国内癌因性疲劳中医药相关临床试验注册现状分析

目的 通过分析中国临床试验注册中心(Chinese clinical trial registry，ChiCTR)注册的与中医药干预癌因性疲劳(cancer-related fatigue，CRF)相关的临床试验，探讨其试验注册现状。方法 检索ChiCTR数据库收录的从建库至2022年6月2日与中医药相关的CRF临床研究注册试验，对检索结果进行筛选并提取所需数据信息，运用WPS Office软件的表格功能对纳入研究数据进行统计分析，并归纳临床试验特征。结果 最终纳入36项CRF中医药相关临床试验，覆盖全国6个省、3个直辖市，其中包括干预性研究34项，观察性研究2项，招募样本量5 327例，干预措施包括内服药物疗法、中药注射液、外治法和中医传统功法。结论 目前有关CRF中医药临床试验注册数量总体呈上升趋势，试验以随机对照试验(randomized controlled trial, RCT)研究居多，干预性研究为主，其空间分布欠均衡，且注册信息的严谨性与结局指标的规范性待进一步提高。

Analysis on Current Status of Clinical Trials Registration of TCM for Cancer Related Fatigue in China

Objective To investigate the status quo of clinical trials on TCM intervention with cancer-related fatigue(CRF) registered in Chinese clinical trial registry(ChiCTR). Methods The CRF clinical research registration trials related to TCM included in ChiCTR database were searched from the establishment of the database to June 2, 2022, and the search results were screened and the required data information was extracted. The selected data were statistically analyzed by using the form function of WPS Office software, and the characteristics of clinical trials were summarized. Results A total of 36 TCM related clinical trials of CRF were included, covering 6 provinces and 3 municipalities in China, including 34 intervention studies and 2 observational studies, with a sample size of 5327 patients. Intervention measures included Chinese medicine oral therapy, Chinese medicine injection, external treatment and traditional Chinese medicine Gongfa. Conclusion The number of CRF TCM clinical trials registered is generally on the rise, and the trials are mostly randomized controlled trials(RCTs), mainly intervention studies. Their spatial distribution is not balanced, and the rigor of registration information and the standardization of outcome indicators need to be further improved.