中医药治疗乳腺癌随机对照试验结局指标分析

目的] 分析近5年发表的中医药治疗乳腺癌随机对照试验的结局指标，为乳腺癌临床试验的核心指标集构建奠定基础。方法] 检索Cochrane Library、Pubmed、Embase、Web of Science、SinoMed、万方数据和中国知网（CNKI）数据库，收集中医药干预乳腺癌的随机对照试验（RCT）。检索时间为2014年1月—2019年10月。由两名研究者严格根据纳入排除标准独立进行文献筛选、资料提取，如有分歧，经第3方讨论决定。结果] 共纳入112篇RCT，包含9 430位患者，共涉及61个结局指标。单个研究采用的指标数为1~7个，平均为3个。指标使用频次排前15位的依次为：临床疗效、不良反应、生活质量、肿瘤标志物、生存情况、免疫功能指标、安全性评价、复发转移情况、中医证候积分、中医证候疗效、中医症状积分、血管生成指标、体力状况、骨髓抑制、睡眠质量。指标存在问题主要包括：终点指标过少、缺乏对指标长期效应的测量、指标组合过于随意、指标测量时间与方法差异性大、指标表达不规范，缺少经济学指标等。结论] 中医药治疗乳腺癌RCT在指标选择、指标测量和表达等方面存在差异大、不规范等问题，需要开展乳腺癌核心指标集研究，以提高相关临床研究的价值。

Outcome measures analysis of ranomized controlled trials in traditional Chinese medicine treating breast cancer

Objective] To analyze the outcomes of randomized controlled trials (RCTs)of traditional Chinese medicine (TCM) for breast cancer published in the past 5 years, and to provide fundamental data for building the Core Outcome Sets(COS) of breast cancer using TCM treatment. Methods] Databases of Cochrane Library, Pubmed, Embase, Web of Science, SinoMed, Wanfang Data and CNKI were retrieved to collect RCTs of breast cancer using TCM intervention. The time limit is from January 2014 to October 2019. Two researchers independently conducted literature screening and data extraction based on inclusion and exclusion criteria. Disagreements were resolved by discussion. Results] A total of 112 RCTs were included, including 9 430 patients and 61 outcome measures. The number of outcomes used in a single study ranged from 1 to 7, with an average of 3. The top 15 outcomes were clinical efficacy, adverse events, quality of life, tumor markers, survival, immune function indicators, safety evaluation, recurrence and metastasis, TCM syndrome scores, TCM syndrome efficacy, TCM symptom score, angiogenesis index, physical condition, myelosuppression, sleep quality. Problems with reported outcomes mainly includetoo few end-point indicators, lack of measurement of long-term effects, too arbitrary combination of indicators, large differences in measurement time and methods of indicators, irregular expression of indicators, inconsistent selection of indicators, lack of TCM characteristic indicators and economic indicators. Conclusion] Outcomes reported in RCTs of TCM for breast cancer vary greatly, with a lack of standardization in the selection of indicators, measurement of indicators, and expression. It is necessary to carry out research on COS of TCM for treating breast cancer to improve the methodological quality and clinical research value.