Remimazolam Dosing for Gastroscopy: A Randomized Noninferiority Trial.

BACKGROUND: Remimazolam, an ultra-short-acting benzodiazepine, may provide adequate sedation for endoscopy while causing less cardiovascular or respiratory disturbance than propofol. Although fixed-dose administration is suggested, body weight affects the volume of the central chamber and thus affects the sedation depth that can be achieved by the first dose. This study aimed to compare the efficacy and safety of different doses of remimazolam and propofol by body weight for sedation during gastroscopy. METHODS: This multicenter, randomized, single-blind, parallel-controlled noninferiority trial recruited patients from five centers between March 2021 and July 2022. A total of 1,883 patients scheduled to undergo gastroscopy were randomized to groups receiving 0.15 mg/kg remimazolam, 0.2 mg/kg remimazolam, or 1.5 mg/kg propofol. The noninferiority margin was set to 5%. The primary outcome was the success rate of sedation. Adverse events were recorded to evaluate safety. RESULTS: The sedation success rate of the 0.2 mg/kg remimazolam group was not inferior to that of the 1.5 mg/kg propofol group (98.7% vs. 99.4%; risk difference, -0.64%; 97.5% CI, -2.2 to 0.7%, meeting criteria for noninferiority). However, the sedation success rate of the 0.15 mg/kg remimazolam group was 88.5%, and that of the 1.5 mg/kg propofol group was 99.4% (risk difference, -10.8%; 97.5% CI, -14.0% to -8.0%), demonstrating inferiority. Simultaneously, the overall adverse events rate of remimazolam was lower than that of propofol, and the incidence of bradycardia, hypotension, subclinical respiratory depression, and hypoxia in the remimazolam groups was significantly lower than that in the propofol group. CONCLUSIONS: This trial established the noninferior sedation success rate of remimazolam (0.2 mg/kg but not 0.15 mg/kg) compared with propofol (1.5 mg/kg), with a superior safety profile.

Adequate dietary magnesium intake may protect females but not males older than 55 years from cognitive impairment.

BACKGROUND: Magnesium is an essential nutrient required to maintain brain health throughout life, and adequate magnesium intake is positively associated with cognitive performance in older adults. However, sex differences in magnesium metabolism have not been adequately assessed in humans. OBJECTIVES: We investigated sex differences in the effect of dietary magnesium intake and the risk of different types of cognitive impairment in older Chinese adults. METHODS: We collected and assessed dietary data and cognitive function status in people aged 55 years and older in northern China who participated in the Community Cohort Study of Nervous System Diseases from 2018 to 2019 to explore the relationship between dietary magnesium intake and the risk of each type of mild cognitive impairment (MCI) in sex-specific cohorts of older adults. RESULTS: The study included 612 people: 260 (42.5%) men and 352 (57.5%) women. Logistic regression results showed that for the total sample and women's sample, high dietary magnesium intake reduced the risk of amnestic MCI (ORtotal = 0.300; ORwomen = 0.190) and multidomain amnestic MCI (ORtotal = 0.225; ORwomen = 0.145). The results of restricted cubic spline analysis showed that the risk of amnestic MCI (ptotal = 0.0193; pwomen = 0.0351) and multidomain amnestic MCI (ptotal = 0.0089; pwomen = 0.0096) in the total sample and women's sample gradually decreased with increasing dietary magnesium intake. CONCLUSIONS: The results suggest that adequate magnesium intake may have a preventive effect against the risk of MCI in older women.

Asynchronous functional linear regression models for longitudinal data in reproducing kernel Hilbert space.

