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早期使用利妥昔单抗治疗新诊断的系统性红斑狼疮患者:一种类固醇节约方案。

Early treatment with rituximab in newly diagnosed systemic lupus erythematosus patients: a steroid-sparing regimen.

机构信息

Department of Rheumatology, University College London Hospital, London NW1 2PG, UK.

出版信息

Rheumatology (Oxford). 2012 Mar;51(3):476-81. doi: 10.1093/rheumatology/ker337. Epub 2011 Nov 16.

DOI:10.1093/rheumatology/ker337
PMID:22096015
Abstract

OBJECTIVES

To assess the effectiveness of B-cell depletion therapy (BCDT) as a steroid-sparing treatment in newly diagnosed SLE patients.

METHODS

Eight female SLE patients were treated with BCDT using a rituximab/CYC-based regimen aiming to avoid the routine use of oral steroids. Post-treatment, patients were given AZA. The BILAG disease activity index was used for clinical assessment. Serum anti-dsDNA, complement (C3), ESR, circulating B lymphocytes (CD19(+)) and protein : creatinine ratio were tested at 0, 1, 3, 6 and 12 months post-treatment. Disease activity and steroid requirement over the first 6 months of treatment were compared with three SLE patients treated conventionally, each carefully matched for ethnicity, sex, age at disease onset and disease duration at diagnosis.

RESULTS

All patients achieved B-cell depletion (CD19 count <0.005 × 10(9)/l). The mean decrease in global BILAG at 6 months for the BCDT patients was -12.0 vs 13.22 for the controls. Post-BCDT, no patient developed any significant deterioration, mean ESR fell from 70.12 to 17.14 mm/h at 6 months, mean serum anti-dsDNA antibody levels fell by >70% at 1 month and serum C3 level normalized in two patients by 6 months. There were no adverse events. The mean cumulative prednisolone dose at 6 months for the BCDT patients was 1287.3 mg (range 250-4501.8 mg) vs 2834.6 mg (range 0-6802.5 mg) for the controls.

CONCLUSION

Early treatment of SLE patients with BCDT is safe and effective and enables a reduction in the overall steroid burden.

摘要

目的

评估 B 细胞耗竭疗法(BCDT)作为新诊断的系统性红斑狼疮(SLE)患者的激素节省治疗的有效性。

方法

8 名女性 SLE 患者接受利妥昔单抗/环磷酰胺(CYC)为基础的方案进行 BCDT,旨在避免常规使用口服类固醇。治疗后,患者给予 AZA。采用 BILAG 疾病活动指数进行临床评估。在治疗后 0、1、3、6 和 12 个月检测血清抗 dsDNA、补体(C3)、ESR、循环 B 淋巴细胞(CD19(+))和蛋白/肌酐比。比较治疗前 6 个月的疾病活动度和激素需求与 3 名接受常规治疗的 SLE 患者,每位患者均仔细匹配种族、性别、发病年龄和诊断时的疾病持续时间。

结果

所有患者均实现 B 细胞耗竭(CD19 计数 <0.005 ×10(9)/l)。BCDT 患者在 6 个月时的全球 BILAG 平均下降为-12.0,而对照组为 13.22。BCDT 后,无患者出现任何明显恶化,ESR 均值从 6 个月时的 70.12 降至 17.14mm/h,血清抗 dsDNA 抗体水平在 1 个月时下降>70%,2 名患者的血清 C3 水平在 6 个月时恢复正常。无不良事件发生。BCDT 患者在 6 个月时的累积泼尼松剂量为 1287.3mg(范围 250-4501.8mg),而对照组为 2834.6mg(范围 0-6802.5mg)。

结论

早期对 SLE 患者进行 BCDT 治疗是安全有效的,可以减少总体激素负担。

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