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Journal of Peking University (Health Sciences) logoLink to Journal of Peking University (Health Sciences)
. 2022 Oct 27;54(6):1086–1093. [Article in Chinese] doi: 10.19723/j.issn.1671-167X.2022.06.005

类风湿关节炎患者生活质量与疾病活动度的横断面研究

Cross-sectional study on quality of life and disease activity of rheumatoid arthritis patients

Jing-feng ZHANG 1, Yin-ji JIN 1, Hui WEI 1, Zhong-qiang YAO 1, Jin-xia ZHAO 1,*
PMCID: PMC9761820  PMID: 36533337

Abstract

Objective

To analyze health related quality of life (HR-QoL) and physical function of outpatient department patients with rheumatoid arthritis (RA), and to analyze disease activity influence in HR-QoL and functional capacity as well as the divergences between different disease activity standards.

Methods

The demographic and clinical data of 207 RA cases from Department of Rheumatology and Immunology, Peking University Third Hospital from Jan 2021 to Jul 2021 were collected. RA-specific quality of life (RA-QoL) and the medical outcome 36-item short form health survey (SF-36)were collected to estimate the quality of life. The t test was used for the quantitative data in accordance with normal distribution.

Results

A total of 207 cases were included, with RA-QoL score of 7.8±7.1, physical component summary (PCS) score of 63.8±23.8, and mental component summary (MCS) score of 71.7±21.0. According to disease activity score 28-erythrocyte sedimentation rate (DAS28-ESR), there were 119 patients (59.5%) with remission and low disease activity, and 125 patients (62.5%) with simplified disease activity index (SDAI). The HR-QoL of the patients with remission or low disease activity was significantly better than that of the patients with moderate or high disease activity. The physical function (76.7±17.2 vs. 86.4±15.0, t=2.855, P < 0.01), bodily pain (67.8±8.5 vs. 77.7±15.6, t=4.277, P < 0.01) and health transition (52.8±22.3 vs. 63.9±24.1, t=2.134, P < 0.05) in the low disease activity (LDA) group were lower than those in the complete remission (REM) group according to DAS28-ESR. Other domains of SF-36 and RA-QoL had no differences between these two groups. PCS in the LDA group was lower than that in the REM group (68.3±15.2 vs. 77.3±15.2, t=2.716, P < 0.01), but MCS was not different between the two groups. Determined by SDAI, the RA-QoL score in the LDA group was significantly higher than that in the REM group (9.4±7.1 vs. 6.0±4.8, t=-2.260, P < 0.05), the various dimensions of physical function in the SF-36 score and the PCS score (69.9±16.4 vs. 81.4±15.1, t=3.879, P < 0.05) were lower than that in the REM group, and the MCS score was lower than that in the REM group (67.9±19.3 vs. 74.5±18.8, t=2.721, P < 0.01).

Conclusion

The RA-QoL and SF-36 scores of RA patients in outpatient clinics were better, and the MCS was higher than the PCS. Treat-to-target is essential to improve HR-QoL. SDAI can better indicate the HR-QoL of each domain in REM and LDA RA patients.

Keywords: Rheumatoid arthritis, Quality of life, Disease activity score, SF-36


类风湿关节炎(rheumatoid arthritis,RA)是一种系统性慢性炎症性疾病,典型表现为对称性多关节炎,常伴有疼痛、疲劳、功能障碍、情绪障碍等,并可致残、致畸,进而严重影响患者的生活质量,导致患者社会参与度下降,造成沉重的社会负担[1]。RA的全球患病率约0.5%~1.0%[2],中国患病率约0.28%~0.45%[3-4],好发于工作年龄人群[5]。类风湿关节炎的治疗目标不仅仅是达到疾病缓解或低疾病活动度,全面提高患者的生活质量、降低疾病对于生活的影响亦是RA治疗的重要目标。

