Objective

2

To observe the effect of modified

Shenling Baizhu Powder

（参苓白术散， SBP） on peripheral blood counts and immune function in breast cancer patients with chemotherapy-induced myelosuppression and spleen-kidney insufficiency syndrome.

Methods

2

A randomized， double-blind， placebo-controlled trial was conducted. A total of 102 breast cancer patients with chemotherapy-induced myelosuppression and spleen-kidney insufficiency syndrome were randomly divided into a treatment group and a control group， with 51 cases in each group. Both groups rece

ived granulocyte colony-stimulating factor （G-CSF） support therapy and blood component transfusion therapy after chemotherapy. The treatment group additionally took modified SBP orally at one dose per day， while the control group was administered with placebo orally at the same dosage. Each chemotherapy cycle lasted 21 days and was defined as one treatment course. A total of four treatment courses were administered， with either herbal medicine or placebo taken orally for three weeks during each course. The primary outcome measures were peripheral blood para-meters including white blood cell count （WBC）， red blood cell count （RBC）， platelet count （PLT）， and hemoglobin （Hb） levels； secondary outcome measures were comprised of immune function parameters including CD3

+

lymphocyte percentage， CD4

+

lymphocyte percentage， CD8

+

lymphocyte percentage， immunoglobulin A （IgA）， immunoglobulin G （IgG）， and immunoglobulin M （IgM）， traditional Chinese medicine （TCM） syndrome scores， chemotherapy completion rate， and incidence of adverse reactions.

Results

2

During the study， 2 cases in the treatment group and 3 cases in the control group were lost， resulting in a final analysis of 49 cases in the treatment group and 48 cases in the control group. Compared with baseline values， WBC， RBC， PLT， Hb， CD3

+

， CD4

+

， CD4

+

/CD8

+

ratio， IgA， IgG and IgM levels increased in both groups， while CD8

+

lymphocyte percentage and TCM syndrome scores decreased （

P

＜0.05）. Compared to the control group after treatment， the treatment group had higher levels of WBC， PLT， Hb， CD3

+

， CD4

+

， IgA， IgG and IgM， and lower levels of CD8

+

lymphocyte percentage and TCM syndrome scores （

P

＜0.05）. The chemotherapy completion rate in the treatment group was 91.84% （45/49）， which was higher than 77.08% （37/48） in the control group （

P

＜0.05）. The overall incidence of adverse

reactions in the treatment group was 30.61% （15/49）， significantly lower than 56.25% （26/48） in the control group （

P

＜0.05）.

Conclusion

2

Modified SBP as an adjuvant therapy can effectively improve the peripheral blood counts， enhance the body's immune function， and demonstrate favorable safety in breast cancer patients with myelosuppression and spleen-kidney insufficiency syndrome during chemotherapy.