizure, and the time to achieve one-year remission.

RESULTS

The three-year seizure-free rates with LTG (39.8 %) and LEV (41.4 %) were significantly better than that with OXC (26.2 %) (both P < 0.05). However, no significant difference was observed among the three drugs for the one-year seizure-free rate. The three-year withdrawal rate was 50.8 %, 46.9 %, and 43.4 % for OXC, LTG, and LEV, respectively (all P > 0.05). The one-year withdrawal rate for OXC (31.7 %) was higher than those for LTG (30.6 %) and LEV (26.3 %) (all P > 0.05). LEV [Relative Risk (RR) = 0.69, 95 % CI: 0.49∼0.99] and LTG (RR = 0.63, 95 % CI: 0.44∼0.9) were significantly better than OXC in preventing first seizure. LEV appears to be the superior option with regard to the time to achieve one-year remission.

SIGNIFICANCE

The results of the study showed that LEV and LTG are significantly more effective than OXC for the treatment of newly diagnosed focal epilepsy. LEV has milder adverse events than OXC and LTG in clinical practice.

摘要

目的

我们开展了一项观察性队列研究,以比较奥卡西平(OXC)、拉莫三嗪(LTG)和左乙拉西坦(LEV)单药治疗新诊断局灶性癫痫患者的长期疗效、耐受性和安全性。

方法

2009年6月至2016年3月期间,388例年龄在1至70岁的新诊断局灶性癫痫患者纳入本研究。其中,191例接受OXC治疗,98例接受LTG治疗,99例接受LEV单药治疗。本研究在真实环境中进行,主要结局为一年和三年无癫痫发作率。次要结局为一年和三年撤药率、撤药时间、首次发作时间以及达到一年缓解的时间。

结果

LTG(39.8%)和LEV(41.4%)的三年无癫痫发作率显著优于OXC(26.2%)(均P<0.05)。然而,三种药物的一年无癫痫发作率未观察到显著差异。OXC、LTG和LEV的三年撤药率分别为50.8%、46.9%和43.4%(均P>0.05)。OXC的一年撤药率(31.7%)高于LTG(30.6%)和LEV(26.3%)(均P>0.05)。在预防首次发作方面,LEV[相对危险度(RR)=0.69,95%可信区间:0.49至0.99]和LTG(RR=0.63,95%可信区间:0.44至0.9)显著优于OXC。在达到一年缓解的时间方面,LEV似乎是更优选择。

意义

研究结果表明,LEV和LTG治疗新诊断局灶性癫痫比OXC显著更有效。在临床实践中,LEV的不良事件比OXC和LTG更轻。

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