A型肉毒毒素治疗先天性内斜视的有效性与安全性的Meta分析OACSTPCD

Objective To explore the effectiveness and safety of botulinum toxin type A(BTA)in the treat-ment of infantile esotropia using the method of Meta-analy-sis,and to provide a theoretical basis for the selection of treatment modalities for patients with infantile esotropia.Methods A systematic search including CNKI,SinoMed,Wanfang Database,VIP Database,PubMed,EMBASE,Web of Science,Clinical Trial,Medline,and Cochrane Library databases was conducted to collect relevant studies on BTA for infantile esotropia,and the search periods were January 1,2000 to October 31,2022.Two researchers independently performed the literature search,screening,and data extraction,and the quality of the included retrospective studies or non-randomized case-control trials was evaluated using the NOS scale evaluation method(Newcastle-Ottawa Scale).Outcome indicators such as intervention(dose,whether to combine sodium hyaluronate,injection technique),success rate,prism degree,the mean times of injections,and complication rate(ptosis,vertical strabismus)were extracted from the selected documents.Heterogeneity among studies in the literature was tested by the Q test and I2 test.The presence or absence of publication bias was assessed by funnel plot.Stata 16.0 software was applied for data processing,and heterogeneity was considered significant if P＜0.05 or I2＞50％.Meta-regression was selected to analyze the source of heterogeneity when the heterogeneity was large,and the data were analyzed using a random-effects model.Results A total of 1278 papers were obtained by searching the databases for initial review,and after checking,9 papers containing 11 studies with a total of 589 patients were finally included.The results of the random-effects model analysis showed that the success rate of BTA for infantile esotropia was 47％(95％CI:33％ to 61％),with a high degree of heterogeneity(I2=90.86％,P＜0.001).Meta-regression was used to determine possible sources of heterogeneity,and the results showed no association between success rate and sample size,age at intervention,baseline prism degree,the times of injections,injection technique,whether sodium hyaluronate was combined,or duration of follow-up.Studies using the same dose of BTA were selected for analysis,and the success rate was 62％(95％CI:48％ to 77％),with a high degree of heterogeneity(I2=72.88％,P＜0.001).Analysis of the sources of heterogeneity by Meta-regression showed a significant effect of baseline prism degree(P=0.017)on the success rate,indicating that the success rate of BTA treatment decreased by 1.25％ for each 1△ increase in baseline prism degree.In addition,the prevalence of ptosis was 14％(95％CI:5％ to 23％)with a high degree of heterogeneity(I2=57.13％,P=0.02),as analyzed by the random-effects model.By Meta-regression analysis,age at intervention,the mean times of injections,injection technique,and whether or not to combine sodium hyaluronate were not associated with the incidence of ptosis.The incidence of vertical strabismus was 3％(95％CI:0％ to 7％),with little heterogeneity(I2=0.02％,P=0.87),and there was no need to analyze the source of heterogeneity.Conclusion BTA injection is a safe treatment for infantile esotropia with better efficacy in patients with small-angle esotropia.However,its ability to replace surgery as a stand-alone treatment needs to be confirmed by more high-quality studies.