Division of Pediatric Nephrology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.
Clin J Am Soc Nephrol. 2010 Dec;5(12):2207-12. doi: 10.2215/CJN.03470410. Epub 2010 Aug 26.
The treatment of idiopathic nephrotic syndrome is often complicated by a refractory and relapsing course, with risk of drug toxicity and progressive renal failure. We report the efficacy and safety of rituximab in patients with steroid-resistant (SRNS) and steroid-dependent nephrotic syndrome (SDNS) refractory to standard therapy.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This was a cohort study in academic, tertiary care centers in India and the United States. Patients with SRNS or SDNS, not responding to medications or showing calcineurin inhibitor toxicity, treated with two to four doses of intravenous rituximab, and followed ≥12 months were included. Remission was termed as complete, partial, or no response.
Thirty-three patients with SRNS (24 initial, 9 late resistance) and 24 with SDNS, with mean ages of 12.7 ± 9.1 and 11.7 ± 2.9 years, respectively, were included. Six months after rituximab therapy, 9 (27.2%) patients with SRNS showed complete remission, 7 (21.2%) had partial remission, and 17 (51.5%) had no response. At 21.5 ± 11.5 months, remission was sustained in 15 (complete: 7, partial: 8) patients. Of 24 patients with SDNS, remission was sustained in 20 (83.3%) at 12 months and in 17 (71%) at follow-up of 16.8 ± 5.9 months. The mean difference in relapses before and 12 months after treatment with rituximab was 3.9 episodes/patient per year.
Therapy with rituximab was safe and effective in inducing and maintaining remission in a significant proportion of patients with difficult SRNS and SDNS.
特发性肾病综合征的治疗常伴有难治性和复发性病程，存在药物毒性和进行性肾功能衰竭的风险。我们报告利妥昔单抗在对标准治疗无效的激素抵抗性肾病综合征（SRNS）和激素依赖性肾病综合征（SDNS）患者中的疗效和安全性。
设计、地点、参与者和测量方法：这是一项在印度和美国的学术性三级护理中心进行的队列研究。纳入了对药物无反应或出现钙调神经磷酸酶抑制剂毒性的 SRNS 或 SDNS 患者，给予 2 至 4 剂静脉用利妥昔单抗治疗，并随访≥12 个月。完全缓解、部分缓解或无缓解。
纳入了 33 例 SRNS（24 例初治，9 例迟发性耐药）和 24 例 SDNS 患者，平均年龄分别为 12.7±9.1 岁和 11.7±2.9 岁。利妥昔单抗治疗后 6 个月，9 例（27.2%）SRNS 患者完全缓解，7 例（21.2%）部分缓解，17 例（51.5%）无缓解。21.5±11.5 个月时，15 例（完全缓解 7 例，部分缓解 8 例）患者的缓解持续存在。24 例 SDNS 患者中，12 个月时缓解持续存在 20 例（83.3%），16.8±5.9 个月时缓解持续存在 17 例（71%）。利妥昔单抗治疗前后复发的平均差异为每年 3.9 例/患者。
利妥昔单抗治疗可诱导和维持大部分难治性和激素依赖性 SRNS 和 SDNS 患者的缓解，且安全性良好。
