Myelodysplastic syndrome (MDS)
Conditions
Interventions
Experimental group:Buxue Formula
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients accord with the diagnostic of WHO criteria and TCM syndrome type for myelodysplastic syndrome. 2. Patients with myelodysplastic syndrome according to the revised International Prognostic Scoring system (IPSS-R) score = 18 years old. 4. Eastern Cooperative Oncology Group (ECOG) physical status 12 weeks. 7. The patients are submitted to the treatment >= 12 weeks. 8. Those who voluntarily signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Secondary MDS; 2. Initial MDS with 5q- and/or chromosome 7 abnormality; 3. Indications of high-intensity therapy (allo-HSCT, chemotherapy, demethylation therapy); 4. Mental illness and inability to cooperate with treatment; 5. Pregnant and lactating patients; 6. Patients with severe liver function impairment, ALT or AST>= 1.5 times the upper limit of normal value; 7. Patients with severe renal function impairment, serum creatinine >= 1.5 times the upper limit of normal value; 8. Complicated with serious heart and lung function or organic damage, serious endocrine and metabolic diseases, and serious systemic infections; Active viral hepatitis or HIV positive; 9. Complicated with other advanced malignant tumors; 10. Allergic to the test drug or its related drug taste and ingredients; 11. Within 1 week of the first use of the drug in this study, the patient has received other hematopoietic treatment (including erythropoietin and similar drugs, rotesil generic similar drugs, androgens, thrombopoietin, platelet receptor agonists, traditional Chinese medicine with similar effects to the drug in this study, etc.) or is participating in other clinical trials and receiving clinical trial drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants who achieved hematologic improvement-erythroid (HI-E)>= 8 weeks from week 1 to week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants who achieved red blood cell transfusion independence (RBC-TI)>= 8 weeks from week 1 to week 12;Percentage of participants who achieved platelet transfusion independence (PLT-TI)>= 8 weeks from week 1 to week 12;Percentage of participants who achieved hematologic improvement-platelet (HI-P)>= 8 weeks from week 1 to week 12;Percentage of participants who achieved hematologic improvement-neutrophil (HI-N)>= 8 weeks from week 1 to week 12;Mean change from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Quality of Life Score;Mean change from baseline in the Function Assessment of Cancer Therapy-Anemia (FACT-An) Score;Incidence and severity of bleeding using the WHO (World Health Organization) Bleeding Scale; | — |
Countries
China
Contacts
Public ContactDai Xiping
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed