国内外超说明书用药的文献计量分析
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摘要
目的:对国内外超说明书用药主题文献进行计量分析。方法:计算机检索中国知网、万方数据、维普网、PubMed、Embase、Web of Science于1991年1月(国外)或2007年1月(国内)起至2018年12月发表的超说明书用药相关文献。对纳入的国内及国外文献的基本情况(包括发文量分布、发文杂志分布)、文章合著(包括核心研究者、研究内容)、关键词共现进行分析总结。结果:共检索到国内文献1 647篇、国外文献4 418篇,其中有效文献国内1 570篇、国外4 238篇。近十年,国内外文献发文量呈上升趋势,2017年国内外发文量最多(国内355篇,国外465篇)。国内外发文量最多的杂志分别是《中国药房》(105篇)、European Journal of Clinical Pharmacology(51篇)。国内外核心研究者分别是李幼平、de la Torre JC。国内研究的内容有超说明书用药政策、儿童超说明书用药现状、眼科超说明书用药、中成药超说明书用药等;国外研究的内容有抗病毒药物超说明书用药、特殊人群(儿童、酒精依赖患者等)超说明书用药等。国内外文献关键词排名前3的分别是超说明书用药、合理用药、药品说明书和human、off-label use、article。结论:国内外超说明书用药的研究逐年递增,各团队积极开展跨地区合作,通过文献计量的方法可助力学者拓宽研究方向,追踪研究热点,选择投稿杂志。
OBJECTIVE:To conduct bibliometric analysis of off-label use in domestic and foreign. METHODS:Retrieved from CNKI,Wanfang database,VIP,PubMed,Embase and Web of Science during Jan. 1991(in foreign) or Jan. 2007(in domestic)to Dec. 2018,related literatures of off-label use were collected. General information(publication numbers distribution,journals distribution),article cooperation(core researchers,research content) and keywords of domestic and foreign literatures were analyzed and summarized. RESULTS:A total of 1 647 domestic and 4 418 foreign literatures were retrieved,including 1 570 domestic and 4 238 foreign valid literatures. Publications increased over the past decade,with the largest number of domestic and foreign publication numbers in 2017(355 in domestic and 465 in foreign). The most published domestic and foreign journals were China Pharmacy(105 literatures) and European Journal of Clinical Pharmacology(51 literatures). The core researchers in domestic and foreign were Li Youping and de la Torre JC. The contents of domestic researches included off-label use policy,current situation of off-label use in children,off-label use in ophthalmology,off-label use of Chinese patent medicine,etc. The contents of foreign researches included off-label use in antiviral drugs,off-label use in special population(children,alcoholic dependence patients,etc.). Off-label use,rational drug use and drug instructions as well as human,off-label use and article were the top 3 keywords in domestic and foreign literatures,respectively. CONCLUSIONS:Off-label use research at home and abroad is increasing year by year. Research teams carry out co-operations actively. Bibliometric methods can help researchers broaden research directions,track research hotspots and select contributing journals.
OBJECTIVE:To conduct bibliometric analysis of off-label use in domestic and foreign. METHODS:Retrieved from CNKI,Wanfang database,VIP,PubMed,Embase and Web of Science during Jan. 1991(in foreign) or Jan. 2007(in domestic)to Dec. 2018,related literatures of off-label use were collected. General information(publication numbers distribution,journals distribution),article cooperation(core researchers,research content) and keywords of domestic and foreign literatures were analyzed and summarized. RESULTS:A total of 1 647 domestic and 4 418 foreign literatures were retrieved,including 1 570 domestic and 4 238 foreign valid literatures. Publications increased over the past decade,with the largest number of domestic and foreign publication numbers in 2017(355 in domestic and 465 in foreign). The most published domestic and foreign journals were China Pharmacy(105 literatures) and European Journal of Clinical Pharmacology(51 literatures). The core researchers in domestic and foreign were Li Youping and de la Torre JC. The contents of domestic researches included off-label use policy,current situation of off-label use in children,off-label use in ophthalmology,off-label use of Chinese patent medicine,etc. The contents of foreign researches included off-label use in antiviral drugs,off-label use in special population(children,alcoholic dependence patients,etc.). Off-label use,rational drug use and drug instructions as well as human,off-label use and article were the top 3 keywords in domestic and foreign literatures,respectively. CONCLUSIONS:Off-label use research at home and abroad is increasing year by year. Research teams carry out co-operations actively. Bibliometric methods can help researchers broaden research directions,track research hotspots and select contributing journals.
