基于共词分析法分析新生儿重症监护领域超药品说明书用药现状
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摘要
目的探讨采用共词分析法对基于文献报道的国内外新生儿重症监护领域超药品说明书用药(OLDU)现状,旨在为该领域OLDU研究提供方向。方法本研究以"新生儿重症监护""超说明书用药"为中文关键词,在中国知网(CNKI)数据库、万方数据库中进行文献检索;同时,以"neonatal intensive care""off-label drug"为英文关键词,在MEDLINE数据库中进行检索。设定文献检索时间为各个数据库建库至2018年6月31日。选择由此获取的符合本研究纳入标准与排除标准的42篇新生儿童症监护领域OLDU相关文献为研究对象。其中,中文文献为3篇,英文文献为39篇。采用Microsoft Office Excel 2016软件对39篇英文文献关键词进行录入、整理。由于该领域中文文献数量太少(3篇),无法建立中文文献的关键词共现矩阵,故仅对英文文献关键词进行提取。对纳入研究的39篇英文文献提取关键词后,继续采用该软件建立关键词共现矩阵,使用Ucinet 6.2绘制关键词共现网络知识图谱,并进行新生儿重症监护领域OLDU共词分析。结果自纳入本研究的新生儿重症监护领域OLDU的39篇英文文献中,提取关键词共计18个,最早的文献发表于1999年,并且进行这方面研究文献的数量呈逐年升高趋势。新生儿重症监护领域OLDU英文文献关键词共现网络知识图谱显示,位于图谱中心的是"neonate(新生儿)""off-label drug(超说明书药物)"和"preterm(早产儿)";其次"audit(审查)""antibiotic(抗菌药物)""inhaled nitric oxide(吸入一氧化氮)"也是较为热门关键词。此外,关键词"pharmacokinetics(药物代谢动力学)"的位置虽然偏离核心关键词,但是与关键词"neonate(新生儿)"的联系较为紧密(连线较粗)。结论新生儿重症监护领域OLDU相关问题并不少见,国外对该领域的关注时间较长、研究范围覆盖面较广。我国对该领域的研究处于起步阶段,目前需要加强对新生儿重症监护领域OLDU的重视和关注,并开展相关临床试验,以保障新生儿患者用药安全。
Objective To analyse status quo of literatures on off-label drug use(OLDU) in the field of neonatal intensive care, aiming at discussing the research status and future prospects for OLDU in this field. Methods The Chinese National Knowledge Infrastructure(CNKI) databases, Wanfang database and MEDLINE database had been searched using the key words of "neonatal intensive care" and "off-label drug". And publication time of the literatures are databases construction until June 31, 2018. A total of 42 articles(3 Chinese and 39 English) in accordance with the accepting criteria of this study were included as the research objects. Key words of the included literatures were entered and collated by using Microsoft Office Excel 2016 software. The co-occurrence matrix was established by Excel 2016. Then Ucinet 6.2 was used to plot the knowledge map. Results In the 39 English-language literatures related to OLDU in the field of neonatal intensive care, 18 key words were included. The earliest published literature was published in 1999, and the number of related literatures in this field is increasing year by year. The co-word analysis of English literature key words revealed that "neonate" "off-label drug" and "preterm" were the core in the research field of neonatal intensive care unit. Furthermore, "audit" "antibiotic" and "inhaled nitric oxide" were also hot key words. In addition, the position of the key word "pharmacokinetics" was off-center, but it was also closely related to the key word "neonate". Conclusions OLDU is very common in the field of neonatal intensive care. Foreign countries have paid attention to this field for a long time and covered a wide range of research. Eyes are just beginning to be cast on OLDU in neonatal intensive care in China. At present, it is necessary to strengthen the attention and pay more attention to the OLDU in the field of neonatal intensive care. Relevant clinical trials should be carried out to ensure the safety of medication for neonatal patients in neonatal intensive care unit.
Objective To analyse status quo of literatures on off-label drug use(OLDU) in the field of neonatal intensive care, aiming at discussing the research status and future prospects for OLDU in this field. Methods The Chinese National Knowledge Infrastructure(CNKI) databases, Wanfang database and MEDLINE database had been searched using the key words of "neonatal intensive care" and "off-label drug". And publication time of the literatures are databases construction until June 31, 2018. A total of 42 articles(3 Chinese and 39 English) in accordance with the accepting criteria of this study were included as the research objects. Key words of the included literatures were entered and collated by using Microsoft Office Excel 2016 software. The co-occurrence matrix was established by Excel 2016. Then Ucinet 6.2 was used to plot the knowledge map. Results In the 39 English-language literatures related to OLDU in the field of neonatal intensive care, 18 key words were included. The earliest published literature was published in 1999, and the number of related literatures in this field is increasing year by year. The co-word analysis of English literature key words revealed that "neonate" "off-label drug" and "preterm" were the core in the research field of neonatal intensive care unit. Furthermore, "audit" "antibiotic" and "inhaled nitric oxide" were also hot key words. In addition, the position of the key word "pharmacokinetics" was off-center, but it was also closely related to the key word "neonate". Conclusions OLDU is very common in the field of neonatal intensive care. Foreign countries have paid attention to this field for a long time and covered a wide range of research. Eyes are just beginning to be cast on OLDU in neonatal intensive care in China. At present, it is necessary to strengthen the attention and pay more attention to the OLDU in the field of neonatal intensive care. Relevant clinical trials should be carried out to ensure the safety of medication for neonatal patients in neonatal intensive care unit.
