临床药物治疗杂志
臨床藥物治療雜誌
림상약물치료잡지
CLINICAL MEDICATION JOURNAL
2015年
1期
49-52
,共4页
易湛苗%李潇潇%周俊文%闫盈盈%翟所迪
易湛苗%李瀟瀟%週俊文%閆盈盈%翟所迪
역담묘%리소소%주준문%염영영%적소적
药品说明书外用法%现状调查%文献分析
藥品說明書外用法%現狀調查%文獻分析
약품설명서외용법%현상조사%문헌분석
off-label use%current situation%bibliometric analysis
目的：调查中国药品说明书外用法的研究现状。方法：计算机检索PubMed，CNKI，SinoMed，WanFang Data，检索时限均从建库至2014年4月，纳入药品说明书外用法的观察性研究论文，统计论文发表情况，并进行文献研究内容分析。结果：共纳入39篇文献，文献发表情况方面，中国自2008年起发表药品说明书外用法相关研究，自2011年起发表英文文献，文献来源地主要集中于北京、四川、广东，涉及33家单位，总引用频次为97次，总下载频次4679次，药师发表的论文占79.49%。研究内容方面，36篇（92.31%）为单一中心研究，34篇（87.18%）为处方或医嘱的调查分析。药物类别以儿科用药为主（14篇，35.90%）。37篇（94.87%）均根据CFDA公布的药品说明书作为药品说明书外用法判断依据。结论：中国药品说明书外用法的研究发展迅速，但在观察主体、研究类型、研究方向和药物类别方面均存在局限性，尚需建立规范化的药品说明书外用法的判定依据。
目的：調查中國藥品說明書外用法的研究現狀。方法：計算機檢索PubMed，CNKI，SinoMed，WanFang Data，檢索時限均從建庫至2014年4月，納入藥品說明書外用法的觀察性研究論文，統計論文髮錶情況，併進行文獻研究內容分析。結果：共納入39篇文獻，文獻髮錶情況方麵，中國自2008年起髮錶藥品說明書外用法相關研究，自2011年起髮錶英文文獻，文獻來源地主要集中于北京、四川、廣東，涉及33傢單位，總引用頻次為97次，總下載頻次4679次，藥師髮錶的論文佔79.49%。研究內容方麵，36篇（92.31%）為單一中心研究，34篇（87.18%）為處方或醫囑的調查分析。藥物類彆以兒科用藥為主（14篇，35.90%）。37篇（94.87%）均根據CFDA公佈的藥品說明書作為藥品說明書外用法判斷依據。結論：中國藥品說明書外用法的研究髮展迅速，但在觀察主體、研究類型、研究方嚮和藥物類彆方麵均存在跼限性，尚需建立規範化的藥品說明書外用法的判定依據。
목적：조사중국약품설명서외용법적연구현상。방법：계산궤검색PubMed，CNKI，SinoMed，WanFang Data，검색시한균종건고지2014년4월，납입약품설명서외용법적관찰성연구논문，통계논문발표정황，병진행문헌연구내용분석。결과：공납입39편문헌，문헌발표정황방면，중국자2008년기발표약품설명서외용법상관연구，자2011년기발표영문문헌，문헌래원지주요집중우북경、사천、엄동，섭급33가단위，총인용빈차위97차，총하재빈차4679차，약사발표적논문점79.49%。연구내용방면，36편（92.31%）위단일중심연구，34편（87.18%）위처방혹의촉적조사분석。약물유별이인과용약위주（14편，35.90%）。37편（94.87%）균근거CFDA공포적약품설명서작위약품설명서외용법판단의거。결론：중국약품설명서외용법적연구발전신속，단재관찰주체、연구류형、연구방향화약물유별방면균존재국한성，상수건립규범화적약품설명서외용법적판정의거。
Objective:To investigate the current situation of studies on off-label use in China.Methods:PubMed, CNKI, SinoMed and WanFang Data were searched through to April 2014 for observational studies on off-label use. Study characteristics and outcomes were extracted and analyzed.Results: In total, 39 studies were included. China began to publish studies on off-label use since 2008, and the ifrst English paper was reported in 2011. The authors involving in 33 institutions were mainly from Beijing, Sichuan and Guangdong provinces. The totally frequency of citation added up to 97 while download times were 4 679. The proportion of studies published by pharmacists reached 79.49%. As for the main contents, 36 reports (92.31%) belonged to single-center studies, and 34 (87.18%) reports focused on prescriptions or doctor's advice. Furthermore, there are 14 papers (35.90%) posted pediatric drugs, and 37 papers (94.87%) referred drug directions approved by CFDA as eligibility criteria to determine whether it was off-label use or not.Conclusion: Though studies on off-label use have been developing rapidly in China, there are still tremendous limitations in such aspects as researchers, types of studies, study focus and drug classes, as well as standard eligibility criteria for off-label use.
