对比检测血清中抗环瓜氨酸肽抗体水平对类风湿关节炎的诊断价值

Diagnostic value of serum anti-cyclic citrullinated peptide antibodies in patients with rheumatoid arthritis

目的比较国产和进口诊断试剂盒检测类风湿关节炎(RA)患者血清中的抗环瓜氨酸肽(CCP)的抗体水平的结果,探讨其对RA的临床诊断价值。方法采用国产和进口试剂以酶联免疫吸附试验(ELISA)方法检测120例RA,71例非RA和50例正常人血清中的抗CCP抗体,用免疫速率散射比浊法检测类风湿因子(RF),绘制受试者工作特性(ROC)曲线并计算ROC曲线下面积,分析抗CCP抗体与RF在诊断RA中的相关性。结果国产和进口试剂盒检测抗CCP抗体在RA组中的阳性率为61.7%(74/120)、69.2%(83/120),显著高于非RA组的9.9%(7/71)、7.0%(5/71)和正常组的0.0%(P<0.001),国产和进口试剂盒检测结果之间的差异不显著(P=0.167)。抗CCP抗体和RF对RA诊断的敏感性分别为69.2%、64.2%,特异性为92.9%、67.6%;阳性预测值和阴性预测值为94.3%、77.0%,64.1%、52.7%;似然比为9.82、1.98。抗CCP抗体的ROC曲线下面积为0.829,RF的ROC曲线下面积为0.740,抗CCP抗体对RA的临床诊断效能优于RF指标。抗CCP抗体和RF的检测结果间存在相关性(r=0.29.P=0.001)。结论抗CCP抗体可作为临床诊断RA的一项很好的血清学指标,在RA早期即有很高的特异性,联合检测RF更可提高对RA的早期诊断,但其与RA的发病及预后的关系有待进一步研究。

Objective To explore the diagnostic value of serum anti-cyclic citrullinated peptide （Anti-CCP） antibodies in patients with rheumatoid arthritis （RA）. Methods Anti-CCP antibodies were detected in the serum samples of 120 RA patients, 71 non-RA patients with various rheumatic diseases, and 50 normal controls by enzyme-linked immunosorbent assay （ELISA） using domestic and imported commercial detection kits. Rheumatoid factors （RF） were assayed by immune-nephelometry. The correlation between Anti-CCP and RF in RA diagnosis was analyzed by calculating the area under curve of the receiver operating characteristic （ROC） curve. Results The positive rates for Anti-CCP, detected using both domestic and imported kits, were 61.7% （74/120） and 69.2% （83/120） in RA group, significantly higher than those in the non-RA group （9.9%, 7/71 and 7.0%, 5/71） and normal control group （both 0, P〈0.001）. The sensitivities for Anti-CCP and RF were 69.2% and 64.2%, and the specificities were 92.9% and 67.6%, respectively. The positive predictive value was 94.3% for Anti-CCP and 77.0% for RF, whereas the negative predictive value was 64.1% for Anti-CCP and 52.7% for RF. The likelihood ratio （LR） was 9.82 for anti-CCP and 1.98 for RF. The area under curve of ROC for Anti-CCP was 0.829 and 0.740 for RF. Anti-CCP antibodies had greater diagnostic value than RF in RA diagnosis, and Anti-CCP showed significant correlation with RF （r=0.29, P=0.001）. Conclusion Anti-CCP antibodies are an excellent serological marker for RA, which shows high diagnostic specificity at early stage, and can increase its diagnostic value when combined with RF detection, but the role of Anti-CCP in the occurrence and prognosis of RA remains to be further investigated.