泰国癫痫患者中时辰冲击疗法与肠溶型丙戊酸盐的对比研究

Chrono impact versus enteric coated valproate in Thai epileptic patients.

作者信息

Towanabut Somchai, Tiemkao Somsak, Thammasupapong Suwanna, Kijjarak Ram, Arayawichanon Arkhom, Poungvarin Niphon, Sirimaharaj Sasithron, Chaisewikul Rungsan, Asawavichenjinda Thanin, Maneesuk Sakarin, Silpakit Orawan

机构信息

Department of Neurology, Prasat Neurological Institute, Bangkok 10400, Thailand.

出版信息

J Med Assoc Thai. 2005 Nov;88(11):1651-9.

PMID:16471115

Abstract

BACKGROUND

Since its first clinical use more than 30 years ago, Valproic acid is still being widely prescribed It has been available in Thailand for more than 20 years. Sodium valproate slow-released (SVSR) form has been used in clinical practice in Thailand since 1990. The objectives of this open study were to access the compliance and satisfaction consequences in the epileptic patients.

MATERIAL AND METHOD

In this prospective, multi-center study, the authors compared the compliance and satisfaction consequences in epileptic patients switched from more than two times daily sodium valproate enteric-coated tablet (SVEC) regimen to the same total daily dose of SVSR form given once or twice daily.

RESULTS

Eighty-nine of the 100 patients completed the study. 43.8% were male (39 of 89 patients). Mean age was 34.74 +/- 12.67 years. Most common etiology of epilepsy was idiopathic 40.4%. Patients were very/fairly happy with the SVSR form 94.4% compared to the SVEC form 56.2% (p = 0.000). Patients had been experiencing no problem with the SVSR form 67.4% compared to SVEC form 38.2% (p = 0.000) and also never missing taking SVSR. form 77.5% compared to SVEC form 40.4% (p = 0.000). According to convenience, patients preferred to administer SVSR form once a day 92.1% and never over taking dosed the antiepileptic drug 96.6%. SVSR form had fewer side effects than the enteric-coated form interms of memory problem (40.4% vs 48.3%) (p = 0.000), sleepiness (30.3% vs 42.7%) (p = 0.041) and difficulty in thinking clearly (38.2% vs 44.9%) (p = 0.001). The patients were seizure free during the study period comparing SVSR form 76.4% to SVEC form 65.2% (p = 0.011).

CONCLUSION

Patients preferred once daily regime. Switching from SVEC to SVSR form increased seizure free, reduced side effects, improved patient's compliance and satisfaction.

摘要

背景

自30多年前首次临床应用以来，丙戊酸仍被广泛处方。它在泰国已有20多年的使用历史。丙戊酸钠缓释（SVSR）剂型自1990年起在泰国临床实践中使用。这项开放性研究的目的是评估癫痫患者的依从性和满意度情况。

材料与方法

在这项前瞻性多中心研究中，作者比较了癫痫患者从每日两次以上服用丙戊酸钠肠溶片（SVEC）方案转换为每日总剂量相同的SVSR剂型，每日服用一次或两次后的依从性和满意度情况。

结果

100名患者中有89名完成了研究。43.8%为男性（89名患者中的39名）。平均年龄为34.74±12.67岁。癫痫最常见的病因是特发性，占40.4%。与SVEC剂型的56.2%相比，94.4%的患者对SVSR剂型非常/相当满意（p = 0.000）。与SVEC剂型相比（38.2%），67.4%的患者使用SVSR剂型没有问题（p = 0.000），并且与SVEC剂型（40.4%）相比，77.5%的患者从未漏服SVSR剂型（p = 0.000）。就便利性而言，92.1%的患者更喜欢每天服用一次SVSR剂型，并且96.6%的患者从未过量服用抗癫痫药物。在记忆问题（40.4%对48.3%）（p = 0.000）、嗜睡（30.3%对42.7%）（p = 0.041）和思维清晰度困难（38.2%对44.9%）（p = 0.001）方面，SVSR剂型的副作用比肠溶片剂型少。在研究期间，使用SVSR剂型的患者无癫痫发作的比例为76.4%，而使用SVEC剂型的为65.2%（p = 0.011）。