引文
[1]国家食品药品监督管理局.药品说明书和标签管理规定[EB/OL].(2006-03-10)[2018-09-11].http://www.nmpa.gov.cn/WS04/CL2174/300623.html.
[2] NCBI. MeSH Database[EB/OL].[2019-02-14].https://www.ncbi.nlm.nih.gov/mesh/?term=off-label+use.
[3]刘夏.临床上超说明书用药的分析及对策[J].药学实践杂志,2014,32(6):465-468.
[4]江依帆,赵敏.超药品说明书用药的相关法律问题[J].医学与法学,2015,7(5):60-66.
[5]郭卓瑶,梅枚,王立波,等.国内外超说明书用药政策评价[J].世界临床药物,2018,39(8):579-582.
[6] CAVO GM. Chapter 6-clinical trials and off-label use of drugs[J]. Pharmaceuticals Policy and Law,2015,17(3/4):409-430.
[7] ECK VNJ,WALTMAN L. Software survey:VOSviewer,a computer program for bibliometric mapping[J]. Scientometrics,2009,84(2):523-538.
[8]邱均平.文献计量学[M].北京:科学技术文献出版社,1988:188-190.
[9]张伶俐,李幼平,梁毅,等.全球门诊儿童超说明书用药现状的系统评价[J].中国循证医学杂志,2012,12(3):305-313.
[10]张伶俐,李幼平,梁毅,等.全球住院儿童超说明书用药现状的系统评价[J].中国循证医学杂志,2012,12(2):176-187.
[11]林悦甜,许艳,杨国瑛,等.精神药物说明书中儿童用药信息标注情况分析[J].今日药学,2017,27(2):137-139,144.
[12]杨国瑛,林悦甜. 120例住院儿童青少年精神疾病患者用药医嘱分析[J].北方药学,2016,13(7):167-168.
[13]蔡浅云,罗蓉,吴惧,等.四川地区新型抗癫痫药物超说明书规定用药分析:一项对儿童患者的多中心调查研究[J].中国现代神经疾病杂志,2012,12(5):536-541.
[14]李亚昙,阿衣古丽·玉努斯,滕亮.我院儿科门诊超说明书用药调查[J].中国药房,2015,26(32):4476-4479.
[15]劳海燕,王启仪,杨敏,等.广东省人民医院超说明书用药临床管理方法与流程研究[J].中国循证医学杂志,2014,14(9):1025-1029.
[16]林璐,劳海燕,伦玉宁,等.广东省人民医院住院患者前列地尔注射剂超说明书剂量用药干预效果分析[J].中国循证医学杂志,2016,16(8):869-875.
[17]杨敏,劳海燕,曾英彤.医疗机构超药品说明书用药管理专家共识[J].中国现代应用药学,2017,34(3):436-438.
[18]韩芙蓉,赵环宇,李荔,等.眼科超说明书用药的现状及分析[J].中华眼科杂志,2017,53(4):300-304.
[19]李荔,韩芙蓉,王家伟.雷珠单抗超说明书用药情况调查分析[J].临床药物治疗杂志,2015,13(6):68-70.
[20]吴凯珊,伍俊妍,张俊州,等.系统性红斑狼疮处方的超药品说明书用药分析[J].今日药学,2015,25(5):347-349,363.
[21]伍俊妍,林茵,何志超,等.治疗类风湿性关节炎处方分析[J].今日药学,2014,24(3):204-206.
[22]伍俊妍,李磊,李国成,等.治疗多囊卵巢综合征处方的超药品说明书用药分析[J].中国药房,2014,25(34):3203-3204.
[23]闫荟羽,徐静波,张文锐,等.儿科住院患者超说明书用药情况[J].医药导报,2017,36(7):835-837.
[24]赵英如,张四喜,张杰,等. 2015-2017年我院508例老年住院患者血必净注射液超说明书用药分析[J].医学综述,2018,24(18):3705-3708.
[25]陈志威,谢雁鸣,廖星,等.注射用丹参多酚酸盐安全性系统评价[J].中国中药杂志,2016,41(19):3686-3695.
[26]崔瑞昭,谢雁鸣,廖星,等.苦碟子注射液用药安全性的系统评价[J].中国中药杂志,2017,42(12):2380-2390.
