Clinical Outcomes of Sanshen Fuzheng Decoction in Preventing Chemotherapy-induced Neutropenia in Ovarian Cancer

Summary

Sanshen Fuzheng Decoction, as an adjuvant to paclitaxel-carboplatin chemotherapy for ovarian cancer, reduces chemotherapy-induced neutropenia and recombinant human granulocyte colony-stimulating factor dosage, improves immune indices, and demonstrates safety without hepatic or renal toxicity. These preliminary findings warrant confirmation in larger multicenter studies.

Abstract

This study aimed to explore the clinical value of Sanshen Fuzheng Decoction in the secondary prevention of chemotherapy-induced neutropenia in patients with malignant ovarian tumors. Sixty patients with primary ovarian cancer who received postoperative chemotherapy between January 2022 and January 2023 were enrolled. Using a random number table, they were equally divided into a treatment group and a control group (n = 30 each). The control group received standard paclitaxel plus carboplatin (TP) chemotherapy (paclitaxel + carboplatin), while the treatment group received TP combined with Sanshen Fuzheng Decoction. Baseline indicators were not significantly different between groups before chemotherapy (P > 0.05). On days 3, 7, 10, 14, and 20 post chemotherapy, both groups showed increased hemoglobin (Hb), red blood cell (RBC), neutrophil (NE) counts, interleukin-2 (IL-2), and interleukin-6 (IL-6), and decreased white blood cell (WBC), lymphocyte (LYM), and platelet (PLT) counts. Compared to the control group, the treatment group showed significantly greater increases in Hb, RBC, NE, interleukin-2 (IL-2), and interleukin-6 (IL-6), and the decrease in LYM was more obvious, while the decrease in WBC and PLT was smaller (all P < 0.05). The total dose of recombinant human granulocyte colony-stimulating factor (rhG-CSF) and the duration of leukopenia were significantly lower in the treatment group (P < 0.05). Additionally, more improvement in Traditional Chinese Medicine (TCM) symptom scores (fatigue, weakness, sweating, dizziness, pale complexion) was observed in the treatment group. The incidence of chemotherapy-related toxic side effects was significantly lower in the treatment group (P < 0.05). No significant differences were observed in liver/kidney function, febrile neutropenia, or absolute neutrophil count (ANC) reduction (P > 0.05). San shen Fu zheng Decoction, as an adjunct to chemotherapy in ovarian cancer, showed potential benefits in improving hematological recovery, reducing rhG-CSF use, and alleviating treatment-related symptoms.

Introduction

Ovarian cancer is the third most common gynecologic malignancy worldwide. It is often diagnosed at an advanced stage, with a high recurrence and mortality rate, and a low survival rate, posing a serious health threat to women¹. Globally, the incidence of ovarian cancer is approximately 5.0 per 100,000 in developing countries and 9.1 per 100,000 in developed countries². The primary treatment for ovarian cancer is surgery, supplemented by chemotherapy, with the goal of reducing residual tumor cells and improving survival outcomes³. Despite advancements in surgical techniques and chemotherapy regimen....

Protocol

Ethics approval for this study was obtained from the Ethics Committee of Jinhua Maternal and Child Health Hospital at Jinhua Maternal and Child Health Center (approval number: 2022KY014). All participants were provided with information regarding the study and gave their written informed consent prior to participation. This study was conducted in compliance with the Declaration of Helsinki and all applicable ethical guidelines.

Study subjects

A total of 60 patients with primary ovarian cancer who underwent postoperative chemotherapy at our hospital between January 2022 and January 2023 were enrolled in this study. P....

Results

Comparison of baseline characteristics between the control and treatment groups

Table 1 presents the baseline characteristics of patients in both groups. There were no significant differences between the two groups across all baseline variables (all p > 0.05). This indicates that the two groups were comparable at the start of the study, eliminating the influence of potential confounding facto.......

