Shengxuening Tablets for the Treatment of Cancer Related Anemia in Hematologic Malignancies: A Multicenter, Prospective, Randomized Controlled Clinical Trial

Abstract Introduction: Cancer related anemia (CRA) is a prevalent comorbidity associated with malignant tumors. Presently, treatments for CRA primarily comprise blood transfusion therapy, erythropoiesis-stimulating agent therapy, and iron supplementation. Conventional oral iron exhibits low bioavailability and significant gastrointestinal irritation, whereas intravenous iron offers rapid iron replenishment. However, excessive iron supplementation may lead to iron overload, and intravenous drug delivery is less accepted among hematological oncology patients. Shengxuening tablets demonstrate clinical efficacy in treating CRA among patients with hematologic malignancies by enhancing endogenous EPO production, stimulating bone marrow hematopoiesis, and regulating iron metabolism.To evaluate the effect of Shengxuening tablets on improving anemia and regulating iron metabolism in patients with hematologic malignancies combined with CRA.

Methods: Patients who met the enrollment criteria were randomly divided into the trial group and the control group. Patients in the trial group received oral treatment with Shengxuening tablets 1 week before chemotherapy, while those in the control group received oral treatment with ferrous succinate 1 week before chemotherapy. The primary endpoints were changes in blood routine after 1 month of treatment. The secondary endpoints were iron metabolism indexes related indexes.

Results:Until July 20, 2024, a total of 48 patients were enrolled in the multiple myeloma group and randomized into two groups: a trial group consisting of 31 patients and a control group consisting of 17 patients. Since the enrollment process has not yet been completed, we only statistically analyzed part of the data that have been obtained so far. Prior to treatment initiation, there was no statistically significant difference in blood routine and iron metabolism indexes between the two groups (P>0.05). After treatment, the mean corpuscular hemoglobin concentration (MCHC) of the trial group increased significantly (P<0.05), while no statistically significant difference was observed in the blood routine indexes of the control group before and after treatment. As of now, apart from two cases of gastrointestinal adverse reactions observed in the control group, no other evident drug-related adverse reactions have been noted.

Conclusion:The use of Shengxuening tablets for the treatment of CRA in patients with multiple myeloma can achieve more ideal efficacy than ferrous succinate and has a manageable safety profile.