Pregnancy and neonatal outcomes after periconceptional exposure to isotretinoin in Koreans

Objective@#Isotretinoin should not be used during pregnancy because of the risk of birth defects. Most pregnant women exposed to isotretinoin choose voluntary pregnancy termination due to concerns about birth defects. However, birth outcome data supporting the termination of pregnancy are lacking. This study aimed to evaluate pregnancy and neonatal outcomes after periconception exposure to isotretinoin. @*Methods@#This was a prospective cohort study. We evaluated pregnancy and neonatal outcomes after exposure to isotretinoin in 151 pregnant women. Among 1,026 callers at the Korean Teratology Information Service from 2001 to 2017 exposed to isotretinoin during the periconception period, 151 pregnant women who received counseling on teratogenic risk after visiting the clinic were included. @*Results@#Among the 151 participants who visited the clinic, only 42 were evaluated using ultrasonography until approximately 20 weeks of gestation. Ultimately, 23 patients were included in the study. The average gestation period during the last exposure to the drug was 2 weeks, and the average daily exposure dose was 12 mg. There were two cases of major birth defects in the exposure group. Spontaneous abortion rates were 17.7% and 8.7% in the exposure and nonexposure groups, respectively (P=0.035). There was no significant difference between the exposure and non-exposure groups in terms of pregnancy and neonatal outcomes. @*Conclusion@#There was no significant difference in pregnancy and neonatal outcomes, including birth defects, between the exposure and non-exposure groups. Further studies with larger sample sizes are required to validate our findings.

The rates of major malformations after gestational exposure to isotretinoin: a systematic review and meta-analysis

Objective@#Isotretinoin is among the most notorious human teratogens, documented originally as causing up to 30% of malformations. This systematic review and meta-analysis aimed to evaluate the rates of major malformation (MM) among isotretinoin-exposed pregnant women over the years through a systematic review and meta-analysis. @*Methods@#Eligible studies were searched and identified using various databases. Single-arm meta-analysis and meta-analysis of odd ratios among controlled studies were performed using Review Manager version 5.3. @*Results@#Ten eligible studies that combined 2,783 isotretinoin-exposed women were included in our study. The rate of MM weighted for the sample size was 15%. Three studies that included an unexposed comparison group were eligible for the meta-analysis. The pooled odds ratio of MM for isotretinoin-exposed women was 3.76. After 2006, the pooled odds ratio of MM for isotretinoin exposure was significantly lower at 1.04. @*Conclusion@#The current rate of MM in isotretinoin-exposed women was substantially lower after 2006.

The rates of major malformations after gestational exposure to isotretinoin: a systematic review and meta-analysis

Objective@#Isotretinoin is among the most notorious human teratogens, documented originally as causing up to 30% of malformations. This systematic review and meta-analysis aimed to evaluate the rates of major malformation (MM) among isotretinoin-exposed pregnant women over the years through a systematic review and meta-analysis. @*Methods@#Eligible studies were searched and identified using various databases. Single-arm meta-analysis and meta-analysis of odd ratios among controlled studies were performed using Review Manager version 5.3. @*Results@#Ten eligible studies that combined 2,783 isotretinoin-exposed women were included in our study. The rate of MM weighted for the sample size was 15%. Three studies that included an unexposed comparison group were eligible for the meta-analysis. The pooled odds ratio of MM for isotretinoin-exposed women was 3.76. After 2006, the pooled odds ratio of MM for isotretinoin exposure was significantly lower at 1.04. @*Conclusion@#The current rate of MM in isotretinoin-exposed women was substantially lower after 2006.

Association of Fatty Acid Ethyl Esters in Meconium of Neonates with Growth Deficits at Birth: a Prospective, Single-Centre Cohort Study

