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During the early months of life, infant formula plays a crucial role as a primary source of both food and essential nutrients for infants, serving as a replacement for or supplement to breast milk. However, nonessential metals in infant formulas are a concern because infants are highly vulnerable to chemical exposure. The aim of this study was to investigate infant exposure to nonessential metals in infant formula products in Taiwan and assess the associated health risks. In this study, concentrations of arsenic (As), barium (Ba), cadmium (Cd), manganese (Mn), lead (Pb), and vanadium (V) in 45 formula products for 0–1‐year‐old infants were determined by inductively coupled plasma mass spectrometry. The mean As, Ba, Cd, Mn, Pb, and V concentrations were 6.42, 280, 3.72, 1425, 20.4, and 21.9 µg/kg, respectively. According to our probabilistic simulation of the estimated daily intake of metals, the proportion of hazard quotients exceeding one was 7.69% for As and 3.29% for Mn, and that of hazard index (HI) values exceeding 1 was >17% for metals. Arsenic had the largest HI contribution (46.9%), followed by Mn (22.3%) and Pb (12.7%). The nonessential metals content in infant formula raises potential noncarcinogenic health concerns for infants in Taiwan. Therefore, regulations for nonessential metals must be imposed on related food products in Taiwan, with a particular focus on As and Mn. [ABSTRACT FROM AUTHOR]

• G and M levels in foods were analyzed by GC–MS followed by Soxtec extraction. • The highest concentrations of G and M were found in processed fats and cookies. • 58% of palm oil-containing foods exceeded the upper limits of G or M set by the EU. • Packaged foods with palm-derived oils had significantly higher levels of G and M. • Main exposures to G and M were from cookies and instant noodles that exceeded TDIs. Glycidyl esters (GEs) and 3-monochloropropane-1,2-diol esters (3-MCPDEs) are carcinogenic contaminants found in refined oils. This study aimed to determine levels of GEs and 3-MCPDEs in packaged foodstuffs, and estimate daily exposure levels using food consumption data. The analysis involved Soxtec extraction and gas chromatography-mass spectrometry, and the recovery of spiked GEs and 3-MCPDEs was within the range of 80%∼110%. Results showed that GEs and 3-MCPDEs were almost ubiquitous in food products (95%), with the highest concentrations found in processed fats, followed by cookies and spreads. Food products containing palm-derived oils had significantly higher levels of contaminants (p < 0.05), with up to 58.1% of palm oil-containing foodstuffs exceeding the upper limits of either GEs or 3-MCPDEs set by the European Union. Cookies and instant noodles were identified as the main sources of exposure to GEs and 3-MCPDEs, with potential daily intake levels exceeding the tolerable daily intakes in children aged 0 ∼ 12 years. [ABSTRACT FROM AUTHOR]

Drug lag—delayed approval or reimbursement—is a major barrier to accessing cutting‐edge drugs. Unlike approval lag, reimbursement lag is under‐researched. We investigated the key determinants of reimbursement lag under Taiwan National Health Insurance (NHI), and compared this lag with those in the United Kingdom, Canada, Australia, Japan, and South Korea. Using retrospective data on 190 new NHI‐reimbursed drugs from 2007 to 2014, we studied reimbursement lag in Taiwan vs. other countries, and investigated associated factors using generalized linear models (GLMs). The median reimbursement lags during before ("first‐generation") and after ("second‐generation") NHI drug reimbursement scheme in Taiwan were 378 and 458 days, respectively. The "first‐generation" lag was shorter only than that in South Korea, whereas the "second‐generation" lag only exceeded those of the United Kingdom and Japan. In GLM models, higher drug expenditure and the introduction of the "second‐generation" NHI were two statistically significant parameters associated with reimbursement lag among antineoplastic and immunomodulating agents. For other drug classes, the reimbursement price proposed by pharmaceutical companies and use of price‐volume agreements were two statistically significant parameters associated with longer reimbursement lags. The current reimbursement lag in Taiwan is longer than 1 year, but only longer than those of the United Kingdom and Japan. The determinants differ between drug categories. A specific review process for antineoplastic and immunomodulating drugs may expedite reimbursement. There is a clear need for systematic data collection and analysis to ascertain factors associated with reimbursement lag and thereby inform future policy making. [ABSTRACT FROM AUTHOR]

