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目的比较左乙拉西坦片与卡马西平片治疗儿童难治性癫痫的临床疗效及安全性。方法将96例难治性癫痫患儿随机分为对照组48例和试验组48例。对照组予以卡马西平4~8 mg·kg~(-1)·d~(-1),分3次口服;试验组予以左乙拉西坦4 mg·kg~(-1),bid,口服,每隔2周增加4 mg·kg~(-1),最高剂量16 mg·kg~(-1)。2组患儿均治疗8个月。比较2组患儿的临床疗效、神经认知功能测评[语言智商(VIQ)、操作智商(PIQ)、总智商(TIQ)及短时视觉记忆(STVM),以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为87.50%(42例/48例)和68.75%(33例/48例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的VIQ评分分别为(106.97±5.65)和(95.25±3.28)分,PIQ分别为(116.45±5.16)和(103.61±2.74)分,TIQ分别为(119.92±4.69)和(95.20±3.24)分,STVM分别为(18.45±2.17)和(13.84±1.81)s,差异均有统计学意义(均P<0.05)。2组患者的药物不良反应以情绪激动、嗜睡、心悸、头晕为主,试验组和对照组的药物不良反应发生率分别为12.50%和16.67%,差异无统计学意义(P>0.05)。结论左乙拉西坦片治疗难治性癫痫患儿的临床疗效显著优于卡马西平片,前者可显著提高患儿的认知能力,且不增加药物不良反应的发生率。
Objective To compare the clinical efficacy and safety of levetiracetam with carbamazepine in the treatment of children with refractory epilepsy. Methods Ninety-six children with refractory epilepsy were randomly divided into control group (48 cases) and experimental group (48 cases). The control group was given carbamazepine 4 ~ 8 mg · kg -1 · d -1 orally for 3 times. The experimental group was treated with levetiracetam 4 mg · kg -1, bid, Oral, 4 mg · kg -1 every 2 weeks, the highest dose of 16 mg · kg -1. Two groups of children were treated for 8 months. The clinical efficacy, neurocognitive function tests [VIQ, PIQ, TIQ and STVM, as well as adverse drug reactions were compared between the two groups. Results After treatment, the total effective rates of the experimental group and the control group were 87.50% (42 cases / 48 cases) and 68.75% (33 cases / 48 cases), respectively. The difference was statistically significant (P <0.05). After treatment, the VIQ scores of the test group and the control group were (106.97 ± 5.65) and (95.25 ± 3.28) points, the PIQ were (116.45 ± 5.16) and (103.61 ± 2.74) points respectively, and the TIQ were (119.92 ± 4.69) And (95.20 ± 3.24) points respectively. The STVM values were (18.45 ± 2.17) and (13.84 ± 1.81) s respectively, with statistical significance (all P <0.05). Two groups of patients with adverse drug reactions to emotional excitement, lethargy, palpitations, dizziness, the experimental group and control group, the incidence of adverse drug reactions were 12.50% and 16.67%, the difference was not statistically significant (P> 0.05). Conclusion The clinical efficacy of levetiracetam tablets in children with refractory epilepsy is significantly better than carbamazepine, the former can significantly improve children’s cognitive ability, and does not increase the incidence of adverse drug reactions.