目的 评价参一胶囊联合化疗治疗恶性肿瘤的临床疗效、安全性及对患者免疫功能的影响。方法 在中国学术期刊全文数据库（http：//www.cnki.net）、万方数据知识服务平台（WanFang Data）、维普生物医学数据库（VIP）、中国生物医学文献数据库（CBM）、PubMed（https：//pubmed.ncbi.nlm.nih.gov）、Web of Science（https：//www.webofscience.com）、The CochraneLibrary、Embase数据库中进行检索建库至2024年6月25日公开发表的参一胶囊联合化疗治疗恶性肿瘤的随机对照试验（RCT）。采用Revman 5.3软件进行Meta分析，并进行敏感性分析和偏倚评价。结果 共纳入24项RCT。与对照组相比，在有效性方面，参一胶囊联合化疗显著提高客观缓解率［OR＝2.28（1.85，2.81），P＜0.000 01］，疾病控制率［OR＝2.47 （1.88，3.25），P＜0.000 01］，降低血管内皮生长因子（VEGF）水平［MD＝-71.02 （-77.99，-64.05），P＜0.00001］，改善患者生活质量［OR＝2.75（2.10，3.61），P＜0.000 01］；在安全性方面，参一胶囊联合化疗在降低患者Ⅲ、Ⅳ度胃肠道不良反应发生方面无显著差别［OR＝0.69 （0.37，1.30），P＝0.25］，但显著改善Ⅲ、Ⅳ度白细胞减少［OR＝0.28（0.18，0.43），P＜0.000 01］和血小板减少［OR＝0.48（0.26，0.88），P＝0.02］情况；在免疫功能方面，参一胶囊联合化疗显著提高CD3⁺T细胞水平（MD＝6.47［4.56，8.37］，P＜0.000 01）、CD4⁺T细胞水平［MD＝5.87（5.28，6.46），P＜0.000 01］、CD4⁺/CD8⁺T细胞水平［MD＝0.41（0.24，0.57），P＜0.000 01］，但在改善CD8⁺T细胞水平上无显著差别［MD＝2.25（-0.47，4.97），P＝0.10］。结论 参一胶囊联合化疗可以显著提高恶性肿瘤患者临床疗效，降低不良反应的发生率，在一定程度上还可提高患者的免疫功能，从而达到增效、减毒的治疗效果。

Objectives To evaluate the effects of Shenyi Capsule combined with chemotherapy on clinical efficacy, safety and immune function of cancer patients. Methods All randomized controlled trials (RCT) of Shenyi Capsule combined with chemotherapy in the treatment of malignant tumors were searched from CNKI, WanFang Data, VIP, CBM, PubMed, Web of Science, The Cochrane Library, Embase databases. The search period was limited from the databases establishment to June 25, 2024. Revman 5.3 software was used for Meta-analysis, and forest maps were drawn, followed by sensitivity analysis and funnel plot bias evaluation. Results A total of 24 RCT were included. Compared with chemotherapy alone, in terms of efficacy, Shenyi Capsule combined chemotherapy group could significantly improve objective response rate (ORR) [OR＝2.28(1.85, 2.81), P <0.000 01] and disease control rate (DCR) [OR＝2.47(1.88, 3.25), P <0.000 01], decrease VEGF levels [MD＝-71.02 (-77.99, -64.05), P <0.000 01], and improve quality of life [OR＝2.75(2.10, 3.61), P <0.000 01]. In terms of safety, Shenyi Capsule combined with chemotherapy showed no significant difference in the occurrence of Ⅲ, Ⅳ grade of gastrointestinal adverse reactions [OR＝0.69(0.37, 1.30), P＝ 0.25], but significantly improved the Ⅲ, Ⅳ grade of leukopenia [OR＝0.28 (0.18, 0.43), P <0.000 01] and thrombocytopenia [OR＝ 0.48(0.26, 0.88), P＝0.02]. In terms of immune function, the level of CD3⁺T cells [MD＝6.47 (4.56, 8.37), P <0.000 01], the level of CD4⁺T cells [MD＝5.87(5.28, 6.46), P <0.000 01] and CD4⁺/CD8⁺T cell levels [MD＝0.41(0.24, 0.57), P <0.000 01] in the combination group. But there was no significant difference in improving CD8⁺T cell levels [MD＝2.25 (- 0.47, 4.97), P＝0.10]. Conclusion Shenyi Capsule combined with chemotherapy can significantly improve the clinical efficacy, reduce the incidence of adverse reactions, and improve the immune function to a certain extent, so as to achieve the therapeutic effect of enhancing efficiency and reducing toxicity.

R285.5;R969.3

国家自然科学基金资助项目（82304986）