养正消积胶囊联合化疗治疗消化道恶性肿瘤疗效和安全性的Meta分析  

Efficacy and safety of Yangzhengxiaoji capsule combined with chemotherapy for malignant digestive tract tumor:a meta-analysis

作　　者：张立双 金鑫瑶 张俊华 杨丰文 张明妍 赵宏杰 李越 季昭臣 

机构地区：[1]天津中医药大学循证医学中心,天津300193

出　　处：《中国循证医学杂志》2018年第1期59-66,共8页Chinese Journal of Evidence-based Medicine

基　　金：教育部新世纪优秀人才项目(编号:NCET-13-0936);天津市青年拔尖人才计划项目(编号:201504)

摘　　要：目的系统评价养正消积胶囊联合化疗治疗消化道恶性肿瘤的有效性和安全性。方法计算机检索CNKI、WangFang Data、PubMed、EMbase、SinoMed、The Cochrane Library数据库,搜集养正消积胶囊联合化疗治疗消化道恶性肿瘤的随机对照试验(RCT),检索时限均为建库至2017年11月20日。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果共纳入15个RCT。Meta分析结果显示:与化疗比较,养正消积胶囊联合化疗治疗消化道恶性肿瘤的疾病控制率[RR=1.26,95%CI(1.07,1.49),P<0.000 01]、中医证候临床疗效[RR=1.71,95%CI(1.50,1.96),P<0.000 01]、患者生活质量[RR=1.44,95%CI(1.13,1.82),P=0.003]均优于单纯化疗,且可改善患者免疫功能,降低不良反应发生。结论化疗基础上加用养正消积胶囊治疗消化道恶性肿瘤,在疾病控制、中医证候疗效、生活质量及改善免疫功能方面均优于单纯化疗。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。Objectives To systematically review the efficacy and safety of Yangzhengxiaoji capsule combined with chemotherapy for malignant digestive tract tumor. Methods CNKI, WanFang Data, PubMed, EMbase, SinoMed and The Cochrane Library databases were searched online to collect randomized controlled trials （RCTs） of Yangzhengxiaoji capsule combined with chemotherapy for malignant tumor of digestive tract from inception to November 20th, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed using ReMan 5.3 software. Resluts A total of 15 RCTs were included. The results of meta-analysis showed that： compared with the chemotherapy alone, Yangzhengxiaoji capsule combined with chemotherapy could significantly improve the disease control rate （RR=1.26, 95%CI 1.07 to 1.49, P〈 0.000 01）, the clinical efficacy of TCM syndrome （RR=l.71, 95%CI 1.50 to 1.96, P〈0.000 01）, and the quality of life scores of patients （RR=l.44, 95%CI 1.13 to 1.82, P=0.003）. The combination therapy could also improve the immune function of patients and reduce the incidence of adverse reactions. Conclusions Current evidence shows that chemotherapy combined with Yangzhengxiaoji capsule is superior to chemotherapy alone for disease control of malignant tumor of digestive tract, clinical efficacy of TCM syndrome, the quality of life, and improving immune function. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.

关 键 词：养正消积胶囊 消化道 恶性肿瘤 系统评价 META分析 随机对照试验 

分 类 号：R735[医药卫生—肿瘤]