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新型抗癫痫药物与传统抗癫痫药物用于全身强直阵挛性发作患者时的代谢参数评估:一项观察性研究。

Evaluation of Metabolic Parameters on Use of Newer Antiepileptics Versus Conventional Antiepileptics in Patients of Generalised Tonic-Clonic Seizure: An Observational Study.

作者信息

Dehury Suhasini, Patro Pallavi, Sahu Lorika, Nayak Laxmipriya, Mallik Ashok K

机构信息

Pharmacology and Therapeutics, Srirama Chandra Bhanja (S C B) Medical College and Hospital, Cuttack, IND.

Pharmacology and Therapeutics, Sanjay Gandhi Post Graduate Institute of Medical Science, Lucknow, IND.

出版信息

Cureus. 2023 Feb 19;15(2):e35181. doi: 10.7759/cureus.35181. eCollection 2023 Feb.

Abstract

Background and objective Epilepsy is the commonest serious neurological condition and around 50 million people live with epilepsy (PWE). Primary and secondary generalised tonic-clonic seizures (GTCS) together constitute up to 50% of adult and adolescent epilepsy. GTCS respond well to broad-spectrum AEDs like valproate, phenytoin, levetiracetam, lamotrigine, and topiramate. Carbamazepine and oxcarbazepine are considered alternatives. Metabolic derangements with the conventional AEDs (phenytoin causes loss of bone mass in women, phenytoin and carbamazepine produce increases in serum lipid and C-reactive protein, weight gain with valproate) are well documented. But, there is limited data regarding the effect of the newer AEDs on metabolic parameters. Thus, this study was undertaken to assess the effects of the newer AEDs on the metabolic profile of patients with epilepsy. Material and methods A prospective observational study was conducted in the Department of Pharmacology, in collaboration with the Department of Neurology at S.C.B. Medical College and Hospital, Cuttack. 100 diagnosed patients with GTCS receiving monotherapy of either conventional or newer anti-epileptics were included in the study. Their metabolic parameters like total cholesterol, serum sodium, serum TSH and fasting blood glucose were collected at baseline, three months, and six months. ADRs were collected during the entire study period and causality assessment was done using WHO-UMC Causality Assessment Scale. All the data were analysed using SPSS 20.0 after applying appropriate statistical tests. Results There was a significant increase in total cholesterol in all four groups (p=0.002) but a pathological increase in the phenytoin and oxcarbazepine groups. There was a significant rise in the serum TSH levels in all groups except levetiracetam, but a pathological increase was seen with phenytoin and valproate, i.e., the conventional ones. Statistically significant hyponatremia was seen with valproate and oxcarbazepine. A rise in the FBS was seen with both phenytoin and valproate (p=0.002) but a pathological rise was seen with phenytoin. Out of the total reported ADRs, 53.5% were seen with conventional AEDs, and the rest 46.5% were seen with newer ones. Conclusion The advent of newer anti-epileptic drugs has unfolded wider horizons to the treatment of epilepsy. Each of these drugs has a unique mechanism of action, making it less prone to resistance. Metabolic derangements are a key determinant in the compliance of these drugs as they can predispose to other co-morbidities. Periodic monitoring of the various metabolic parameters is useful and together with patient counselling can improve the effectiveness of the anti-epileptic drugs.

摘要

背景与目的 癫痫是最常见的严重神经系统疾病,全球约有5000万人患有癫痫(癫痫患者)。原发性和继发性全面强直阵挛发作(GTCS)在成人和青少年癫痫中占比高达50%。GTCS对丙戊酸盐、苯妥英、左乙拉西坦、拉莫三嗪和托吡酯等广谱抗癫痫药物(AEDs)反应良好。卡马西平和奥卡西平被视为替代药物。传统AEDs的代谢紊乱(苯妥英会导致女性骨质流失,苯妥英和卡马西平会使血脂和C反应蛋白升高,丙戊酸盐会导致体重增加)已有充分记录。但是,关于新型AEDs对代谢参数影响的数据有限。因此,本研究旨在评估新型AEDs对癫痫患者代谢谱的影响。

材料与方法 本前瞻性观察研究由SCB医学院和医院(位于库塔克)药理学系与神经学系合作开展。100例确诊为GTCS且正在接受传统或新型抗癫痫药物单药治疗的患者纳入本研究。在基线、三个月和六个月时收集他们的代谢参数,如总胆固醇、血清钠、血清促甲状腺激素(TSH)和空腹血糖。在整个研究期间收集不良反应(ADRs),并使用世界卫生组织药物不良反应因果关系评估量表进行因果关系评估。在应用适当的统计检验后,使用SPSS 20.0对所有数据进行分析。

结果 所有四组患者的总胆固醇均显著升高(p = 0.002),但苯妥英和奥卡西平组出现病理性升高。除左乙拉西坦组外,所有组的血清TSH水平均显著升高,但苯妥英和丙戊酸盐组(即传统药物组)出现病理性升高。丙戊酸盐和奥卡西平组出现具有统计学意义的低钠血症。苯妥英和丙戊酸盐组的空腹血糖均升高(p = 0.002),但苯妥英组出现病理性升高。在报告的所有ADRs中,53.5%出现在传统AEDs组,其余46.5%出现在新型AEDs组。

结论 新型抗癫痫药物的出现为癫痫治疗开辟了更广阔的前景。这些药物中的每一种都有独特的作用机制使其不易产生耐药性。代谢紊乱是这些药物依从性的关键决定因素,因为它们可能引发其他合并症。定期监测各种代谢参数是有用的,并且与患者咨询相结合可以提高抗癫痫药物的疗效。

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