引文
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[11] 李志玲, 徐峰, 胡文娟, 等. 新生儿万古霉素低谷浓度和高谷浓度肾毒性的比较[J]. 药学服务与研究, 2016, 16(1): 29-33.
[12] Hoppu K. Paediatric clinical pharmacology: at the beginning of a new era [J]. Eur J Clin Pharmacol, 2008, 64(2): 201-205.
[13] Agostino R, Pietravalle A. Drugs and newborn [J]. J Matern Fetal Neonatal Med, 2009, 22(Suppl 3): 43-45.
[14] Anderson BJ, Holford NHG. Understanding dosing: children are small adults, neonates are immature children [J]. Arch Dis Child, 2013, 98(9): 737-744.
[15] Banga V, Mallada A, Kannan S, et al. Awareness about and views of parents on the off-label drug use in children [J]. Int J Risk Saf Med, 2014, 26(2): 61-70.
[16] Lenk C, Koch P, Zappel H, et al. Off-label, off-limits? Parental awareness and attitudes towards off-label use in paediatrics [J]. Eur J Pediatr, 2009, 168(12): 1473-1478.
[17] Czaja AS, Reiter PD, Schultz ML, et al. Patterns of off-label prescribing in the pediatric intensive care unit and prioritizing future research [J]. J Pediatr Pharmacol Ther, 2015, 20(3): 186-196.
[18] 中华医学会儿科学分会临床药理学组. 中国儿科超说明书用药专家共识[J]. 中华儿科杂志, 2016, 54(2): 101-103.
[19] 张伶俐, 李幼平, 曾力楠, 等. 15国超说明书用药政策的循证评价[J]. 中国循证医学杂志, 2012, 12(4): 426-435.
[20] Allegaert K, van den Anker JN. Clinical pharmacology in neonates: small size, huge variability [J]. Neonatology, 2014, 105(4): 344-349.
[21] Allegaert K, van de Velde M, van den Anker J. Neonatal clinical pharmacology [J]. Paediatr Anaesth, 2014, 24(1): 30-38.
[22] Lenk C, Duttge G. Ethical and legal framework and regulation for off-label use: European perspective [J]. Ther Clin Risk Manag, 2014, 10: 537-546.
[23] De Zen L, Marchetti F, Barbi E, et al. Off-label drugs use in pediatric palliative care [J]. Ital J Pediatr. 2018, 44: 144.
[24] Corny J, Bailey B, Lebel D, et al. Unlicensed and off-label drug use in paediatrics in a mother-child tertiary care hospital [J]. Paediatr Child Health, 2016, 21(2): 83-87.
[25] Gore R, Chugh PK, Tripathi CD, et al. Pediatric off-label and unlicensed drug use and its implications [J]. Curr Clin Pharmacol, 2017, 12(1): 18-25.
[26] Oshikoya KA, Wharton GT, Avant D, et al. Serious adverse events associated with off-label use of azithromycin or fentanyl in children in intensive care units: a retrospective chart review [J]. Paediatr Drugs, 2019, 21(1): 47-58.
[27] Liu L, Yang HY, Lou Y, et al. Off-label prescriptions in intensive care unit: the Chinese experience [J]. Ther Clin Risk Manag, 2018, 14: 195-202.
[28] Landwehr C, Richardson J, Bint L, et al. Cross-sectional survey of off-label and unlicensed prescribing for inpatients at a paediatric teaching hospital in Western Australia [J]. PLoS One, 2019, 14(1): e0210237.
[29] Saullo F, Saullo E, Caloiero M, et al. A questionnaire-based study in Calabria on the knowledge of off-label drugs in pediatrics [J]. J Pharmacol Pharmacother, 2013, 4(Suppl1): S51-S54.
[2] 杨晓燕, 赵静, 石晶, 等. 儿童超说明书用药可视化分析[J]. 中国现代应用药学, 2015, 32(5): 620-625.
[3] 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.
[4] 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.
