ProMACE-CytaBOM方案与CHOP方案治疗非霍奇金淋巴瘤的随机对照研究

背景与目的:CHOP方案一直是治疗中、高度恶性非霍奇金淋巴瘤(non鄄Hodgkin蒺slymphoma,NHL)的基本方案,近年有文献报道ProMACE鄄CytaBOM方案可以提高中、高度恶性NHL的完全缓解(completeresponse,CR)率及生存率。本研究中我们比较ProMACE鄄CytaBOM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:选择经病理组织学证实的中、高度恶性NHL的患者146例,随机分为ProMACE鄄CytaBOM组和CHOP组两组,分别采用上述两种方案治疗。两组生存率采用Kaplan鄄Meier法分析,组间比较采用χ2检验。结果:ProMACE鄄CytaBOM组CR29例(39.7%),部分缓解(partialresponse,PR)28例(38.4%),缓解率(responserate,RR,CR+PR)为78.1%(57/73);CHOP组CR23例(31.5%),PR21例(28.8%),RR为60.3%(44/73);两组比较有显著性差异(P<0.05)。ProMACE鄄CytaBOM组患者1、3、5年生存率分别为89.3%、76.2%和45.7%,CHOP组分别为82.1%、51.4%和32.3%,两组比较有显著性差异(P<0.05)。两组出现的主要不良反应是白细胞下降、血小板下降及恶心等,两组比较无显著性差异(P>0.05)。两组各有1例治疗相关性死亡病例。结论:与CHOP方案相比,ProMACE鄄CytaBOM方案疗效较好,不良反应可以耐受,可作为治疗中、高度恶性NHL的

Clinical randomized comparative trial of ProMACE-CytaBOM regimen and CHOP regimen in treating non-Hodgkin's lymphoma

BACKGROUND & OBJECTIVE: CHOP regimen is the routine modality for mod erately or highly malignant non-Hodgkin's lymphoma (NHL). Previous reports show that ProMACE-CytaBOM regimen could elevate complete response rate and survival r ate of patients with moderately or highly malignant NHL. This study was to compa re efficacies and safeties of ProMACE-CytaBOM and CHOP regimens in treating this disease, to indicate the standard treatment for it. METHODS: A total of 146 pat ients with moderately or highly malignant NHL, verified by pathology or histolog y, were randomized into trial group (73 patients treated with ProMACE-CytaBOM re gimen) and control group (73 patients treated with CHOP regimen). Survival rate was analyzed by Kaplan-Meier method. Chi-square test was performed between group s. RESULTS: The complete response rate, partial response rate, and response rate was significantly higher in ProMACE-CytaBOM group than in CHOP group (39.7% vs. 31.5%, 38.4% vs. 28.8%, and 78.1% vs. 60.3%, respectively, P < 0.05). The 1-, 3 -, and 5-year survival rates were significantly higher in ProMACE-CytaBOM group than in CHOP group (89.3% vs. 82.1%, 76.2% vs. 51.4%, and 45.7% vs. 32.3%, respe ctively, P < 0.05). The major side effects, appeared with no differences (P > 0. 05) in incidences between 2 groups, were leukopenia, thrombocytopenia, and nause a. Each group had 1 case of treatment-related death. CONCLUSIONS: The results sh ow higher efficacy of ProMACE-CytaBOM regimen over CHOP regimen. ProMACE-CytaBOM regimen may prolong survival time of patients with moderately or highly maligna nt NHL.