Motivated by the analysis of longitudinal neuroimaging studies, we study the longitudinal functional linear regression model under asynchronous data setting for modeling the association between clinical outcomes and functional (or imaging) covariates. In the asynchronous data setting, both covariates and responses may be measured at irregular and mismatched time points, posing methodological challenges to existing statistical methods. We develop a kernel weighted loss function with roughness penalty to obtain the functional estimator and derive its representer theorem. The rate of convergence, a Bahadur representation, and the asymptotic pointwise distribution of the functional estimator are obtained under the reproducing kernel Hilbert space framework. We propose a penalized likelihood ratio test to test the nullity of the functional coefficient, derive its asymptotic distribution under the null hypothesis, and investigate the separation rate under the alternative hypotheses. Simulation studies are conducted to examine the finite-sample performance of the proposed procedure. We apply the proposed methods to the analysis of multitype data obtained from the Alzheimer's Disease Neuroimaging Initiative (ADNI) study, which reveals significant association between 21 regional brain volume density curves and the cognitive function. Data used in preparation of this paper were obtained from the ADNI database (adni.loni.usc.edu).

[Association between vitamin E intake and mild cognitive impairment in people aged 55 years and older in Hebei Province].

OBJECTIVE: To investigate the relationship between dietary vitamin E(VE) intake and mild cognitive impairment(MCI). METHODS: Based on the data of Hebei Province in the 2018 National Key Research and Development Program Nervous system disease CCSNSD, 612 subjects were included in this study. All study participants were surveyed for dietary VE intake by the Dietary Frequency Questionnaire and assessed for cognitive function by the Montreal Cognitive Assessment Scale. The relationship between dietary VE intake and MCI and its subtypes was analyzed using logistic regression and restricted cubic splines. RESULTS: The study subjects included 260(42.5%) males and 352(57.5%) females, with an average age of(66.8±7.4) years and an average dietary VE intake of(12.17±4.91) mg/d. The prevalence of cognitive impairment in the study population was 41.3%. After adjusting the covariates of age, gender, energy intake, residence, education level, employment status, BMI, smoking, drinking, physical activity, hypertension, diabetes, VE intake was not associated with the risk of non-amnesic(naMCI), single-domain amnesic(aMCI-SD), but relate to the risk of multi-domain amnesic(aMCI-MD). What's more, compared to dietary vitamin E intake Q1 group, the OR(95%CI) for multi-domain amnesic mild cognitive impairment in Q2, Q3 and Q4 groups were 1.628(0.836-3.170), 0.313(0.124-0.791) and 0.727(0.330-1.602), respectively. Using vitamin E intake as a continuous-type variable, a non-linear dose-response relationship was found between VE intake and mild cognitive dysfunction of the multi-domain amnesic type(P=0.02). When VE intake was about 17 mg/d, the risk of aMCI-MD was the lowest. CONCLUSION: There is an approximate "U" shaped dose-response relationship between dietary VE intake and the risk of mild cognitive impairment with multi-domain amnesia type. Research suggests that moderate VE intake has a preventive effect on the development of mild cognitive impairment.

Multiply robust subgroup analysis based on a single-index threshold linear marginal model for longitudinal data with dropouts.

Identifying subpopulations that may be sensitive to the specific treatment is an important step toward precision medicine. On the other hand, longitudinal data with dropouts is common in medical research, and subgroup analysis for this data type is still limited. In this paper, we consider a single-index threshold linear marginal model, which can be used simultaneously to identify subgroups with differential treatment effects based on linear combination of the selected biomarkers, estimate the treatment effects in different subgroups based on regression coefficients, and test the significance of the difference in treatment effects based on treatment-subgroup interaction. The regression parameters are estimated by solving a penalized smoothed generalized estimating equation and the selection bias caused by missingness is corrected by a multiply robust weighting matrix, which allows multiple missingness models to be taken account into estimation. The proposed estimator remains consistent when any model for missingness is correctly specified. Under regularity conditions, the asymptotic normality of the estimator is established. Simulation studies confirm the desirable finite-sample performance of the proposed method. As an application, we analyze the data from a clinical trial on pancreatic cancer.

The association between low carbohydrate diet scores and cardiometabolic risk factors in Chinese adults.

