Effects of Qixuekang oral liquid in leukopenia during chemotherapy and radiotherapy in patients with malignant tumors: A randomized, double-blind, placebo-controlled, multicenter study

Objective: To assess the efficacy and safety of Qixuekang oral liquid in the treatment of leukopenia during chemotherapy and radiotherapy. Methods: This randomized, double-blind, placebo-controlled, multicenter clinical trial was conducted between July 2018 and May 2021. A total of 234 patients with malignant tumors were enrolled from 12 medical centers. They were randomly assigned to receive either Qixuekang oral liquid or placebo in addition to standard chemotherapy and radiotherapy, with a treatment duration ≤42 days. The primary outcome was defined as the change in peripheral white blood cell (WBC) count, determined by routine laboratory hematology tests, from baseline (D-7 to D0) to Day 42 (±2 days) of dosing (D42). Results: In the full analysis set comprising 227 patients (113 and 114 in the experimental and control groups, respectively), a significant reduction in WBC count was observed after treatment (P < .001). The experimental group exhibited a smaller reduction in WBC count than did the control group (P = .038). In the per-protocol set (n = 188), a trend favoring the experimental group was evident, although not statistically significant (P = .091). No significant differences were observed in the vital signs, laboratory results, or adverse events between the two groups (P > .05). Conclusion: Qixuekang oral liquid may exert a therapeutic effect in mitigating leukopenia induced by chemotherapy and radiotherapy, while exhibiting favorable safety profiles.