目的 系统评价槐耳颗粒联合术后辅助化疗治疗乳腺癌的临床应用价值。方法 通过计算机检索维普数据库（VIP）、中国生物医学文献数据库（CBM）、万方数据库（WanFang Data）、中国知网（CNKI）、PubMed、Embase、Cochrane Library自建库至2021年1月有关槐耳颗粒联合术后辅助化疗治疗乳腺癌的随机对照试验（randomized controlled trials， RCTs）文献。根据研究需求挑选文献，并评价文献质量，运用RevMan5.3软件分析数据。结果 纳入文献14篇，患者1049例。Meta分析结果表明：槐耳颗粒联合术后辅助化疗对比单纯术后辅助化疗治疗乳腺癌能够提高患者免疫指标T淋巴细胞CD4⁺（MD=4.85， 95%CI ［3.02， 6.67］， P<0.00001）、CD4⁺/CD8⁺（MD=0.26， 95%CI ［0.16， 0.36］， P<0.00001）和NK细胞（MD=3.86， 95%CI ［1.85， 5.87］， P=0.0002）；提高乳腺癌患者生存质量（OR=7.35， 95%CI ［4.18， 12.95］， P<0.00001）；提高乳腺癌患者KPS评分（MD=9.19， 95%CI ［7.47， 10.91］， P<0.00001）；提高晚期乳腺癌患者生存率（OR=2.14， 95%CI ［1.42， 3.23］， P=0.0003）；提高免疫指标T细胞亚群CD3⁺（MD=3.04， 95%CI ［-3.09， 9.16］， P=0.33），但结果不具有统计学意义（P>0.05）。降低骨髓抑制（OR=0.37， 95%CI ［0.22， 0.63］， P=0.00003）；减轻胃肠道反应（OR=0.47， 95%CI ［0.25， 0.90］， P=0.02）；降低复发率（OR=0.46， 95%CI ［0.25， 0.86］， P=0.01）。但对于免疫指标T淋巴细胞亚群中CD8⁺（MD=-2.48， 95%CI ［-5.38， 0.42］， P=0.09）方面。本研究表明，槐耳颗粒联合术后辅助化疗治疗乳腺癌并不能提高免疫指标CD8⁺。结论 槐耳颗粒联合术后辅助化疗治疗乳腺癌能够提高乳腺癌患者免疫指标T淋巴亚群（CD3⁺、CD4⁺、CD4⁺/CD8⁺、NK）、生存质量、KPS评分和晚期乳腺癌患者生存率，降低骨髓抑制、胃肠道反应和复发率。但对于免疫指标CD8⁺T细胞，本研究显示证据不足，这与当前研究结果一致，需更规范的开展大样本，高质量研究以探讨槐耳颗粒对CD8⁺的影响。

Objective To evaluate the clinical application value of Huaier Granules combined with postoperative adjuvant chemotherapy in the treatment of breast cancer.Methods A computer search was performed on the RCTs of Huaier Granules combined with postoperative adjuvant chemotherapy in the treatment of breast cancer from the VIP full text database (VIP), China Biomedical Literature Database (CBM), WanFang Database (WanFang Data), China Knowledge Network (CNKI), PubMed, Embase and Cochrane Library to January 2021. Literature was selected according to research needs, and literature quality was evaluated, and data were analyzed using RevMan5.3 software.Results 14 literatures were included, including 1049 patients. The results of Meta analysis showed that Huaier Granules combined with postoperative adjuvant chemotherapy could improve the immune index T lymphocyte subsets of patients compared with postoperative adjuvant chemotherapy alone CD4⁺ T cells (MD=4.85, 95% CI [3.02, 6.67], P<0.00001), CD4 ⁺/CD8⁺ (MD=0.26, 95% CI [0.16, 0.36], P<0.00001) and the NK cells (MD=3.86, 95% CI [1.85, 5.87], P=0.0002); improved the quality of life of breast cancer patients (OR=7.35, 95%CI [4.18,12.95], P<0.00001); the KPS score of breast cancer patients was improved (MD=9.19, 95%CI [7.47,10.91], P<0.00001); improved the survival rate of advanced breast cancer patients (OR=2.14, 95%CI [1.42,3.23], P=0.0003); T cell subsets CD3⁺ (MD=3.04, 95%CI [-3.09,9.16], P=0.33) were increased, but the results were not statistically significant (P>0.05); decreased myelosuppression (OR=0.37, 95%CI [0.22,0.63], P=0.00003); reduced gastrointestinal reactions (OR=0.47, 95%CI [0.25,0.90], P=0.02); the recurrence rate was decreased (OR=0.46, 95%CI [0.25,0.86], P=0.01). However, as for CD8⁺ (MD=-2.48, 95%CI [-5.38,0.42], P=0.09) in the T lymphocyte subsets of immune indexes, this study showed that Huaier Granules combined with postoperative adjuvant chemotherapy for breast cancer could not improve the immune indexes CD8⁺.Conclusion Huaier Granules combined with postoperative adjuvant chemotherapy in the treatment of breast cancer can improve the immune index T lymphocyte subsets (CD3⁺, CD4⁺, CD4⁺/CD8⁺, NK), quality of life, KPS score and survival rate of advanced breast cancer patients, and reduce the myelosuppression, gastrointestinal reaction and recurrence rate. However, for the immune indicator CD8⁺T cells, this study showed insufficient evidence, this is consistent with current research, and it is necessary to conduct more standardized large scale, high quality studies to explore the effects of Huaier Granules on CD8⁺T cells.

贵州省科学技术厅省部级项目（黔科合平台人才[2020]5013）：贵州省中医肿瘤传承与科技创新人才团队，负责人：唐东昕；贵州省科学技术厅省部级项目（黔科合人才（2016）4032号）：贵州省高层次创新型人才培养计划（百层次），负责人：唐东昕；贵阳市科学技术局市级项目（筑科合同[2019]2-18号）：CHEK2基因功能区SNP与三阴性乳腺癌中医辩证分型、凤膏疗效的关联性，负责人：罗莉。