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·循证药学·

氯巴占附加治疗儿童难治性癫痫的有效性和安全性单组率的
Meta分析 Δ

涂彩霞 ，任丹阳，沈建玲，李云巍，杨琰茗，严爱花，李 琳，李惠英 [昆明市儿童医院（昆明医科大学附属儿童医
#
＊
院）药剂科，昆明 650228]

中图分类号 R971；R985；R969.3 文献标志码 A 文章编号 1001-0408（2024）15-1893-06
DOI 10.6039/j.issn.1001-0408.2024.15.16

摘 要 目的 探讨氯巴占附加治疗儿童难治性癫痫的有效性和安全性，为临床安全、合理用药提供参考。方法 计算机检索
PubMed、The Cochrane Library、Embase、中国知网、维普网、万方数据中有关氯巴占附加治疗儿童难治性癫痫的文献，检索时限为
建库起至2023年11月。筛选文献、提取资料，并参考非随机对照试验的方法学评价指标质量评价工具对纳入的文献进行质量评
价后，采用RevMan 5.3软件进行单组率的Meta分析和敏感性分析。结果 共纳入18项单臂研究，共计1 424例患儿。结果显示，
与加用氯巴占之前比，氯巴占附加治疗后，无癫痫发作（癫痫发作减少100%）的患儿占比经转换后为24%[95%CI（0.18，0.32），P＜
0.000 01]；癫痫发作减少≥75%的患儿占比经转换后为32%[95%CI（0.25，0.40），P＜0.000 1]；癫痫发作减少≥50%的患儿占比为
53%[95%CI（0.44，0.61），P＜0.000 01]；癫痫发作减少＜50% 或无变化的患儿占比经转换后为 35%[95%CI（0.24，0.49），P＝0.04]；
癫痫发作增加的患儿占比经转换后为 9%[95%CI（0.05，0.18），P＜0.000 01]。发生不良反应的患儿占比经转换后为 31%[95%CI
（0.23，0.40），P＜0.000 1]；因不良反应停用氯巴占的患儿占比经转换后为10%[95%CI（0.07，0.15），P＜0.000 01]；常见的不良反应
为嗜睡、疲劳、行为改变等。敏感性分析显示，本研究所得结果较稳健。结论 氯巴占是一种儿童难治性癫痫的有效附加治疗药
物，但需警惕其不良反应。
关键词 氯巴占；难治性癫痫；儿童；附加治疗；Meta分析

Efficacy and safety of clobazam in the additional treatment of refractory epilepsy in children： meta-
analysis of single-group rate
TU Caixia，REN Danyang，SHEN Jianling，LI Yunwei，YANG Yanming，YAN Aihua，LI Lin，LI Huiying [Dept. of
Pharmacy， Kunming Children’s Hospital（The Affiliated Children’s Hospital of Kunming Medical University），
Kunming 650228， China]

ABSTRACT OBJECTIVE To investigate the efficacy and safety of clobazam in the additional treatment of refractory epilepsy in
children， and provide reference for clinically safe and rational drug use. METHODS The literatures about additional clobazam
treatment for refractory epilepsy in children were searched from PubMed， The Cochrane Library， Embase， CNKI， VIP and
Wanfang database during the inception to November 2023. After literature screening and data extraction， the quality of included
literature was evaluated according to quality evaluation tool for methodological evaluation indicators of non-randomized controlled
trial， and then meta-analysis of single-group rate and sensitivity analysis were performed by using RevMan 5.3 software. RESULTS
Finally， 18 one-arm studies were included， with a total of 1 424 children. The results showed that compared with before additional
treatment， the proportion of patients with seizures-free （proportion of patients with seizure reduction of 100%） was 24%[95%CI
（0.18，0.32）， P＜0.000 01] after conversion； the proportion of patients with seizure reduction ≥75% was 32%[95%CI（0.25，0.40），
P＜0.000 1] after conversion； the proportion of patients with seizure reduction ≥50% was 53%[95%CI（0.44，0.61），P＜0.000 01]；
the proportion of patients with seizure reduction ＜50% or no change was 35%[95%CI（0.24，0.49），P＝0.04] after conversion； the
proportion of patients with seizure increase was 9%[95%CI（0.05，0.18），P＜0.000 01] after conversion. The proportion of patients
with adverse reactions was 31%[95%CI（0.23，0.40），P＜0.000 1] after conversion； the proportion of patients with discontinuation
due to adverse reactions was 10%[95%CI（0.07， 0.15）， P＜0.000 01] after conversion. The common adverse drug reactions were
drowsiness， fatigue and behavior change， etc. The results of
the sensitivity analysis showed that the study was robust.
Δ 基金项目 昆 明 市 卫 生 科 技 人 才 培 养 项 目 [No. 2023-SW
（技）-19]；昆明市卫生健康委员会卫生科研项目（No.2023-13-01-014） CONCLUSIONS Clobazam is an effective additional therapy
＊第一作者 主管药师，硕士。研究方向：临床药学、循证药学。电 for refractory epilepsy in children， but its adverse effects
话：0871-63308948。E-mail：tu_caixia@163.com should be vigilant.
# 通信作者 主任药师，硕士。研究方向：药事管理、临床药学。电 KEYWORDS clobazam； refractory epilepsy； children；
话：0871-63309256。E-mail：444766802@qq.com additional treatment； meta-analysis

中国药房 2024年第35卷第15期 China Pharmacy 2024 Vol. 35 No. 15 · 1893 ·