A Study of Shengxuening Tablet in the Treatment of Chemotherapy-related Anemia in Hematologic Tumors
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
Cancer-related anemia (CRA) is one of the common accompanying diseases of malignant tumors.
In 2019, a cross-sectional survey on the anemia status of 7324 malignant tumor patients in 97
hospitals in China found that the incidence of CRA was about 49.24%. 92.84% of the patients
have not been given enough attention and effective treatment. According to the European
Oncological Anemia Survey, CRA has the highest incidence in leukemia patients, followed by
lymphoma/myeloma. CRA not only leads to a decline in the quality of life of patients, but
also reduces the sensitivity to radiotherapy and chemotherapy, and also causes hypoxia in
tumor tissue, which affects the prognosis of patients as an independent factor. At present,
the treatment of CRA mainly includes blood transfusion therapy, erythropoiesis-stimulating
agent (ESA) therapy, iron supplementation, etc. Conventional oral iron has low
bioavailability and strong gastrointestinal irritation. Although intravenous iron can quickly
replenish iron, excessive iron supplementation is prone to iron overload. Less acceptable.
Shengxuening Tablets are derived from silkworm excrement. The main components of iron
chlorophyllin and chlorophyll derivatives are very similar in structure to heme, and can be
directly absorbed by small intestinal mucosal cells, effectively supplementing the iron
elements required in the process of hematopoiesis. The investigators found that Shengxuening
Tablets can increase the number of peripheral blood cells in mouse models of
myelosuppression, improve bone marrow morphology, reverse the decrease in body weight and
spleen index, and increase the levels of serum erythropoietin and granulocyte-macrophage
colony-stimulating factor . Real-time fluorescent quantitative PCR and Western blot analysis
showed increased expression levels of stem cell factor (SCF), JAK2 and STAT3 in the liver.
These results indicated that Shengxuening Tablets promoted the recovery of hematopoietic
function in myelosuppressive models by increasing the secretion of hematopoietic factors and
activating the JAK2/STAT3 pathway. Therefore, in order to further confirm the preventive
effect, effectiveness and safety of Shengxuening Tablets in the treatment of anemia in
patients with hematological tumors complicated with anemia, this clinical trial was designed.