临床标本抗核抗体102651例检测结果回顾性分析

Retrospective analysis of antinuclear antibody test results of 102 651 specimens

目的探讨抗核抗体（ANA）在临床就诊患者中的阳性分布趋势及在自身免疫病（AID）中的临床意义。方法采用间接免疫荧光法（ⅡF）检测102651份来自2004年至2008年期间北京协和医院就诊患者血清标本中的ANA（男女比例1：3，平均年龄41岁）。选取符合AID诊断的患者3064例，其中：SLE1757例、干燥综合征（SS）250例、类风湿关节炎（RA）518例、多发性肌炎／皮肌炎（PM／DM）150例、系统性硬化症（SSc）171例、原发性胆汁性肝硬化（PBC）108例、自身免疫性肝炎（AIH）44例及强直性脊柱炎（AS）66例。疾病对照组560例，其中：炎症性疾病452例和肿瘤108例。分析ANA在不同性别、年龄（≤20岁组、21-49岁组、≥150岁组）和AID患者中的阳性率、滴度以及荧光模式的分布。结果在102651份检测标本中，ANA阳性率为49％，其中男性为26％，女性为56％，二者差异有统计学意义（X^2=6652.84，P〈0.01）。不同年龄组间ANA阳性患者的阳性率差异也有统计学意义（≤20岁组46％、21-49岁组50％、≥50岁组47％，X^2=108.68，P〈0.01）。ANA阳性患者荧光模式分析表明，单一荧光模式以斑点型（34％）和均质型（16％）为主，混合荧光模式以斑点／均质型为主（16％）。而AID组中的SLE、SS、RA、PM／DM患者单一荧光模式以斑点型为主（分别为32％、40％、28％、31％），PBC患者以核膜型、着丝点型为主（分别为36％、14％）。AID患者的ANA阳性率为82％，与疾病对照组（13％）比较，差异有统计学意义（X^2=1114.15，P〈0.01）。其中SLE的阳性率最高为94％。AID患者滴度以≥1：160为主，疾病对照组患者以1：80滴度为主。结论临床就诊患者中ANA的阳性率在不同性别、年龄组间存在差异；不同AID患者中的ANA阳性率和滴度均存在差异，临床检验工作中应重视ANA滴度在AID诊断中的临床价值。另外，ANA阳性患者的荧光模式呈现多样性，特别是某些特殊荧光模式对AID的诊断具有重要临床意义，但仅根据荧光模式来判断AID则有一定的片面性。

Objective To explore the positive distribution trend of the anti-nuclear antibodies （ANA） in outpatients and its significance in patients with autoimmune disease（AID）. Methods The ANA in 102 651 specimens were measured by indirect immunofluorescence （ⅡF） from department of clinical laboratory, Peking Union Medical College Hospital from 2004 to 2008 （male： female： 1：3, mean age：41 years old）. Three thousand sixty-four cases with AIDS were chosen, which consist of 1 757 SLE, 250 SS, 518 RA, 150 PM/DM, 171 SSc, 108 PBC, 44 MH and 66 AS. Meanwhile, the diseases control group was consist of 560 cases from 452 patients with inflammation and 108 patients with tumor. The positive distribution of ANA, title and fluorescence pattern in gender groups, age groups （≤20 years old ,21-49 years old, ≥50 years old）, and diseases groups were investigated, and the values of the results for AIDS diagnosis were evaluated. Results Of the 102 651 specimens, the positive rate of ANA was 49%. The positive rates for male patients and female patients were 26% and 56% respectively. The positive rate in female patients was statistically higher than that in male （X^2=6652.84 ,P〈0.01）. In the different age group of ≤20 years old , 21-49 years old and≥50 years old, there was statistical significance of ANA positive rate （46%, 50% ,47% ,X^2=108.68, P 〈0.01）. The results indicated that the major pure fluorescence patterns were speckled pattern （34%） and homogenous pattern （ 16% ）, and the major mix fluorescence pattern was speckled pattern/homogenous pattern（ 16% ）. The major pure fluorescence pattern was speckled pattern in SLE, SS, RA, PM/DM（32%, 40%, 28%, 31% ）, membranous pattern and centromere pattern in PBC （ 36%, 14% ）. The positive rate of ANA was 82% in AIDS patients, and reach up to 94% in SLE patients whereas the positive rate of ANA in control group was 13%. There was statistical significance of the ANA positive rate between AIDS group and control group （X2=1114.15 ,P 〈0.01）. The titers of ANA in patients with AID were predominantly above 1：160 and less than 1：80 in control group. Conclusions The positive rates of ANA in outpatients are different in term of gender and age. The positive rates and titers of antibodies are varied among different AIDS patients. The clinical laboratorians should pay attention to the value of ANA titer in AIDS diagnosis. In addition, the fluorescence pattern represents the diversity. There exists one- sidedness for diagnosis of AIDS depending on the fluorescence pattern, although some specific fluorescence pattern could provide some important diagnostic information for AIDS.