Inflammatory Response to Hydroxyurea Therapy in Sickle Cell Disease
Maneno muhimu
Kikemikali
Maelezo
Plasmatic proinflammatory molecules (C-reactive protein, orosomucoid, RANTES, IL-6, IL-8, MCP-1, IL-1A, IL-1B, ET-1, IL-4, IL-10, TNFalpha, IFNgamma), hormones from the hypothalami-pituitary-adrenal axis (cortisol, ACTH), and hypothalamic peptids (arginine vasopressin, corticotrophin-releasing hormone) will be measured from SCD children treated or not with HU (20 treated children, 20 untreated children with a history of vaso-occlusive events, 20 asymptomatic children, and 20 healthy African controls).
Tarehe
| Imethibitishwa Mwisho: | 12/31/2012 |
| Iliyowasilishwa Kwanza: | 10/26/2008 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 10/30/2008 |
| Iliyotumwa Kwanza: | 11/01/2008 |
| Sasisho la Mwisho Liliwasilishwa: | 01/29/2013 |
| Sasisho la Mwisho Lilichapishwa: | 01/30/2013 |
| Tarehe halisi ya kuanza kwa masomo: | 04/30/2009 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 09/30/2012 |
| Tarehe ya Kukamilisha Utafiti: | 10/31/2012 |
Hali au ugonjwa
Uingiliaji / matibabu
Drug: Hydroxycarbamide, Hydroxyurea (drug)
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Homozygous SS sickle cell children Hydroxycarbamide, Hydroxyurea (drug):
Homozygous SS sickle cell children, aged > 3 years, of sub-Saharian Africa extraction, in a steady-state of disease , taken no drug except penicillin-V, folate or iron supplementation, hydroxyurea, divided into three groups :
children treated with hydroxyurea 20-25 mg/kg/day since at least 3 months with clinical efficacy on vaso-occlusive events
untreated children with major vaso-occlusive events
children > 5 year-old without a history of vaso-occlusive events
Controls : heterozygous AS parents or siblings of the patients, and AA siblings or healthy African unrelated subjects, aged > 3 years, taken no drug on the day of blood sampling. | |
| Homozygous SS children Hydroxycarbamide, Hydroxyurea (drug):
Homozygous SS children, aged > 3 years, of sub-Saharian Africa extraction, in a steady-state of disease, taken no drug except penicillin-V, folate or iron supplementation, hydroxyurea, divided into three groups :
children treated with hydroxyurea 20-25 mg/kg/day since at least 3 months with clinical efficacy on vaso-occlusive events
untreated children with major vaso-occlusive events
children > 5 year-old without a history of vaso-occlusive events
Controls : heterozygous AS parents or siblings of the patients, and AA siblings or healthy African unrelated subjects, aged > 3 years, taken no drug on the day of blood sampling. |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 3 Years Kwa 3 Years |
| Jinsia Inastahiki Kujifunza | All |
| Njia ya sampuli | Non-Probability Sample |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | INCLUSION CRITERIA: 1. Homozygous SS sickle cell children, aged > 3 years, of sub-Saharian Africa extraction, in a steady-state of disease (free of any infectious or vaso-occlusive events for the 4 weeks prior to and 2 weeks after blood sampling, and transfusion-free for 4 months prior to blood sampling), taken no drug except penicillin-V, folate or iron supplementation, hydroxyurea, divided into three groups : - children treated with hydroxyurea 20-25 mg/kg/day since at least 3 months with clinical efficacy on vaso-occlusive events - untreated children with major vaso-occlusive events - children > 5 year-old without a history of vaso-occlusive events Signed informed consent obtained from the subjects (if possible) and their parents 2. Controls : heterozygous AS parents or siblings of the patients, and AA siblings or healthy African unrelated subjects, aged > 3 years, taken no drug on the day of blood sampling. Signed informed consent obtained from the subjects (if possible) and their parents EXCLUSION CRITERIA: - Children in a acute-phase of the disease - Parent's or patient's refusal - Taking any drug except penicillin-V, folate or iron supplementation, hydroxyurea - Un-healthy control or taking drug |
Matokeo
Hatua za Matokeo ya Msingi
1. Determination of plasma inflammatory markers [Day 1]
Hatua za Matokeo ya Sekondari
1. Clinical data [Day 1]
2. Hematological at baseline [Day 1]
3. Determination of HbF [Day 1]
4. Determination of markers of the "acute phase" [Day 1]
5. Plasma concentrations [Day 1]