Human biomonitoring (HBM) provides information to identify chemicals that need to be assessed regarding potential health risks to human populations. We established a population-representative sample in Taiwan, namely the Taiwan Environmental Survey for Toxicants (TESTs) in 2013–2016. In total, 1871 participants (aged 7–97 years) were recruited from throughout Taiwan. A questionnaire survey was applied to obtain individuals' demographic characteristics, and urine samples were obtained to assess metal concentrations. Inductively coupled plasma-mass spectrometry was used to determine concentrations of urinary As (total), Cd, Co, Cr, Cu, Fe, Ga, In, Mn, Ni, Pb, Se, Sr, Tl, and Zn. The purpose of this study was to establish the human urinary reference levels (RVs) for metals in the general population of Taiwan. We found that median concentrations of urinary Cu, Fe, Pb, and Zn in males were statistically significant (p < 0.05) higher than in females (Cu: 11.48 vs. 10.00 μg/L; Fe: 11.48 vs. 10.46 μg/L; Pb: 0.87 vs. 0.76 μg/L; and Zn: 448.93 vs. 348.35 μg/L). On the contrary, Cd and Co were significantly lower in males than in females (Cd: 0.61 vs. 0.64 μg/L; and Co: 0.27 vs. 0.40 μg/L). Urinary Cd levels in the ≥18-year-old group (0.69 μg/L) were significantly higher than those in the 7-17-year-old group (0.49 μg/L, p < 0.001). Among the investigated metals, most were significantly higher in the 7-17-year-old group than in the ≥18-year-old group, except for Cd, Ga, and Pb. Participants who lived in central Taiwan had higher median levels of urinary Cd, Cu, Ga, Ni, and Zn than those in other regions. Median levels of urinary As, Cd, Pb, and Se were significantly higher in participants who lived in harbor (94.12 μg/L), suburban (0.68 μg/L), industrial (0.92 μg/L), and rural (50.29 μg/L) areas, respectively, than the others who lived in other areas. RV 95 percentiles of urinary metals (ng/mL) for 7–17/≥18-year-old groups were As (346.9/370.0), Cd (1.41/2.21), Co (2.30/1.73), Cr (0.88/0.88), Cu (28.02/22.78), Fe (42.27/42.36), Ga (0.13/0.12), In (0.05/0.04), Mn (3.83/2.91), Ni (8.09/6.17), Pb (8.09/5.75), Se (122.4/101.9), Sr (556.5/451.3), Tl (0.57/0.49), and Zn (1314.6/1058.8). In this study, we have highlighted the importance of As, Cd, Pb, and Mn exposure in the general population of Taiwan. The established RV 95 of urinary metals in Taiwanese would be fundamental information to promote the reduction of metal exposure or policy intervention. We concluded that urinary levels of exposure to certain metals in the general Taiwanese population varied by sex, age, region, and urbanization level. References of metal exposure in Taiwan were established in the current study. [ABSTRACT FROM AUTHOR]

Background Arsenic exposure is a global health concern. Several studies have focused on chronic arsenic exposure in adults; however, limited data are available regarding the potential adverse effects of prenatal exposure on fetuses and neonates. Objectives To assess which time point maternal arsenic exposure may influence the fetus during pregnancy and birth outcomes. Methods In this study, total arsenic concentrations were analyzed in urine samples collected from 130 women with singleton pregnancies (22–45 years old) in Taiwan from March to December of 2010. All fetal biometric measurements in each trimester period and birth outcomes at delivery were obtained. We applied a generalized estimating equation model and multivariate regression models to evaluate the associations between maternal urinary total arsenic (UtAs) exposure during pregnancy, fetal biometric measurements, and neonatal birth outcomes. Results We observed statistically significant correlations between maternal UtAs levels and the fetal biparietal diameter over all three trimesters (β = − 1.046 mm, p < 0.05). Multiple regression analyses showed a negative association between maternal UtAs levels and chest circumference in the first trimester (β = − 0.721 cm, p < 0.05), and second-trimester UtAs exposure was associated with decreases in birth weight (β = − 173.26 g, p < 0.01), head circumference (β = − 0.611 cm, p < 0.05), and chest circumference (β = − 0.654 cm, p < 0.05). Dose-response relationships were also observed for maternal UtAs exposure and birth outcomes. Conclusions We identified a negative relationship between maternal UtAs levels during pregnancy, fetal development, and neonatal birth outcomes. These findings should be confirmed in future studies with large sample sizes. [ABSTRACT FROM AUTHOR]

