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1.
Neuropsychopharmacol Rep ; 44(2): 308-313, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38624143

ABSTRACT

In December 2022, the Ministry of Health, Labour and Welfare (MHLW) of Japan issued and implemented the guideline for evaluating the effects of psychotropic drugs on motor vehicle driving performance. This guideline recommends the use of a tiered approach to assess clinically meaningful driving impairment. It is noted that adverse events cannot be solely explained by pharmacokinetics, as the onset and duration of these events vary. Among these adverse events, those affecting alertness, such as drowsiness caused by psychotropic drugs on driving performance, are more frequently observed during initial treatment stages and dose escalation. Hence, when evaluating the effects of psychotropic drugs on driving performance, it becomes crucial to assess the persistence of clinically meaningful impairment. Therefore, the MHLW guideline, developed by the authors, emphasizes the need to assess the temporal profile of adverse events affecting driving in all clinical trials. Additionally, the guideline states that when conducting driving studies, the timing of multiple dosing should consider not only the pharmacokinetics of the investigational drug but also its tolerance.


Subject(s)
Automobile Driving , Psychotropic Drugs , Humans , Japan , Psychotropic Drugs/adverse effects , Psychotropic Drugs/administration & dosage , Psychotropic Drugs/pharmacokinetics , Psychomotor Performance/drug effects
2.
Chemosphere ; 355: 141837, 2024 May.
Article in English | MEDLINE | ID: mdl-38554863

ABSTRACT

Radioactivity of Ra isotopes in natural waters is of serious concern. Control of 226Ra concentrations in tailings ponds, which store waste from U ore extraction processes, is an important issue in mill tailings management. In this study, we tested microbially formed Mn(IV) oxide as an adsorbent for removal of Ra in water treatment. Biogenic Mn(IV) oxide (BMO) was prepared using a Mn(II)-oxidizing fungus, Coprinopsis urticicola strain Mn-2. First, adsorption experiments of Sr and Ba, as surrogates for Ra, onto BMO were conducted in aqueous NaCl solution at pH 7. Distribution coefficients for Ba and Sr were estimated to be ∼106.5 and ∼104.3 mL/g, respectively. EXAFS analysis indicated that both Sr and Ba adsorbed in inner-sphere complexes on BMO, suggesting that Ra would adsorb in a similar way. From these findings, we expected that BMO would work effectively in removal of Ra from water. Then, BMO was applied to remove Ra from mine water collected from a U mill tailings pond. Just 7.6 mg of BMO removed >98% of the 226Ra from 3 L of mine water, corresponding to a distribution coefficient of 107.4 mL/g for Ra at pH ∼7. The obtained value was convincingly high for practical application of BMO in water treatment. At the same time, the high distribution coefficient indicates that Mn(IV) oxide can be an important carrier and host phase of Ra in the environment.


Subject(s)
Oxides , Radium , Radium/analysis , Adsorption
3.
Sci Rep ; 14(1): 6337, 2024 03 15.
Article in English | MEDLINE | ID: mdl-38491068

ABSTRACT

The association between daily breakfast habits during pregnancy and offspring neurodevelopment remains unknown. We evaluated the association between breakfast habits during pregnancy and offspring neurodevelopment. Data of 72,260 women with singleton deliveries at and after 37 weeks of gestation enrolled during 2011-2014 in the Japan Environment and Children's Study were analysed. Offspring neurodevelopmental delays at 3 years of age were evaluated using the Ages and Stages Questionnaire, Third Edition (ASQ-3). Participants were stratified by tertiles of maternal daily energy intake (DEI) (Groups 1, 2, and 3:< 1400, 1400-1799, and ≥ 1800 kcal, respectively) during pregnancy and by offspring sex. The adjusted odds ratio (aOR) for abnormality in communication among participants with daily breakfast consumption habit was 0.87 (95% confidence interval, 0.80-0.96). A stratified analysis based on total DEI showed no significant differences in the neurodevelopment of Group 1 offspring. The aOR for abnormality in communication was 0.80 (95% confidence interval, 0.68-0.94) in Group 2. The aOR for abnormality in personal-social characteristics was 0.84 (95% confidence interval, 0.71-0.99) in Group 3. Maternal daily breakfast habits are associated with offspring neurodevelopment at 3 years of age, with the association influenced by maternal DEI and offspring sex.


