CAJ | 학술논문

目的：论证《国家基本药物目录》（2012年版）（以下简称2012版基药目录）中适宜儿童使用的化学药品和生物制品（以下简称化药）。方法依据化药最新版说明书、《中国国家处方集（化学药品与生物制品卷·儿童版）》、第4版《WHO儿童基本药物标准清单》以及文献和临床专家调研的结果，论证适宜儿童使用的活性成分和品种。提出适宜不同年龄段儿童的剂型，并据此筛选出相应的品种。通过计算，得出适宜不同年龄段儿童的规格。结果适宜儿童使用的化药有283种活性成分，占91.59％。适宜不同年龄段儿童的品种和规格占比：＜2岁分别为44.29％、28.14％；2～5岁分别为76.30％、50.06％；＞5岁分别为84.95％、80.60％。结论2012版基药目录化药部分为儿童用药提供了重要保障，但适宜低龄儿童的剂型和规格仍存在较大缺失。
목적：론증《국가기본약물목록》（2012년판）（이하간칭2012판기약목록）중괄의인동사용적화학약품화생물제품（이하간칭화약）。방법의거화약최신판설명서、《중국국가처방집（화학약품여생물제품권·인동판）》、제4판《WHO인동기본약물표준청단》이급문헌화림상전가조연적결과，론증괄의인동사용적활성성분화품충。제출괄의불동년령단인동적제형，병거차사선출상응적품충。통과계산，득출괄의불동년령단인동적규격。결과괄의인동사용적화약유283충활성성분，점91.59％。괄의불동년령단인동적품충화규격점비：＜2세분별위44.29％、28.14％；2～5세분별위76.30％、50.06％；＞5세분별위84.95％、80.60％。결론2012판기약목록화약부분위인동용약제공료중요보장，단괄의저령인동적제형화규격잉존재교대결실。
Objective To demonstrate the chemical and biological prod-ucts suitable for children in National Essential Medicine List (2012 Edi-tion)(NEML).Methods The active ingredients and formulations sui-table for children in NEML were demonstrated based on the latest version of instructions , ‘Chinese National Formulary ( Chemicals and Biological Products for Children ) ’ , the fourth edition ‘World Health Organization (WHO) Model List of Essential Medicines for Children ’, the results of literature and the suggestions from clinic experts.List the dosage forms , formulations and strengths suitable for children of different ages.Results The amount of active ingredients suitable for children are 283 , accounting for 91.59%.The proportion of formulations and strengths suitable for children of different ages: less than 2 years old is 44.29%and 28.14% respectively , 2 -5 years old is 76.30% and 50.06%respectively , more than 5 years old is 84.95%and 80.60% respective-ly.Conclusion Chemical and biological products in NEML provide important safeguard for children , but the dosage forms and strengths are not enough for young children.