Epidemiological studies on the association between the low carbohydrate diet (LCD) score and cardiovascular disease risk factors have limited and inconsistent results. Data are from the baseline survey of Community-based Cohort Study on Nervous System Diseases. A total of 4609 adults aged ≥18 years were included in the study. Dietary data were assessed using a validated semi-quantitative Food Frequency Questionnaire. Multivariable logistic regression analyses were used to estimate relationships of three LCD scores with low high-density lipoprotein cholesterol (HDL-C), high low-density lipoprotein cholesterol (LDL-C), hypercholesterolemia, hypertriglyceridemia, impaired fasting glucose (IFG), high blood pressure, and hyperuricemia after adjusting for potential confounders. A higher LCD score was negatively associated with low HDL-C [OR (95%CI): 0.65 (0.50, 0.83), P=0.0001] and IFG [OR (95%CI): 0.65 (0.51, 0.81), P=0.001] after the final adjustment. However, there are gender differences in this result. Males in the highest quintile of the animal-based or plant-based LCD scores showed a decreased risk of low HDL-C, and females in the highest quintile of the animal-based or plant-based LCD scores showed a decreased risk of IFG than those in the lowest quintile of the LCD scores. These results suggest that gender differences should be considered when using LCD to treat dyslipidemia and reduce fasting blood glucose.

Generalized integrative principal component analysis for multi-type data with block-wise missing structure.

High-dimensional multi-source data are encountered in many fields. Despite recent developments on the integrative dimension reduction of such data, most existing methods cannot easily accommodate data of multiple types (e.g. binary or count-valued). Moreover, multi-source data often have block-wise missing structure, i.e. data in one or more sources may be completely unobserved for a sample. The heterogeneous data types and presence of block-wise missing data pose significant challenges to the integration of multi-source data and further statistical analyses. In this article, we develop a low-rank method, called generalized integrative principal component analysis (GIPCA), for the simultaneous dimension reduction and imputation of multi-source block-wise missing data, where different sources may have different data types. We also devise an adapted Bayesian information criterion (BIC) criterion for rank estimation. Comprehensive simulation studies demonstrate the efficacy of the proposed method in terms of rank estimation, signal recovery, and missing data imputation. We apply GIPCA to a mortality study. We achieve accurate block-wise missing data imputation and identify intriguing latent mortality rate patterns with sociological relevance.

Ultrasensitive Electrochemical Biosensor of Bacterial 16S rRNA Gene Based on polyA DNA Probes.

Traditional microbiology analysis is usually hindered by the long time-cost and lack of portability in many urgent situations. In this work, we developed a novel electrochemical DNA biosensor (E-biosensor) for sensitive analysis of the 16S rRNA gene of five bacteria, using a consecutive adenine (polyA) probe. The polyA probe consists of a polyA tail and a recognition part. The polyA tail can combine onto the gold surface with improved controllability of the surface density, by conveniently changing the length of polyA. The recognition part of the capture probe together with two biotin-labeled reporter probes hybridize with the target DNA and form a stable DNA-tetramer sandwich structure, and then avidin-HRP enzyme was added to produce a redox current signal for the following electrochemical detection. Finally, we realized sensitive quantification of artificial target DNA with a limit of detection (LOD) of 10 fM, and excellent selectivity and reusability were also demonstrated. Importantly, the detection capability was equally good when facing bacterial genomic DNA, due to the base-stacking force of our multireporter-probe system, which can help to break the second structure and stabilize the probe-target complexes. Our biosensor was constructed on a 16-channel electrode chip without any polymerase chain reaction (PCR) process needed, which took a significant step toward a portable bacteria biosensor.

Dose selection of central or peripheral administration of sufentanil affect opioid induced cough?: a prospective, randomized, controlled trial.

