来氟米特在IgG4相关性疾病诱导缓解及维持治疗阶段的治疗效果  

THERAPEUTIC EFFECT OF LEFLUNOMIDE IN THE INDUCTION AND MAINTENANCE STAGES OF IGG4-RELATED DISEASES

作　　者：郭庆敏[1] 赵旋 温大蔚 辛苗苗[1] 潘琳[1] 孙明姝[1] GUO Qingmin;ZHAO Xuan;WEN Dawei;XIN Miaomiao;PAN Lin;SUN Mingshu(Department of Rheumatology and Immunology,Affiliated Hospital of Qingdao University,Qingdao 266003,China)

机构地区：[1]青岛大学附属医院风湿免疫科,山东青岛266003 [2]济宁医学院附属医院风湿科

出　　处：《青岛大学学报（医学版）》2022年第6期838-843,共6页Journal of Qingdao University(Medical Sciences)

基　　金：山东省自然科学基金资助项目(ZR2018MH015)。

摘　　要：目的 探讨来氟米特(LEF)在免疫球蛋白G4相关性疾病(IgG4-RD)诱导缓解及维持治疗中的有效性及安全性。方法 回顾性纳入已随访12个月的活动期IgG4-RD病人,以糖皮质激素(GC)联合LEF治疗者(LEF组)为病例组,匹配起始治疗时年龄、性别组成、病程、受累器官数、IgG4-RD反应指数(RI)及相关实验室指标后,以仅使用GC治疗者(单药组)及使用GC联合其他免疫抑制剂治疗者(其他组)为对照组。分析所有研究对象在0、1、3、6和12个月时的RI,3、6和12个月时的疾病缓解率,12个月的累积复发率及累积GC剂量等。结果研究共纳入84例病人,其中LEF组15例、单药组23例、其他组46例。3组病人在12个月时RI的下降程度均>50%;在3、6、12个月时,LEF组的RI均优于单药组(F=4.288~7.020,P<0.05),但与其他组无明显差别(P>0.05)。LEF组在6、12个月时的缓解率(66.7%和86.7%)均显著高于单药组(17.4%和43.5%)(χ^(2)=9.474、7.088,P<0.05),与其他组(52.2%和76.1%)相比差异均无显著性(P>0.05)。LEF组12个月的累积复发率低于单药组(χ^(2)=4.799,P<0.05),累积GC剂量也低于单药组(H=15.993,P<0.01),但与其他组比较差异均无显著性(P>0.05)。LEF组在3、6、12个月时的GC剂量低于单药组和其他组(F=4.001~4.708,P<0.05)。所有病人均未发生严重不良事件。结论 在IgG4-RD的诱导缓解和维持治疗阶段,LEF与GC联合治疗效果优于GC单药治疗,有效性、安全性与GC联合其他免疫抑制剂治疗相似,但GC用量更少。Objective To investigate the efficacy and safety of leflunomide(LEF) in the induction and maintenance stages of IgG4-related diseases(IgG4-RD). Methods A retrospective analysis was performed for the patients with active IgG4-RD who had been followed for 12 months, and the patients who were treated with glucocorticoid(GC) and LEF were enrolled as LEF group. After matching for age, sex composition, course of disease, number of organs involved, IgG4-RD response index(RI), and related laboratory markers at the beginning of treatment, the patients who were treated with GC alone were enrolled as monotherapy group, and those treated with GC and alternative immunosuppressants were enrolled as alternative group. All subjects were analyzed in terms of RI at 0, 1, 3, 6, and 12 months, disease remission rate at 3, 6, and 12 months, and cumulative recurrence rate and cumulative GC dose at 12 months. Results A total of 84 patients were enrolled in the study, with 15 patients in the LEF group, 23 in the monotherapy group, and 46 in the alternative group. RI was reduced by more than 50% at 12 months in all three groups, and the LEF group had a better RI than the monotherapy group at 3, 6, and 12 months(F=4.288-7.020,P<0.05), but there was no significant difference in RI between the LEF group and the alternative group(P>0.05). The LEF group had a significantly higher remission rate than the monotherapy group at 6 and 12 months(6 months: 66.7% vs 17.4%, χ^(2)=9.474,P<0.05;12 months: 86.7% vs 43.5%, χ^(2)=7.088,P<0.05), but there was no significant difference between the LEF group and the alternative group(66.7%/86.7% vs 52.2%/76.1%, P>0.05). Compared with the monotherapy group after 12 months, the LEF group had significantly lower cumulative recurrence rate(χ^(2)=4.799,P<0.05) and cumulative GC dose(H=15.993,P<0.01), but there were no significant differences between the LEF group and the alternative group(P>0.05). At 3, 6, and 12 months, the LEF group had a significantly lower GC dose than the monotherapy group and the alternat

关 键 词：免疫球蛋白G4相关疾病 来氟米特 糖皮质激素类 治疗结果 

分 类 号：R593.2[医药卫生—内科学]