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目的观察拉莫三嗪联合丙戊酸钠治疗小儿癫痫临床疗效及安全性。方法将52例癫痫患儿随机分为对照组26例与试验组26例。对照组予以口服起始剂量15 mg·kg~(-1)·d~(-1)丙戊酸钠,每日2~3次,逐渐增加至25 mg·kg~(-1)·d~(-1)维持剂量,4周内完成加量;试验组在对照组的基础上,予以口服拉莫三嗪0.15~0.30 mg·kg~(-1),每日1次,逐渐增加剂量至1~5 mg·kg~(-1)·d~(-1),8周内完成加量。2组患儿均治疗4个月。比较2组患儿的临床疗效、血清中肿瘤坏死因子-α(TNF-α)、超敏C-反应蛋白(hs-CRP)、同型半胱氨酸(Hcy)、血细胞比容和红细胞沉降率以及不良反应发生情况。结果治疗后,试验组的总有效率为92.31%(24/26例)显著高于对照组的69.23%(18/26例,P<0.05)。治疗后,试验组与对照组的血清TNF-α分别为(28.73±3.04),(54.84±5.63)pg·m L~(-1);hs-CRP分别为(4.92±0.52),(8.02±1.01)mg·L~(-1);Hcy分别为(11.84±1.21),(16.64±2.03)μmol·L~(-1);血细胞比容分别为(40.28±4.37)%,(43.98±5.28)%;红细胞沉降率分别为(3.02±0.34),(3.89±0.46)mm·h~(-1),且试验组治疗后的上述指标均显著低于对照组(P<0.05)。2组患者不良反应以神经系统症状为主,且对照组不良反应发生率为19.23%略高于试验组11.53%,差异无统计学意义(P>0.05)。结论拉莫三嗪联合丙戊酸钠治疗小儿癫痫的临床疗效显著,且不增加不良反应发生率。
Objective To observe the clinical efficacy and safety of lamotrigine and valproate in the treatment of children epilepsy. Methods Fifty-two children with epilepsy were randomly divided into control group (n = 26) and experimental group (n = 26). The control group was given orally with the initial dose of 15 mg · kg -1 · d -1 sodium valproate twice or three times per day and gradually increased to 25 mg · kg -1 · d -1. (-1) to maintain the dose within 4 weeks to complete the dosage; the experimental group in the control group, based on oral lamotrigine 0.15 ~ 0.30 mg · kg ~ (-1) once a day, and gradually increase the dose to 1 ~ 5 mg · kg -1 · d -1, and the dosage was completed within 8 weeks. Two groups of children were treated for 4 months. The clinical efficacy, serum levels of TNF-α, hs-CRP, homocysteine (Hcy), hematocrit and erythrocyte sedimentation rate As well as the occurrence of adverse reactions. Results After treatment, the total effective rate of the experimental group was 92.31% (24/26 cases), which was significantly higher than 69.23% (18/26 cases, P <0.05) of the control group. After treatment, the serum levels of TNF-α in experimental group and control group were (28.73 ± 3.04) and (54.84 ± 5.63) pg · m L -1, respectively. The hs-CRP levels were 4.92 ± 0.52 and 8.02 ± 1.01) mg · L -1 and Hcy were (11.84 ± 1.21) and (16.64 ± 2.03) μmol·L -1, respectively. The hematocrit values were (40.28 ± 4.37)% and (43.98 ± 5.28) ). The erythrocyte sedimentation rates were (3.02 ± 0.34) and (3.89 ± 0.46) mm · h ~ (-1) respectively, and the above indexes in the experimental group were significantly lower than those in the control group (P <0.05). Adverse reactions of the two groups were mainly neurological symptoms, and the incidence of adverse reactions in the control group was 19.23% slightly higher than that in the experimental group (11.53%), with no significant difference (P> 0.05). Conclusion Lamotrigine combined with sodium valproate treatment of children with epilepsy clinical efficacy was significant, and did not increase the incidence of adverse reactions.