Subject(s)
Breakfast , Family , Child , Pregnancy , Humans , Female , Child, Preschool , Japan/epidemiology , Surveys and Questionnaires
4.
Nutrients ; 16(5)2024 Feb 29.
Article in English | MEDLINE | ID: mdl-38474840

ABSTRACT

Preterm birth (PTB) is a leading cause of neonatal morbidity and mortality. Therefore, this study aimed to determine whether preconception dietary fiber intake is associated with PTB. This was a prospective cohort Japan Environmental and Children's Study (JECS). The study population comprised 85,116 singleton live-birth pregnancies from the JECS database delivered between 2011 and 2014. The participants were categorized into five groups based on their preconception dietary fiber intake quintiles (Q1 and Q5 were the lowest and highest groups, respectively). Multiple logistic regression analysis was performed to determine the association between preconception dietary fiber intake and PTB. Multiple logistic regression analysis revealed that the risk for PTB before 34 weeks was lower in the Q3, Q4, and Q5 groups than in the Q1 group (Q3: adjusted odds ratio [aOR] 0.78, 95% confidence interval [CI] 0.62-0.997; Q4: aOR 0.74, 95% CI 0.57-0.95; Q5: aOR 0.68, 95% CI 0.50-0.92). However, there was no significant difference between preconception dietary fiber intake and PTB before 37 weeks. In conclusion, higher preconception dietary fiber intake correlated with a reduced the risk for PTB before 34 weeks. Therefore, new recommendations on dietary fiber intake as part of preconception care should be considered.


Subject(s)
Premature Birth , Pregnancy , Female , Child , Humans , Infant, Newborn , Premature Birth/epidemiology , Cohort Studies , Japan/epidemiology , Prospective Studies , Dietary Fiber
5.
J Colloid Interface Sci ; 661: 317-332, 2024 May.
Article in English | MEDLINE | ID: mdl-38301469

ABSTRACT

Adsorption reactions of various cations on clay minerals have different effects on their environmental behaviors depending on the molecular-scale adsorption structure. Some cations form outer-sphere complexes via hydration, while others create inner-sphere complexes through dehydration. This preference dictates their environmental impact. However, the factors controlling these complex formations remain unclear. Furthermore, research on the adsorption preferences of radium (Ra) is lacking. Thus, this study conducted the first EXAFS study of Ra2+ adsorbed on clay minerals and showed that Ra2+ forms inner-sphere complexes on vermiculite, which can be surprising because Ra2+ is a divalent cation and prefers to be hydrated. In order to investigate the factors controlling the complex formations, this study conducted systematic EXAFS measurements and DFT calculations for alkali and alkaline earth metal cations. The results showed the importance of the size-matching effect between the adsorbed cation and the cavity of the tetrahedral sheets and that the complex formation can be estimated by the combination of the ionic radius and hydration enthalpy of the adsorbed cation. Furthermore, this study also analyzed environmental core samples. Their results showed the fixation of Ra2+ by clay minerals and the controlling factors can effectively predict cation environmental behavior.

