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中华肺部疾病杂志(电子版)

中华肺部疾病杂志(电子版) ›› 2026, Vol. 19 ›› Issue (02) : 253 -261. doi: 10.3877/cma.j.issn.1674-6902.2026.02.011

论著

血清糖链抗原6和肺表面活性蛋白D预测221例结缔组织病相关间质性肺病及严重程度的研究
姚平1, 顾翔2, 韩静3, 杨苗苗1, 沈鑫1, 孙建1, 戚小艳1,†()   
  1. 1223800　宿迁，江苏省人民医院宿迁医院医学检验科
    2223800　宿迁，江苏省人民医院宿迁医院呼吸内科
    3223800　宿迁，江苏省人民医院宿迁医院风湿免疫科
  • 收稿日期:2025-11-17 出版日期:2026-04-25
  • 通信作者: 戚小艳
  • 基金资助:
    江苏省卫生健康委科研项目(M2020035); 宿迁市临床医学检验实验室(M201902)

Study on Krebs von den lungen-6 and surfactant protein-D in predicting the occurrence and severity of connective tissue disease-related interstitial lung disease in 221 patients

Ping Yao1, Xiang Gu2, Jing Han3, Miaomiao Yang1, Xin Shen1, Jian Sun1, Xiaoyan Qi1,†()   

  1. 1Department of Laboratory, Jiangsu Provincial People′s Hospital Suqian Hospital, Suqian 223800, China
    2Department of Respiratory Medicine, Jiangsu Provincial People′s Hospital Suqian Hospital, Suqian 223800, China
    3Department of Rheumatology and Immunology, Jiangsu Provincial People′s Hospital Suqian Hospital, Suqian 223800, China
  • Received:2025-11-17 Published:2026-04-25
  • Corresponding author: Xiaoyan Qi
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引用本文：

姚平, 顾翔, 韩静, 杨苗苗, 沈鑫, 孙建, 戚小艳. 血清糖链抗原6和肺表面活性蛋白D预测221例结缔组织病相关间质性肺病及严重程度的研究[J/OL]. 中华肺部疾病杂志(电子版), 2026, 19(02): 253-261.

Ping Yao, Xiang Gu, Jing Han, Miaomiao Yang, Xin Shen, Jian Sun, Xiaoyan Qi. Study on Krebs von den lungen-6 and surfactant protein-D in predicting the occurrence and severity of connective tissue disease-related interstitial lung disease in 221 patients[J/OL]. Chinese Journal of Lung Diseases(Electronic Edition), 2026, 19(02): 253-261.

目的

探讨结缔组织病相关间质性肺病(connective tissue disease-related interstitial lung disease, CTD-ILD)患者血清糖链抗原6(Krebs von den lungen-6, KL-6)和肺表面活性蛋白D(surfactant protein-D, SP-D)水平与疾病严重程度的关系。

方法

回顾性纳入2022年1月至2025年12月我院收治的CTD患者221例，CTD-ILD 81例、CTD 140例，根据3个月内是否接受过抗CTD药物治疗分组，CTD-ILD未治疗组39例、治疗组42例；CTD未治疗组66例、治疗组74例。采用酶联免疫吸附方法测定血清KL-6和SP-D水平。采用二元Logistic回归和受试者工作特征(receiver operating characteristic, ROC)曲线预测血清KL-6、SP-D对CTD-ILD诊断。利用Spearman相关性分析KL-6、SP-D与肺功能、HRCT评分关系。

结果

与CTD组相比，CTD-ILD组患者血清KL-6[855.39(419.03，1 281.28)U/ml比182.71(138.83，231.68)U/ml]、SP-D[64.56(61.10，68.36)ng/ml比49.27(46.94，52.50)ng/ml]和红细胞分布宽度-标准差(red blood cell distribution width-standard deviation, RDW-SD)[48.30(45.00，51.40)fL比44.40(42.00，48.10)fL]升高(P<0.05)。多因素Logistic回归显示SP-D(OR＝1.085，P<0.001)、KL-6(OR＝1.009，P<0.001)和RDW-SD(OR＝1.061，P＝0.014)是CTD-ILD发生的危险因素。ROC曲线分析显示，KL-6、SP-D和RDW-SD联合预测CTD-ILD在未治疗组和治疗组曲线下面积分别为0.975和0.951，对应未治疗组的敏感性和特异度分别达100.00%和94.31%，治疗组分别为76.89%和95.12%。Spearman相关性分析显示，治疗组和未治疗组CTD-ILD患者的KL-6、SP-D与肺功能参数呈负相关(r＝－0.618~－0.278，P<0.05)，与HRCT评分呈正相关，未治疗组r＝0.356和0.478，治疗组r＝0.331和0.412(P<0.05)。

