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1.
N Engl J Med ; 359(16): 1655-65, 2008 Oct 16.
Article in English | MEDLINE | ID: mdl-18923170

ABSTRACT

BACKGROUND: In 1988, the World Health Assembly resolved to eradicate poliomyelitis. Although substantial progress toward this goal has been made, eradication remains elusive. In 2004, the World Health Organization called for the development of a potentially more immunogenic monovalent type 1 oral poliovirus vaccine. METHODS: We conducted a trial in Egypt to compare the immunogenicity of a newly licensed monovalent type 1 oral poliovirus vaccine with that of a trivalent oral poliovirus vaccine. Subjects were randomly assigned to receive one dose of monovalent type 1 oral poliovirus vaccine or trivalent oral poliovirus vaccine at birth. Thirty days after birth, a single challenge dose of monovalent type 1 oral poliovirus vaccine was administered in all subjects. Shedding of serotype 1 poliovirus was assessed through day 60. RESULTS: A total of 530 subjects were enrolled, and 421 fulfilled the study requirements. Thirty days after the study vaccines were administered, the rate of seroconversion to type 1 poliovirus was 55.4% in the monovalent-vaccine group, as compared with 32.1% in the trivalent-vaccine group (P<0.001). Among those with a high reciprocal titer of maternally derived antibodies against type 1 poliovirus (>64), 46.0% of the subjects in the monovalent-vaccine group underwent seroconversion, as compared with 21.3% in the trivalent-vaccine group (P<0.001). Seven days after administration of the challenge dose of monovalent type 1 vaccine, a significantly lower proportion of subjects in the monovalent-vaccine group than in the trivalent-vaccine group excreted type 1 poliovirus (25.9% vs. 41.5%, P=0.001). None of the serious adverse events reported were attributed to the trial interventions. CONCLUSIONS: When given at birth, monovalent type 1 oral poliovirus vaccine is superior to trivalent oral poliovirus vaccine in inducing humoral antibodies against type 1 poliovirus, overcoming high preexisting levels of maternally derived antibodies, and increasing the resistance to excretion of type 1 poliovirus after administration of a challenge dose. (Current Controlled Trials number, ISRCTN76316509.)


Subject(s)
Antibodies, Viral/blood , Poliomyelitis/prevention & control , Poliovirus Vaccine, Oral/immunology , Poliovirus/immunology , Virus Shedding , Egypt , Feces/virology , Female , Humans , Infant, Newborn , Male , Poliomyelitis/immunology , Poliovirus/isolation & purification , Poliovirus Vaccine, Oral/administration & dosage
2.
J Trop Pediatr ; 50(6): 339-47, 2004 Dec.
Article in English | MEDLINE | ID: mdl-15537719

ABSTRACT

This prospective study over 24 months aimed to evaluate the outcome of early management of disseminated intravascular coagulation (DIC) among high-risk patients (n = 50) admitted to a pediatric intensive care unit (PICU). It also included all cases presenting with overt DIC (OD) concomitantly (n = 30). The high-risk group (pre-DIC) was subdivided, according to their D-dimer assay, into negative (n = 14) and positive (n = 36) D-dimer groups. All three groups were evaluated, on admission, for their prothrombin time (PT), activated partial thromboplastin time (APTT), plasma fibrinogen level (Fi), fibrinogen degradation products (FDP), platelet count, and presence/absence of schistocytes in peripheral blood. The combination of D-dimer and FDP assay showed the best correlation for early pre-DIC diagnosis (r = 0.9048). FDP assay was the best parameter for followup of progress of DIC condition in the PICU. The lowest mortality was among negative D-dimer, followed by positive D-dimer and OD groups (28.6 per cent, 77.8 per cent, and 93.3 per cent, respectively). Among the positive D-dimer group the lowest mortality was encountered in the subgroup treated with plasma, heparin and tranexamic acid (33 per cent) while those treated with non-specific therapy, plasma only, or plasma and heparin showed higher mortality (100 per cent, 80 per cent, and 100 per cent, respectively). The deceased subgroup, among positive D-dimer cases showed a significantly higher number of patients presenting with multiple organ failure on admission compared with the discharged group. In summary, early diagnosis and proper management of pre-DIC, before overt bleeding, in high-risk patients admitted to a PICU using combined D-dimer and FDP assays had a positive impact on their prognosis.


Subject(s)
Disseminated Intravascular Coagulation/diagnosis , Disseminated Intravascular Coagulation/therapy , Early Diagnosis , Blood Coagulation Tests , Chi-Square Distribution , Child, Preschool , Combined Modality Therapy , Developing Countries , Disseminated Intravascular Coagulation/mortality , Egypt , Evaluation Studies as Topic , Female , Fluid Therapy , Heparin/therapeutic use , Hospitals, University , Humans , Infant , Infant, Newborn , Intensive Care Units, Pediatric , Logistic Models , Male , Partial Thromboplastin Time , Probability , Prognosis , Prospective Studies , Risk Assessment , Severity of Illness Index , Survival Rate , Treatment Outcome
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