目的 評價參芪扶正注射液輔助化療干預晚期胃癌患者的有效性及對患者免疫功能的影響。方法 檢索中英文數據庫，包括中國學術期刊全文數據庫（CNKI）、中國生物醫(yī)學文獻數據庫（CBM）、維普生物醫(yī)學數據庫（VIP）、萬方數據庫、Cochrane Library、PubMed、Embase等，檢索時間為建庫至2021年6月，篩選參芪扶正注射液輔助治療晚期胃癌的臨床對照試驗，采用RevMan 5.3軟件對納入的研究進行Meta分析。結果 共納入8篇研究，662例患者。Meta分析結果顯示：相較于對照組，參芪扶正注射液輔助化療可以提高臨床療效［RR=1.36，95% CI=（1.22，1.51）］；提高表面抗原分化簇3（CD3⁺）水平［SMD=1.25，95% CI=（1.04，1.46）］、表面抗原分化簇4（CD4⁺）水平［SMD=1.25，95% CI=（0.88，1.95）］、表面抗原分化簇8（CD8⁺）水平［SMD=-1.68，95% CI=（-1.92，-1.44）］，CD4⁺/CD8⁺［SMD=1.10，95% CI=（0.86，1.34）］，且差異均有統(tǒng)計學意義（P<0.01）。結論 參芪扶正注射液輔助化療可以改善免疫功能，降低相關指標水平，綜合提高晚期胃癌患者的近期療效，但相關研究較少，化療方案不統(tǒng)一，各研究納入的患者數量相對較少，相關指標存在一定的異質性，對患者生存時間的評估仍需要更深入的臨床研究。

Objective To evaluate the efficacy of Shenqi Fuzheng Injection as adjuvant chemotherapy in patients with advanced gastric cancer and its effect on immune function. Methods Chinese and English databases were searched, including CNKI, CBM, VIP, Wanfang, Cochrane Library, PubMed, Embase, etc., from the establishment of the database to June 2021. Screening the clinical controlled trial of shenqi Fuzheng injection in the adjuvant treatment of advanced gastric cancer. Meta-analysis was performed on the included studies using RevMan 5.3 software. Results A total of 662 patients were included in 8 studies. Meta-analysis showed that compared with the control group, Shenqi Fuzheng Injection assisted chemotherapy could improve the clinical efficacy[RR=1.36, 95%CI=(1.22, 1.51)]; increased the level of CD3⁺[SMD=1.25, 95%CI=(1.04, 1.46)], CD4⁺[SMD=1.25, 95%CI=(0.88, 1.95)], CD8⁺[SMD=-1.68, 95%CI=(-1.92, -1.44)], CD4⁺/CD8⁺[SMD=1.10, 95%CI=(0.86, 1.34)], and the differences were statistically significant (P<0.01). Conclusion Shenqi Fuzheng Injection adjuvant chemotherapy can improve the immune function, lower levels of related indicators, comprehensive improve the recent curative effect of patients with advanced gastric cancer, but the related research is less, chemotherapy regimens are not unified, the research into the relatively small number of patients, the index has certain heterogeneity, survival time of patients of evaluation still needs further clinical research.

R286.5

國家自然科學基金青年基金資助項目（81803951）；國家自然科學基金面上資助項目（8197667）