Division of Nephrology and Hypertension, University of North Carolina at Chapel Hill, 7030 Burnett Womack Building, Chapel Hill, NC 27599-7155, USA.
Clin J Am Soc Nephrol. 2012 Feb;7(2):240-7. doi: 10.2215/CJN.05610611. Epub 2011 Dec 1.
The optimal course of glucocorticoid therapy in anti-neutrophil cytoplasmic autoantibody (ANCA) disease is unknown. This cohort study evaluates effects of glucocorticoid therapy duration on patient outcomes and adverse events.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This study assessed 147 patients diagnosed between January 1, 2000 and January 1, 2009 who were treated with glucocorticoids and cyclophosphamide. Patients with end stage kidney disease at presentation, treatment resistance, or who had died within 6 months were excluded. Patients were divided into three groups: 0, 5, or >5 mg prednisone daily at 6 months after therapy initiation. The latter two groups were combined for assessment of adverse events. Wilcoxon rank sum, Kruskal-Wallis, or Fisher's exact tests were used for between-group comparisons. Time to relapse was evaluated by the Kaplan-Meier method with log-rank test for comparison.
There were no differences between groups in ANCA specificity, serum creatinine, frequency of risk factors for relapse, or length of therapy with immunosuppressants. Length of glucocorticoid therapy had no impact on time to relapse (hazard ratio, 0.69 [95% confidence interval (CI), 0.23-2.02]; 1.01, [95% CI, 0.57-1.81] for the 5-mg and >5-mg groups, respectively), relapse-free survival, end stage kidney disease, or death. Patients receiving glucocorticoids beyond 6 months had significantly higher incidence of infections (0.64 infections per person-year versus 0.39, P<0.0001) and a marginally significant higher frequency of new-onset diabetes mellitus (odds ratio, 2.03; 95% CI, 0.94-4.38).
Glucocorticoid therapy beyond 6 months is associated with a significantly greater risk of infections but not a significantly decreased risk of relapse.
抗中性粒细胞胞浆抗体(ANCA)相关性血管炎患者糖皮质激素治疗的最佳疗程尚不明确。本队列研究旨在评估糖皮质激素治疗持续时间对患者结局和不良事件的影响。
设计、地点、参与者和测量:该研究纳入了 147 例 2000 年 1 月 1 日至 2009 年 1 月 1 日期间诊断为 ANCA 相关性血管炎且接受糖皮质激素和环磷酰胺治疗的患者。研究排除了起病时即存在终末期肾病、治疗抵抗或治疗后 6 个月内死亡的患者。患者被分为三组:治疗开始后 6 个月时每日泼尼松剂量分别为 0、5 或 >5mg。后两组合并评估不良事件。组间比较采用 Wilcoxon 秩和检验、Kruskal-Wallis 检验或 Fisher 确切概率法。通过 Kaplan-Meier 法和对数秩检验评估复发时间。
三组间 ANCA 特异性、血清肌酐、复发危险因素频率或免疫抑制剂治疗时间均无差异。糖皮质激素治疗时间对复发时间(风险比,0.69[95%置信区间(CI),0.23-2.02];5mg 和 >5mg 组分别为 1.01[95%CI,0.57-1.81])、无复发生存、终末期肾病或死亡均无影响。糖皮质激素治疗超过 6 个月的患者感染发生率显著更高(0.64 例/人年比 0.39,P<0.0001),新发糖尿病频率有更高的趋势(比值比,2.03;95%CI,0.94-4.38)。
糖皮质激素治疗超过 6 个月与感染风险显著增加相关,但与复发风险降低无关。