社会药房药学服务的影响因素及其效果评价研究
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摘要
我国社会药房药学服务是社区卫生服务体系建设的重要组成部分，但国内社会药房药学服务发展处于初级阶段，药学服务在理论和实践方面亟待完善。本研究基于这一国情，跟踪国际研究热点问题，对国内外社会药房药学服务研究内容、形式进行系统分析，开展了相关影响因素及其相互关系的研究，进一步搜集药学服务效果评价的证据。这一基础和前沿探索性研究对于指导我国社会药房药学服务实践工作，对于配合卫生体制改革和药品流通体制改革的推进，对于保证公众用药安全、构建和谐的医药患关系具有重要意义。通过研究，本论文获得以下结果：
(1)国内外社会药房药学服务研究比较
系统分析了国外社会药房药学服务研究的进展，国外研究囊括了疾病防治、健康促进、用药咨询、药学服务效果评估和影响因素等各个方面。比较国内外社会药房药学服务研究的差异，国外研究相对于国内研究理论丰富、方法科学、对象明确、内容充实，为国内研究提供了重要借鉴。对国内外社会药房药学服务的影响因素研究进行综述，将国内影响因素概括为政策、行业发展、企业自身、药学从业人员素质、药学服务的社会评价等；而发达国家和其他发展中国家中相关的影响因素集中在药师不足、药师药学服务实践技能和意识欠缺、药师的知识结构有待优化、药师的继续教育需要强化等方面。
(2)社会药房药学服务的德尔菲专家访谈法(Delphi Method)研究
采用Delphi法，研究我国社会药房药学服务的概况，建立了我国社会药房药学服务综合评价指标，该指标体系包括现状、影响因素、对策措施和发展前景四个方面，各由4、3、10、6个指标组成，共计23项指标。该评价体系揭示：药学服务在社会药房的深入开展是大势所趋，药师人才的匮乏和素质不高是影响药学服务开展的最主要障碍，必须从人员、政策、企业内部、观念等各方面采取措施，深化药学服务，为药品零售业的发展注入新活力。该指标体系对于完善我国药学服务法规政策、指导药学服务实践具有重要的参考价值。
(3)基于结构方程模型(SEM)的西安市社会药房药学服务的影响因素研究
在全面掌握国内药学服务概况的基础上，本研究引入结构方程模型的方法，建立11项研究假设，探析西安市社会药房药学服务的影响因素及其相互关系。以西安市社会药房驻店药师为研究对象，通过在西安市多家药店进行问卷调查，获得定量数据，运用SPSS 13.0进行统计学处理，采用LISREL 8.70进行结构方程模型的拟合，对假设逐一进行验证。结果所获取的数据能够较好地拟合理论模型，部分研究假设得到了验证，其中，医药行业发展对社会药房有直接的正向影响；社会药房自身对社会评价有直接的正向影响；社会药房自身对在社会药房中推行基本药学服务有直接的正向影响：社会药房自身对在社会药房中推行高级药学服务有直接的正向影响；药师状况对社会评价有直接的正向影响；药师状况对在社会药房中推行中级药学服务有直接的正向影响。本研究采用SEM方法建立的西安市社会药房药学服务影响因素模型，是该方向的首次实证研究，具有探索性意义，可用于指导药学服务实践。
(4)我国社会药房药学服务法规建设研究
通过分析国内外社会药房药学服务法规体系，提出这一法规体系在宏观层面包括各国药师法、药房法中有关药学服务的规定，还包括各国规范药学服务的优良药房工作规范(GPP)；微观层面表现为实施药学服务工作的具体操作标准。采用文献研究中的二次分析法，对选取的国内可能涉及药学服务的16部规范性文件进行整理和分析，就完善我国社会药房药学服务法规建设提出如下建议：提高现有法规的法律地位，增加社会药房开展药学服务的规定，并制定药学服务项目实施、考核评估、监督管理的指南性规定，以法制建设来推动我国社会药房药学服务工作。
(5)社会药房实施哮喘患者药学服务干预的效果评价
社会药房哮喘患者药学服务的效果评价证据不足，对此，本文将最能科学、全面地评判干预效果，证据价值最为理想的系统评价和meta-分析引入研究，开展了基于meta-分析的社会药房哮喘患者药学服务干预的效果评价，评估干预项目对于哮喘患者最大呼气流速(PEFRs)指标的改善情况。系统检索中国期刊全文数据库(CNKI)、Academic Search Premier(ASP)，Blackwell，Elsevier，John Wiley等数据库1997～2006年间国内外发表的相关文献，选择以用药咨询、健康教育等为干预措施的随机对照试验，由2位评价者对文献进行筛查。采用Review Manager4.2软件对符合条件的文献进行meta-分析。结果共有4项试验纳入本研究，哮喘患者样本1298例，异质性分析结果x~2=1.28，P=0.73，采用固定效应模型进行统计分析。与对照组比较，药学服务干预组的PEFRs改善更明显，合并后的SMD值为0.19，95％的置信区间为0.08～0.30(P=0.0006)。研究表明：开展以用药咨询、健康教育等为主要内容的药学服务项目可以改善哮喘患者的症状，提示在药店开展哮喘药学服务干预项目是一种有效的疾病管理模式。
Pharmaceutical care(PC) in community pharmacy in China, as an important part of community health service, is still on its initial stage for which need to be improved both in theory and practice. Based on this national condition, we aimed at the hot spot of international researchs in this field and stressed on the basic and advanced investigation about the content and form of PC studies in community pharmacy in China and abroad, related influence factors and their relationships, and the evidences to the effect of PC in community pharmacy. This study was significant to the PCpractice in community pharmacy, the development of health system reform and drug supplying system reform, the protection of drug safety of people and the harmony of relationship between professionals and patients. The results are as follows:
(1)Comparison of researches on pharmaceutical care in community pharmacy in China and abroad
To analysis the progess on the PC studies in China and abroad, related studies aborad included aspects such as diseases prevention and controlling, health promotion, drug uses counseling, effect evaluation of PC, factors influening PC and so on. To compare the contents and forms of pharmaceutical care researches in community pharmacy in China and abroad, the pharmaceutical care researches in community pharmacy abroad featured abundant in theories, scientific in methodology, definite in object, and rich in content, which will be beneficial for similar researches in China. To summarize the factors influencing PC in community pharmacy, the factors in China included policies, business development stage, pharmaceutical professionals quality, and social evaluation of PC; the factors aborad emerged as shortage of pharmacists, deficiency of pharmacists' PC skill and sense, pharmacists' unreasonable structure of knowledge, and weak continuing education and so on.
