Objective:The Delphi method was used to propose health effect evaluation indicators to assess foods for special medical purposes(FSMPs).This lays the foundation for the formation of a big data model for human health t...Objective:The Delphi method was used to propose health effect evaluation indicators to assess foods for special medical purposes(FSMPs).This lays the foundation for the formation of a big data model for human health testing,as well as a big data platform for the health and safety evaluation of special medical foods.Methods:The Delphi method was used to conduct two rounds of expert consultation on the constructed FSMP health effect evaluation indicators.Results:Ten major items were identified after two rounds of expert consultation.Among these,there were 10 primary entries,32 secondary entries,50 tertiary entries,and 28 quaternary entries.Conclusion:The complete list of evaluation indicators contains 10 entries,which can comprehensively and systematically monitor adverse reactions to the use of FSMPs.The present findings lay the foundation for a big data platform to evaluate the health and safety of special foods.展开更多
In this paper,the background,principles,and main contents of the rules for the examination of production licenses of foods for special medical purposes are introduced.The contents including general rules,production si...In this paper,the background,principles,and main contents of the rules for the examination of production licenses of foods for special medical purposes are introduced.The contents including general rules,production sites,equipment facilities,equipment layout,technological process,personnel management,management system and supplementary rules are interpreted item by item.This study has important value and historical significance for promoting the development of Chinese enterprises and industries of foods for special medical purposes.展开更多
Multi-drug(or multi-element)combinations are often prescribed in the practice of clinical medicine and as foods for special medical purposes.The main motivations for these combinations are that most diseases contain m...Multi-drug(or multi-element)combinations are often prescribed in the practice of clinical medicine and as foods for special medical purposes.The main motivations for these combinations are that most diseases contain multiple related targets and an appropriate combination can maximize benefits while minimizing adverse reactions.As such,it is especially important to derive mathematical models for their quantitative calculation.In this paper,we introduce mathematical rules for the synergistic,additive,and antagonistic effects of multi-drug combinations developed in our laboratory.We have established a“onebelt,one-line”model and provide examples of the quantitative calculation of the synergistic,additive,and antagonistic effects of a combination of multiple components.We also explain how to scientifically and precisely determine the intensity of these synergies,additions and antagonisms,as well as their corresponding dose ranges,thereby laying a solid theoretical foundation for market listing combinatorial drugs and foods for special medical purposes.展开更多
目的:梳理特殊医学用途配方食品(Food for Special Medical Purpose,FSMP)的法规标准,汇总分析已获批产品的相关信息,为产品研发、申请注册、临床使用等提供参考。方法:从管理和应用的角度,对与FSMP密切相关的法律法规、标准进行汇总、...目的:梳理特殊医学用途配方食品(Food for Special Medical Purpose,FSMP)的法规标准,汇总分析已获批产品的相关信息,为产品研发、申请注册、临床使用等提供参考。方法:从管理和应用的角度,对与FSMP密切相关的法律法规、标准进行汇总、解读和说明;从产品数量、产品类型、适用人群等方面对已批复特殊医学用途配方食品进行总结分析。结果:特殊医学用途配方食品已形成相对完善的标准和法律法规体系;截至2024年3月,特殊医学用途配方食品已注册181个产品。结论:特殊医学用途配方食品标准和法律法规是产品研发生产、注册审批及临床使用的依据,FSMP的批复信息是产品研发、临床应用的重要参考信息,应加强了解和掌握,促进FSMP的研究开发和临床应用。展开更多
特殊医学用途配方食品(food for special medical purpose,FSMP)是为了满足进食受限、消化吸收障碍、代谢紊乱或特定疾病状态人群需要的一种配方食品。《国民营养计划(2017-2030)》中临床营养行动提出推动FSMP的规范化应用。FSMP在医院...特殊医学用途配方食品(food for special medical purpose,FSMP)是为了满足进食受限、消化吸收障碍、代谢紊乱或特定疾病状态人群需要的一种配方食品。《国民营养计划(2017-2030)》中临床营养行动提出推动FSMP的规范化应用。FSMP在医院的规范化应用是当前临床营养管理工作关注的重点之一。由于我国FSMP发展起步较晚,还存在相关法规和政策有待完善、临床应用经验较为缺乏等诸多问题,国家卫生健康委医院管理研究所委托临床营养项目专家工作组,组织相关领域专家,在充分分析国内外相关文献、行业政策及制度规范的基础上编写适用于医疗机构的FSMP临床管理专家共识。本共识从总则、组织架构和职责、FSMP管理、FSMP临床应用规范、推荐意见、结语6个方面进行介绍,以进一步规范医院内FSMP的临床应用和管理,促进FSMP的营养治疗价值最大化。展开更多
目的:探讨特殊医学用途配方食品(food for special medical purpose,FSMP)营养治疗新路径在痔疮患者术后快速康复中的有效性。方法:选取2017-10-01~2018-05-31在我院肛肠外科进行手术治疗的男性混合痔疮患者60例,随机分为观察组及对照...目的:探讨特殊医学用途配方食品(food for special medical purpose,FSMP)营养治疗新路径在痔疮患者术后快速康复中的有效性。方法:选取2017-10-01~2018-05-31在我院肛肠外科进行手术治疗的男性混合痔疮患者60例,随机分为观察组及对照组。观察组采用FSMP营养治疗新路径进行营养干预,对照组采用一般术后快速康复饮食治疗,观察两组患者住院时间、首次排便时间、术后前3d平均排便次数、主观满意度、出院时营养状况及营养风险发生率、术后不良反应发生率等。结果:观察组住院时间、首次排便时间、术后前3d平均排便次数、出院时营养风险发生率及术后不良反应发生率(术后疼痛、出血、感染、低血糖)均明显低于对照组;观察组患者出院时营养状况及主观满意度明显高于对照组,差异均具有统计学意义(P<0.05或P<0.01)。结论:FSMP营养治疗新路径能加快痔疮患者术后快速康复,应在临床广泛推广。展开更多
基金This research was supported by the National Key Research and Development Program of China(2019YFC1606400).