• AA exposure and health risk assessment were studied in the general population of Taiwan. • Urinary AAMA levels positively correlated sweetened beverages and oily snacks consumption in the 6–18-year-old group. • Monte Carlo simulation showed that 1.75-19.48% among all age groups exceeded the reference dose of 2 μg/kg-body weight/day. We determined the urinary levels of acrylamide (AA) metabolites of the general Taiwanese population, explore the association between AA internal exposure and dietary intake frequency, and assess the health risk. Urine samples and dietary questionnaires were collected from the subjects of the Nutrition and Health Survey in Taiwan. AA metabolite [ N -acetyl-S-(propionamide)-cysteine (AAMA)] concentrations were analyzed by ultra-high-performance liquid chromatography-quadrupole time-of-flight mass spectrometry (UPLC-ToF-MS). Multiple regression was used to examine associations between AA metabolite levels and dietary patterns. A total of 706 subjects were studied. We found that per increase in weekly frequency of sweetened beverages in the 6–11-years group (β = 0.322, p = 0.018) and oily snacks intakes in the 12–18-years group (β = 0.335, p = 0.012) will increase 10 β of urinary AAMA concentrations. Assuming that 50% of the AA intake is excreted as urinary AAMA, the Monte Carlo simulation showed that 1.75–19.48% among all age groups have exceeded the reference dose of 2 μg/kg-body weight/day. [ABSTRACT FROM AUTHOR]

Since a 2011 incident involving phthalate-tainted food, Taiwanese people have become concerned with food quality, and they are still being exposed to certain levels of phthalates. However, no nationwide human biomonitoring survey had been conducted to gather information on levels or reference values (RVs) of phthalates in the Taiwanese population. We aimed to establish the urinary levels and RVs of phthalate metabolites and identify exposure characteristics among Taiwan's population. We enrolled 1857 participants 7 years of age and older from the Taiwan Environmental Survey for Toxicants (TESTs) conducted during 2013-2016. Levels of 11 phthalate metabolites in each participant's urine samples were determined using liquid chromatography-tandem mass spectrometry. For all phthalate metabolites except for mono-methyl phthalate (MMP), mono-ethyl phthalate (MEP), and mono-ethylhexyl phthalate (MEHP), urinary median levels were significantly higher in the 7-17-year old group than in the ≧18-year-old group. For most phthalate metabolites and in the general population, the geometric mean decreased with increasing age. Median levels of MEP (19.55 μg/L), mono-benzyl phthalate (MBzP) (2.11 μg/L), mono-(2-ethyl-5-hydroxyhexyl) phthalate (MEHHP) (22.82 μg/L), mono-(2-ethyl-5-hydroxyhexyl) phthalate (MEOHP) (16.08 μg/L), ΣDibutyl phthalate metabolites (ΣDBPm) (0.17 nmol/mL), Σdi-(2-ethylhexyl) phthalate metabolites (ΣDEHPm) (0.29 nmol/mL) were higher in participants from central Taiwan than those from other areas. The median level of DBP (ΣDBPm: 0.20 nmol/mL) was significantly higher in participants from harbor areas than those from other urbanization groups. The RV of the 95 percentile (P95) for phthalate metabolites in the 7-17/≧18-year-old groups were 185.95/208.19 μg/L for MMP, 198.46/265.81 μg/L for MEP, 119.85/69.99 μg/L for mono-isononyl phthalate (MiBP), 165.19/204.32 μg/L for Mono-n-butyl phthalate (MnBP), 15.61/11.73 μg/L for MBzP, 62.09/59.23 μg/L for MEHP, 149.70/69.66 μg/L for MEHHP, 112.06/35.07 μg/L for MEOHP, 195.20/93.83 μg/L for mono-(2-ethyl-5-carboxypentyl) phthalate (MECPP), 45.66/27.69 μg/L for mono-(2-carboxymethylhexyl) phthalate (MCMHP), and 9.09/12.13 μg/L for mono-iso-nonyl phthalate (MiNP). We concluded that phthalate exposure of the general population in Taiwan varies by sex, age, region, and urbanization level. Exposure by the 7-17-year-old group to DMP, DBP, and DEHP in Taiwan remains higher than that of youth from other countries. RV of phthalate metabolites in Taiwan were established in the current study. [ABSTRACT FROM AUTHOR]

