用儿童药物利用指数评价儿科用药剂量合理性的思考与探索
|
摘要
目的儿科用药缺证据、缺适宜剂型、品种规格和科学折算的标准与方法,导致儿童用药剂量不合理已成为儿科用药中最突出的问题。科学合理地建立儿科用药剂量评价方法、监测儿科药物治疗的合理性,成为全球儿童药物治疗领域亟待解决的问题。基于"解剖化学分类/限定日剂量"(ATC/DDD)体系的"药物利用指数"(Drug Utilization Index,DUI)评价方法已广泛用于成人用药剂量合理性评价。2009年韩璐等依据DUI评价原理首次提出"儿童限定日剂量"(Children De ned Daily Dose,cDDD)和"儿童药物利用指数"(Children Utilization Index,cDUI)的概念,并用于评价汶川地震0～1岁儿科伤员用药剂量合理性。本文旨在探讨cDUI用于儿科用药剂量合理性评价的方法学问题。方法基于课题组前期研究,探讨cDUI用于儿科用药剂量合理性的如下问题:①cDDD的含义;②标准体系建立;③儿科用药剂量的分类评价。结果①cDDD的定义虽参考限定日剂量的形式,但其内涵与后者有本质区别。与DDD作为用药评价的测量单位不同,设立cDDD的目的是以其为标准,衡量儿科用药剂量的合理性。因此,cDDD应为儿科临床实际选用的标准剂量。②cDDD标准体系应用于儿科常见或重大疾病且已广泛使用的药品,接受时间和实践检验;针对药品的不同适应症分别设定相应儿童限定日剂量;对同种药物不同给药途径分别设立标准用药剂量。③评价体系应考虑年龄、体重、疾病种类与病情轻重对用药剂量的影响,采用分类评价的方法,对上述因素分别赋予相应权重,客观、综合地评价用药剂量。结论规范儿科用药剂量对提高儿科医疗质量,保障儿童用药的安全、有效与经济具有重要意义。cDUI方法体系的建立作为一种积极探索,为该领域的研究提供有益的思路与经验。尽管现有方法体系和已有评价研究存在缺陷,但前期研究实践表明,该方法原理在儿科用药剂量合理性评价领域的应用具有可行性。
Objective Inappropriate drug dosage is a serious problem in pediatrics,mainly due to the lack of clinical evidence in children,suitable preparation formulation,and standardized methods for dose adjustment.A method for evaluating and monitoring appropriate dosage in pediatrics is urgently needed.The drug utilization index(DUI) based on the Anatomical Therapeutic Chemical/Defined Daily Dose(ATC/DDD) has been widely used in the assessment of appropriate dosage in adults.We explored possible methods for assessing appropriate dosage in children.Methods Based on our previous studies,we discuss cDUI in the assessment of appropriate dosage in children as follows: the meaning of cDDD,the establishment of a standardized system,and the classified evaluation of dosage in pediatrics.Results Although the definition of cDDD draws on the concept of defined daily dose(DDD),the meaning of cDDD is different from that of the latter.Specifically,the purpose of cDDD is to evaluate appropriate pediatric dose,while DDD is a unit of measurement.cDDD could be used to assess dose rationality for common and serious pediatric diseases,and would be refined over time.A single cDDD should be assigned per drug and indication and given per drug and route of administration.The influence of age,weight,diagnosis,and administration route on the dosage should be considered.Classified evaluation should be used and weight should be given to the above mentioned factors in order to evaluate the appropriate dose objectively and comprehensively.Conclusion Dosage regulation in pediatrics has an important role in improving medical quality and protecting the safety,effectiveness,and economy of medical therapy in children.The establishment of a cDUI system is a good try in pediatric dosage evaluation.Although there are still defects within this proposed system and methodology,the principle seems feasible.
