Treatment of polyarteritis nodosa and microscopic polyangiitis with poor prognosis factors:: A prospective trial comparing glucocorticoids and six or twelve cyclophosphamide pulses in sixty-five patients
Treatment of polyarteritis nodosa and microscopic polyangiitis with poor prognosis factors:: A prospective trial comparing glucocorticoids and six or twelve cyclophosphamide pulses in sixty-five patients
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DOI：
10.1002/art.10922
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发表时间：
2003-02-15
期刊：
影响因子：
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通讯作者：
Cordier, JF
中科院分区：
文献类型：
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作者：
Guillevin, L;Cohen, P;Cordier, JF
Objective.由于环磷酰胺（CY）治疗无病毒感染和显微镜下多血管炎（MPA）的严重结节性多动脉炎（PAN）的最佳治疗时间尚未确定，我们进行了一项试验，以比较6与12 CY脉冲与皮质类固醇（CS）联合给药的有效性。65例（18例PAN，47例MPA）既往未经治疗的患者随机接受12（n = 34）或6（n = 31）CY脉冲联合CS治疗。PAN和MPA经组织学证实或符合ACR标准。所有患者均表现出大于或等于1个严重度因子（根据五因子评分（FFS））。CY脉冲每2周给药1个月，然后每4周给药一次。研究的终点是根据意向治疗策略分析的每组中发生的事件（复发和/或死亡）的数量。采用考克斯比例风险分析法评价疗效。两组的基线特征相似。平均（+/- SD）随访时间为32 +/- 21个月。生存分析显示，12-CYP脉冲组复发概率显著降低（P = 0.02;风险比[HR] = 0.34），无事件生存率显著提高（P = 0.02，HR = 0.44），而死亡率无显著差异（P = 0.47）。这些结果表明，6 CY脉冲比12 CY脉冲治疗严重PAN和MPA的效果差，特别是在复发风险方面。
Objective. Because the optimal cyclophosphamide (CY) treatment duration for severe polyarteritis nodosa (PAN) without vir-us infection and microscopic polyangiitis (MPA) has not been established, we conducted a trial to compare the effectiveness of 6 versus 12 CY pulses given in combination with corticosteroids (CS).Methods. Sixty-five (18 PAN, 47 MPA) previously untreated patients were randomized to receive 12 (n = 34) or 6 (n 31) CY pulses combined with CS. PAN and MPA were histologically proven or met ACR criteria. All patients presented greater than or equal to1 factor of severity according to the five factor score (FFS). CY pulses were administered every 2 weeks for 1 month, then every 4 weeks. The end point of the study was the number of events (relapses and/or deaths) occurring in each group, analyzed according to an intention-to-treat strategy. The outcome was evaluated by Cox proportional hazards analysis.Results. The baseline characteristics were similar for both groups. The mean (+/- SD) followup was 32 +/- 21 months. Survival analysis showed a significantly lower relapse probability (P = 0.02; hazards ratio [HR] = 0.34) and higher event-free survival (P = 0.02, HR = 0.44) for the 12 CY-pulse group while the mortality rates were not significantly different (P = 0.47).Conclusion. These results suggest that 6 CY pulses are less effective than 12 CY pulses to treat severe PAN and MPA, particularly with respect to the risk of relapses.