2018, Number 2
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Acta Pediatr Mex 2018; 39 (2)
Mexican consensus for the use of immunoglobulin G as replacement and immunomodulation treatment
Espinosa-Rosales FJ, Bergés-García A, Coronado-Zarco IA, Dávila-Gutiérrez G, Faugier-Fuentes E, García-Campos JA, Lugo-Reyes SO, Martínez- Murillo C, Mogica-Martínez MD, Segura-Méndez NH, Salmerón-Mercado ME, Staines-Boone AT, Vargas-Cañas ES, Yamazaki-Nakashimada MA
Language: Spanish
References: 300
Page: 134-171
PDF size: 1509.25 Kb.
ABSTRACT
Background: The availability, licensing and commercialization of
human immunoglobulin G (IG) as a therapeutic product has drastically
changed the course of several diseases. Currently IG represents first
line therapy for at least 10 different diseases, and is used as off-label
in many other conditions. The majority of such conditions are rare
diseases (i.e. affecting ‹ 1 in 2,000 individuals), which imposes a
considerable obstacle for the generation of robust clinical evidence
from randomized clinical trials.
Objective: To develop evidence-based clinical guidelines for the use
of IG as replacement or immunomodulation therapy in our country.
Material and Methods: We conformed a group of several clinical
experts from different specialties (work-group) to develop a critical
and systematic analysis of the current evidence for the different uses of
IG. We carried systematic reviews through Medical Subject Headings
(MeSH) terms and the Spanish equivalent “Descriptores en Ciencias
de la Salud (DeCS)” specific for each clinical condition and looking
for clinical practice guidelines, other types of guidelines, systematic
reviews, meta-analysis, randomized clinical trials, non-randomized
clinical trials, descriptive, observational and economic studies. We
used the PICO construct whenever possible using the following
databases: MEDLINE, EMBASE, BVS/LILACS, NGS, NICE, CENETEC,
Imbiomed, TripDatabase, and Medigraphic. We organized 8 smaller
specialty-specific groups to study corresponding evidence within their
área of expertise and answer the clinical questions and write specific
recommendations to make a draft. Such document was discussed in a
plenary session to agree a final document which was then submitted
to external validation by the major representatives of the academia in
our country. Finally, we wrote this document as a reference for clinicians
regarding the therapeutic uses of IG in our country.
Conclusions: We see this document as an instrument to allow
clinicians in the second and third level of health care of our country
to correctly use IG as replacement and/or immune-modulation.
Therapeutic use of IG is an active area of clinical research; this document
shall be reviewed, modified and enriched accordingly and in
a timely-manner.
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