Objective  To explore the efficacy and safety of Shenqi Fuzheng injection (SFI) combined with docetaxel treatment regime in patients with metastatic castration-resistant prostate cancer (mCRPC).

Methods  The present studyretrospectively selected mCRP patients diagnosed and treated in the department of urology of Weinan Central Hospital from January 2017 to January 2022 from the electronic medical record system. According to the treatment plan, mCRPC patients were divided into Docetaxel group and Docetaxel+SFI group, receiving docetaxel+prednisone acetate treatment and docetaxel+prednisone acetate+SFI treatment, respectively. The short-term efficacy [objective response rate (ORR) and disease control rate (DCR)] and long-term efficacy [progression free survival (PFS) and overall survival (OS)] of two groups of mCRPC patients were eveluated. The occurrence of adverse reactions during treatment in mCRPC patients was eveluated using were eveluated the common terminology standard for good events (CTCAE 4.03).

Results  A total of 305 mCRPC patients were included in this study, including 159 cases in Docetaxel+SFI group and 146 cases in Docetaxel group. The ORR and DCR of the Docetaxel+SFI group were significantly higher than those of the Docetaxel group (P<0.05). The median PFS and median OS of mCRPC patients in the Docetaxel+SFI group were significantly higher than those in the camrelizumab group (P<0.001). In addition, the incidence of adverse events such as hair loss, diarrhea, nausea and vomiting, anorexia, peripheral edema, and neutropenia in mCRPC patients in the Docetaxel+SFI group was significantly lower than that in the Docetaxel group (P<0.05).

Conclusion  Shenqi Fuzheng injection combined with docetaxel has a significant therapeutic effect on mCRP patients, which can improve disease control rate, prolong PFS and OS, and reduce the incidence of adverse reactions.

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