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目的评价左乙拉西坦(LEV)治疗≤4岁儿童癫癎的疗效及安全性。方法采用开放性、自身对照研究方法 ,选择2007年9月-2008年11月本院年龄4个月～4岁的癫癎患儿70例。应用LEV治疗,其中添加治疗组52例,单药治疗组18例。LEV起始剂量62.5～250.0mg·d-1(7.8～20.0mg·kg-1.d-1),每周增加62.5～250.0mg·d-1,加量期0～7周,目标剂量250.0～1000.0mg·d-1(14.7～70.0mg·kg-1·d-1)。观察其疗效及不良反应。结果失访3例,2例因经济困难停药,65例随防时间≥6个月。添加治疗组总有效率为70.8%(34/48例),无发作率为16.7%(8/48例);单药治疗组总有效率为82.4%(14/17例),无发作率为35.3%(6/17例)。二组总有效率和无发作率比较差异均无统计学意义(χ2=0.2、0.9,Pa>0.05)。肌阵挛发作总有效率为83.3%(5/6例),局限/泛化全面发作总有效率82.8%(24/29例),全身强直/阵挛发作总有效率80.0%(8/10例),婴儿痉挛发作总有效率58.3%(7/12例),Lennox-Gastaut综合征总有效率57.1%(4/7例)。1例失张力发作无效。不良反应:行为异常7.7%(5/65例),食欲差4.6%(3/65例),嗜睡3.1%(2/65例),便秘1.5%(1/65例)。无因不良反应停药者。结论 LEV添加治疗或单药治疗≤4岁儿童各种类型癫癎,疗效好、安全、不良反应轻,是婴幼儿癫癎治疗的理想选择。
Objective To evaluate the efficacy and safety of levetiracetam (LEV) in the treatment of epilepsy in children younger than 4 years old. Methods A total of 70 children with epilepsy aged 4 months to 4 years old in our hospital from September 2007 to November 2008 were selected as the open and self-controlled study. Application of LEV treatment, including the treatment group of 52 patients, monotherapy group of 18 patients. The initial dose of LEV was 62.5 ~ 250.0mg · d-1 (7.8 ~ 20.0mg · kg-1.d-1), with an increase of 62.5 ~ 250.0mg · d-1 every week. The dosage of LEV was 0 ~ 7 weeks and the target dose was 250.0 To 1000.0 mg · d -1 (14.7 to 70.0 mg · kg -1 · d -1). Observe its efficacy and adverse reactions. Results There were 3 patients lost to follow-up, 2 patients discontinued due to financial difficulties, and 65 patients were stopped ≥6 months. The total effective rate of the treatment group was 70.8% (34/48 cases) and no seizure rate was 16.7% (8/48 cases). The total effective rate of the single treatment group was 82.4% (14/17 cases) 35.3% (6/17 cases). There was no significant difference between the two groups in total effective rate and non-seizure rate (χ2 = 0.2,0.9, Pa> 0.05). The total effective rate of myoclonus episodes was 83.3% (5/6 cases), the total effective rate was 82.8% (24/29 cases) for generalized / generalized seizures and 80.0% (8/10) for general tonic / clonic seizures ), The total effective rate of infantile spasms was 58.3% (7/12 cases), Lennox-Gastaut syndrome’s total effective rate was 57.1% (4/7 cases). One case of loss of tension onset invalid. Adverse reactions: Behavioral abnormalities 7.7% (5/65 cases), poor appetite 4.6% (3/65 cases), drowsiness 3.1% (2/65 cases), constipation 1.5% (1/65 cases). No due to adverse drug withdrawal. Conclusion LEV treatment or monotherapy in children with various types of ≤ 4 years of epilepsy, good efficacy, safety, adverse reactions, ideal for infantile epilepsy treatment.