Objective： To evaluate the population attributable risks （PARs） between cigarette smoking and deaths of all causes, all cancers, lung cancer and other chronic diseases in urban Shanghai. Methods： In total, 61,480 ...Objective： To evaluate the population attributable risks （PARs） between cigarette smoking and deaths of all causes, all cancers, lung cancer and other chronic diseases in urban Shanghai. Methods： In total, 61,480 men aged 40-74 years from 2002 to 2006 and 74,941 women aged 40-70 years from 1997 to 2000 were recruited to undergo baseline surveys in urban Shanghai, with response rates of 74.0% and 92.3%, respectively. A Cox proportional hazards regression model was used to estimate relative risks （RRs） and 95% confidence intervals （95% CIs） of deaths associated with cigarette smoking. PARs and 95 % CIs for deaths were estimated from smoking exposure rates and the estimated RRs. Results： Cigarette smoking was responsible for 23.9% （95% CI： 19.4-28.3%） and 2.4% （95% Ch 1.6- 3.2%） of all deaths in men and women, respectively, in our study population. Respiratory disease had the highest PAR in men [37.5% （95% CI： 21.5-51.6%）], followed by cancer [31.3% （95% Ch 24.6-37.7%）] and cardiovascular disease （CVD） [24.1% （95% CI： 16.7-31.2%）]. While the top three PARs were 12.7% （95% CI： 6.1-19.3%）, 4.0% （95% CI： 2.4-5.6%）, and 1.1% （95% CI： 0.0-2.3%）, for respiratory disease, CVD, and cancer, respectively in women. For deaths of lung cancer, the PAR of smoking was 68.4% （95% CI： 58.2- 76.5%） in men. Conclusions： In urban Shanghai, 23.9% and 2.4% of all deaths in men and women could have been prevented if no people had smoked in the area. Effective control programs against cigarette smoking should be strongly advocated to reduce the increasing smoking-related death burden.展开更多
From a regulatory perspective,drug quality consistency evaluation must concern different processes used for the same drug.In this study,an assessment strategy based on quality by design(QbD)was developed for populatio...From a regulatory perspective,drug quality consistency evaluation must concern different processes used for the same drug.In this study,an assessment strategy based on quality by design(QbD)was developed for population pharmaceutical quality evaluation.A descriptive analysis method based on QbD concept was first established to characterize the process by critical evaluation attributes(CEAs).Then quantitative analysis method based on an improved statistical process control(SPC)method was established to investigate the process indicators(PIs)in the process population,such as mean distribution,batch-to-batch difference and abnormal quality probability.After that rules for risk assessment were established based on the SPC limitations and parameters.Both the SPC parameters of the CEAs and the risk of PIs were visualized according to the interaction test results to obtain a better understanding of the population pharmaceutical quality.Finally,an assessment strategy was built and applied to generic drug consistency assessment,process risk assessment and quality trend tracking.The strategy demonstrated in this study could help reveal quality consistency from the perspective of process control and process risk,and further show the recent development status of domestic pharmaceutical production processes.In addition,a process risk assessment and population quality trend tracking provide databased information for approval.Not only can this information serve as a further basis for decisionmaking by the regulatory authority regarding early warnings,but it can also reduce some avoidable adverse reactions.With continuous addition of data,dynamic population pharmaceutical quality is meaningful for emergencies and decision-making regarding drug regulation.展开更多
原发性肝癌是世界上常见的恶性肿瘤之一,具有较高的发病率和死亡率。本文详述了目前我国原发性肝癌的流行病学情况、人群归因分值及其相关危险因素。本文通过检索PubMed、Web of Science、中国知网等数据库发现,乙型肝炎病毒和丙型肝炎...原发性肝癌是世界上常见的恶性肿瘤之一,具有较高的发病率和死亡率。本文详述了目前我国原发性肝癌的流行病学情况、人群归因分值及其相关危险因素。本文通过检索PubMed、Web of Science、中国知网等数据库发现,乙型肝炎病毒和丙型肝炎病毒仍是原发性肝癌发病的主要危险因素。随着乙型肝炎病毒疫苗接种以及抗病毒治疗,我国原发性肝癌的发病率略有下降,但代谢性因素如糖尿病、肥胖和非酒精性脂肪性肝病等引起的原发性肝癌的发病率正逐步上升;吸烟、饮酒等也是重要的危险因素。本文综述了原发性肝癌的流行病学特点及危险因素,可为制订原发性肝癌防控措施提供切实有力的循证医学证据。展开更多
