Abstract
This systematic review and meta-analysis evaluated the efficacy and safety of Xiaoaiping Injection (XAP) combined with chemotherapy versus chemotherapy alone in patients with breast cancer and aimed to provide an evidence-based reference for clinical treatment. PubMed, Embase, Web of Science, the Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang Data, and the China Biomedical Literature Database (CBM) were searched from inception to April 30, 2025, for studies on breast cancer. Pairwise meta-analyses were performed using Stata 17.0 and RevMan 5.4.1. A total of eight studies were included. Pooled analysis indicated that, compared with chemotherapy alone, Xiaoaiping Injection combined with chemotherapy significantly improved outcomes in patients with breast cancer (P < 0.05), reduced the incidence of chemotherapy-induced adverse effects [RR = 0.67, 95% CI (0.54, 0.82), Z = 3.79, P = 0.0002], and increased the objective response rate [RR = 1.37, 95% CI (1.21, 1.55), Z = 5.11, P < 0.00001]. Thus, Xiaoaiping Injection combined with chemotherapy was more effective than chemotherapy alone for breast cancer, reducing the incidence of gastrointestinal adverse reactions and improving the objective response rate. Nevertheless, further studies are needed to provide more robust supporting evidence.