类风湿关节炎特异性生活质量(RA-specific quality of life,RA-QoL)评估量表是针对RA患者研发的疾病特异性生活质量评估工具,其包含30个答案为“是”或“否”的问题,积分0~30分,分值越高,生活质量越低。在多种语言环境下均具有很好的一致性和重测信度,对于疾病有较高的敏感性,其简便易行,仅需花费患者约6 min时间即可完成[6]。36项简明健康调查问卷(the medical outcome 36-item short form health survey,SF-36)是广泛应用的生活质量自我评估工具,在RA患者中亦有广泛应用,是一种非疾病特异性评估工具[7]。问卷由36个项目组成,分为8个领域:身体功能(physical function,PF)、躯体角色(role physical,RP)、身体疼痛(bodily pain,BP)、一般健康(general health,GH)、活力(vitality,VT)、社会功能(social function,SF)、情绪角色(role emotional,RE)和心理健康(mental health,MH),前4个项目反映身体健康,后4个项目反映心理健康。这8个领域通常也被结合起来产生两个汇总领域,躯体功能汇总(physical component summary,PCS)和心理功能汇总(mental component summary,MCS)。除此之外,健康变化(health transition,HT)也是另一个可以用来评估过去一年总体健康状况的指标。每个领域的得分范围为0~100,得分越高表示功能越好。

患者报告结局日益被视为衡量医疗保健及其有效性的关键方法。RA作为慢性致残性疾病,更强调以患者为中心,然而,由于评估工具的复杂性、耗时性,评估生活质量的指标并未被风湿病临床医生广泛使用[8-9]。关于我国RA患者HR-QoL的相关调查研究结果较为有限,不同疾病活动度评估标准下各个活动度RA患者HR-QoL的差别尚不明确。

本研究为RA生活质量横断面调查,拟应用上述评估工具评估本中心门诊就诊的RA患者各维度生活质量情况,及其与疾病活动度的相关关系。

1. 资料与方法

1.1. 研究对象

纳入2021年1—7月于北京大学第三医院风湿免疫科门诊就诊且规律治疗3个月以上的RA患者,患者自愿参加本研究,所有患者均符合1987年美国风湿病学会(American College of Rheumatology,ACR) RA分类标准或者2010年美国风湿病学会/欧洲抗风湿病联盟(ACR/the European League Against Rheumatism,EULAR) RA分类标准,排除血清阴性脊柱关节炎、痛风、感染性关节炎、系统性红斑狼疮、系统性硬化症、皮肌炎/多发性肌炎、原发性干燥综合征、混合性结缔组织病、恶性肿瘤。

1.2. 研究方法

收集患者一般情况(年龄、性别、病程、发病年龄)、关节肿胀压痛情况、疼痛视觉模拟评分(pain visual analogue scale,P-VAS)、总体视觉模拟评分(global-visual analogue scale,G-VAS),28个关节疾病活动度评分(disease activity score 28,DAS28)、简明类风湿关节炎疾病活动指数(simplified disease activity index, SDAI),临床类风湿关节炎活动指数(clinical disease activity index, CDAI),RA-QoL评分及SF-36评分。

根据DAS28评分判断疾病活动度:缓解,DAS28 ≤ 2.6;低疾病活动度,2.6 < DAS28 ≤ 3.2;中度活动,3.2 < DAS28 ≤ 5.1;高度活动,DAS28 > 5.1。根据CDAI评分判断疾病活动度:缓解,CDAI ≤ 2.8;低疾病活动度,2.8 < CDAI ≤ 10;中度活动,10 < CDAI ≤ 22;高度活动,CDAI > 22。根据SDAI评分判断疾病活动度:缓解,SDAI ≤ 3.3;低疾病活动度,3.3 < SDAI ≤ 11;中度活动,11 < SDAI ≤ 26;高度活动,SDAI > 26。记录病情活动指标:红细胞沉降率(erythrocyte sedimentation rate,ESR)、C-反应蛋白(C-reactive protein,CRP)以及自身抗体[包括类风湿因子(rheumatic factor, RF)、抗环瓜氨酸多肽抗体(anti-cyclic citrullinated peptide,anti-CCP)]。记录患者药物治疗情况,记录患者血常规检查结果[包括白细胞(white blood cell,WBC)、血红蛋白(hemoglobin,Hb)、血小板(platelet,PLT)],血清免疫球蛋白G(immunoglobulin G,IgG)、IgA、IgM以及25(OH)VD3水平。