6.
BMJ Open ; 14(2): e063619, 2024 02 05.
Article in English | MEDLINE | ID: mdl-38316589

ABSTRACT

OBJECTIVES: To evaluate the association between urinary 8-hydroxy-2'-deoxyguanosine (U8-OHdG) level-a marker of oxidative stress-and the incidence of preterm births (PTBs). DESIGN: Prospective cohort study. SETTING: The Japan Environment and Children's Study (JECS). PARTICIPANTS: Data from 92 715 women with singleton pregnancies at and after 22 weeks of gestation who were enrolled in the JECS, a nationwide birth cohort study, between 2011 and 2014 were analysed. U8-OHdG levels were assessed once in the second/third trimester using liquid chromatography-tandem mass spectrometry. Participants were categorised into the following three or five groups: low (<1.95 ng/mg urinary creatinine (Cre)), moderate (1.95-2.94 ng/mg Cre) and high (≥2.95 ng/mg Cre) U8-OHdG groups, or groups with <1.87, 1.87-2.20, 2.21-2.57, 2.58-3.11 and ≥3.12 ng/mg Cre. For stratification, participants with representative causes for artificial PTB were excluded. PRIMARY AND SECONDARY OUTCOME MEASURES: Adjusted OR (aOR) for PTB before 37 and 34 weeks of gestation were calculated using a multivariable logistic regression model while adjusting for confounding factors; the moderate or lowest U8-OHdG group was used as the reference, respectively. RESULTS: The aORs for PTB before 37 weeks of gestation in the high U8-OHdG group were 1.13 (95% CI 1.05 to 1.22) and 1.13 (95% CI 1.04 to 1.23) after stratification. The aOR for PTB before 37 weeks in the fourth group was 0.90 (95% CI 0.81 to 0.99). After stratification, the aORs for PTB before 37 and 34 weeks in the fifth group were 1.15 (95% CI 1.03 to 1.29) and 1.46 (95% CI 1.08 to 1.97), respectively. CONCLUSIONS: High U8-OHdG levels were associated with increased PTB incidence, especially in participants without representative causes for artificial PTB. Our results can help identify the mechanisms leading to PTB, considering the variable aetiologies of this condition; further validation is needed to clarify clinical impacts.


Subject(s)
Premature Birth , Pregnancy , Child , Humans , Infant, Newborn , Female , Premature Birth/epidemiology , Premature Birth/etiology , 8-Hydroxy-2'-Deoxyguanosine , Cohort Studies , Prospective Studies , Japan/epidemiology
7.
Int J Gynaecol Obstet ; 165(1): 244-255, 2024 Apr.
Article in English | MEDLINE | ID: mdl-37984054

ABSTRACT

OBJECTIVE: Although prior attempts have failed to identify the beneficial effects of intensive fetal monitoring on cerebral palsy, the association between nonreassuring fetal status (NRFS) during labor and the incidence of long-term neurodevelopmental delays in offspring remains unclear. This study aimed to evaluate this association using a nationwide birth cohort. METHODS: Data from 72 869 women with singleton deliveries at and after 37 weeks of gestation from the Japan Environment and Children's Study (2011-2014) were analyzed. Multivariable logistic regression models were used to analyze the odds ratios (ORs) for neurodevelopmental delays using the Ages & Stages Questionnaire (Third Edition) in offspring aged 3 years. RESULTS: The adjusted ORs for personal-social problems were 1.52 (95% confidence interval [CI], 1.06-2.16) for offspring delivered vaginally by nulliparous mothers and 1.51 (95% CI, 1.05-2.18) (for males, 1.70 [95% CI, 1.15-2.50]) for those delivered via cesarean section. No significant changes in adjusted ORs for neurodevelopmental delays were observed among participants without neonatal Apgar scores (ASs) <7 and without umbilical arterial pH (UmA-pH) <7.20. CONCLUSION: NRFS during labor was associated with an increased incidence of personal-social problems in offspring aged 3 years. However, this association was not confirmed after excluding participants with neonatal ASs <7 and UmA-pH <7.20. The association between NRFS and offspring's neurodevelopmental delays might vary based on delivery settings, offspring sex, and short-term neonatal outcomes.


Subject(s)
Cesarean Section , Labor, Obstetric , Child , Infant, Newborn , Male , Pregnancy , Female , Humans , Fetal Distress/epidemiology , Japan/epidemiology , Fetal Monitoring , Retrospective Studies
8.
J Womens Health (Larchmt) ; 33(1): 80-89, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38019576

ABSTRACT

Objective: We investigated the association between maternal antepartum intimate partner violence (IPV) and autism spectrum disorder (ASD) in 3-year-old offspring. Materials and Methods: Secondary analysis of the Japan Environment and Children's Study, a nationwide prospective birth-cohort study, for preconceptional and antepartum psychological/physical IPV against mothers was undertaken based on data obtained from a maternal self-report questionnaire. Subgroup analysis by four-level IPV frequency versus no IPV was conducted, and the incidence of ASD diagnosed during ages 2-3 years was estimated using self-reported questionnaire data of participants from when the child was 3 years old. Multivariate logistic regression was used to determine the association of preconceptional/antepartum IPV with ASD in 3-year-old offspring. Results: Among 79,324 offspring, 355 (0.45%) had ASD; preconceptionally and prenatally, 1,504 (1.9%) and 839 (1.1%) mothers were exposed to physical IPV whereas 9,162 (11.6%) and 10,240 (12.9%) mothers were exposed to psychological IPV, respectively. Multivariate logistic regression revealed a significant association of preconceptional physical IPV with ASD in offspring (adjusted odds ratio, 3.21; 95% confidence interval, 1.24-8.31), but not for antepartum physical IPV and preconceptional and antepartum psychological IPV. Conclusion: Preconceptional, but not antepartum, physical IPV was associated with ASD in 3-year-old offspring. Preconceptional and antepartum psychological IPV was unassociated with ASD in 3-year-old offspring. Preconceptional care through prevention of preconceptional physical IPV is important for neurodevelopment in offspring, and the mechanisms underlying the effects of IPV among nonpregnant individuals on ASD development in offspring should be elucidated.


