系统性红斑狼疮患者达标治疗情况——基于大样本长期随访队列的分析

Treat-to-target in patients with systemic lupus erythematosus:an analysis based on a large sample long-term follow-up cohort

目的报告北京大学第一医院系统性红斑狼疮(SLE)队列(PKUFHS)患者达标情况,为我国推行SLE达标治疗提供证据参考。方法纳入PKUFHS队列患者,采集流行病学特征,收集基线及历次随访的临床表现、实验室指标、SLEDAI和医师整体评价(PGA)评分、用药情况,评价基线及历次随访的狼疮低疾病活动状态(LLDAS)和SLE缓解定义(DORIS)达标情况。采用Kaplan-Meier法计算LLDAS和DORIS标准的达标所需时间及历年累积达标率,用Kaplan-Meier生存曲线描述累积达标率的变化趋势。结果本研究共纳入632例患者5.26(3.43,7.87)年的随访数据。其中,83.2%(526/632)或69.0%(436/612)的患者至少1次实现LLDAS或DORIS达标,46.8%(296/632)或31.8%(167/632)的患者至少一半时间处于LLDAS或DORIS状态,总计48.8%(308/632)或31.8%(167/632)的随访时间处于LLDAS或DORIS状态。分析LLDAS和DORIS标准中各定义的基线和随访达标情况发现,入组时不符合任一标准的586例患者中,LLDAS或DORIS的中位达标时间分别为20.4(13.4,37.1)个月或33.7(19.9,55.9)个月。结论LLDAS和DORIS标准均可应用于我国SLE患者达标治疗临床实践。

ObjectiveTo report the target achievement of patients in Peking University First Hospital SLE(PKUFHS)cohort according to the treat-to-target(T2T)concept,and to provide evidence for the implementation of T2T in SLE in China.MethodsPatients from the PKUFHS cohort were included.The epidemiological characteristics were collected,clinical manifestations,laboratory test results,SLEDAI and PGA scores,and medication use were collected at baseline and each follow-up visits.The achievement of lupus low disease activity status(LLDAS)and definition of remission of SLE(DORIS)at baseline and each follow-up visits were evaluated.Kaplan-Meier method was used to calculate the time to LLDAS and DORIS,as well as the cumulative achievement rates over the years.Kaplan-Meier survival curve was used to describe the trend in cumulative achievement rates.ResultsA total 632 patients with a median of 5.26(3.43,7.87)-year follow-up were included in this study.Of these patients,83.2%(526/632)or 69.0%(436/612)achieved LLDAS or DORIS at least once,46.8%(296/632)or 31.8%(167/632)were in LLDAS or DORIS at least half the time,and a total time of 48.8%(308/632)or 31.8%(167/632)were in LLDAS or DORIS during follow-up.The study further analyzed the attainment of each definition of LLDAS and DORIS criteria both at baseline and throughout the follow-up.Of the 586 patients who initially failed to meet either criteria,the median time to reach LLDAS or DORIS was approximately 20.4(13.4,37.1)months and 33.7(19.9,55.9)months,respectively.ConclusionBoth LLDAS and DORIS can be applied to the clinical practice of T2T in SLE in China.