Background and Objectives: Three post-marketing clinical follow-up studies were performed in Europe to confirm the safety and performance of four nonprescription, nasal cleansing medical devices: Otrivin Sea Water (OS...Background and Objectives: Three post-marketing clinical follow-up studies were performed in Europe to confirm the safety and performance of four nonprescription, nasal cleansing medical devices: Otrivin Sea Water (OSW) pressurized spray, OSW with aloe vera (OSWAV), Otrisal 0.74% NaCl Metered-Dose Spray (MDS), and Prorhinel spray. Material and Methods: Observational, single-arm, retrospective studies consisting of a single online questionnaire were performed between July 2021 and December 2021. Eligible participants were adults who used the device or supervised use of the device in a participant under 18 years of age within 6 months of completing the questionnaire. Demographics, safety, and device performance were assessed. Results: Based on questionnaires submitted on OSW (n = 556), OSWAV (n = 555), Otrisal MDS (n = 555), and Prorhinel (n = 555), proportions of users who reported safety events were 1.8% for OSW, 2.3% for OSWAV, 1.4% for Otrisal MDS, and 2.0% for Prorhinel. Proportions of users who indicated they were satisfied or very satisfied with device performance ranged from 72.0% - 89.0% across all devices. Device performance for all products was also supported for additional preventative and symptomatic uses through exploratory analyses. Conclusions and Significance: These data confirm device safety and performance of OSW, OSWAV, Otrisal MDS, and Prorhinel for their intended uses.展开更多
Background and Objectives:Large-scale studies on the role of multivitamin-mineral(MVM)supplementation in preventing and managing acute respiratory infections(AURIs)are limited in Chinese populations.This study eval ua...Background and Objectives:Large-scale studies on the role of multivitamin-mineral(MVM)supplementation in preventing and managing acute respiratory infections(AURIs)are limited in Chinese populations.This study eval uated the impact of routine MVM use on AURI prevalence and symptom severity in a community-based Chinese cohort.Methods and Study Design:This retrospective study was conducted among community-based populations across China(n=3,415).Using a structured questionnaire,participants self-reported episodes of AURIs over three months.Based on regular use of MVM for at least 3 months,eligible participants were categorized into the MVM group and the control group.The impact of MVM on the frequency and severity of AURIs was assessed.Rigorous methodological approaches were applied to minimize potential biases.Results:The period prevalence of AURIs was significantly lower in the MVM group(29.9%)compared to controls(45.6%),odds ratio(OR)=0.508(p<0.001).After propensity score matching,demographic and lifestyle factors were comparable between groups.The period prevalence of AURIs was 31.7%and 44.8%in the MVM and control groups(OR=0.572,p<0.001).Subgroup analysis indicated the protective effect of MVM supplementation was particularly significant among participants aged≥45 years(OR=0.407,p<0.001).The MVM group reported lower prevalence of nasal congestion(OR=0.624,p<0.001),sore throat(OR=0.575,p<0.001),headache(OR=0.642,p<0.001),diarrhea(OR=0.718,0.026),sneezing(OR=0.651,p=0.002),and fatigue(OR=0.694,p=0.004)relative to the control group.Conclu sions:Daily MVM supplementation for at least 3 months reduced the period prevalence of the common cold and influenza and may contribute to enhanced immune resilience in the Chinese population.展开更多
文摘Background and Objectives: Three post-marketing clinical follow-up studies were performed in Europe to confirm the safety and performance of four nonprescription, nasal cleansing medical devices: Otrivin Sea Water (OSW) pressurized spray, OSW with aloe vera (OSWAV), Otrisal 0.74% NaCl Metered-Dose Spray (MDS), and Prorhinel spray. Material and Methods: Observational, single-arm, retrospective studies consisting of a single online questionnaire were performed between July 2021 and December 2021. Eligible participants were adults who used the device or supervised use of the device in a participant under 18 years of age within 6 months of completing the questionnaire. Demographics, safety, and device performance were assessed. Results: Based on questionnaires submitted on OSW (n = 556), OSWAV (n = 555), Otrisal MDS (n = 555), and Prorhinel (n = 555), proportions of users who reported safety events were 1.8% for OSW, 2.3% for OSWAV, 1.4% for Otrisal MDS, and 2.0% for Prorhinel. Proportions of users who indicated they were satisfied or very satisfied with device performance ranged from 72.0% - 89.0% across all devices. Device performance for all products was also supported for additional preventative and symptomatic uses through exploratory analyses. Conclusions and Significance: These data confirm device safety and performance of OSW, OSWAV, Otrisal MDS, and Prorhinel for their intended uses.
基金funded by the National Key R&D Program of China(2022YFF1100600/2022YFF1100604)Haleon China.
文摘Background and Objectives:Large-scale studies on the role of multivitamin-mineral(MVM)supplementation in preventing and managing acute respiratory infections(AURIs)are limited in Chinese populations.This study eval uated the impact of routine MVM use on AURI prevalence and symptom severity in a community-based Chinese cohort.Methods and Study Design:This retrospective study was conducted among community-based populations across China(n=3,415).Using a structured questionnaire,participants self-reported episodes of AURIs over three months.Based on regular use of MVM for at least 3 months,eligible participants were categorized into the MVM group and the control group.The impact of MVM on the frequency and severity of AURIs was assessed.Rigorous methodological approaches were applied to minimize potential biases.Results:The period prevalence of AURIs was significantly lower in the MVM group(29.9%)compared to controls(45.6%),odds ratio(OR)=0.508(p<0.001).After propensity score matching,demographic and lifestyle factors were comparable between groups.The period prevalence of AURIs was 31.7%and 44.8%in the MVM and control groups(OR=0.572,p<0.001).Subgroup analysis indicated the protective effect of MVM supplementation was particularly significant among participants aged≥45 years(OR=0.407,p<0.001).The MVM group reported lower prevalence of nasal congestion(OR=0.624,p<0.001),sore throat(OR=0.575,p<0.001),headache(OR=0.642,p<0.001),diarrhea(OR=0.718,0.026),sneezing(OR=0.651,p=0.002),and fatigue(OR=0.694,p=0.004)relative to the control group.Conclu sions:Daily MVM supplementation for at least 3 months reduced the period prevalence of the common cold and influenza and may contribute to enhanced immune resilience in the Chinese population.