1.3. 统计学分析

应用SPSS 22.0软件,符合正态分布的定量资料以x±s表示,非正态分布的定量资料使用中位数(四分位数间距)描述。两组间差异比较采用t检验,多组间差异比较采用方差分析,P < 0.05为差异有统计学意义。

2. 结果

2.1. 一般情况

共纳入207例RA患者,其中女性166例(80.2%),男性41例(19.8%),年龄19~85岁,平均年龄52.3±15.6岁。起病年龄平均44.1±16.1岁,平均病程6 (8)年。ESR升高者60例(30%),平均ESR为13.0 (14.8) mm/h。CRP升高者57例(28.5%),平均CRP为3.8 (8.0) mg/L。应用生物制剂的患者23例(11.2%),应用Janus激酶(Janus-activated kinase, JAK)抑制剂的患者19例(9.2%),应用1种、2种、3种传统缓解病情抗风湿药(conventional disease modifying antirheumatic drugs,c-DMARDs)的患者比例分别为18.9%(n=39)、42.2%(n=87)、18.4%(n=38),见表 1

表 1.

RA患者人口学资料与临床资料

Demographic and clinical characteristics of RA patient

Items Patients (n=207)
Data are presented as x±s or median (interquartile range). RA, rheumatoid arthritis; RF, rheumatoid factor; CCP, cyclic citrullinated peptide; ANA, anti-nuclear antibodies; TJC, tender joint count; SJC, swollen joint count; ESR, erythrocyte sedimentation rate; CRP, C-reactive protein; cDMARD, conventional disease modifying anti-rheumatic drug; tDMARDs, target disease modifying anti-rheumatic drugs.
Age/years 52.3±15.6
Age at diagnosis/years 44.1±16.1
Female 80.2%
Disease duration/years 6 (8)
Antibodies
  RF+ anti-CCP+ 49.0%
  RF+ anti-CCP- 17.5%
  RF- anti-CCP+ 19.0%
  RF- anti-CCP- 14.5%
Anemia 22.5%
Thrombocytosis 10.0%
Hyperglobulinemia 23.7%
Decreased 25(OH)VD3 63.8%
Positive ANA 30.7%
TJC 1 (4)
SJC 0 (3)
ESR/(mm/h) 13.0 (14.8)
CRP/(mg/L) 3.8 (8.0)
Treated with biologics 11.2%
Treated with 1 cDMARD 18.9%
Treated with 2 cDMARDs 42.2%
Treated with 3 cDMARDs 18.4%
Treated with tDMARDs 9.2%

2.2. 疾病活动度情况

以DAS28-ESR为标准判断疾病活动度,病情缓解、低疾病活动度患者的比例分别为46.0%(n=92)和13.5%(n=27),共计59.5%;中、高疾病活动度患者的比例分别为25.5%(n=51)和15.0%(n=30),共计40.5%。以DAS28-CRP为标准判断不同疾病活动度的患者比例与DAS28-ESR基本一致,病情缓解的患者比例略高(53.0%,n=106),高疾病活动度患者的比例略低(10.5%,n=21)。以SDAI为标准评估疾病活动度,病情缓解与低疾病活动度患者的比例分别为23.0%(n=46)和39.5%(n=79),共计62.5%;中、高疾病活动度患者的比例分别为24.5%(n=49)和13.0%(n=26),共计37.5%。以CDAI为评估标准的结果与SDAI的评估结果较为一致(表 2)。

表 2.

RA患者疾病活动度情况

Disease activity of RA patient  n(%)

Items DAS28-ESR DAS28-CRP CDAI SDAI
RA, rheumatoid arthritis; REM, remission; LDA, low disease activity; MDA, moderate disease activity; HDA, high disease activity; DAS-28, disease activity score 28; ESR, erythrocyte sedimentation rate; CDAI, clinical disease activity index; SDAI, simplified disease activity index.
REM 92 (46.0) 106 (53.0) 43 (21.5) 46 (23.0)
LDA 27 (13.5) 22 (11.0) 83 (41.5) 79 (39.5)
MDA 51 (25.5) 51 (25.5) 43 (21.5) 49 (24.5)
HDA 30 (15.0) 21 (10.5) 31 (15.5) 26 (13.0)

2.3. 临床指标与患者报告结局之间的相关性分析

表 3可见,G-VAS、P-VAS以及RA-QoL与DAS28-ESR、SDAI、TJC、SJC、ESR之间均呈正相关,与年龄和CRP呈低度正相关,与病程不具有相关性。SF-36身体健康各领域以及PCS与上述临床指标均呈负相关,心理健康各领域以及MCS与上述指标则呈低度负相关,而与病程无关。

表 3.

