中医药联合化疗治疗胃癌术后的Meta分析

Meta-Analysis of Traditional Chinese Medicine Plus Chemotherapy in Treatment of Postoperative Gastric Cancer

检索中国期刊全文数据库、维普中文期刊数据库、万方学术期刊全文数据库2001.01至2010.12国内10年间的相关文献,收集中医药联合化疗治疗胃癌术后的随机对照试验(RCTs)。按纳入排除标准筛选试验、评价研究质量、提取有效数据,并采用RevMan 5.0软件进行统计分析。最终纳入21个RCT,Meta分析结果显示,①KPS评分:共有10个RCT报告,分类变量5个RCT之间无异质性,KPS评分[RR=2.35,95%CI(1.78,3.10),P<0.01],差异有统计学意义;连续变量5个RCT之间无异质性,KPS评分[SMD=0.69,95%CI(0.46,0.92),P<0.01],差异有统计学意义;②免疫功能:共纳入5个RCT,各研究存在异质性,采用随机效应模型,CD3[SMD=1.11,95%CI(0.64,1.58),P<0.01],CD4[SMD=1.07,95%CI(0.52,1.62),P=0.01],CD4/CD8[SMD=1.14,95%CI(0.39,1.89),P=0.003],差异均有统计学意义;③生存率:共纳入3个RCT,各研究无异质性,故采用固定效应模型,1年生存率[RR=1.10,95%CI(1.01,1.21),P=0.04],2年生存率[RR=1.29,95%CI(1.11,1.50),P=0.01],3年生存率[RR=1.43,95%CI(1.15,1.76),P=0.01],差异均有统计学意义;④胃肠道反应:共纳入5个RCT,各研究组无异质性,采用固定效应模型,Ⅱ度以上食欲下降[RR=0.58,95%CI(0.45,0.75),P<0.01],Ⅱ度以上恶心呕吐[RR=0.48,95%CI(0.34,0.66),P<0.01],差异均有统计学意义;⑤血细胞毒性:共纳入7个RCT,各研究无异质性,采用固定效应模型,Ⅱ度以上白细胞减少[RR=0.26,95%CI(0.18,0.37),P<0.01],Ⅱ度以上血红蛋白下降[RR=0.38,95%CI(0.25,0.58),P<0.01],Ⅱ度以上血小板下降[RR=0.35,95%CI(0.14,0.88),P=0.03],差异均有统计学意义。中医药联合化疗治疗胃癌术后有效,可以改善KPS评分,提高免疫功能和生存率,减轻胃肠道反应和血细胞毒性。但由于本系统评价纳入研究的方法学质量较低,尚需开展更多设计合理、执行严格的多中心大样本且随访时间足够长的随机对照试验验证其疗效及安全性。

To evaluate the efficacy and safety of traditional Chinese medicine .（TCM） in treating postoperative gastric cancer. We searched CNKI,VIP,WanFang （2001 to 2010） for randomized control trials about traditional Chinese medicine plus chemotherapy in the treatment of postoperative gastric cancer. Trial screening, quality assessment of included trials, and data extract were conducted. Statistical analysis was conductedby using RevMan 5.0 software. A total of 21 randomized controlled trials were included, meta analysis showed, （!） KPS score has 10 RCTs. 5 RCTs of classification variables no heterogeneity, KPS score [RR =2.35,95% CI（ 1.78, 3.10） ,P 〈 0. 01 ] , 5 RCTs of continuous variables no heterogeneity, KPS score [ SMD = 0.69,95% CI （0.46, 0.92） ,P 〈0.01 ] ,the differences are significant. ① Immune function 5 RCTs have heterogeneity and use random effects model. CD3[ SMD = 1.11,95% CI（0.64,1.58） ,P 〈0.01 ] CD4 [ SMD = 1.07,95% CI（0.52,1.62） ,P =0.01 ], CD4/CD8 [ SMD = 1. 14,95% CI（0. 39,1.89）,P=0, 003 ]. The difforanes are signifiant.③ Survival 3 RCTs have no heterogeneity, and use fixed effects modal, One year survival rgte is [ RR = 1.10,95% CI（ 1, 0, 1.21 ） ,P =0.04] ,2 year survival rate[ RR = 1.29,95% CI（1.11,1. 50） ,P =0. 01 ] ,3 year survival rate[ RR= 1.43,95% CI（ 1.15,1.76）, P =0.01 ]. The differences are significant. ④ Gastrointestinal reaction 5 RCTs have no heterogeneity, and use fixed effects model. Bad appetite above II degrees is [ RR = 0. 58,95% CI（0. 45, 0. 75） ,P 〈 0.01 ], Nausea and vomiting above II degrees are [ RR = 0. 48,95% CI （0. 34, 0. 66 ）, P 〈 0. 01 ]. The differences are significant. ⑤ Blood toxicity 7 RCTs have no heterogeneity, and use fixed effects model. Leucopenia reduce above lI degrees [ RR = 0, 26 , 95 % CI （0. 18,0.37 ）, P 〈 0.01 ], HB reduce above lI degrees [RR=0. 38,95%CI（0. 25,0.58）,P〈0.01],PLT reduce above II degrees [RR=0.35,95%CI（0.14,0.88）, P = 0. 03 ]. The differences are significant, Traditional Chinese medicine plus chemotherapy is effective in curing postoperative gastric cancer. It can improve KPS scre, immune function and survival rate, and reduce gastrointestinal reaction and blood toxicity. But the quality randomized trials are needed. of studies is low, more large-scale multi-center randomized trials are needed.