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抗癫痫药物治疗耐药性特发性全面性癫痫患者的临床试验:荟萃分析。

Anti epileptic drug trials for patients with drug resistant idiopathic generalised epilepsy: A meta-analysis.

机构信息

Department of Neurology, Galway University Hospital, Newcastle Road, Galway, Ireland.

RCSI School of Nursing & Midwifery, Royal College of Surgeons in Ireland, 123 St. Stephens Green, Dublin, Ireland.

出版信息

Seizure. 2017 Oct;51:145-156. doi: 10.1016/j.seizure.2017.08.007. Epub 2017 Aug 20.

Abstract

PURPOSE

Determine the impact of anti-epileptic drugs (AED) for drug resistant patients with idiopathic generalised epilepsy.

METHODS

A systematic search of Medline, Cumulative Index to Nursing an Allied Health Literature (CINAHL), Cochrane Epilepsy Group Central Specialised Register, Cochrane Central Register of controlled Trials (CENTRAL), Embase and Lenus was performed. Nine randomised controlled trials were included. All trials compared antiepileptic drugs to placebo. Outcome measures assessed were 50% or greater reduction in seizure, seizure freedom and adverse events.

RESULTS

Seven trials report a 50% or greater reduction in seizure frequency. This was statistically significant (p=<0.00001) with a narrow confidence interval implying that the overall this meta-analysis has reasonable power to detect an effect. It demonstrated a significant statistical difference of seizure freedom occurring in the drug treatment group compared to placebo. Adverse events were identified with each drug and are reported. There were however methodological issues with the trials included. Quality appraisal was undertaken using the risk of bias assessment from Rev Man 5.3 tool for all randomised controlled trials retrieved.

CONCLUSION

This systematic review demonstrated efficacy of adjunctive anti-epileptic drugs with regard to 50% reduction and seizure freedom. Adverse events are identified in all of the studies in the drug treatment groups but are consistent with previous studies of these drugs. Additional adequately powered studies with long term follow up needs to be conducted to unequivocally establish the long term efficacy and tolerability of anti-epileptic drug's for patients with drug resistant idiopathic generalised epilepsy.

摘要

目的

确定抗癫痫药物(AED)对特发性全面性癫痫耐药患者的影响。

方法

系统检索了 Medline、Cumulative Index to Nursing an Allied Health Literature(CINAHL)、Cochrane 癫痫组中央专业登记处、Cochrane 中央对照试验登记处(CENTRAL)、Embase 和 Lenus。纳入了 9 项随机对照试验。所有试验均比较了抗癫痫药物与安慰剂。评估的结局指标包括癫痫发作减少 50%或更多、癫痫无发作和不良事件。

结果

7 项试验报告癫痫发作频率减少 50%或更多。这在统计学上是显著的(p<0.00001),置信区间较窄,这意味着总体而言,这项荟萃分析有合理的能力检测到效果。它表明药物治疗组与安慰剂组相比,癫痫无发作的发生率存在显著的统计学差异。已确定每种药物的不良事件,并进行了报告。然而,纳入的试验存在方法学问题。使用 Rev Man 5.3 工具对所有检索到的随机对照试验进行了风险偏倚评估,并进行了质量评估。

结论

这项系统评价表明,辅助抗癫痫药物在减少 50%的癫痫发作和癫痫无发作方面具有疗效。药物治疗组的所有研究都发现了不良事件,但与这些药物的先前研究一致。需要进行更多具有长期随访的充分效力研究,以明确确定抗癫痫药物对耐药性特发性全面性癫痫患者的长期疗效和耐受性。

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