WHO、印度、南非儿童基本药物目录与中国2012版基本药物目录的比较研究
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摘要
目的比较全球现有儿童基本药物目录与中国2012年版国家基本药物目录的异同,为建立中国儿童基本药物目录提供参考依据。方法计算机检索世界卫生组织(WHO)官网及英文、中文国家卫生部及药品监督管理部门网站,查找已颁布的儿童基本药物目录(essential medicine list for children,EMLc),对比各国EMLc与中国2012年版国家基本药物目录的更新情况、药物数量、分类、药物剂型等的异同。结果截至2013年8月,WHO、印度和南非已建立儿童基本药物目录。中国目录因未限制使用人群,数量居所有目录首位。WHO、印度和中国均采用药理学分类;南非采用解剖学、治疗学及化学分类法(anatomical therapeutic chemical,ATC)分类。除WHO外,印度、南非和中国目录均无新生儿用药和关节疾病用药分类。四版目录均以口服、注射和局部皮肤给药为主。WHO与印度目录有药物使用限制,南非、中国无使用限制。结论中国2012年版国家基本药物目录下药物种类与儿童疾病负担不适应、儿童适用剂型缺乏、未制定用药限制,此版目录于儿童适用性存在较大局限。
Objective Comparing the worldwide Essential Medicines Lists for Children(EMLcs) and National Essential Medicine List(NEML) of China(2012 edition), to provide evidence for establishing EMLc of China. Method We searched the official websites of WHO and Ministry of Health of some countries to identify published EMLcs. We compared the situation of updating, the number and classification of medicines, and the dosage forms between these EMLcs and NEML of China(2012). Result By August 2013, the WHO, India and South Africa had established EMLc. The number of medicines of NEML of China(2012) ranked first in the four lists. The WHO, India and China classified the medicines by pharmacologic action, while South Africa classified it by anatomical therapeutic chemical(ATC) classification. Except the WHO, India, South Africa and China did not have specific medicines for neonatal care or medicines for diseases of joints. The main administration routes in these four lists were oral administration, injection, and topical application. There were medicine restrictions in EMLcs of WHO and India, while no medicine restrictions in lists of South Africa and China. Conclusion Medicines listed in NEML of China(2012) do not match children's disease burden of China. The applicable dosage forms for children are few and the medicine restrictions are absent for the list. So this list is not suitable for Children.
Objective Comparing the worldwide Essential Medicines Lists for Children(EMLcs) and National Essential Medicine List(NEML) of China(2012 edition), to provide evidence for establishing EMLc of China. Method We searched the official websites of WHO and Ministry of Health of some countries to identify published EMLcs. We compared the situation of updating, the number and classification of medicines, and the dosage forms between these EMLcs and NEML of China(2012). Result By August 2013, the WHO, India and South Africa had established EMLc. The number of medicines of NEML of China(2012) ranked first in the four lists. The WHO, India and China classified the medicines by pharmacologic action, while South Africa classified it by anatomical therapeutic chemical(ATC) classification. Except the WHO, India, South Africa and China did not have specific medicines for neonatal care or medicines for diseases of joints. The main administration routes in these four lists were oral administration, injection, and topical application. There were medicine restrictions in EMLcs of WHO and India, while no medicine restrictions in lists of South Africa and China. Conclusion Medicines listed in NEML of China(2012) do not match children's disease burden of China. The applicable dosage forms for children are few and the medicine restrictions are absent for the list. So this list is not suitable for Children.
引文
1 WHO.Essential medicine.Available at:http://www.who.int/medicines/services/essmedicines_def/en/.
2张川,王莉,袁强,等.我国基本药物目录、基本医疗保险药物目录和WHO基本药物目录比较.中国循证医学杂志,2009,9(7):765-773.
3张伶俐,张川,梁毅,等.我国2009版基本药物目录(基层)与WHO 2010版儿童基本药物示范目录比较分析.中国循证医学杂志,2010,10(9):1027-1036.
