Effect of compound kushen injection on immune function for patients with newly diagnosed multiple myeloma undergoing chemotherapy

Background: Therapy integrating traditional Chinese and Western medicine has been the most distinctive method for treating malignant tumors in China. As a representative of traditional Chinese medicine (TCM), compound Kushen injection (CKI, also known as Yanshu injection) is extracted from the Kushen (Radix sophorae flavescentis) and Baituling (Rhizoma smilacis glabrae) herbs, using modern standardized Good Manufacturing Processes (GMP). There have been numerous clinical reports demonstrating the anti‐ cancer effect of CKI, including the use of CKI to treat gastric cancer, liver cancer, lung cancer, breast cancer, ovarian cancer, colorectal cancer and additional cancer types. However, the literature contains little experimental data involving CKI in MM, and the underlying complex mechanisms of its anti‐cancer effects are not fully understood. Aims: The aim of the present study was to assess the clinical effectiveness and safety of compound Kushen injection (CKI) plus (vincristine, doxorubicin and dexamethasone) VAD regimen chemotherapy for the treatment of newly diagnosed multiple myeloma (MM). Methods: A total of 142 newly‐diagnosed MM patients were randomly assigned to the treatment group (n=72), and were treated with CKI plus chemotherapy, or the control group (chemotherapy only; n=70). After four treatment cycles, the treatment effect was evaluated including, overall response rate (ORR), quality of life (QoL), lymph cellular immunity function, secretion of cytokines and toxicity reactions. Results: Before treatment, the peripheral blood CD3+CD4+, CD3+CD8+, NK cells and cytokine (IL‐2, IFN‐γ) levels of MM patients were significantly decreased compared with health volunteers (p<0.05). In addition, TNF‐α levels were significantly increased in MM patients (p<0.05) compared with healthy volunteers. Post‐treatment, patients in the treatment group showed significantly higher levels of CD3+CD4+, CD3+CD8+, NK cells, IL‐2 and IFN‐γ than the control group (p <0.05). Furthermore, TNF‐α levels were significantly lower in the treatment group compared with the control group (p<0.05). ORR and QoL improvement rate in the treatment group was significantly higher than the control (87.5%vs 71.4%, p<0. 05; 65.3%vs 54.3%, p<0. 05, respectively), as was bone pain relief 3 months later for chemotherapy (p<0.05). In addition, the control group had more incidences of hematologic and nonhematologic toxicity compared with the treatment group (p<0.05). Summary/Conclusion: In conclusion, CKI plus standard chemotherapy appears to have enhanced short‐term efficacy and lower toxicity compared with standard chemotherapy alone, which may depend on increasing the patient's immunological function and improving the QoL.