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Adverse cutaneous drug reactions are undesirable and typically unanticipated reactions independent of the intended therapeutic purpose of a medication. It may be either immunologic (eg, drug allergy) or non-immunologic. Adverse cutaneous drug reaction produce a wide range of clinical manifestations such as pruritus, maculopapular eruptions, urticaria, angioedema, phototoxic and photo allergic reactions, fixed drug reactions, erythema multiforme,vesiculobullous reactions (eg, Stevens-Johnson syndrome and toxic epidermal necrolysis) and serum sickness .They must be considered in the differential diagnosis of sudden symmetric eruption
Erythema multiforme is an acute immune mediated disorder It is a type IV hypersensitivity reaction leading to dermal vasculitis. Erythema multiforme major usually as a result of medications such as sulphonamides, non-steroidal anti-inflammatories and penicillin and there is skin and mucosal involvement.
Steven-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are considered a spectrum of acute life-threatening mucocutaneous reactions that differ only in severity. Both diseases are characterized by mucous membrane and skin involvement, are often caused by medications and are collectively known as epidermal necrolysis or scalded skin syndrome.Stevens-Johnson syndrome (SJS) is classified as an epidermal loss <10% of the body surface area.Toxic Epidermal Necrolysis (TEN) is indicated by >30% body surface area erosion. The range of epidermal loss between 10% and 30% is called Stevens-Johnson syndrome-Toxic Epidermal Necrolysis (SJS-TEN) overlap. Severity of illness score [Score of Toxic Epidermal Necrolysis(TEN) ] has been devised to predict prognosis in patients with Epidermal Necrolysis.This scoring system addresses 7 prognostic factors: age, malignancy, heart rate,Body Surface Area involved, serum urea, serum glucose and serum bicarbonate levels.
Interleukin-21 regulates both innate and adaptive immune responses and it is not only has key roles in antitumour and antiviral responses that promote the development of autoimmune diseases and inflammatory disorders. It is recently discovered member of the type 1 cytokine family which is produced by activated clusters of differentiation 4+ T cells ,Natural killer cells and follicular helper T cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | measure serum interleukin 21 level in patients with severe adverse drug reaction who show change in serum interleukin 21 before and after therapy the following investigation will be done at the begning of the study to patients: Complete Blood Picture Erythrocyte Sedimentation Rate Random blood sugar Liver function tests Kidney function tests |
|
| control group | Placebo Comparator | compare serum interleukin 21 level in patients with severe adverse drug reaction and healthy control subjects |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| serum interleukin 21 | Diagnostic Test | it is cytokine used as a marker to detect it's level in patients with adverse drug reactions |
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| Measure | Description | Time Frame |
|---|---|---|
| the patients with severe adverse cutaneous drug reaction who show change in serum interleukin 21 before and after therapy | blood sample will be taken from patients | one month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fathya Ali, MD | Contact | 01000197217 | Askar21@yahoo.com | |
| Hanan Ahmed, MD | Contact | 01064447881 | hanan-morsy2003@yahoo.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25709487 | Result | Farshchian M, Ansar A, Zamanian A, Rahmatpour-Rokni G, Kimyai-Asadi A, Farshchian M. Drug-induced skin reactions: a 2-year study. Clin Cosmet Investig Dermatol. 2015 Feb 9;8:53-6. doi: 10.2147/CCID.S75849. eCollection 2015. | |
| 25246464 | Result | Hidajat C, Loi D. Drug-mediated rash: erythema multiforme versus Stevens-Johnson syndrome. BMJ Case Rep. 2014 Sep 22;2014:bcr2014205543. doi: 10.1136/bcr-2014-205543. |
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| Complete Blood Picture | Diagnostic Test | It is a blood sample will taken from patients to detect any abnormalities in blood component at the start of the study |
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| Liver function test | Diagnostic Test | It is a blood sample will taken from patients to detect any associated liver disease at the start of the study |
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| Random Blood Sugar | Diagnostic Test | measure blood sugar in patients included in the study at the start of the study |
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| Erythrocyte Sedimentation Rate | Diagnostic Test | blood sample will be taken from patients to detect any abnormalities in erythrocyte sedimentation rate at the start of the study |
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| Kidney function tests | Diagnostic Test | blood sample will be taken from patients to detect any kidney disease before the start of the study |
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| 25249808 | Result | Ellender RP, Peters CW, Albritton HL, Garcia AJ, Kaye AD. Clinical considerations for epidermal necrolysis. Ochsner J. 2014 Fall;14(3):413-7. |
| 24649038 | Result | Gong F, Su Q, Pan YH, Huang X, Shen WH. The emerging role of interleukin-21 in allergic diseases (Review). Biomed Rep. 2013 Nov;1(6):837-839. doi: 10.3892/br.2013.166. Epub 2013 Sep 12. |
| ID | Term |
|---|---|
| D008111 | Liver Function Tests |
| D001799 | Blood Sedimentation |
| D007677 | Kidney Function Tests |
| ID | Term |
|---|---|
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D003950 | Diagnostic Techniques, Urological |
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