Myelodysplastic Syndrome
Conditions
Interventions
Control group :Azacitidine
Treatment group:Sanzi Huangshi No.3 Pill Combined with Azacitidine
Sponsors
Shanghai municipal Hospital of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 75 years old; 2. Meet the diagnostic criteria of Western medicine for MDS; 3. The risk is classified as higher risk; 4. Do not meet the indications for transplantation (transplant indications include: age < 65 years old, high-risk group MDS patients; age < 65 years old, with severe cytopenia, ineffective after other treatments, or with genetic abnormalities with poor prognosis i.e. -7, 3q26 rearrangement, TP53 gene mutation, complex karyotype, monosomy karyotype lower-risk group patients.) or patients who refused to accept transplantation; 5. Agree to be followed up; 6. Complete follow-up and clinically relevant medical records; 7. Those who voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: The study was excluded if any of the following criteria were met: 1. Secondary MDS; 2. 5q-patients; 3. Transplant patients and peri-transplant patients; 4. The risk is classified as lower risk; 5. Patients with other hematologic or non-hematologic tumors; 6. Combined with more serious cardiovascular and cerebrovascular, liver, kidney and other organic diseases and peripheral neuropathy; 7. Pregnant or lactating women; 8. Patients with mental illness who cannot cooperate with the treatment; 9. Patients with Class A and Class B infectious diseases; 10. Patients with active hepatitis; 11. Patients who are participating in other clinical trials; 12. Patients with poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine;Blood cell production assay;Tumor-related indicators;Tumor Microenvironment Detection;Bone marrow biopsy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Arsenic concentrations in blood T;Urine routine;Fecal routine;Liver function;Kidney function;electrocardiogram; | — |
Countries
China
Contacts
Public ContactJiahui Lu
Shanghai municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed