加巴喷丁胶囊添加治疗癫痫的临床疗效和安全性

Clinical efficacy and safety of gabapentin as add-on therapy in patients with epilepsy

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。

AIM:To evaluate the clinical efficacy and safety of domestic gabapentin. METHODS:The multicenter, double-blind, placebo-controlled, parallel-group clinical trial was performed to evaluate the efficacy and safety of gabapentin as add-on therapy in patients with simple partial seizures(SPS), complex partial seizures(CPS) and secondary generalized tonic-clonic seizures(SGTCS) for 24 wk. Two hundred and twenty-nine patients were divided into two groups (218 patients evaluable). One hundred and ten patients of gabapentin group received, gabapentin 900 mg·d -1 and 108 patients of control group received placebo. RESULTS: The total effective rate (the number of seizures decreased by at least 50 % from baseline) was 52.7 % in gabapentin group, compared with 31.5 % in control group (P<0.01). In comparison of clinical efficiency in two groups, patients with the number of seizure over 4 times per 28 d was 60 % for gabapentin group and 39 % for control group (P<0.05). In analysis of efficacy in patients with different seizures those who received gabapentin as add-on therapy showed that SGTCS was better than other two types(P< 0.01). The rate of epileptiform discharges decreased by at least 25 % from baseline was 80 % in gabapentin group and 60 % in control group(P<0.05). There was no significant difference in occurrence of adverse reactions between two groups (P>0.05). CONCLUSION: Domestic gabapentin is an effective and safe antiepileptic drug that shows significant potency for the treatment of partial and secondarily generalized tonic-clonic seizures as add-on therapy.