Celiac Disease(CD)had been considered uncommon in Asia for a long time.However,several studies suggested that,in the Indian subcontinent and Middle East countries,CD is present and as prevalent as in Western countries...Celiac Disease(CD)had been considered uncommon in Asia for a long time.However,several studies suggested that,in the Indian subcontinent and Middle East countries,CD is present and as prevalent as in Western countries.Outside these Asian regions,the information about the epidemiology of CD is still lacking or largely incomplete for different and variable reasons.Here,we discuss the epidemiological aspects and the diagnostic barriers in several Asian regions including China,Japan,Southeast Asia and Russia/Central Asia.In some of those regions,especially Russia and Central Asia,the prevalence of CD is very likely to be underestimated.Several factors may,to a different extent,contribute to CD underdiagnosis(and,thus,underestimation of its epidemiological burden),including the poor disease awareness among physicians and/or patients,limited access to diagnostic resources,inappropriate use or interpretation of the serological tests,absence of standardized diagnostic and endoscopic protocols,and insufficient expertise in histopathological interpretation.展开更多
基金Nazarbayev University Faculty Development Competitive Research Grant 2020-2022,No.240919FD3912.
文摘Celiac Disease(CD)had been considered uncommon in Asia for a long time.However,several studies suggested that,in the Indian subcontinent and Middle East countries,CD is present and as prevalent as in Western countries.Outside these Asian regions,the information about the epidemiology of CD is still lacking or largely incomplete for different and variable reasons.Here,we discuss the epidemiological aspects and the diagnostic barriers in several Asian regions including China,Japan,Southeast Asia and Russia/Central Asia.In some of those regions,especially Russia and Central Asia,the prevalence of CD is very likely to be underestimated.Several factors may,to a different extent,contribute to CD underdiagnosis(and,thus,underestimation of its epidemiological burden),including the poor disease awareness among physicians and/or patients,limited access to diagnostic resources,inappropriate use or interpretation of the serological tests,absence of standardized diagnostic and endoscopic protocols,and insufficient expertise in histopathological interpretation.
文摘目的:对中美日三国仿制药一致性评价政策进行比较研究,为我国仿制药质量和疗效一致性评价政策的完善提供参考。方法:以"仿制药""一致性评价""Generic drug""Quality evaluation""DESI"等为主题词检索1950年1月1日-2016年6月30日在中国知网、Web of Science、Elsevier、Springer数据库以及美国FDA等网站中发表或报道的相关文献或信息,对中美日三国仿制药一致性评价政策出台的历史背景、评价方法、政策实施效果等进行比较分析。结果:中美日三国仿制药一致性评价政策出台的历史背景、评价方法、参与主体及政策影响力均不同。美国针对历史上药品法规不完善进行的药品有效性再评价,采用专家团队进行审查,依据FDA、企业、科学文献三方证据以及专家所长进行评价;日本仿制药再评价主要采用体外溶出试验的方法;我国仿制药一致性评价的重点在于仿制药市场准入评价,主要采用体内生物等效性评价方法,参比制剂的标准从原基本类似药品逐步上升为原研药。结论:与美日等以创新药为主的国家相比,我国仿制药评价中参比制剂可获得性较低,政策环境更为复杂。我国应进一步完善法律法规,给予仿制药企业合理的缓冲期,并充分考虑评价方法的多样性、特殊情况的豁免情形以及我国医药工业的现状,注重技术监管与制度监管的平衡。
