METHODS: This retrospective observational study enrolled patients started on drugs for COVID-19 in Sungai Buloh Hospital from 1 March 2020 to 31 May 2020. The clinical staging of COVID-19 patients was decided by the treating physician in accordance with the Clinical Management of Confirmed COVID-19 Case in Adults (Annex 2E). Suspected ADRs were evaluated with a trigger tool of pre-defined laboratory values or the adverse events listed in the registered product insert. Causality assessment was conducted when an ADR was suspected using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) system, and only cases classified as certain, probable and possible ADR were considered. Data analysis was completed with descriptive, univariate and multivariate analysis.
RESULTS: The study (N = 1,080) identified 217 patients (20.1%) who experienced ADR, with 246 adverse events detected. Most events were related to the gastrointestinal (43.5%), hepatobiliary (36.2%) and cardiac (16.3%) systems. The most commonly suspected drugs were atazanavir (52.7%), chloroquine (36.8%) and lopinavir/ritonavir (34.6%). The independent risk factors of ADR were female (adjusted odds ratio (OR): 1.53; 95% CI 1.06-2.20; P = 0.024), diagnosis of COVID-19 stage 3 (adjusted OR: 2.58; 95% CI 1.20-5.55; P = 0.015) and stage 4 (adjusted OR: 4.17; 95% CI 1.79-9.73; P = 0.001), and the number of COVID-19 drugs (adjusted OR: 3.34; 95% CI 2.51-4.44; P
STUDY DESIGN: Retrospective cohort study using data submitted prospectively to the Malaysian National Neonatal Registry (MNNR).
SETTING: 44 Malaysian NICUs.
PARTICIPANTS: All neonates born in 2015- 2020.
RESULTS: EOS was reported in 991 neonates. The annual incidence of EOS increased from 0.46 to 0.49/1000 livebirths over the six years. The most common pathogen was Streptococcus agalactiae or Group B haemolytic streptococcus (GBS) (n=388, 39.2%), followed by Escherichia coli (E. coli) (n=80, 8.1%), Klebsiella spp (n=73, 7.4%), coagulase negative staphylococcus (CONS) (n=73, 7.4%), Pseudomonas spp (n=44, 4.4%) and methicillin-sensitive Staphylococcus aureus (n=34, 3.4%). The incidence of EOS due to GBS increased from 0.17 to 0.22/1000 livebirths. Morbidities and mortality were higher in those with EOS than without EOS. Multiple logistic regression analysis showed that Indian ethnic group, chorioamnionitis, gestation≥37weeks, female, spontaneous vaginal delivery, instrumental delivery, and surfactant therapy were significantly associated with increased risk of EOS due to GBS. Four factors were significantly associated with increased risk of non-GBS EOS (outborns, birthweight lt;1000 g, vaginal delivery, and surfactant therapy). Early continuous positive airway pressure was associated with significantly lower risk of EOS.
CONCLUSION: The incidence of EOS showed an increasing trend in Malaysian NICUs. GBS was the most common causative pathogen. Several modifiable risk factors associated with EOS have been identified.