Efficacy and Safety of Clobazam as Adjunctive Therapy for Pediatric Patients with Refractory Epilepsy in Xinjiang, China: A Multicenter Real-World Study.
7 affiliations
- 1Department of Pharmacology, School of Pharmacy, Xinjiang Medical University, Urumqi, Xinjiang, People's Republic of China.
- 2Department of Xinjiang Key Laboratory of Biopharmaceuticals and Medical Devices, Urumqi, Xinjiang, People's Republic of China.
- 3Department of Pharmacy, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang, People's Republic of China.
- 4Department of Precision Medicine, Institute of Clinical Pharmacy of Xinjiang Uygur Autonomous Region, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang, People's Republic of China.
- 5Department of Neurology, Xinjiang Hospital of Beijing Children's Hospital, Children's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang, People's Republic of China.
- 6Engineering Research Center of Xinjiang and Central Asian Medicine Resources, Ministry of Education, Xinjiang Medical University, Urumqi, Xinjiang, People's Republic of China.
- 7Xinjiang Key Laboratory of Natural Medicines Active Components and Drug Release Technology, Xinjiang Medical University, Urumqi, Xinjiang, People's Republic of China.
Abstract
Objective
This real-world retrospective observational study evaluated the efficacy and safety of clobazam as adjunctive therapy in pediatric patients with refractory epilepsy (RE) in Xinjiang to provide evidence for its rational clinical application.Methods
Treatment efficacy was assessed according to the four-level efficacy criteria established by the First National Epilepsy Academic Conference of the Chinese Medical Association using seizure frequency recorded at the final follow-up. Changes in seizure frequency from baseline were evaluated at 3, 6, and 12 months after treatment initiation. All adverse drug reactions occurring during follow-up were recorded.Results
The response rates to clobazam therapy were 50.7%, 50.7%, 53.8%, and 56.7% at 1, 3, 6, and 12 months, respectively. The effective group received a significantly higher daily clobazam dose than the ineffective group (P < 0.05). The proportion of pediatric patients with no reduction in seizure frequency decreased significantly from 14.7% at 1 month to 1.7% at ≥12 months (P < 0.05), while the proportion of pediatric patients with a <50% reduction in seizure frequency gradually increased over time. The highest efficacy was observed in patients with a disease duration of 3-6 years (62.5%, 10/16), while those with a duration of <1 year showed relatively lower efficacy (30.8%, 4/13). Sex and comorbidities were significant predictors of clobazam controlling seizures (P = 0.039 and P = 0.030, respectively). During the clobazam treatment period, 31 pediatric patients (41.33%) experienced at least one adverse drug reaction.Conclusion
Clobazam demonstrated favorable efficacy, safety, and tolerability as adjunctive therapy in pediatric patients with RE. These real-world findings provide clinical evidence supporting the rational use of clobazam in pediatric RE.
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BibTeX
@article{zhao2026efficacy,
title = {{Efficacy and Safety of Clobazam as Adjunctive Therapy for Pediatric Patients with Refractory Epilepsy in Xinjiang, China: A Multicenter Real-World Study.}},
author = {Ting Zhao and Hong-Jian Li and Hui-Lan Zhang and Lu-Hai Yu and Jing Yu and Yan Sun and Lu-Feng Cheng},
journal = {Drug design, development and therapy},
year = {2026},
month = oct,
doi = {10.2147/dddt.s652340},
url = {https://europepmc.org/article/MED/42898882},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Efficacy and Safety of Clobazam as Adjunctive Therapy for Pediatric Patients with Refractory Epilepsy in Xinjiang, China: A Multicenter Real-World Study.
AU - Ting Zhao
AU - Hong-Jian Li
AU - Hui-Lan Zhang
AU - Lu-Hai Yu
AU - Jing Yu
AU - Yan Sun
AU - Lu-Feng Cheng
PY - 2026
DA - 2026/10/15
JO - Drug design, development and therapy
DO - 10.2147/dddt.s652340
UR - https://europepmc.org/article/MED/42898882
AB - Objective This real-world retrospective observational study evaluated the efficacy and safety of clobazam as adjunctive therapy in pediatric patients with refractory epilepsy (RE) in Xinjiang to provide evidence for its rational clinical application.Methods Treatment efficacy was assessed according to the four-level efficacy criteria established by the First National Epilepsy Academic Conference of the Chinese Medical Association using seizure frequency recorded at the final follow-up. Changes in seizure frequency from baseline were evaluated at 3, 6, and 12 months after treatment initiation. All adverse drug reactions occurring during follow-up were recorded.Results The response rates to clobazam therapy were 50.7%, 50.7%, 53.8%, and 56.7% at 1, 3, 6, and 12 months, respectively. The effective group received a significantly higher daily clobazam dose than the ineffective group (P < 0.05). The proportion of pediatric patients with no reduction in seizure frequency decreased significantly from 14.7% at 1 month to 1.7% at ≥12 months (P < 0.05), while the proportion of pediatric patients with a <50% reduction in seizure frequency gradually increased over time. The highest efficacy was observed in patients with a disease duration of 3-6 years (62.5%, 10/16), while those with a duration of <1 year showed relatively lower efficacy (30.8%, 4/13). Sex and comorbidities were significant predictors of clobazam controlling seizures (P = 0.039 and P = 0.030, respectively). During the clobazam treatment period, 31 pediatric patients (41.33%) experienced at least one adverse drug reaction.Conclusion Clobazam demonstrated favorable efficacy, safety, and tolerability as adjunctive therapy in pediatric patients with RE. These real-world findings provide clinical evidence supporting the rational use of clobazam in pediatric RE.
SN - 1177-8881
ER -