Prescrire Int. 2005 Feb;14(75):3-5.
(1) Oral chlorambucil is the reference first-line treatment for patients with symptomatic chronic lymphocytic leukaemia. Intravenous fludarabine is a second-line option. (2) The indications for intravenous fludarabine have now been extended to cover first-line use. (3) The clinical evaluation dossier mainly contains data from two unblinded comparative trials. One trial compared intravenous fludarabine with chlorambucil in 509 patients for one year; the complete remission rate was significantly higher in the group receiving intravenous fludarabine (20% versus 4%) but, after 62 months of follow-up, the survival rate was no different (about 50% in both groups). Note that the dose of chlorambucil used in this trial may have been inadequate. (4) The other unblinded trial included 938 patients treated for six months with fludarabine, the CAP protocol, or the CHOP protocol. The median survival time did not differ among the three groups (67 to 70 months). (5) In the trial versus chlorambucil, the incidence of serious adverse events was significantly higher in the fludarabine group (55% of patients, versus 44%). The commonest serious adverse events were neutropenia, other haematological disturbances, and infections. (6) Oral chlorambucil is more convenient than intravenous fludarabine, which necessitates five infusions per month. Intravenous fludarabine costs 10 times more than oral chlorambucil. (7) In practice, chlorambucil remains the reference first-line treatment for chronic lymphocytic leukaemia.
(1) 口服苯丁酸氮芥是有症状的慢性淋巴细胞白血病患者的一线参考治疗方法。静脉注射氟达拉滨是二线选择。(2) 静脉注射氟达拉滨的适应证现已扩展至一线使用。(3) 临床评估档案主要包含两项非盲比较试验的数据。一项试验将509例患者的静脉注射氟达拉滨与苯丁酸氮芥进行了为期一年的比较；接受静脉注射氟达拉滨的组完全缓解率显著更高（20% 对 4%），但在随访62个月后，生存率无差异（两组均约为50%）。请注意，该试验中使用的苯丁酸氮芥剂量可能不足。(4) 另一项非盲试验纳入了938例接受氟达拉滨、CAP方案或CHOP方案治疗六个月的患者。三组的中位生存时间无差异（67至70个月）。(5) 在与苯丁酸氮芥对比的试验中，氟达拉滨组严重不良事件的发生率显著更高（55% 的患者，对比44%）。最常见的严重不良事件是中性粒细胞减少、其他血液学紊乱和感染。(6) 口服苯丁酸氮芥比静脉注射氟达拉滨更方便，后者每月需要进行五次输液。静脉注射氟达拉滨的费用是口服苯丁酸氮芥的10倍。(7) 在实际应用中，苯丁酸氮芥仍是慢性淋巴细胞白血病的一线参考治疗方法。
