PURPOSE: Immunoglobulin substitution therapy is an essential therapeutic approach for patients with primary antibody deficiencies. Different methods of administration, including intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (SCIG) preparations, provide effective and tolerable treatment and enable the adjustment of therapy to patients' needs. A new 20% SCIG represents a new therapeutic option and a new route of administration using rapid-push application. The aim of the Czech Hizentra Noninterventional Study With Rapid Push (CHHINSTRAP) is to evaluate patient satisfaction with as well as the tolerability and efficacy of nonmedical switch to 20% SCIG from previous treatment with IVIG or SCIG and rapid push as a new way to administer SCIG. CHHINSTRAP is the first Phase IV, noninterventional, open-label, prospective, multicentric study of this type conducted in Central and Eastern Europe. METHODS: Primary end points, including efficacy, adverse effects, convenience of use, and overall satisfaction, were evaluated by Treatment Satisfaction Questionnaire for Medication version II. Secondary end points, such as serum IgG trough levels, infusion duration, number of application sites, frequency of infections, related hospital admissions, and antibiotic consumption, were obtained from patients at each follow-up visit. FINDINGS: Together, 50 eligible patients with primary antibody deficiency were switched from SCIG or IVIG to an equivalent dose of 20% SCIG and were followed up for 12 months during 5 consecutive visits. The results indicate that patients switched from previous IVIG or SCIG preparations had significantly higher serum trough IgG levels and a lower incidence of infections and related events, such as hospital admissions or consumption of antibiotics. These findings were also reflected in gradually increasing convenience of use and overall satisfaction reported by patients. Apart from duration of application, no differences were found between patients previously receiving SCIG or IVIG. Moreover, our study found a high level of safety of 20% SCIG rapid push, which was comparable to other preparations and application methods. IMPLICATIONS: On the basis of the results of CHHINSTRAP study, we conclude that 20% SCIG is a tolerable and effective immunoglobulin preparation, representing a new therapeutic approach in patients with primary antibody deficiencies. Its efficacy and tolerability have been found in patients on nonmedical switch from previous treatment with IVIG or SCIG.
- MeSH
- dítě MeSH
- dospělí MeSH
- imunoglobulin G aplikace a dávkování škodlivé účinky MeSH
- injekce subkutánní MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- průzkumy a dotazníky MeSH
- senioři MeSH
- spokojenost pacientů MeSH
- subkutánní infuze MeSH
- syndromy imunologické nedostatečnosti farmakoterapie MeSH
- výsledek terapie MeSH
- Check Tag
- dítě MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze IV MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Česká republika MeSH
Prevalence potravinové alergie v průběhu posledních let roste, v současné době je udávána až u 7 % dětí a až u 5 % dospělých. Rozši řuje se a mění spektrum nejčastějších alergenů , stupňuje se tíže projevů . Ve výskytu potravinové alergie, typech senzibilizace a symptomů existují poměrn ě významné geografické rozdíly. Podobně se v jednotlivých regionech liší nejčastější příčiny potravinových anafylaxí. V současné době v podstatě neexistují relevantní epidemiologická data, která by popisovala spektrum potravinových alergií v České republice. Registr DAFALL (Database of Food Allergies) byl z iniciativy pracoviště Immuno-flow, s.r.o., založen s cílem sběru dat pacientů s nově diagnostikovanou potravinovou alergií. V tomto sdělení prezentujemevýsledky 275 pacientů zařazených do registru v průběhu prvních 6 měsíců jeho fungování.
Food allergy prevalence has increased in recent years. Currently, it is described to be present in 7% of children and 5% of adu lts. The spectrum of most frequent allergens has changed and widened, symptoms are becoming more severe. There are significant geographical diffe rences in the incidence of food allergy, types of senzitization and symptoms. Accordingly, the most common causes of food anaphylaxis are different in respective regions. No recent relevant epidemiological data on occurence of food allergy in Czech republic are available. DAFAL L registry (Database of Food Allergies) has been founded on iniciative of Immuno-flow, s.r.o., to collect data from patients with newly di agnosed food allergy. In this report we present results from 275 patients enrolled into the registry during the first six months of its exis tence.
- Klíčová slova
- DAFALL (Database of Food Alergies),
- MeSH
- alergeny * izolace a purifikace škodlivé účinky MeSH
- anamnéza MeSH
- databáze jako téma MeSH
- informovaný souhlas pacienta MeSH
- klinické laboratorní techniky metody využití MeSH
- kožní testy MeSH
- lidé MeSH
- potravinová alergie * diagnóza etiologie prevence a kontrola MeSH
- prospektivní studie MeSH
- průzkumy a dotazníky využití MeSH
- registrace * MeSH
- rozložení podle pohlaví MeSH
- statistika jako téma MeSH
- Check Tag
- lidé MeSH
- Geografické názvy
- Česká republika MeSH