myelodysplastic syndrome.
Conditions
Interventions
Test group:Pai-neng-da capsule 3 capsules a day two times + Andriol capsule 80 mg a day two times + thalidomide 100mg every night a + need transfusion symptomatic and supportive treatment
Control Group:Andriol capsule 80 mg a day two times + thalidomide 100mg every night a + need transfusion symptomatic and supportive treatment
Sponsors
Ningbo First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. In accordance with the Vienna diagnostic criteria for diagnosis of MDS, including refractory anemia (RA), refractory blood cells reduce monophyletic dysplasia associated with refractory blood cells (RCUD) and reduce associated with multi lineage dysplasia (RCMD) three types. And according to IPSS score, 0-1 points of the middle and low risk group patients; 2. the diagnosis of TCM Deficiency Syndrome MDS based on the diagnosis of Western medicine, according to the "guiding principle for clinical research on new drug", the main symptoms of the deficiency syndrome are as follows. The main symptoms of complexion owed to China, dizziness, God fatigue, palpitations, insomnia, dizziness, tinnitus, dry mouth and throat, hectic fever and sweating, shape cold limbs, appetite loss, dry stool or a pond rotten, or Nvxue, thin white fur / white or less moss, tongue pale or fat and tender with scalloped or red tongue, thready pulse, or breakdown. There are 2 or more of the above symptoms, tongue and pulse can be diagnosed and / or; 3. age 18-75 years old, men and women are not limited; 4. expected to survive for more than 1 years; 5. the function of the liver and kidney was normal and the electrocardiogram was normal.
Exclusion criteria
Exclusion criteria: 1. a woman with a pregnancy or a lactation or a psychiatric patient; 2. serum creatinine Cr>1.5mg/ml (133 mol/L) or corrected creatinine clearance 2 times the upper limit); 4. known for any drug or drug having the same chemical structure as the test drug; 5. the assessment of the study may be affected by the combined severity of any disease; 6. the researchers considered the poor patient compliance; 7. Bone marrow hyperplasia comprehensive anomalies of certain types of syndrome: refractory anemia with excess of blasts, the 5q - syndrome, myelodysplastic syndrome unclassified; or IPSS score greater than or equal to 1.5 points requires the use of more aggressive treatment, such as methyl treatment, chemotherapy and bone marrow transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine test;Bone marrow routine test; | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence of infection;Amount of blood transfusion; | — |
Countries
China
Contacts
Public ContactGuifang Ouyang
Outcome results
None listed