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目的:比较利妥昔单克隆抗体(RTX)与环磷酰胺(CTX)静脉冲击诱导治疗难治性重症狼疮肾炎(LN)的临床疗效。方法:27例经肾活检诊断为Ⅲ+Ⅴ、Ⅳ+Ⅴ型的活动性LN患者,分为2组。RTX组(12例):糖皮质激素甲基强的松龙500 mg静脉冲击治疗3 d联合环磷酰胺0.8 g静脉冲击治疗2次(0、2周)后,尽快在8周内使激素减量至较小剂量(≤10 mg/d)维持,利妥昔单抗(375 mg/m2)分别于第0、2、4、6周,每2周使用1次,共4次。CTX组(15例):甲基强的松龙500 mg静脉冲击治疗3 d后,按标准激素疗程维持治疗,联合每月使用环磷酰胺0.8 g静脉冲击维持治疗1次。比较两组治疗3、6个月后的临床疗效。评价分为完全缓解(CR),部分缓解(PR)及无效(NR)。结果:治疗3个月时,RTX组的有效率明显高于CTX组(75.0%vs 26.7%,P<0.05)。治疗6个月时,RTX组的完全缓解率高于CTX组(66.7%vs 20%,P<0.05),RTX组有效率高于CTX组(83.3%vs53.3%,P>0.05);RTX组24 h尿蛋白定量下降,狼疮活动指数(SLEDAI)评分减少,血清白蛋白、C3、C4增加,CD19+B细胞百分比下降,比CTX组差异均有统计学意义(P<0.05),而且出现不良反应较CTX组无增加。结论:与传统CTX组相比,利妥昔单抗具有快速有效地诱导难治性重症LN缓解、不良反应少、安全性好等优点。
Objective: To compare the clinical effects of rituximab (RTX) and cyclophosphamide (CTX) induced by intravenous pulse therapy in refractory severe lupus nephritis (LN). Methods: Twenty-seven active LN patients diagnosed as type Ⅲ + Ⅴ, Ⅳ + Ⅴ by renal biopsy were divided into two groups. RTX group (12 cases): glucocorticoid methylprednisolone 500 mg intravenous pulse therapy 3 d combined with cyclophosphamide 0.8 g intravenous pulse treatment 2 times (0,2 weeks), as soon as possible within 8 weeks of hormone reduction (≤10 mg / d), rituximab (375 mg / m2) at Weeks 0, 2, 4 and 6, once every 2 weeks, for 4 doses. CTX group (n = 15): Methylprednisolone 500 mg intravenous pulse therapy for 3 days, according to standard hormone therapy to maintain treatment, combined with monthly use of cyclophosphamide 0.8 g intravenous pulse therapy 1 time. The clinical effects of the two groups after 3 and 6 months of treatment were compared. The evaluation was divided into complete remission (CR), partial remission (PR) and ineffective (NR). Results: At 3 months, the effective rate of RTX group was significantly higher than that of CTX group (75.0% vs 26.7%, P <0.05). At 6 months, the complete remission rate in RTX group was higher than that in CTX group (66.7% vs 20%, P <0.05). The effective rate in RTX group was higher than that in CTX group (83.3% vs53.3%, P> 0.05) Compared with CTX group, the levels of urinary protein decreased, the score of lupus activity index (SLEDAI) decreased, the levels of serum albumin, C3 and C4 increased and the percentage of CD19 + B cells decreased in 24 hours, but the difference was statistically significant (P <0.05) Adverse reactions no increase compared with CTX group. Conclusion: Compared with the traditional CTX group, rituximab has the advantages of rapid and effective induction of refractory severe LN remission, fewer adverse reactions, good safety and so on.