Discussion

Chemotherapy remains a cornerstone in the management of ovarian cancer, primarily through the cytotoxic effects of antineoplastic agents that inhibit the synthesis of functional proteins and suppress tumor cell proliferation, ultimately inducing apoptosis in malignant cells. However, due to the intrinsic toxicity of these agents, chemotherapy-induced leukopenia (CIN) has emerged as one of the most common dose-limiting toxicities. This condition directly compromises immune function, thereby increasing the susceptibility t.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Carboplatin for Injection (AUC 5–6)	Qilu Pharmaceutical Co., Ltd., Jinan, China	National Drug Approval No. H20093458	Administered intravenously on day 1, every 3 weeks
ELISA Kit for IL-2	Invitrogen, Thermo Fisher Scientific, USA	Cat. No. 88-7346-88	Quantitative detection of plasma IL-2 levels
ELISA Kit for IL-6	Invitrogen, Thermo Fisher Scientific, USA	Cat. No. EH2IL6	Quantitative detection of plasma IL-6 levels
Hematology Analyzer	Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, China	BC-7500 CRP	Fully automated hematology analyzer; daily calibration; used for WBC, RBC, Hb, PLT, LYM, NE; RRID: SCR_021849
Microplate Reader	Shenzhen Huisong Technology Co., Ltd., China	Model MB-530	Optical density measured at 430 nm
Paclitaxel for Injection (175 mg/m²)	Bristol-Myers Squibb Co., Ltd., Shanghai, China	National Drug Approval No. H20030009	Used in TP chemotherapy regimen; intravenous infusion over 3 h, day 1, every 3 weeks
Recombinant Human G-CSF (rhG-CSF)	Kyowa Kirin China Pharmaceutical Co., Ltd., Shanghai, China	National Drug Approval No. J20180062	Subcutaneous injection, 5 μg/kg/day during neutropenia until ANC ≥ 1.0×109/L
Sanshen Fuzheng Decoction	Prepared by Hospital Pharmacy, Jinhua Maternal and Child Health Hospital	—	Prescription verified by hospital pharmacy; herbs obtained from GMP-certified manufacturer (Jinhua Intech Pharmaceutical Co., Ltd., Jinhua, China); decoction freshly prepared daily
— Angelica sinensis (Danggui)	Jinhua Intech Pharmaceutical Co., Ltd., China	Batch No. 20220511	15 g; blood tonic
— Astragalus membranaceus (Huangqi)	Jinhua Intech Pharmaceutical Co., Ltd., China	Batch No. 20220508	30 g; tonic herb for Qi reinforcement
— Codonopsis pilosula (Dangshen)	Jinhua Intech Pharmaceutical Co., Ltd., China	Batch No. 20220510	30 g; supports spleen and lung Qi
— Honey-fried Glycyrrhiza uralensis (Zhigancao)	Jinhua Intech Pharmaceutical Co., Ltd., China	Batch No. 20220520	3 g; harmonizing herb
— Jujube (Dazao)	Jinhua Intech Pharmaceutical Co., Ltd., China	Batch No. 20220519	15 g; Qi tonic and harmonizing herb
— Poria cocos (Fuling)	Jinhua Intech Pharmaceutical Co., Ltd., China	Batch No. 20220518	15 g; diuretic and spleen tonic
— Salvia miltiorrhiza (Danshen)	Jinhua Intech Pharmaceutical Co., Ltd., China	Batch No. 20220512	15 g; promotes blood circulation
— Saposhnikovia divaricata (Fangfeng)	Jinhua Intech Pharmaceutical Co., Ltd., China	Batch No. 20220517	10 g; dispels wind and relieves exterior
— Scrophularia ningpoensis (Xuanshen)	Jinhua Intech Pharmaceutical Co., Ltd., China	Batch No. 20220509	10 g; nourishes Yin and clears heat
— Stir-fried Atractylodes macrocephala (Baizhu)	Jinhua Intech Pharmaceutical Co., Ltd., China	Batch No. 20220513	15 g; strengthens spleen Qi
— Stir-fried Paeonia lactiflora (Baishao)	Jinhua Intech Pharmaceutical Co., Ltd., China	Batch No. 20220515	15 g; nourishes blood and harmonizes Ying
— Wheat grain from Huai region (Huai Xiaomai)	Jinhua Intech Pharmaceutical Co., Ltd., China	Batch No. 20220516	30 g; calms the spirit
Vacuum Blood Collection Tubes (Heparin, EDTA)	Becton Dickinson (BD Vacutainer), Franklin Lakes, NJ, USA	—	Used for plasma and serum sample collection