中医药治疗EGFR-TKI相关皮疹结局指标及评价工具的现状分析  

Status Quo Analysis of Outcome Indexes and Evaluation Tool in Treatment of Skin Rash Caused by EGFR-TKI with Traditional Chinese Medicine

作　　者：田雪琪 王喆 焦丽静 龚亚斌[1] 许玲[1,3] Tian Xueqi;Wang Zhe;Jiao Lijing;Gong Yabin;Xu Ling(Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Tranditional Chinese Medicine,Shanghai 200437,China;Institute of Tumor Transformation of Integrated Chinese and Western Medicine,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China;Tumor disease Project Team,China Evidence-based Medicine Center of Traditional Chinese Medicine,Shanghai 200437,China)

机构地区：[1]上海中医药大学附属岳阳中西医结合医院,上海200437 [2]上海中医药大学附属岳阳中西医结合医院中西医结合肿瘤转化研究所,上海200437 [3]中国中医药循证医学中心肿瘤疾病项目组,上海200437

出　　处：《世界科学技术-中医药现代化》2023年第6期2147-2158,共12页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：上海申康医院发展中心重大临床研究项目(SHDC2020CR1052B):益气养阴解毒方联合化疗治疗EGFR敏感突变晚期肺腺癌的TKI耐药后的随机对照双盲研究,负责人:许玲;上海市科学技术委员会科技计划项目(20Y21902000):益气养阴法联合EGFR-TKI靶向治疗IV期肺癌优势人群的前瞻性研究,负责人:许玲。

摘　　要：目的分析中医药治疗表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)相关性皮疹随机对照试验(RCT)中结局指标的使用情况。方法检索7个数据库,按照纳排标准筛选文献,汇总结局指标进行分类、频次统计与分析。结果初检出2241篇文献,最终纳入40篇。按功能属性分为症状/体征(37.97%)、生活质量(17.65%)、安全性评价(13.37%)、中医症状/证候(16.58%)、远期预后(1.60%)、血生化指标(9.09%)、其他(3.74%)七个指标域。目前中医药治疗EGFR-TKI相关皮疹的临床试验偏倚风险较高;测量时点差异大,缺乏考虑皮疹严重程度;复合结局指标、安全性评价的报告过度简化;缺乏治疗时间窗和全程观察;皮疹分级标准缺乏统一性;生活质量评价工具的功能相对单一。结论目前中医药治疗EGFR-TKI相关皮疹RCT结局指标的使用尚不规范,未来应推广采用国际标准的评价工具,同时构建具有中医治疗特色的症候核心指标集。Objective To analyze the outcome indexes selected in the randomized controlled trials(RCTs)on traditional Chinese medicine(TCM)for skin rash caused by EGFR-TKI.Methods Seven databases were researched and the literature was screened according to the inclusion and exclusion criteria,then summarize and categorize outcome indexes to calculate frequency of outcomes and analyze.Results 46 out of 2241 papers were included.The outcome indexes of 40 RCTs were mainly divided into seven categories,that is physical symptoms/signs(37.97%),quality of life(17.65%),safety indicators(13.37%),traditional Chinese medicine symptoms/syndromes(16.58%),long-term prognosis(1.60%),blood biochemical index(9.09%)and others(3.74%).Problems as follow:First,there is a high risk of clinical trial bias in the treatment of EGFR-TKI-associated rash with TCM.Besides,the measurement time points was largely different with the severity of rash not considered.What's more,oversimplify the reports of compound outcome indicators and safety evaluation,lack of treatment time window and full process observation.Last,grading criteria for rash were inconsistent and the function of quality of life assessment tool was relatively simple.Conclusion At present,the use of outcome indicators has not been standardized in the RCTs for skin rash related EGFR-TKI by TCM,and relevant construction work should be carried out in the future to build a core index set with the characteristics of TCM treatment.

关 键 词：EGFR-TKI 皮疹 随机对照试验 结局指标 核心指标集 

分 类 号：R-058[医药卫生]