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目的评价左乙拉西坦(LEV)对促皮质素(ACTH)治疗失败婴儿痉挛症的疗效和安全性。方法选择中南大学湘雅医院儿科2007年9月-2008年10月接受ACTH治疗的21例婴儿症挛症患儿,对其中8例ACTH治疗失败后进行序贯LEV治疗的婴儿痉挛症患儿进行开放性自身对照随访研究。依据下列标准判断疗效,(1)完全控制:发作频率减少100%,VEEG未见高度失律;(2)显效:发作频率减少≥75%,VEEG清醒状态下未见高度失律;(3)有效:发作频率减少≥50%且<75%,VEEG清醒状态下可见间断高度失律;(4)无效:发作频率减少<50%,VEEG未见明显改善;(5)加重:发作频度增加>25%,VEEG未见明显改善。结果 8例患儿均随访4～12个月。总有效率为87.5%(7/8例),4例(50.0%)完全控制,2例(25.0%)有效,显效、无效各1例(各12.5%)。5例出现不良反应,包括乏力3例,嗜睡、激惹2例,主要表现为激惹。不良反应主要出现在治疗4周内,未见肝肾功能损害或血液学改变等严重不良事件发生。结论 LEV能有效改善ACTH治疗失败的婴儿痉挛症患儿的癫发作,且具有良好的安全性。
Objective To evaluate the efficacy and safety of levetiracetam (LEV) in infantile spasms with failed corticotropin (ACTH) treatment. METHODS: A total of 21 infantile schizophrenia patients treated with ACTH from September 2007 to October 2008 in the Department of Pediatrics, Xiangya Hospital of Central South University, and 8 infants with infantile spasms who were treated with sequential LEV Open self-control follow-up study. According to the following criteria to determine the efficacy, (1) complete control: 100% reduction in seizure frequency, VEEG no high degree of irregularity; (2) markedly effective: seizure frequency reduction of 75%, VEEG sober state, Effective: Seizure frequency reduced by ≥50% and <75%, VEEG awake state can be seen intermittent height loss; (4) invalid: seizure frequency decreased by <50%, VEEG no significant improvement; > 25%, VEEG no significant improvement. Results 8 cases of children were followed up for 4 to 12 months. The total effective rate was 87.5% (7/8 cases), 4 cases (50.0%) were completely controlled, 2 cases (25.0%) were effective, one was markedly effective and one was ineffective (12.5% each). 5 cases of adverse reactions, including fatigue in 3 cases, lethargy, irritation in 2 cases, mainly manifested as irritation. Adverse reactions mainly in the treatment of 4 weeks, no liver and kidney dysfunction or hematologic changes and other serious adverse events occurred. Conclusions LEV can effectively improve the epileptic seizures in children with infantile spasms failing ACTH and has good safety.