结论

KL-6和SP-D可预测CTD-ILD严重程度，不受CTD疾病亚型和药物干扰影响。

关键词: 结缔组织病相关间质性肺病, 糖链抗原6, 肺表面活性蛋白D, 肺功能, 生物标志物
Objective

To analyze the relationship between serum levels of glycan antigen 6 (KL-6) and pulmonary surfactant protein D (SP-D) in patients with connective tissue disease-related interstitial lung disease (CTD-ILD) and the diagnosis and severity of chest high-resolution computed tomography (HRCT), in order to investigate their clinical significance.

Methods

A total of 221 patients with CTD admitted to our hospital from January 2022 to December 2025 were retrospectively enrolled, comprising 81 patients with CTD-ILD and 140 patients with CTD alone. Based on whether they had received anti-CTD medication within the preceding 3 months, the patients were stratified into the following subgroups: the untreated CTD-ILD group 39 cases and the treated CTD-ILD group 42 cases; the untreated CTD group 70 cases and the treated CTD group 70 cases. Enzyme linked immunosorbent assay was used to measure serum KL-6 and SP-D levels. The diagnostic efficacy of serum KL-6 and SP-D were evaluated to predict CTD-ILD using binary logistic regression and receiver operating characteristic (ROC) curves. Spearman correlation analysis was used to explore the relationship between KL-6, SP-D and pulmonary function and HRCT scores.

Results

Compared with the CTD group, the serum levels of KL-6 [855.39 (419.03, 1 281.28) U/ml vs. 182.71 (138.83, 231.68)U/ml], SP-D[64.56(61.10, 68.36) ng/ml vs. 49.27 (46.94, 52.50)ng/ml], and red blood cell distribution width-standard deviation (RDW-SD) [48.30(45.00, 51.40) fL vs. 44.40 (42.00, 48.10) fL] were significantly higher in the CTD-ILD group (P<0.05). Multivariate logistic regression analysis demonstrated that SP-D (OR=1.085, P<0.001), KL-6 (OR=1.009, P<0.001), and RDW-SD (OR=1.061, P=0.014) were independent risk factors for the development of CTD-ILD. ROC curve analysis indicated that the combination of KL-6, SP-D, and RDW-SD yielded the optimal predictive performance for CTD-ILD. The areas under the curve in the untreated and treated groups were 0.975 and 0.951, respectively, with corresponding sensitivity and specificity reaching 100.00% and 94.31% in the untreated group, and 76.89% and 95.12% in the treated group. Spearman correlation analysis showed that in both treated and untreated CTD-ILD patients, KL-6 and SP-D were significantly negatively correlated with pulmonary function parameters (r=-0.618~-0.278, P<0.05), and positively correlated with HRCT scores (untreated group: r=0.356 and 0.478; treated group: r=0.331 and 0.412; all P<0.05).

Conclusion

KL-6 and SP-D could be more promising biomarkers for diagnosing CTD-ILD and assessing its severity, and their diagnostic value is not affected by CTD disease subtypes and drug interference.

