ANN RHEUM DIS:ANCA相关性血管炎缓解期延长治疗研究

2017-05-28 xiangting MedSci原创

缓解后延长硫唑嘌呤/泼尼松龙维持治疗至诊断后24个月以上能够减少48个月内的复发风险,并改善AAV的肾功能。

这是一项前瞻性随机试验,用于比较两种不同持续时间的免疫抑制治疗,用以预防抗中性粒细胞胞浆抗体(ANCA)相关性血管炎(AAV)的复发。

AAV患者如果经过环磷酰胺/泼尼松龙诱导后硫唑嘌呤/泼尼松龙维持治疗后稳定缓解,则在诊断后18-24个月入组。他们被随机(1:1)接受持续的硫唑嘌呤/泼尼松龙至诊断后48个月(维持组)或24个月停用硫唑嘌呤/泼尼松龙(停药组)。主要终点是从随机分组时到诊断后48个月的复发风险。

117例患者随机分组,110例患者坚持到随访结束。入组时,中位血清肌酐为116μmol/ L(范围58-372),53%为ANCA阳性。停药组复发患者的比例高于维持组(63%vs 22%,p <0.0001,OR 5.96,95%CI 2.58-13.77)。随机分组的ANCA阳性与复发风险相关(51%vs 29%,p = 0.017,OR 2.57,95%CI 1.16至5.68)。肾功能、ANCA特异性、血管炎类型和年龄不能预测复发。维持组严重不良事件比停药组更频繁(9 vs 3),但维持组患者肾功能更好(0例vs 4例终末期肾病),患者生存率无差异。

可见,缓解后延长硫唑嘌呤/泼尼松龙维持治疗至诊断后24个月以上能够减少48个月内的复发风险,并改善AAV的肾功能。

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    2017-05-30 Boyinsh