利妥昔单抗治疗B细胞非霍奇金淋巴瘤系统评价

A systematic review of rituximab for B-cell non-Hodgkin's lymphoma

目的：采用Cochrane系统评价方法评价利妥昔单抗联合化疗治疗B细胞淋巴瘤的有效性和安全性。方法：根据循证医学的原则,采用Cochrane系统评价的方法,计算机检索Cochrane图书馆（issue 2,2013）,MEDLINE（1966—2013.6）,EMBASE.com（1980—2013.6）,Science Citation Index（1945—2013.6）,Google及中国生物医学文献数据库（CBMdisc）（1980—2013.6）,中国期刊全文数据库（1994—2013.6）和中文科技期刊全文数据库（1994—2013.6）,检索当前在研数据库和会议论文集等灰色文献数据库,并手检国内外相关杂志和文献的参考文献。纳入随机对照试验。由2名研究员独立进行文献纳入、质量评价、数据提取。异质性检验（χ^2检验）P值≤0.1,应用随机效应模型;反之,应用固定效应模型。二分类变量（binary variable）资料效应量采用相对比（relative risk,RR）（95%可信区间）表示。采用Revman 5.0和和STATA11.0软件相关数据统计分析。结果：检索到相关文献2 498篇。查阅全文后,12个随机对照试验（包括4 939例患者）符合纳入标准进入系统评价。利妥昔单抗联合化疗组的总反应率优于单纯化疗组（RR1.20,95%CI 1.12-1.28,P〈0.05）。利妥昔单抗联合化疗组的2年总生存率优于单纯化疗组（RR1.10,95%CI 1.07-1.13,P〈0.05）。结论：利妥昔单抗联合常规化疗对B细胞淋巴瘤患者治疗有益,但不良反应相对较多。

OBJECTIVE To assess the efficacy and safety of rituximab combined with routine chemotherapy in the treatment of B-cell lymphoma according to Cochrane systematic review method.METHODS According to the methods recommended by the Cochrane Collaboration,we searched Cochrane library（issue 2,2013）,MEDLINE（1966—2013.6）,EMBASE.com（1980—2013.6）,Science Citation Index（1945—2013.6）,Google search,CBM（1980—2013.6）,CNKI（1994—2013.6）,VIP（1994—2013.6）,ongoing clinical trials database,and conference abstracts database.We also hand-searched the key domestic and international journals related to the field.All the randomized controlled trials were included in the systematic review.Two reviewers independently screened the retrieved papers,assessed the quality and extracted data using a standard form.Heterogeneity was assessed by（2test.Random-effect model was used if the P value of statistical heterogeneity test was ≤0.1,otherwise,fixedeffects model was used.The binary outcomes were expressed as relative risk（RR）with 95% Confidence Intervals（CI）.All the analysis was carried by RevMan5.0and STATA11.0.RESULTS We retrieved 2498 papers.After reading the full texts,12 randomized controlled trials（including 4939 patients）met the eligible criteria.Our results showed that rituximab combined with routine chemotherapy improved overall response rate（RR1.20,95% CI 1.12-1.28,P0.05）,and also the 2-year overall survival rate（RR1.10,95% CI 1.07-1.13,P〈0.05）.CONCLUSION The therapy of rituximab in combination with routine chemotherapy is superior to chemotherapy alone in patients with B-cell non-Hodgkin＇s lymphoma but with more adverse effects.