Cyclical hormonal changes during an ovarian cycle may affect immune responses, which is crucial for the embryonic implantation. We aim to investigate whether the levels and activity of T, B, and NK cells change during a menstrual cycle. Twenty-two normally cycling women were enrolled and peripheral blood was drawn serially during a menstrual cycle. Intracellular cytokine expression of CD3+CD4+ and CD3+CD8+ cells, and Th1/Th2 cytokine-producing T cell ratios were determined using flow cytometric analysis. NK cell cytotoxicity was measured by flow cytometric analysis at E:T ratios of 50:1, 25:1, and 12.5:1 and also using LU at 20%. Proportions (percentage) of CD3+ (p = 0.046) and CD3+CD4+ (p = 0.002) T cells were increased in the follicular phase compared with the luteal phase. The levels of CD3−CD56+ (p = 0.010) and CD3−CD56dim (p = 0.012) NK cells and NK cytotoxicity at E:T ratio of 50:1, 25:1, and 12.5:1 and LU at 20% were significantly increased in the luteal phase compared with the follicular phase. Even though IL-10–producing CD3+CD4+ T cells were significantly lower in the midluteal phase as compared with the early follicular phase, proportions of CD19+ B cells, CD3+CD56+ NKT cells, Th1 cytokine-producing T cell subsets, and ratios of Th1/Th2 cytokine-producing T cells were not significantly changed during a menstrual cycle. We conclude that peripheral blood NK and T cell levels as well as NK cytotoxicity are changed during a menstrual cycle. Neuroendocrine regulation on immune responses is suggested during an ovarian cycle, which may be critical for embryonic implantation and pregnancy.
Pharmacogenomics (PGx) is a key subset of precision medicine that relates genomic variation to individual response to pharmacotherapy. We assessed longitudinal trends in US FDA approval of new drugs labeled with PGx information. Drug labels containing PGx information were obtained from Drugs@FDA and guidelines from PharmGKB were used to compare the actionability of PGx information in drug labels across therapeutic areas. The annual proportion of new drug approvals with PGx labeling has increased by nearly threefold from 10.3% (n = 3) in 2000 to 28.2% (n = 11) in 2020. Inclusion of PGx information in drug labels has increased for all clinical areas over the last two decades but most prominently for cancer therapies, which comprise the largest proportion (75.5%) of biomarker–drug pairs for which PGx testing is required. Clinically actionable information was more frequently observed in biomarker–drug pairs associated with cancer drugs compared to those for other therapeutic areas (n = 92 (59.7%) vs. n = 62 (40.3%), p < 0.0051). These results suggest that further evidence is needed to support the clinical adoption of pharmacogenomics in non-cancer therapeutic areas.
Evidence-based social skills interventions for young adults are limited, despite social difficulties in autism spectrum disorder (ASD) persisting after transition to adulthood. The Program for the Education and Enrichment of Relational Skills for Young Adults (PEERS®-YA) is an evidence-based intervention found to be effective in improving relational skills in young adults with ASD. To translate the original American version of the PEERS®-YA treatment manual into Korean, intensive interviews were performed. Based on results from interviews, several rules of dating etiquette and social activities were modified to be culturally sensitive and linguistically appropriate. Next, young adults diagnosed with ASD (18–35 years of age; IQ > 70) and their social coaches were recruited for the randomized controlled trial (RCT). Participants were randomly assigned either to a treatment group (TG; n = 19) or a delayed treatment group (DTG; n = 18). In the analysis of group differences in the TG and DTG, social skills knowledge was improved. The within group analyses showed positive effects of improving social skills knowledge on reducing depression and anxiety symptoms. After modest cultural adaptations focusing on dating and social activities, the implementation of the PEERS®-YA-K was found feasible for the Korean community. This is one of only a few cross-cultural validation trials establishing evidence-based treatment in young adults with ASD.Clinical Trial Registration: This trial was registered at ClinicalTrials.gov, identifier: NCT03310775.
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