Chinese Abstract

Chinese Abstract

Objective: To investigate the function and mechanism of Pei's Hematopoietic Granules (PG) on enhancing efficacy and reducing toxicity through observing the PG combined with 5-Fu on the weights of solid tumor and the immune organs, the levels of T-cell subgroups and Interleukin-2 (IL-2) in H22 bearing mice.

Methods: The fifty models of solid tumor by hepatoma cell H22 transplantation in mice were divided into five groups: model group, 5-Fu group, PG low, medium and high dose combined with 5-Fu groups. There were ten mice in each group. The next day, except the model group the rest groups were dealt with drug-intervention, once a day for ten days. After that, all mice were killed, and the weights of solid tumor, thymus and spleen were measured, and the tumor inhibiting rates, the thymus index (TI) and the spleen index (SI) were calculated. The levels of CD3、CD4、CD8+ was measured by flow cytometric technique and IL-2 was measured by RIA.

Results: The experiment showed: 1. The tumor inhibiting rates were higher in each PG combined with 5-Fu groups than that in the 5-Fu group and in PG high dose combined with 5-Fu group it was 72.4%; 2. The TI and SI was increased in PG combined with 5-Fu groups. In PG high dose combined with 5-Fu group they were significantly increased, The TI was 14.2mg/10g (p<0.05) and The SI was 52.4mg/10g (p<0.05); 3. The levels of CD3、CD4+、CD4/CD8+ were higher while CD8+ was lower in the three PG combined with 5-Fu groups than those in the 5-Fu groups, and CD4+/CD8+ in PG combined with 5-Fu groups were: 5.9、6.4、5.2 (p<0.05); 4. The levels of IL-2 in PG medium dose combined with 5-Fu group was 1.18ng/ml, it was markedly higher in 5-Fu group (p<0.05).

Conclusion: PG can enhance efficacy and reduce toxicity obviously. Improving the anti-tumor effect of 5-Fu can reflect the enhancing efficacy, especial the PG high dose combined with 5-Fu group. Improving the levels of CD3、CD4 and IL-2 can reflect the reducing toxicity, especial the PG medium dose combined with 5-Fu group. PG can regulate the immune function of tumor-bearing mouse, improve the reaction of economy, consequently it can attain the function of improving the immune function and reducing the adverse reactions of chemotherapy.

KEY WORDS: Peishishengxue Granule; tumor inhibiting rates; SI; TI; the T-cell subgroups; IL-2

Research on Pei Zhengxue's Series of Formulas and Medicines

ABSTRACT

Objective: To investigate the function and mechanism of Pei's Hematopoietic Granules (PG) on enhancing efficacy and reducing toxicity through observing the PG combined with 5-Fu on the weights of solid tumor and the immune organs, the levels of T-cell subgroups and Interleukin-2 (IL-2) in H22 bearing mice.

Methods: The fifty models of solid tumor by hepatoma cell H22 transplantation in mice were divided into five groups: model group, 5-Fu group, PG low, medium and high dose combined with 5-Fu groups. There were ten mice in each group. The next day, except the model group the rest groups were dealt with drug-intervention, once a day for ten days. After that, all mice were killed, and the weights of solid tumor, thymus and spleen were measured, and the tumor inhibiting rates, the thymus index (TI) and the spleen index (SI) were calculated. The levels of CD3、CD4、CD8+ was measured by flow cytometric technique and IL-2 was measured by RIA.

Results: The experiment showed: 1. The tumor inhibiting rates were higher in each PG combined with 5-Fu groups than that in the 5-Fu group and in PG high dose combined with 5-Fu group it was 72.4%; 2. The TI and SI was increased in PG combined with 5-Fu groups. In PG high dose combined with 5-Fu group they were significantly increased, The TI was 14.2mg/10g (p<0.05) and The SI was 52.4mg/10g (p<0.05); 3. The levels of CD3、CD4+、CD4/CD8+ were higher while CD8+ was lower in the three PG combined with 5-Fu groups than those in the 5-Fu groups, and CD4+/CD8+ in PG combined with 5-Fu groups were: 5.9、6.4、5.2 (p<0.05); 4. The levels of IL-2 in PG medium dose combined with 5-Fu group was 1.18ng/ml, it was markedly higher in 5-Fu group (p<0.05).

Conclusion: PG can enhance efficacy and reduce toxicity obviously. Improving the anti-tumor effect of 5-Fu can reflect the enhancing efficacy, especial the PG high dose combined with 5-Fu group. Improving the levels of CD3、CD4 and IL-2 can reflect the reducing toxicity, especial the PG medium dose combined with 5-Fu group. PG can regulate the immune function of tumor-bearing mouse, improve the reaction of economy, consequently it can attain the function of improving the immune function and reducing the adverse reactions of chemotherapy.

