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• The majority of full-term newborns with donated CBUs and whose only abnormal findings were an increased NRBC count were in good health according to the 2nd questionnaire after one year. • An increased NRBC count in a full-term normal delivery is a surrogate marker of effective cells in CBUs. • Providing the NRBC count together with the NRBC-corrected TNC count will be useful for CBU selection. Increased nucleated red blood cell (NRBC) counts have been reported to be associated with adverse fetal outcomes, and cord blood units (CBUs) with increased NRBC counts require a 2nd questionnaire to determine their suitability for transplantation. However, a recent study demonstrated a positive correlation of NRBCs with CD34+ cells and total nucleated cells (TNCs). We evaluated the association between the NRBC count and hematopoietic progenitor cell (HPC) content (TNC and CD34+ cell counts) in Korean full-term newborn CBUs. In addition, we assessed whether an increased NRBC count is associated with newborn health problems that impair CBU safety. Among the 32,876 units processed from May 2006 to December 2018, a total of 23,385 CBUs with a TNC count ≥ 7 × 108 and reliable perinatal information were analyzed to assess the association of the NRBC count with CBU parameters, and the newborns associated with 457 CBUs that required the 2nd questionnaire due to an increased NRBC (≥ 15 NRBCs/100 WBCs) were assessed at one year for health problems that threatened CBU safety. The majority of the CBUs that required the 2nd questionnaire due to an increased NRBC count (96.9%) were determined to be suitable for transplantation. Those with an increased NRBC count showed significantly higher CD34+ cell and TNC counts and a higher rate of transplantation (P < 0.001, < 0.001 and 0.025, respectively). NRBCs showed a significant positive correlation with TNCs and CD34+ cells and a significant negative correlation with birth weight (all P < 0.001; adjusted r = 0.185, 0.369 and - 0.029, respectively). In the multiple linear regression analysis, NRBCs showed independent and positive correlations with TNCs and CD34+ cells after adjustments for birth weight and gestational age (all P < 0.001; β = 0.182, adjusted R2 = 0.053 and β = 0.367, adjusted R2 = 0.418). An increased NRBC count in full-term normal delivery is a surrogate marker of HPCs in CBUs rather than an exclusion criterion for CBU safety. Moreover, providing the NRBC count together with the NRBC-corrected TNC count will be useful for clinicians to select CBUs for transplantation. [ABSTRACT FROM AUTHOR]

HLA class II haplotypes often contain a second expressed HLA-DRB locus tightly linked to the classical HLA-DRB1 locus on the haplotype, which can be either HLA-DRB3, -DRB4 or -DRB5. These encode the HLA-DR51, -DR52 or -DR53 supertypic specificities and mark the ancestral lineages. HLA-DRB3/B4/B5 heterozygote excess in Welsh male newborns has been reported, suggesting a possibility of male-specific major histocompatibility complex (MHC)-mediated prenatal selection. However, it has not been confirmed in newborns of other ethnic groups or in adult populations. We analyzed the HLA-DRB1 and HLA-DRB3/B4 B5 genes in Korean newborns and healthy adults to examine whether MHC-mediated prenatal or postnatal selection exists. A total of 1,038 newborns (cord blood registry, 516 males and 522 females) and 2,082 healthy adults (hematopoieti stem cell donor registry, 1,111 males and 971 females) were HLA typed. HLA DRB1/B3/B4/B5 DNA typing was performed using Dynal RELI HLA-DRB SSO Kit (Dyanl Biotech, Wirral, U.K.). Genotype frequencies and homozygosity and heterozygosity rates for DRB3/B4/B5 supertypic loci were compared between males and females in newborns and adults. There were no significant difference in the HLA-DRB3/B4/B5 homozygosity and heterozygosity rates between male and females in both newborns and adults. In the comparison between newborns and adults, homozygosity rate was significantly higher in newborn females than in adult females (31.0% vs 25.0%, p = 0.01). Whether there is an age-related change from newborns toward adults has not been well studied in other populations, and further studies are warranted. In conclusion, male-specific heterozygosity excess reported in Welsh newborns has not been observed in Korean population, and there might be some ethnic differences in the gender-specific prenatal selection events. [ABSTRACT FROM AUTHOR]

Good review practices (GRP) for drug products are a system to ensure the consistency, transparency, fairness, and objectivity of the review process. To this end, the standardized guidelines on process and procedures for the review of drag products were developed for efficient conduct of the review process, and ongoing training activities were conducted to improve the expertise level of reviewers. Since the introduction of the GRP system in 2004, the Korea Food and Drug Administration has initiated various research activities to reflect the results in the review process. Major accomplishments arising from the introduction of the GRP are as follows: (1) standardized review forms for various review areas and guidelines on considerations in reviewing drug products were developed to improve the efficiency and effectiveness of the review process; (2) the review-related regulations were newly developed or revised and guidelines were published to ensure the consistency and fairness of the review process; (3) the procedure for disclosure of review results was developed and various data and information have been disclosed to the public to improve the transparency and reliability of the review process and results; and (4) training programs for reviewers have been developed and implemented to improve the expertise level of reviewers and ensure reliable review results. In addition, a road map for the GRP system was developed, which has been systematically executed to improve the quality of the review process and confidence in the review results. [ABSTRACT FROM AUTHOR]

Long-term observation of the prevalence of sexually transmitted infections (STIs) is unclear in sexual assault victims (SAVs).We aimed to identify the trends in the prevalence of STIs in SAVs and factors correlated with STIs. Between January 2010 and May 2019, a retrospective observational study was conducted in a regional sexual assault center in Seoul. Data were collected from sexual assault questionnaires and laboratory results. PCR for STIs, including Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma genitalium (MG), Mycoplasma hominis (MH), Ureaplasma urealyticum (UU), Trichomonas vaginalis (TV) and cytomegalovirus (CMV), was performed via vaginal swab. Associations between STIs and covariates were examined by logistic regression. A total of 1843 SAVs were included, and 60.2% were positive for at least one STI. UU was the dominant agent (32.6%), followed by MH (27.7%) and CT (17.4%). The annual positivity rate ofMH showed a significant decreasing trend (tau = -0.600, P value = 0.020). The highest positivity rate of STI by age group was 68.0% (282/415) in the 15-19 years of age group. Age (OR = 0.951, 95% confidence interval [CI] = 0.934-0.968) and pyuria (OR = 1.898, 95% CI = 1.543-2.329) were associated with clinically important STIs (NG, CT and TV). The prevalence of STIs in SAVs was consistently high over 10 years, and most STIs were more prevalent in SAVs than in the general population. Presumptive treatment is still needed, especially for young SAVs with pyuria. [ABSTRACT FROM AUTHOR]