RESUMO
Based on the statistics of 350 technical evaluations of changes in licensing items of class Ⅱ passive and active medical devices completed in Henan province from July 2017 to November 2018, this paper summarized and analysed the common problems and requirements listed in the correction notifications of the technical evaluation, and put forward relevant countermeasures or suggestions, with a view to further speeding up the evaluation and approval of medical devices.
Assuntos
Equipamentos e Provisões , Padrões de Referência , Regulamentação Governamental , LicenciamentoRESUMO
Objective To investigate the relationship between body mass index (BMI) and all-cause mortality in hypertensive population.Methods All participants were selected from a prospective cohort study based on a rural population from Henan province,China.Cox proportional hazards regression models were used to estimate the associations of different levels of BMI stratification with all-cause mortality.Restricted cubic spline models were used to detect the doseresponse relation.Results Among the 5 461 hypertensive patients,a total of 31 048.38 person-years follow-up was conducted.The median of follow-up time was 6 years,and 589 deaths occurred during the follow-up period.Compared to normal weight group (18.5 kg/m2＜BMI＜24.0 kg/m2) the multivariate-adjusted hazard ratios for all-cause mortality associated with BMI levels (＜ 18.5 kg/m2,24-28 kg/m2,and ≥28 kg/m2) were 0.83 (95％CI:0.37-1.87),0.81 (95％CI:0.67-0.97),and 0.72 (95％CI:0.56-0.91),respectively.The dose-response analysis showed a nonlinear,reverse "S" shaped relationship (non-linearity P＜0.001).Conclusion Overweight or obese might have a protective effect on all-cause mortality in hypertensive population,which supports the "obesity paradox" phenomenon.
RESUMO
Objective To study the modification effect of age on the association between body mass index and the risk of hypertension.Methods People age ≥ 18 years old were selected by clusters,from a rural area of Henan province.In total,20 194 people were recruited at baseline during 2007 and 2008,and the follow-up study was completed from 2013 to 2014.Logistic regression model was used to assess the risk of incident hypertension by baseline BMI and age-specific BMI.Results During the 6-year follow-up period,1 950 hypertensive persons were detected,including 784 men and 1 166 women,with cumulative incidence rates as 19.96％,20.51％,and 19.61％,respectively.Compared with those whose BMI＜22 kg/m2,the RRs of hypertension were 1.09 (0.93-1.27),1.17 (1.01-1.37),1.34 (1.14-1.58) and 1.31 (1.09-1.56) for participants with BMI as 22-,24-,26-and ≥28 kg/m2,respectively.In young and middle-aged populations,the risk of hypertension gradually increased with the rise of BMI (trend P＜0.05).However,in the elderly,the increasing trend on the risk of hypertension risk was not as significantly obvious (trend P＞0.05).Conclusion The effect of BMI on the incidence of hypertension seemed to depend on age.Our findings suggested that a weight reduction program would be more effective on young or middle-aged populations,to prevent the development of hypertension.
RESUMO
Objective To investigate the relationship between body mass index (BMI) and all-cause mortality in hypertensive population.Methods All participants were selected from a prospective cohort study based on a rural population from Henan province,China.Cox proportional hazards regression models were used to estimate the associations of different levels of BMI stratification with all-cause mortality.Restricted cubic spline models were used to detect the doseresponse relation.Results Among the 5 461 hypertensive patients,a total of 31 048.38 person-years follow-up was conducted.The median of follow-up time was 6 years,and 589 deaths occurred during the follow-up period.Compared to normal weight group (18.5 kg/m2＜BMI＜24.0 kg/m2) the multivariate-adjusted hazard ratios for all-cause mortality associated with BMI levels (＜ 18.5 kg/m2,24-28 kg/m2,and ≥28 kg/m2) were 0.83 (95％CI:0.37-1.87),0.81 (95％CI:0.67-0.97),and 0.72 (95％CI:0.56-0.91),respectively.The dose-response analysis showed a nonlinear,reverse "S" shaped relationship (non-linearity P＜0.001).Conclusion Overweight or obese might have a protective effect on all-cause mortality in hypertensive population,which supports the "obesity paradox" phenomenon.
RESUMO
Objective To study the modification effect of age on the association between body mass index and the risk of hypertension.Methods People age ≥ 18 years old were selected by clusters,from a rural area of Henan province.In total,20 194 people were recruited at baseline during 2007 and 2008,and the follow-up study was completed from 2013 to 2014.Logistic regression model was used to assess the risk of incident hypertension by baseline BMI and age-specific BMI.Results During the 6-year follow-up period,1 950 hypertensive persons were detected,including 784 men and 1 166 women,with cumulative incidence rates as 19.96％,20.51％,and 19.61％,respectively.Compared with those whose BMI＜22 kg/m2,the RRs of hypertension were 1.09 (0.93-1.27),1.17 (1.01-1.37),1.34 (1.14-1.58) and 1.31 (1.09-1.56) for participants with BMI as 22-,24-,26-and ≥28 kg/m2,respectively.In young and middle-aged populations,the risk of hypertension gradually increased with the rise of BMI (trend P＜0.05).However,in the elderly,the increasing trend on the risk of hypertension risk was not as significantly obvious (trend P＞0.05).Conclusion The effect of BMI on the incidence of hypertension seemed to depend on age.Our findings suggested that a weight reduction program would be more effective on young or middle-aged populations,to prevent the development of hypertension.