Key words: Connective tissue disease-associated interstitial lung disease, Carbohydrate antigen 6, Surfactant protein D, Lung function, Biomarker
图1 典型HRCT图像A-B为患者，女，59岁，确诊类风湿关节炎。两肺下叶胸膜下网格状高密度影，可见胸膜下线，两下肺支气管稍扩张；C-D为患者，男，71岁，确诊皮肌炎2年。两肺局部呈蜂窝状及网格状改变。双侧胸腔见积液
表1 CTD、CTD-ILD患者临床资料结果比较
临床资料 CTD(n＝140) CTD-ILD(n＝81) χ2/t/Z值 P值
男性[n(%)] 27(19.29) 29(35.80) 7.399 0.007
身体质量指数[kg/m2，(±s)] 23.37±4.28 23.89±3.80 －0.803 0.423
年龄[岁，(±s)] 47.54±17.35 62.96±12.81 －7.550 0.000
住院时间(天)[M50(P25，P75)] 9.00(7.00，14.00) 10.00(8.00，13.00) －0.393 0.694
吸烟史[n(%)] 12(8.57) 15(18.52) 4.734 0.030
合并症[n(%)]        
高血压 39(27.86) 26(32.10) 0.445 0.505
糖尿病 11(7.86) 14(17.28) 4.545 0.033
呼吸困难 5(3.57) 43(53.09) 73.993 0.000
咳嗽 11(7.86) 39(48.15) 47.583 0.000
用药史[n(%)] 70(50.00) 42(51.85) 0.070 0.791
糖皮质激素[n(%)] 48(34.29) 36(44.44) 2.247 0.134
免疫抑制剂[n(%)]        
环磷酰胺 9(6.43) 8(9.88) 0.859 0.354
吗替麦考酚酯 13(9.29) 6(7.41) 0.230 0.631
来氟米特 13(9.29) 6(7.41) 0.230 0.631
甲氨蝶呤 11(7.86) 7(8.64) 0.042 0.837
钙调节剂 4(2.86) 1(1.23) 0.611 0.434
雷公藤 8(5.71) 10(12.35) 3.120 0.077
硫酸羟氯喹[n(%)] 20(14.29) 8(9.88) 0.902 0.342
生物制剂[n(%)] 4(2.86) 1(1.23) 0.611 0.434
非甾体类抗炎药[n(%)] 7(5.00) 4(4.94) 0.000 0.984
表2 CTD、CTD-ILD患者实验室指标比较[M50(P25，P75)]
实验室指标 CTD(n＝140) CTD-ILD(n＝81) Z值 P值
白细胞(×109/L) 5.09(3.77，7.24) 7.14(5.20，8.79) －4.364 0.000
中性粒细胞(×109/L) 3.10(2.14，4.81) 4.63(3.24，6.74) －4.365 0.000
淋巴细胞(×109/L) 1.33(1.05，1.84) 1.38(0.94，1.87) －0.084 0.933
单核细胞(×109/L) 0.38(0.27，0.52) 0.46(0.34，0.67) －3.271 0.001
RDW-SD(fL) 44.40(42.00，48.10) 48.30(45.00，51.40) －4.543 0.000
RDW-CV(%) 13.40(12.70，14.62) 14.00(13.20，15.10) －2.788 0.005
血小板数(×109/L) 214.00(171.75，276.50) 220.00(157.00，291.00) －0.481 0.630
白蛋白(g/L) 35.70(31.17，38.59) 33.55(31.20，37.99) －0.983 0.326
AST(U/L) 18.37(11.93，31.98) 18.23(11.96，29.18) －0.116 0.907
ALT(U/L) 21.09(16.27，32.73) 23.25(17.85，31.33) －1.138 0.255
NLR 2.13(1.46，3.81) 3.35(2.08，5.62) －3.265 0.001
SII 500.26(285.79，929.62) 677.00(348.98，1 260.99) －2.435 0.015
MLR 0.27(0.21，0.38) 0.37(0.23，0.53) －2.830 0.005
PLR 156.62(120.98，212.41) 162.26(101.03，222.00) －0.020 0.984
KL-6(U/ml) 182.71(138.83，231.68) 855.39(419.03，1 281.28) －10.474 0.000
SP-D(ng/ml) 49.27(46.94，52.50) 64.56(61.1，68.36) －11.546 0.000
D-二聚体(ng/ml) 255.50(122.25，610.75) 349.00(148.75，874.50) －1.212 0.226
红细胞沉降率(mm 1 h) 26.00(13.00，58.25) 40.00(16.00，58.50) －1.545 0.122
C反应蛋白(mg/L) 3.75(3.30，18.20) 7.72(3.34，24.33) －1.401 0.161
表3 治疗与否对CTD与CTD-ILD患者实验室指标影响比较[M50(P25，P75)]
实验室指标 未治疗组(n＝109) 治疗组(n＝112)
CTD(n＝66) CTD-ILD(n＝39) Z值 P值 CTD(n＝74) CTD-ILD(n＝42) Z值 P值
SP-D(ng/ml) 50.30(34.07，58.68) 65.84(59.05，72.50) －5.421 0.000 47.70(31.09，62.69) 63.61(58.47，70.89) －4.306 0.000
NLR 1.98(1.34，3.34) 2.42(1.70，6.15) －2.450 0.014 2.84(1.61，4.31) 3.76(2.60，5.31) －1.956 0.053