[5] 钟伟金, 李佳. 共词分析法研究(一)——共词分析的过程与方式[J]. 情报杂志, 2008, 27(5): 70-72.
[6] 储节旺, 郭春侠. EXCEL实现共词分析的方法——以国内图书情报领域知识管理研究为例[J]. 情报杂志, 2011, 30(3): 45-49.
[7] 王宪磊. 信息管理论[M]. 北京: 社会科学文献出版社, 2004:333.
[8] 李姣,杨晓燕,石晶,等. 基于共词分析法分析我国新生儿输血的研究现状 [J/CD] . 中华妇幼临床医学杂志(电子版),2018,14(1):38-43.
[9] 冯文彬, 戴虹, 刘敏敏, 等. 2014-2016年惠州市第二妇幼保健院新生儿重症监护病房用药分析[J]. 中国医院用药评价与分析, 2017, 17(2): 232-234.
[10] 唐红波, 庄太凤, 王芳, 等. 2010-2013年我院新生儿重症监护病房用药分析[J]. 儿科药学杂志, 2016, 22(5): 44-47.
[11] 李志玲, 徐峰, 胡文娟, 等. 新生儿万古霉素低谷浓度和高谷浓度肾毒性的比较[J]. 药学服务与研究, 2016, 16(1): 29-33.
[12] Hoppu K. Paediatric clinical pharmacology: at the beginning of a new era [J]. Eur J Clin Pharmacol, 2008, 64(2): 201-205.
[13] Agostino R, Pietravalle A. Drugs and newborn [J]. J Matern Fetal Neonatal Med, 2009, 22(Suppl 3): 43-45.
[14] Anderson BJ, Holford NHG. Understanding dosing: children are small adults, neonates are immature children [J]. Arch Dis Child, 2013, 98(9): 737-744.
[15] Banga V, Mallada A, Kannan S, et al. Awareness about and views of parents on the off-label drug use in children [J]. Int J Risk Saf Med, 2014, 26(2): 61-70.
[16] Lenk C, Koch P, Zappel H, et al. Off-label, off-limits? Parental awareness and attitudes towards off-label use in paediatrics [J]. Eur J Pediatr, 2009, 168(12): 1473-1478.
[17] Czaja AS, Reiter PD, Schultz ML, et al. Patterns of off-label prescribing in the pediatric intensive care unit and prioritizing future research [J]. J Pediatr Pharmacol Ther, 2015, 20(3): 186-196.
[18] 中华医学会儿科学分会临床药理学组. 中国儿科超说明书用药专家共识[J]. 中华儿科杂志, 2016, 54(2): 101-103.
[19] 张伶俐, 李幼平, 曾力楠, 等. 15国超说明书用药政策的循证评价[J]. 中国循证医学杂志, 2012, 12(4): 426-435.
[20] Allegaert K, van den Anker JN. Clinical pharmacology in neonates: small size, huge variability [J]. Neonatology, 2014, 105(4): 344-349.
[21] Allegaert K, van de Velde M, van den Anker J. Neonatal clinical pharmacology [J]. Paediatr Anaesth, 2014, 24(1): 30-38.
[22] Lenk C, Duttge G. Ethical and legal framework and regulation for off-label use: European perspective [J]. Ther Clin Risk Manag, 2014, 10: 537-546.
[23] De Zen L, Marchetti F, Barbi E, et al. Off-label drugs use in pediatric palliative care [J]. Ital J Pediatr. 2018, 44: 144.
[24] Corny J, Bailey B, Lebel D, et al. Unlicensed and off-label drug use in paediatrics in a mother-child tertiary care hospital [J]. Paediatr Child Health, 2016, 21(2): 83-87.
[25] Gore R, Chugh PK, Tripathi CD, et al. Pediatric off-label and unlicensed drug use and its implications [J]. Curr Clin Pharmacol, 2017, 12(1): 18-25.
[26] Oshikoya KA, Wharton GT, Avant D, et al. Serious adverse events associated with off-label use of azithromycin or fentanyl in children in intensive care units: a retrospective chart review [J]. Paediatr Drugs, 2019, 21(1): 47-58.
[27] Liu L, Yang HY, Lou Y, et al. Off-label prescriptions in intensive care unit: the Chinese experience [J]. Ther Clin Risk Manag, 2018, 14: 195-202.
[28] Landwehr C, Richardson J, Bint L, et al. Cross-sectional survey of off-label and unlicensed prescribing for inpatients at a paediatric teaching hospital in Western Australia [J]. PLoS One, 2019, 14(1): e0210237.
[29] Saullo F, Saullo E, Caloiero M, et al. A questionnaire-based study in Calabria on the knowledge of off-label drugs in pediatrics [J]. J Pharmacol Pharmacother, 2013, 4(Suppl1): S51-S54.