Comparison of the efficacy of Tegatard and Tegretol as a monotherapy in patients with focal seizure with or without secondary generalization.

IF 1.4 Q4 IMMUNOLOGY
American journal of clinical and experimental immunology Pub Date : 2020-10-15 eCollection Date: 2020-01-01
Mohammad Reza Najafi, Mohammad Amin Najafi, Ramin Shayan-Moghadam, Zahra Saadatpour, Keyvan Ghadimi
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Abstract

Background: Carbamazepine is a first line treatment for focal epilepsy. Tegretol and Tegatard are two trade name of Carbamazepine. Tegretol is produced by Novartis Pharmaceutical Company, Switzerland. Recently, Raha pharmaceutical Company in Iran has produced CBZ which trade named is Tegatard. Extended usage of Tegatard instead of Tegretol has economic benefits for Iranian families. In this clinical trial, we aimed to compare therapeutic efficacy and safety of Tegretol and Tegatard in patients suffering from focal seizures with or without secondary generalization.

Methods: 200 patients with provoked or non-provoked focal seizure with or without secondary generalization were screened and 180 patients were fulfilled the criteria to enter this double blinded clinical trial study. Patients were divided into two groups, the first group (A) received Tegretol and the second group (B) Tegatard. Carbamazepine (CBZ) was prescribed with doses 10-20 mg/kg every 12 hours by neurologists. The patients were visited after 1, 3 and 6 months and the side effects and lab data in patients were investigated.

Results: Patients were divided into two groups, 88 patients in group A (Tegretol) (50 males and 38 females) and 92 in group B (Tegatard) (51 males and 41 females). Mean age of patients was 35.39±11.17 years. There was no significant difference according to age and gender, Carbamazepine dosage, EEG recording, neuroimaging change and adverse effects of antiepileptic drug between two groups (P>0.05). Regarding the drug efficacy, in group A and B, 60 (68%) and 58 (63%) patients were seizure free after 6 month follow up; respectively. The differences between two groups were not statistically significant (P value =0.46).

Conclusion: Tegatard is an effective drug with similar efficacy, similar side effects and cost-effectiveness compared with Tegretol and could be used widely when indicated.

比较 Tegatard 和 Tegretol 作为单一疗法对伴有或不伴有继发性全身泛化的局灶性癫痫发作患者的疗效。
背景:卡马西平是治疗局灶性癫痫的一线药物:卡马西平是治疗局灶性癫痫的一线药物。Tegretol 和 Tegatard 是卡马西平的两个商品名。替格瑞洛由瑞士诺华制药公司生产。最近,伊朗 Raha 制药公司生产了 CBZ,商品名为 Tegatard。扩大泰格列特的使用范围,取代泰格列特,可为伊朗家庭带来经济效益。在这项临床试验中,我们旨在比较替格瑞托和替格达对伴有或不伴有继发性全身泛化的局灶性癫痫发作患者的疗效和安全性。方法:我们筛选了 200 名伴有或不伴有继发性全身泛化的诱发或非诱发局灶性癫痫发作患者,其中 180 名患者符合双盲临床试验研究的标准。患者被分为两组,第一组(A)接受替格瑞洛治疗,第二组(B)接受替加特治疗。卡马西平(CBZ)由神经科医生处方,剂量为每 12 小时 10-20 毫克/千克。1个月、3个月和6个月后对患者进行回访,调查患者的副作用和实验室数据:患者分为两组,A 组(替格瑞洛)88 人(男性 50 人,女性 38 人),B 组(替加特)92 人(男性 51 人,女性 41 人)。患者的平均年龄为(35.39±11.17)岁。两组患者在年龄、性别、卡马西平用量、脑电图记录、神经影像学变化和抗癫痫药物不良反应等方面无明显差异(P>0.05)。在药物疗效方面,A 组和 B 组分别有 60 名(68%)和 58 名(63%)患者在随访 6 个月后癫痫不再发作。两组之间的差异无统计学意义(P 值 =0.46):结论:与替格瑞托相比,替加达是一种疗效、副作用和成本效益相似的有效药物,可在必要时广泛使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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