中国非霍奇金淋巴瘤患者行利妥昔单抗联合CHOP方案化疗疗效与安全性的Meta分析

Effectiveness and Safety of Rituximab Plus CHOP Chemotherapy for Treating Non-Hodgkin Lymphoma Among Chinese People: A Meta-Analysis

目的系统评价中国非霍奇金淋巴瘤患者接受利妥昔单抗联合CHOP方案化疗的疗效与安全性。方法以"美罗华"、"利妥昔单抗"、"非霍奇金淋巴瘤"、"系统评价"、"meta分析"、"随机对照试验"为检索词,计算机检索中国期刊网全文数据库(1991-2010年)、中国生物医学文献数据库(1991-2010年)、维普数据库(1991-2010年)、万方数据库(1991-2010年),手工检索可纳入文献的参考文献及可以利用的综述,收集国内关于利妥昔单抗联合CHOP方案治疗非霍奇金淋巴瘤的随机对照临床试验,两名评价者独立依据纳入标准筛选文献,对纳入文献行方法学质量评价后提取数据,统计学分析采用RevMan4.2软件进行。结果共纳入4个随机对照试验,包括218例患者。Meta分析结果显示,利妥昔单抗联合CHOP方案化疗与单用CHOP方案比较,其完全缓解率(相对危险度1.32,95%可信区间1.01～1.73)和总有效率(相对危险度1.22,95%可信区间1.04～1.44)差异有统计学意义,主要的化疗相关不良反应(白细胞下降、血小板下降、恶心呕吐、肝损害)的发生率差异无统计学意义。结论国内目前有限的证据表明,与单用CHOP方案相比,联合应用利妥昔单抗能提高中国非霍奇金淋巴瘤患者的完全缓解率和总有效率,同时并不增加治疗的不良反应。但由于纳入的研究样本量较小,随机试验的总体质量不高,以上结论尚有待于更多大样本、设计完善、实施良好的前瞻性随机双盲对照试验进一步证实。

Objective To assess the effectiveness and safety of Rituximab plus CHOP chemotherapy for treating non-Hodgkin lymphoma among Chinese people. Methods Using the words ＂Rituximab＂, ＂non-hodgkin lymphoma＂, ＂systematic review＂, ＂meta-analysis＂, ＂randomized controlled trial＂ as searching words, we searched CNKI（1991-2010）, CBM（1991-2010）, VIP（1991-2010） and WANGFANG（1991-2010） databases. We also hand searched the relevant references of included studies and review. Randomized controlled trials performed in China on rituximab plus CHOP chemotherapy for treating non-Hodgkin lymphoma were collected. Two reviewers independently screened trails,evaluated the quality of included trials and extracted data. The Cochrane Collaboration？s RevMan 4.2 software was used for statistical analysis. Results Four trails involving 218 patients were included. Results of meta-analyses showed that significant differences were found in the total effective rate （RR=1.22, 95%CI 1.04～1.44） and complete remission rate （RR=1.32, 95%CI 1.01～1.73）, but not in the major chemotherapy-related adverse reactions （leukocytopenia, thrombocytopenia, nausea/vomiting, liver-damage） between rituximab plus CHOP and CHOP alone. Conclusion Based on the present domestic trails, compared with CHOP chemotherapy, treatment for non-Hodgkin lymphoma with Rituximab plus CHOP chemotherapy can improve the total effective rate and the complete remission rate and meanwhile it doesn？t increase the adverse reactions. However, because of the low quality and small sample of included RCTs, more large-sample, well-designed, exactly-performed, double-blind, randomized and controlled trials are still required.