机构地区:[1]首都医科大学附属北京同仁医院,北京同仁眼科中心,北京市眼科学与视觉科学重点实验室,100730
出 处:《中国斜视与小儿眼科杂志》2024年第1期21-24,I0001-I0004,共8页Chinese Journal of Strabismus & Pediatric Ophthalmology
基 金:国家自然科学基金面上项目(82070998);北京市科委科技计划项目(Z201100005520044);北京市医院管理中心临床技术创新项目(XMLX202103);国家自然科学基金青年科学基金(82101174);首都卫生发展科研专项项目(2022-1-2053);北京市医院管理中心“青苗”计划(QML20230205)。
摘 要:目的采用Meta分析方法,探索A型肉毒毒素(BTA)治疗IE的有效性及安全性,为IE患者治疗方式选择提供理论依据.方法系统检索包括中国知网、生物医学文献数据库、万方数据库、维普数据库、PubMed、EMBASE、Web of Science、Clinical Trial、Medline及Cochrane Library数据库,搜集BTA治疗IE的相关研究,检索时间均为2000年1月1日至2022年10月31日.两位评价者独立进行文献检索、筛选及数据提取,采用NOS量表评价方法(Newcastle-Ottawa Scale)对纳入的回顾性研究或非随机病例对照试验进行质量评价.从选取的文件中提取干预措施(剂量、是否联合玻璃酸钠、注射技术)、成功率、斜视度、平均注射次数、并发症发生率(上睑下垂、垂直斜视)等结局指标.各文献研究间的异质性采用Q检验和I^(2)检验.通过漏斗图评估有无发表偏倚.应用Stata16.0软件进行数据处理,如P<0.05或I^(2)>50%则认为异质性较大.当异质性较大时,选用Meta回归分析异质性来源,数据采用随机效应模型进行分析.结果检索各数据库初检共获得文献1278篇,经逐层筛选后,最终纳入文献9篇,含11项研究,共589例患者.随机效应模型分析结果显示,BTA治疗IE的成功率为47%(95%CI:33%~61%),具有高度的异质性(I^(2)=90.86%,P<0.001).通过Meta回归确定异质性可能的来源,结果表明成功率和样本量、干预年龄、基线斜视度、平均注射次数、注射技术、是否联合玻璃酸钠、随访时间之间没有关联.选取了使用相同剂量BTA的研究进行分析,成功率为62%(95%CI:48%~77%),具有高度的异质性(I^(2)=72.88%,P<0.001).通过Meta回归分析异质性来源,结果表明基线斜视度(P=0.017)对成功率有显著影响,说明基线斜视度每增加1^(△),BTA治疗的成功率下降1.25%.此外,经随机效应模型分析,上睑下垂的发生率为14%(95%CI:5%~23%),具有高度的异质性(I^(2)=57.13%,P=0.02).经Meta回归分析,干预年龄、平均注射次数、注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 I^(2) 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 I^(2)>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 1l 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(I^(2)=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,a
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