[27]司继刚.胸腺法新的临床应用进展[J].中国药房,2015,26(23):3304-3306.
[28] MARTINEZ-SOBRIDO L,DE LA TORRE JC. Novel strategies for development of hemorrhagic fever arenavirus live-attenuated vaccines[J]. Expert Rev Vaccines,2016,15(9):1113-1121.
[29] ROLLAND B,JAILLETTE E,CARTON L,et al. Assessing alcohol versus baclofen withdrawal syndrome in patients treated with baclofen for alcohol use disorder[J]. J Clin Psychopharmacol,2014,34(1):153-156.
[30] ROLLAND B,VALIN T,LANGLOIS C,et al. Safety and drinking outcomes among patients with comorbid alcohol dependence and borderline personality disorder treated with high-dose baclofen:a comparative cohort study[J].Int Clin Psychopharmacol,2015,30(1):49-53.
[31] ROLLAND B,DEHEUL S,DANEL T,et al. Temporary recommendation for use on off-label baclofen:viewpoint of prescribers of the CAMTEA system[J]. Therapie,2015,70(2):235-238.
[32] LARKIN I,ANG D,AVORN J,et al. Restrictions on pharmaceutical detailing reduced off-label prescribing of antidepressants and antipsychotics in children[J]. Health Affairs,2014,33(6):1014-1023.
[33] WANG B,STUDDERT DM,SARPATWARI A,et al. The effect of federal and state off-label marketing investigations on drug prescribing:the case of olanzapine[J]. PLoS One,2017.DOI:10.1371/journal.pone.0175313.
[34] NEUBERT A,WONG IC,BONIFAZI A,et al. Defining off-label and unlicensed use of medicines for children:results of a delphi survey[J]. Pharmacol Res,2008,58(5/6):316-322.
[35] NEUBERT A,LUKAS K,LEIS T,et al. Drug utilisation on a preterm and neonatal intensive care unit in Germany:a prospective,cohort-based analysis[J]. Eur J Clin Pharmacol,2010,66(1):87-95.
[36]林璐,劳海燕,伦玉宁,等. PDCA循环管理法在前列地尔注射液超说明书剂量用药干预中的应用[J].中国药房,2015,26(27):3791-3793.
[37]黄琪.替加环素临床应用疗效及合理性评价[J].中国新药杂志,2018,27(19):2332-2336.
[2] NCBI. MeSH Database[EB/OL].[2019-02-14].https://www.ncbi.nlm.nih.gov/mesh/?term=off-label+use.
[3]刘夏.临床上超说明书用药的分析及对策[J].药学实践杂志,2014,32(6):465-468.
[4]江依帆,赵敏.超药品说明书用药的相关法律问题[J].医学与法学,2015,7(5):60-66.
[5]郭卓瑶,梅枚,王立波,等.国内外超说明书用药政策评价[J].世界临床药物,2018,39(8):579-582.
[6] CAVO GM. Chapter 6-clinical trials and off-label use of drugs[J]. Pharmaceuticals Policy and Law,2015,17(3/4):409-430.
[7] ECK VNJ,WALTMAN L. Software survey:VOSviewer,a computer program for bibliometric mapping[J]. Scientometrics,2009,84(2):523-538.
[8]邱均平.文献计量学[M].北京:科学技术文献出版社,1988:188-190.
[9]张伶俐,李幼平,梁毅,等.全球门诊儿童超说明书用药现状的系统评价[J].中国循证医学杂志,2012,12(3):305-313.
[10]张伶俐,李幼平,梁毅,等.全球住院儿童超说明书用药现状的系统评价[J].中国循证医学杂志,2012,12(2):176-187.
[11]林悦甜,许艳,杨国瑛,等.精神药物说明书中儿童用药信息标注情况分析[J].今日药学,2017,27(2):137-139,144.
[12]杨国瑛,林悦甜. 120例住院儿童青少年精神疾病患者用药医嘱分析[J].北方药学,2016,13(7):167-168.
[13]蔡浅云,罗蓉,吴惧,等.四川地区新型抗癫痫药物超说明书规定用药分析:一项对儿童患者的多中心调查研究[J].中国现代神经疾病杂志,2012,12(5):536-541.
[14]李亚昙,阿衣古丽·玉努斯,滕亮.我院儿科门诊超说明书用药调查[J].中国药房,2015,26(32):4476-4479.
