左乙拉西坦治疗婴儿痉挛症的疗效

Curative Effect of Levetiracetam for Infantile Spasms

目的探讨左乙拉西坦(LEV)对婴儿痉挛症(IS)的疗效和安全性。方法对武汉市4家医院进行多中心联合研究。采用前瞻性研究,制定严格研究方案,统一纳入标准和排除标准,选择完成3个月以上疗程的IS患儿13例。男10例,女3例;年龄2.5～24个月。LEV起始剂量10mg/(kg.d),每周添加10mg/(kg.d)至最小有效剂量;治疗期间检测肝、肾功能及血常规,每2～4周门诊或电话随访1次,密切观察临床疗效及不良事件,应用3个月以上评价临床疗效。结果完全缓解4例(30.8%),有效5例(38.5%),无效4例(30.8%);LEV起效剂量(17.772±9.511)mg/(kg.d),完全缓解剂量(20.938±6.084)mg/(kg.d);起效时间(1.50±0.535)周,完全缓解时间(6.750±6.602)周。4例出现不良反应(30.8%),食欲下降、嗜睡各2例(各15.4%),未见严重致死性不良反应,治疗期间未见肝、肾功能及血常规异常改变。结论LEV治疗IS具有良好疗效及安全性。

Objective To explore the efficacy and safety of levetiracetam for infantile spasms （IS）. Methods In this prospective multi - centre and open - label study, 13 patients （ 10 male and 3 female ; aged 2.5 - 24 months） with IS were treated with LEV and followed up for 3 months. The starting dose was 10 mg/（ kg . d） and the dosage increased by 10 mg/（ kg . d）each week, up to the least effective dosage. During LEV treatment, blood samples were obtained for routine laboratory examination. Seizure frequency and adverse events were reported directly to physicians in charge of the patients by telephone or in the out - patient department per 2 to 4 weeks. Treatment was evaluated in the third months. Results Four subjects （30.8%） was free from seizure,5 cases （38.5%） had at least 50% reduction in seizures, and 4 cases （30.8%） had no change in seizure frequency. Mean effective dose （17. 772 ± 9. 511 ） rag/（ kg . d） was obtained, and seizure free dose was （20. 938 ± 6. 084） mg/（ kg . d）. The mean time interval between the start of LEV therapy and the reduction ≥50% of seizures was （1.50 ± 0. 535 ） weeks, and the time between the start and seizure free was （6.750 ± 6. 602 ） weeks. Side effects of LEV occurred in 4 （30.8%） subjects, including poor appetite （2 cases, 15.4% ） and somnolence （2 cases, 15.4% ）. No abnormal change of routine laboratory examination occurred during the LEV therapy. None had life threatening adverse events. Conclusions LEV is effective and well tolerated in patients with IS.