4 WHO.WHO Model List of Essential Medicines for Children 4th list(April 2013)Available at:http://www.who.int/medicines/publications/essentialmedicines/4th_EMLc_FINAL_web_8Jull3.pdf.
5 Indian Academy of Pediatrics.Indian Academy of Pediatrics List of Essential Medicines for Children of India First List-October2011.Available at:http://www.iapindia.org/files/IAP%20EMLc%20October%2031.pdf
6 The National Department of Health,Pretoria,South Africa.Standard treatment guidelines and essential drugs list for South Africa hospital level paediatrics 2006 edition.Available at:http://www.kznhealth.gov.za/chrp/documents/Guidelines/Guidelines%20National/EDL%20Paediatrics/EDL%20Paediatrics%20Hospital%20Level%202006.pdf.
7胡仪吉,金有豫,主编.第1版.中国国家处方集(化学药品与生物制品卷·儿童版).北京:人民军医出版社,2013.
8 WHO.South Africa Statistics.Available at:http://www.who.int/countries/zaf/en/.
9 WHO.India Statistics.Available at:http://www.who.int/countries/ind/en/.
10 WHO.China Statistics.Available at:http://www.who.int/countries/chn/zh/index.Html.
11 GBD.Global Burden of Disease Study 2010-China Results by Cause1990-2010.Available at:http://ghdx.healthmetricsandevaluation.org/global-burden-disease-study-2010-gbd-2010-data-downloads.
12 GBD.Global Burden of Disease Study 2010-India Results by Cause1990-2010.Available at:http://ghdx.healthmetricsandevaluation.org/global-burden-disease-study-2010-gbd-2010-data-downloads.
13 GBD.Global Burden of Disease Study 2010-South Africa Results by Cause 1990-2010.Available at:http://ghdx.healthmetricsandevaluation.org/global-burden-disease-study-2010-gbd-2010-data-downloads.
14 Murray CJL,Ezzati M,Flaxman AD,et al.GBD 2010:design,defnitions,and metrics.Lancet,2012,380(9859):2063-2066.
15王莉,周帮旻,宋佳佳,等.25国基本药物目录循证评价.中国循证医学杂志,2009,9(7):754-764.
16 WHO.Guidelines for ATC classification and DDD assignment2013.Available at:http://www.whocc.no/filearchive/publications/1_2013guidelines.pdf.
17 Unedited Report of the 19th WHO Expert Committee on the Selection and Use of Essential Medicines(including the 18th WHO Model List of Essential Medicines and the 4th WHO Model List of Essential Medicinesfor Children).Available at:http://www.who.int/medicines/EC19uneditedReport.pdf.
18卫生部.国家基本药物目录(2012年版)相关政策问答.Available at:http://www.moh.gov.cn/mohywzc/s3582/201303/57a7b9ead4074247b9f9bf31al37689b.shtml.
19 WHO Technical Report Series 958 The selection and use of essential medicines Report of the WHO Expert Committee,2009(including the 16th WHO Model List of Essential Medicines and the 2nd WHO Model List of Essential Medicines for Children).Available at:http://whqlibdoc.who.int/trs/WHO_TRS_958_eng.pdf.
20 WHO technical report series 950 the selection and use of essential medicines Report of the WHO Expert Committee,October 2007(including the Model List of Essential Medicines).Available at:http://whqlibdoc.who.int/trs/WHO_TRS_950_eng.pdf.
21 WHO.Medicines:medicines for children.Available at:http://www.who.int/mediacentre/factsheets/fs341/en/index.html.
22张伶俐,李幼平,胡蝶,等.我国儿童药物短缺的现状分析.中国循证医学杂志,2012,12(10):1159-1164.
2张川,王莉,袁强,等.我国基本药物目录、基本医疗保险药物目录和WHO基本药物目录比较.中国循证医学杂志,2009,9(7):765-773.