BACKGROUND: In this prospective cohort study, we investigated the association between fatty acid ethyl esters (FAEEs) in meconium as biomarkers of prenatal ethanol exposure and growth deficits, as birth outcomes, that constitute several of the key cardinal features of fetal alcohol syndrome. METHODS: A total of 157 meconium samples were collected from enrolled infants within 24 hours of birth, and nine FAEEs were quantified using liquid chromatography/tandem mass spectrometry. The relationships between cumulative concentrations of nine species of FAEEs in meconium and birth parameters of growth (age-sex-specific centiles of head circumference [HC], weight, and length) and respective and combined birth outcomes of growth deficits (HC ≤ 10th centile, weight ≤ 10th centile, and length ≤ 10th centile) were determined. RESULTS: Multivariate logistic regression analysis demonstrated that higher cumulative concentrations of meconium FAEEs correlated with elevated risks for HC and length, both, 10th percentile or less (adjusted odds ratio [aOR], 2.94; 95% confidence interval [CI], 1.12–7.74; P = 0.029) and HC and weight and length, all of them, 10th percentile or less (aOR, 3.27; 95% CI, 1.12–9.59; P = 0.031). CONCLUSION: The elevated cumulative FAEEs in meconium were associated with combined growth deficits at birth, specifically HC and length, both, 10th percentile or less, which might be correlated with detrimental alcohol effects on fetal brain and bone development, suggesting a plausible alcohol-specific pattern of intrauterine growth restriction.

Efficacy of the Measurement of 25-Hydroxyvitamin D2 and D3 Levels by Using PerkinElmer Liquid Chromatography-Tandem Mass Spectrometry Vitamin D Kit Compared With DiaSorin Radioimmunoassay Kit and Elecsys Vitamin D Total Assay

No abstract available.

Performance Evaluation of Method for Detecting Serum 25-Hydroxyvitamin D2 and 25-Hydroxyvitamin D3 by Using PerkinElmer MSMS Vitamin D Kit / 임상검사와정도관리

BACKGROUND: Determining the concentration profiles of serum 25-hydroxyvitamin D (25OHD) may aid in the clinical diagnosis and treatment of vitamin D deficiency. To date, the standardized liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay has been used for accurate and precise determination of 25-hydroxyvitamin D levels. Here, we evaluated the performance of the recently developed and introduced PerkinElmer Vitamin D kit and compared the measurements obtained by RIA and LC-MS/MS methods. METHODS: We evaluated the accuracy, precision, linearity, lower limit of quantification (LLOQ), recovery, and carry-over of the MSMS Vitamin D kit. Clinical specimens from 80 patients were used for the comparison between the MSMS Vitamin D kit (PerkinElmer, USA) and the RIA kit (DiaSorin, USA). RESULTS: The MSMS Vitamin D kit was found to produce intra-assay and inter-assay coefficients of variation (CVs) of less than 6% for precision and showed a bias of less than 5%. The MSMS Vitamin D kit displayed linearity within the range for total vitamin D levels of 4.5-150 ng/mL, and the lower limit of quantification for 25OHD was 0.38 ng/mL. The RIA measurements of 25OHD showed a correlation of y=0.9931x+0.2216 (r2=0.74) with the LC-MS/MS values. CONCLUSIONS: The LC-MS/MS assay of 25OHD3 and 25OHD2 showed excellent performance when using the MSMS Vitamin D kit and in terms of 4-phenyl-1,2,4-triazoline-3,5-dione (PTAD) derivatization. Further, the results obtained were well correlated with those obtained using the RIA method. Thus, assays using the MSMS Vitamin D kit are considered as more standardized, and they enable quicker and more accurate analysis and help reduce inter-laboratory variation than that by other existing methods.

Marked Individual Variation in Isoflavone Metabolism After a Soy Challenge Can Modulate the Skeletal Effect of Isoflavones in Premenopausal Women

Soy-isoflavones may act as estrogenic agonists or antagonists depending on the endogenous hormone status. These clinical effects can be exerted variably in individuals by the metabolic ability to produce a more potent metabolite than precursors. The objective of this randomized, double-blind, placebo-controlled study was to investigate the skeletal effect of isoflavones according to their metabolic variability in premenopausal women. Volunteers were randomly assigned to receive either soy-extract isoflavones (n=32) or lactose (n=21) once a day for three menstrual cycles. After intervention, the urinary excretions of isoflavones and their metabolites were significantly higher in the soy group than in the placebo group and showed a large inter-individual variation. Women in the soy group were divided into subgroups according to their ability to excrete more potent metabolites. Serum osteocalcin and urine deoxypyridinoline showed a tendency to increase after a challenge in equol high-excretors. Serum osteocalcin concentration in the genistein high-excretors increased significantly after a challenge (P=0.04) but did not increase in either the placebo or genistein low-excretors. An estrogenic antagonistic effect of isoflavones on bone turnover was observed in premenopausal women who are able to produce more potent metabolites.