AIM To determine the distribution of anthropometric parameter(AP)-z-scores and characterize associations between medications/serum biomarkers and AP-z-scores in pediatric Crohn's disease(CD).METHODS CD patients [&...AIM To determine the distribution of anthropometric parameter(AP)-z-scores and characterize associations between medications/serum biomarkers and AP-z-scores in pediatric Crohn's disease(CD).METHODS CD patients [< chronological age(CA) 21 years] were enrolled in a cross-sectional study. Descriptive statistics were generated for participants' demographic characteristics and key variables of interest. Paired t-tests were used to compare AP-z-scores calculated based on CA(CA z-scores) and bone age(BA)(BA z-scores) for interpretation of AP's. Linear regression was utilized to examine associations between medications and serum biomarkers with AP-z-scores calculated based on CA(n = 82) and BA(n = 49). We reported regression coefficients as well as their corresponding p-values and 95% confidence intervals.RESULTS Mean CA at the time of the study visit was 15.3 ± 3.5(SD; range = 4.8-20.7) years. Mean triceps skinfold(P = 0.039), subscapular skinfold(P = 0.002) and midarm circumference(MAC)(P = 0.001) BA z-scores were higher than corresponding CA z-scores. Medications were positively associated with subscapular skinfold [adalimumab(P = 0.018) and methotrexate(P = 0.027)] and BMI CA z-scores [adalimumab(P = 0.029)]. Azathioprine/6-mercaptopurine were negatively associated with MAC(P = 0.045), subscapular skinfold(P = 0.014), weight(P = 0.002) and BMI(P = 0.013) CA z-scores. ESR, CRP, and WBC count were negatively associated, while albumin and IGF-1 BA z-scores were positively associated, with specific AP z-scores(P < 0.05). Mean height CA z-scores were higher in females, not males, treated with infliximab(P = 0.038). Hemoglobin(P = 0.018) was positively associated, while platelets(P = 0.005), ESR(P = 0.003) and CRP(P = 0.039) were negatively associated with height CA z-scores in males, not females. CONCLUSION Our results suggest poor efficacy of thiopurines and a possible sex difference in statural growth response to infliximab in pediatric CD. Prospective longitudinal studies are required.展开更多
Young women are an important target group in microbicide research, yet little is known about why they participate and stay in microbicide trials. Our study examined motivations for participating in a Phase I microbici...Young women are an important target group in microbicide research, yet little is known about why they participate and stay in microbicide trials. Our study examined motivations for participating in a Phase I microbicide trial among 61 women ages 18 - 24 years in the continental USA and Puerto Rico. We also examined their perspectives on study participation. Participants underwent a semi-structured in-depth interview in which they were asked about factors that motivated enrollment and their experiences while participating. They also completed a Web-based Computer Assisted Self Interview in which they were asked to rate study burden (1 = low to 4 = high). Factors that motivated enrollment were altruism (29%), compensation (17%), a combination of altruism and compensation (37%) and free medical exams (17%). Factors that encouraged participants to stay in the study were study staff (95%), confirmation of good health (41%), and the opportunity to learn about their bodies (17%). Mean ratings of study burden ranged from 1.83 (having to travel to site) to 2.41 (colposcopy), indicating that participants were not highly bothered by visits or procedures. Although Phase I trials require invasive procedures, participants were not highly bothered by them and recognized them as necessary. Good relationships with staff and clear information about how procedures contribute to study goals may encourage participants to remain in trials. Young women may be motivated to enter microbicide trials by stressing the role they will play in discovering better HIV-prevention methods and highlighting the comprehensive preventive exams they will receive.展开更多
