国产普瑞巴林添加治疗成人难治性、部分性癫痫的临床疗效和安全性评价

目的评价国产普瑞巴林添加治疗成人难治性、部分性癫痫的临床疗效和安全性。方法采用随机对照双盲方法，将43例成人难治性、部分性癫痫的患者分为普瑞巴林治疗组（治疗组，n-21）和安慰剂对照组（对照组，n-22）；治疗组给予普瑞巴林，对照组给予安慰剂，治疗14w后进行疗效评价和安全性评价。结果有效性：FAS集，普瑞巴林治疗组为（-38．2土36．7），安慰剂对照组为（-3．6±44．1），差异有统计学意义，P〈0．001；PP集，普瑞巴林治疗组为（-38．5±32．1），安慰剂对照组为（-9．7±40．6），差异有统计学意义，P〈0．05安全性：不良反应包括头晕、嗜睡、昏睡，两组比较差异无统计学意义。结论国产普瑞巴林添加治疗成人难治性、部分性癫痫的临床疗效优于安慰剂对照组，安全耐受性良好。

Evaluation of Efficacy and Safety of PregabaUn Add-On Treatment to Adults with Intractable and Partial Seizures

Objective To assess the efficacy and safety of Pregabalin add-on treatment to adults with intractable and partial seizures. Methods 43 adults with intractable and partial seizures were randomly divided into Pregabalin add-on treatment group （ treatment group, n=21 ） and placebo treatment group （ placebo group, n=22 ）. After received 14 weeks treatment with Pregabalin,all patients responses were evaluated with response ratio（RR）, adverse event（AE）and adverse drug reaction（ADR）. Results In full analysis set（FAS）, the RR of treatment group and placebo group are （-38.2±36.7） and （-3.6±44.1） respectively,P〈0. 001 ;While in per-protocol set（PP）,the RR of treatment group and placebo group are （-38.5±32.1） and （-9.75±40.6） ,respectively,P〈0.05. Conclusion The results suggest that Pregabalin add-on treatment adults with intractable and partial seizures produce better efficacy than placebo and more tolerable.