中药预防肿瘤化疗后白细胞减少症随机对照试验的系统评价及Meta分析  

Treatment of Chemotherapy-induced Leucopenia in Patients with Malignant Tumor by Chinese Herbal Medicine: a Systematic Review and Meta-analysis of Randomized Clinical Trials

作　　者：李华[1] 马箐[1] 艾萍[1] 张惠敏[2] 马立新[1] 

机构地区：[1]河北大学公共卫生学院营养与食品卫生教研室,河北071000 [2]北京中医药大学基础医学院医学综合课程教学中心,北京100029

出　　处：《中国中西医结合杂志》2015年第2期157-166,共10页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：河北大学校内基金资助项目(No.2013-264)

摘　　要：目的评价中药预防肿瘤化疗后白细胞减少症的临床疗效和安全性。方法检索中文数据库(CNKI、VIP、CBM、万方数据)及英文数据库(Medline、Cochrane Library),检索截止日期为2013年9月。研究对象为已确诊肿瘤等待化疗的患者,干预措施及比较类型为:化疗加中药与化疗加安慰剂比较、化疗加中药与单纯化疗比较、化疗加中药与化疗加升白细胞西药比较的预防白细胞减少症的随机、对照试验(randomized clinical trials,RCTs),化疗加升白西药加中药与化疗加升白西药比较的RCTs也被纳入。结局指标为外周血白细胞计数、白细胞减少发生率及不良反应等。采用Cochrane协作组织制定的偏倚风险评价标准对纳入研究的文献质量(包括随机化、分配、隐藏、盲法、退出与失访)进行评价,使用Rev Man5.2软件对资料进行汇总分析。结果 87个以中文发表的RCTs(共8 468个研究对象)被纳入研究。除2篇文献质量较高外,其余RCTs均未能准确报告随机、方案隐藏、盲法、脱落或失访、样本量估算等。汇总分析显示,与单纯应用化疗药比较,中药作为辅助疗法预防肿瘤化疗后白细胞减少症,可提高化疗后白细胞计数水平[MD 0.64×109/L(0.41,0.88),P<0.01]。复方阿胶浆、地榆升白片、具有健脾补肾作用的中药复方等在化疗过程中的辅助应用可以提高患者外周血白细胞计数水平,降低白细胞减少症的发生率。结论中药可能具有潜在的预防肿瘤化疗后白细胞减少症的疗效,但还需进一步开展高质量的试验加以证实。Objective To assess the effectiveness and safety of traditional Chinese herbal medi- cine （TCHM） for chemotherapy-induced leucopenia in patients with malignant tumor. Methods Chinese database （CNKI, VIP, CBM, Wanfang Database） and English database （Medline, Cochrane Library） were retrieved with the deadline of September 2013. Participants were cancer patients confirmed by pa- thology waiting for chemotherapy. We included randomized clinical trials （RCTs） testing chemotherapy plus TCHM vs chemotherapy plus placebo, chemotherapy alone, conventional treatment, or TCHM plus chemotherapy combined with conventional treatment vs chemotherapy combined with conventional treatment. The primary outcomes were WBC count, leucopenia incidence, and adverse reactions. Assessments of methodological quality, including randomization, allocation, concealment, blindness, droppingout, loss of follow-ups were also conducted according to the Cochrane Handbook for Systematic Review of Interventions. Meta-analysis was performed using RevMan5.2 Software provided by Cochrane Collabo-ration. Results Eighty-seven RCTs （ involving 8 468 patients） were included. All these studies were pub- lished in Chinese. Of these only two papers were of high quality. Methods of randomization, scheme concealment, blindness, dropping-out, loss of follow-up, samples estimation were not accurately reported in the rest RCTs. The pooled results of WBC count showed that chemotherapy combined with TCHM was generally better than chemotherapy alone E MD =0.64 x 109/L （0.41,0.88）, P 〈0.01 ]. Auxiliary treat- ment of Compound Ejiao Syrup, Diyu Shengbai Tablet, Chinese compounds for invigorating Pi and sup- plementing Shen during the chemotherapeutic course could elevate peripheral blood WBC counts, and decrease the incidence of leucopenia. Conclusion Chinese herbal medicine might have potential effects in preventing the occurrence of leucopenia, which need to be confirmed by launching higher quality clinical trials.

关 键 词：白细胞减少症 中药 化学疗法 荟萃分析 

分 类 号：R730.53[医药卫生—肿瘤]