BACKGROUND: Opioid-induced cough (OIC) is one of the most common complications of opioids during anesthesia induction. This study was designed to assess the incidence of OIC mediated by different intravenous route. METHODS: A total of 102(ASA I-II) scheduled for elective surgery under general anesthesia were randomly allocated into two groups: central vein group (group CV, n = 51) and peripheral vein group (group PV, n = 51). The incidence, onset time and severity of OIC were evaluated within 1 min just after sufentanil injection during induction. Meanwhile, heart rate (HR) and blood pressure (BP) were also recorded to assess the hemodynamic changes. RESULTS: The incidence of OIC was 10/51 (20.4%) in group CV and 16/51 (32%) in group PV, patients received central venous administration of sufentanil experienced less OIC compared with those injected by peripheral venous route (P < 0.05), as well as a significantly lower incidence of severe OIC (P < 0.05). Nevertheless, the onset of OIC and hemodynamic data were comparable between two groups (P > 0.05). CONCLUSION: Our study indicates that sufentanil administration by central venous route reduces the incidence and severity of OIC, but without significant changes in hemodynamic status. TRIAL REGISTRATION: Chinese Clinical Trial Registry with registration number ChiCTR-IOR-15006075 . Registered 28 February 2015.

The median effective concentration (EC50) of propofol with different doses of fentanyl during colonoscopy in elderly patients.

BACKGROUND: Propofol and fentanyl are the most widely administered anesthesia maintaining drugs during colonoscopy. In this study, we determined the median effective concentration (EC50) of propofol required for colonoscopy in elderly patients, and the purpose of this study was to describe the pharmacodynamic interaction between fentanyl and propofol when used in combination for colonoscopy in elderly patients. METHODS: Ninety elderly patients scheduled for colonoscopy were allocated into three groups in a randomized, double-blinded manner as below, F0.5 group (0.5 µg.kg(-1) fentanyl), F1.0 group (1.0 µg.kg(-1) fentanyl) and saline control group. Anaesthesia was achieved by target-controlled infusion of propofol (Marsh model, with an initial plasma concentration of 2.0 µg.ml(-1)) and fentanyl. Colonoscopy was started 3 min after the injection of fentanyl. The EC50 of propofol for colonoscopy with different doses of fentanyl was measured by using an up-and-down sequential method with an adjacent concentration gradient at 0.5 µg.ml(-1) to inhibit purposeful movements. Anaesthesia associated adverse events and recovery characters were also recorded. RESULTS: The EC50 of propofol for colonoscopy in elderly patients were 2.75 µg.ml(-1) (95% CI, 2.50-3.02 µg.ml(-1)) in F0.5 group, 2.05 µg.ml(-1) (95% CI, 1.98-2.13 µg.ml(-1)) in F1.0 group and 3.08 µg.ml(-1) (95% CI, 2.78-3.42 µg.ml(-1)) in control group respectively (P < 0.05). Patients in the F1.0 group had a significantly longer awake time and length of hospital stay than those in control group (P < 0.05). CONCLUSION: Increasing doses of fentanyl up to 1.0 µg.kg(-1) reduces the propofol EC50 required for elderly patients undergoing colonoscopy, and there was no significant difference in anaesthesia associated adverse events but prolonged awake and discharge time. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR15006368. Date of registration: May 3, 2015.

Impact of home-delivered meal programs on diet and nutrition among older adults: a review.

BACKGROUND: Poor diet quality and insufficient nutrient intake is of particular concern among older adults. The Older Americans Act of 1965 authorizes home-delivered meal services to homebound individuals aged 60 years and older. OBJECTIVE: The purpose of this study was to review scientific evidence on the impact of home-delivered meal services on diet and nutrition among recipients. METHODS: Keyword and reference searches were conducted in Cochrane Library, Google Scholar, PubMed and Web of Science. Inclusion criteria included: study design (randomized controlled trials, cohort studies, pre-post studies, or cross-sectional studies); main outcome (food and nutrient intakes); population (home-delivered meal program participants); country (US); language (articles written in English); and article type (peer-reviewed publications or theses). RESULTS: Eight studies met the inclusion criteria, including two randomized controlled trial studies (from the same intervention), one cohort study, two pre-post studies, and three cross-sectional studies. All but two studies found home-delivered meal programs to significantly improve diet quality, increase nutrient intakes, and reduce food insecurity and nutritional risk among participants. Other beneficial outcomes include increased socialization opportunities, improvement in dietary adherence, and higher quality of life. CONCLUSIONS: Home-delivered meal programs improve diet quality and increase nutrient intakes among participants. These programs are also aligned with the federal cost-containment policy to rebalance long-term care away from nursing homes to home- and community-based services by helping older adults maintain independence and remain in their homes and communities as their health and functioning decline.

