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布立西坦添加治疗难治性局灶性癫痫的快速卫生技术评估
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| 篇名： | 布立西坦添加治疗难治性局灶性癫痫的快速卫生技术评估 |
| TITLE： | Rapid health technology assessment of brivaracetam as adjunctive therapy for drug-resistant focal epilepsy |
| 摘要： | 目的 评估布立西坦（BRV）添加治疗难治性局灶性癫痫的有效性、安全性和经济性。方法检索PubMed、Embase、CochraneLibrary、WebofScience、中国知网、万方数据等数据库及各卫生技术评估机构官网，收集BRV相关的卫生技术评估（HTA）报告、系统评价/Meta分析和药物经济学研究，检索时限自建库至2026年1月31日。经文献筛选、质量评价后，进行描述性分析。结果共纳入21篇文献，包括13篇系统评价/Meta分析、7篇药物经济学研究（其中1篇同时开展了系统评价/Meta分析）和2篇HTA报告。有效性方面，BRV较安慰剂可显著提高50%应答率[风险比（RR）＝1.81]和癫痫无发作率（RR＝5.89）；在第三代抗癫痫发作药物中，BRV的癫痫无发作率排第1～2位，50%应答率中等；成人最佳剂量为100mg/d。安全性方面，BRV总不良事件发生率与安慰剂无显著差异，但因不良事件停药率略高，耐受性在第三代抗癫痫发作药物中排第1～2位；精神行为不良事件发生率（6.4%）低于左乙拉西坦（14.1%）。经济性方面，BRV在定价较低的澳大利亚、芬兰等国具有药物经济学优势；日本仅高危人群具有药物经济学优势；美国、意大利在当前价格下不具备药物经济学优势。我国BRV已纳入2025年国家医保目录，上市初期的经济性结论已过时，需重新评估。结论BRV疗效确切、安全性良好，尤其适合左乙拉西坦不耐受的患者。但受定价和医保政策影响，我国BRV进入医保后的经济性尚需重新评估。 |
| ABSTRACT： | OBJECTIVE To evaluate the efficacy， safety， and cost-effectiveness of brivaracetam （BRV） as adjunctive therapy in patients with drug-resistant focal epilepsy.METHODS PubMed， Embase， Cochrane Library， Web of Science， CNKI， Wanfang， and official health technology assessment （HTA） agency websites were searched from inception to January 31， 2026 for HTA reports， systematic reviews/meta-analyses， and pharmacoeconomic studies on BRV. After literature screening and quality assessment， a descriptive analysis was performed.RESULTS A total of 21 publications were included： 13 systematic reviews/meta-analyses， 7 pharmacoeconomic studies （including one study that simultaneously conducted a systematic review/meta-analysis）， and 2 HTA reports. Regarding efficacy， BRV significantly improved the 50% responder rate [risk ratio （RR）＝1.81] and seizure-freedom rate （RR＝5.89） versus placebo. Among third-generation anti-seizure medications （ASMs）， BRV ranked 1st-2nd for seizure freedom， while its 50% responder rate was at a moderate level. The optimal adult dose for seizure freedom was 100 mg/d. Regarding safety， BRV was well tolerated， overall adverse event rates did not differ from placebo， though withdrawal due to adverse event rates were higher than with placebo. Tolerability ranked 1st-2nd among the third-generation ASMs. Psychiatric/behavioral adverse event rates were lower with BRV （6.4%） than with levetiracetam （14.1%）. Regarding cost-effectiveness， BRV showed pharmacoeconomic advantages in countries with lower drug pricing （Australia， Finland） and only in high-risk subgroups in Japan， but did not show such advantages at current prices in the US or Italy. BRV has been included in China’s national reimbursement drug list in 2025， and the economic conclusions drawn during its initial market launch are outdated and require re-evaluation.CONCLUSIONS BRV has proven efficacy and good safety， especially suitable for patients intolerant to levetiracetam. However， due to pricing and medical insurance policies， the cost-effectiveness of BRV after its inclusion in China’s national reimbursement drug list still needs to be re-evaluated. |
| 期刊： | 2026年第37卷第17期 |
| 作者： | 丑晓华；张倩；仇欣然；张波；姜道利 |
| AUTHORS： | CHOU Xiaohua，ZHANG Qian，QIU Xinran，ZHANG Bo，JIANG Daoli |
| 关键字： | 布立西坦；难治性局灶性癫痫；快速卫生技术评估；有效性；安全性；经济性 |
| KEYWORDS： | drug-resistant focal epilepsy;rapid health technology assessment;efficacy;safety;cost-effectiveness |
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