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目的观察托吡酯联合丙戊酸钠治疗小儿癫疒间的临床疗效及安全性。方法选取76例小儿癫疒间患儿,按入院顺序随机分为2组,每组38例,观察组采用托吡酯联合丙戊酸钠治疗,对照组单独采用托吡酯治疗,其中托吡酯初始剂量为0.5~1.0 mg/(kg·d),逐渐增至维持量4~8 mg/(kg·d),2次/d;丙戊酸钠口服液初始剂量为10~15 mg/(kg·d),逐渐增加至维持量20~40 mg/(kg·d),3次/d,两组患儿均连续治疗3~6个月。观察两组患儿癫疒间发作次数及发作频率,对两组患儿疗效进行评定并比较,治疗期间严密监测血常规、尿常规及肝肾功能等,仔细记录两组患儿不良反应发生情况。结果观察组完全控制率为42.11%,对照组为34.21%,两组比较差异无统计学意义(P>0.05);观察组总有效率为97.37%,对照组为84.21%,两组比较差异有统计学意义(P<0.05)。两组患儿治疗期间肝肾功能、血常规及尿常规等均无显著改变,不良反应主要表现为感觉异常、胃肠道反应、体重改变及嗜睡等轻微不良反应,其中观察组不良反应发生率为18.42%(7/38),对照组为10.53%(4/38),两组比较差异无统计学意义(P>0.05)。结论托吡酯联合丙戊酸钠治疗小儿癫疒间临床疗效优于单用托吡酯治疗,未明显增加不良反应发生率,患儿耐受性好,安全可行,值得推广应用。
Objective To observe the clinical efficacy and safety of topiramate combined with sodium valproate in children with epilepsy. Methods A total of 76 children with epilepsy were selected and randomly divided into two groups according to the order of admission. Each group consisted of 38 patients. The observation group was treated with topiramate plus sodium valproate. The control group was treated with topiramate alone. The initial dose of topiramate was 0.5 ~ 1.0 mg / (kg · d), and gradually increased to maintain the amount of 4 ~ 8 mg / (kg · d), 2 times / d; sodium valproate oral initial dose of 10 ~ 15 mg / (kg · d) Gradually increased to the maintenance dose of 20 ~ 40 mg / (kg · d), 3 times / d, two groups of children were treated for 3 to 6 months. The number of seizures and the frequency of seizures were observed between the two groups. The curative effect of the two groups was evaluated and compared. Blood, urine and liver and kidney function were closely monitored during the treatment. Adverse reactions of the two groups were carefully recorded . Results The total control rate was 42.11% in the observation group and 34.21% in the control group, with no significant difference between the two groups (P> 0.05). The total effective rate was 97.37% in the observation group and 84.21% in the control group Statistical significance (P <0.05). There was no significant change in liver and kidney function, blood routine and urine routine during treatment in both groups. Adverse reactions mainly included mild side effects such as sensory abnormality, gastrointestinal reaction, body weight change and lethargy. The incidence of adverse reactions in the observation group 18.42% (7/38) in the control group and 10.53% (4/38) in the control group. There was no significant difference between the two groups (P> 0.05). Conclusion Topiramate combined with sodium valproate in children with epilepsy clinical efficacy superior to topiramate alone, did not significantly increase the incidence of adverse reactions, children with good tolerance, safe and feasible, it is worth promoting the application.