Zhang Lixin, Wei Guangyan, Wang Kaiping, Han Xu
Department of Anorectal Surgery, The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang, China.
College of Pharmacy, Yanbian University, Yanji, China.
Front Pharmacol. 2025 Apr 3;16:1565031. doi: 10.3389/fphar.2025.1565031. eCollection 2025.
Colorectal cancer (CRC) is one of the most common malignant tumors worldwide. Chemotherapy and radiotherapy remain cornerstone treatments; however, they often lead to significant immune suppression and an increased risk of infection. Enhancing immune function in CRC patients is critical for improving clinical outcomes and prognosis.
To evaluate the effects of Compound Kushen Injection (CKI) on immune function and its role in mitigating chemotherapy-induced adverse effects in patients with CRC.
We retrieved randomized controlled trials (RCTs) evaluating the effects of CKI on immune function in patients with CRC from eight Chinese and English databases, up until 31 December 2024. The Cochrane Handbook was used to assess the quality of the included studies. For the meta-analysis, we utilized Review Manager 5.4.1 software. Sensitivity analysis and publication bias assessment were conducted using Stata 17.0 software.
A total of 2,663 patients (1,550 males and 1,113 females) from 30 RCTs were included. Compared to conventional chemotherapy (CC), the combination of CKI with CC significantly enhanced immune function, increasing CD3 levels (MD = 6.15, 95% CI: 4.78 to 7.53, < 0.00001), CD4 levels (MD = 8.05, 95% CI: 6.99 to 9.11, < 0.00001), CD4+/CD8+ levels (MD = 0.36, 95% CI: 0.28 to 0.44, < 0.00001), NK cell levels (MD = 3.60, 95% CI: 2.85 to 4.34, < 0.00001), while reducing CD8 levels (MD = -4.19, 95% CI: -5.11 to -3.27, < 0.00001). CKI also improved the objective response rate (ORR, RR = 1.50, 95% CI: 1.38 to 1.62, < 0.00001) and disease control rate (DCR, RR = 1.15, 95% CI: 1.10 to 1.19, < 0.00001), decreased CEA levels (MD = -1.79, 95% CI: -2.81 to -0.76, = 0.0007) and CA199 levels (MD = -0.73, 95% CI: -1.35 to -0.12, = 0.02), and reduced chemotherapy-induced adverse reactions, including nausea, vomiting, hepatic dysfunction, myelosuppression, neurotoxicity, leukopenia, thrombocytopenia, and mouth ulcers.
Current evidence suggests that the combination of CKI with CC may have beneficial effects on immune function, ORR, DCR, and chemotherapy-induced adverse reactions in CRC patients. However, given the variability in study quality and the absence of disease stage stratification, these findings should be interpreted with caution. Furthermore, the lack of long-term follow-up data limits the understanding of CKI's impact on survival and quality of life. High-quality, large-scale RCTs with extended follow-up are needed to further assess the long-term efficacy, safety, and clinical applicability of CKI in CRC management.
https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=632516, identifier CRD42025632516.
结直肠癌（CRC）是全球最常见的恶性肿瘤之一。化疗和放疗仍然是主要的治疗方法；然而，它们常常导致显著的免疫抑制和感染风险增加。增强CRC患者的免疫功能对于改善临床结局和预后至关重要。
评估复方苦参注射液（CKI）对CRC患者免疫功能的影响及其在减轻化疗引起的不良反应中的作用。
我们从八个中英文数据库中检索了截至2024年12月31日评估CKI对CRC患者免疫功能影响的随机对照试验（RCT）。使用Cochrane手册评估纳入研究的质量。对于荟萃分析，我们使用Review Manager 5.4.1软件。使用Stata 17.0软件进行敏感性分析和发表偏倚评估。
共纳入30项RCT的2663例患者（男性1550例，女性1113例）。与传统化疗（CC）相比，CKI与CC联合使用显著增强了免疫功能，提高了CD3水平（MD = 6.15，95%CI：4.78至7.53，<0.00001）、CD4水平（MD = 8.05，95%CI：6.99至9.11，<0.00001）、CD4+/CD8+水平（MD = 0.36，95%CI：0.28至0.44，<0.00001）、NK细胞水平（MD = 3.60，95%CI：2.85至4.34，<0.00001），同时降低了CD8水平（MD = -4.19，95%CI：-5.11至-3.27，<0.00001）。CKI还提高了客观缓解率（ORR，RR = 1.50，95%CI：1.38至1.62，<0.00001）和疾病控制率（DCR）（RR = 1.15，95%CI：1.10至1.19，<0.00001），降低了CEA水平（MD = -1.79，95%CI：-2.81至-0.76，P = 0.0007）和CA199水平（MD = -0.73，95%CI：-1.35至-0.12，P = 0.02），并减少了化疗引起的不良反应，包括恶心、呕吐、肝功能障碍、骨髓抑制、神经毒性、白细胞减少、血小板减少和口腔溃疡。
目前的证据表明，CKI与CC联合使用可能对CRC患者的免疫功能、ORR、DCR和化疗引起的不良反应有有益影响。然而，鉴于研究质量的差异和缺乏疾病分期分层，这些发现应谨慎解释。此外，缺乏长期随访数据限制了对CKI对生存和生活质量影响的理解。需要高质量、大规模的RCT并延长随访时间，以进一步评估CKI在CRC管理中的长期疗效、安全性和临床适用性。
https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=632516，标识符CRD42025632516。
