[Feasibility of administering Tegeline at home. Retrospective study of efficacy, safety and tolerance].
OBJECTIVE
To demonstrate the feasibility of administration Tegeline at home from a point of view of efficacy, safety, tolerance, to validate the pertinence of the selection and the training of patients who could benefit from this type of administration and to assess the long term efficacy and safety.


METHODS
This retrospective study was conducted in patients exhibiting primary immune deficiency and formerly treated with intravenous immunoglobulins at least six months in hospital settings, trained by the centre for the training of children in the home (Centre de formation au traitement à domicile de l'enfant--CFTDE) and having received at least one administration of Tegeline at home from January 1st 2000. Tegeline contains a mean of 97.6% of whole IgG (58.8% of IgG1, 34.1% of IgG2, 5.4% of IgG3 and 1.7% of IgG4).


RESULTS
Two hundred and eighteen follow-up sheets were completed by 13 patients in whom all the eligibility criteria were fulfilled. The total number of infusions per patient ranged from 4 to 41. No difficulty in administration was reported in 10 patients, difficulties in placing the needle were encountered in 3 other patients and motivating their return to the hospital for treatment (after 6 and 10 months) in 2 cases. The infusion flow rate was usually of 2 to 3 ml/kg/h. During the follow-up period, no episode of infection was noted in 5 patients and 8 presented infections that were treated with antibiotics. Regarding safety, the security 'kits' (corticosteroids, adrenalin) that were supplied to each patient were never used. Over time, the median duration of the infusions at home was of 5 years and 6 months.


CONCLUSIONS
In trained and selected patients, this study demonstrated the efficacy, safety and tolerance to the administration of Tegeline at home.
Debré
M
M
Unité immuno-hématologie, Hôpital Necker-Enfants malades, Paris.
Clairicia
M
M
Bonnaud
F
F
Jubin
O
O
Thiébaux-Boucard
D
D
D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D002648:Child; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D018718:Home Infusion Therapy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D007153:Immunologic Deficiency Syndromes / Q000150:complications / Q000188:drug therapy*; D007239:Infections / Q000188:drug therapy / Q000209:etiology; D008297:Male; D010353:Patient Education as Topic; D010359:Patient Readmission / Q000706:statistics & numerical data; D018579:Patient Selection; D012189:Retrospective Studies; D012449:Safety; D012651:Self Medication; D013997:Time Factors; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D016756:Immunoglobulins, Intravenous