Shechter Tamar, Shorer Zamir, Kramer Uri, Lerman-Sagie Tally, Ronen Elisheva, Rotem Rimona, Gorodischer Rafael
Pharmacy Services, Soroka Medical Center, Be'er Sheva, Israel.
Pharmacoepidemiol Drug Saf. 2005 Mar;14(3):187-92. doi: 10.1002/pds.1041.
To review the adverse drug reactions (ADRs) of Topiramate and Lamotrigine among children in Israel, and to compare the two drugs, based on their side effect profile and tolerability among this population.
We performed a cross-sectional study. Four paediatric neurologists from three different tertiary medical centres in Israel documented all cases of children from birth to the age 18 years, treated with Topiramate and/or Lamotrigine in their respective outpatient clinics and hospital wards. All present ADRs and their characteristics were recorded.
Reports on 45 and 65 children treated with Topiramate and Lamotrigine respectively, were received. Half of the children treated with Topiramate suffered from one or more ADRs, as opposed to one-third of the children treated with Lamotrigine (p = 0.03). Most reactions were considered mild to moderate. There were no deaths or hospitalisations, but the drug had to be discontinued in about 10% of the patients due to ADRs. Most Topiramate and Lamotrigine ADRs appeared early in the treatment and were more frequent when Topiramate was an add-on versus a monotherapy drug. Most ADRs of both Topiramate and Lamotrigine were related to the central nervous system; while poor appetite, drowsiness, speech difficulties and weight loss were observed only with Topiramate, and rash and headaches only with Lamotrigine. Nervousness and seizure aggravation were more frequent ADRs of Topiramate whereas sleep disturbances were observed more in children treated with Lamotrigine.
Results of this study indicate that Lamotrigine causes ADRs less frequently than Topiramate; however both medications are generally well tolerated. Topiramate and Lamotrigine differ in their central nervous system side effect profile.
回顾以色列儿童使用托吡酯和拉莫三嗪后的药物不良反应（ADR），并根据这两种药物在此人群中的副作用特征和耐受性进行比较。
我们进行了一项横断面研究。来自以色列三个不同三级医疗中心的四名儿科神经科医生记录了各自门诊和医院病房中所有接受托吡酯和/或拉莫三嗪治疗的18岁以下儿童病例。记录了所有出现的ADR及其特征。
分别收到了45名和65名接受托吡酯和拉莫三嗪治疗儿童的报告。接受托吡酯治疗的儿童中有一半出现了一种或多种ADR，而接受拉莫三嗪治疗的儿童中这一比例为三分之一（p = 0.03）。大多数反应被认为是轻度至中度。没有死亡或住院情况，但约10%的患者因ADR不得不停药。大多数托吡酯和拉莫三嗪的ADR在治疗早期出现，且当托吡酯作为附加药物而非单一疗法药物时更频繁。托吡酯和拉莫三嗪的大多数ADR都与中枢神经系统有关；而仅在托吡酯治疗中观察到食欲减退、嗜睡、言语困难和体重减轻，仅在拉莫三嗪治疗中观察到皮疹和头痛。紧张和癫痫加重是托吡酯更常见的ADR，而睡眠障碍在接受拉莫三嗪治疗的儿童中更常见。
本研究结果表明，拉莫三嗪引起ADR的频率低于托吡酯；然而，两种药物总体耐受性良好。托吡酯和拉莫三嗪在中枢神经系统副作用方面存在差异。
