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肾脏病与透析肾移植杂志 ›› 2012, Vol. 21 ›› Issue (2): 101-108.

• 论文 •    下一篇

多靶点治疗Ⅳ+Ⅴ型狼疮性肾炎的长期随访

  

  • 出版日期:2012-04-28 发布日期:2012-04-18

Multi-target therapy as maintenance  treatment for class Ⅳ+Ⅴ lupus nephritis

  • Online:2012-04-28 Published:2012-04-18

摘要:

目的:既往研究发现多靶点疗法(multi-target therapy, MT)治疗IV+V型狼疮性肾炎(Lupus nephritis, LN)较传统的静脉环磷酰胺冲击疗法(intravenous cyclophosphamide, IVCY)能获得更高的诱导缓解率,本文进一步探讨多靶点疗法长期治疗IV+V型LN的疗效和安全性。 方法:80例经肾活检证实的IV+V型LN,随机分为MT组(MT诱导缓解后MT维持, n=40),或IVCY-AZA组(IVCY诱导缓解后硫唑嘌呤维持, n=40)。两组均同时予口服激素。总随访时间24月。主要疗效指标为完全缓解率,次要指标包括部分缓解,肾脏复发和不良反应发生率。 结果:MT组和IVCY-AZA组分别有36例(90%)和24例(60%)获得诱导缓解(P < 0.01),MT组6个月(45% vs 12.5%, P < 0.01)和24个月完全缓解率(80% vs 47.5%, P < 0.01)显著高于IVCY-AZA组。MT组和IVCY-AZA组分别有36例、21例进入维持期观察,两组24个月内肾脏复发率(8.3% vs 4.8%, P > 0.05)及肾脏无复发生存率无差别。诱导期MT组和IVCY-AZA组感染发生率均为22.5%,IVCY-AZA组脱发、胃肠道症状发生率高于MT组(17.5% vs 2.5%, 22.5% vs 5%, P均< 0.05),新发高血压仅出现在MT组(15% vs 0%, P < 0.05)。维持期两组不良反应少见,分别有10%和15%出现白细胞减低(P > 0.05)。 结论:采用多靶点疗法诱导,并维持治疗IV+V型LN能获得较高缓解率、安全性好。

关键词: 狼疮性肾炎, 多靶点疗法, 疗效

Abstract:

To further evaluate the long-term efficacy and safety of multi-target therapy (MT) as continuous induction and maintenance therapy for Class IV+V LN. Methodology:Eighty patients with biopsy-proved Class IV+V LN were included in this study. They were randomly assigned to MT group (n=40, MT inducing remission followed by MT maintenance) and IVCY-AZA group (n=40, IVCY inducing remission followed by AZA maintenance), both in combination with prednisolone. The total duration of observation was 24 months. The primary end point had complete remission, and the secondary end point had partial remission, renal relapse, and adverse effects. Results:36 patients in MT group and 24 patients in IVCY-AZA group responded favorably (complete or partial remission) to induction treatment (P <0.01). In MT group, the complete-remission rate at 6 mo (45% vs 12.5%, P < 0.01) and 24 mo (80% vs 47.5%, P < 0.01) were significantly higher than those in IVCY-AZA group. The rate of renal relapse and renal relapse-free survival were similar between the two groups (8.3% vs 4.8%, P>0.05). Infections were noted in more than 20% of patients in both groups (P >0.05). Alopecia, nausea and vomiting were more common during IVCY induction (P<0.05), conversely, new onset hypertension occurred only in patients with MT induction (P<0.05). During maintenance, both groups had favorable safety profile, with 10% and 15% patients of leucopenia episode (P >0.05). Conclusions:MT therapy was an effective induction and maintenance treatment for patients with Class IV+V LN, with higher response rate and favorable tolerability. 

Key words: lupus nephritis, multi-target therapy, curative effect