原发性干燥综合征2012年美国风湿病学会分类标准的临床验证

Validation of the American College of Rheumatology Classification Criteria for primary Sjgren's syndrome in Chinese patients

目的:验证2012年美国风湿病学会提出的新的原发性干燥综合征(primary Sjgren’s syndrome,pSS)分类(诊断)标准在中国pSS患者中的敏感度和特异度。方法:对2008年1月至2012年12月于北京大学口腔医院口腔黏膜科就诊的临床怀疑为pSS的患者,共291例进行回顾性分析。凡经2位以上专家根据其临床表现和实验室检查结果认为是pSS者列为pSS组,凡不符合pSS诊断标准的其他患者列为非pSS组。结果:共有239例pSS患者(160例完成唇腺活检,79例未做活检)和52例非pSS患者(9例完成唇腺活检,43例未做唇腺活检)分别纳入pSS组和非pSS组,两组年龄匹配。根据2012年美国风湿病学会诊断标准对纳入该研究的受试者进行诊断验证,经验证该诊断标准的敏感度为90.37%,特异度为88.46%,阳性似然比为7.83,阴性似然比为0.109。进一步按照是否行唇腺活检进行分层分析,显示该标准对行活检的pSS患者诊断敏感度和特异度分别为88.75%和88.89%,对于未进行活检的pSS患者诊断敏感度和特异度分别为93.67%和88.37%。该标准的3个单项条目中,敏感度最高的一项为角结膜染色,达85.77%;特异度最高的一项为唇腺活检,达88.89%。结论:2012年美国风湿病学会pSS诊断标准在中国患者中具有较高的敏感度和特异度,将其用于临床诊断和研究具有一定价值,但是该标准仍有待于进一步修订和完善。

Objective：To validate the American College of Rheumatology Classification （ACR） Criteria （2012） for the diagnosis of primary Sjogren＇ s syndrome in Chinese patients. Methods： All patients involved in this study came from the Department of Oral Medicine Peking University Stomatology Hospital. They were devided into two groups of pSS and non-pSS according to the diagnoses made by two experts. Both groups of the patients had completed medical records kept in the hospital. Results： A total of 239 pSS patients （160 with labial salivary gland biopsy, and 79 without biopsy） and 52 age-matched non-pSS patients [ （55.17 ± 14.295）, and （55.90 ± 13.38） years old, P 〉 0.05 ] （9 with biopsy, and 43 without biopsy） were involved in this study. The sensitivity and specificity of ACR criteria in diagnosing pSS were 90.37 % and 88.46 % respectively. The positive and negative likelihood ratios were 7.83 and 0. 109, respectively. The sensitivities of ACR criteria in diagnosing pSS patients with and without labial biopsy were 88.75% and 93.67 % , respectively, with specificities of 88.89% and 88.37%, respectively. The most sensitive item adopted in ACR criteria was the ocular staining score with a sensitivity of 85.77% , and the most specific item was the labial salivary gland biopsy, with a specificity of 88.89%. Conclusion ：The sensitivity and specificity of ACR criteria in diagnosing Chinese pSS patients were relatively high, and may serve as the diagnosis criteria in research and clinical practice. However, the ACR criteria need to be validated and further revised in the future .