Data Sheet 1_Efficacy and safety of traditional Chinese medicine as an adjuvant to postoperative chemotherapy in colorectal cancer: a meta-analysis.docx

ObjectiveTo systematically evaluate the efficacy and safety of traditional Chinese medicine (TCM) for postoperative adjuvant chemotherapy for colorectal cancer.
MethodsCNKI, VIP, Wanfang, CBM, PubMed, and Web of Science were searched for the randomized controlled trials (RCT) of TCM participating in postoperative adjuvant chemotherapy for colorectal cancer. The search period was from January 1, 2018 to December 31, 2024. Cochrane bias risk assessment tool was used to evaluate the quality of included studies, and RevMan5.4 was used for meta-analysis.
ResultsA total of 41 randomized controlled trials involving 2918 patients with colorectal cancer was ultimately included. The results demonstrated that the combination of TCM with chemotherapy was superior to chemotherapy alone in several aspects. These included the objective response rate (ORR), improvement of TCM-related symptoms, levels of tumor markers CEA and CA199, immune function indicators (CD3+, CD4+, CD4+/CD8+, NK cells), and quality of life as measured by the KPS score. Additionally, the combination therapy reduced CD8+ levels and mitigated abnormal laboratory indicators caused by chemotherapy, such as leukopenia, thrombocytopenia, decreased hemoglobin, and abnormal liver and kidney function. Furthermore, it alleviated chemotherapy-related adverse effects (AEs), including nausea, vomiting, and peripheral nerve toxicity.
ConclusionsTCM may be associated with improvements in quality of life and reduce chemotherapy side effects in postoperative colorectal cancer patients, though large-scale rigorous trials are needed to confirm efficacy and safety.
Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42025635900.

研究目的：本研究旨在系统评价中医药（Traditional Chinese Medicine，TCM）用于结直肠癌术后辅助化疗的疗效与安全性。
研究方法：本研究检索了中国知网（CNKI）、维普资讯网（VIP）、万方数据知识服务平台（Wanfang）、中国生物医学文献数据库（CBM）、PubMed及Web of Science中关于中医药用于结直肠癌术后辅助化疗的随机对照试验（randomized controlled trial，RCT）。检索时限为2018年1月1日至2024年12月31日。采用Cochrane偏倚风险评估工具对纳入研究的质量进行评价，并使用RevMan5.4软件开展Meta分析。
研究结果：最终共纳入41项随机对照试验，涉及2918例结直肠癌患者。分析结果显示，中医药联合化疗方案在多方面表现优于单纯化疗方案：包括客观缓解率（objective response rate，ORR）、中医药相关症状改善情况、肿瘤标志物癌胚抗原（CEA）与糖链抗原199（CA199）水平、免疫功能指标（CD3+、CD4+、CD4+/CD8+、NK细胞）以及以KPS评分衡量的生活质量。此外，联合治疗可降低CD8+水平，并减轻化疗所致的实验室指标异常，如白细胞减少症、血小板减少症、血红蛋白降低及肝肾功能异常。同时，联合治疗还可缓解化疗相关不良反应（adverse effects，AEs），包括恶心、呕吐及外周神经毒性。
研究结论：结直肠癌术后患者接受中医药联合化疗，或可改善生活质量并减轻化疗不良反应，但仍需开展大规模严谨的临床试验以验证其疗效与安全性。
系统评价注册信息：注册平台为https://www.crd.york.ac.uk/prospero/，注册编号为CRD42025635900。