Gupta Prem P, Thacker Anup Kumar, Haider Jamal, Dhawan Shilpi, Pandey Neerjesh, Pandey Awanish Kumar
Department of Pharmacology, All India Institute of Medical Sciences, Patna, Bihar, India.
Department of Neurology, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.
J Neurosci Rural Pract. 2014 Apr;5(2):144-8. doi: 10.4103/0976-3147.131657.
To study the significance of topiramate (TPM) addition on seizure control in treatment of epilepsy.
A prospective open label add-on trial of TPM addition in patients with epilepsy was done. The events of baseline phase of 12 weeks followed by titration and maintenance phases were recorded. Assessment of the number of seizure and emergent adverse effects was done by a monthly visit for each case.
Reduction of more than 50% mean seizure frequency or response ratio of 0.33 was taken as the criteria for responders.
Normal Z-test for significance of differences between two proportions and Chi-square test for presence of association was applied and mean age, median duration, sex ratio, percentage prevalence were depicted.
Significant responses to TPM in both partial as well as generalized seizures were observed (Z = 6.66, P < 0.001 and Z = 4.185, P < 0.01). The effect was more pronounced in patients with partial seizures. However, the overall response was highly significant (Z = 7.839, P < 0.001). The best response was noted at the dose of 200-300 mg/day (Z = 6.708, P < 0.001). More than 35% cases of partial and generalized seizures reported more than 75% reduction levels. The drug was well tolerated in more than 65% cases for side effects on psychosis, giddiness, and anorexia. Mild side effects were seen only in about less than 35% cases.
TPM was found as a significantly effective add-on anticonvulsant with some limitation or mild side effects.
研究添加托吡酯（TPM）对癫痫治疗中癫痫控制的意义。
对癫痫患者进行了一项前瞻性开放标签添加TPM的试验。记录了为期12周的基线期，随后是滴定和维持期的事件。通过每月对每个病例进行访视来评估癫痫发作次数和出现的不良反应。
平均癫痫发作频率降低超过50%或反应率为0.33被作为反应者的标准。
应用两个比例之间差异显著性的正态Z检验和关联存在情况的卡方检验，并描述了平均年龄、中位病程、性别比、患病率百分比。
观察到TPM对部分性发作和全身性发作均有显著反应（Z = 6.66，P < 0.001和Z = 4.185，P < 0.01）。该效果在部分性发作患者中更为明显。然而，总体反应非常显著（Z = 7.839，P < 0.001）。在200 - 300毫克/天的剂量时观察到最佳反应（Z = 6.708，P < 0.001）。超过35%的部分性和全身性发作病例报告癫痫发作水平降低超过75%。超过65%的病例对药物在精神病、头晕和厌食方面的副作用耐受性良好。仅约不到35%的病例出现轻微副作用。
发现TPM是一种显著有效的添加型抗惊厥药物，但有一些局限性或轻微副作用。
