左乙拉西坦添加治療兒童難治性癲癇部分性發(fā)作的臨床研究
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本文關(guān)鍵詞: 左乙拉西坦 添加治療 難治性癲癇 兒童 出處:《山西醫(yī)科大學》2012年碩士論文 論文類型:學位論文
【摘要】:目的:評價左乙拉西坦(Levetiratam,LEV)作為添加劑治療兒童難治性癲癇部分性發(fā)作的療效和安全性。 方法:采用開放性自身對照研究,收集2009年6月-2011年6月山西省兒童醫(yī)院神經(jīng)內(nèi)科門診及住院確診的難治性癲癇部分性發(fā)作患兒72例(男40例,女32例,年齡7月~15歲)為研究對象,治療隨訪6-24月,觀察治療療效及不良反應的發(fā)生情況。 結(jié)果: ①左乙拉西坦(Levetiratam,LEV)作為添加劑治療兒童難治性癲癇部分性發(fā)作達到完全控制8例(8/68),占11.8%,有效25例(25/68),占36.7%,總有效率達48.5%。治療前后癲癇發(fā)作次數(shù)比較,二者差異有統(tǒng)計學意義(P0.05)。 ②LEV添加治療簡單部分性發(fā)作總有效率54.5%,復雜部分性發(fā)作總有效率46.4%,部分性發(fā)作繼發(fā)全面性發(fā)作總有效率48.3%三組比較差異無統(tǒng)計學意義(P0.05); LEV添加治療(?)4歲年齡組總有效率48.6%,4歲年齡組總有效率48.4%,兩組比較差異無統(tǒng)計學意義(p0.05); LEV添加治療病程(?)3年患兒總有效率50.0%,病程3年患兒總有效率46.7%,兩組比較差異無統(tǒng)計學意義(P0.05); LEV添加治療頭顱影像學有異;純嚎傆行47.2%,無異;純嚎傆行50.0%,兩組比較差異無統(tǒng)計學意義(P0.05)。 ③LEV添加治療3、6、12和24個月無發(fā)作率分別為8.8%、14.7%、11.8%和11.8%,治療6個月、12個月和24個月與3個月總有效率比較均無統(tǒng)計學意義(P0.05)。 ④LEV添加治療的有效劑量為10-60mg/(kg.d),平均有效劑量為37mg/(kg.d) ⑤LEV添加治療不良反應發(fā)生率為33.8%,其中11例情緒異常(攻擊行為、脾氣暴躁、摔東西)(16.1%),6例乏力、睡眠多(8.8%);4例興奮、語言多、睡眠時間減少(5.9%);皮疹1例(1.5%);腹瀉1例(1.5%)。減量或在2-4周后自然消失。未導致停藥。未發(fā)現(xiàn)過敏及血液系統(tǒng),肝腎功能異常等不良反應。 ⑥LEV添加治療3、6、12和24個月保留率為94.1%、51、5%、45.6%和44.1%。 結(jié)論:LEV添加治療兒童難治性癲癇部分性發(fā)作有確切的療效,患兒發(fā)作類型、年齡、病程、頭顱影像學有無異常對其療效影響不大,LEV長期治療效果穩(wěn)定,有良好的安全性,保留率較高,可在臨床進一步推廣使用。
[Abstract]:Objective: to evaluate the efficacy and safety of Levetiratamme Levetiratamlov as an additive in the treatment of intractable partial seizure in children. Methods: from June 2009 to June 2011, 72 children (40 males and 32 females) with refractory partial epileptic seizures diagnosed in Department of Neurology, Department of Neurology, Shanxi Children's Hospital, were collected by an open self-control study. Age from July to 15 years old). Follow up for 6-24 months to observe the curative effect and the occurrence of adverse reactions. Results:. (1) Levetiratamme Levetiratammov (Levetiratammov) as an additive in the treatment of intractable partial seizures in children achieved complete control (8 / 68), accounting for 11.8%, effective 25 / 68 (36.7%), and the total effective rate was 48.5%. There was a statistically significant difference between the two groups in the number of epileptic seizures before and after treatment (P0.05). 2The total effective rate of simple partial attack was 54.5%, the total effective rate of complex partial attack was 46.4%, the total effective rate of partial secondary comprehensive attack was 48.3%, there was no significant difference among three groups (P 0.05). The total effective rate of the 4-year-old group was 48.6% and the total effective rate of the 4-year-old group was 48.4%, the difference between the two groups was not statistically significant (p 0.05). ) the total effective rate was 50.0% in 3 years and 46.7% in course of disease. There was no significant difference between the two groups (P 0.05), and the total effective rate of LEV plus therapy was 47.2% and 50.0% in children with abnormal cranial imaging. There was no significant difference between the two groups (P 0.05). The rates of no attack at 12 and 24 months after treatment with 3 LEV were 8. 8% and 11. 8%, respectively. There was no significant difference in the total effective rate between 6 months, 12 months and 24 months and 3 months after treatment (P 0. 05%). 4 the effective dose of LEV plus therapy is 10-60 mg / r / kg 路dL, and the average effective dose is 37 mg / r / kg 路d). (5) the incidence of adverse effects of LEV supplementation was 33.8. Among them, 11 cases had abnormal mood (aggressive behavior, grumpy temper, 6 cases of fatigue, 8. 8% sleep and 8. 8%), and 4 cases were excitatory and verbal. Sleep time was decreased by 5.9%; rash in 1 case was involved in 1 case; diarrhea in 1 case was reduced or disappeared naturally after 2-4 weeks. No side effects such as allergies, blood system, abnormal liver and kidney function were found. The retention rates of 6LEV for 12 and 24 months were 94.1% and 44.1%, 45.6% and 44.1%, respectively. Conclusion the effect of the addition of Lev on refractory partial seizure in children is definite. The type of attack, age, course of disease, and abnormal brain imaging have little effect on the long-term therapeutic effect of Lev, and it has good safety. The retention rate is high and can be further popularized in clinic.
【學位授予單位】:山西醫(yī)科大學
【學位級別】:碩士
【學位授予年份】:2012
【分類號】:R742.1
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