MLR 0.25(0.19，0.34) 0.36(0.22，0.55) －2.883 0.004 0.31(0.24，0.44) 0.37(0.23，0.51) －1.025 0.305
KL-6(U/ml) 170.34(127.45，206.34) 956.26(438.99，1 402.84) －7.330 0.000 191.96(142.72，243.91) 768.62(370.05，1 239.12) －7.429 0.000
RDW-SD(fL) 43.45(41.32，46.20) 47.10(44.00，50.00) －3.616 0.000 46.10(43.12，50.20) 49.50(46.30，52.27) －3.096 0.002
RDW-CV(%) 13.05(12.53，14.78) 13.60(13.20，15.00) －1.910 0.056 13.50(13.10，14.57) 14.10(13.43，15.17) －2.288 0.022
图2 不同亚型CTD患者血清KL-6和SP-D水平比较注：CTD为结缔组织病；CTD-ILD为结缔组织病相关间质性肺病；KL-6为糖链抗原6；SP-D为肺表面活性蛋白D；RA为类风湿性关节炎；IM为炎症性肌病；SS为干燥综合征
表4 CTD-ILD发生的影响因素Logistic回归分析
变　量 单因素 多因素
β S.E Z值 P值 OR(95%CI) β S.E Z值 P值 OR(95%CI)
男性 0.848 0.316 2.686 0.007 2.334(1.257~4.333) 0.073 0.816 0.090 0.928 1.076(0.218~5.325)
吸烟史 0.886 0.416 2.129 0.033 2.424(1.073~5.477) －0.450 1.184 －0.380 0.704 0.638(0.063~6.501)
糖尿病 0.896 0.430 2.084 0.037 2.450(1.055~5.694) 1.192 0.797 1.496 0.135 3.294(0.691~15.704)
呼吸困难 3.419 0.507 6.746 0.000 30.553(11.313~82.514) 1.230 1.443 0.852 0.394 3.421(0.202~57.895)
咳嗽 2.388 0.385 6.204 0.000 10.890(5.122~23.153) 1.596 0.919 1.736 0.083 4.932(0.814~29.894)
SP-D 0.076 0.012 6.047 0.000 1.078(1.052~1.105) 0.082 0.023 3.604 0.000 1.085(1.038~1.135)
NLR 0.119 0.050 2.382 0.017 1.126(1.021~1.241) 0.076 0.201 0.377 0.706 1.079(0.727~1.600)
SII 0.001 0.000 2.029 0.042 1.001(1.001~1.001) －0.000 0.001 －0.195 0.845 1.000(0.999~1.001)
MLR 2.716 0.782 3.473 0.000 15.127(3.265~70.073) 2.807 2.552 1.100 0.271 16.563(0.111~2 460.371)
KL-6 0.009 0.002 6.154 0.000 1.009(1.006~1.013) 0.009 0.002 4.340 0.000 1.009(1.005~1.013)
白细胞数 0.152 0.047 3.218 0.001 1.164(1.061~1.277) 0.594 0.508 1.171 0.242 1.812(0.670~4.901)
中性粒细胞数 0.173 0.055 3.155 0.002 1.189(1.068~1.324) －0.602 0.538 －1.120 0.263 0.548(0.191~1.572)
单核细胞数 1.835 0.559 3.281 0.001 6.262(2.093~18.733) －2.072 2.692 －0.770 0.442 0.126(0.001~24.642)
RDW-SD 0.065 0.011 5.758 0.000 1.068(1.044~1.092) 0.059 0.024 2.466 0.014 1.061(1.012~1.112)
RDW-CV 0.093 0.062 1.495 0.135 1.098(0.971~1.241)          
表5 KL-6、RDW-SD和SP-D水平与CTD-ILD患者肺功能和疾病严重程度相关性分析
参　数 未治疗组 治疗组
KL-6 RDW-SD SP-D KL-6 RDW-SD SP-D
r值 P值 r值 P值 r值 P值 r值 P值 r值 P值 r值 P值
FVC －0.418 0.005 －0.052 0.755 －0.324 0.039 －0.375 0.014 －0.149 0.352 －0.303 0.011
FVC% －0.430 0.006 －0.009 0.948 －0.344 0.024 －0.455 0.002 －0.098 0.571 －0.308 0.010
FEV1 －0.278 0.070 －0.025 0.859 －0.473 0.003 －0.354 0.021 －0.078 0.610 －0.353 0.024
FEV1% －0.319 0.041 －0.024 0.862 －0.420 0.006 －0.470 0.002 －0.062 0.675 －0.324 0.031
DLCO －0.542 0.000 －0.323 0.039 －0.185 0.242 －0.387 0.015 －0.065 0.679 －0.040 0.814
DLCO% －0.618 0.000 －0.299 0.048 －0.147 0.378 －0.582 0.000 －0.175 0.295 －0.017 0.895
HRCT评分 0.356 0.021 0.118 0.462 0.478 0.004 0.331 0.028 0.096 0.541 0.412 0.012
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