Applicability of the Global Lung Function Initiative prediction equations in Hong Kong Chinese children.

BACKGROUND AND OBJECTIVE: This study aimed to assess the applicability of the Global Lung Function Initiative (GLI) prediction equations for spirometry in Hong Kong children and to develop prediction equations based on the Generalized Additive Models for Location, Scale, and Shape (GAMLSS) modeling. METHODS: Healthy Chinese children and adolescents aged 6-17 years old were recruited from randomly selected schools to undergo spirometry. The measurements were transformed to z-score according to the GLI-2012 equations for South East (SE) Asians and the GLI-2022 global race-neutral equations. Prediction equations for spirometric indices were developed with GAMLSS modeling to identify predictors. RESULTS: A total of 886 children (477 boys) with a mean age of 12.5 years (standard deviation [SD] 3.3 years) were included. By the GLI-2012 SE Asian equations, positive mean z-scores were observed in forced expiratory volume in 1 s (FEV1 ) (boys: 0.138 ± SD 0.828; girls: 0.206 ± 0.823) and forced vital capacity (FVC) (boys: 0.160 ± 0.930; girls: 0.310 ± 0.895) in both sexes. Negative mean z-scores were observed in FEV1 /FVC ratio (boys: -0.018 ± 0.998; girls: -0.223 ± 0.897). In contrast, negative mean z-scores in FEV1 and FVC, and positive mean z-scores in FEV1 /FVC were observed when adopting the GLI-2022 race-neutral equations. The mean z-scores were all within the range of ±0.5. By GAMLSS models, age and height were significant predictors for all four spirometric indices, while weight was an additional predictor for FVC and FEV1 . CONCLUSION: Our study provided data supporting the applicability of the GLI prediction equations in Hong Kong Chinese children. The GLI-2012 equations may underestimate FEV1 and FVC, while the GLI-2022 equations may overestimate the parameters, but the differences lie within the physiological limits. By GAMLSS modeling, weight was an additional predictor for FVC and FEV1 .

Efficacy and safety of remimazolam tosylate for sedation during upper gastrointestinal endoscopy: study protocol for a multicenter randomized controlled trial.

BACKGROUND: Gastrointestinal endoscopy has been associated with difficult experiences and can leave patients with an unpleasant impression. Propofol and midazolam are the most commonly used intravenous anesthetics for sedation during gastrointestinal endoscopy. However, cardiac and pulmonary adverse events are the primary concerns associated with the use of these sedatives. Remimazolam tosylate is an ultra-short-acting benzodiazepine drug with a mild inhibitory effect on the respiratory and circulatory systems. These properties qualify remimazolam tosylate to be used as a replacement for propofol or midazolam as a sedative during gastrointestinal endoscopy. This study aims to describe the efficacy and safety of remimazolam tosylate as a sedative for upper gastrointestinal endoscopy. METHODS: A multicenter, randomized, single-blind, parallel-controlled, noninferiority clinical study will be conducted to evaluate the efficacy and safety of remimazolam tosylate as a sedative during upper gastrointestinal endoscopy. Participants (n = 1800) will be randomized to receive remimazolam tosylate at 0.15 mg/kg (experimental group 1), remimazolam tosylate at 0.2 mg/kg (experimental group 2), or propofol at 1.5 mg/kg (control group). Procedure success will be assessed and defined as the completion of upper gastrointestinal endoscopy without the administration of a rescue sedative agent or more than two top-up doses of the trial drug in any 5-min period after initial administration. Sedation quality will be evaluated using the Modified Observer's Assessment of Alertness/Sedation score. Adverse events will be recorded to evaluate safety. DISCUSSION: This study will determine the optimal dosage of remimazolam tosylate during upper gastrointestinal endoscopy and will describe its efficacy and safety. These findings may contribute to a more comfortable and safer experience for patients compared with that when the conventional sedative propofol is used. TRIAL REGISTRATION: ClinicalTrials.gov NCT04727034. Registered on February 18, 2021.

