摘要
目的比较国产奥卡西平和进口奥卡西平的有效性及安全性。方法根据入组标准选取90例癫痫部分性发作患者,基线期稳定服用进口奥卡西平至少6个月以上,之后全部更换为国产奥卡西平并维持原用药剂量、方法及原合并用药。观察6个月,比较替换治疗1个月和6个月时与基线期的治疗有效率、脑电图改善有效率,计算不良反应发生率及药物保留率。结果基线期治疗有效率为96.67%,替换治疗1个月和6个月治疗有效率分别为93.33%和93.26%,与基线期比较差异无统计学意义(P>0.05);基线期脑电图改善有效率为83.33%,替换治疗1个月和6个月脑电图改善有效率分别为86.67%和89.89%,与基线期比较差异无统计学意义(P>0.05)。替换治疗后和基线期不良反应发生率均为1.11%,差异无统计学意义(P>0.05),国产奥卡西平的药物保留率为98.89%。结论国产奥卡西平抗癫痫疗效好,不良反应少,药物保留率高,患者有很好的依从性和耐受性,值得临床推广应用。
Objective To compare the efficacy and safety of domestic oxcarbazepine with imported oxcarbazepine. Methods A total of 90 patients with partial epilepsy, who took the imported oxcarbazepine for at least 6 months, were selected. Those patients changed to take domestic oxcarbazepine maintaining the original dosage, method and original drug combination for another 6 months. The effect rate and improvement EEG rate were compared between baseline period with after 1 month and 6 month replacement, the adverse reaction rate and retention rate were counted. Results The effect rate in baseline period was 96.67%, and the effect rates after 1 month and 6 month replacement were 93.33% and 93.26%. There was no significant difference between baseline period and after replacement(P>0.05). The EEG improvement rate in baseline period was 83.33%, and the EEG improvement rates after 1 month and 6 month replacement were 86.67% and 89.89%. There was no significant difference between baseline period and after replacement(P>0.05). The adverse reaction rate of both baseline period and after replacement was 1.11%, there was no significant difference(P>0.05). The retention rate of domestic drug oxcarbazepine was 98.89%. Conclusion The antiepileptic effect of domestic oxcarbazepine is satisfactory, it has less adverse reactions, low cost and patients have good compliance and tolerance.
出处
《世界临床药物》
CAS
2017年第3期180-183,共4页
World Clinical Drug
基金
清华大学自主科研计划项目(编号:2015THZ01)
关键词
奥卡西平
替换治疗
临床疗效
安全性
oxcarbazepine
replacement therapy
clinical curative effect
safety
