Wong I C, Mawer G E, Sander J W
Pharmacy Practice, School of Pharmacy, University of Bradford, Bradford, BD7 1DP, UK.
Epilepsia. 2001 Feb;42(2):237-44. doi: 10.1046/j.1528-1157.2001.254001.x.
This postmarketing surveillance study of lamotrigine (LTG) was performed to provide complementary data to large-scale Prescription-Event Monitoring study with a retrospective case records survey in five tertiary referral epilepsy centres in the United Kingdom.
Adverse events were recorded and compared with those of two other new antiepileptic drugs (AEDs), gabapentin (GBP) and vigabatrin (VGB). All deaths were followed up and standardised mortality ratios (SMRs) were calculated. Serious adverse events were assessed individually.
A total of 2,701 patients was identified as being exposed to LTG and/or the comparators. It was necessary to exclude 1,326 patients because LTG and/or comparators had been commenced outside the study centres. The adverse events with LTG reported by this study were similar to those reported in the literature. Skin rash was the major adverse event. Life-threatening hepatic failure, acute exacerbation of ulcerative colitis, disseminated intravascular coagulation, and renal failure were reported. No death could be directly attributed to the use of LTG. The SMR was slightly higher than that reported in the literature; this probably reflects severity of epilepsy in the study population.
The safety profile of LTG was similar to that in the large-scale Prescription-Event Monitoring study and generally acceptable. Life-threatening adverse reactions were rare.
本拉莫三嗪（LTG）上市后监测研究旨在通过对英国5家三级转诊癫痫中心的回顾性病例记录调查，为大规模处方事件监测研究提供补充数据。
记录不良事件，并与另外两种新型抗癫痫药物（AEDs）加巴喷丁（GBP）和vigabatrin（VGB）的不良事件进行比较。对所有死亡病例进行随访并计算标准化死亡率（SMR）。对严重不良事件进行单独评估。
共识别出2701例暴露于LTG和/或对照药物的患者。由于LTG和/或对照药物是在研究中心以外开始使用的，因此有必要排除1326例患者。本研究报告的LTG不良事件与文献报道的相似。皮疹是主要不良事件。报告了危及生命的肝衰竭、溃疡性结肠炎急性加重、弥散性血管内凝血和肾衰竭。没有死亡可直接归因于LTG的使用。SMR略高于文献报道；这可能反映了研究人群中癫痫的严重程度。
LTG的安全性与大规模处方事件监测研究相似，总体上是可接受的。危及生命的不良反应很少见。
