目的：对中药注射液治疗晚期乳腺癌的文献进行质量评价，明确中药注射液治疗晚期乳腺癌的疗效及存在的问题。方法：选择“万方数据库”（1989-2013）及“中国知网”（1979-2013），以“晚期乳腺癌”、“转移性乳腺癌”、“随机”、“对照”为检索词，对1979年1月-2013年12月期刊发表的随机对照临床试验文献进行检索。对纳入文献的随机方法、分配隐藏、诊断标准、疗效判定标准、组间均衡性、盲法、随访、依从性及统计方法等方面进行评价。结果：符合纳入标准的文献共20篇。缺乏多中心临床研究，有明确诊断标准2篇（10%）；有明确疗效判定标准的16篇（80%）；做组间均衡性比较11篇（55%）；正确使用随机分配方法的6篇（30%）；所有文献均未描述对受试对象的依从性检测；有随访记录的2篇（10%）；正确使用统计方法15篇（70%），确切给出检验值的5篇（20%）；所有文献均报道了不良反应。结论：中药注射液治疗晚期乳腺癌的研究中，40%及60%的文献分别指出中药注射液联合化疗在总有效率及生活质量评分方面优于单纯化疗组，但缺乏多中心研究，诊断标准不明确，随机、分配隐藏和随访、依从性等有关研究方案质量的评价较低。%Objective:To observe the efficacy and analyze the problem of Chinese traditional medicine injection (CMI)therapy for advanced breast cancer by quality evaluation of literature.Method:The randomized controlled clinical trials published in the journals from January 1998 to December 2013 were searched by using"advanced breast cancer "," metastatic breast cancer "," random " and " control " as the search words from" WANFANG data"(1989-2013)and"CNKI.NET"(1979-2013)database. The collected literature were analyzed and evaluated according to randomization,allocation concealment,diagnostic criteria,efficacy criteria,baseline comparability,follow-up,compliance and statistical methods.Result:There were 20 articles met the inclusion criteria,2 articles(10%)with clear diagnostic criteria;16 articles(80%)with efficacy criteria;11 articles(55%)with balanced comparison between groups,6 articles(30%)with proper randomized controlled method;none of the articles described the compliance;2 articles(10%)with follow-up record;15 articles(70%)with clear statistical methods but only 5 articles(20%)showed exact test value. All the literature reported adverse reactions.Conclusion:40%and 60%of the literatures,respectively, pointed out CMI combined with chemotherapy was superior to chemotherapy alone group in total effective rates and quality of life. CMI therapy for advanced breast cancer is lack of multi-center study with efficacy assessment and low quality of research program.
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