Pulse versus daily oral cyclophosphamide for induction of remission in ANCA-associated vasculitis: long-term follow-up
Pulse versus daily oral cyclophosphamide for induction of remission in ANCA-associated vasculitis: long-term follow-up
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DOI：
10.1136/annrheumdis-2011-200477
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发表时间：
2012-06-01
影响因子：
27.4
通讯作者：
Jayne, David
中科院分区：
文献类型：
--
作者：
Harper, Lorraine;Morgan, Matthew D.;Jayne, David
前言：先前报道的环磷酰胺脉冲治疗方案的随机对照试验表明，当两者与相同的糖皮质激素方案联合使用时，环磷酰胺与每日口服（DO）环磷酰胺对诱导抗神经细胞胞质自身抗体相关的系统性血管炎缓解同样有效。（CYCLOPS研究（每日口服与脉冲环磷酰胺作为ANCA相关系统性血管炎治疗的随机试验，发表于Groot K，哈珀L等人Ann Int Med 2009））。这项研究在检测复发差异方面的能力有限。本研究描述了CYCLOPS研究中的患者的长期结局。方法回顾性研究了148例CYCLOPS试验招募的患者的长期结局。从医生记录中回顾性收集生存、复发、免疫抑制治疗、癌症发病率、骨折、血栓栓塞性疾病和心血管发病率的数据。所有患者进行了分析，根据组，他们是randomized.Results随访中位持续时间为4.3年（IQR，2.95-5.44年）。两条肢体之间的生存率无差异（p=0.92）。15例（20.8%）DO和30例（39.5%）脉冲患者至少有一次复发。DO肢体的复发风险显著低于脉冲肢体（HR=0.50，95% CI 0.26至0.93; p=0.029）。尽管接受脉冲治疗的患者复发风险增加，但研究结束时肾功能无差异（p=0.82）。在不良事件方面，两组治疗肢之间无差异。讨论脉冲环磷酰胺与DO环磷酰胺相比，复发风险更高。然而，这与死亡率或长期发病率的增加无关。虽然这项研究是回顾性的，但原始试验中90%的患者返回了数据。
Introduction The previously reported randomised controlled trial of a consensus regimen of pulse cyclophosphamide suggested that it was as effective as a daily oral (DO) cyclophosphamide for remission induction of antineutrophil cytoplasm autoantibodies-associated systemic vasculitis when both were combined with the same glucocorticoid protocol (CYCLOPS study (Randomised trial of daily oral versus pulse Cyclophosphamide as therapy for ANCA-associated Systemic Vasculitis published de groot K, harper L et al Ann Int Med 2009)). The study had limited power to detect a difference in relapse. This study describes the long-term outcomes of patients in the CYCLOPS study.Methods Long-term outcomes were ascertained retrospectively from 148 patients previously recruited to the CYCLOPS Trial. Data on survival, relapse, immunosuppressive treatment, cancer incidence, bone fractures, thromboembolic disease and cardiovascular morbidity were collected from physician records retrospectively. All patients were analysed according to the group to which they were randomised.Results Median duration of follow-up was 4.3 years (IQR, 2.95-5.44 years). There was no difference in survival between the two limbs (p=0.92). Fifteen (20.8%) DO and 30 (39.5%) pulse patients had at least one relapse. The risk of relapse was significantly lower in the DO limb than the pulse limb (HR=0.50, 95% CI 0.26 to 0.93; p=0.029). Despite the increased risk of relapse in pulse-treated patients, there was no difference in renal function at study end (p=0.82). There were no differences in adverse events between the treatment limbs.Discussion Pulse cyclophosphamide is associated with a higher relapse risk than DO cyclophosphamide. However, this is not associated with increased mortality or long-term morbidity. Although the study was retrospective, data was returned in 90% of patients from the original trial.