| [Background]Systematic review is a systematic approach to collect,critically evaluate,integrate,and present the results of multiple studies on a topic of interest or a clinical problem to be solved.Quantitative review is required when researchers wish to assemble many studies that empirically test the same hypothesis,which is meta-analysis.Systematic review and meta-analysis are at the top of the evidence pyramid,mainly aimed at solving specific clinical problems,such as comparison of drug efficacy（generally meta-analysis of randomized controlled trials）,investigation of disease complication rate（generally meta-analysis of cross-sectional studies）,etiology exploration,etc.Evidence mapping summarizes the method is a kind of evidence,is the system to retrieve the focus areas（e.g.,age groups）of related research,the basic characteristics of the system,sum up the research and as a result,the research evidence and accurately demonstrate the existing problems,and to provide the outline of the research in this field for clinical practice,improve the validity and the practicability of the research in this field to help clinicians better serve patients.For a broad clinical problem,the preparation of evidence mapping in the clinical field can reflect the research status and further discover the research gaps.The value of evidence maps lies in the fact that they explore a range of clinical issues and thus paint a global picture of the evidence in this area,thus indicating the direction and focus of future research design.Based on the problems existing in the clinical practice of children epilepsy,this study explored the application of systematic review and evidence mapping.Epilepsy is a clinical manifestation caused by abnormal,excessive or synchronous firing of neurons mainly located in the cerebral cortex.This kind of abnormal partial firing activity is intermittent,usually self-limited,lasting a few seconds to a few minutes.Epilepsy is the most common chronic nervous system disease in children and has a worldwide incidence.In the pediatric population,focal epilepsy accounts for 40%to 50%of all epilepsy.A large number of new antiepileptic drugs have been introduced into clinical practice.Considering the different efficacy and tolerability of these antiepileptic drugs,clinicians need to provide the most appropriate choice for patients with focal epilepsy.There are no guidelines to guide the use of antiepileptic drugs in children with focal epilepsy compared to adults,and there is no high level of evidence supporting the most effective antiepileptic drugs.Previous studies have compared the use of most antiepileptic drugs for the treatment of focal epilepsy,but no published meta-analysis supporting the use of Lamotrigine（LTG）for the monotherapy of focal epilepsy in children has been published.In order to solve these problems,a systematic review and meta-analysis were conducted in this study to explore the efficacy and safety of LTG in the treatment of children and adolescents with focal epilepsy,and to provide high-level evidence support for clinicians to use LTG in the treatment of children and adolescents with focal epilepsy.Of clinical medicine in children with epilepsy in carding process,we found that children epilepsy,clinical study,age group has been blurred,not like before we understand according to the practical pediatrics age grouping method,explain simply according to children’s growth and development characteristics in age groups also cannot meet the specific needs of the clinical study,In order to clarify this problem,this study will draw an evidence map of age grouping in the field of pediatric epilepsy,and discuss the status quo of age group.[Objective]1.To explore the application of systematic evaluation and meta-analysis in efficacy comparison:to systematically evaluate the effectiveness and safety of lamotrigine in the treatment of focal epilepsy in children,and to provide high-level evidence support for the clinical use of this group.2.To explore the application of evidence maps in broad clinical areas:to describe the status of age groups in pediatric epilepsy clinical research,and to suggest the direction of age groups in future related research.[Methods]1.Effectiveness and safety of lamotrigine in the treatment of focal epilepsy in children and adolescents:We searched the published randomized controlled trials of lamotrigine in the treatment of focal epilepsy in children and adolescents,searched the MEDLINE database,EMBASE database,Chinese database including Chinese Biomedical Literature Database,CNKI,WANFANG Medical Database,and VIP database by using computer via Ovid SP database.The retrieval time limit is until February 5,2021.The retrieval results were screened primarily according to the title and abstract,and then re-screened after reading the full text.Data extraction was carried out for the included studies finally obtained.Literature screening and data extraction were conducted independently and cross-checked by two people.In case of different opinions,a third party with more experience was involved in