Effect of compound kushen injection on immune function in patients with colorectal cancer: a systematic review and meta-analysis

BackgroundColorectal 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 fo...

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Main Authors: Lixin Zhang, Guangyan Wei, Kaiping Wang, Xu Han
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-04-01
Series:Frontiers in Pharmacology
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Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2025.1565031/full
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author Lixin Zhang
Guangyan Wei
Kaiping Wang
Xu Han
author_facet Lixin Zhang
Guangyan Wei
Kaiping Wang
Xu Han
author_sort Lixin Zhang
collection DOAJ
description BackgroundColorectal 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.ObjectiveTo evaluate the effects of Compound Kushen Injection (CKI) on immune function and its role in mitigating chemotherapy-induced adverse effects in patients with CRC.MethodsWe 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.ResultA 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, p < 0.00001), CD4+ levels (MD = 8.05, 95% CI: 6.99 to 9.11, p < 0.00001), CD4+/CD8+ levels (MD = 0.36, 95% CI: 0.28 to 0.44, p < 0.00001), NK cell levels (MD = 3.60, 95% CI: 2.85 to 4.34, p < 0.00001), while reducing CD8+ levels (MD = −4.19, 95% CI: −5.11 to −3.27, p < 0.00001). CKI also improved the objective response rate (ORR, RR = 1.50, 95% CI: 1.38 to 1.62, p < 0.00001) and disease control rate (DCR, RR = 1.15, 95% CI: 1.10 to 1.19, p < 0.00001), decreased CEA levels (MD = −1.79, 95% CI: −2.81 to −0.76, p = 0.0007) and CA199 levels (MD = −0.73, 95% CI: −1.35 to −0.12, p = 0.02), and reduced chemotherapy-induced adverse reactions, including nausea, vomiting, hepatic dysfunction, myelosuppression, neurotoxicity, leukopenia, thrombocytopenia, and mouth ulcers.ConclusionCurrent 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.Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=632516, identifier CRD42025632516
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spelling doaj-art-62a103bf243243cdb2ccab8ec42e52252025-08-20T03:04:15ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-04-011610.3389/fphar.2025.15650311565031Effect of compound kushen injection on immune function in patients with colorectal cancer: a systematic review and meta-analysisLixin Zhang0Guangyan Wei1Kaiping Wang2Xu Han3Department of Anorectal Surgery, The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang, ChinaCollege of Pharmacy, Yanbian University, Yanji, ChinaDepartment of Anorectal Surgery, The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang, ChinaDepartment of Anorectal Surgery, Chongqing Changshou Traditional Chinese Medicine Hospital, Chongqing, ChinaBackgroundColorectal 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.ObjectiveTo evaluate the effects of Compound Kushen Injection (CKI) on immune function and its role in mitigating chemotherapy-induced adverse effects in patients with CRC.MethodsWe 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.ResultA 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, p < 0.00001), CD4+ levels (MD = 8.05, 95% CI: 6.99 to 9.11, p < 0.00001), CD4+/CD8+ levels (MD = 0.36, 95% CI: 0.28 to 0.44, p < 0.00001), NK cell levels (MD = 3.60, 95% CI: 2.85 to 4.34, p < 0.00001), while reducing CD8+ levels (MD = −4.19, 95% CI: −5.11 to −3.27, p < 0.00001). CKI also improved the objective response rate (ORR, RR = 1.50, 95% CI: 1.38 to 1.62, p < 0.00001) and disease control rate (DCR, RR = 1.15, 95% CI: 1.10 to 1.19, p < 0.00001), decreased CEA levels (MD = −1.79, 95% CI: −2.81 to −0.76, p = 0.0007) and CA199 levels (MD = −0.73, 95% CI: −1.35 to −0.12, p = 0.02), and reduced chemotherapy-induced adverse reactions, including nausea, vomiting, hepatic dysfunction, myelosuppression, neurotoxicity, leukopenia, thrombocytopenia, and mouth ulcers.ConclusionCurrent 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.Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=632516, identifier CRD42025632516https://www.frontiersin.org/articles/10.3389/fphar.2025.1565031/fullcompound kushen injectioncolorectal cancerimmune functionrandomized controlled trialssystematic reviewmeta-analysis
spellingShingle Lixin Zhang
Guangyan Wei
Kaiping Wang
Xu Han
Effect of compound kushen injection on immune function in patients with colorectal cancer: a systematic review and meta-analysis
Frontiers in Pharmacology
compound kushen injection
colorectal cancer
immune function
randomized controlled trials
systematic review
meta-analysis
title Effect of compound kushen injection on immune function in patients with colorectal cancer: a systematic review and meta-analysis
title_full Effect of compound kushen injection on immune function in patients with colorectal cancer: a systematic review and meta-analysis
title_fullStr Effect of compound kushen injection on immune function in patients with colorectal cancer: a systematic review and meta-analysis
title_full_unstemmed Effect of compound kushen injection on immune function in patients with colorectal cancer: a systematic review and meta-analysis
title_short Effect of compound kushen injection on immune function in patients with colorectal cancer: a systematic review and meta-analysis
title_sort effect of compound kushen injection on immune function in patients with colorectal cancer a systematic review and meta analysis
topic compound kushen injection
colorectal cancer
immune function
randomized controlled trials
systematic review
meta-analysis
url https://www.frontiersin.org/articles/10.3389/fphar.2025.1565031/full
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AT kaipingwang effectofcompoundkusheninjectiononimmunefunctioninpatientswithcolorectalcancerasystematicreviewandmetaanalysis
AT xuhan effectofcompoundkusheninjectiononimmunefunctioninpatientswithcolorectalcancerasystematicreviewandmetaanalysis