Comparing the effects of three therapeutic regimens of oral prednisolone, intravenous methylprednisolone, and oral prednisolone plus recombinant human thrombopoietin on platelet increase in patients with primary immune thrombocytopenic purpura: a clinical trial study.

Comparative effect of three therapeutic methods of prednisolone combined with recombinant human thrombopoietin and prednisolone alone and pulse methylprednisolone alone as first line treatment in patients with primary immune thrombocytopenic purpura

Randomized clinical trial work on 75 Mitla patients

In this study, the number of 75 patients with immune thrombocytopenic purpura who were diagnosed with ITP based on the existing symptoms and signs according to the international guidelines of the working group and are in the age range of 18 years and above, or people who have been diagnosed with ITP for three months and have platelets less than 30 x 10 9 / L or platelets above 30 x 10 9 / L with signs of bleeding based on the grading scores of bleeding symptoms will be included in the study.

Inclusion criteria include age 18-60 years, having a normal spleen size Patients with kidney failure, diabetes, pregnancy, secondary IIP (MDS, APS and collagen disease) and people who have taken drugs due to another disease in the last 3 months will be excluded from the study.

The first group: they will receive pulse methylprednisolone 2-3 mg/kg intravenously for 3 days every 2 weeks for 4 weeks until re-examination. The second group: They will receive oral prednisolone tablets 1 mg/kg daily for 4-6 weeks until re-examination. The third group: the analogue of the human compound will receive 250 micrograms weekly subcutaneously for 4 weeks along with oral prednisolone tablets 0.5 mg/kg daily until re-examination.

High doses of corticosteroids have many and varied side effects, including headache, anorexia, weakness, and nausea. Cardiovascular symptoms, eye symptoms, metabolic symptoms, and an increase in the possibility of infections (4)

All eligible subjects will be randomly assigned to one of the three groups receiving prednisolone alone, prednisolone + recombinant human thrombopoietin, and pulse methylprednisolone alone with a ratio of 1:1:1. The randomization method will be permuted block randomization, which will be done in 7 blocks of sizes 6, 9, 12, 15 until the sample size is exhausted using "Ralloc" package in STATA software. Patients will be included in each group based on the determined sample size and based on the list of randomized individuals (along with a specific research code for each individual).

All patient information will be entered into the database (Excel format) and after checking the the outliers terms and data cleaning, it will be prepared for statistical analysis. The final data file will be provided to the research unit of internal diseases department to conduct further studies.

The access period starts 6 months after the results are published

Researchers in academic institutions

If there is a positive outcome and to need for further studies in this field

Dr. Rehane Azimi Nobari-Imam Hossein Hospital- internal disease clinics

using application form in research unit of hospital