系统性红斑狼疮国际合作组对SLE 分类诊断标准的验证
艾伯维风湿免疫组医学事务专员 金晶
摘要 目的:SLICC对美国风湿病学会(American College of Rheumatology, ACR)的SLE的分类标准提出修订并进行验证,旨在提高其临床意义,符合严格的方法要求,并纳入SLE免疫学相关新知识。(具体临床和免疫学标准见附录表2、表3.)
方法:该分类标准推导自一系列(共702个)专家评级的患者场景。基于SLICC医师达成的共识,采用递归分割法进行简化和提炼,获得其初始规则。SLICC工作小组进一步在一个新的验证样本(包括690个专家评级的新患者场景)中验证了该分类标准。
结果:共有17项标准得到鉴定。在推导组中,SLICC分类标准较目前的ACR分类标准产生更少的错误分类(49:70, P = 0.0082),且具有更高的灵敏度(94%:86%, P <0 .0001),以及相同的特异性(92%: 93%, p="0.39)(表1)。在验证组中,SLICC分类标准较目前的ACR分类标准产生更少的错误分类(62:74," p="0.24),且具有更高的灵敏度(97%:" 83%, p < 0.0001),但特异性较低(84%:96%, p <0.0001)。
结论:新的SLICC分类标准在大样本专家评级的患者情景中表现良好。根据SLICC的SLE分类规则,患者必须满足至少4个条件,包括至少1个临床标准和一个免疫标准;或者患者必须经活检证实狼疮性肾炎中存在抗核抗体或抗双链DNA抗体。
表1 推导组中新SLE分类标准的敏感性和特异性
标准
| 敏感性( %) *
| 特异性(%) ?
|
抗核抗体
| 96.5
| 45.2
|
关节炎
| 79.0
| 43.6
|
颊部红斑/光敏性皮疹/急性皮肤红斑狼疮
| 65.2
| 80.1
|
补体降低
| 59.0
| 92.6
|
抗ds-DNA抗体
| 57.1
| 95.9
|
抗磷脂抗体
| 53.6
| 86.0
|
淋巴细胞减少,<1500 /mm3
| 49.0
| 81.6
|
白细胞减少
| 46.4
| 94.8
|
口鼻部溃疡
| 44.2
| 92.1
|
浆膜炎
| 35.2
| 97.2
|
肾脏病变
| 32.9
| 96.4
|
非瘢痕性脱发
| 31.9
| 95.7
|
抗Sm抗体
| 26.1
| 98.7
|
盘状红斑
| 19.7
| 93.6
|
淋巴细胞减少,<1000 /mm3
| 17.0
| 94.7
|
血小板减少
| 13.5
| 98.0
|
溶血性贫血
| 7.1
| 99.5
|
神经系统病变
| 5.5
| 99.0
|
* 在310个患者场景中超过80%的临床医生分类为SLE; ? 在392个患者场景中超过80%的临床医生分类为SLE
附原文: Abstract OBJECTIVE: The Systemic Lupus International Collaborating Clinics (SLICC) group revised and validated the American College of Rheumatology (ACR) systemic lupus erythematosus (SLE) classification criteria in order to improve clinical relevance, meet stringent methodology requirements, and incorporate new knowledge regarding the immunology of SLE.METHODS: The classification criteria were derived from a set of 702 expert-rated patient scenarios. Recursive partitioning was used to derive an initial rule that was simplified and refined based on SLICC physician consensus. The SLICC group validated the classification criteria in a new validation sample of 690 new expert-rated patient scenarios.RESULTS: Seventeen criteria were identified. In the derivation set, the SLICC classification criteria resulted in fewer misclassifications compared with the current ACR classification criteria (49 versus 70; P = 0.0082) and had greater sensitivity (94% versus 86%; P < 0.0001) and equal specificity (92% versus 93%; p="0.39)." in the validation set, the slicc classification criteria resulted in fewer misclassifications compared with the current acr classification criteria (62 versus 74; p="0.24)" and had greater sensitivity (97% versus 83%; p < 0.0001) but lower specificity (84% versus 96%; p < 0.0001).conclusion: the new slicc classification criteria performed well in a large set of patient scenarios rated by experts. according to the slicc rule for the classification of sle, the patient must satisfy at least 4 criteria, including at least one clinical criterion and one immunologic criterion or the patient must have biopsy-proven lupus nephritis in the presence of antinuclear antibodies or anti-double-stranded dna antibodies.
引自:Petri M, Orbai AM, Alarcón GS, et al. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012,64(8):2677-86.