DICE方案与CHOP方案治疗中高度恶性非霍奇金淋巴瘤的随机对照研究

Comparison of DICE and CHOP regimen in the treatment of intermediate and high grade Non-Hodgkin's lymphoma-a clinical phase Ⅲ trial

背景与目的长期以来,CHOP方案被认为是治疗中、高度恶性非霍奇金淋巴瘤(non-Hodgkin'slym-phoma,NHL)的基本方案,近年有文献报道DICE方案可以提高中、高度恶性NHL的疗效。本研究中我们比较DICE方案与CHOP方案治疗中、高度恶性NHL的疗效与安全性,为中、高度恶性NHL的规范治疗提供依据。方法选择经病理学或组织学证实的中、高度恶性NHL的患者74例,按信封法随机分为DICE组与CHOP组两组,分别采用上述两种方案治疗。结果DICE组CR15例(40.5%),PR14例(37.8%),缓解率RR(CR+PR)为78.3%(29/37);CHOP组CR11例(29.7%),PR10例(27.0%),RR为56.7%(21/37);两组比较有显著性差异(P<0.05)。DICE组的1、3、5年生存率分别为89.2%、76.0%和46.7%,CHOP组分别为81.2%、52.6%和36.4%,两组比较有显著性差异(P<0.05)。两组出现的主要不良反应为Ⅲ/Ⅳ度粒细胞和血小板减少及恶心等,两组比较无显著性差异(P>0.05)。结论与CHOP方案相比,DICE方案疗效较好,不良反应可以耐受,但是否可作为治疗中、高度恶性NHL的首选方案之一,值得进一步研究。

Background and purpose： CHOP regimen is the standard modality for the treatment of intermediate and high grade non-Hodgkin＇s lymphoma （ NHL）. Previous reports showed that DICE regimen might improve response rate of patients with intermediate and high grade NHL. This study compares the efficacy and safety of DICE and CHOP regimens in the treatment of this disease so that it could provide a rationale for evident-based treatment. Methods： A total of 74 patients with histopathologically proved intermediate or high malignant NHL were randomized into trial group （37 patients treated with DICE regimen） and control group （37 patients treated with CHOP regimen）. Survival analysis was performed by Kap- lan-Meier method, Results： The complete response rate, partial response rate, and total response rate were significantly higher in DICE group than in CHOP group （40.5% vs. 29.7%, 37.8% vs, 27.0%, and 78.3% vs. 56.7%, respectively, P 〈0.05）. The 1-, 3-, and 5-year survival rates were significantly higher in DICE group than in CHOP group （89. 2% vs. 81.2%, 76.0% vs. 52.6% %, and 46.7% vs. 36.4%, respectively, P 〈 0.05）. The major side effects were leucopenia, thrombocytopenia, and nausea in both groups, there were no significant differences in terms of morbidity or side effects in both groups. Three episodes of clinical cystitis or gross haematuria seem to be associated with the treatment by the DICE regimen. Conclusions： The results show higher efficacy of DICE regimen over CHOP regimen. DICE regimen may prolong survival time of patients with intermediate or highly malignant NHL.