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| Name | Class |
|---|---|
| Instituto de OftalmologÃa Fundación Conde de Valenciana | OTHER |
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The purpose of this study is to determine the changes of quality of life of patients with allergic rhinoconjunctivitis treated with standard medications plus Dialyzable Leukocyte Extracts (DLE). All patients will receive DLE in combination with current guide lines-suggested standard medication.
DLE are heterogenous mixtures of peptides under 10 kilo Daltons (kDa) obtained after disruption of peripheral blood leukocytes from healthy human donors. DLE have been reported to improve clinical response in allergies, such as asthma and atopic dermatitis.
The therapeutic effect of DLE is related to an immune modulatory effect that changes innate signaling pathways, such as Toll Like Receptors, and Nuclear Factor -kappa B; production of cytokines might also be modified with the use of DLE, including Tumor Necrosis Factor a, Interleukin (IL)-6, and induction of Interferon-g secretion, driving immune response to a T-helper Th1 immune-regulatory response, and thus helping to reduce allergy symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLE plus standard medications | Experimental | DLE + Second generation anti histamines + Nasal corticosteroids DLE 2mg/5 milliliters (mL) P.O. every 24h per 5 days, followed by 2 mg/mL P.O. twice weekly for 5 weeks, follow by 2 mg/5mL per week for 5 weeks. Second generation anti histamines at standard dosis every 24h, and Nasal corticosteroids two spray released per nostril every 24 h per 11 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DLE | Biological | Adjuvant treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Quality of Life evaluated by Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(s)) Spanish version for Mexico | 11 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toni Homberg, MD | National Polytechnic Institute | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37417619 | Derived | Homberg TA, Lara I, Andaluz C, Cervantes-Trujano E, Hernandez-Martinez PM, Perez-Tapia SM, Jimenez-Martinez MC. Quality of life in adult patients using dialyzable leukocyte extract for allergic rhinitis. Medicine (Baltimore). 2023 Jul 7;102(27):e34186. doi: 10.1097/MD.0000000000034186. |
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| ID | Term |
|---|---|
| D014165 | Transfer Factor |
| ID | Term |
|---|---|
| D008222 | Lymphokines |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| Second generation anti histamines + Nasal corticosteroids | Other | Standard treatment |
|
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |