Xu Rongzhong, Lin Liubing, Li Yong, Li Yan
Oncology Department of Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Digestive Department of Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
PLoS One. 2017 Sep 27;12(9):e0185254. doi: 10.1371/journal.pone.0185254. eCollection 2017.
This study aims to investigate cellular immunity and clinical efficacy of ShenQi FuZheng Injection (SFI) in the associated chemotherapy of colorectal cancer (CRC).
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.
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).
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.
本研究旨在探讨参芪扶正注射液（SFI）在结直肠癌（CRC）联合化疗中的细胞免疫及临床疗效。
通过检索PubMed、Cochrane图书馆、EMBASE、中国知网（CNKI）、维普中文科技期刊全文数据库（VIP）、万方数据库和中国生物医学文献数据库（CBM），以识别SFI联合化疗与单纯化疗治疗CRC患者的随机对照试验。根据Jadad量表评估每个试验的质量，并使用Review Manager 5对结果进行统计分析。
本综述纳入了8项研究，共722例患者。荟萃分析表明，联合化疗组的总缓解率显著更高（OR 1.89；CI：1.10 - 3.24；p = 0.02）、KPS评分（OR 2.35；CI：1.55 - 3.56；p<0.01）、CD3 +细胞（MD 10.29；CI：8.46 - 12.12；p<0.01）、CD4 +细胞（MD 7.06；CI：5.33 - 8.794；p<0.01）、CD4/CD8 +细胞（MD 0.32；CI：0.25 - 0.40；p<0.01）、NK +细胞（MD 7.20；CI：2.02 - 12.37，p = 0.006）、白细胞（WBC，MD 1.24；CI：0.59 - 1.89；p<0.01）、血红蛋白（HB，MD 14.55；CI：7.47 - 21.63；p<0.01）和血小板（PLT，MD 19.05；CI：4.29 - 33.81；p = 0.01）；但与单纯化疗相比，联合化疗组白细胞减少的严重毒性（OR 0.37；CI：0.17 - 0.80；p = 0.01）、血小板减少（OR 0.32；CI：0.14 - 0.74；p = 0.008）、胃肠道毒性（OR 0.48；CI：0.24 - 0.96；p = 0.04）更低。两组在肝功能障碍（OR 0.44；CI：0.18 - 1.08；p = 0.07）和CD8 +细胞（MD 0.54；CI： - 1.89 - 2.96；p = 0.66）方面相似。此外，CD8结果存在异质性；敏感性分析后，CD8 +细胞结果相反（MD 1.57；CI：0.32 - 2.81；p = 0.01）。根据Egger检验（P = 0.19）和Begg检验（P = 0.23），各研究之间无显著发表偏倚。
SFI与化疗联合应用可提高CRC患者的化疗效果，同时还可改善患者的免疫功能。
