摘要
目的采用证据图的研究方法,对近十年中医药治疗原发性肝癌的随机对照试验(RCTs)进行整理与分析,以展现该领域的证据分布情况。方法通过计算机检索7大中英文数据库,检索时间范围为从2014年1月1日至2024年8月31日,纳入符合纳排标准的中医药治疗原发性肝癌的RCTs文献,并以图表形式直观呈现其证据分布。结果共纳入620篇RCTs文献,且2021年的发文量达到了峰值,近年来整体趋势稳定。多数RCTs的样本量集中在40至80例之间,干预时间多在8周以内。中药干预措施主要包括口服中药汤剂、口服中成药、中药注射液和穴位贴敷等,大部分研究采用了中西医结合的干预措施。文献中涉及47首经方,出现频次最高的为小柴胡汤、逍遥散和黄芪四君子汤;涉及22种中成药,出现频次最高的为槐耳颗粒、大黄蛰虫丸及八宝丹胶囊;涉及10种中药注射液,出现频次最高的为华蟾素注射液、艾迪注射液和复方苦参注射液。关注的主要疗效评价指标有临床疗效、中医证候积分、肝功能指标、肿瘤标记物和生活质量相关指标等。然而,多数文献未详细描述随机化过程中的分配隐藏方案和盲法的使用情况。结论中医药治疗原发性肝癌具有独特的优势,但多大数RCTs文献存在样本量少、研究周期短及偏倚风险较高等问题。因此,未来应多加强高质量、大规模、多中心的RCT研究,为中医药防治肝癌提供更高级别的循证依据。
Objective To organize and analyze randomized controlled trials(RCTs)on traditional Chinese medicine(TCM)for the treatment of primary liver cancer over the past decade,using evidence mapping methods to illustrate the distribution of evidence in this field.Methods A computer search was conducted across seven major Chinese and English databases,covering the period from January 1,2014,to August 31,2024.RCT literature that met the inclusion and exclusion criteria regarding TCM treatments for primary liver cancer were included,and their evidence distribution was presented visually in charts.Results A total of 620 RCTs were included,with the number of publications peaking in 2021,while the overall trend has remained stable in recent years.Most RCTs had sample sizes concentrated between 40 and 80 cases,with intervention durations mostly under eight weeks.The TCM interventions consisted mainly of oral herbal decoctions,oral proprietary Chinese medicines,injectable Chinese medicines,and acupoint applications.Furthermore,the majority of studies employed a combination of TCM and Western medicine interventions.The literature involves 47 classical prescriptions,among which Xiao Chaihu Decoction,Xiaoyao Powder and Huangqi Sijunzi Decoction appear most frequently;22 Chinese patent medicines were involved,among which Huaier Granules,Dahuang Zhechong Pills and Babaodan Capsules appear most frequently;10 Chinese medicine injections were involved,among which Cinobufotalin Injection,Aidi Injection and Compound Kushen Injection appear most frequently.The primary efficacy evaluation indicators included clinical efficacy,TCM syndrome scores,liver function indicators,tumor markers,and quality of life-related indicators.However,most literature did not provide detailed descriptions of the allocation concealment and blinding methods used during randomization.Conclusion TCM demonstrates unique advantages in the treatment of primary liver cancer;however,many of the RCTs exhibit issues such as small sample sizes,short study durations,and high risks of bias.Thus,future research should focus on conducting more high-quality,large-scale,multi-center RCTs to provide higher levels of evidence for the use of TCM in the prevention and treatment of liver cancer.
作者
黄锦桢
吴泽铭
杜海燕
蔡涛
贺楠
廖勉勉
HUANG Jinzhen;WU Zeming;DU Haiyan;CAI Tao;HE Nan;LIAO Mianmian(Shenzhen Hospital(Futian)of Guangzhou University of Chinese Medine,Shenzhen 518033,China;Department of Hepatology,Shenzhen Traditional Chinese Medicine Hospital,Shenzhen 518033,China)
出处
《现代中药研究与实践》
2025年第2期72-77,共6页
Research and Practice on Chinese Medicines
基金
国家自然科学基金青年项目(82205040)
深圳市优秀科技创新人才培养项目(RCBS20221008093118043)。
关键词
中医药
原发性肝癌
随机对照试验
证据图
Traditional Chinese medicine
primary liver cancer
randomized controlled trial
evidence map
