摘要
该研究系统梳理中医药防治结直肠癌(CRC)的相关文献,旨在以更直观简洁的方式展示现有证据全貌。计算机检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)四大中文数据库,纳入中医药防治CRC的随机对照试验(RCT),检索时间为建库至2023年8月1日,采用文字与图表相结合的方式进行证据展示。共纳入1 778篇RCTs,发文量整体呈上升趋势。RCT质量普遍较低,样本量集中在60~100例;疗程以4、12、8周为多;关键词主要聚焦于结直肠癌晚期、结直肠癌术后、免疫功能和胃肠功能等;并发症多由手术或放化疗引起,包括肠梗阻、周围神经病变、腹泻和焦虑抑郁等。干预措施种类繁多,主要包括中药汤剂、中药注射剂、中医护理、中成药和针刺等,其中中药汤剂(自拟方除外)以参苓白术散(32篇,1.80%)、四君子汤(22篇,1.24%)等为主,中药注射剂以复方苦参注射液(54篇,3.04%)、艾迪注射液(46篇,2.59%)等为主,中成药以华蟾素胶囊(16篇,0.90%)、复方斑蝥胶囊(10篇,0.56%)等为主。共将结局指标划分为13个指标域,包括近期疗效、生活质量、安全性事件、中医证候/症状积分等。结果表明,现存结局指标多沿用西医评价体系,种类繁杂且无统一标准,缺乏具有中医特色的结局指标/量表,在远期疗效、焦虑抑郁等领域关注相对不足。未来需进一步优化临床研究设计,构建具有中医特色的核心指标集和临床评价体系,产出更多高级别循证证据,为中医药防治CRC的安全性和有效性提供强力支撑。
This study systematically reviewed the literature on the prevention and treatment of colorectal cancer(CRC)with traditional Chinese medicine(TCM),aiming to present a more intuitive and concise overview of existing evidence.Four major Chinese databases,including CNKI,Wanfang,VIP,and SinoMed,were searched for randomized controlled trial(RCT)on TCM treatment of CRC.The retrieval period was from database inception to August 1,2023.The evidence was presented using a combination of text and charts.A total of 1778 RCTs were included,and the overall publication volume showed an upward trend.The quality of the RCTs was generally low,with sample sizes concentrated between 60 and 100 cases.The Sijunzi Decoction (22 articles, 1.24%). TCM injections included Fufang Kushen Injection (54 articles, 3.04%) and AidiInjection (46 articles, 2.59%). Chinese patent medicines included Cinobufacin Capsules (16 articles, 0.90%) and FufangBanmao Capsules (10 articles, 0.56%). The outcome indicators were divided into 13 domains, including recent efficacy,quality of life, safety events, and TCM syndrome/symptom scores. The existing outcome indicators mostly followed thewestern medicine evaluation system, with complex types and no unified standards, lacking outcome indicators or scales withTCM characteristics, and relatively insufficient attention to long-term efficacy, anxiety, and depression. Future researchshould optimize clinical study designs, build a core index set and clinical evaluation system with TCM characteristics, andproduce more high-level evidence to support the safety and effectiveness of TCM in preventing and treating CRC.
作者
张东
倪明欣
魏小曼
耿雪尘
李柳
程海波
ZHANG Dong;NI Ming-xin;WEI Xiao-man;GENG Xue-chen;LI Liu;CHENG Hai-bo(the First Clinical Medical College,Nanjing University of Chinese Medicine,Nanjing 210023,China;Affiliated Hospital of Nanjing University of Chinese Medicine,Nanjing 210029,China;Jiangsu Collaborative Innovation Center of Traditional Chinese Medicine in Prevention and Treatment of Tumor,Nanjing 210023,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2024年第23期6512-6520,共9页
China Journal of Chinese Materia Medica
基金
国家中医药管理局高水平中医药重点学科建设项目(国中医药人教函[2023]85号)
国家中医药管理局中医药创新团队及人才支持计划项目(ZYYCXTD-C-202208)
江苏高校优势学科建设工程项目。
关键词
中医药
结直肠癌
临床研究
证据图
随机对照试验
traditional Chinese medicine
colorectal cancer
clinical study
evidence map
randomized controlled trial
