美罗华对传统免疫抑制剂疗效……
美罗华对传统免疫抑制剂疗效不佳的狼疮有效
作者:Tanaka Y, et al.
翻译:北医三院何婉毓
摘要: 目的:本研究旨在评估美罗华在传统免疫抑制治疗效果不佳的日本系统性红斑狼疮和狼疮性肾炎患者中的疗效及安全性。方法:经过筛选的患者接受美罗华治疗的剂量如下:第1天、第15天、第169天及第183天分别予以1000mg美罗华,并在首次应用美罗华53周内进行随访观察。每个月对患者的疾病的活动程度评估1次,计算BILAG活动指数。我们评估了合并狼疮性肾炎的患者(入组时尿蛋白/尿肌酐≥ 1.0)的肾脏情况,依据ACR的诊断标准及LUNAR研究。结果:共计有34名患者参与研究,接受了至少1次美罗华的治疗。其中16名患者(76.5%)疾病活动度在治疗后下降。17名合并狼疮性肾炎的患者中,肾脏治疗有反应的为58.8%(ACR标准)和 52.9%(LUNAR标准)。激素逐渐减量成功与否和疾病的缓解程度有关。患者对美罗华的耐受程度较好,最多见的药物不良反应的程度为1-2级。结论:美罗华对传统免疫抑制治疗效果不佳的日本系统性红斑狼疮和狼疮性肾炎患者的治疗是有效的。
附原文:Abstract: OBJECTIVES: To evaluate the efficacy and safety of rituximab in Japanese patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN) who are refractory to conventional immunosuppressive therapy. METHODS:Eligible patients received rituximab at a dose of 1,000 mg at days 1, 15, 169, and 183, and were followed for 53 weeks after the first dose of rituximab. Overall disease activity was assessed monthly using a British Isles Lupus Assessment Group activity index. Patients with LN (Upr/Ucr ≥ 1.0 at study entry) were identified and their renal responses were evaluated according to the criteria proposed by the American College of Rheumatology (ACR) and the Lupus Nephritis Assessment with Rituximab (LUNAR) study. RESULTS:A total of 34 patients were enrolled and received at least one dose of rituximab. Decrease in disease activity was achieved in 16 (76.5%) out of 34 patients. In 17 patients with LN, response rates of 58.8% and 52.9% by ACR and LUNAR criteria, respectively, were seen. Successful steroid tapering was achieved in association with disease remission. Rituximab was well tolerated, and most adverse drug reactions were grade 1-2 in severity. CONCLUSIONS: Rituximab is effective for treatment of Japanese patients with SLE and LN refractory to conventional therapy.
引自: Tanaka Y, Takeuchi T, Miyasaka N et.al. Efficacy and safety of rituximab in Japanese patients with systemic lupus erythematosus and lupus nephritis who are refractory to conventional therapy. Mod Rheumatol. 2016;26(1):80-6.
作者:Tanaka Y, et al.
翻译:北医三院何婉毓
摘要: 目的:本研究旨在评估美罗华在传统免疫抑制治疗效果不佳的日本系统性红斑狼疮和狼疮性肾炎患者中的疗效及安全性。方法:经过筛选的患者接受美罗华治疗的剂量如下:第1天、第15天、第169天及第183天分别予以1000mg美罗华,并在首次应用美罗华53周内进行随访观察。每个月对患者的疾病的活动程度评估1次,计算BILAG活动指数。我们评估了合并狼疮性肾炎的患者(入组时尿蛋白/尿肌酐≥ 1.0)的肾脏情况,依据ACR的诊断标准及LUNAR研究。结果:共计有34名患者参与研究,接受了至少1次美罗华的治疗。其中16名患者(76.5%)疾病活动度在治疗后下降。17名合并狼疮性肾炎的患者中,肾脏治疗有反应的为58.8%(ACR标准)和 52.9%(LUNAR标准)。激素逐渐减量成功与否和疾病的缓解程度有关。患者对美罗华的耐受程度较好,最多见的药物不良反应的程度为1-2级。结论:美罗华对传统免疫抑制治疗效果不佳的日本系统性红斑狼疮和狼疮性肾炎患者的治疗是有效的。
附原文:Abstract: OBJECTIVES: To evaluate the efficacy and safety of rituximab in Japanese patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN) who are refractory to conventional immunosuppressive therapy. METHODS:Eligible patients received rituximab at a dose of 1,000 mg at days 1, 15, 169, and 183, and were followed for 53 weeks after the first dose of rituximab. Overall disease activity was assessed monthly using a British Isles Lupus Assessment Group activity index. Patients with LN (Upr/Ucr ≥ 1.0 at study entry) were identified and their renal responses were evaluated according to the criteria proposed by the American College of Rheumatology (ACR) and the Lupus Nephritis Assessment with Rituximab (LUNAR) study. RESULTS:A total of 34 patients were enrolled and received at least one dose of rituximab. Decrease in disease activity was achieved in 16 (76.5%) out of 34 patients. In 17 patients with LN, response rates of 58.8% and 52.9% by ACR and LUNAR criteria, respectively, were seen. Successful steroid tapering was achieved in association with disease remission. Rituximab was well tolerated, and most adverse drug reactions were grade 1-2 in severity. CONCLUSIONS: Rituximab is effective for treatment of Japanese patients with SLE and LN refractory to conventional therapy.
引自: Tanaka Y, Takeuchi T, Miyasaka N et.al. Efficacy and safety of rituximab in Japanese patients with systemic lupus erythematosus and lupus nephritis who are refractory to conventional therapy. Mod Rheumatol. 2016;26(1):80-6.
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