(2)Delphi study on the PC in community pharmacy
Delphi method was used to study the situation of PC in community pharmacy. An comprehensive evaluation indicators of PC in community pharmacy, being comprised of present condition, influence factors, strategies and prospects, were formed. The four parts included 4,3,10,6 indicators respectively, adding up to 23 indicators. The evaluation indicators revealed that the development of PC in community pharmacy is an irresistible trend, the factors that restrict PC most are the shortage of pharmacists and their low quality. Measures from the perspectives of professional, policy, drugstore itself and concept are needed to promote PC further so as to benefit the development of community pharmacies in China. The indicators are significant to the fulfillment of PC regulations and the PC practice.
(3)Factors affecting pharmaceutical care in community pharmacy in Xi' an on the basis of SEM
After understanding the general conditions of PC in China, we used structural equation modeling (SEM) to set up 11 hypotheses to explore the pharmacist' s perspective on the factors affecting the community pharmacy-based PC and their relationships in Xi'an. An questionnaire investigation was conducted among pharmacists in community pharmacies in Xi'an, SPSS 13.0 for Windows was used to statistic data and LISREL 8.70 was used to simulate the SEM. According to SEM testing results, development of industry is positively related to community pharmacy; community pharmacy has a directpositive impact on social evaluation, the providing of basic PC, and senior PC; the quality of pharmacists has a direct positive impact on the social evaluation, and the providing of senior PC. The SEM method was used to construct the factor model, which is the first empirical analysis in this research field in China.
(4)Study on the construction of laws & regulations concerning Chinese PC in drugstores
This paper put forward that laws & regulations concerning Chinese PC in drugstores was comprised of two parts, one is related regulations in pharmacist law, pharmacy law, and Good Pharmacy Practice(GPP) from macroscopic perspective, the other is operating strandards in PC practice from microscopic perspective. 16 laws and regulations were sorted and analyzed by content analysis method, and following suggestions were put forward: the status of the current laws & regulations need to be improved, meanwhile, the contents of pharmaceutical care should be added to some regulations, and the guided regulations concerning the enforcement, checking and evaluation, supervising and administration of pharmaceutical care items should be formulated, the pharmaceutical care in Chinese drugstores should be promoted through the construction of legal system.
A meta-analysis of effect of pharmaceutical care program in asthma patients in community pharmacy
Evidences on the effect of pharmaceutical care program in asthma patients in community pharmacy are insufficient, so we used systematic review and meta-analysis, the most scientific and comprehensive evaluation method, to conduct a meta-analysis of randomized controlled trials (RCTs) of pharmaceutical care(PC) program in asthma patients and its effect on peak expiratory flow rates(PEFRs) in community pharmacies. We searched 5 electronic databases (CNKI, Academic Search Premier, Blackwell, Elsevier, John Wiley) ranging from 1997 to 2006. A meta-analysis was conducted by means of Review Manager 4.2 software using a fixed effects model as appropriate (homogeneityte test x~2=1.28, P=0.73). We included 4 RCTs, 1298 asthma patients. As compared with the control group, the PC program increased patients' PEFRs in PC group significantly(the combined SMD=0.19, 95% confidence interval:0.08-0.30, P=0.0006). PC program in community pharmacies is an effective option in asthma prevention and treatment.