RA患者临床指标与患者报告结局之间的相关关系

Correlation coefficients between clinical variables and patient-reported outcomes of RA patient

Items DAS28-ESR SDAI Age Duration of disease TJC SJC ESR CRP
* P < 0.05, ** P < 0.01. RA, rheumatoid arthritis; G-VAS, global visual analogue scale; P-VAS, pain visual analogue scale; RA-QoL, rheumatoid arthritis-specifific quality of life; SF-36, the medical outcome 36-item short form health survey; PF, physical function; RP, role physical; BP, bodily pain; GH, general health; VT, vitality; SF, social function; RE, role emotional; MH, mental health; HT, health transition; PCS, physical component summary; MCS, mental component summary; DAS-28, disease activity score 28; ESR, erythrocyte sedimentation rate; SDAI, simplified disease activity index; TJC, tender joint count; SJC, swollen joint count; CRP, C-reactive protein.
G-VAS r= 0.736** r=0.744** r=0.290** r=0.081 r=0.586** r=0.545** r=0.511** r=0.391**
P-VAS r=0.742** r=0.734** r=0.230** r=-0.003 r=0.599** r=0.586** r=0.482** r=0.356**
RA-QoL r=0.637** r=0.617** r=0.306** r=0.125 r=0.524** r=0.552** r=0.482** r=0.342**
SF-36
  PF r=-0.663** r=-0.643** r=-0.453** r=-0.025 r=-0.522** r=-0.526** r=-0.562** r=-0.461**
  RP r=-0.574** r=-0.537** r=-0.241** r=0.016 r=-0.477** r=-0.467** r=-0.398** r=-0.324**
  BP r=-0.718** r=-0.689** r=-0.299** r=-0.018 r=-0.573** r=-0.579** r=-0.542** r=-0.402**
  GH r=-0.501** r=-0.450** r=-0.248** r=-0.077 r=-0.347** r=-0.322** r=-0.346** r=-0.284**
  VT r=-0.448** r=-0.454** r=-0.255** r=0.002 r=-0.349** r=-0.328** r=-0.385** r=-0.303**
  SF r=-0.514** r=-0.488** r=-0.307** r=0.013 r=-0.403** r=-0.373** r=-0.438** r=-0.312**
  RE r=-0.371** r=-0.360** r=-0.152* r=0.117 r=-0.317** r=-0.321** r=-0.296** r=-0.151*
  MH r=-0.361** r=-0.372** r=-0.140* r=0.020 r=-0.273** r=-0.291** r=-0.339** r=-0.260**
HT r=-0.532** r=-0.482** r=-0.216** r=0.004 r=-0.435** r=-0.404** r=-0.390** r=-0.252**
PCS r=-0.710** r=-0.668** r=-0.349** r=-0.021 r=-0.561** r=-0.553** r=-0.527** r=-0.421**
MCS r=-0.492** r=-0.484** r=-0.243** r=0.064 r=-0.396** r=-0.389** r=-0.417** r=-0.279**

