Beavis Janine, Meek Andrea, Felce David, Kerr Michael
Welsh Centre for Learning Disabilities, School of Medicine, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff CF14 4YS, Wales, UK.
Seizure. 2009 May;18(4):279-84. doi: 10.1016/j.seizure.2008.11.001. Epub 2008 Dec 11.
To investigate the efficacy and safety of levetiracetam in adults with intellectual disabilities who have uncontrolled partial or generalised epilepsy.
An open label prospective study compared seizure frequency, adverse effects, participant challenging behaviour, carers' concerns about epilepsy and perceived participant quality of life between a baseline observation prior to the use of levetiracetam and follow-up observations at 3, 6, 9 and 12 months afterwards. Challenging behaviour, carers' concerns about epilepsy and perceived quality of life were assessed using standardized measures.
Recruitment was low (n=42). Six participants did not enter the trial. Two participants withdrew at initiation of treatment, one with seizures worsening and one with a rash, and a further one later on with a rash; all were felt to be drug related. Three other participants withdrew for independent reasons. Twelve months follow-up was achieved for 26 participants (62%) and at least 6 months follow-up for 30 participants (71%). Median seizure frequency reduced from baseline levels of 4.2 per week to average post-intervention levels of 2.2 for the 30 participants (z=-2.53, p<.05). No overall change in challenging behaviour was found, although increases in behaviour problems were reported for a minority. Patient concerns about seizures and medical treatment declined and perceived quality of life relating to seizure severity improved whilst that related to behaviour deteriorated. Increased adverse effects were reported immediately after initiation of levetiracetam but declined towards baseline levels by study completion.
Conclusions must remain tentative due to methodological weaknesses. Further investigation of the possible changes found here within a controlled study is merited.
探讨左乙拉西坦对患有无法控制的部分性或全身性癫痫的成年智障患者的疗效和安全性。
一项开放标签前瞻性研究比较了在使用左乙拉西坦之前的基线观察与之后3、6、9和12个月的随访观察之间的癫痫发作频率、不良反应、参与者的攻击性行为、护理人员对癫痫的担忧以及感知到的参与者生活质量。使用标准化测量方法评估攻击性行为、护理人员对癫痫的担忧以及感知到的生活质量。
招募人数较少（n = 42）。6名参与者未进入试验。2名参与者在治疗开始时退出，1名癫痫发作恶化，1名出现皮疹，另有1名后来出现皮疹；所有这些都被认为与药物有关。另外3名参与者因独立原因退出。26名参与者（62%）完成了12个月的随访，30名参与者（71%）完成了至少6个月的随访。30名参与者的癫痫发作中位数频率从基线水平的每周4.2次降至干预后的平均水平2.2次（z = -2.53，p <.05）。虽然少数人报告行为问题增加，但未发现攻击性行为有总体变化。患者对癫痫发作和医疗治疗的担忧减少，与癫痫发作严重程度相关的感知生活质量有所改善，而与行为相关的感知生活质量则恶化。在开始使用左乙拉西坦后立即报告不良反应增加，但在研究结束时降至基线水平。
由于方法学上的弱点，结论必须保持暂定。值得在对照研究中对这里发现的可能变化进行进一步研究。
