类风湿关节炎临床缓解期患者复发相关因素的真实世界研究

Real-world Study on Factors Associated with Replase in Patients with Rheumatoid Arthritis in Clinical Remission Period

目的基于真实世界临床数据探讨影响类风湿关节炎(RA)临床缓解期患者疾病复发的相关因素。方法纳入2019年10月1日至2022年10月1日中国中医风湿病注册研究信息平台(CERTAIN)中达到临床缓解[基于血沉的28个关节疾病活动度(DAS28-ESR)评分≤2.6分]标准并接受规律随访的RA患者。收集患者人口学信息、相关临床资料及实验室检查结果。所有患者至少3个月进行1次随访,持续1年。将DAS28-ESR>3.2分判定为复发,根据随访1年内是否复发分为持续缓解组和复发组。统计两组患者用药情况,将用药方案总体分为中药、西药、中药+西药三类。采用Cox回归分析评估RA临床缓解期患者1年内复发的影响因素。采用Kaplan-Meier分析不同用药方案(中药组、西药组、中药+西药组)患者复发情况。结果共纳入630例RA临床缓解期患者,其中持续缓解组284例(45.08%),复发组346例(54.92%)。多因素Cox回归分析结果显示,病程≥5年、晨僵、乏力、关节肿胀是RA临床缓解期复发的危险因素(P<0.05或P<0.01);中药、中药+西药治疗是RA临床缓解期复发的保护因素(P<0.01)。Kaplan-Meier曲线分析显示,西药组、中药组、中药+西药组患者1年内复发率分别为69.34%、51.85%、50.73%,中药组、中药+西药组较西药组差异有统计学意义(P<0.01)。结论RA临床缓解期在1年内复发率较高,病程长、晨僵、乏力、关节肿胀是导致RA复发的重要因素,持续中药或中药联合西药治疗则有助于RA持续缓解。

Objective To explore the related factors associated with relapse in patients with rheumatoid arthritis(RA)during clinical remission period based on real-world data.Methods Patients with RA who achieved clinical remission,that is the disease activity score-28 for rheumatoid arthritis with erythrocyte sedimentation rate(DAS28-ESR)≤2.6,and received regular follow-up in the China Rheumatoid Arthritis Registry of Patients with Chinese Medi-cine(CERTAIN)from October 1st,2019 to October 1st,2022 were included in the study.Baseline demographic,clinical,and laboratory data were collected.All patients were followed up at least once every 3 months for 1 year.Re-lapse was defined as DAS28-ESR greater than 3.2,and therefore patients were divided into the sustained remission group and the relapse group.According to the medications of patients,there were generally three categories,which were Chinese herbal medicine(CHM),western medicine,and the integrated medicine(CHM plus western medi-cine).Cox regression analysis was used to identify factors associated with relapse in patients with remission-phase RA.The Kaplan-Meier method was used to analyze the relapse rate among patients treated with different medication regimens(CHM,western medicine and integrated medicine).Results A total of 630 patients with remission-phase RA were included in this study,of whom 284 cases(45.08%)were in the sustained remission group and 346(54.92%)were in the relapse group.Multivariate analysis showed that disease duration of≥5 years,morning stff-ness,fatigue,and joint swelling were risk factors for relapse in patients with remission-phase RA(P<0.05 or P<0.01),while the use of CHM and integrated medicine were protective factors for relapse in these patients(P<0.01).Kaplan-Meier curve analysis showed that the relapse rates within one year were 69.34%,51.85%,and 50.73%in the western medicine group,CHM group,and integrated medicine group,respectively,and the CHM group and integrated medicine group had significantly lower relapse rates than the western medicine group(P<O.O1).Conclusion The relapse rate within 1 year is relatively high in patients with remission-phase RA,and those with longer disease duration,morning stiffness,fatigue,and joint swelling are more likely to have relapse.The use of CHN or integrated medicine may help these patients sustain remission.