Objective Inappropriate drug dosage is a serious problem in pediatrics,mainly due to the lack of clinical evidence in children,suitable preparation formulation,and standardized methods for dose adjustment.A method for evaluating and monitoring appropriate dosage in pediatrics is urgently needed.The drug utilization index(DUI) based on the Anatomical Therapeutic Chemical/Defined Daily Dose(ATC/DDD) has been widely used in the assessment of appropriate dosage in adults.We explored possible methods for assessing appropriate dosage in children.Methods Based on our previous studies,we discuss cDUI in the assessment of appropriate dosage in children as follows: the meaning of cDDD,the establishment of a standardized system,and the classified evaluation of dosage in pediatrics.Results Although the definition of cDDD draws on the concept of defined daily dose(DDD),the meaning of cDDD is different from that of the latter.Specifically,the purpose of cDDD is to evaluate appropriate pediatric dose,while DDD is a unit of measurement.cDDD could be used to assess dose rationality for common and serious pediatric diseases,and would be refined over time.A single cDDD should be assigned per drug and indication and given per drug and route of administration.The influence of age,weight,diagnosis,and administration route on the dosage should be considered.Classified evaluation should be used and weight should be given to the above mentioned factors in order to evaluate the appropriate dose objectively and comprehensively.Conclusion Dosage regulation in pediatrics has an important role in improving medical quality and protecting the safety,effectiveness,and economy of medical therapy in children.The establishment of a cDUI system is a good try in pediatric dosage evaluation.Although there are still defects within this proposed system and methodology,the principle seems feasible.
引文
1 WHO.Rational use of medicines.http://www.who.int/medicines/areas/rational_use/en/index.Html.
2 Wong IC,Ghaleb MA,Franklin BD,et al.Incidence and nature of dosing errors in paediatric medications:a systematic review.Drug Saf,2004,27(9):661-670.
3 Kaushal R,Bates DW,Landrigan C,et al.Medication errors and adverse drug events in pediatric inpatients.JAMA,2001,285(16):2114-2120.
4 Kozer E,Scolnik D,Macpherson A,et al.Variables associated with medication errors in pediatric emergency medicine.Pediatrics,2002,110(4):737-742.
5 Neuberta A,Wonga ICK,Bonifazi A,et al.Defining off-label and unlicensed use of medicines for children:Results of a Delphi survey.Pharmacological Research,2008,58(43):316-322.
6 Hsien L,Breddemann A,Frobel AK.Off-label drug use among hospitalised children:identifying area with the highest need for re-search.Pharm World Sci,2008,30(32):497–502.
7彭翠英,何周康.507份药品说明书内容现状调查分析.儿科药学杂,2009,15(4):45-47.
8 Santos DB,Clavenna A,Bonati M,et al.Off-label and unlicensed drug utilization in hospitalized children in Fortaleza,Brazil.Euro-pean Journal of Clinical Pharmacology,2008,64(11):1111-1118.
9 Schirm E,Tobi H,de Jong-van den Berg LT.Risk factors for unli-censed and o-label drug use in children outside the hospital.Pedi-atrics,2003,111(2):291-295.
10韩璐,曾力楠,张伶俐,等.329例汶川地震妇女儿童伤病员药物利用分析.中国循证医学杂志,2009,9(3):265-227.
11 World Health Organization.Introduction to Drug Utilization Re-search.Oslo,Norway,2003.http://www.whocc.no/learchive/publi-cations/drug_utilization_research.pdf.
12 Wade O.Drug utilization studies-the rst attempts.Drug utilization studies:implications for medical care.Acta MedicaScandinavica,1984,Suppl 683:7-9.
13 Dukes MNG.Development from Crooks to the nineties.In:Audit-ing Drug Therapy Approaches towards rationality at reasonable costs.Pharmaceutical Press,1992
14 Bergman U.e history of the DrugUtilizati on Research Group in Europe1Phar macoep idemiol.Drug Saf,2006,15(2):95-98
15 Baksaas AI.Drug dose statistics,list of de ned daily doses for drugs registered in Norway.Oslo,Norsk Medicinal Depot,1975.
16 Ghodse AH,Baigent B,Evans TC,et al.e use of a drug utilisation index to monitor psychotropic drug use in hospitals.Journal of So-cial Psychiatry,1987,33(1):21-29.
17阎爱荣,武改梅.我院2005年住院患者麻醉性镇痛药应用分析与评价.中国药房,2007,18(32):2493-2494.
