ACR干燥综合征新分类标准
发表者：智良
日期：2015-03-04
浏览次数：291
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摘要:
目的：生物制剂作为治疗干燥综合征(SS)及其相关合并症的潜在治疗方法，需要制定一种新的分类标准来加以规范。本文介绍的新SS分类标准适用于具有SS症状/体征的患者。
方法：该标准基于名义群体法所获得的专家意见，以及对干燥综合征国际临床协作研究的分析结果。对该初步标准的验证包括：与美欧共识小组(AECG)分类标准比较、与通过对多种诊断试验结果进行隐类分析(LCA)所获得的基于模型的“金标准”比较、及在非用于建立该标准的人群中进行患者与对照之间比较。
结果：验证结果说明该标准具有很高的灵敏性和特异性。具有以下3点特征中最少2点者可被诊断为SS患者：1) 血清抗SSA和/或抗SSB抗体阳性，或者类风湿因子阳性且抗核抗体滴度≥1:320；2) 角结膜染色评分≥3分；3)唇腺病理活检显示存在局灶性淋巴细胞性涎腺炎，每4mm2≥1个病灶。当本标准所用指标均为客观检测结果时，其与AECG标准的一致性很高。不过，当AECG分类诊断基于对疾病症状的评估，而不是客观检查结果时，其结果则与本标准及基于LCA的分类结果一致性很差。
结论：新的SS分类标准基于对注册研究的客观指标进行标准化测量所获得的结果。验证分析显示，相对于现有的分类标准，新的分类标准具有更好的诊断能力，并可以避免误诊产生的潜在风险。
附原文: Objectives—We propose new classification criteria for Sjogren’s Syndrome (SS), which are needed considering the emergence of biological agents as potential treatments and their associated co-morbidity. These criteria target individuals with signs/symptoms suggestive of SS. Methods—Criteria are based on expert opinion elicited using the Nominal Group Technique, and analyses of data from the Sjogren’s International Collaborative Clinical Alliance. Preliminary criteria validation included comparisons with classifications based on the American-European- Consensus-Group (AECG) criteria, a model-based “gold standard” obtained from Latent Class Analysis (LCA) of data from a range of diagnostic tests, and a comparison with cases and controls collected from sources external to the population used for criteria development. Results—Validation results indicate high levels of sensitivity and specificity for the criteria. Case definition requires at least 2 out of the following 3: (1) Positive serum anti-SSA and/or anti-SSB or [positive rheumatoid factor and ANA ≥1:320];(2)Ocular staining score ≥ 3;(3)Presence of focal lymphocytic sialadenitis with focus score ≥ 1 focus/4mm2 in labial salivary gland biopsies. Observed agreement with the AECG criteria is high when these are applied using all objective tests. However, AECG classification based on allowable substitutions of symptoms for objective tests results in poor agreement with the proposed and LCA-derived classifications. Conclusion—These classification criteria developed from registry data collected using standardized measures are based on objective tests. Validation indicates improved classification performance relative to existing alternatives, making them more suitable for application in situations where misclassification may present health risks. （注：干燥综合症病人或亲属可加QQ群交流，群号： 118194945 ，本网站站长私人微信号： ssgzz88 ）
目的：生物制剂作为治疗干燥综合征(SS)及其相关合并症的潜在治疗方法，需要制定一种新的分类标准来加以规范。本文介绍的新SS分类标准适用于具有SS症状/体征的患者。
方法：该标准基于名义群体法所获得的专家意见，以及对干燥综合征国际临床协作研究的分析结果。对该初步标准的验证包括：与美欧共识小组(AECG)分类标准比较、与通过对多种诊断试验结果进行隐类分析(LCA)所获得的基于模型的“金标准”比较、及在非用于建立该标准的人群中进行患者与对照之间比较。
结果：验证结果说明该标准具有很高的灵敏性和特异性。具有以下3点特征中最少2点者可被诊断为SS患者：1) 血清抗SSA和/或抗SSB抗体阳性，或者类风湿因子阳性且抗核抗体滴度≥1:320；2) 角结膜染色评分≥3分；3)唇腺病理活检显示存在局灶性淋巴细胞性涎腺炎，每4mm2≥1个病灶。当本标准所用指标均为客观检测结果时，其与AECG标准的一致性很高。不过，当AECG分类诊断基于对疾病症状的评估，而不是客观检查结果时，其结果则与本标准及基于LCA的分类结果一致性很差。
结论：新的SS分类标准基于对注册研究的客观指标进行标准化测量所获得的结果。验证分析显示，相对于现有的分类标准，新的分类标准具有更好的诊断能力，并可以避免误诊产生的潜在风险。
附原文: Objectives—We propose new classification criteria for Sjogren’s Syndrome (SS), which are needed considering the emergence of biological agents as potential treatments and their associated co-morbidity. These criteria target individuals with signs/symptoms suggestive of SS. Methods—Criteria are based on expert opinion elicited using the Nominal Group Technique, and analyses of data from the Sjogren’s International Collaborative Clinical Alliance. Preliminary criteria validation included comparisons with classifications based on the American-European- Consensus-Group (AECG) criteria, a model-based “gold standard” obtained from Latent Class Analysis (LCA) of data from a range of diagnostic tests, and a comparison with cases and controls collected from sources external to the population used for criteria development. Results—Validation results indicate high levels of sensitivity and specificity for the criteria. Case definition requires at least 2 out of the following 3: (1) Positive serum anti-SSA and/or anti-SSB or [positive rheumatoid factor and ANA ≥1:320];(2)Ocular staining score ≥ 3;(3)Presence of focal lymphocytic sialadenitis with focus score ≥ 1 focus/4mm2 in labial salivary gland biopsies. Observed agreement with the AECG criteria is high when these are applied using all objective tests. However, AECG classification based on allowable substitutions of symptoms for objective tests results in poor agreement with the proposed and LCA-derived classifications. Conclusion—These classification criteria developed from registry data collected using standardized measures are based on objective tests. Validation indicates improved classification performance relative to existing alternatives, making them more suitable for application in situations where misclassification may present health risks. （注：干燥综合症病人或亲属可加QQ群交流，群号： 118194945 ，本网站站长私人微信号： ssgzz88 ）