Abstract：
OBJECTIVE: Combination therapy of glucocorticoids (GCs) plus leflunomide (LEF) and GCs plus mycophenolate mofetil (MMF) was reported to have good efficacy and safety in the management of IgG4-RD. However, studies comparing the efficacy and safety of these two combination therapies were unavailable. Herein, this study aimed to compare the efficacy and safety of GCs plus LEF and GCs plus MMF in treating IgG4-RD.
METHODS: This study included 130 newly diagnosed IgG4-RD patients who received the therapy of GCs plus LEF (group I) and GCs plus MMF (group II). Clinical data at baseline and after treatment, treatment response, relapse rate, and adverse effects were recorded and analyzed.
RESULTS: Patients in both groups responded well to the treatment in the 1st-month follow-up, and 100% of patients achieved treatment response. However, at the 6th and 12th-month follow-up, the total response rate of group II was higher than that in group I (75.6 vs. 53.7%, p = 0.038 and 85.4% vs. 61.0%, p = 0.013, respectively). In addition, the duration of disease remission in group II was longer than that in group I (9 (6-9) vs. 6 (6-6) months, p = 0.014). Moreover, more patients in group I had adverse effects compared with group II (36.6 vs. 7.3%, p < 0.01); and the most common adverse events of LEF were rash (12.2%) and elevation of liver enzymes (9.8%).
CONCLUSIONS: The combination therapy of GCs plus low-dose MMF had better efficacy and safety in the management of IgG4-RD compared with the therapy of GCs plus LEF.
METHODS: This study included 130 newly diagnosed IgG4-RD patients who received the therapy of GCs plus LEF (group I) and GCs plus MMF (group II). Clinical data at baseline and after treatment, treatment response, relapse rate, and adverse effects were recorded and analyzed.
RESULTS: Patients in both groups responded well to the treatment in the 1st-month follow-up, and 100% of patients achieved treatment response. However, at the 6th and 12th-month follow-up, the total response rate of group II was higher than that in group I (75.6 vs. 53.7%, p = 0.038 and 85.4% vs. 61.0%, p = 0.013, respectively). In addition, the duration of disease remission in group II was longer than that in group I (9 (6-9) vs. 6 (6-6) months, p = 0.014). Moreover, more patients in group I had adverse effects compared with group II (36.6 vs. 7.3%, p < 0.01); and the most common adverse events of LEF were rash (12.2%) and elevation of liver enzymes (9.8%).
CONCLUSIONS: The combination therapy of GCs plus low-dose MMF had better efficacy and safety in the management of IgG4-RD compared with the therapy of GCs plus LEF.
摘要：
目的：据报道，糖皮质激素（GCs）加来氟米特（LEF）和GCs加霉酚酸酯（MMF）的联合治疗在IgG4-RD的治疗中具有良好的疗效和安全性。然而,没有比较这两种联合疗法疗效和安全性的研究.在这里，本研究旨在比较GCs加LEF和GCs加MMF治疗IgG4-RD的疗效和安全性.
方法：本研究包括130例新诊断的IgG4-RD患者，他们接受了GC加LEF（I组）和GC加MMF（II组）的治疗。基线和治疗后的临床数据，治疗反应,复发率,并对不良反应进行记录和分析。
结果：两组患者在第1个月的随访中对治疗反应良好，100%的患者达到治疗反应。然而,在第6个月和第12个月的随访中，II组的总有效率高于I组(75.6vs.53.7%,p=0.038和85.4%vs.61.0%,分别为p=0.013)。此外,II组的疾病缓解持续时间长于I组（9（6-9）与6(6-6)个月,p=0.014)。此外，与II组相比，I组患者有更多的不良反应(36.6vs.7.3%，p<0.01）；LEF最常见的不良事件是皮疹（12.2％）和肝酶升高（9.8％）。
结论：GCs联合小剂量MMF治疗IgG4-RD的疗效和安全性优于GCs联合LEF。
方法：本研究包括130例新诊断的IgG4-RD患者，他们接受了GC加LEF（I组）和GC加MMF（II组）的治疗。
结果：两组患者在第1个月的随访中对治疗反应良好，
结论：GCs联合小剂量MMF治疗IgG4-RD的疗效和安全性优于GCs联合LEF。
