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目的 :评价国产加巴喷丁的临床疗效和安全性。方法 :采用多中心、双盲、安慰剂对照、平行试验方法观察加巴喷丁添加治疗癫痫部分性发作(PS)和泛化性全身强直 阵挛发作 (SGTCS) 2 4wk。分 2组 :加巴喷丁组 (原基础抗癫痫药 +加巴喷丁胶囊 90 0mg·d- 1) 110例 ,对照组 (原基础抗癫痫药 +安慰剂 ) 10 8例。结果 :加巴喷丁组总有效率5 2 .7% (5 8/ 110 ) ,对照组 31.5 % (34/ 10 8) ,2组比较 ,P <0 .0 1;2组基线期发作次数≥ 4次 (2 8d)病人的疗效比较 ,P <0 .0 5 ;不同发作类型的疗效比较SGTCS >复杂部分性发作 (CPS) >简单部分性发作(SPS) (P <0 .0 1) ;2组痫样放电减少≥ 2 5 %的疗效比较 ,P <0 .0 5。2组不良反应发生率比较差异无显著性 (P >0 .0 5 )。结论 :国产加巴喷丁添加治疗对控制癫痫PS和SGTCS是有效而安全的。
Objective: To evaluate the clinical efficacy and safety of domestic gabapentin. METHODS: A multicenter, double-blind, placebo-controlled, parallel-controlled trial was conducted to observe the effects of gabapentin in the treatment of partial and total seizures (PSS) and generalized tonic-clonic seizures (SGTCS) 24 weeks. Divided into 2 groups: gabapentin group (the original basic antiepileptic drug + gabapentin capsules 90 0mg · d-1) 110 cases, the control group (the original basic antiepileptic drug + placebo) 108 cases. Results: The total effective rate of gabapentin group was 52.7% (51/81) and that of control group was 31.5% (34/108), P <0.01; the incidence of baseline episode in group 2 was> 4 times (P <0.05). The curative effect of different seizure types was compared with that of SGTCS> complicated partial seizure (CPS)> simple partial seizure (SPS) (P <0. 01) Epileptiform discharges reduced ≥ 25% of the efficacy, P <0 .5 5.2 The incidence of adverse reactions was no significant difference (P> 0.05). Conclusion: The domestic gabapentin addition therapy is effective and safe for the control of PS and SGTCS in epilepsy.