Reações adversas a medicamentos em pediatria: uma revisão sistemática de estudos prospectivos Adverse drug reactions in pediatrics: a systematic review of prospective studies

O objetivo desta revisão foi explorar e comparar as informações derivadas de estudos prospectivos sobre a incidência de reações adversas a medicamentos (RAM) em pediatria, publicados de janeiro de 1966 a novembro de 2003 em revistas indexadas nas bases MEDLINE, IPA e LILACS. Foram buscados trabalhos que abordassem a ocorrência de RAM em crianças atendidas em ambulatório, durante a hospitalização ou como causa de internação hospitalar não focalizados em tratamentos ou condições clínicas específicas. A análise incluiu vinte estudos de coorte prospectivos, entre os quais a incidência de RAM variou de 0,75% a 11,1% em ambulatório, de 0,6 a 4,3% como causa de internação hospitalar e de 4,4 a 18,1% entre crianças hospitalizadas. O trabalho ressalta o potencial de contribuição dos estudos prospectivos para o uso seguro de medicamentos em pediatria e sugere que a padronização de definições e de critérios metodológicos poderia torná-los mais úteis para esse objetivo.<br>The aim of this literature review is to explore and to compare information derived from prospective studies of adverse drug reactions (ADR) incidence in pediatrics. A systematic literature research was performed looking for studies involving outpatient and inpatient children as well hospitalizations due to ADR. The studies were identified in MEDLINE, IPA and LILACS databases from January 1966 to November 2003. Investigation focused on specific treatments or morbidities was not included in the review. Twenty prospective cohort studies were included in the analysis. In outpatient investigations ADR incidence varied from 0.75% to 11.1% between the studies; 0.6% to 4.3% of hospital admissions were related to ADR with ADR frequency during hospitalization varying from 4.4% to 18.1% of the children. The lack of definition standards and of methodological criteria hindered results comparison and could partly explain the different observations

Immunogenicity, reactogenicity and consistency of production of a Brazilian combined vaccine against diphtheria, tetanus, pertussis and Haemophilus influenzae type b

A randomized, double-blinded study evaluating the immunogenicity, safety and consistency of production of a combined diphtheria-tetanus-pertussis-Haemophilus influenzae type b vaccine entirely produced in Brazil by Bio-Manguinhos and Instituto Butantan (DTP/Hib-BM) was undertaken. The reference vaccine had the same DTP vaccine but the Hib component was produced using purified materials supplied by GlaxoSmithKline (DTP/Hib-GSK), which is registered and has supplied the Brazilian National Immunization Program for over more than five years. One thousand infants were recruited for the study and received vaccinations at two, four and six months of age. With respect to immunogenicity, the vaccination protocol was followed in 95.6% and 98.4% of infants in the DTP/Hib-BM and DTP/Hib-GSK groups, respectively. For the Hib component of the study, there was 100% seroprotection (>0.15 µg/mL) with all three lots of DTP/Hib-BM and DTP/Hib-GSK. The geometric mean titer (GMT) was 9.3 µg/mL, 10.3 µg/mL and 10.3 µg/mL for lots 1, 2 and 3 of DTP/Hib-BM, respectively, and the GMT was 11.3 g/mL for DTP/Hib-GSK. For diphtheria, tetanus and pertussis, seroprotection was 99.7%, 100% and 99.9%, respectively, for DTP/Hib-BM, three lots altogether and 99.2%, 100% and 100% for DTP/Hib-GSK. GMTs were similar across all lots and vaccines. Adverse events rates were comparable among the vaccine groups. The Brazilian DTP/Hib vaccine demonstrated an immunogenicity and reactogenicity profile similar to that of the reference vaccine