类风湿关节炎不同分类标准的多中心临床比较

doi:10.19723/j.issn.1671-167X.2020.05.017

摘要/Abstract

摘要：

目的:验证并比较早期类风湿关节炎(early rheumatoid arthritis, ERA) 分类标准与1987年美国风湿病学会(American College of Rheumatology, ACR)和2010年ACR/欧洲抗风湿联盟(European League Against Rheumatism, EULAR)制定的分类标准在ERA患者诊断中的敏感性和特异性。方法:在4所医院中入选年龄≥16岁、病程≤1年、存在≥1个关节肿痛的关节炎患者,观察指标包括临床表现、实验室检查及影像学检查。ERA的诊断经2名风湿病专科医师根据临床症状、用药情况、影像学检查进行临床诊断。结果: (1)共纳入关节炎患者325例,男性98例(30.15%), 女性227例(69.85%),平均年龄(47.53±14.44)岁,中位病程5(2, 8)个月。最终诊断为ERA 236例,非ERA 89例 (Non-ERA,包括骨关节炎、反应性关节炎、未分化关节炎、脊柱关节炎等)。(2) ERA标准的敏感性为87.29%,特异性为84.37%,敏感性高于1987年ACR标准 (χ²=43.641,P<0.001), 与2010年ACR/EULAR标准相比差异无统计学意义 (χ²=0.446,P=0.593);特异性低于1987年 ACR年标准 (χ²=4.891, P=0.027),与2010年ACR/EULAR标准比较差异无统计学意义 (χ²=0.044,P=1.000)。(3)在病程≤3个月和病程≤6个月关节炎患者中,ERA分类标准敏感性分别为81.71%、86.79%,均高于1987年ACR标准 (χ²=7.131,P=0.008和χ²=22.015,P<0.001), 与2010年ACR/EULAR标准比较差异无统计学意义 (χ²=0.220,P=0.755和χ²=0.473,P=0.491), 3个标准的特异性比较差异均无统计学意义。(4) 3种分类标准与临床诊断存在一致性,其中ERA标准、2010年ACR/EULAR标准与临床诊断一致性较好(Kappa>0.6)。3种分类标准间一致性比较结果提示,ERA标准与2010年ACR/EULAR标准间一致性较好(Kappa=0.836)。结论:ERA分类标准在ERA诊断中的敏感性高于1987年ACR分类标准,与2010年ACR/EULAR年标准相当,3种标准间特异性比较差异无统计学意义;ERA标准在病程≤3个月的极早期关节炎中仍可识别出RA患者。

关键词: 关节炎, 类风湿关节炎, 早期诊断

Abstract:

Objective: To evaluate the classification criteria of early rheumatoid arthritis (ERA) and compare the sensitivity and specificity with the criteria of 1987 American College of Rheumatology (ACR) criteria and 2010 ACR/European League Against Rheumatism (EULAR). Methods: Patients from 4 hospitals, aged more than 16 years, with arthritis, whose disease duration was ≤1 year, and with ≥1 joint pain and swelling were enrolled in the study. The indicators including clinical manifestations, laboratory tests and imaging examinations were observed. The ERA patients were dignosed by two experienced rheumatologists based on the clinical features, drug therapy information and radiography features. Results: (1) A total of 325 patients with arthritis were enrolled, including 98 males (30.15%) and 227 females (69.85%), The average age was (47.53±14.44) years, and the median disease duration was 5 (2, 8) months. Finally, 236 patients were dignosed with ERA, and 89 patients were dignosed with other diseases (Non-ERA, including osteoarthritis, reactive arthritis, undifferentiated arthritis, spondyloarthritis, etc). (2) The sensitivity of ERA criteria was 87.29%, and the specificity was 84.37%. The sensitivity was higher than that of 1987 ACR criteria (χ ²=43.641, P<0.001), and had no significant difference compared with 2010 ACR/EULAR criteria (χ²=0.446, P=0.593). But the specificity of ERA criteria was lower than that of 1987 ACR criteria (χ²=4.891, P=0.027), which was not statistically significant compared with 2010 ACR/EULAR criteria (χ²=0.044, P=1.000). (3) In the patients with arthritis whose disease duration was ≤3 months and ≤6 months, the sensitivity of ERA criteria was 81.71% and 86.79%, respectively, both were higher than the 1987 ACR criteria (χ²=7.131, P=0.008; χ²=22.015, P<0.001) and had no statistically difference compared with the 2010 ACR/EULAR criteria (χ²=0.220,P=0.755; χ²=0.473,P=0.491). The differences of the three criteria in specificity were not statistically significant. (4) The three different classification criteria were consistent with the clinical diagnosis, among which the ERA criteria and 2010 ACR/EULAR criteria were slightly higher (Kappa>0.6). The results of the consistency comparison between the three criteria showed that the ERA criteria and 2010 ACR/EULAR criteria had a better consistency (Kappa=0.836). Conclusion: The sensitivity of ERA classification criteria in the diagnosis of ERA was higher than that of 1987 ACR criteria, and was equivalent to that of 2010 ACR/EULAR criteria. There is no significant difference in specificity between these three criteria. The ERA criteria can also identify patients with RA at a very early stage in arthritis with disease duration ≤3 months.

