多靶点治疗Ⅳ+Ⅴ型狼疮性肾炎的长期随访

摘要

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 was complete remission,and the secondary end point included partial remission,renal relapse,and adverse effects. Results; Thirty-six 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% us 12.5% , P<0. 01) and 24 mo (80% us 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% us 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 11. 1% and 28.6% patients of leucopenia episode (P > 0.05). Conclusion: MT therapy was an effective induction and maintenance treatment for patients with Class Ⅳ + Ⅴ LN, with higher response rate and favorable tolerability.%目的:既往研究证实多靶点疗法(MT)治疗Ⅳ+Ⅴ型狼疮性肾炎(LN)较传统静脉环磷酰胺冲击疗法(IVCY)能获得更高的诱导缓解率,本研究进一步探讨MT治疗Ⅳ+Ⅴ型LN的长期疗效和安全性. 方法:将80例经肾活检证实的Ⅳ+Ⅴ型LN患者随机分为MT组(MT诱导缓解后MT维持,40例),和IVCY-硫唑嘌呤(AZA)组(IVCY诱导缓解后AZA维持,40例).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、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月(45％vs 12.5％,P＜0.01)和24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明显差异.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＜0.05),新发高血压仅出现在MT组.维持期MT组和IVCY-AZA组分别有11.1％和28.6％患者出现白细胞减低(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.