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| 基于WHO-ICTRP的癌性疲乏临床对照试验现状分析与思考 |
| Current Status Analysis and Considerations of Controlled Clinical Trials on Cancer-Related Fatigue Based on WHO ICTRPJiaqi Di, Dongwei Yu, Kai Shi, Shuang Bian, Zhemin Feng, Yuejuan Feng* |
| 投稿时间：2025-09-04 修订日期：2025-12-12 |
| DOI： |
| 中文关键词: 癌性疲乏 临床对照试验 临床试验注册 |
| 英文关键词: |
| 基金项目:浙江省医药卫生科技计划(2024KY1343),培元计划培育基金(PYJH202309) |
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| 中文摘要: |
| 基于国际临床试验数据库（WHO-ICTRP）分析癌性疲乏（CRF）临床对照试验的注册特点，为该领域研究方向提供参考。方法：以“Fatigue”为检索词，检索WHO-ICTRP自建库至2025年4月12日关于CRF的临床对照试验，根据纳排标准提取相关信息并进行统计分析。结果：共纳入CRF临床对照试验419项，其中已完成的试验有217项（51.79%），正在进行的研究有66项（15.75%），暂未招募的有40项（9.55%），状态不明/终止/撤销/暂停的有96项（22.91%）；注册国家以美国最多（196项），中国位居第二（39项）。疾病分类排名前三的是乳腺癌128项（30.54%）、不限类型的癌症127项（30.31%）、血液系统的癌症34项（8.11%）。排在干预措施前五位的是运动疗法93次（22.20%）、药物疗法73次（17.42%）、身心疗法40次（9.55%）、远程医疗36次（8.59%）、中医传统疗法（不包括中药）30次（7.16%）。CRF评估工具主要有慢性疾病治疗功能评估疲劳量表（FACT-F)79次（18.29）、简短疲劳量表（BFI）62次（14.35%）等。结论：CRF的临床对照试验数量成波浪式增长，尤其是发达国家研究数量较多，我国在中医药干预方面的研究较为突出。未来研究应着重开发更加全面和客观的测量工具，并在不同癌种的CRF研究中提出个性化的治疗方案。 |
| 英文摘要: |
| Based on the analysis of the registration characteristics of cancer-related fatigue (CRF) clinical controlled trials in the World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP), this study provides references for future research directions. Method: Using "Fatigue" as the search term, controlled clinical trials related to CRF were retrieved and collected from the WHO-ICTRP database up to April 12, 2024. Information including registration time, country, trial completion status, disease type, interventions, and CRF assessment tools was extracted and analyzed statistically. Results: A total of 419 RCTs on CRF were included, with 217 (51.79%) completed, 66 (15.75%) ongoing, 40 (9.55%) not yet recruited, and 96 (22.91%) in unknown/terminated/paused states. The registration countries were dominated by the United States (196 trials) and China (39 trials). The top three disease categories were breast cancer (128 trials, 30.54%), unspecified cancer types (127 trials, 30.31%), and hematological cancers (34 trials, 8.11%). The top five intervention measures were exercise therapy (93 times, 22.20%), pharmacological therapy (73 times, 17.42%), mind-body therapy (40 times, 9.55%), telemedicine (36 times, 8.59%), and traditional Chinese medicine (excluding Chinese herbs) (30 times, 7.16%). The primary CRF assessment tools were the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACT-F) (79 times, 18.29%) and the Brief Fatigue Inventory (BFI) (62 times, 14.35%). Conclusion: The number of controlled clinical trials for CRF has shown a wave-like growth trend, with a higher number of studies conducted in developed countries. China has made notable progress in research on TCM-based interventions. Future research should prioritize the development of more comprehensive and objective measurement tools and propose personalized treatment strategies for CRF across different cancer types. |
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