摘要目的 通过前瞻性、多中心、随机双盲平行对照临床试验,评价应用国产迷走神经刺激器治疗药物难治性癫痫(PRE)的疗效和安全性.方法 纳入2014年8月至2014年12月5家医院收治的72例PRE患者,采用国产迷走神经刺激器进行迷走神经刺激术(VNS)治疗.72例患者分为试验组(35例)和对照组(37例).术后2周试验组真开机;对照组模拟开机,术后4个月开机并揭盲.根据McHugh分级和改良Engel分级标准,于术后4个月和8个月评价刺激器治疗PRE的有效性和安全性.结果 术后4个月,McHugh分级Ⅰ级、Ⅱ级、Ⅲ级、Ⅳ级和Ⅴ级试验组分别有16、8、8、0、3例,对照组分别有9、3、16、0、9例;改良Engel分级Ⅰ级、Ⅱ级、Ⅲ级、Ⅳ级试验组分别有8、4、12、11例,对照组分别有4、5、3、25例.术后4个月试验组癫痫发作情况较术前有明显改善,试验组与对照组癫痫发作频率分别下降63.0％和34.0％ (P =0.006).术后8个月,McHugh分级Ⅰ级、Ⅱ级、Ⅲ级、Ⅳ级和Ⅴ级试验组分别有15、10、7、2、1例,对照组分别有9、9、19、0、0例;改良Engel分级Ⅰ级、Ⅱ级、Ⅲ级、Ⅳ级试验组分别有7、2、19、9例,对照组分别有4、2、12、19例.对照组的疗效逐渐与试验组趋同,两组癫痫发作情况较术前均明显改善(P ＜0.001).术后8个月,33.3％的患者发作频率减少80％以上,59.7％的患者发作频率减少50％以上.结论 应用国产迷走神经刺激器能显著降低PRE患者的发作频率,具有较高的有效性和安全性,适用于PRE患者的治疗.

abstractsObjective To evaluate the efficacy and safety of domestic vagus nerve stimulator for the treatment of pharmaco-resistant epilepsy (PRE) through a prospective,multicenter,randomized,doubleblind,parallel controlled trial.Methods A total of 72 patients with PRE in 5 hospitals were enrolled from August 2014 to December 2014.A domestic vagus nerve stimulator was used to conduct vagus nerve stimulation (VNS).All patients with PRE were divided into either a test group (n =35) or a control group (n =37) according to the principle of central randomization.Two weeks after procedure,the vagus nerve stimulator of the test group was turned on really.The parameters (electric current,pulse width,frequency,duration of stimulation,and time interval) of the stimulus set were optimized;whereas that of the control group was turned on simulatedly.At 4 months after operation,the stimulator was turned on and unblinded.According to the Mchugh classification and the modified Engel classification standards,the effectiveness and safety of using the stimulator to treat PRE were evaluated at 4 and 8 months after procedure in both groups.Results At 4 months after procedure,there were 16,8,8,0,and 3 patients,respectively in the McHugh classification grade Ⅰ,Ⅱ,Ⅲ,Ⅳ and Ⅴ test groups,and 9,3,16,0,and 9 patients in the control group,respectively.There were 8,4,12,and 11 patients,respectively in the modified Engel classification grade Ⅰ,Ⅱ,Ⅲ,Ⅳ and Ⅴ test groups,and there were 4,5,3,and 25 in the control group,respectively.At 4 months after procedure,the seizures in the test groups were improved obviously compared with before procedure.The improvement of the test groups were significantly better than the control group (the improvement rates of seizures were-63.0％ and-34.0％,respectively;P =0.006).The symptoms were improved gradually after turning on the stimulator in the control group.At 8 months after procedure,there were 15,10,7,2,and 1 patient,respectively in the Mchugh classification grade Ⅰ,Ⅱ,Ⅲ,Ⅳ,and Ⅴ test groups,and there were 9,9,19,0,and 0 patients in control group,respectively.There were 7,2,19,and 9 patients respectively in the modified Engel classification grade Ⅰ,Ⅱ,Ⅲ and Ⅳ test groups,respectively,and there were 4,2,12,and 19 patients in the control group,respectively.The efficacy of the control group was gradually similar to the test groups.Compared with the baseline,the efficacy was improved significantly (P ＜0.001).At 8 months after procedure,the seizure frequency of 33.3％ of patients reduced more than 80％,and that of 59.7％ of patients reduced more than 50％.Conclusions Using domestic vagus nerve stimulators can significantly reduce the seizure frequency in patients with PRE.It has higher effectiveness and safety.It is suitable for the treatment of patients with PRE.