目的 評價參一膠囊聯(lián)合化療治療惡性腫瘤的臨床療效、安全性及對患者免疫功能的影響。方法 在中國學(xué)術(shù)期刊全文數(shù)據(jù)庫（http：//www.cnki.net）、萬方數(shù)據(jù)知識服務(wù)平臺（WanFang Data）、維普生物醫(yī)學(xué)數(shù)據(jù)庫（VIP）、中國生物醫(yī)學(xué)文獻數(shù)據(jù)庫（CBM）、PubMed（https：//pubmed.ncbi.nlm.nih.gov）、Web of Science（https：//www.webofscience.com）、The CochraneLibrary、Embase數(shù)據(jù)庫中進行檢索建庫至2024年6月25日公開發(fā)表的參一膠囊聯(lián)合化療治療惡性腫瘤的隨機對照試驗（RCT）。采用Revman 5.3軟件進行Meta分析，并進行敏感性分析和偏倚評價。結(jié)果 共納入24項RCT。與對照組相比，在有效性方面，參一膠囊聯(lián)合化療顯著提高客觀緩解率［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］，降低血管內(nèi)皮生長因子（VEGF）水平［MD＝-71.02 （-77.99，-64.05），P＜0.00001］，改善患者生活質(zhì)量［OR＝2.75（2.10，3.61），P＜0.000 01］；在安全性方面，參一膠囊聯(lián)合化療在降低患者Ⅲ、Ⅳ度胃腸道不良反應(yīng)發(fā)生方面無顯著差別［OR＝0.69 （0.37，1.30），P＝0.25］，但顯著改善Ⅲ、Ⅳ度白細胞減少［OR＝0.28（0.18，0.43），P＜0.000 01］和血小板減少［OR＝0.48（0.26，0.88），P＝0.02］情況；在免疫功能方面，參一膠囊聯(lián)合化療顯著提高CD3⁺T細胞水平（MD＝6.47［4.56，8.37］，P＜0.000 01）、CD4⁺T細胞水平［MD＝5.87（5.28，6.46），P＜0.000 01］、CD4⁺/CD8⁺T細胞水平［MD＝0.41（0.24，0.57），P＜0.000 01］，但在改善CD8⁺T細胞水平上無顯著差別［MD＝2.25（-0.47，4.97），P＝0.10］。結(jié)論 參一膠囊聯(lián)合化療可以顯著提高惡性腫瘤患者臨床療效，降低不良反應(yīng)的發(fā)生率，在一定程度上還可提高患者的免疫功能，從而達到增效、減毒的治療效果。

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

國家自然科學(xué)基金資助項目（82304986）