真实世界接受IGU治疗的RA患者的人群特征、疗效及影响因素

Characteristics,efficacy and influencing factors of RA patients treated with iguratimod in the real world

目的回顾性分析2015年7月-2020年10月间接受艾拉莫德(iguratimod,IGU)治疗至少6个月,有3次以上随访记录的类风湿关节炎(rheumatoid arthritis,RA)患者的人群特征、疗效及影响因素。方法本研究纳入105例RA患者,所有患者均连续接受IGU治疗至少6个月,随访3次。观察治疗前后的临床表现、红细胞沉降率(ESR)、C反应蛋白(CRP)、疾病活动指数(DAS28)评分、类风湿因子(RF)、抗环瓜氨酸肽(ACPA)、免疫球蛋白(IgG、IgA和IgM)、淋巴细胞亚群,同时观察记录不良反应。结果IGU组RA患者病程、ACPA阳性率明显低于IGU联合甲氨蝶呤(methotrexate,MTX)治疗组(P<0.05)。IGU治疗组RA患者DAS28-ESR明显低于IGU联合MTX治疗组以及IGU联合来氟米特组(leflunomide,LEF)治疗组(P<0.05)。连续治疗6个月后,IGU组视觉模拟评分(visual analogue scale/score,VAS)、CRP和DAS28(ESR/CRP)明显减低;随治疗时间延长至1年,以上指标进一步改善,且关节肿胀数目(SW)、关节压痛数目(TEN)也发生统计学意义的改变。连续治疗1年以后,IGU组不良反应发生率为32.3%(10/31)。结论对于疾病早期、病程较短、抗体阴性的RA患者,IGU是一种有效的治疗药物,是合并间质性肺病的RA患者的一个治疗选择。IGU耐受性好,也是一个有效、安全的联合治疗选择。

Objective To conduct a retrospective study of the population characteristics,efficacy and influencing factors of rheumatoid arthritis(RA)patients who received iguratimod(IGU)treatment for at least 6 months from July 2015 to October 2020 and had more than 3 follow-up records.Methods In this study,105 patients with RA were enrolled,and all the patients received IGU treatment for at least 6 months and were followed up three times.We observed their clinical manifestations before and after treatment,erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),disease activity index(DAS28),rheumatoid factor(RF),anticyclic citrullinated peptide(ACPA),immunoglobulins(IgG,IgA,and IgM),lymphocyte subsets,and observed and recorded adverse reactions.Results The course of disease and the positive rate of ACPA were significantly lower in IGU group than in the group of IGU combined with(MTX)treatment(P<0.05).The DAS28-ESR of the patients in IGU group was significantly lower than that in the IGU+MTX treatment group and IGU+leflunomide(LEF)treatment group(P<0.05).After 6 months of continuous treatment,visual analogue scale/score(VAS),CRP and DAS28(ESR/CRP)in IGU group were significantly reduced.As the treatment time was extended to one year,the above indicators further improved,and the number of joint swelling(SW)and the number of joint tenderness(TEN)also significantly improved.After one year’s continuous treatment,the incidence of adverse reactions in IGU group was32.3%(10/31).Conclusion For RA patients with early onset,short-course,and antibody-negative,IGU is an effective therapeutic drug and a treatment option for RA patients with interstitial lung disease.IGU is well tolerated and is also an effective and a safe combination therapy option.