2.4. 以DAS28-ESR为标准评估各个疾病活动度患者生活质量差异

全部患者的G-VAS评分为3(4),P-VAS评分为3(4),RA-QoL评分为6(11),PCS评分为63.8±23.8,MCS评分为71.7±21.0。以DAS28-ESR为评估标准,分析病情缓解组与低疾病活动度组生活质量的差异,低疾病活动度组G-VAS评分与P-VAS评分均高于完全缓解组(P < 0.01),而两组间RA-QoL评分差异无统计学意义。低疾病活动度组的生理功能、身体疼痛评分均低于完全缓解组(P < 0.01),健康变化得分低于缓解组(P < 0.05),其他各个维度生活质量评分两组间差异无统计学意义。低疾病活动度组的躯体功能评分低于缓解组(P < 0.01),精神功能评估两组间差异无统计学意义。高疾病活动度组与中疾病活动度组相比,G-VAS、P-VAS和RA-QoL评分均明显高于后者(P < 0.01)。SF-36评分中,除整体健康评分与精神健康评分两组间差异无统计学意义外,其余各个维度生活质量评分均是高疾病活动度组更低(P < 0.05),高疾病活动度组的PCS评分和MCS评分均低于中疾病活动度组(P < 0.05),见表 4

表 4.

不同疾病活动度组患者报告结局(以DAS-28ESR为标准)

Patient-reported outcomes in different disease activity (determined by DAS28-ESR)

graphic file with name bjdxxbyxb-54-6-1086-T4.jpg

2.5. 以SDAI为标准评估各个疾病活动度患者生活质量差异

以SDAI为标准分析,低疾病活动度组G-VAS、P-VAS和RA-QoL评分均显著高于缓解组(P < 0.05),SF-36评分中躯体功能的各个维度以及总体评分均低于缓解组(P < 0.05),活力评分与精神健康评分亦低于缓解组(P < 0.05),MCS评分低于缓解组(P < 0.01)。中、高疾病活动度组之间各维度生活质量差异更为显著,除精神健康评分两组间差异无统计学意义外,其余SF-36各维度评分高疾病活动度组均显著低于中疾病活动度组,G-VAS、P-VAS及RA-QoL则明显高于中疾病活动度组,见表 5

表 5.

不同疾病活动度组患者报告结局(以SDAI为标准)

Patient-reported outcomes in different disease activity (determined by SDAI)

graphic file with name bjdxxbyxb-54-6-1086-T5.jpg

2.6. DAS28-ESR与SDAI评估标准下各维度生活质量对比

DAS28-ESR评估标准下,低疾病活动度组与完全缓解组在心理健康各个维度上几无差异,而躯体功能方面完全缓解组优于低疾病活动度组(图 1)。

图 1.

以DAS28-ESR为标准比较不同疾病活动度组SF-36各领域差异

Comparison of SF-36 among levels of disease activity determined by DAS28-ESR

DAS-28, disease activity score 28; ESR, erythrocyte sedimentation rate; SF-36, the medical outcome 36-item short form health survey; PF, physical function; RP, role physical; BP, bodily pain; GH, general health; VT, vitality; SF, social function; RE, role emotional; MH, mental health; REM, remission; LDA, low disease activity; MDA, moderate disease activity; HDA, high disease activity.

图 1

SDAI评估标准下,躯体功能与心理健康各个维度完全缓解组均优于低疾病活动度组(图 2)。

图 2.

以SDAI为标准比较不同疾病活动度组SF-36各领域差异

Comparison of SF-36 among levels of disease activity determined by SDAI

SDAI, simplified disease activity index; other abbreviations as in Figure 1.

图 2

3. 讨论

本研究为RA患者生活质量的横断面调查,发现RA患者整体生活质量情况尚可,SF-36心理健康的总体情况略优于生理机能情况。DAS28-ESR达缓解及低疾病活动度的患者比例达59.5%,SDAI达缓解及低疾病活动度的患者比例达62.5%,考虑与本研究纳入患者为临床稳定随访的患者有关。Rosa-Goncalves等[10]分析了154例RA患者的SF-36评分,发现平均PCS评分为32(14~66),而MCS评分为52(23~69)。Gerhold等[11]的大规模研究发现平均PCS评分为30.5~43.3,平均MCS评分为49.4~57.3,DAS28-ESR均值为4.5~5.4。Zhou等[12]在中国人群中的大规模研究结果提示,807例患者PCS平均为40.4,MCS平均为49.0。一项纳入31项临床研究的meta分析结果显示,RA患者平均PCS为34.1,MCS为45.6[13]。本研究中全部患者的RA-QoL平均分为7.8。一项纳入51例RA患者的横断面研究中,RA-QoL得分为11[14]。与既往研究相比,本研究纳入患者的整体生活质量情况更好,可能与本研究纳入人群为门诊就诊人群,缓解及低疾病活动度患者的比例较高有关。与既往研究结果类似,本研究中患者生活质量中的心理健康评分优于生理机能评分,提示RA活动对于生理机能的影响程度大于对于心理健康的影响程度。