基金supported by the funds of Key Discipline and Specialty Foundation of Shanghai Municipal Commission of Health and Family Planningthe National Key Basic Research Program "973 project" (2015CB554000)grants from US National Institutes of Health (R37 CA070867, R01 CA82729, UM1CA173640, and UM1 CA182910)
文摘Objective： To evaluate the population attributable risks （PARs） between cigarette smoking and deaths of all causes, all cancers, lung cancer and other chronic diseases in urban Shanghai. Methods： In total, 61,480 men aged 40-74 years from 2002 to 2006 and 74,941 women aged 40-70 years from 1997 to 2000 were recruited to undergo baseline surveys in urban Shanghai, with response rates of 74.0% and 92.3%, respectively. A Cox proportional hazards regression model was used to estimate relative risks （RRs） and 95% confidence intervals （95% CIs） of deaths associated with cigarette smoking. PARs and 95 % CIs for deaths were estimated from smoking exposure rates and the estimated RRs. Results： Cigarette smoking was responsible for 23.9% （95% CI： 19.4-28.3%） and 2.4% （95% Ch 1.6- 3.2%） of all deaths in men and women, respectively, in our study population. Respiratory disease had the highest PAR in men [37.5% （95% CI： 21.5-51.6%）], followed by cancer [31.3% （95% Ch 24.6-37.7%）] and cardiovascular disease （CVD） [24.1% （95% CI： 16.7-31.2%）]. While the top three PARs were 12.7% （95% CI： 6.1-19.3%）, 4.0% （95% CI： 2.4-5.6%）, and 1.1% （95% CI： 0.0-2.3%）, for respiratory disease, CVD, and cancer, respectively in women. For deaths of lung cancer, the PAR of smoking was 68.4% （95% CI： 58.2- 76.5%） in men. Conclusions： In urban Shanghai, 23.9% and 2.4% of all deaths in men and women could have been prevented if no people had smoked in the area. Effective control programs against cigarette smoking should be strongly advocated to reduce the increasing smoking-related death burden.
基金The National Major Scientific and Technological Special Project for‘Significant New Drugs Development’(Grant No.:2017ZX0901001-007)provides support for this study.
文摘From a regulatory perspective,drug quality consistency evaluation must concern different processes used for the same drug.In this study,an assessment strategy based on quality by design(QbD)was developed for population pharmaceutical quality evaluation.A descriptive analysis method based on QbD concept was first established to characterize the process by critical evaluation attributes(CEAs).Then quantitative analysis method based on an improved statistical process control(SPC)method was established to investigate the process indicators(PIs)in the process population,such as mean distribution,batch-to-batch difference and abnormal quality probability.After that rules for risk assessment were established based on the SPC limitations and parameters.Both the SPC parameters of the CEAs and the risk of PIs were visualized according to the interaction test results to obtain a better understanding of the population pharmaceutical quality.Finally,an assessment strategy was built and applied to generic drug consistency assessment,process risk assessment and quality trend tracking.The strategy demonstrated in this study could help reveal quality consistency from the perspective of process control and process risk,and further show the recent development status of domestic pharmaceutical production processes.In addition,a process risk assessment and population quality trend tracking provide databased information for approval.Not only can this information serve as a further basis for decisionmaking by the regulatory authority regarding early warnings,but it can also reduce some avoidable adverse reactions.With continuous addition of data,dynamic population pharmaceutical quality is meaningful for emergencies and decision-making regarding drug regulation.
文摘原发性肝癌是世界上常见的恶性肿瘤之一,具有较高的发病率和死亡率。本文详述了目前我国原发性肝癌的流行病学情况、人群归因分值及其相关危险因素。本文通过检索PubMed、Web of Science、中国知网等数据库发现,乙型肝炎病毒和丙型肝炎病毒仍是原发性肝癌发病的主要危险因素。随着乙型肝炎病毒疫苗接种以及抗病毒治疗,我国原发性肝癌的发病率略有下降,但代谢性因素如糖尿病、肥胖和非酒精性脂肪性肝病等引起的原发性肝癌的发病率正逐步上升;吸烟、饮酒等也是重要的危险因素。本文综述了原发性肝癌的流行病学特点及危险因素,可为制订原发性肝癌防控措施提供切实有力的循证医学证据。
