Merkel P A, Chang Y, Pierangeli S S, Convery K, Harris E N, Polisson R P
Arthritis Unit, Massachusetts General Hospital, Harvard Medical School, Boston 02114, USA.
Am J Med. 1996 Dec;101(6):576-83. doi: 10.1016/s0002-9343(96)00335-x.
To determine the prevalence and clinical associations of anticardiolipin antibodies (aCL) in a blinded, controlled study of patients with a variety of connective tissue diseases (CTD) using a standardized aCL testing system.
Anticardiolipin antibodies (IgG, IgM, and IgA) were measured by direct enzyme-linked immunosorbent assay (ELISA) in the baseline serum samples of patients enrolled in a Cooperative Study of Systematic Rheumatic Diseases (CSSRD), National Institutes of Health (NIH) supported, 5-year inception-cohort, prospective study of early rheumatic diseases: rheumatoid arthritis (RA, n = 70), systemic lupus erythematosus (SLE, n = 70), scleroderma (PSS, n = 45), myositis (PM/DM, n = 36), and early undifferentiated connective tissue disease (EUCTD, n = 165). Diagnosis was based on standardized criteria and determined at the last study visit. A nested group of patients with Sjögren's syndrome (SJ, n = 44) was also defined. Serum from 200 blood donors (BB) served as controls. Additional patients with known antiphospholipid syndrome (APS, n = 33) and ANCA-related renal vasculitis (ANCA, n = 52) were also studied. Laboratory personnel were blinded to sample diagnostic group.
The prevalence of either IgG or IgM aCL among each diagnostic group was RA 15.7%, SLE 15.76%, PSS 6.7%, PM/DM 8.3%, EUCTD 9.1%, SJ 6.8%, ANCA 3.8%, and BB controls 4.0%. Prevalence of aCL was significantly different for both the RA and SLE groups versus BB controls (P < 0.01) but not among other diagnostic groups. Only 2 study patients had positive tests for IgA aCL (1 with PM/DM and 1 with EUCTD) versus 15% of APS with positive IgA aCL. Study patients positive for IgG or IgM aCL were significantly more likely to have hemolytic anemia or a positive serologic test for syphilis and less likely to have Raynaud's phenomenon. However, no associations were found between aCL positivity and thrombocytopenia, seizures, renal insufficiency, presence of a positive antinuclear antibody or rheumatoid factor, subcutaneous nodules or digital ulcers.
Based on results from this large CSSRD inception cohort, anticardiolipin antibodies are present in approximately 16% of patients with RA or SLE but are less common in patients with PSS, PM/DM, EUCTD, SJ, and ANCA vasculitis, where their prevalence approaches that in the normal population. Few consistent clinical association can be found among patients with CTD who are aCL positive. The complete diagnostic and prognostic importance and specificity of these antibodies remains to be fully determined.
在一项针对多种结缔组织病（CTD）患者的盲法对照研究中，使用标准化的抗心磷脂抗体（aCL）检测系统，确定抗心磷脂抗体的患病率及其临床相关性。
通过直接酶联免疫吸附测定（ELISA），检测参与国立卫生研究院（NIH）资助的系统性风湿性疾病合作研究（CSSRD）的患者基线血清样本中的抗心磷脂抗体（IgG、IgM和IgA）。这是一项为期5年的起始队列前瞻性研究，涉及早期风湿性疾病：类风湿关节炎（RA，n = 70）、系统性红斑狼疮（SLE，n = 70）、硬皮病（PSS，n = 45）、肌炎（PM/DM，n = 36）以及早期未分化结缔组织病（EUCTD，n = 165）。诊断基于标准化标准，并在最后一次研究访视时确定。还定义了一组巢式干燥综合征（SJ，n = 44）患者。200名献血者（BB）的血清用作对照。另外还研究了已知抗磷脂综合征（APS，n = 33）和抗中性粒细胞胞浆抗体相关肾血管炎（ANCA，n = 52）的患者。实验室工作人员对样本诊断组不知情。
各诊断组中IgG或IgM aCL的患病率分别为：RA 15.7%、SLE 15.76%、PSS 6.7%、PM/DM 8.3%、EUCTD 9.1%、SJ 6.8%、ANCA 3.8%以及BB对照4.0%。RA和SLE组的aCL患病率与BB对照相比有显著差异（P < 0.01），但在其他诊断组之间无差异。仅有2例研究患者IgA aCL检测呈阳性（1例PM/DM患者和1例EUCTD患者），而APS患者中IgA aCL阳性率为15%。IgG或IgM aCL检测呈阳性的研究患者发生溶血性贫血或梅毒血清学检测呈阳性的可能性显著更高，而发生雷诺现象的可能性更低。然而，未发现aCL阳性与血小板减少、癫痫发作、肾功能不全、抗核抗体或类风湿因子阳性、皮下结节或指端溃疡之间存在关联。
基于这项大型CSSRD起始队列的结果，抗心磷脂抗体在约16%的RA或SLE患者中存在，但在PSS、PM/DM、EUCTD、SJ和ANCA血管炎患者中较少见，其患病率接近正常人群。在CTD且aCL阳性的患者中，几乎未发现一致的临床关联。这些抗体完整的诊断和预后重要性及特异性仍有待充分确定。
