风湿

延长硫唑嘌呤维持治疗时间不能减少ANCA相关性血管炎的复发率

作者:de Joode AAE, et al 翻译:北医三院柴静, 审校:赵金霞 来源:中国风湿病公众论坛 日期:2018-06-14
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         延长硫唑嘌呤维持治疗时间不能减少ANCA相关性血管炎的复发率

        摘要:目的:研究在长期随访过程中ANCA相关性血管炎患者硫唑嘌呤(AZA)维持治疗时间是否影响复发率。

        方法:从6个欧洲研究中心共纳入380例新诊断的且用硫唑嘌呤(AZA)维持治疗的ANCA相关性血管炎患者;58%为男性,诊断的中位年龄为59.4岁(四分位数:48.3-68.2岁);肉芽肿性多血管炎,n=236;显微镜下多血管炎,n=132;或者局限于肾脏的血管炎,n=12。患者根据诱导缓解后硫唑嘌呤维持的时间进行分组:≤18个月,≤24个月,≤36个月,≤48个月或者>48个月。首要结局为60个月时无复发生存率。

        结果:随访期间,84例第一次复发发生在AZA维持治疗期间(每117人月1次复发)及71例停用硫唑嘌呤后(每113月1次复发)。停用后的第一个12月20例复发(1次复发/119月)及停用大于12月后29次复发(1次复发/186月)。确诊后AZA维持>18个月患者60个月无复发生存率为65.3%,而维持治疗≤18个月的患者为55%(P=0.11)。无复发生存率与诱导缓解方案(静脉vs口服)和ANCA特异性(PR3-ANCA vs MPO-ANCA/阴性)相关。

        结论:试验数据的析因分析提示,停用AZA维持治疗不会显著增加复发率,而确诊后AZA维持超过18月不能显著影响无复发生存率。ANCA特异性较维持治疗持续时间对无复发生存率的影响更大,且其应该应用于个体化精减方案。

        附原文:OBJECTIVE:We studied whether in ANCA-associated vasculitis patients, duration of AZA maintenance influenced relapse rate during long-term follow-up.METHODS:Three hundred and eighty newly diagnosed ANCA-associated vasculitis patients from six European multicentre studies treated with AZA maintenance were included; 58% were male, median age at diagnosis 59.4 years (interquartile range: 48.3-68.2 years); granulomatosis with polyangiitis, n = 236; microscopic polyangiitis, n = 132; or renal limited vasculitis, n = 12. Patients were grouped according to the duration of AZA maintenance after remission induction: ⩽18 months, ⩽24 months, ⩽36 months, ⩽48 months or > 48 months. Primary outcome was relapse-free survival at 60months.RESULTS:During follow-up, 84 first relapses occurred during AZA-maintenance therapy (1 relapse per 117 patient months) and 71 after withdrawal of AZA (1 relapse/113 months). During the first 12 months after withdrawal, 20 relapses occurred (1 relapse/119 months) and 29 relapses >12 months after withdrawal (1 relapse/186 months). Relapse-free survival at 60 months was 65.3% for patients receiving AZA maintenance >18 months after diagnosis vs 55% for those who discontinued maintenance ⩽18 months (P = 0.11). Relapse-free survival was associated with induction therapy (i.v. vs oral) and ANCA specificity (PR3-ANCA vs MPO-ANCA/negative).CONCLUSION:Post hoc analysis of combined trial data suggest that stopping AZA maintenance therapy does not lead to a significant increase in relapse rate and AZA maintenance for more than 18 months after diagnosis does not significantly influence relapse-free survival. ANCA specificity has more effect on relapse-free survival than duration of maintenance therapy and should be used to tailor therapy individually.

        引自:de Joode AAE, Sanders JSF, Puéchal X, et al.Long term azathioprine maintenance therapy in ANCA-associated vasculitis: combined results of long-term follow-up data.Rheumatology (Oxford). 2017 Nov 1;56(11):1894-1901.

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