CAJ | 학술논문

目的了解国内儿童应用托吡酯的不良反应(ADR)发生情况及其相关因素。方法计算机检索中国知网(CNKI)文献数据库,收集国内关于抗癫痫药物托吡酯用于儿童的临床研究文献,由2位研究者采用统一的资料提取表格,提取纳入文献中ADR病例的原患疾病,托吡酯用药剂量,ADR 病例的性别及年龄,ADR出现时间、类型、处理及转归等资料。对儿童应用托吡酯导致的 ADR 及其相关因素采用 SPSS 16.0统计学软件进行数据分析。结果经文献检索,最终符合本研究纳入标准的关于儿童托吡酯 ADR的研究文献共计22篇,关于托吡酯疗效的研究文献共计110篇,共计纳入13011例患儿,其中2771例发生ADR,ADR发生率为21.3%。关于托吡酯 ADR 的研究中,55.1%的 ADR 涉及神经及精神系统(泌汗障碍、影响自主神经功能等),34.5%涉及内分泌系统(影响骨代谢及生长发育等)；关于托吡酯疗效的研究文献报道的 ADR中,35.2%涉及神经及精神系统(出汗减少、记忆力下降、注意力不集中、头昏等),27.1%涉及消化系统(食欲下降、胃肠道反应等),19.5%为全身反应(体质量下降、发热等)。99.6%的儿童应用托吡酯发生的 ADR的严重程度为Ⅲ~Ⅳ级,多数在降低托吡酯剂量或停药后症状减轻。结论本研究纳入的132篇关于儿童应用托吡酯发生 ADR的研究文献中,均未提示重大 ADR发生,但由于受到研究设计和样本量局限,同时,纳入本研究的关于 ADR的文献,均存在关键信息不完整、研究报告质量欠佳等情况,因此建议进一步对儿童应用托吡酯开展上市后循证再研究及再评价,以确保临床用药安全。儿童应用托吡酯治疗导致的 ADR及药物安全性问题,有待以后高质量、大样本、多中心的随机对照研究进一步证实。
목적료해국내인동응용탁필지적불량반응(ADR)발생정황급기상관인소。방법계산궤검색중국지망(CNKI)문헌수거고,수집국내관우항전간약물탁필지용우인동적림상연구문헌,유2위연구자채용통일적자료제취표격,제취납입문헌중ADR병례적원환질병,탁필지용약제량,ADR 병례적성별급년령,ADR출현시간、류형、처리급전귀등자료。대인동응용탁필지도치적 ADR 급기상관인소채용 SPSS 16.0통계학연건진행수거분석。결과경문헌검색,최종부합본연구납입표준적관우인동탁필지 ADR적연구문헌공계22편,관우탁필지료효적연구문헌공계110편,공계납입13011례환인,기중2771례발생ADR,ADR발생솔위21.3%。관우탁필지 ADR 적연구중,55.1%적 ADR 섭급신경급정신계통(비한장애、영향자주신경공능등),34.5%섭급내분비계통(영향골대사급생장발육등)；관우탁필지료효적연구문헌보도적 ADR중,35.2%섭급신경급정신계통(출한감소、기억력하강、주의력불집중、두혼등),27.1%섭급소화계통(식욕하강、위장도반응등),19.5%위전신반응(체질량하강、발열등)。99.6%적인동응용탁필지발생적 ADR적엄중정도위Ⅲ~Ⅳ급,다수재강저탁필지제량혹정약후증상감경。결론본연구납입적132편관우인동응용탁필지발생 ADR적연구문헌중,균미제시중대 ADR발생,단유우수도연구설계화양본량국한,동시,납입본연구적관우 ADR적문헌,균존재관건신식불완정、연구보고질량흠가등정황,인차건의진일보대인동응용탁필지개전상시후순증재연구급재평개,이학보림상용약안전。인동응용탁필지치료도치적 ADR급약물안전성문제,유대이후고질량、대양본、다중심적수궤대조연구진일보증실。
Objective To assess the adverse drug reaction (ADR)and related factors of topiramate in the treatment of domestic children.Methods Clinical studies of topiramate in the treatment of various diseases for domestic children were searched from China National Knowledge Infrastructure (CNKI ) database.The relevant information such as primary diseases of ADR cases,dosage of topiramate,the age and gender of ADR cases,and the emergence time,category,treatment and prognosis of ADR were collected and analyzed using a standardized data collection form by two reviewers independently.Collected data were analyzed by SPSS 16.0 statistical software.Results We included 22 ADR reports and 110 clinical studies of efficacy evaluation which met the inclusion criteria,involving 13 011 patients,a total of 2 771 ADR cases were reported,the ADR incidence rate was 2 1 .3%.For ADR reports,5 5 .1% of ADR were related to neurological and mental systems (such as sweat secretion disorder,effecting autonomic nervous system function,etc.),34.5% were related to endocrine system (such as effecting bone metabolism,growth and development,etc.).For clinical studies,35.2% of ADR were related to neurological and mental system (such as decreased sweating,memory decline,inability to concentrate,dizziness,etc.),27.1% were related to digestive system(such as decreased appetite,gastrointestinal reactions,etc.),19.5% were systemic reactions (such as weight loss,fever,etc.).The severity of 99.6% ADR cases were Ⅲ to Ⅳ class.Most symptoms of ADR relieved when reducing the dose of topiramate or withdrawal it.Conclusions Serious ADR of topiramate did not occur in 132 researches which were included in our study.Due to the limitations of the research design and small sample size,key information in ADR reports and clinical studies were incomplete, and poor quality of research reports,it is recommended to carry out evidence-based research and evaluation of topiramate to ensure the safety of clinical practice.It deserves to confirm the safety of topiramate by further high-quality,large sample and multi-center randomized controlled research of ADR.