中药注射剂治疗非小细胞肺癌临床试验结局指标文献研究

目的]分析中药注射剂治疗非小细胞肺癌随机对照试验(RCT)的结局指标,为构建肺癌临床试验的核心指标集提供基础。方法]计算机检索中国知网数据库(CNKI),万方数据(WanFang),维普数据库(VIP),中国生物医学文献服务系统(SinoMed),Embase,Cochrane library,Web of Science和PubMed 8个数据库。以2018年发表的文献为样本,由2位作者严格按照纳入与排除标准独立筛选文献、提取资料,如有分歧,经讨论解决。结果]纳入94个RCT研究中共包含8450位患者,共采用64种结局指标。单个研究指标数量最少为1个,最多达10个,平均每个研究结局指标的数量为3.3个。使用频次排前10位的结局指标依次为:临床疗效、不良反应、生活质量、免疫功能、肿瘤标志物水平、卡氏(KPS)评分、毒副作用、T细胞亚群变化、中医证候积分、总生存期。94个RCT研究普遍存在结局指标临床相关性差、缺少中医药特色指标、指标组合随意、指标测量时点多样、时间跨度较大、指标测量工具不一致等问题。结论]中医药治疗非小细胞肺癌临床试验结局指标存在较多问题,需要建立核心指标集提高相关临床研究质量。

Literature review of outcome in clinical trials of traditional Chinese medicine injections for non-small cell lung cancer

Objective] To analyze the outcome measures of randomized controlled trials (RCTs) of Chinese herbal injections for non-small cell lung cancer (NSCLC),so as to provide a basis for the establishment of a core outcome set for clinical trials of lung cancer. Methods] The 8 databases including CNKI,WanFang,VIP,SinoMed,Embase,Cochrane Library,Web of Science and PubMed were searched electronically. Two authors independently screened the literatures and extracted the data in strict accordance with the inclusion and exclusion criteria from literatures published in 2018. Any differences were discussed and resolved. Results] A total of 8 450 patients were included in 94 RCTs,retrieving a total of 64 outcome measures. The number of outcomes from a single study ranged from 1 to 10,with an average number of outcomes at 3.3. The top 10 outcome measures frequently used were clinical efficacy,adverse events,quality of life,immune function,tumor marker level,KPS score,toxicity and side effects,T cell subpopulation change,traditional Chinese medicine(TCM) syndrome score and overall survival. Among the 94 RCT studies,there were existing problems such as poor clinical correlation of outcome measures,lack of TCM characteristic outcomes,random combination of outcomes,diverse measurement time points,large time span and inconsistent measurement tools. Conclusion] There are problems seen in outcomes reported in clinical trials of non-small cell lung cancer for TCM,hence it is necessary to establish a set of core indexes to improve the quality of relevant clinical studies.