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难治性部分性癫痫患者使用辅助布瓦西坦:随机安慰剂对照试验的荟萃分析。

Adjunctive brivaracetam for patients with refractory partial seizures: A meta-analysis of randomized placebo-controlled trials.

作者信息

Ma Junpeng, Huang Siqing, You Chao

机构信息

Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, China.

Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, China.

出版信息

Epilepsy Res. 2015 Aug;114:59-65. doi: 10.1016/j.eplepsyres.2015.04.017. Epub 2015 May 1.

Abstract

OBJECTIVE

To evaluate the clinical efficacy and safety of the newer antiepileptic drug (AED), brivaracetam (BRV), as adjunctive therapy for adults with refractory partial seizures.

METHODS

Randomized-controlled trials (RCTs) of BRV in the treatment of refractory partial seizure were systematically reviewed and quantified using fixed- or random-effects meta-analysis. 50% responder rate, seizure free rate and adverse events in the treatment period were analyzed as outcomes for measuring efficacy and safety. Pooled effects of risk ratio (RR) and 95% confidence interval (CI) were derived from meta-analysis implemented in RevMan 5.2.

RESULTS

Five RCTs were identified for inclusion, and included a total of 1639 patients. The pooled RR of BRV vs. placebo as adjunctive therapy for adults with refractory partial seizure was 1.80 (95% CI 1.43-2.26, P < 0.00001) for 50% responder rates, 4.11 (95% CI 1.39-12.21, P = 0.01) for seizure free rates, 1.08 (95% CI 0.73-1.59; P = 0.70) for withdrawal rates. There was no evidence of a statistically significant association between the use of BRV and most adverse events, except somnolence (RR 1.63, 95% CI 1.08-2.45, P = 0.02) and fatigue (RR 2.05, 95% CI 1.19-3.53, P = 0.009).

CONCLUSION

This study confirmed significant effects of BRV as adjunctive treatment of refractory partial seizures. This study also demonstrated the good tolerability profile of adjunctive BRV for patients with epilepsy. Further large clinical and pharmacovigilance studies are needed to investigate the long-term efficacy and safety of BRV and, furthermore, to suggest an optimal BRV dosage for clinical use.

摘要

目的

评估新型抗癫痫药物(AED)布瓦西坦(BRV)作为难治性部分性发作成人患者辅助治疗的临床疗效和安全性。

方法

系统回顾布瓦西坦治疗难治性部分性发作的随机对照试验(RCT),并采用固定效应或随机效应荟萃分析进行量化。将治疗期间的50%缓解率、无癫痫发作率和不良事件作为衡量疗效和安全性的指标进行分析。风险比(RR)和95%置信区间(CI)的合并效应来自于RevMan 5.2中实施的荟萃分析。

结果

确定纳入5项RCT,共纳入1639例患者。布瓦西坦与安慰剂相比,作为难治性部分性发作成人患者辅助治疗的50%缓解率的合并RR为1.80(95%CI 1.43 - 2.26,P < 0.00001),无癫痫发作率的合并RR为4.11(95%CI 1.39 - 12.21,P = 0.01),停药率的合并RR为1.08(95%CI 0.73 - 1.59;P = 0.70)。除嗜睡(RR 1.63,95%CI 1.08 - 2.45,P = 0.02)和疲劳(RR 2.05,95%CI 1.19 - 3.53,P = 0.009)外,没有证据表明使用布瓦西坦与大多数不良事件之间存在统计学上的显著关联。

结论

本研究证实布瓦西坦作为难治性部分性发作的辅助治疗有显著效果。本研究还表明布瓦西坦辅助治疗对癫痫患者具有良好的耐受性。需要进一步进行大规模的临床和药物警戒研究,以调查布瓦西坦的长期疗效和安全性,并进一步提出临床使用的最佳布瓦西坦剂量。

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