基金Supported by National Institutes of Health,No.DK077734(NG)Children’s Digestive Health and Nutrition Foundation(now known as North American Society for Pediatric Gastroenterology,Hepatology,and Nutrition Foundation)/Crohn’s and Colitis Foundation of America(now known as Crohn’s and Colitis Foundation)Award for New Investigators,No.CDHNF-06-002(NG)+2 种基金Crohn’s and Colitis Foundation of America(now known as Crohn’s and Colitis Foundation)Career Development Award,No.Award ID 1743(NG)University of California San Francisco Department of Pediatrics Pediatric Clinical Research Center Clinical Research Pilot Funding Award(NG)National Institutes of Health/National Center for Research Resources University of California San Francisco-Clinical and Translational Science Institute,No.UL1 RR024131
文摘AIM To determine the distribution of anthropometric parameter(AP)-z-scores and characterize associations between medications/serum biomarkers and AP-z-scores in pediatric Crohn's disease(CD).METHODS CD patients [< chronological age(CA) 21 years] were enrolled in a cross-sectional study. Descriptive statistics were generated for participants' demographic characteristics and key variables of interest. Paired t-tests were used to compare AP-z-scores calculated based on CA(CA z-scores) and bone age(BA)(BA z-scores) for interpretation of AP's. Linear regression was utilized to examine associations between medications and serum biomarkers with AP-z-scores calculated based on CA(n = 82) and BA(n = 49). We reported regression coefficients as well as their corresponding p-values and 95% confidence intervals.RESULTS Mean CA at the time of the study visit was 15.3 ± 3.5(SD; range = 4.8-20.7) years. Mean triceps skinfold(P = 0.039), subscapular skinfold(P = 0.002) and midarm circumference(MAC)(P = 0.001) BA z-scores were higher than corresponding CA z-scores. Medications were positively associated with subscapular skinfold [adalimumab(P = 0.018) and methotrexate(P = 0.027)] and BMI CA z-scores [adalimumab(P = 0.029)]. Azathioprine/6-mercaptopurine were negatively associated with MAC(P = 0.045), subscapular skinfold(P = 0.014), weight(P = 0.002) and BMI(P = 0.013) CA z-scores. ESR, CRP, and WBC count were negatively associated, while albumin and IGF-1 BA z-scores were positively associated, with specific AP z-scores(P < 0.05). Mean height CA z-scores were higher in females, not males, treated with infliximab(P = 0.038). Hemoglobin(P = 0.018) was positively associated, while platelets(P = 0.005), ESR(P = 0.003) and CRP(P = 0.039) were negatively associated with height CA z-scores in males, not females. CONCLUSION Our results suggest poor efficacy of thiopurines and a possible sex difference in statural growth response to infliximab in pediatric CD. Prospective longitudinal studies are required.
基金the US National Institutes of Health (NIH)CONRAD and Starpharma Pty Ltd+1 种基金the Microbicide Tri- als Network (MTN-004, Ian McGowan, PI) the Ado- lescent Trials Network (ATN-062, Alex Carballo-Diéguez, PI)
文摘Young women are an important target group in microbicide research, yet little is known about why they participate and stay in microbicide trials. Our study examined motivations for participating in a Phase I microbicide trial among 61 women ages 18 - 24 years in the continental USA and Puerto Rico. We also examined their perspectives on study participation. Participants underwent a semi-structured in-depth interview in which they were asked about factors that motivated enrollment and their experiences while participating. They also completed a Web-based Computer Assisted Self Interview in which they were asked to rate study burden (1 = low to 4 = high). Factors that motivated enrollment were altruism (29%), compensation (17%), a combination of altruism and compensation (37%) and free medical exams (17%). Factors that encouraged participants to stay in the study were study staff (95%), confirmation of good health (41%), and the opportunity to learn about their bodies (17%). Mean ratings of study burden ranged from 1.83 (having to travel to site) to 2.41 (colposcopy), indicating that participants were not highly bothered by visits or procedures. Although Phase I trials require invasive procedures, participants were not highly bothered by them and recognized them as necessary. Good relationships with staff and clear information about how procedures contribute to study goals may encourage participants to remain in trials. Young women may be motivated to enter microbicide trials by stressing the role they will play in discovering better HIV-prevention methods and highlighting the comprehensive preventive exams they will receive.