Six new secoiridoid glycosides from the stem barks of Syringa Reticulata (Bl.) Hara.

Six new secoiridoids, syrretosides E-J (1-6) and four known secoiridoids (7-10), were isolated from the stem barks of Syringa reticulata. Their structures were established by the 1D and 2D NMR spectra, HR-ESI-MS, and comparison with the literature. The cytotoxicity of the isolated monomeric compounds against RAW264.7 cells was investigated by the CCK8 assay, and the results showed that the individual compounds were not cytotoxic to RAW264.7. The anti-inflammatory activity of these compounds was evaluated using the LPS-induced RAW264.7 inflammatory cell model and the results showed that compounds 3-7 and 9 showed varying degrees of anti-inflammatory activity.

Randomized controlled trial for time-restricted eating in overweight and obese young adults.

Time-restricted eating (TRE) is known to improve metabolic health, whereas very few studies have compared the effects of early and late TRE (eTRE and lTRE) on metabolic health. Overweight and obese young adults were randomized to 6-h eTRE (eating from 7 a.m. to 1 p.m.) (n = 21), 6-h lTRE (eating from 12 p.m. to 6 p.m.) (n = 20), or a control group (ad libitum intake in a day) (n = 19). After 8 weeks, 6-h eTRE and lTRE produced comparable body weight loss compared with controls. Compared with control, 6-h eTRE reduced systolic blood pressure, mean glucose, fasting insulin, insulin resistance, leptin, and thyroid axis activity, whereas lTRE only reduced leptin. These findings shed light on the promise of 6-h eTRE and lTRE for weight loss. Larger studies are needed to assess the promise of eTRE to yield better thyroid axis modulation and overall cardiometabolic health improvement.

Preoperative Chronic Pain as a Risk Factor for Early Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Hip Joint Replacement Surgery: A Prospective Observational Cohort Study.

Background: Although major joint replacement surgery has a high overall success rate, postoperative cognitive dysfunction (POCD) is a common complication after anesthesia and surgery, increasing morbidity and mortality. Identifying POCD risk factors would be helpful to prevent and decrease the occurrence of POCD. We hypothesized that preoperative chronic pain increases the risk of POCD. Methods: A single-center, observational, prospective cohort study was conducted from January 2018 to March 2020. All consecutive elderly patients (>65 years) who underwent elective total hip arthroplasty or hemiarthroplasty with general anesthesia by the same surgeon were enrolled. The patients underwent neuropsychological testing preoperatively and at 7 days and 2 months after surgery. To determine POCD, a nonsurgical control group was recruited from the general community. Results: Of the 141 patients who finished the neuropsychological testing 7 days after surgery, 61 (43.2%) had preoperative chronic pain. Of the 61 patients, 17 (27.9%) developed POCD; of the 79 patients with no chronic pain, 10 (12.7%) had developed POCD by 7 days after surgery. Multivariate logistic regression analysis identified preoperative chronic pain as a risk factor of POCD assessed 7 days after surgery (odds ratio 6.527; P = 0.009). There was no significant difference in the POCD incidence 2 months after surgery between patients with and without preoperative chronic pain. Conclusion: Preoperative chronic pain was a risk factor of developing POCD within 7 days after surgery in elderly patients following hip joint replacement surgery. Clinical Trial Registration: [www.ClinicalTrials.gov], identifier [NCT03393676].