Key words: Arthritis, Rheumatoid arthritis, Early diagnosis

中图分类号:

R593.22

罗采南,李正芳,武丽君,陈海娟,杨春梅,徐文晖,刘小玲,唐薇,乔平,热娜·白合提亚. 类风湿关节炎不同分类标准的多中心临床比较[J]. 北京大学学报（医学版）, 2020, 52(5): 897-901.

Cai-nan LUO,Zheng-fang LI,Li-jun WU,Hai-juan CHEN,Chun-mei YANG,Wen-hui XU,Xiao-ling LIU,Wei TANG,Ping QIAO,Baihetiya Rena. Multicenter performance of the different classification criteria for rheumatoid arthritis[J]. Journal of Peking University (Health Sciences), 2020, 52(5): 897-901.

图/表 7

表1

ERA组和非ERA组临床资料比较"

Items	ERA(n=236)	Non-ERA(n=89)	P
Male/female, n	60/176	38/51	0.002
Age/years, $x -$ ±s	49.59±13.85	44.89±15.70	0.001
Disease duration/months, median (IQR)	5(2.25, 8.00)	3(1.00,10.00)	0.068
Swollen joint count, median (IQR)	5(2, 10)	2(1, 4)	<0.001
Tender joint count, median (IQR)	11(6, 20)	4(2, 10)	<0.001
Morning stiffness(>30 min), n(%)	151(63.98)	14(15.73)	<0.001
RF positive, n(%)	162(68.64)	8(8.99)	<0.001
Anti-CCP positive, n(%)	183(77.54)	6(6.74)	<0.001
ESR/(mm/h), median (IQR)	41.50(24.00, 59.75)	27.00(14.00, 54.00)	0.008
CRP/(mg/L), median (IQR)	11.60(4.60, 36.38)	10.11(2.00, 46.48)	0.287

表1

表2

病程≤3月和病程≤6月关节炎患者临床资料比较"

Items	Disease duration≤3 months(n=129)	Disease duration≤6 months(n=220)	P
Male/female, n	43/86	74/146	0.954
Age/years, $x -$ ±s	47.09±15.89	49.80±14.16	0.345
Swollen joint count, median (IQR)	4(1, 8)	4(1, 9)	0.688
Tender joint count, median (IQR)	7(3, 14)	8(4, 18)	0.063
Morning stiffness(>30 min), n(%)	66(51.16)	115(52.27)	0.841
RF positive, n(%)	56(43.41)	115(52.27)	0.110
anti-CCP positive, n(%)	62(48.06)	125(56.82)	0.113
ESR, mm/h, median (IQR)	39.00(20.75, 58.00)	40.00(22.00, 58.25)	0.758
CRP, mg/L, median (IQR)	13.26(3.04, 44.79)	11.60(4.17, 42.40)	0.839

表2

表3

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表5

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表7

参考文献 8

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[7]	van der Linden MP, Knevel R, Huizinga TW, et al. Classification of rheumatoid arthritis: Comparison of the 1987 American College of Rheumatology criteria and the 2010 American College of Rheumatology/European League Against Rheumatism criteria[J]. Arthritis Rheum, 2011,63(1):37-42. doi: 10.1002/art.30100 pmid: 20967854
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Classification criteria	Sensitivity/%	Specificity/%	Positive predictive value/%	Negative predictive value/%
ERA	87.29	84.27	93.64	71.43
1987 ACR	60.59	94.38	96.62	47.45
2010 ACR/EULAR	85.17	86.52	94.37	68.75

Classification criteria	Sensitivity/%	Specificity/%	Positive predictive value/%	Negative predictive value/%
ERA	81.71	91.49	94.37	74.14
1987 ACR	54.88	100.00	100.00	63.51
2010 ACR/EULAR	79.27	93.62	95.59	72.13

Classification criteria	Sensitivity/%	Specificity/%	Positive predictive value/%	Negative predictive value/%
ERA	86.79	90.12	94.52	77.66
1987 ACR	64.15	97.53	98.08	25.00
2010 ACR/EULAR	83.02	91.36	94.96	73.27

Items	Consistency rate/%	Kappa	P
Clinical diagnosis & ERA	86.46	0.678	<0.001
Clinical diagnosis & 1987 ACR	69.85	0.420	<0.001
Clinical diagnosis & 2010 ACR/EULAR	85.54	0.663	<0.001

Items	Consistency rate/%	Kappa	P
ERA & 1987 ACR	78.15	0.577	<0.001
ERA & 2010 ACR/EULAR	92.31	0.836	<0.001
2010 ACR/EULAR & 1987 ACR	75.38	0.521	<0.001