Subject(s)
Autism Spectrum Disorder , Intimate Partner Violence , Female , Child , Humans , Child, Preschool , Cohort Studies , Autism Spectrum Disorder/epidemiology , Prospective Studies , Japan/epidemiology , Intimate Partner Violence/psychology
9.
Arch Gynecol Obstet ; 2023 Oct 13.
Article in English | MEDLINE | ID: mdl-37831176

ABSTRACT

PURPOSE: To evaluate differences in maternal characteristics and obstetric and offspring childhood outcomes between births at and after 37 weeks of gestation (referred to as term and post-term births) according to the use of tocolytic treatment. METHODS: Data for 63,409 women with singleton births at and after 37 weeks of gestation were analyzed using data from the Japan Environment and Children's Study (JECS). We compared maternal characteristics, obstetric outcomes, and offspring childhood outcomes between term and post-term births exposed and not exposed to tocolytic treatment. Additionally, multivariable logistic regression models were used to calculate adjusted odds ratios for offspring childhood outcomes with significant between-group differences in the univariable analysis, with term and post-term births without tocolytic agents as the reference group. RESULTS: We observed differences in maternal characteristics and obstetric outcomes between term and post-term births exposed and not exposed to tocolytic treatment. The incidence of offspring childhood developmental disorders showed no significant between-group differences. However, participants exposed to tocolytic agents had higher incidence of offspring childhood allergic disorders. The adjusted odds ratio for any of the offspring childhood allergic disorders in term and post-term births with tocolytic agents was 1.08 (95% confidence interval, 1.03-1.13). CONCLUSION: This study found no significant difference in the incidence of offspring developmental disorders between term and post-term births exposed and not exposed to tocolytic treatment. However, tocolytic treatment was associated with differences in maternal characteristics and obstetric outcomes, along with a marginal increase in the incidence of childhood allergic disorders in offspring.

10.
Fukushima J Med Sci ; 69(3): 191-196, 2023 Nov 15.
Article in English | MEDLINE | ID: mdl-37766560

ABSTRACT

The incidence of Acinetobacter infections has increased in recent years. Acinetobacter infections are resistant to most antibiotics and can be found in hospitalized patients. Pregnancies complicated by severe sepsis or septic shock are associated with a higher rate of preterm labor and delivery, fetal infection, and operative delivery. This case report describes septic shock due to Acinetobacter lwoffii infection in the 31st week of gestation. A 47-year-old woman, with a gestation of 31 weeks and one day, presented with a fever, and signs of bacterial infection on laboratory tests. Although the patient was started on tazobactam/piperacillin, she went into septic shock, and was transferred to our hospital. Cesarean section was performed at a gestation of 31 weeks and 4 days because of severe maternal pneumonia and non-reassuring fetal status. A. lwoffii was detected in blood cultures collected at the previous hospital, and susceptibility to piperacillin and meropenem to A. lwoffii was confirmed. The pneumonia responded to antibiotic treatment and there were no findings of infection in the neonate. Maternal sepsis is an infrequent but important complication, causing significant maternal and fetal morbidity and fetal and neonatal mortality; therefore, early antibiotic therapy is required to improve the clinical outcome.