the discussion and decision.The risk of bias in the included randomized controlled trials was assessed using the risk bias assessment tool published by the Cochrane Collaboration.Meta-analysis was performed using Rev Man version 5.4.Risk ratio and risk difference were used as effect analysis statistics for the Dicar copious outcome variables,and 95%confidence intervals were calculated.P<0.05 was considered statistically significant.Heterogeneity among the included results was analyzed using Mantel-Haenszel method,and the magnitude of heterogeneity was quantitatively determined with I~2.Fixed effects model was used for Meta-analysis with small heterogeneity.First,the source of heterogeneity was analyzed.After the exclusion of obvious clinical heterogeneity,a random-effects model was used for Meta-analysis.Considering the effect of treatment cycles on outcomes,subgroup analysis was conducted according to different treatment cycles.2.Status of age groups in pediatric epilepsy clinical research:Published randomized controlled trials in the field of epilepsy in children and adolescents were searched.Pub Med,Embase,and Web of Science databases were searched by computer,and the retrieval time was from the database establishment to February 5,2021.The retrieval results were screened primarily according to the title and abstract,and then re-screened after reading the full text.Data extraction was carried out for the included studies finally obtained.Literature screening and data extraction were conducted independently and cross-checked by two people.In case of different opinions,a third party with more experience was involved in the discussion and decision.Quantitative analysis was used to describe the distribution of published studies on childhood epilepsy.Tree and bar charts were used to show the research direction,time of publication,country/region,etc.We use tables and bubble charts to show evidence for age groups.[Results]1.Effectiveness and safety of lamotrigine in the treatment of focal epilepsy in children and adolescents:1.1 A>50%reduction in seizure frequency was significantly greater in lamotrigine than in placebo（RR,2.95,95%CI,1.88～4.61;RD,0.30,95%CI,0.19～0.40;P<0.00001）;There was no significant difference in>50%reduction rate of seizure frequency between lamotrigine group and carbamazepine/oxazepane group（RR,0.95,95%CI,0.85～1.05,RD,-0.04,95%CI,-0.12～0.04;P=0.30）.The results of the subgroup analysis according to the treatment cycle were consistent with the results of the ungrouped meta-analysis.1.2 Fever between lamotrigine and placebo（RR,1.17,95%CI,0.60～2.29;RD,0.02,95%CI,-0.06～0.10;P=0.64）,infection（RR,1.07,95%CI,0.64～1.80;RD,0.01,95%CI,-0.09～0.11;P=0.79）,rash（RR,0.97,95%CI,0.54～1.77;RD,0,95%CI,-0.09～0.09;P=0.53）was not statistically significant;The incidence of adverse events was significantly lower in the lamotrigine group than in the carbamazepine/ox carbamazepine group（fixed effect model:RR,0.64,95%CI,0.45～0.90;RD,-0.09,95%CI,-0.17～-0.02;P=0.01）.1.3 There was no statistically significant difference in withdrawal rates between the lamotrigine group and placebo group（fixed-effect model:RR,0.78,95%CI,0.52～1.16;RD,-0.05,95%CI,-0.13～0.03;P=0.21）.2.Status of age groups in pediatric epilepsy clinical research:2.1 The age groups of the published RCT studies were mainly the rough segmentation method（n=81）,the whole method（n=36）,the custom method（n=29）,and the subdivision method（n=10）.The age distribution of published quasi-RCTs was similar to that of published RCTs.2.2 For the studies with journal impact factor less than 3,the main age grouping method was the rough division method（n=88）,followed by the whole method（n=35）,the custom method（n=34）,and the subdivision method（n=12）.The age distribution of the journal impact factor was similar on a scale of 3 to 6.For the studies with journal impact factor greater than 6 points,the main age grouping method was the whole method（n=13）,followed by the rough division method（n=11）,the custom method（n=3）and the subdivision method（n=1）.In the studies published before 2000,the main age grouping methods are the rough segmentation method（n=25）,the whole method（n=5）,the custom method（n=4）,and the subdivision method（n=1）.The age distribution of studies published between 2000 to 2010,and 2011 to 2020 was similar to that of studies published before 2000.[Conclusion]1.Lamotrigine as an additive treatment can effectively reduce the frequency of epileptic seizures;Lamotrigine was not superior to carbamazepine/oxcarbazepine as monotherapy.Lamotrigine was associated with fewer adverse events than carbamazepine/ox carbamazepine,suggesting a better safety profile for Lamotrigine.2.In these randomized controlled trials published in the field of pediatric epilepsy,the most common age grouping method is the rough division of learning segments,followed by the whole method,the subdivision of learning segments,and the custom method.3.Evidence-based medicine is well applied to specific clinical problems and clinical status in a wide range of fields. |
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