Status Quo Analysis of Outcome Indexes and Evaluation Tool in Treatment of Skin Rash Caused by EGFR-TKI with Traditional Chinese Medicine
- VernacularTitle: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
- Author:
Xueqi TIAN
1
;
Zhe WANG
;
Lijing JIAO
;
Yabin GONG
;
Ling XU
Author Information
- Keywords: EGFR-TKI; Skin rash; Randomized controlled trial; Outcome indicator; Core outcome index set
- From: World Science and Technology-Modernization of Traditional Chinese Medicine 2023;25(6):2147-2158
- CountryChina
- Language:Chinese
- Abstract: 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.
