Evidence map›Paper›PMID 40217527›Full record

ArticleActa epileptologica2024

The safety of valproic acid treatment in children with epilepsy: a retrospective real-world research.

Xiner Chen, Yujie Zhang, Xinan Liu, Ruoyu Tan, Dezhi Cao, Li Chen, Yan Hu, Bing Li, Tieshuan Huang, Qiang Zhou and 2 more

Abstract read
In one paragraph

Article in Acta epileptologica, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Xiner ChenDepartment of Pediatrics, Shenzhen Children's HospitalAffiliated to, China Medical University , Shenzhen, 518038, China.
Yujie ZhangPediatric Neurology, Shenzhen Children's Hospital, Shenzhen, 518038, China.
Xinan LiuGuangdong Provincial Key Laboratory of Brain Connectome and Behavior, CAS Key Laboratory of Brain Connectome and Manipulation, Brain Cognition and Brain Disease Institute (BCBDI), Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences, Shenzhen, 518055, China.
Ruoyu TanPediatric Neurology, Shenzhen Children's Hospital, Shenzhen, 518038, China.
Dezhi CaoPediatric Neurology, Shenzhen Children's Hospital, Shenzhen, 518038, China.
Li ChenPediatric Neurology, Shenzhen Children's Hospital, Shenzhen, 518038, China.
Yan HuPediatric Neurology, Shenzhen Children's Hospital, Shenzhen, 518038, China.
Bing LiPediatric Neurology, Shenzhen Children's Hospital, Shenzhen, 518038, China.
Tieshuan HuangPediatric Neurology, Shenzhen Children's Hospital, Shenzhen, 518038, China.
Qiang ZhouShenzhen Graduate School, Peking University, University Town of Shenzhen, Nanshan District, Xili, Shenzhen, 518055, China.
Jialun Wen *Pediatric Neurology, Shenzhen Children's Hospital, Shenzhen, 518038, China. jialunwenhos@sina.com.
Jianxiang Liao *Pediatric Neurology, Shenzhen Children's Hospital, Shenzhen, 518038, China. epilepsycenter@vip.163.com.ORCID http://orcid.org/0000-0001-9769-3365

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLiver damage, coagulopathy, hyperammonemia, fracture, menstrual disorder and amenorrhea are the most concerned adverse drug reactions of valproic acid (VPA). This study was aimed to retrospectively investigate the incidence of adverse drug reactions of VPA in the real world and its association with the age of patients and duration of treatment in order to obtain the safety data of VPA in children with epilepsy.

methodsA total of 1943 patients diagnosed as epilepsy by the Pediatric Neurology Department of Shenzhen Children's Hospital between December 2013 and December 2023, were included in the study. They received VPA as an initial treatment, and had followed up examinations over a time span of at least two years focusing on the adverse drug reactions of VPA.

resultsThere was no significant difference in the incidence of liver damage, coagulation test abnormalities, and nasal bleeding during VPA monotherapy (30-90 days, 90-180 days, and > 2 years). Adolescent female patients (first visit age ≥ 12 years) showed no significant difference in the incidence of adverse reactions and abnormal ultrasound of the reproductive system pre- versus post-treatment at the first visit, similar for those below 12 years. However, laboratory blood tests revealed significantly age-dependent changes in certain biochemical markers. Two patients stopped VPA treatment due to thrombocytopenia and ovarian cystic mass comorbid with endometrial hyperplasia, recovering after VPA withdrawal.

conclusionsThe initial monotherapy of VPA is generally safe in children with epilepsy of all age ranges. In the real world, VPA does not increase the risk of liver damage, coagulation disorder, elevated blood ammonia, fractures, or low serum sodium, but may significantly decrease the platelet count at 3, 6, 12, and 24 months of treatment. There is no evidence showing that VPA may increase the incidence of impairment of adolescent female reproductive system. Among children under 1 year old, it is recommended to monitor the levels of serum ammonia and aspartate aminotransferase carefully.

trial registrationChiCTR2300075115.

Indexed as

Adverse reactionChildrenEpilepsyReal-world researchValproic acid

Identifiers

PMID40217527
PMCPMC11960323

What Socratic holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.