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Hydroxychloroquine has been reported to have a clinically significant effect on the platelet count in systemic lupus thrombocytopenia. Its action may be due to its immune modulator effect. Immune thrombocytopenia (ITP) is known as an immune-mediated acquired disease characterized by transient or persistent decrease of the platelet count. However, refractory ITP is lacking of effective treatments and the efficacy of decitabine in ITP remains poorly understood. Data from this study may provide some idea of Hydroxychloroquine in the treatment of ITP in comparison to other lines of treatment as detected by the standardized definitions.
This study will include patients with chronic ITP attending the out patients clinic of Clinical Hematology Unit of Internal Medicine Department of Assiut university Hospital to evaluate the safety and efficacy of hydroxychloroquine in comparison to other lines of treatment as detected by the standardized definitions . Detect the predictors for chronic ITP especially anti-nuclear antibodies (ANA) role and the effect of the proposed drugs on the level of anti-platelet antibodies. Evaluation of the health-related quality of life after treatments to answer this question; Is the most effective drug is linked to the best quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hydroxychloroquine group | Experimental | hydroxychloroquine tablets 200mg ,two times/day for at least 6 month |
|
| vincristine group | Active Comparator | vincristine ampoule , 1mg/ week, I.v drep over 2 hours for 4 weeks |
|
| azathioprine group | Active Comparator | azathioprine tablet 50mg, dose 100-150 mg daily for 6 month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | 200mg twice daily orally for at least 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet count | to detect response as the standard definition | Follow up untill response or death from any cause up to six months |
| side effects | any complication for any line of treatments line | Up to six months |
| Measure | Description | Time Frame |
|---|---|---|
| anti- nuclear antibodies role | Detecting the predictors for chronic ITP especially ANA role | before enrollment |
| Anti-platelets antibodies role | Evaluation of the effect of the proposed drugs on the level of anti-platelet antibodies . |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university hospital | Asyut | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26588926 | Background | Park YH, Yi HG, Lee MH, Kim CS, Lim JH. Clinical efficacy and tolerability of vincristine in splenectomized patients with refractory or relapsed immune thrombocytopenia: a retrospective single-center study. Int J Hematol. 2016 Feb;103(2):180-8. doi: 10.1007/s12185-015-1903-0. Epub 2015 Nov 20. | |
| 27935917 | Background |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| D014750 | Vincristine |
| D001379 | Azathioprine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| vincristine |
| Drug |
1mg intravenous weekly for 4 weeks |
|
| azathioprine | Drug | dose 100mg daily for at least 3 weeks |
|
|
| after6 months |
| Health quality life | The Arabic version of the 36-Item Short Form Survey Instrument (SF-36) questionnaire will be administered to all patients before & after treatment. This questionnaire is a validated one which assesses general health functioning . | after 6 months of treatment |
| Poudyal BS, Sapkota B, Shrestha GS, Thapalia S, Gyawali B, Tuladhar S. Safety and Efficacy of Azathioprine as a Second Line Therapy for Primary Immune Thrombocytopenic Purpura. JNMA J Nepal Med Assoc. 2016 Jul-Sep;55(203):16-21. |
| 28295192 | Background | Cooper N. State of the art - how I manage immune thrombocytopenia. Br J Haematol. 2017 Apr;177(1):39-54. doi: 10.1111/bjh.14515. Epub 2017 Mar 10. |
| 19200301 | Background | Michel M. Immune thrombocytopenic purpura: epidemiology and implications for patients. Eur J Haematol Suppl. 2009 Mar;(71):3-7. doi: 10.1111/j.1600-0609.2008.01206.x. |
| 24254965 | Result | Khellaf M, Chabrol A, Mahevas M, Roudot-Thoraval F, Limal N, Languille L, Bierling P, Michel M, Godeau B. Hydroxychloroquine is a good second-line treatment for adults with immune thrombocytopenia and positive antinuclear antibodies. Am J Hematol. 2014 Feb;89(2):194-8. doi: 10.1002/ajh.23609. Epub 2013 Nov 20. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |