唑尼沙胺作为中国局灶性或继发性双侧强直阵挛性癫痫患者首次附加治疗的疗效和安全性：一项观察性前瞻性研究。
Efficacy and safety of zonisamide as the first additional treatment in Chinese patients with focal or secondary bilateral tonic-clonic seizures: An observational ,prospective study.
作者信息
Han Tao, Jin Yang, Jiang Jing
机构信息
Department of Neurology, Qilu Hospital of Shandong University, China.
Department of Neurology, Shandong Provincial Hospital, Shandong University, China.
出版信息
Heliyon. 2023 Jun 20;9(7):e17384. doi: 10.1016/j.heliyon.2023.e17384. eCollection 2023 Jul.
BACKGROUND
To evaluate the efficacy and safety of zonisamide (ZNS) as the first additional treatment for focal or secondarily bilateral tonic-clonic seizure (sBTCS).
METHODS
A total of 118 patients between 18 and 75 years of age with focal or sBTCS were recruited from multiple hospitals in Shandong province between May 13, 2021, and February 16, 2022. All received ZNS as the first additional treatment after clinical judgment. Seizure frequency, retention, and adverse events (AEs) were assessed 2 and 5 months after the introduction of ZNS.
RESULTS
Overall response rates at 2 and 5 months were 79.5% and 75.5%, respectively, whereas seizure-free rates at the same point were 53.6% and 51%, respectively. The review's retention rates at 2 and 5 months were 95% and 86%, respectively. The most common AEs were anorexia with weight loss (11.8%), dizziness (6.9%), and headache (3.9%).
CONCLUSIONS
Our real-world study confirmed the efficacy and safety of ZNS as a first-additional treatment for focal or sBTCS in Chinese patients, with a high short-term retention rate.
背景
评估唑尼沙胺（ZNS）作为局灶性或继发性双侧强直阵挛性癫痫发作（sBTCS）首次附加治疗的疗效和安全性。
方法
2021年5月13日至2022年2月16日期间，从山东省多家医院招募了118例年龄在18至75岁之间、患有局灶性或sBTCS的患者。所有患者在临床判断后均接受ZNS作为首次附加治疗。在引入ZNS后2个月和5个月评估癫痫发作频率、保留率和不良事件（AE）。
结果
2个月和5个月时的总体缓解率分别为79.5%和75.5%，而同期的无癫痫发作率分别为53.6%和51%。该综述在2个月和5个月时的保留率分别为95%和86%。最常见的不良事件是食欲不振伴体重减轻（11.8%）、头晕（6.9%）和头痛（3.9%）。
结论
我们的真实世界研究证实了ZNS作为中国患者局灶性或sBTCS首次附加治疗的疗效和安全性，短期保留率较高。
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