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目的系统评价免疫比浊法和高效液相色谱法(HPLC)测定HbA_1c的一致性。方法计算机检索国内外重要数据库,搜索有关免疫比浊法和HPLC测定HbA1c的方法学评价文献。按照纳入和排除标准筛选文献,提取资料及进行方法学质量评价(QUADAS量表),并采用Stata 12.0软件进行Meta分析。结果共纳入8篇文献,合计3634例患者。免疫比浊法测定HbA_1c与HPLC测定结果检验,差异无统计学意义(Z=0.77,P=0.444);漏斗图、Begg秩相关检验(Z=1.36,P=0.174)及Egger线性回归法(t=1.91,P=0.105)均提示无发表偏倚;敏感性分析结果说明敏感性低,结果可信;亚组分析表明,小样本组较大样本组仍存在较高的异质性,中国的研究异质性较外国高。结论免疫比浊法和HPLC测定HbA_1c一致性较好,检测结果有可比性。
Objective To evaluate the consistency of HbA_1c by immunoturbidimetry and high performance liquid chromatography (HPLC). Methods A computer-based search of important databases at home and abroad was conducted to search for methodological evaluation of HbA1c by immunoturbidimetry and HPLC. According to inclusion and exclusion criteria, the literature was screened, data were extracted and methodological quality was assessed (QUADAS scale), and Meta analysis was performed using Stata 12.0 software. Results A total of 8 articles were included, a total of 3634 patients. (P = 0.174, P = 0.174) and Egger’s linear regression method (t = 0.77, P = 0.444) = 1.91, P = 0.105) all showed no publication bias. The results of sensitivity analysis showed that the sensitivity was low and the results were credible. Subgroup analysis showed that there was still high heterogeneity in the large sample group with small sample size. Heterogeneity is higher than that of foreign countries. Conclusion Immunoturbidimetry and HPLC determination of HbA_1c consistency is good, the test results are comparable.