论文题名(中文): | 中国系统性红斑狼疮患者达标队列研究 |
姓名: | |
论文语种: | chi |
学位: | 博士 |
学位类型: | 学术学位 |
学位授予单位: | 北京协和医学院 |
学校: | 北京协和医学院 |
院系: | |
专业: | |
指导教师姓名: | |
论文完成日期: | 2021-05-01 |
论文题名(外文): | Frequency, predictors and prognostic benefits of LLDAS and remission in systemic lupus erythematosus: a multicenter cohort study in China |
关键词(中文): | |
关键词(外文): | systemic lupus erythematosus T2T lupus low disease activity state (LLDAS) remission predictors new organ damage |
论文文摘(中文): |
目的:基于中国系统性红斑狼疮协作组(CSTAR)数据平台,建立大规模、多中心SLE低疾病活动度达标队列及缓解达标队列。描述我国SLE患者低疾病活动度(LLDAS)、缓解达标情况,探究LLDAS、缓解达标预测因素及达标状态对器官损伤的影响。方法:本研究为回顾性、多中心队列研究。入组CSTAR数据平台中符合纳排标准的SLE患者,采集基线和每次随访时的病历资料,包括人口学特征和病程情况、临床表现、免疫学特征、病情评估指标、药物使用情况。使用APLC和DORIS提出的方法定义LLDAS和缓解状态。描述入组患者LLDAS、缓解达标情况。通过Cox回归和Logistic回归分析寻找达标预测因素,探究达标状态对器官损伤的影响。结果:LLDAS达标队列共纳入496例患者。随访过程中至少达到一次LLDAS的患者有391人,占总人数78.8%,达到LLDAS50的患者有179人,占总人数36.1%。口鼻部溃疡[OR 0.554, 95%CI(0.343-0.895), P=0.016]、肾脏受累[OR 0.635, 95%CI(0.426-0.948), P=0.026]为LLDAS50达标的影响因素。达到LLDAS50状态的患者与未达到该状态的患者相比,新发器官损伤可能性更低[HR 0.395, 95%CI(0.236-0.660), P<0.001]。首次缓解达标相关研究共纳入患者1163例。随访过程中至少达到一次缓解状态的有498人,占总人数的42.8%。按照患者首次达缓解时的状态将其分为完全缓解组(4.2%)、治疗下完全缓解组(56.6%)、临床缓解组(1.6%)、治疗下临床缓解组(37.6%)。基线使用免疫抑制剂[HR 1.978, 95%CI(1.101-3.553), P=0.023]、口鼻部溃疡[HR 0.622, 95%CI(0.446-0.868), P=0.005]、脱发[HR 0.767, 95%CI(0.597-0.987), P=0.039]、抗dsDNA抗体阳性[HR 0.757, 95%CI(0.585-0.987), P=0.035]、补体降低[HR 0.701, 95%CI(0.543-0.904), P=0.006]为首次缓解达标的影响因素。持续缓解达标相关研究纳入患者1183例。随访过程中达到持续缓解状态的有376人,占总人数的31.8%。按照患者持续缓解过程中的最低达标状态将其分为持续完全缓解组(4.0%)、持续治疗下完全缓解组(34.3%)、持续临床缓解组(5.1%)、持续治疗下临床缓解组(56.6%)。对于基线未缓解的患者而言,越早达到首次缓解,后续达持续缓解的可能性越大[OR 0.973, 95%CI(0.951-0.995), P=0.018]。使用强化免疫抑制剂为达持续缓解预测因素[OR 1.365, 95%CI(1.060-1.759), P<0.016]。达到持续缓解状态的患者与未达到该状态的患者相比,新发器官损伤可能性更低[HR 0.275, 95%CI(0.174-0.435), P<0.001]。结论:本研究为目前规模最大的针对中国SLE患者LLDAS、缓解达标状况的研究,结果显示将LLDAS和缓解作为中国狼疮患者达标治疗的目标是可实现的。LLDAS和缓解状态有助于减少新发器官损伤。临床医师应早期筛查、干预对达标造成影响的因素,提高患者达标率,减少器官损伤的出现。
﹀
|
论文文摘(外文): |
Objective: Based on the data platform of CSTAR, we established a large-scale, multicenter SLE LLDAS and remission cohort, aiming to describe the LLDAS and remission achievement in Chinese SLE patients, determine the predictors of these statuses, and explore the prognostic benefits of these targets on organ damage. Methods: This study was a retrospective, multicenter cohort study. SLE patients in the CSTAR registration platform who met the criteria for inclusion and exclusion were enrolled. Medical records were collected at baseline and each follow-up, including demographic characteristics and course of the disease, clinical manifestations, immunological characteristics, disease evaluation index, and medication. LLDAS and remission statuses were defined base on the framework proposed by APLC and DORIS. The frequency of LLDAS and remission achievement was described. Cox regression analysis and Logistic regression analysis were used to find the predictive factors of reaching these targets and explore the influence of these targets on organ damage. Results: A total of 496 patients were enrolled in the LLDAS cohort. During the follow-up, 391 (78.8%) patients achieved LLDAS at least once, and 179 (36.1%) patients achieved LLDAS50. Patients who had ulcers [OR 0.554, 95%CI(0.343-0.895), P=0.016] and renal involvement [OR 0.635, 95%CI(0.426-0.948), P=0.026] were less likely to achieve LLDAS50. Patients who reached the LLDAS50 status had fewer new organ damages than those who did not [HR 0.395, 95%CI(0.236-0.660), P<0.001]. A total of 1163 patients were enrolled in the first-time remission study. During the follow-up, 498 (42.8%) people reached remission at least once. Patients were further divided into complete remission (4.2%), complete remission on treatment (56.6%), clinical remission (1.6%), clinical remission on treatment (37.6%). Baseline use of immunosuppressive agents [HR 1.978, 95%CI (1.101-3.553), P=0.023], ulcers [HR 0.622, 95%CI(0.446-0.868), P=0.005], alopecia [HR 0.767, 95%CI(0.597-0.987), P=0.039], anti-dsDNA antibody positive [HR 0.757, 95%CI(0.585-0.987), P=0.035] and hypocomplementemia [HR 0.701, 95%CI(0.543-0.904), P=0.006] were associated with remission achievement. 1183 patients were enrolled in the sustained remission study. During the follow-up, 376 people achieved sustained remission, accounting for 31.8% of the total number. Patients were divided into sustained complete remission (4.0%), sustained complete remission on treatment (34.3%), sustained clinical remission (5.1%), sustained clinical remission group on treatment (56.6%). The sooner the patients achieved the remission state, the more likely they would reach subsequent sustained remission [OR 0.973, 95%CI(0.951-0.995), P=0.018]. Patients who reached the sustained remission status had fewer new organ damages than those who did not [HR 0.275, 95%CI(0.174-0.435), P<0.001]. Conclusion: This study is currently the largest LLDAS and remission study for Chinese SLE patients. The results showed that LLDAS and remission are achievable and desirable for Chinese lupus patients, which help reduce new organ damage. Clinicians should screen and intervene in the factors that affect target achievement and therefore prevent new organ damages.
﹀
|
开放日期: | 2021-05-01 |