3张伶俐,张川,梁毅,等.我国2009版基本药物目录(基层)与WHO 2010版儿童基本药物示范目录比较分析.中国循证医学杂志,2010,10(9):1027-1036.
4 WHO.WHO Model List of Essential Medicines for Children 4th list(April 2013)Available at:http://www.who.int/medicines/publications/essentialmedicines/4th_EMLc_FINAL_web_8Jull3.pdf.
5 Indian Academy of Pediatrics.Indian Academy of Pediatrics List of Essential Medicines for Children of India First List-October2011.Available at:http://www.iapindia.org/files/IAP%20EMLc%20October%2031.pdf
6 The National Department of Health,Pretoria,South Africa.Standard treatment guidelines and essential drugs list for South Africa hospital level paediatrics 2006 edition.Available at:http://www.kznhealth.gov.za/chrp/documents/Guidelines/Guidelines%20National/EDL%20Paediatrics/EDL%20Paediatrics%20Hospital%20Level%202006.pdf.
7胡仪吉,金有豫,主编.第1版.中国国家处方集(化学药品与生物制品卷·儿童版).北京:人民军医出版社,2013.
8 WHO.South Africa Statistics.Available at:http://www.who.int/countries/zaf/en/.
9 WHO.India Statistics.Available at:http://www.who.int/countries/ind/en/.
10 WHO.China Statistics.Available at:http://www.who.int/countries/chn/zh/index.Html.
11 GBD.Global Burden of Disease Study 2010-China Results by Cause1990-2010.Available at:http://ghdx.healthmetricsandevaluation.org/global-burden-disease-study-2010-gbd-2010-data-downloads.
12 GBD.Global Burden of Disease Study 2010-India Results by Cause1990-2010.Available at:http://ghdx.healthmetricsandevaluation.org/global-burden-disease-study-2010-gbd-2010-data-downloads.
13 GBD.Global Burden of Disease Study 2010-South Africa Results by Cause 1990-2010.Available at:http://ghdx.healthmetricsandevaluation.org/global-burden-disease-study-2010-gbd-2010-data-downloads.
14 Murray CJL,Ezzati M,Flaxman AD,et al.GBD 2010:design,defnitions,and metrics.Lancet,2012,380(9859):2063-2066.
15王莉,周帮旻,宋佳佳,等.25国基本药物目录循证评价.中国循证医学杂志,2009,9(7):754-764.
16 WHO.Guidelines for ATC classification and DDD assignment2013.Available at:http://www.whocc.no/filearchive/publications/1_2013guidelines.pdf.
17 Unedited Report of the 19th WHO Expert Committee on the Selection and Use of Essential Medicines(including the 18th WHO Model List of Essential Medicines and the 4th WHO Model List of Essential Medicinesfor Children).Available at:http://www.who.int/medicines/EC19uneditedReport.pdf.
18卫生部.国家基本药物目录(2012年版)相关政策问答.Available at:http://www.moh.gov.cn/mohywzc/s3582/201303/57a7b9ead4074247b9f9bf31al37689b.shtml.
19 WHO Technical Report Series 958 The selection and use of essential medicines Report of the WHO Expert Committee,2009(including the 16th WHO Model List of Essential Medicines and the 2nd WHO Model List of Essential Medicines for Children).Available at:http://whqlibdoc.who.int/trs/WHO_TRS_958_eng.pdf.
20 WHO technical report series 950 the selection and use of essential medicines Report of the WHO Expert Committee,October 2007(including the Model List of Essential Medicines).Available at:http://whqlibdoc.who.int/trs/WHO_TRS_950_eng.pdf.
21 WHO.Medicines:medicines for children.Available at:http://www.who.int/mediacentre/factsheets/fs341/en/index.html.
22张伶俐,李幼平,胡蝶,等.我国儿童药物短缺的现状分析.中国循证医学杂志,2012,12(10):1159-1164.