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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
Efficacy and safety of clobazam in the additional treatment of refractory epilepsy in children： meta-analysis of single-group rate
- 中国药房 2024年35卷第15期 页码：1893-1898
- 作者机构：
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
- 作者简介：
主管药师，硕士。研究方向：临床药学、循证药学。电话：0871-63308948。E-mail：tu_caixia@163.com
主任药师，硕士。研究方向：药事管理、临床药学。电话：0871-63309256。E-mail：444766802@qq.com
- 基金信息：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(2023-13-01-014)
DOI：10.6039/j.issn.1001-0408.2024.15.16
中图分类号： R971;R985;R969.3纸质出版日期：2024-08-15，
收稿日期：2024-01-19，
修回日期：2024-06-25，
- 稿件说明：
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涂彩霞,任丹阳,沈建玲等.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[J].中国药房,2024,35(15):1893-1898.
TU Caixia,REN Danyang,SHEN Jianling,et al.Efficacy and safety of clobazam in the additional treatment of refractory epilepsy in children： meta-analysis of single-group rate[J].ZHONGGUO YAOFANG,2024,35(15):1893-1898.
涂彩霞,任丹阳,沈建玲等.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[J].中国药房,2024,35(15):1893-1898. DOI： 10.6039/j.issn.1001-0408.2024.15.16.
TU Caixia,REN Danyang,SHEN Jianling,et al.Efficacy and safety of clobazam in the additional treatment of refractory epilepsy in children： meta-analysis of single-group rate[J].ZHONGGUO YAOFANG,2024,35(15):1893-1898. DOI： 10.6039/j.issn.1001-0408.2024.15.16.
摘要
目的
2
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
2
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
2
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
2
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。
Abstract
OBJECTIVE
2
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
2
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
2
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.
CONCLUSIONS
2
Clobazam is an effective additional therapy for refractory epilepsy in children， but its adverse effects should be vigilant.
关键词
氯巴占难治性癫痫儿童附加治疗Meta分析
Keywords
refractory epilepsychildrenadditional treatmentmeta-analysis
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