抗α-胞衬蛋白抗体对干燥综合征诊断价值的荟萃分析

Diagnostic value of anti-α-fodrin antibody testing for Sjogren＇s syndrome： a meta-analysis

目的系统评价抗α-胞衬蛋白抗体对干燥综合征（SS）的诊断价值。方法检索1997年1月至2007年12月Cochrane图书馆、Medline、Embase和中国生物医学文献数据库等数据库，按照Cochrane协作网推荐的诊断试验的纳入标准筛选文献，采用QUADAS工具评价纳入文献质量，应用MATLAB软件、Review Manager 4．2软件及Meta—Disc 1．4软件对纳入研究进行综合定量评价，分析异质性来源及绘制综合受试者工作曲线（SROC）。结果共纳入18个中英文研究均检测抗α-胞衬蛋白IgG类抗体，合并敏感性为0．40[95％CI（0．37—0．43）]，合并特异性为0．82[95％CI（0．79～0．84）]，SROC下面积（AUC）是0．8029，标准误（距）是0．0580；8个研究检测抗α-胞衬蛋白IgA类抗体，合并敏感性为0．34[95％CI（0．30～0．38）]，合并特异性为0．83[95％CI（0．79～0．86）]，AUC：0．6374，SE=0．1841；合并数据均有异质性。分别从年龄、人种、实验方法、试剂来源、诊断标准和研究国家进行分层分析，其中来自中国的4个研究和日本的6个研究无异质性，抗α-胞衬蛋白IgG类抗体对SS临床诊断价值SROC分析结果分别为AUC=0．7343，SE=0．0448和AUC=0．9273，SE=0．0394。结论纳入研究存在异质性，诊断标准、试剂来源、实验方法、民族地域和年龄等是异质性的主要来源；综合定量分析结果显示抗α-胞衬蛋白IgG／IgA类抗体对于SS的临床诊断均具有较低的敏感性和较高的特异性，抗体阴性对于临床排除SS诊断意义不大，抗体阳性对于确定SS诊断可能具有更高的临床价值。

Objective To evaluate the diagnostic accuracy of anti-α-fodrin antibody for Sjogren＇s syndrome （SS）. Methods Qualified literatures on evaluation of anti-α-fodrin antibody in diagnosis of SS in English and Chinese published between January 1997 and December 2007 were retrieved from the Cocharane Library, Medline, Embase, and China National Knowledge Infrastructure （CNKI） databases, etc. Two reviewers independently assessed the methodological quality of each study with the tool QUADAS （ quality assessment of diagnostic accuracy studies ）. Statistical analysis was performed by employing MATLAB, Review Manager 4.2 and Meta-Discl. 4. A meta-analysis of the reported sensitivity and specificity of each study and Summary Receiver Operating Characteristic （SROC） curve was performed. Results Eighteen literatures were included at last. After testing the heterogeneity of the included articles, proper effect model was selected to calculate the pooled weighted sensitivity and specificity with 95% confidence interval： for anti-vfodrin antibody IgG, the sensitivity was 0.40 [ 95% CI（0. 37-0.43 ） ] and the specificity was 0.82 [95% CI（0. 79-0.84） ], the area under the curve （AUC） of SROC was 0. 8029 （SE = 0. 0580）. Eight studies tested anti-vfodrin antibody IgA, the pooled weighted sensitivity and specificity with 95% confidence interval were 0.34 [95% CI（0. 30-0.38） ] and 0.83 [95% CI（0. 79-0.86） ] respectively, the AUC of SROC was 0. 6374 （ SE = 0. 1841 ）, the synthesis data all showed heterogeneity. The subgroups were analyzed to identify the sources of heterogeneity according to age, race, assay method, agent source, diagnostic criteria, and country. There was homogenicity among the 4 studies from China, and the 6 studies from Japan,the AUC of SROC were 0. 7343 （ SE = 0. 0448 ） and 0. 9273 （ SE = 0. 0394 ）, respectively . Conclusion Diagnostic criteria, agent source, assay method, age, race, and country are the important sources of heterogeneity. Anti-α-fodrin antibodies IgG and IgA have relatively low pooled sensitivity and relatively high pooled specificity. Negative anti-α-fodrin antibody has not important value in excluding SS, but positive anti-α-fodrin antibody may be a useful parameter in clinical diagnosis of SS.