[Research on the association between the occurrence of spermarche and menarche and psychological distress among Chinese children and adolescents aged 9-18 years].

Objective: To analyze the association between the occurrence of spermarche and menarche and psychological distress among Chinese Han children and adolescents aged 9 to 18 years. Methods: Data were drawn from the 2019 Chinese National Survey on Students' Constitution and Health, and a total of 54 438 boys aged 11 to 18 years and 76 376 girls aged 9 to 18 years with psychological distress, spermarche/menarche records were included in the final analysis. The occurrence of spermarche/menarche was recorded by physicians, and psychological distress was classified according to the Kessler Psychological Distress Scale scores. The chi-square test was used to compare the difference between groups in the occurrence of spermarche/menarche, and the multinomial logistic regression model and stratification analysis was established to analyze the association between psychological distress and spermarche/menarche. Results: The incidence of spermarche/menarche in 2019 ranged from 6.3% to 96.5% for eight age groups of Chinese boys and 2.8% to 99.0% for ten age groups of girls. The rates of high psychological distress among boys and girls were 32.5% and 32.7%. Among boys aged 11 to 18 years, the rate of high psychological distress increased with age, with a trend test P<0.001, and the difference in the rate of high psychological distress between those who had and had not had their spermarche was not statistically significant in all age groups. Among girls aged 9 to 18 years, the rate of high psychological distress increased with age, with a trend P<0.001; the rate of high psychological distress was higher in the group with menarche at age 10 and 12 than in the group without menarche (all P<0.05). High psychological distress was positively correlated with spermarche among boys aged 13-15 years living in urban areas and hight level economic development areas (OR=1.11, 95%CI: 1.02-1.21;OR=1.18, 95%CI: 1.06-1.32). Overall, high psychological distress was positively correlated with menarche in girls aged 9-12 and 13-15 years (OR=1.33, 95%CI: 1.25-1.42; OR=1.22, 95%CI: 1.07-1.39). High psychological distress was positively correlated with menarche among girls aged 9-12 years living in different regions except for the Northeast region, in areas with different levels of economic development, and in urban and rural areas, in girls aged 13-15 years living in urban, central, and western regions, and in girls aged 16-18 years residing in the central region. Conclusions: This study found an association between the occurrence of spermarche/menarche and psychological distress among Chinese Han children and adolescents aged 9 to 18 years in 2019, which was particularly significant among girls aged 9 to 12 years and boys aged 13 to 15 years living in areas with higher levels of socioeconomic development.

[Prevalence of psychological distress among Chinese children and adolescents aged 9-18 years].

Objective: To describe the prevalence of psychological distress and to analyze its influencing factors among Chinese children and adolescents aged 9-18 years in 2019. Methods: Data was from the 2019 Chinese National Survey on Students' Constitution and Health, and 148 892 children and adolescents were included. Psychological distress was measured using the Kessler Psychological Distress Scale (K10): scores ≤19 were defined as no psychological distress, scores between 20-24 were defined as mild psychological distress, scores between 25-29 were defined as moderate psychological distress, and scores ≥30 were defined as severe psychological distress (moderate to severe psychological distress were defined as high psychological distress). The ANOVA, t test, and χ2 test were used to compare the differences in K10 scores and high psychological distress rates among children and adolescents with different characteristics. The ANOVA and trend χ2 test were used to analyze the trends. Modified-Poisson regression models were used to determine influencing factors of high psychological distress. Results: The K10 scores for Chinese children and adolescents aged 9-18 years in 2019 was 21.5±9.2, and their rate of high psychological distress was 31.6%. The rates of high psychological distress among children and adolescents aged 9-12, 13-15, and 16-18 years were 22.3%, 35.9%, and 38.8%. K10 scores and rates of high psychological distress showed an increasing trend as age increased (trends test all P<0.001). K10 scores and rates of high psychological distress were higher among children and adolescents who were older, female, rural, in areas with medium to low GDP per capita level, and with lower parental education (all P<0.001). Multifactorial modified-Poisson regression analysis showed that children and adolescents aged 13-15 years, 16-18 years, female, rural, and in areas with low to moderate GDP per capita level were at higher risk of high psychological distress (all P<0.05), with aOR (95%CI) of 1.55 (1.52-1.58), 1.66 (1.63-1.69), 1.07 (1.05-1.09), 1.02 (1.01-1.04), 1.10 (1.07-1.12). Children and adolescents in areas with medium to high GDP per capita level, whose father had a secondary or high school degree, whose father had a college degree or above, whose mother had a secondary or high school degree, and whose mother had a college degree or above were at lower risk of high psychological distress (all P<0.05), with aOR (95%CI) of 0.96 (0.94-0.98), 0.92 (0.90-0.93), 0.84 (0.82-0.86), 0.95 (0.93-0.97), 0.86 (0.83-0.88). Conclusions: The prevalence of psychological distress was high among Chinese children and adolescents aged 9-18 years in 2019, which is a vital problem. Mental health interventions need to be implemented among children and adolescents that were older, girls, rural, live in areas with lower economic levels, and whose parents have a lower education level.

[Research on the association between the status of physical fitness and psychological distress among Chinese children and adolescents aged 13-18 years].