(1)国内外社会药房药学服务研究比较
系统分析了国外社会药房药学服务研究的进展，国外研究囊括了疾病防治、健康促进、用药咨询、药学服务效果评估和影响因素等各个方面。比较国内外社会药房药学服务研究的差异，国外研究相对于国内研究理论丰富、方法科学、对象明确、内容充实，为国内研究提供了重要借鉴。对国内外社会药房药学服务的影响因素研究进行综述，将国内影响因素概括为政策、行业发展、企业自身、药学从业人员素质、药学服务的社会评价等；而发达国家和其他发展中国家中相关的影响因素集中在药师不足、药师药学服务实践技能和意识欠缺、药师的知识结构有待优化、药师的继续教育需要强化等方面。
(2)社会药房药学服务的德尔菲专家访谈法(Delphi Method)研究
采用Delphi法，研究我国社会药房药学服务的概况，建立了我国社会药房药学服务综合评价指标，该指标体系包括现状、影响因素、对策措施和发展前景四个方面，各由4、3、10、6个指标组成，共计23项指标。该评价体系揭示：药学服务在社会药房的深入开展是大势所趋，药师人才的匮乏和素质不高是影响药学服务开展的最主要障碍，必须从人员、政策、企业内部、观念等各方面采取措施，深化药学服务，为药品零售业的发展注入新活力。该指标体系对于完善我国药学服务法规政策、指导药学服务实践具有重要的参考价值。
(3)基于结构方程模型(SEM)的西安市社会药房药学服务的影响因素研究
在全面掌握国内药学服务概况的基础上，本研究引入结构方程模型的方法，建立11项研究假设，探析西安市社会药房药学服务的影响因素及其相互关系。以西安市社会药房驻店药师为研究对象，通过在西安市多家药店进行问卷调查，获得定量数据，运用SPSS 13.0进行统计学处理，采用LISREL 8.70进行结构方程模型的拟合，对假设逐一进行验证。结果所获取的数据能够较好地拟合理论模型，部分研究假设得到了验证，其中，医药行业发展对社会药房有直接的正向影响；社会药房自身对社会评价有直接的正向影响；社会药房自身对在社会药房中推行基本药学服务有直接的正向影响：社会药房自身对在社会药房中推行高级药学服务有直接的正向影响；药师状况对社会评价有直接的正向影响；药师状况对在社会药房中推行中级药学服务有直接的正向影响。本研究采用SEM方法建立的西安市社会药房药学服务影响因素模型，是该方向的首次实证研究，具有探索性意义，可用于指导药学服务实践。
(4)我国社会药房药学服务法规建设研究
通过分析国内外社会药房药学服务法规体系，提出这一法规体系在宏观层面包括各国药师法、药房法中有关药学服务的规定，还包括各国规范药学服务的优良药房工作规范(GPP)；微观层面表现为实施药学服务工作的具体操作标准。采用文献研究中的二次分析法，对选取的国内可能涉及药学服务的16部规范性文件进行整理和分析，就完善我国社会药房药学服务法规建设提出如下建议：提高现有法规的法律地位，增加社会药房开展药学服务的规定，并制定药学服务项目实施、考核评估、监督管理的指南性规定，以法制建设来推动我国社会药房药学服务工作。
(5)社会药房实施哮喘患者药学服务干预的效果评价
社会药房哮喘患者药学服务的效果评价证据不足，对此，本文将最能科学、全面地评判干预效果，证据价值最为理想的系统评价和meta-分析引入研究，开展了基于meta-分析的社会药房哮喘患者药学服务干预的效果评价，评估干预项目对于哮喘患者最大呼气流速(PEFRs)指标的改善情况。系统检索中国期刊全文数据库(CNKI)、Academic Search Premier(ASP)，Blackwell，Elsevier，John Wiley等数据库1997～2006年间国内外发表的相关文献，选择以用药咨询、健康教育等为干预措施的随机对照试验，由2位评价者对文献进行筛查。采用Review Manager4.2软件对符合条件的文献进行meta-分析。结果共有4项试验纳入本研究，哮喘患者样本1298例，异质性分析结果x~2=1.28，P=0.73，采用固定效应模型进行统计分析。与对照组比较，药学服务干预组的PEFRs改善更明显，合并后的SMD值为0.19，95％的置信区间为0.08～0.30(P=0.0006)。研究表明：开展以用药咨询、健康教育等为主要内容的药学服务项目可以改善哮喘患者的症状，提示在药店开展哮喘药学服务干预项目是一种有效的疾病管理模式。
Pharmaceutical care(PC) in community pharmacy in China, as an important part of community health service, is still on its initial stage for which need to be improved both in theory and practice. Based on this national condition, we aimed at the hot spot of international researchs in this field and stressed on the basic and advanced investigation about the content and form of PC studies in community pharmacy in China and abroad, related influence factors and their relationships, and the evidences to the effect of PC in community pharmacy. This study was significant to the PCpractice in community pharmacy, the development of health system reform and drug supplying system reform, the protection of drug safety of people and the harmony of relationship between professionals and patients. The results are as follows:
(1)Comparison of researches on pharmaceutical care in community pharmacy in China and abroad
To analysis the progess on the PC studies in China and abroad, related studies aborad included aspects such as diseases prevention and controlling, health promotion, drug uses counseling, effect evaluation of PC, factors influening PC and so on. To compare the contents and forms of pharmaceutical care researches in community pharmacy in China and abroad, the pharmaceutical care researches in community pharmacy abroad featured abundant in theories, scientific in methodology, definite in object, and rich in content, which will be beneficial for similar researches in China. To summarize the factors influencing PC in community pharmacy, the factors in China included policies, business development stage, pharmaceutical professionals quality, and social evaluation of PC; the factors aborad emerged as shortage of pharmacists, deficiency of pharmacists' PC skill and sense, pharmacists' unreasonable structure of knowledge, and weak continuing education and so on.
(2)Delphi study on the PC in community pharmacy