文摘Objective:The Delphi method was used to propose health effect evaluation indicators to assess foods for special medical purposes(FSMPs).This lays the foundation for the formation of a big data model for human health testing,as well as a big data platform for the health and safety evaluation of special medical foods.Methods:The Delphi method was used to conduct two rounds of expert consultation on the constructed FSMP health effect evaluation indicators.Results:Ten major items were identified after two rounds of expert consultation.Among these,there were 10 primary entries,32 secondary entries,50 tertiary entries,and 28 quaternary entries.Conclusion:The complete list of evaluation indicators contains 10 entries,which can comprehensively and systematically monitor adverse reactions to the use of FSMPs.The present findings lay the foundation for a big data platform to evaluate the health and safety of special foods.
基金The authors acknowledge the support from“National Key R&D Program of China”(Project No.2018YFC1603400).
文摘In this paper,the background,principles,and main contents of the rules for the examination of production licenses of foods for special medical purposes are introduced.The contents including general rules,production sites,equipment facilities,equipment layout,technological process,personnel management,management system and supplementary rules are interpreted item by item.This study has important value and historical significance for promoting the development of Chinese enterprises and industries of foods for special medical purposes.
文摘Multi-drug(or multi-element)combinations are often prescribed in the practice of clinical medicine and as foods for special medical purposes.The main motivations for these combinations are that most diseases contain multiple related targets and an appropriate combination can maximize benefits while minimizing adverse reactions.As such,it is especially important to derive mathematical models for their quantitative calculation.In this paper,we introduce mathematical rules for the synergistic,additive,and antagonistic effects of multi-drug combinations developed in our laboratory.We have established a“onebelt,one-line”model and provide examples of the quantitative calculation of the synergistic,additive,and antagonistic effects of a combination of multiple components.We also explain how to scientifically and precisely determine the intensity of these synergies,additions and antagonisms,as well as their corresponding dose ranges,thereby laying a solid theoretical foundation for market listing combinatorial drugs and foods for special medical purposes.
文摘目的:梳理特殊医学用途配方食品(Food for Special Medical Purpose,FSMP)的法规标准,汇总分析已获批产品的相关信息,为产品研发、申请注册、临床使用等提供参考。方法:从管理和应用的角度,对与FSMP密切相关的法律法规、标准进行汇总、解读和说明;从产品数量、产品类型、适用人群等方面对已批复特殊医学用途配方食品进行总结分析。结果:特殊医学用途配方食品已形成相对完善的标准和法律法规体系;截至2024年3月,特殊医学用途配方食品已注册181个产品。结论:特殊医学用途配方食品标准和法律法规是产品研发生产、注册审批及临床使用的依据,FSMP的批复信息是产品研发、临床应用的重要参考信息,应加强了解和掌握,促进FSMP的研究开发和临床应用。
文摘特殊医学用途配方食品(food for special medical purpose,FSMP)是为了满足进食受限、消化吸收障碍、代谢紊乱或特定疾病状态人群需要的一种配方食品。《国民营养计划(2017-2030)》中临床营养行动提出推动FSMP的规范化应用。FSMP在医院的规范化应用是当前临床营养管理工作关注的重点之一。由于我国FSMP发展起步较晚,还存在相关法规和政策有待完善、临床应用经验较为缺乏等诸多问题,国家卫生健康委医院管理研究所委托临床营养项目专家工作组,组织相关领域专家,在充分分析国内外相关文献、行业政策及制度规范的基础上编写适用于医疗机构的FSMP临床管理专家共识。本共识从总则、组织架构和职责、FSMP管理、FSMP临床应用规范、推荐意见、结语6个方面进行介绍,以进一步规范医院内FSMP的临床应用和管理,促进FSMP的营养治疗价值最大化。
文摘目的:探讨特殊医学用途配方食品(food for special medical purpose,FSMP)营养治疗新路径在痔疮患者术后快速康复中的有效性。方法:选取2017-10-01~2018-05-31在我院肛肠外科进行手术治疗的男性混合痔疮患者60例,随机分为观察组及对照组。观察组采用FSMP营养治疗新路径进行营养干预,对照组采用一般术后快速康复饮食治疗,观察两组患者住院时间、首次排便时间、术后前3d平均排便次数、主观满意度、出院时营养状况及营养风险发生率、术后不良反应发生率等。结果:观察组住院时间、首次排便时间、术后前3d平均排便次数、出院时营养风险发生率及术后不良反应发生率(术后疼痛、出血、感染、低血糖)均明显低于对照组;观察组患者出院时营养状况及主观满意度明显高于对照组,差异均具有统计学意义(P<0.05或P<0.01)。结论:FSMP营养治疗新路径能加快痔疮患者术后快速康复,应在临床广泛推广。
