Rihová Z, Jancová E, Merta M, Zabka J, Rysavá R, Bartůnková J, Kolárova I, Tesar V
First Department of Medicine, U Nemocnice 2, 128 08 Praha 2, Czech Republic.
Prague Med Rep. 2004;105(1):64-8.
The aim of the multicentric randomized trial CYCLOPS is to optimize the treatment of induction of remission in patients with generalized, but not immediately life-threatening ANCA (antineutrophil cytoplasmic antibodies) -associated vasculitis. This will be achieved by reducing the dose of cyclophosphamide by administering it as intermittent pulses. The lower cumulative dose will be very probably accompanied with lower toxicity, whereas the effectivity should be comparable. We have enrolled 28 patients to the study. At present, 18 of them are suitable for evaluation. Our preliminary results show that pulse intermittent administration of cyclophosphamide is safer from the point of morbidity and mortality due to infectious complications. In our hands, this treatment modality does not seem to be less effective than the conventional daily oral cyclophosphamide. However, unambiguous results and treatment recommendations will not be available until the final evaluation of all patients enrolled in the trial.
多中心随机试验CYCLOPS的目的是优化对广泛性但并非立即危及生命的抗中性粒细胞胞浆抗体(ANCA)相关血管炎患者的诱导缓解治疗。这将通过间歇性脉冲给药来减少环磷酰胺的剂量来实现。较低的累积剂量很可能伴随着较低的毒性,而有效性应相当。我们已招募28名患者参与该研究。目前,其中18名患者适合评估。我们的初步结果表明,从因感染并发症导致的发病率和死亡率来看,脉冲间歇性给予环磷酰胺更安全。在我们看来,这种治疗方式似乎并不比传统的每日口服环磷酰胺效果差。然而,在对试验中所有入组患者进行最终评估之前,不会有明确的结果和治疗建议。