Background. Using conventional esophagogastroduodenoscopy (EGD) to evaluate the infrapapillary area is not feasible. The use of sedative EGD may enable endoscopists to investigate the infrapapillary condition of the duodenum. In this study, we aimed to evaluate lesions in the infrapapillary regions by using sedative EGD. Methods. In this retrospective observational study, we used the data of patients who underwent sedative EGD examinations at a tertiary hospital in southern Taiwan. The endoscopists evaluated the esophagus, stomach, and proximal duodenum and then attempted to explore the infrapapillary portion of the duodenum as deeply as possible. We assessed the success rate for the exploration of infrapapillary areas. Furthermore, we analyzed specific clinical findings of sedative EGD examination. Results. In total, 2973 patients underwent sedative EGD between November 1, 2010, and December 31, 2011. For 2632 of these patients, it was their first sedative EGD examination. In 2511 patients (95.4%), the exploration of the infrapapillary areas was successful. In approximately 10% of the patients, specific findings were detected over the infrapapillary region, and 7 of these patients exhibited clinically significant findings (i.e., gallbladder cancer with metastasis, periampullary Vater adenoma, natural killer cell enteropathy, villous adenoma with moderate dysplasia, infrapapillary duodenal adenoma with dysplasia, duodenal perforation with tumor-like formation, and follicular lymphoma). No patient experienced minor or major adverse reactions during the sedative EGD procedure. Conclusions. The current study provided evidence that sedative EGD examination enables a safe, comfortable, and effective endoscopic examination of deeper sections of the duodenum to evaluate the papillary and infrapapillary regions. [ABSTRACT FROM AUTHOR]

Highlights: [•] A cohort of pregnant women was established and followed until delivery. [•] Maternal NP exposure profile throughout three trimesters was characterized. [•] For multiparas and primiparas, urinary NP levels were not significantly different during gestation. [•] Second-trimester NP level is associated with a risk of low neonatal weight, especially for primiparas. [Copyright &y& Elsevier]

The contamination of a clouding agent with di(2-ethylhexyl) phthalate (DEHP), a substitute emulsifier-containing compound used in a variety of foods was announced on May 23, 2011. The aims of this study were as follows (1) compare the urine phthalates (PAE) metabolites concentration and estimate the daily intake (DI) of PAEs in pregnant women before and after the tainted food scandal and (2) examine the effect of relatively high PAEs exposure on birth outcome. One-hundred twelve pregnant women in Northern Taiwan participated in this study from March to December 2010, i.e., before the tainted food scandal. After the tainted food scandal, we collected 69, 73, and 180 urine specimens (January 2013 to August 2014) from women whom were in their first, second, and third trimesters of pregnancy, respectively. We measure urinary DEHP metabolite concentrations to estimate the DI of DEHP and the hazard quotient (HQ) of subjects. This was the first study to assess the effects of DEHP-tainted food scandal exposure in pregnant women across the three trimesters of pregnancy. After the tainted food report, the concentrations of urine PAE metabolite were significantly decreased, especially those of DEHP metabolites. Based on different reference limit values, the percentages of pregnant women whose HQ DEHP value exceeded the limit ranged from 0.53% to 8.93%. Despite this low frequency, the higher ΣPAE exposure during the second trimester may significantly increase the risk of relatively low birth height compared to the lower exposure group (β = − 0.63 (− 1.20 to − 0.06)). Our results support the hypothesis that exposure to relatively high concentrations of DEHP in pregnant Taiwanese women may have an adverse effect on birth outcomes. The percentage of subjects whose exposure level exceeded the exposure limit was low; however, high PAEs exposure appears to be significantly associated with birth outcomes. Therefore, we suggest that reference dose for PAEs should be revised. [ABSTRACT FROM AUTHOR]

Background: The World Health Organization reported that more than 10 % of women are severely affected by infertility, making the condition a major worldwide public health problem. Lead (Pb), cadmium (Cd), and arsenic (As) are environmental pollutants that may contribute to reproductive disorders. This cross-sectional study investigated the association between blood concentrations of Pb, Cd, and As and risk factors for infertility in women.Methods: Women who were infertile (N = 310) or pregnant (N = 57) were recruited from the gynecology and obstetrics department of a hospital. The participants were interviewed to obtain their sociodemographic, reproductive, and lifestyle information. The concentrations of Pb, Cd, and As in their blood samples were measured using inductively coupled plasma mass spectrometry.Results: Our findings suggested that the concentrations of Pb and As, but not Cd, were significantly higher in the blood of infertile women than in that of pregnant women. A higher percentage of the infertile women consumed more alcohol, used Chinese herbal medicine more frequently, and lacked physical activity compared with the pregnant women. After accounting for potentially relevant predictors, we observed that blood Pb levels might be elevated by using Chinese herbal medicine 1-6 times per week (aOR = 2.82, p = 0.05). In addition, engaging in physical activity 1-2 times per week (aOR = 0.37, p = 0.05) might assist in reducing Pb accumulation in infertile women, though the p value was borderline.Conclusions: Lack of physical activity and frequent use of Chinese herbal medicine may be associated with elevated blood Pb levels in infertile women. Chinese herbal medicine use was observed to increase the Pb body burden of both infertile and pregnant women in this study. The risk-benefit for Chinese herbal medicine intake should be evaluated by women of childbearing age. [ABSTRACT FROM AUTHOR]