Delphi method was used to study the situation of PC in community pharmacy. An comprehensive evaluation indicators of PC in community pharmacy, being comprised of present condition, influence factors, strategies and prospects, were formed. The four parts included 4,3,10,6 indicators respectively, adding up to 23 indicators. The evaluation indicators revealed that the development of PC in community pharmacy is an irresistible trend, the factors that restrict PC most are the shortage of pharmacists and their low quality. Measures from the perspectives of professional, policy, drugstore itself and concept are needed to promote PC further so as to benefit the development of community pharmacies in China. The indicators are significant to the fulfillment of PC regulations and the PC practice.
(3)Factors affecting pharmaceutical care in community pharmacy in Xi' an on the basis of SEM
After understanding the general conditions of PC in China, we used structural equation modeling (SEM) to set up 11 hypotheses to explore the pharmacist' s perspective on the factors affecting the community pharmacy-based PC and their relationships in Xi'an. An questionnaire investigation was conducted among pharmacists in community pharmacies in Xi'an, SPSS 13.0 for Windows was used to statistic data and LISREL 8.70 was used to simulate the SEM. According to SEM testing results, development of industry is positively related to community pharmacy; community pharmacy has a directpositive impact on social evaluation, the providing of basic PC, and senior PC; the quality of pharmacists has a direct positive impact on the social evaluation, and the providing of senior PC. The SEM method was used to construct the factor model, which is the first empirical analysis in this research field in China.
(4)Study on the construction of laws & regulations concerning Chinese PC in drugstores
This paper put forward that laws & regulations concerning Chinese PC in drugstores was comprised of two parts, one is related regulations in pharmacist law, pharmacy law, and Good Pharmacy Practice(GPP) from macroscopic perspective, the other is operating strandards in PC practice from microscopic perspective. 16 laws and regulations were sorted and analyzed by content analysis method, and following suggestions were put forward: the status of the current laws & regulations need to be improved, meanwhile, the contents of pharmaceutical care should be added to some regulations, and the guided regulations concerning the enforcement, checking and evaluation, supervising and administration of pharmaceutical care items should be formulated, the pharmaceutical care in Chinese drugstores should be promoted through the construction of legal system.
A meta-analysis of effect of pharmaceutical care program in asthma patients in community pharmacy
Evidences on the effect of pharmaceutical care program in asthma patients in community pharmacy are insufficient, so we used systematic review and meta-analysis, the most scientific and comprehensive evaluation method, to conduct a meta-analysis of randomized controlled trials (RCTs) of pharmaceutical care(PC) program in asthma patients and its effect on peak expiratory flow rates(PEFRs) in community pharmacies. We searched 5 electronic databases (CNKI, Academic Search Premier, Blackwell, Elsevier, John Wiley) ranging from 1997 to 2006. A meta-analysis was conducted by means of Review Manager 4.2 software using a fixed effects model as appropriate (homogeneityte test x~2=1.28, P=0.73). We included 4 RCTs, 1298 asthma patients. As compared with the control group, the PC program increased patients' PEFRs in PC group significantly(the combined SMD=0.19, 95% confidence interval:0.08-0.30, P=0.0006). PC program in community pharmacies is an effective option in asthma prevention and treatment.
引文
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