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周萌萌,沈敏鹤,冯冠,阮善明.健脾方药治疗大肠癌术后患者随机对照试验的系统评价和Meta分析[J].浙江中西医结合杂志,2018,28(5):
健脾方药治疗大肠癌术后患者随机对照试验的系统评价和Meta分析
A Systematic Review and Meta-analysis of Randomized Controlled Trials:Postoperative Colorectal Cancer PatientsTreated with Invigorating Spleen Herbs
投稿时间:2017-06-16  修订日期:2017-10-06
DOI:
中文关键词:  健脾方药  大肠癌术后  随机对照试验  Meta分析
英文关键词:invigorating spleen herbs  postoperative colorectal cancer  randomized controlled trials  Meta analysis
基金项目:国家自然科学基金面上项目(81573902)、浙江省重大科技专项计划项目(2014C03036)、浙江省中医药科技计划(2015ZZ013、2014ZB029)
作者单位E-mail
周萌萌 浙江中医药大学 414078184@qq.com 
沈敏鹤* 浙江中医药大学附属第一医院 shenminhe@aliyun.com 
冯冠 浙江中医药大学第一临床医学院  
阮善明 浙江中医药大学附属第一医院  
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中文摘要:
      [目的]系统评价健脾方药治疗大肠癌术后患者的疗效和安全性。[方法]系统全面检索国内数据库(CNKI、VIP、CBM、万方)、国外数据库(Pubmed、Cochrane图书馆)及美国临床试验注册系统,检索截止日期为2017年3月9日。研究对象为大肠癌术后患者,干预措施及对照措施为健脾方药联合化疗与单用化疗。由两人独立提取资料,采用Cochrane协作网提供的质量评价标准及RevMan 5.3.5软件进行资料分析。结局效应指标为相对危险度(RR)或均数差(MD),均以95%可信区间表示。[结果]共纳入23个随机对照试验(共2036个研究对象),所纳入的文献质量普遍较低。汇总分析显示,健脾方药联合化疗与单用化疗相比,除了在红细胞减少方面差异无统计学意义(P>0.05),在临床疗、生存质量、毒副反应(白细胞减少、血小板降低、恶心呕吐、腹泻、周围神经毒性)方面,差异均具有统计学意义(P<0.05)。[结论]与单用化疗相比,健脾方药联合化疗对提高大肠癌术后临床疗效、生存质量,降低毒副反应存在优势,但仍需要进一步大样本严格设计的临床试验予以证实。
英文摘要:
      [Objective] To review systematically the curative effect and safety of invigorating spleen herbs on patients with postoperative colorectal cancer. [Methods]The domestic databases (CNKI, VIP, CBM, Wanfang), international databases (Pubmed, Cochrane Library) and American Clinical Trials Registration System were retrieved till Mar. 9, 2017. The randomized controlled trials (RCT) about the comparison in treatment of patients with invigorating spleen herbs combined with chemotherapy, chemotherapy alone were identified and included. The quality of included RCT extracted independently by two persons was reviewed according to recognized criterions provided by Cochrane Collaboration Network, and the effect was analyzed systematically and comprehensively by RevMan 5.3.5. The outcome index was relative risk (RR) or average difference (MD), both expressed as 95% confidence interval. [Results] There were totally 23 RCT included (involving 2036 patients). The methodological quality of included RCT was generally lower. The summary shows that compared with chemotherapy alone, invigorating spleenherbs combined with chemotherapy has statistical difference in recent effect, quality of life, toxicity (leukopenia, thrombocytopenia, nausea and vomiting, diarrhea, peripheral neurotoxicity) (P<0.05), but not in the reduction of red blood cell (P>0.05). [Conclusion] Compared with chemotherapy alone, invigorating spleen herbs combined with chemotherapy has advantages in improving the recent effect and quality of life, reducing toxicity after surgery of colorectal cancer, but more rigorous designed and large-sample clinical trials are needed for further confirmation.
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