Objective: To describe the status of physical fitness of children and adolescents aged 13-18 years in China in 2019 and analyze its association with psychological distress. Methods: Data were drawn from the 2019 Chinese National Survey on Students' Constitution and Health, and 90 633 Han children and adolescents aged 13-18 years were included. Physical fitness was evaluated by "National Students Constitutional Health Standards" (2014 revised edition). Psychological distress was classified according to the scores of the Kessler Psychological Distress Scale: ≤19, 20-24, 25-29, and ≥30 scores indicated no, mild, moderate, and severe psychological distress, respectively, with moderate and severe psychological distress collectively referred to as high psychological distress. The χ2 test was used to compare the distribution differences between boys and girls, the Cochran-Armitage test was used to analyze the trend, and the multinomial logistic regression in the mixed effect model was established to analyze the association between physical fitness and psychological distress. Results: In 2019, the unqualified rate of physical fitness among children and adolescents aged 13-18 years in China was 17.2%, and the prevalence of excellent and good physical fitness was 18.2%, which was lower among boys (15.9%) than girls (20.5%) with a statistically significant difference (P<0.05). The excellent and good physical fitness rate showed a significantly decreasing trend with age (trend test P<0.05). The rate of high psychological distress among children and adolescents aged 13-18 years in China in 2019 was 39.3%, with boys (37.0%) having a lower prevalence than girls (41.6%), supported by a statistically significant difference (P<0.05), and a decreasing trend with the degree of physical fitness was observed both in boys and girls (trend test P<0.05). The multinomial logistic regression model showed that the prevalence of moderate (OR=0.83, 95%CI: 0.79-0.88, P<0.001) and severe (OR=0.81, 95%CI: 0.77-0.86, P<0.001) psychological distress were both lower in children and adolescents with excellent and good physical fitness. Conclusion: The status of physical fitness and psychological distress of Chinese children and adolescents aged 13-18 in 2019 was not optimistic, with physical fitness showing a significantly negative association with psychological distress.

The effect of age on the apparent clearance of felbamate: a retrospective analysis using nonlinear mixed-effects modeling.

The effects of age on felbamate apparent clearance were examined through a retrospective analysis of plasma concentration data from 700 pediatric and adult epileptic patients (age range, 2-74 years) enrolled in six clinical studies. Patients received felbamate as monotherapy or in combination with either the antiepileptic drugs (AEDs) carbamazepine (CBZ), phenytoin (PHT), or valproate (VPA). Data were analyzed using a nonlinear mixed-effects pharmacostatistical modeling technique (NONMEM). Factors in the model included age, body weight, and concomitant AEDs. Apparent clearance was highest in the very young and decreased during the early teenage years, with minimal changes observed beyond 13 years. Mean apparent clearance values were approximately 40% higher in children (2-12 years) compared with those in adults (13-65 years). This pattern and its magnitude were consistent whether felbamate was administered alone or coadministered with CBZ, PHT, or VPA. The increase in clearance is minimal compared with other AEDs including PHT, CBZ, and phenobarbital. Enzyme-inducing AEDs (CBZ and PHT) increased felbamate apparent clearance by 32-38% relative to monotherapy, whereas coadministration with VPA had a minimal effect on felbamate apparent clearance. Dose/concentration linearity was observed at all ages during mono- or polytherapy. These findings suggest that felbamate dosing should be relatively uncomplicated in children relative to that in adults.

Pharmacokinetic-pharmacodynamic (PK-PD) modeling for a new antihypertensive agent (neutral metalloendopeptidase inhibitor SCH 42354) in patients with mild to moderate hypertension.

SCH 42354, a neutral metalloendopeptidase (NEP) inhibitor, is the pharmacologically active form of the prodrug SCH 42495. It exerts antihypertensive effects by potentiating atrial natriuretic peptide (ANP) activity through inhibition of its hydrolysis by NEP. The objective of this study was to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of SCH 42354 in hypertensive males. SCH 42495 12.5 to 400 mg was administered orally to hypertensive men twice daily in a double-blind, placebo controlled multiple-dose parallel group design. Plasma SCH 42354 concentration and diastolic blood pressure (DBP) data were used to develop a PK-PD model using two approaches. In the first (non-integrated) approach, the ¿link¿ model was used to predict effect-site concentrations, and was applied to data obtained at the 300 and 400 mg BID doses only; data at the other (lower) doses were not amenable to modeling because of high variability. Effect-site concentration and DBP data were then fit to a sigmoid Emax PD model. For the 300 mg BID dose, PD parameters were: maximum effect (Emax), 8.1 mmHg; no-drug effect (Eo), 3.6 mmHg; concentration corresponding to 50% of maximum response (EC50), 0.87 microgram x ml(-1); and gamma, 3.9. In the second (time-integrated) approach, plasma SCH 42354 concentration and effect data obtained over the entire dose range were integrated with respect to time. Average plasma concentration and DBP data were then fit to a simple Emax PD model. PD parameters obtained over the dose range were: Emax, 10.3 mmHg; Eo, 2.0 mmHg; and EC50 0.7 microgram x ml(-1). These were similar to the estimates obtained from the first approach, demonstrating that the integrated (average) data allow PK-PD modeling over the (entire) dose range. The analysis showed that, at steady-state, a 400 mg BID dose of SCH 42495 produced an approximate 10 mmHg decrease in DBP in hypertensive males; the average plasma SCH 42354 concentration attained at this dose was approximately 1.8 microgram x ml(-1).