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Objective  This study aims to investigate cellular immunity and clinical efficacy of ShenQi FuZheng Injection (SFI) in the associated chemotherapy of colorectal cancer (CRC).    Methods  PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Full-text Database (VIP), WanFang Database and Chinese Biomedical Literature Database (CBM) searches were undertaken to identify randomized controlled trials of SFI plus chemotherapy versus chemotherapy alone in CRC patients. The quality of each trial was assessed according to the Jadad’s scale, and Review Manager 5 was used to statisitically analyze the outcomes.    Results  Eight studies involving 722 patients were included in this review. The meta-analyses suggested there was a significantly higher overall response rate (OR 1.89; CI: 1.10–3.24; p = 0.02), grades of KPS (OR 2.35; CI: 1.55–3.56; p<0.01), CD3+cells (MD 10.29; CI: 8.46–12.12; p<0.01), CD4+cells (MD 7.06; CI: 5.33–8.794; p<0.01), CD4/CD8+cells (MD 0.32; CI: 0.25–0.40; p<0.01), NK+ (MD 7.20; CI: 2.02–12.37, p = 0.006), WBC (MD 1.24; CI: 0.59–1.89; p<0.01), HB (MD 14.55; CI: 7.47–21.63; p<0.01), and PLT (MD 19.05; CI: 4.29–33.81; p = 0.01), but lower severe toxicity for leukocytopenia (OR 0.37; CI: 0.17–0.80; p = 0.01), thrombocytopenia (OR 0.32; CI: 0.14–0.74; p = 0.008), gastrointestinal toxicity (OR 0.48; CI: 0.24–0.96; p = 0.04), when chemotherapy combined with SFI was compared with chemotherapy alone. There were similarities between two groups in liver dysfunction (OR 0.44; CI: 0.18–1.08; p = 0.07) and CD8+ (MD 0.54; CI: -1.89–2.96; p = 0.66). Also, there was presence of heterogeneity in the CD8 results; after the sensitivity analysis, the result of CD8+ was reversed (MD 1.57; CI: 0.32–2.81; p = 0.01). There was no significant publication bias across studies according to the Egger’s (P = 0.19) and Begg’s test (P = 0.23).    Conclusion  SFI enhances chemotherapy efficiency as they are combined and used in the treatment of colorectal cancer patients. At the same time, SFI also improves patients’ immunity function.

ShenQi FuZheng Injection combined with chemotherapy in the treatment of colorectal cancer: A meta-analysis