Efficiency of donepezil in elderly patients undergoing orthopaedic surgery due to underlying post-operative cognitive dysfunction: study protocol for a multicentre randomised controlled trial.

BACKGROUND: Post-operative cognitive dysfunction (POCD) is an overarching term used to describe cognitive impairment identified in the preoperative or post-operative period. After surgical operations, older patients are particularly vulnerable to memory disturbances and other types of cognitive impairment. However, the pathogenesis of POCD remains unclear with no confirmed preventable or treatable strategy available. Our previous study demonstrated that the concentration of choline acetyl transferase in the cerebral spinal fluid was a predictive factor of POCD and that donepezil, which is an acetylcholinesterase inhibitor used in clinical settings for the treatment of Alzheimer's disease, can prevent learning and memory impairment after anaesthesia/surgery in aged mice. This study aimed to determine the critical role of donepezil in preventing cognitive impairment in elderly patients undergoing orthopaedic surgery. METHODS: A multicentre, double-blind, placebo-controlled, crossover clinical trial will be performed to assess the efficacy of donepezil in elderly patients undergoing orthopaedic surgery. Participants (n = 360) will receive donepezil (5 mg once daily) or placebo from 1 day prior to surgery until 5 days after surgery. Neuropsychological tests will be measured at 1 day before the operation and 1 week, 1 month, 6 months and 1 year after the operation. DISCUSSION: This research project mainly aimed to study the effects of donepezil in elderly patients undergoing orthopaedic surgery due to underlying POCD and to investigate the underlying physiological and neurobiological mechanisms of these effects. The results may provide important implications for the development of effective interfering strategies, specifically regarding cognitive dysfunction therapy using drugs. TRIAL REGISTRATION: ClinicalTrials.gov NCT04423276 . Registered on 14 June 2020.

Associations Between Dietary Inflammatory Index and Sex Hormones Among 6- to 19-Year-Old Children and Adolescents in NHANES 2015-2016.

Objectives: This study aimed to assess the relationship between dietary inflammatory index (DII) and sex steroids in children (6-11 years old) and adolescents (12-19 years old) in the U.S. National Health and Nutrition Examination Survey, 2015-2016. Methods: Participants between the ages of 6-19 have 24-hour dietary intake data, serum sex hormones [total testosterone (TT), estradiol (E2)], and sex hormone-binding globulin (SHBG) available data (n = 1382). The free androgen index (FAI) is calculated as TT divided by SHBG and the ratio of TT to E2 (TT/E2). The constructed puberty state is defined as high levels of steroid hormones (TT≥50 ng/dL in men, E2≥20 pg/ml in women) or onset of menarche. Multiple linear regression analysis was stratified by gender-age and gender-pubertal status groups to evaluate the association between DII and sex hormone levels. Results: After adjusting for covariates, the association between consecutive DII and sex hormone indicators by gender and age group. In male adolescents, DII was always negatively associated with TT (P-trend = 0.09), FAI (P-trend = 0.03) and E2 (P-trend = 0.01), and monotonically positively associated with SHBG (P-trend = 0.02).In female adolescents, with the increase of DII, a significant positive correlation with SHBG was observed (ß 0.017, 95%CI: 0.009,0.053) (Table 3). Among female adolescents, a significant negative association between DII and TT and a significant positive association between SHBG were observed in this group. Moreover, DII was positively associated with SHBG of prepubertal males and negatively associated with FAI of prepubertal females. Conclusions: DII was associated with decreased levels of certain sex steroid hormones (TT, FAI, and E2) and increased levels of SHBG in adolescents or pubertal individuals, with the associations presenting somewhat sex-dependent pattern. However, there is little evidence that there is a significant association in children or prepubertal children. Further research needs to be carried out to verify our results.