Clinical Observation on Effect of Shuanghuang Shengbai Granule (双黄升白冲剂) on Chemotherapy Induced Myelosuppression in Tumor Patients and on Ultrastructure of Bone Marrow in Mice

To observe the leucocyte increasing effect of Shuanghuang Shengbai Granule (SHSBG) in tumor patients treated by chemotherapy and the bone marrow microenvironment protecting effect in mice.Methods: Patients of non-small-cell pulmonary, mammary, gastric or intestinal cancer, who were ready for receiving re-treatment of chemotherapy, were enrolled and divided into 4 groups randomly. The 28 cases in SHSBG group A received chemotherapy combined with SHSBG; the 27 in the SHSBG group B received chemotherapy alone at first, and SHSBG was added when their peripheral white blood cell (WBC) count lowered to ＜4×109/L; the 33 in control group A and 24 in control group B were treated by the method similar to that applied to SHSBG group A and B respectively but with Rubidate instead of SHSBG. Experimental study of electron microscopic observation on bone marrow ultrastructure in mice was also conducted.Results: The total leukocyte increasing effective rate occurred in SHSBG group A and B was 75.00% and 88.89%, while in control group A and B, 54.55% and 58.33% respectively, and the difference between the SHSBG groups and the control groups was significant (P<0.01). Experimental study showed that SHSBG has good bone marrow hematopoietic microenvironment protecting and improving effect in mice.Conclusion: SHSBG has obvious protecting and treating effect on chemotherapy induced bone marrow suppression in tumor patients.

Clinical Observation of Shuanghuang Shengbai Granule(双黄升白颗粒) on Prevention and Treatment of Myelosuppression Caused by Chemotherapy in Cancer Patients

Objective： To study the efficacy and safety of Shuanghuang Shengbai Granule（双黄升白颗粒, SSG）, a traditional Chinese herbal medicine, on myelosuppression of cancer patients caused by chemotherapy. Methods： A total of 330 patients were randomly assigned to the treatment group（220 cases, analysed 209 cases） and the control group（110 cases, analysed 102 cases） with a 2：1 ratio by envelope method. The patients in the treatment group at the first day of chemotherapy started to take SSG for 14 days, while the patients in the control group took Leucogon Tablets. The changes of the blood routine, clinical symptoms and immune function in both groups were observed for safety and efficacy evaluation. Results： At the 7th day of chemotherapy, the white blood cells（WBCs） level in the treatment group was significantly higher than that in the control group（P〈0.05）. After treatment, the WBCs rate in the normal range accounted for 50.2% in the treatment group, the myelosuppression of WBCs and neutrophil were mainly grade Ⅰ, while 8.1% and 5.7% of patients emerged grade Ⅲ and grade Ⅳ myelosuppression, respectively. The incidence of myelosuppression of the treatment group was significantly lower than that of the control group（P〈0.05）. The total effective rate of Chinese medicine syndrome in the treatment group was significantly higher than that in the control group（84.2% vs. 72.5%, P〈0.05）. The immune cell levels in both groups were maintained in the normal range. Compared with that before treatment, the levels of CD3~＋ and CD4~＋ cells were significantly increased in the treatment group after treatment（P〈0.05）. The discrepancy of CD3~＋ and CD4~＋ cell activity before and after treatment in both groups were significantly different（P〈0.05）. No obvious adverse event occurred in both groups. Conclusion： SSG had a protection effect on bone marrow suppression, and alleviated the clinical symptoms together with clinical safety.