Subject(s)
Acinetobacter Infections , Pneumonia , Shock, Septic , Infant, Newborn , Humans , Pregnancy , Female , Middle Aged , Shock, Septic/drug therapy , Shock, Septic/etiology , Acinetobacter Infections/drug therapy , Acinetobacter Infections/diagnosis , Acinetobacter Infections/microbiology , Cesarean Section , Anti-Bacterial Agents/therapeutic use , Piperacillin/therapeutic use , Pneumonia/drug therapy
11.
Sci Rep ; 13(1): 12839, 2023 08 08.
Article in English | MEDLINE | ID: mdl-37553437

ABSTRACT

We evaluated the association between gestational age at threatened preterm birth (TPTB) diagnosis and preterm birth (PTB) incidence using a nationwide birth cohort. Data of 94,236 women with singleton deliveries from the Japan Environment and Children's Study (enrolled between 2011 and 2014) were analysed. Participants were divided based on parity and gestational age at TPTB diagnosis (22-24, 25-27, 28-30, 31-33, and 34-36 weeks). Multivariable logistic regression models were used to calculate the odds ratios (ORs) for PTB before 37 and 34 weeks in women from all groups, using participants without TPTB as the reference. The adjusted ORs for PTB before 37 weeks were the highest in the latest gestational age group in nulliparous and multiparous women without previous PTB, while those before 34 weeks were the highest in the earliest and latest gestational age group in multiparous women without previous PTB and in the earliest gestational age group in multiparous women with previous PTB. The association between gestational age at TPTB diagnosis and PTB incidence varies based on maternal parity and PTB before 37 or 34 weeks. Further studies with detailed clinical data and a unified TPTB diagnosis protocol are necessary to clarify this association.


Subject(s)
Premature Birth , Pregnancy , Humans , Infant, Newborn , Female , Child , Infant , Premature Birth/epidemiology , Premature Birth/etiology , Incidence , Gestational Age , Japan/epidemiology , Risk Factors
12.
J Matern Fetal Neonatal Med ; 36(2): 2232073, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37408127

ABSTRACT

OBJECTIVE: Resuscitative endovascular balloon occlusion of the aorta for placenta accreta spectrum is used to control maternal hemorrhage during cesarean hysterectomy. This study aimed to assess the efficacy of resuscitative endovascular balloon occlusion of the aorta for placenta accreta spectrum by examines the change in the quantitative blood loss after applying resuscitative endovascular balloon occlusion of the aorta. METHODS: This retrospective cohort study included patients with placenta accreta spectrum who required cesarean hysterectomy (n = 37) between 2003 and 2022 at a tertiary care center. Patients were divided into two groups (with resuscitative endovascular balloon occlusion of the aorta, n = 13; without resuscitative endovascular balloon occlusion of the aorta, n = 24). The quantitative blood loss was compared between the groups. Generalized linear mixed models were used to examine changes in quantitative blood loss during cesarean hysterectomy after resuscitative endovascular balloon occlusion of the aorta was applied. The operating surgeon was set as the random effect. RESULTS: Operation time did not differ significantly between the groups (p = .09). The quantitative blood loss was significantly higher in patients who did not undergo resuscitative endovascular balloon occlusion of the aorta (2160 g) than in patients who did (1110 g; p < .01). Resuscitative endovascular balloon occlusion of the aorta significantly decreased the quantitative blood loss during cesarean hysterectomy (partial regression coefficient, 2312; 95% confidence interval, 49-4577; p < .05). CONCLUSION: Resuscitative endovascular balloon occlusion of the aorta decreased the quantitative blood loss during cesarean hysterectomy in patients with placenta accreta spectrum without significantly increasing the operation time. This suggests that resuscitative endovascular balloon occlusion of the aorta is effective in patients with placenta accreta spectrum.


Subject(s)
Balloon Occlusion , Placenta Accreta , Pregnancy , Female , Humans , Retrospective Studies , Placenta Accreta/surgery , Blood Loss, Surgical/prevention & control , Hysterectomy , Aorta/surgery
13.
Matern Child Health J ; 27(7): 1229-1237, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37131017

