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

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.

研究目的
本研究旨在探讨参芪扶正注射液（ShenQi FuZheng Injection, SFI）联合化疗治疗结直肠癌（colorectal cancer, CRC）的细胞免疫效应与临床疗效。

研究方法
本研究通过检索PubMed、Cochrane图书馆、EMBASE、中国知网（China National Knowledge Infrastructure, CNKI）、中国科技期刊全文数据库（Chinese Scientific Journals Full-text Database, VIP）、万方数据库以及中国生物医学文献数据库（Chinese Biomedical Literature Database, CBM），筛选结直肠癌患者接受参芪扶正注射液联合化疗对比单纯化疗的随机对照试验。采用Jadad量表对纳入研究的质量进行评价，并使用Review Manager 5统计软件对结局指标进行统计学分析。

研究结果
本研究共纳入8项相关研究，涉及722例患者。Meta分析结果显示，与单纯化疗组相比，参芪扶正注射液联合化疗组的客观缓解率（比值比OR=1.89；95%置信区间CI:1.10~3.24；P=0.02）、卡氏功能状态评分（Karnofsky Performance Status, KPS；OR=2.35；95%CI:1.55~3.56；P<0.01）、CD3+T细胞（均数差MD=10.29；95%CI:8.46~12.12；P<0.01）、CD4+T细胞（MD=7.06；95%CI:5.33~8.79；P<0.01）、CD4+/CD8+细胞比值（MD=0.32；95%CI:0.25~0.40；P<0.01）、自然杀伤细胞（NK细胞；MD=7.20；95%CI:2.02~12.37；P=0.006）、白细胞计数（WBC；MD=1.24；95%CI:0.59~1.89；P<0.01）、血红蛋白（HB；MD=14.55；95%CI:7.47~21.63；P<0.01）及血小板计数（PLT；MD=19.05；95%CI:4.29~33.81；P=0.01）均显著升高；而严重白细胞减少症（OR=0.37；95%CI:0.17~0.80；P=0.01）、严重血小板减少症（OR=0.32；95%CI:0.14~0.74；P=0.008）及胃肠道毒性反应（OR=0.48；95%CI:0.24~0.96；P=0.04）的发生率显著降低。两组在肝功能异常（OR=0.44；95%CI:0.18~1.08；P=0.07）与CD8+T细胞水平（MD=0.54；95%CI:-1.89~2.96；P=0.66）方面无显著差异。此外，CD8+T细胞的分析结果存在异质性；经敏感性分析后，CD8+T细胞水平的分析结果发生逆转（MD=1.57；95%CI:0.32~2.81；P=0.01）。根据Egger检验（P=0.19）与Begg检验（P=0.23）结果，本研究未发现显著的发表偏倚。

研究结论
参芪扶正注射液联合化疗可提升结直肠癌患者的化疗疗效，同时可改善患者的免疫功能。