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目的观察左乙拉西坦治疗儿童部分性癫痫的临床疗效及安全性。方法将57例部分性癫痫患儿分为对照组10例和试验组47例。对照组在保留原有药物剂量不变的情况下,予以口服左乙拉西坦,起始剂量10 mg·kg-1·d~(-1),每5~7 d增加5~10 mg·kg-1·d~(-1),经2~4周达到维持剂量为20~60mg·kg-1·d~(-1)。试验组予以左乙拉西坦单药治疗,用法用量和对照组一样。2组患儿治疗至少12个月。比较2组患儿的临床疗效和药物不良反应的发生情况。结果治疗3,6,12个月,试验组的癫痫完全控制率分别为53.19%,57.45%,48.94%,总有效率分别为80.85%,78.72%,68.09%;对照组的癫痫完全控制率均为20.00%,总有效率分别为30.00%,50.00%,30.00%。2组患儿治疗6个月的癫痫完全控制率及治疗3,12个月的总有效率比较差异均有统计学意义(P<0.05)。试验组发生的药物不良反应共11例,包括易激惹、皮疹、多动等,对照组发生的药物不良反应共4例,包括攻击行为、嗜睡、皮疹等,2组患儿的药物不良反应多数为一过性,症状轻微。试验组和对照组的药物不良反应发生率分别为23.40%和40.00%,差异无统计学意义(P>0.05)。结论左乙拉西坦治疗婴幼儿及年幼儿童部分性癫痫是有效的,且不增加药物不良反应的发生率。
Objective To observe the clinical efficacy and safety of levetiracetam in children with partial epilepsy. Methods Fifty-seven patients with partial epilepsy were divided into control group (n = 10) and experimental group (n = 47). The control group received oral administration of levetiracetam with the same dose of 10 mg · kg-1 · d -1, while the dosage of levetiracetam was increased from 5 mg · kg-1 · d -1 kg-1 · d ~ (-1). After 2 ~ 4 weeks, the maintenance dose was 20 ~ 60 mg · kg-1 · d ~ (-1). The experimental group was treated with levetiracetam monotherapy, usage and dosage the same as the control group. Two groups of children treated for at least 12 months. The clinical efficacy and adverse drug reactions in two groups were compared. Results The total control rates of epilepsy in experimental group were 53.19%, 57.45% and 48.94% respectively at 3, 6 and 12 months. The total effective rates were 80.85%, 78.72% and 68.09% respectively. The complete epilepsy control rate For 20.00%, the total effective rate was 30.00%, 50.00%, 30.00% respectively. The complete control rate of epilepsy and the total effective rate of 3 and 12 months after treatment in both groups were statistically significant (P <0.05). A total of 11 cases of adverse drug reactions occurred in the experimental group, including irritability, rash, hyperactivity and other adverse reactions in the control group, a total of 4 cases, including aggressive behavior, lethargy, rash, two groups of children with adverse drug reactions The majority of transient, mild symptoms. The incidence of adverse drug reactions in the experimental and control groups were 23.40% and 40.00%, respectively, with no significant difference (P> 0.05). Conclusion Levetiracetam is effective in treating partial epilepsy in infants and young children, and does not increase the incidence of adverse drug reactions.