18覃开羽.我院2006年口服降糖药利用分析.中国药房,2008,19(11):819-821.
19刘鹰,杨传辉,李荡,等.门诊患者抗菌药物应用调查.中华医院感染学杂志,2008,18(5):701-711.
20 WHO Collaborating Centre for Drug Statistics Methodology.Guidelines for ATC classi cation and DDD assignment 2010.Oslo,Norway,2009.
21金卫.我院儿科门诊处方抗菌药物的利用分析.广东药学,2005,l15(6):48-50
22张振财.某院门诊儿科抗菌素合理使用情况分析.安徽医药,2005,9(12):934-936.
2 Wong IC,Ghaleb MA,Franklin BD,et al.Incidence and nature of dosing errors in paediatric medications:a systematic review.Drug Saf,2004,27(9):661-670.
3 Kaushal R,Bates DW,Landrigan C,et al.Medication errors and adverse drug events in pediatric inpatients.JAMA,2001,285(16):2114-2120.
4 Kozer E,Scolnik D,Macpherson A,et al.Variables associated with medication errors in pediatric emergency medicine.Pediatrics,2002,110(4):737-742.
5 Neuberta A,Wonga ICK,Bonifazi A,et al.Defining off-label and unlicensed use of medicines for children:Results of a Delphi survey.Pharmacological Research,2008,58(43):316-322.
6 Hsien L,Breddemann A,Frobel AK.Off-label drug use among hospitalised children:identifying area with the highest need for re-search.Pharm World Sci,2008,30(32):497–502.
7彭翠英,何周康.507份药品说明书内容现状调查分析.儿科药学杂,2009,15(4):45-47.
8 Santos DB,Clavenna A,Bonati M,et al.Off-label and unlicensed drug utilization in hospitalized children in Fortaleza,Brazil.Euro-pean Journal of Clinical Pharmacology,2008,64(11):1111-1118.
9 Schirm E,Tobi H,de Jong-van den Berg LT.Risk factors for unli-censed and o-label drug use in children outside the hospital.Pedi-atrics,2003,111(2):291-295.
10韩璐,曾力楠,张伶俐,等.329例汶川地震妇女儿童伤病员药物利用分析.中国循证医学杂志,2009,9(3):265-227.
11 World Health Organization.Introduction to Drug Utilization Re-search.Oslo,Norway,2003.http://www.whocc.no/learchive/publi-cations/drug_utilization_research.pdf.
12 Wade O.Drug utilization studies-the rst attempts.Drug utilization studies:implications for medical care.Acta MedicaScandinavica,1984,Suppl 683:7-9.
13 Dukes MNG.Development from Crooks to the nineties.In:Audit-ing Drug Therapy Approaches towards rationality at reasonable costs.Pharmaceutical Press,1992
14 Bergman U.e history of the DrugUtilizati on Research Group in Europe1Phar macoep idemiol.Drug Saf,2006,15(2):95-98
15 Baksaas AI.Drug dose statistics,list of de ned daily doses for drugs registered in Norway.Oslo,Norsk Medicinal Depot,1975.
16 Ghodse AH,Baigent B,Evans TC,et al.e use of a drug utilisation index to monitor psychotropic drug use in hospitals.Journal of So-cial Psychiatry,1987,33(1):21-29.
17阎爱荣,武改梅.我院2005年住院患者麻醉性镇痛药应用分析与评价.中国药房,2007,18(32):2493-2494.
18覃开羽.我院2006年口服降糖药利用分析.中国药房,2008,19(11):819-821.
19刘鹰,杨传辉,李荡,等.门诊患者抗菌药物应用调查.中华医院感染学杂志,2008,18(5):701-711.
20 WHO Collaborating Centre for Drug Statistics Methodology.Guidelines for ATC classi cation and DDD assignment 2010.Oslo,Norway,2009.
21金卫.我院儿科门诊处方抗菌药物的利用分析.广东药学,2005,l15(6):48-50
22张振财.某院门诊儿科抗菌素合理使用情况分析.安徽医药,2005,9(12):934-936.
版权所有：© 2023 中国地质图书馆 中国地质调查局地学文献中心