[15]劳海燕,王启仪,杨敏,等.广东省人民医院超说明书用药临床管理方法与流程研究[J].中国循证医学杂志,2014,14(9):1025-1029.
[16]林璐,劳海燕,伦玉宁,等.广东省人民医院住院患者前列地尔注射剂超说明书剂量用药干预效果分析[J].中国循证医学杂志,2016,16(8):869-875.
[17]杨敏,劳海燕,曾英彤.医疗机构超药品说明书用药管理专家共识[J].中国现代应用药学,2017,34(3):436-438.
[18]韩芙蓉,赵环宇,李荔,等.眼科超说明书用药的现状及分析[J].中华眼科杂志,2017,53(4):300-304.
[19]李荔,韩芙蓉,王家伟.雷珠单抗超说明书用药情况调查分析[J].临床药物治疗杂志,2015,13(6):68-70.
[20]吴凯珊,伍俊妍,张俊州,等.系统性红斑狼疮处方的超药品说明书用药分析[J].今日药学,2015,25(5):347-349,363.
[21]伍俊妍,林茵,何志超,等.治疗类风湿性关节炎处方分析[J].今日药学,2014,24(3):204-206.
[22]伍俊妍,李磊,李国成,等.治疗多囊卵巢综合征处方的超药品说明书用药分析[J].中国药房,2014,25(34):3203-3204.
[23]闫荟羽,徐静波,张文锐,等.儿科住院患者超说明书用药情况[J].医药导报,2017,36(7):835-837.
[24]赵英如,张四喜,张杰,等. 2015-2017年我院508例老年住院患者血必净注射液超说明书用药分析[J].医学综述,2018,24(18):3705-3708.
[25]陈志威,谢雁鸣,廖星,等.注射用丹参多酚酸盐安全性系统评价[J].中国中药杂志,2016,41(19):3686-3695.
[26]崔瑞昭,谢雁鸣,廖星,等.苦碟子注射液用药安全性的系统评价[J].中国中药杂志,2017,42(12):2380-2390.
[27]司继刚.胸腺法新的临床应用进展[J].中国药房,2015,26(23):3304-3306.
[28] MARTINEZ-SOBRIDO L,DE LA TORRE JC. Novel strategies for development of hemorrhagic fever arenavirus live-attenuated vaccines[J]. Expert Rev Vaccines,2016,15(9):1113-1121.
[29] ROLLAND B,JAILLETTE E,CARTON L,et al. Assessing alcohol versus baclofen withdrawal syndrome in patients treated with baclofen for alcohol use disorder[J]. J Clin Psychopharmacol,2014,34(1):153-156.
[30] ROLLAND B,VALIN T,LANGLOIS C,et al. Safety and drinking outcomes among patients with comorbid alcohol dependence and borderline personality disorder treated with high-dose baclofen:a comparative cohort study[J].Int Clin Psychopharmacol,2015,30(1):49-53.
[31] ROLLAND B,DEHEUL S,DANEL T,et al. Temporary recommendation for use on off-label baclofen:viewpoint of prescribers of the CAMTEA system[J]. Therapie,2015,70(2):235-238.
[32] LARKIN I,ANG D,AVORN J,et al. Restrictions on pharmaceutical detailing reduced off-label prescribing of antidepressants and antipsychotics in children[J]. Health Affairs,2014,33(6):1014-1023.
[33] WANG B,STUDDERT DM,SARPATWARI A,et al. The effect of federal and state off-label marketing investigations on drug prescribing:the case of olanzapine[J]. PLoS One,2017.DOI:10.1371/journal.pone.0175313.
[34] NEUBERT A,WONG IC,BONIFAZI A,et al. Defining off-label and unlicensed use of medicines for children:results of a delphi survey[J]. Pharmacol Res,2008,58(5/6):316-322.
[35] NEUBERT A,LUKAS K,LEIS T,et al. Drug utilisation on a preterm and neonatal intensive care unit in Germany:a prospective,cohort-based analysis[J]. Eur J Clin Pharmacol,2010,66(1):87-95.
[36]林璐,劳海燕,伦玉宁,等. PDCA循环管理法在前列地尔注射液超说明书剂量用药干预中的应用[J].中国药房,2015,26(27):3791-3793.
[37]黄琪.替加环素临床应用疗效及合理性评价[J].中国新药杂志,2018,27(19):2332-2336.