Background: Nonylphenol (NP) has been proven as an endocrine disrupter and had the ability to interfere with the endocrine system. Though the health effects of NP on pregnant women and their fetuses are sustained, these negative associations related to the mechanisms of regulation for estrogen during pregnancy need to be further clarified. The objective of this study is to explore the association between maternal NP and hormonal levels, such as estradiol, testosterone, luteinizing hormone (LH) and follicle stimulating hormone (FSH), and progesterone. Methods: A pregnant women cohort was established in North Taiwan between March and December 2010. Maternal urine and blood samples from the first, second, and third trimesters of gestation were collected. Urinary NP concentration was measured by high-performance liquid chromatography coupled with fluorescent detection. A mixed-effects model using a generalised estimating equation (GEE) was applied to assess the associations between maternal NP concentration and plasma hormones throughout the three trimesters. Results: In total, 162 singleton pregnant women completed this study through delivery. The geometric mean of creatinine-adjusted urinary NP concentrations were 4.27, 4.21, and 4.10 µg/g cre. in the first, second, and third trimesters respectively. A natural log-transformation of urinary NP concentrations were significantly associated with LH in the GEE model (β = −0.23 mIU/ml, p<0.01). Conclusion: This perspective cohort study demonstrates that negative association occurs between maternal NP exposure and plasma LH levels. The estrogen-mimic effect of NP might influence the negative feedback on LH during pregnancy. [ABSTRACT FROM AUTHOR]

Abstract: Background: Nonylphenol (NP) is an environmental hormone with proven estrogenic effects. Although its adverse effects on animals are well documented, the effects of NP exposure on humans remain unclear, and those on the human foetus are completely unknown. This study explores the effects of intrauterine NP exposure on neonates. Methods: A cohort of pregnant women was established in a medical centre in northern Taiwan. Urine samples from the first, second, and third trimesters of gestation were collected. Urinary NP concentration was measured by high-performance liquid chromatography coupled with fluorescent detection. Neonatal outcomes were evaluated immediately after delivery. A mixed-effects model using a generalised estimating equation was applied to assess the association between gestational age, maternal body weight, and maternal NP concentration throughout the three trimesters. A multivariable regression model was used to determine the association between maternal NP level in urine in each trimester and neonatal outcomes. Results: In total, 162 singleton pregnant women completed this study through delivery. The geometric mean of creatinine-adjusted urinary NP concentrations were 4.27μg/g, 4.21μg/g, and 4.10μg/g in the first, second, and third trimesters, respectively. Pregnant women whose urinary NP concentrations were above the median in the second trimester had low maternal weight gain (β=−1.55kg, p=0.02) and short neonatal body length (β=−0.47cm, p=0.04). Women with an above-median urinary NP concentration had an odds ratio of having a small for gestational age (SGA) neonate of 7.81 (p<0.05). Conclusions: This study indicates that maternal high NP exposure in the second trimester is associated with SGA, decreased foetal body length at birth, and low maternal weight gain. The effects of this endocrine-disrupting substance on pregnant women and foetuses should be a concern during gestation. [Copyright &y& Elsevier]

• Exposure to DEHP increased the risk of early recurrent pregnancy loss. • Cumulative risks indices of phthalate related to early pregnancy loss. • New approaches of hazard index, relative potency and receptor effect posed for female reproduction. Phthalates, which are commonly used in flexible plastics and consumer products, have been reported to be toxic to reproductive and developmental function in mammals. Past studies have focused on the toxic effects on male reproduction, with only a few studies conducted on the risks that cumulative exposure to phthalates have on the female reproductive system. We recruited 260 patients with recurrent pregnancy loss (RPL) of unknown etiology and 203 controls from the clinics of Obstetrics and Gynecology at a medical center in southern Taiwan from 2013 to 2020. The daily intake of phthalates was estimated from urine samples using the back-calculation method, after which the cumulative risk was determined using multiple hazard indices, including a dose-addition model, a receptor effect model, and a hazard index approach. The patients with RPL had a significantly higher cumulative exposure to phthalates (p < 0.05) than did the controls with a hazard index above one. After adjusted logistic regression analysis, we found that the risk of RPL was strongly related to the higher quartiles of DEHP, the DEHP TEQ for the antiandrogenic effect and adverse effects of the female reproductive system and the ER α binding effect (p < 0.05). Our work suggests that more attentions should be paid to the adverse effects induced by phthalates on female reproduction, especially the effects caused by the cumulative exposure to phthalates in women of reproductive age. [ABSTRACT FROM AUTHOR]