Efficacy and safety of clobazam in the additional treatment of refractory epilepsy in children：meta-analysis of single-group rate
- VernacularTitle: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
- Author:
Caixia TU
1
;
Danyang REN
1
;
Jianling SHEN
1
;
Yunwei LI
1
;
Yanming YANG
1
;
Aihua YAN
1
;
Lin LI
1
;
Huiying LI
1
Author Information
1. Dept. of Pharmacy，Kunming Children’s Hospital（The Affiliated Children’s Hospital of Kunming Medical University），Kunming 650228，China
- Publication Type:Journal Article
- Keywords:
clobazam;
refractory epilepsy;
children
- From:
China Pharmacy
2024;35(15):1893-1898
- CountryChina
- Language:Chinese
-
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. CONCLUSIONS Clobazam is an effective additional therapy for refractory epilepsy in children， but its adverse effects should be vigilant.