ABSTRACT

OBJECTIVE: To evaluate the association between maternal asthma (MA) and obstetric complications, while considering subdivided total serum immunoglobulin E (IgE) levels. METHODS: Data of the participants enrolled in the Japan Environment and Children's Study between 2011 and 2014 were analyzed. In total, 77,131 women with singleton live births at and after 22 weeks of gestation were included. MA was defined based on a self-administered questionnaire. Women with MA were stratified based on the quartile of total serum IgE levels during pregnancy as follows: low IgE levels (< 52.40 IU/mL), moderate IgE levels (52.40-331.00 IU/mL), and high IgE levels (> 331.00 IU/mL). The adjusted odds ratios (aORs) for preterm births (PTB), small for gestational age (SGA) infants, gestational diabetes mellitus, and hypertensive disorders of pregnancy (HDP) were calculated using multivariable logistic regression, while considering women without MA as reference and maternal socioeconomic factors as confounders. RESULTS: The aORs for SGA infants and HDP in women with MA and high total serum IgE levels were 1.26 (95% confidence interval [CI], 1.05-1.50) and 1.33 (95% CI, 1.06-1.66), respectively. The aOR for SGA infants among women with MA and moderate total serum IgE levels was 0.85 (95% CI, 0.73-0.99). The aOR for PTB among women with MA and low total serum IgE levels was 1.26 (95% CI, 1.04-1.52). CONCLUSIONS FOR PRACTICE: MA with subdivided total serum IgE levels was associated with obstetric complications. Total serum IgE level may be a potential prognostic marker to predict obstetric complications in pregnancies with MA.


What is Already Known on this Subject? Maternal asthma (MA) is associated with several obstetric complications, including preterm births (PTB), small for gestational age (SGA) infants, and hypertensive disorders of pregnancy (HDP). Few studies with data from nationwide cohorts have elucidated the association between MA and obstetric complications comprehensively while accounting for the subdivided objective biomarkers of MA.What this Study Adds? MA with subdivided total serum IgE levels was associated with various obstetric complications. Total serum IgE level may be a potential prognostic marker for pregnant women with MA to predict the potential risk of PTB, SGA infants, and HDP.


Subject(s)
Diabetes, Gestational , Pre-Eclampsia , Premature Birth , Pregnancy , Infant, Newborn , Infant , Female , Child , Humans , Japan/epidemiology , Premature Birth/epidemiology , Premature Birth/etiology , Infant, Small for Gestational Age , Diabetes, Gestational/epidemiology , Immunoglobulin E
15.
Br J Nutr ; : 1-9, 2023 May 26.
Article in English | MEDLINE | ID: mdl-37232101

ABSTRACT

This study evaluated the association between maternal magnesium intake (MMI) and childhood wheezing incidence in 3-year-old offspring. We hypothesised that higher MMI imparts anti-inflammatory and antioxidant effects that decrease childhood wheezing incidence in offspring. Data of 79 907 women (singleton pregnancy, ≥ 22 weeks) from the Japan Environment and Children's Study (enrolled between 2011 and 2014) were analysed. Participants were categorised into quintiles of MMI (< 148·00, 148·00-187·99, 188·00-228·99, 229·00-289·99 and ≥ 290·00 mg/d), quintiles of adjusted MMI for daily energy intake (aMMI) (< 0·107, 0·107-0·119, 0·120-0·132, 0·133-0·149 and ≥ 0·150 mg/kcal) and MMI levels either below or above the ideal value (< 310·00 or ≥ 310·00 mg/d). Multivariable logistic regression analysis was performed to calculate OR for the incidence of childhood wheezing in offspring among participants in each MMI category, with the lowest MMI group considered the reference group. Maternal demographic, socio-economic, medical and other nutrient intake backgrounds were considered potential confounding factors. The adjusted OR (aOR) for childhood wheezing in the offspring of women with the highest MMI was 1·09 (95 % CI, 1·00, 1·20), whereas that calculated based on aMMI categories and offspring of women with above-ideal MMI levels remained unchanged. The highest MMI was associated with slightly increased childhood wheezing incidence in the offspring. MMI during pregnancy had an insignificant clinical impact on this incidence; moreover, modifying MMI would not significantly improve childhood wheezing incidence in offspring. Therefore, further studies should clarify the association between other prenatal factors and childhood wheezing incidence in offspring.