KEY WORDS: Peishishengxue Granule; tumor inhibiting rates; SI; TI; the T-cell subgroups; IL-2

Research on Pei Zhengxue's Series of Formulas and Medicines

Foreword

Pei's Hematopoietic Granules is a specialized formula for treating hematological diseases, formulated by Professor Pei Zhengxue, a renowned expert in integrated Chinese and Western medicine and my mentor, through long-term clinical practice. This formula is mainly composed of Liuwei Dihuang Decoction combined with Shengmai Powder, with appropriate modifications. Liuwei Dihuang Decoction tonifies the kidney, while Shengmai Powder strengthens the spleen; additionally, Taizishen, Lüdangshen, and Beishashen are added to replenish qi and consolidate the root. In 1968, this formula completely cured a patient named Ma Changsheng suffering from acute monocytic leukemia (M₅), and at the National Hematology Conference held in Suzhou in 1974, it was officially named the "Lanzhou Formula" [1]. The formula has demonstrated remarkable efficacy in the clinical treatment of tumors and hematological diseases. In 1997, as an in-house preparation of the Gansu Provincial Academy of Medical Sciences, it was developed into "Pei's Hematopoietic Granules." Starting in 2002, this preparation was used as a clinical research project of the Gansu Provincial Academy of Medical Sciences for experimental studies and subsequently passed the evaluation of research outcomes. It was awarded the First Prize of the Huangfu Mi Science and Technology Achievement Award of Gansu Province in 2003.

Pei's Hematopoietic Granules takes "supporting the righteous and consolidating the root" as its fundamental principle, focusing on regulating the body's reactivity—specifically, enhancing immune function—so that the state of immune deficiency in the body can be improved to varying degrees, thereby achieving clinical efficacy. This traditional Chinese medicine approach of "supporting the righteous and consolidating the root" shares striking similarities with modern medical disciplines such as immunology, molecular biology, and genomics [2].

Over more than 40 years of clinical application, Pei's Hematopoietic Granules has proven not only effective for hematological diseases but also for malignant tumors, particularly in improving the immune dysfunction caused by radiotherapy and chemotherapy in cancer patients. Clinical practice has shown that this formula exhibits significant therapeutic effects on esophageal cancer, liver cancer, malignant lymphoma, aplastic anemia, and other conditions. According to incomplete statistics gathered during my time as a disciple and assistant in clinical practice, this granule has cured three cases of leukemia, three cases of aplastic anemia, three cases of primary liver cancer, one case of gastric cancer, and three cases of esophageal cancer [3–6].

Li et al. [7] conducted an efficacy observation study using Pei's Hematopoietic Granules in combination with chemotherapy for 10 cancer patients, which showed that, in terms of short-term efficacy, the Pei's Hematopoietic Granules group outperformed the chemotherapy-only group (P<0.05); in terms of toxic side effects, the Pei's Hematopoietic Granules group experienced significantly milder adverse reactions than the chemotherapy-only group (P<0.01). Qiu et al. [8] observed the use of Pei's Hematopoietic Granules combined with radionuclide therapy for 15 liver cancer patients, where the treatment group received radionuclides plus Pei's Hematopoietic Granules, while the control group received only radionuclides. They found that the treatment group had markedly fewer toxic side effects than the control group, and there was also a significant difference in therapeutic efficacy between the two groups. Xue et al. [9] used Pei's Hematopoietic Granules to treat primary liver cancer, resulting in a noticeable reduction in tumor size, complete recovery of liver function, improved quality of life, and prolonged survival.

Regarding experimental studies on Pei's Hematopoietic Granules, previous researchers have conducted various animal experiments, demonstrating that Pei's Hematopoietic Granules can improve immune function in aplastic anemia model mice and tumor-bearing mice [10–15]. This paper, based on the establishment of an H₂₂ tumor-bearing mouse model, investigates the effects of Pei's Hematopoietic Granules on tumor growth, immune organ indices, peripheral blood levels of CD₃⁺, CD₄⁺, and CD₈⁺ T lymphocytes, and serum IL-2 content in tumor-bearing mice after 5-Fu chemotherapy, aiming to explore the drug's detoxification and synergistic effects as well as their underlying mechanisms. The goal is to identify new anti-tumor targets for Pei's Hematopoietic Granules and provide scientific, microscopic, and objective evidence for its widespread clinical application.

Experimental Study