本研究中,RA-QoL与DAS28-ESR、SDAI、年龄、TJC、SJC、ESR、CRP之间均呈正相关,而SF-36各个领域与上述指标均呈负相关,提示疾病活动度对于RA相关生活质量具有重要影响。年龄大的患者各项生活质量评分均更差,而病程长短对生活质量无明显影响。以往多项研究结果提示,RA疾病活动对疾病相关生活质量产生严重负面影响[15-16]。有研究认为,年龄、病程对于RA生活质量均有较大影响[17]。Tander等[18]和Bedi等[16]的研究中均未发现病程与HR-QoL之间存在相关性,与本研究结果一致,可能与纳入的长病程患者长期规律治疗、病情稳定有关。

RA疾病活动度对于生活质量具有负面影响。目前RA最常用的疾病活动度评估指标包括DAS-28、CDAI以及SDAI[19],其中,DAS-28简便易行,与CDAI相比, SDAI因包含客观指标,可更好地反映疾病活动度。本研究中以DAS28-ESR为标准判断疾病活动情况,发现高疾病活动度组不论PCS、MCS亦或RA-QOL均较中疾病活动度组为差,而在低疾病活动度组与缓解组之间的差异则较小,两组间MCS和RA-QOL差异均无统计学意义,仅在PCS方面表现出差别。Waimann等[20]的研究提示DAS28-ESR与RA-QoL具有强相关性。Chiu等[21]发现RA疾病活动度对于RA生活质量具有全方位的影响,不仅影响其躯体机能,同时亦影响其精神健康。Rosa-Goncalves等[10]的研究发现,在疾病活动度高的患者中PCS评分减低,但MCS评分无差别。Schmalz等[22]的研究提示,疾病活动度与RA患者的生活质量之间具有显著相关性。RA疾病活动度会显著影响RA患者的生活质量,但应用不同的生活质量评估量表,在不同人群中得到的结果不尽相同。由于RA疾病所致机体功能方面生活质量下降往往更为明显,而心理健康相关生活质量的影响在不同研究报道的差异较大。本研究中,高疾病活动度患者的生活质量全方位下降,较中度疾病活动度的患者在各个维度均有明显差异。低疾病活动度患者与缓解患者相比,虽然整体疾病活动度偏高,但心理健康评估与RA-QoL的整体评分均未见差异,也提示对于缓解患者和低疾病活动度患者,DAS28-ESR评分似乎难以满足对于生活质量全方位评估的需求。

以SDAI作为疾病活动度评估标准,再次对各个不同疾病活动度的患者进行生活质量比较,发现低疾病活动度组与缓解组相比,在生活质量评估的各个维度均显示出明显差异,不论是躯体机能情况还是心理健康情况,缓解组均优于低疾病活动度组,RA-QoL评分亦显示出差异,高疾病活动度组与中疾病活动度组的差异仍然明显。对于缓解及低疾病活动度的患者,SDAI评分与DAS28-ESR评分相比,对RA各个维度生活质量的影响更为明显,可以更全面地提示RA包括心理健康情况在内的全方位的生活质量。

综上所述,本研究中RA患者的RA-QoL以及SF-36评分的情况更优于既往文献报道,心理健康汇总评分高于躯体健康汇总评分。病情缓解或低疾病活动度患者各个维度HR-QoL均显著优于治疗未达标的患者,可见达标治疗对于改善HR-QoL具有至关重要的意义。以DAS28-ESR为疾病活动度评估标准,缓解与低疾病活动度组在RA-QoL和MCS方面均无差异,而以SDAI作为评估标准,则两组间在各个维度均有差异,提示SDAI标准在缓解及低疾病活动度的RA患者中可以更好地提示各个维度HR-QoL情况。

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