16.
Neuropsychopharmacol Rep ; 43(2): 172-176, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37057649

ABSTRACT

In December 2022, the new guideline for evaluating the effect of psychotropic drugs on the performance to drive a motor vehicle was issued by the Ministry of Health, Labour and Welfare (MHLW) and implemented in Japan. Of the safety information, information on the influence of medications on driving performance is particularly important because it can be relevant to the social functioning of patients. In principle, the package inserts of medications are designed based on evidence and provide precautions regarding the operation of heavy machinery such as automobiles in Japan, the United States, and Europe. The effects of medications on driving performance are generally evaluated in a tiered approach involving nonclinical and clinical studies. Because of the wide variety of functional domains involved in automobile driving, the selection of evaluation methods for a given medication depends on their characteristics, which is a complicated method. Therefore, to evaluate the effects of psychotropic drugs on driving performance efficiently and appropriately, we developed the MHLW guideline that specifically defines the evaluation methods used in pharmacological studies, the neuropsychological tests used in pharmacodynamic studies, and the situations in which driving studies are necessary. Regarding the planning of appropriate drug development strategies, we review the background of the MHLW guideline and its differences from the US Food and Drug Administration (FDA) guideline.


Subject(s)
Motor Vehicles , Psychotropic Drugs , United States , Humans , Japan , United States Food and Drug Administration , Psychotropic Drugs/adverse effects , Pharmaceutical Preparations
17.
PLoS One ; 18(3): e0282671, 2023.
Article in English | MEDLINE | ID: mdl-36888637

ABSTRACT

Previous evidence indicated that interventions with combined neuromuscular electrical stimulation (NMES) and voluntary muscle contractions could have superior effects on corticospinal excitability when the produced total force is larger than each single intervention. However, it is unclear whether the superior effects exist when the produced force is matched between the interventions. Ten able-bodied individuals performed three intervention sessions on separate days: (i) NMES-tibialis anterior (TA) stimulation; (ii) NMES+VOL-TA stimulation combined with voluntary ankle dorsiflexion; (iii) VOL-voluntary ankle dorsiflexion. Each intervention was exerted at the same total output of 20% of maximal force and applied intermittently (5 s ON / 19 s OFF) for 16 min. Motor evoked potentials (MEP) of the right TA and soleus muscles and maximum motor response (Mmax) of the common peroneal nerve were assessed: before, during, and for 30 min after each intervention. Additionally, the ankle dorsiflexion force-matching task was evaluated before and after each intervention. Consequently, the TA MEP/Mmax during NMES+VOL and VOL sessions were significantly facilitated immediately after the interventions started until the interventions were over. Compared to NMES, larger facilitation was observed during NMES+VOL and VOL sessions, but no difference was found between them. Motor control was not affected by any interventions. Although superior combined effects were not shown compared to voluntary contractions alone, low-level voluntary contractions combined with NMES resulted in facilitated corticospinal excitability compared to NMES alone. This suggests that the voluntary drive could improve the effects of NMES even during low-level contractions, even if motor control is not affected.


Subject(s)
Ankle , Muscle, Skeletal , Humans , Young Adult , Ankle/physiology , Electric Stimulation/methods , Muscle, Skeletal/physiology , Muscle Contraction/physiology , Transcranial Magnetic Stimulation/methods , Evoked Potentials, Motor/physiology , Electromyography
18.
J Dev Orig Health Dis ; 14(3): 389-401, 2023 06.
Article in English | MEDLINE | ID: mdl-36650740

ABSTRACT

Maternal prenatal psychological distress, including depression and anxiety, may affect offspring's motor/cognitive development. However, research findings have been inconsistent. We used a dataset from the Japan Environment and Children's Study to evaluate associations between maternal six-item Kessler Psychological Distress Scale (K6) scores and motor/cognitive development among offspring at two years of age. Their offspring's motor/cognitive development was assessed using the Kyoto Scale of Psychological Development 2001. Records for 1859 male and 1817 female offspring were analyzed. The maternal K6 was administered twice during pregnancy: at a median of 14.6 weeks (M-T1) and 27.3 weeks (M-T2) of gestation. Multiple regression analysis was performed with the group with K6 scores ≤4 at both M-T1 and M-T2 as a reference. In the group with K6 scores ≥5 at both M-T1 and M-T2, male offspring had significantly lower developmental quotients (DQ) in the posture-motor area (partial regression coefficient [B]: -3.68, 95% confidence interval [CI]: -5.92 to -1.44) and language-social area (B: -1.93; 95%CI: -3.73 to -0.12), while female offspring had a lower DQ for the language-social area (B: -1.95; 95%CI: -3.73 to -0.17). In those with K6 scores ≥5 only at M-T1 or M-T2, male and female offspring did not differ significantly in DQ for any area. Continuous maternal psychological distress from the first to the second half of pregnancy was associated with lower motor and verbal cognitive development in male offspring and lower verbal cognitive development in female offspring at 2 years compared with the group without persistent maternal prenatal psychological distress.


