25国基本药物目录循证评价

目的系统比较25国已有国家基本药物目录（EML），为我国制定EML和建立配套保障制度提供决策参考。方法检索各国卫生部和药品监督管理机构的官方网站，系统收集正式颁布的EML。两名评价员独立筛选文献、提取资料。通过描述性分析比较各国EML的制定时间、更新周期、遴选委员会组成、遴选标准、药品类别划分标准、品种数、药品信息和配套标准治疗指南的情况。结果截至2009年5月，共检索纳入25国36个版次的国家EML，其中英文34个、中文2个：25国从1982～2009年开始出版国家EML，更新周期4个月～8年。参与制定EML的部门包括：中央政府、卫生或药品监督管理、公共卫生、基本药物、教育培训等部门。药物遴选委员会包括：临床医学、卫生行政管理、药学（药理学）、高等医学教育、经济学、统计和流行病学、国际组织专家（WHO或UNICEF）、财政、病人代表、制药业等领域的专家。各国普遍依据WHO对基本药物的定义和遴选标准，结合本国国情制定了基于药品安全、有效和经济性的科学证据、兼顾疾病负担和药品合理使用及生产供应等方面的遴选标准。EML纳入药品数在103～2033种，中位数为447种：最多为中国，2033种，其中西药773种、中药1260种；最少的是索马里103种。药品分类借鉴WHO解剖-治疗-化学代码（ATC法），药品信息包括通用名、剂量、剂型和给药途径：各国按医疗机构级别、医生的执业职称及执业范围分级配置和使用EML。配套的标准治疗指南或处方集覆盖73～163种疾病，主要包括疾病的诊断、治疗方法的选择、合理用药、禁忌症和药品不良反应等内容。结论由于各国经济、文化、疾病负担和医疗卫生服务发展水平不同，各国基本药物目录差异较大。在基本药物遴选与使用、标准治疗指南制定、配套制度等方面，澳大利亚、南非等国都有较好的经验值得借鉴。建议建立我国基本药物决策管理体系，制定覆盖我国主要疾病负担，针对常见病、多发疾病的基层医疗机构基本药物目录。

Evidence-Based Evaluation of National Essential Medicine Lists in Twenty-five Countries

Objective To provide the evidence on the selection and related policies of essential medicine for policy-makers through systematic review of the National Essential Medicine List(NEML) around the world. Method We systematically searched the official websites of the health authorities, like the departments of health and pharmaceutical administrations. We selected the published NEML. Two reviewers independently selected literature and extracted data. We analyzed the time of NEML published and updated, NEML committees, selection criteria, medicine category, number of medicines, and medicine information in NEML and standard treatment guidelines (STGs) as well. Results Thirty-six NEMLs from 25 countries were included with 34 in English and 2 in Chinese. From 1982 to 2009, Twenty-five countries developed their NEMLs respectively. They were updated from four months to eight years. The NEML committee members came from central government, ministry of health, pharmaceutical administrations, ministry of public health, ministry of education, essential medicine division, etc. The committees were composed of clinical specialists, health officials, pharmacists (pharmacologists), medicine educators, economist, statisticians, epidemiologist and experts from WHO/ UNICEF, etc. Most of the countries took the WHO's concept of essential medicine and selection criteria as standard. The applications of essential medicine were reviewed by considering the following aspects: safety, effectiveness, economic characteristics, the main disease burden, rational use of drug and supply. The medicines in NEMLs of 25 countries varied from 103 to 2 033, and the median is 447. The Anatomical Therapeutic Chemical (ATC) classification was used to classify the medicines in NEMLs of 12 countries. The drug information was provided, including generic name, dosage,form of medication and administration route as well. The STGs or formularies covered from 73 to 167 common diseases, including the diagnosis, treatments, rational use of drug, contraindications, adverse effects, etc. Conclusions The NEMLs in 25 countries have shown great differences because of the variation of the social and economic developments, disease burdens and the developments of health care systems in different countries. We can learn from the experience of other countries, like Australia and South Africa, in the selection and use of essential medicines, STGs and related policies. We should develop the national essential medicine system for policy making and administration, especially the national essential medicine list for common diseases base on the high quality evidence, the local disease burden as well as specific demands in different areas.