中国循证医学杂志
中國循證醫學雜誌
중국순증의학잡지
CHINESE JOURNAL OF EVIDENCE-BASED MEDICINE
2009年
7期
754-764
,共11页
王莉%周帮旻%宋佳佳%彭静%袁强%许晓波%李幼平
王莉%週幫旻%宋佳佳%彭靜%袁彊%許曉波%李幼平
왕리%주방민%송가가%팽정%원강%허효파%리유평
基本药物目录%合理用药%药物遴选标准%标准治疗指南%循证评价
基本藥物目錄%閤理用藥%藥物遴選標準%標準治療指南%循證評價
기본약물목록%합리용약%약물린선표준%표준치료지남%순증평개
Essential medicine list (EML)%Rational use of medicine%Drug selection criteria%standard treatment guideline%Evidence-based evaluation
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,共检索纳人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103～2 033种,中位数为447种:最多为中国,2033种,其中西药773种、中药1 260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.
目的 繫統比較25國已有國傢基本藥物目錄(EML),為我國製定EML和建立配套保障製度提供決策參攷.方法 檢索各國衛生部和藥品鑑督管理機構的官方網站,繫統收集正式頒佈的EML.兩名評價員獨立篩選文獻、提取資料.通過描述性分析比較各國EML的製定時間、更新週期、遴選委員會組成、遴選標準、藥品類彆劃分標準、品種數、藥品信息和配套標準治療指南的情況.結果 截至2009年5月,共檢索納人25國36箇版次的國傢EML,其中英文34箇、中文2箇.25國從1982～2009年開始齣版國傢EML,更新週期4箇月～8年.參與製定EML的部門包括:中央政府、衛生或藥品鑑督管理、公共衛生、基本藥物、教育培訓等部門.藥物遴選委員會包括:臨床醫學、衛生行政管理、藥學(藥理學)、高等醫學教育、經濟學、統計和流行病學、國際組織專傢(WHO或UNICEF)、財政、病人代錶、製藥業等領域的專傢.各國普遍依據WHO對基本藥物的定義和遴選標準,結閤本國國情製定瞭基于藥品安全、有效和經濟性的科學證據、兼顧疾病負擔和藥品閤理使用及生產供應等方麵的遴選標準.EML納入藥品數在103～2 033種,中位數為447種:最多為中國,2033種,其中西藥773種、中藥1 260種;最少的是索馬裏103種.藥品分類藉鑒WHO解剖-治療-化學代碼(ATC法),藥品信息包括通用名、劑量、劑型和給藥途徑.各國按醫療機構級彆、醫生的執業職稱及執業範圍分級配置和使用EML.配套的標準治療指南或處方集覆蓋73～163種疾病,主要包括疾病的診斷、治療方法的選擇、閤理用藥、禁忌癥和藥品不良反應等內容.結論 由于各國經濟、文化、疾病負擔和醫療衛生服務髮展水平不同,各國基本藥物目錄差異較大.在基本藥物遴選與使用、標準治療指南製定、配套製度等方麵,澳大利亞、南非等國都有較好的經驗值得藉鑒.建議建立我國基本藥物決策管理體繫,製定覆蓋我國主要疾病負擔,針對常見病、多髮疾病的基層醫療機構基本藥物目錄.
목적 계통비교25국이유국가기본약물목록(EML),위아국제정EML화건립배투보장제도제공결책삼고.방법 검색각국위생부화약품감독관리궤구적관방망참,계통수집정식반포적EML.량명평개원독립사선문헌、제취자료.통과묘술성분석비교각국EML적제정시간、경신주기、린선위원회조성、린선표준、약품유별화분표준、품충수、약품신식화배투표준치료지남적정황.결과 절지2009년5월,공검색납인25국36개판차적국가EML,기중영문34개、중문2개.25국종1982～2009년개시출판국가EML,경신주기4개월～8년.삼여제정EML적부문포괄:중앙정부、위생혹약품감독관리、공공위생、기본약물、교육배훈등부문.약물린선위원회포괄:림상의학、위생행정관리、약학(약이학)、고등의학교육、경제학、통계화류행병학、국제조직전가(WHO혹UNICEF)、재정、병인대표、제약업등영역적전가.각국보편의거WHO대기본약물적정의화린선표준,결합본국국정제정료기우약품안전、유효화경제성적과학증거、겸고질병부담화약품합리사용급생산공응등방면적린선표준.EML납입약품수재103～2 033충,중위수위447충:최다위중국,2033충,기중서약773충、중약1 260충;최소적시색마리103충.약품분류차감WHO해부-치료-화학대마(ATC법),약품신식포괄통용명、제량、제형화급약도경.각국안의료궤구급별、의생적집업직칭급집업범위분급배치화사용EML.배투적표준치료지남혹처방집복개73～163충질병,주요포괄질병적진단、치료방법적선택、합리용약、금기증화약품불량반응등내용.결론 유우각국경제、문화、질병부담화의료위생복무발전수평불동,각국기본약물목록차이교대.재기본약물린선여사용、표준치료지남제정、배투제도등방면,오대리아、남비등국도유교호적경험치득차감.건의건립아국기본약물결책관리체계,제정복개아국주요질병부담,침대상견병、다발질병적기층의료궤구기본약물목록.
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.