Subject(s)
Family , Psychological Distress , Pregnancy , Humans , Female , Male , Child , Child, Preschool , Japan/epidemiology , Regression Analysis , Multivariate Analysis , Stress, Psychological/complications , Stress, Psychological/psychology
19.
Anal Chim Acta ; 1240: 340755, 2023 Feb 01.
Article in English | MEDLINE | ID: mdl-36641142

ABSTRACT

Accurate determination of cerium (Ce) valence state is important for interpreting the Ce anomaly in geological archives for (paleo)redox reconstruction. However, the routine application of Ce L3-edge X-ray absorption near-edge structure (XANES) spectroscopy for detecting trace Ce in geological samples can often be restricted by coexisting titanium (Ti) due to the proximity of their fluorescence emission lines. Therefore, the signal-to-noise ratio of Ce L3-edge XANES spectra may not be sufficiently high for high-quality spectroscopic analysis. This study introduces a semi-quantitative approach appropriate for Ti-rich, Ce-dilute geological materials by synchrotron-based X-ray measurement at the Ce L2-edge. First, the results confirm that Ce L2-edge XANES spectra are able to avoid overlapping Ti Kß emissions and provide more reliable information on the Ce valence state in Ti-rich materials relative to L3-edge XANES. Moreover, the application of transition-edge sensor (TES) could reach the higher sensitivity with better energy resolution than conventional silicon drift detector (SDD) to detect fluorescence X-ray (Ce Lß1). The investigation on bauxites developed from the Columbia River Basalts shows that combining Ce L2-edge XANES and TES allows for resolving weak Ce fluorescence lines at the L2-edge from Ti-rich, Ce-dilute samples (Ti/Ce mass ratio up to ∼6000, tens of ppm Ce). The outcome emphasizes the practical possibility of investigating Ce redox state in Ti-rich geological samples.


Subject(s)
Cerium , Cerium/chemistry , Titanium , Aluminum Oxide , X-Ray Absorption Spectroscopy , Oxidation-Reduction
20.
J Obstet Gynaecol Res ; 49(3): 812-827, 2023 Mar.
Article in English | MEDLINE | ID: mdl-36592955

ABSTRACT

AIM: The 2011 Great East Japan Earthquake (GEJE) was a disaster leading to radiation exposure and psychological distress, particularly among pregnant women. However, it is not known how this affected the seasonal changes of pregnancy and childbirth. Therefore, this study investigated the impact of the GEJE in the Fukushima Prefecture on spontaneous and induced abortions with regard to seasonal variability. METHODS: We used the data of vital statistics of live birth and stillbirth registry and the census survey of the Fukushima Maternity Care Facility. We calculated the spontaneous and induced abortion rate for 2011-2016 using two different methods (cross-sectional and longitudinal). We calculated the quartiles and outliers to determine the impact and duration of the GEJE. Periodicity was investigated using spectral density analysis. The data were analyzed for the entire Fukushima Prefecture and by region. RESULTS: The spontaneous abortion rate did not show specific changes after the GEJE. Contrarily, the monthly analysis in the cross-sectional method, revealed specific increases in induced abortion rate during the year after the GEJE; in the longitudinal method, induced abortions increased among women who became pregnant within 1 year after the GEJE. Spontaneous abortion showed no specific periodicity, while induced abortion showed cycles of 6 and 12 months, with a particular increase in May each year. CONCLUSIONS: The spontaneous abortion rate was not affected by the GEJE. The changes in the induced abortion rate after the disaster may have overlapped with the timing of the increased periodicity, and cannot be attributed solely to the GEJE.


Subject(s)
Abortion, Induced , Abortion, Spontaneous , Earthquakes , Fukushima Nuclear Accident , Maternal Health Services , Vital Statistics , Female , Pregnancy , Humans , Longitudinal Studies , Japan , Cross-Sectional Studies , Censuses
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