定痫丸加减联合左乙拉西坦治疗小儿癫痫痰火扰神证疗效及对认知功能、生活质量的影响

Clinical Efficacy of Modified Dingxianwan Combined with Levetiracetam on Syndrome of Phlegm-fire Disturbing Mind in Children with Epilepsy and Effect on Cognitive Function and Life Quality

目的：探讨小儿癫痫痰火扰神证应用定痫丸加减联合左乙拉西坦治疗的临床效果。方法：选取本院2015年9月至2017年9月收治的114例痰火扰神型癫痫患儿,采用随机数字表法均分为两组。对照组（57例）口服左乙拉西坦片,观察组（57例）在此基础上加用定痫丸加减治疗,所有患儿均治疗6个月。比较两组临床疗效,治疗前后中国修订韦氏儿童智力量表（C-WISC）,儿童癫痫生存质量问卷（QOLCE）评分变化,不良反应发生情况,检测治疗前后白细胞介素-6（IL-6）,白细胞介素-1β（IL-1β）,肿瘤坏死因子-α（TNF-α）,超氧化物歧化酶（SOD）,还原型谷胱甘肽（GSH）,谷胱甘肽过氧化物酶（GSH-Px）和丙二醛（MDA）水平。结果：治疗6个月后,观察组总有效率为93.0%,较对照组的77.2%明显升高（χ^2=5.600,P〈0.05）。两组治疗后C-WISC中各智力功能[操作智商（PIQ）,言语智商（VIQ）]及全智商（FIQ）评分较本组治疗前均明显增高（P〈0.05）,且观察组上升更明显（P〈0.05）。与本组治疗前相比,两组治疗后QOLCE中各维度（包括躯体功能、情感健康、行为功能等）评分和总体健康、自评生存质量评分及QOLCE总分均明显增高（P〈0.05）,且观察组升高更明显（P〈0.05）。与对照组不良反应5.3%（3/57）相比,观察组不良反应为8.8%（5/57）,差异无统计学意义;治疗后观察组IL-6,IL-1β,TNF-α,MDA水平均低于对照组（P〈0.05）;血清SOD,GSH,GSH-Px水平均高于对照组（P〈0.05）。结论：小儿癫痫痰火扰神证应用定痫丸加减联合左乙拉西坦治疗能明显减轻患儿症状,控制癫痫发作,改善认知功能,提高生活质量,疗效明显,安全可靠。

Objective： To explore the clinical efficacy of modified Dingxianwan combined with levetiracetam on syndrome of phlegm-fire disturbing mind in children with epilepsy. Method： The 114 children with epilepsy of phlegm-fire disturbing mind type admitted in our hospital from September 2015 to September 2017,were evenly divided into two groups on the basis of random number table. The patients in control group（ 57 cases）were given with levetiracetam tablets orally,while the patients in observation group（ 57 cases） received modified Dingxianwan in addition to what was applied to control group. All children from the two groups were treated for 6 months. The clinical efficacy,changes of Chinese revised Wechsler Intelligence Scale for children（ C-WISC） and the Quality of Life in Childhood Epilepsy（ QOLCE） scores before and after treatment,and adverse reactions,interleukin-6（ IL-6）,interleukin-1β（ IL-1β）,tumor necrosis factor-α（ TNF-α）,and superoxide dismutase（ SOD）,reduced glutathione（ GSH）,glutathione peroxidase（ GSH-Px） and malondialdehyde（ MDA） levels were detected and compared between two groups. Result： After 6 months of treatment,the overall effective rate was 93. 0%（ 53/57） in observation group,much higher than 77. 2%（ 44/57） in control group（ χ^2= 5. 600,P〈0. 05）. After treatment, both groups showed a remarkable increase in scores for their intellectual function[performance intelligence quotient（ PIQ）,verbal intelligence quotient（ VIQ） ] and full intelligence quotient（ FIQ） as compared with those before treatment（ P〈0. 05）,and the increase in observation group was more obvious（ P〈0. 05）. As compared with those before treatment,the scores for all QOLCE dimensions（ including physical function,emotional well-being,and behavioral function,etc.）,general health,self-rating life quality,and the total score for QOLCE were obviously increased in both groups after treatment（ P〈0. 05）,and observation group showed a more significant increase（ P〈0. 05）. As compared with control group [5. 3%（ 3/57） ],the adverse reaction rate was 8. 8%（ 5/57） in observation group,with no statistically significant difference. The levels of IL-6,IL-1β,TNF-α and MDA in observation group were lower than those in control group（ P〈0. 05）; the levels of serum SOD,GSH,and GSH-Px were higher than those in control group（ P〈0. 05）. Conclusion： In treating children with epilepsy（ syndrome of phlegm-fire disturbing mind）, the combination of modified Dingxianwan and levetiracetam can significantly relieve the symptom in the children,mitigate epileptic seizures,and improve cognitive function and life quality,proving to be effective and safe.