全球住院兒童超說明書用藥現狀的系統評價_《中國循證醫學雜志》

作者：

張伶俐 ^1,2 ,  李幼平 ¹ , 梁毅 ^2,3 , 曾力楠 ² , 劉怡 ^2,3 , 陳敏 ^2,3

1. 四川大學華西醫院中國循證醫學中心（成都 610041）；2. 四川大學華西第二醫院藥學部（成都 610041）；3. 四川大學華西藥學院（成都 610041）;

關鍵詞：

住院兒童超說明書系統評價

DOI：

10.7507/1672-2531.20120030

視頻：

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目的　系統評價國內外住院兒童超說明書用藥現狀。
方法　計算機檢索PubMed、EMbase、CBM、CNKI和VIP數據庫，納入中、英文發表的0～18歲住院兒童超說明書用藥研究，以Combieg工具評價納入研究質量，描述性分析各病房和年齡段兒童超說明書用藥發生率，比較各類超說明書用藥構成比。
結果　共納入29個橫斷面研究，合計8 560例住院兒童，41 655條醫囑。① 各病房超說明書用藥發生率中位數（四分位數間距）：新生兒ICU 52.5%（23.0%～44.8%），兒科ICU 43.5%（34.5%～60%），普通兒科35.5%（23.8%～43.3%），兒科手術病房27.5%（23.0%～44.8%）；② 各研究報告不同年齡段超說明書用藥發生率大小不一致；③ 超說明書用藥類型構成比依次為無兒童用藥信息（7%～54%）、超劑量和療程（8%～86%）及超年齡用藥（3%～67%）。
結論　① 超說明書用藥在全球兒科和新生兒病房普遍存在，不同國家和病房報告的超說明書用藥發生率差異大；② 超說明書用藥發生率在ICU中可能高于非ICU，新生兒病房可能高于兒科病房；③ “無兒童用藥信息”的超說明書用藥最常見，將來的兒科臨床試驗應重點關注高質量兒童用藥證據完全空白的領域。④ 建議將來超說明書用藥研究應統一設計，并盡快立項開展我國住院兒童超說明書用藥多中心研究，為政策制定提供基線證據。

引用本文： 張伶俐,李幼平,梁毅,曾力楠,劉怡,陳敏. 全球住院兒童超說明書用藥現狀的系統評價. 中國循證醫學雜志, 2012, 12(2): 176-187. doi: 10.7507/1672-2531.20120030 復制

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14.	Neubert A, Dormann H, Weiss J. The Impact of Unlicensed and Off-Label Drug Use on Adverse Drug Reactions in Paediatric Patients. Drug Safety, 2004, 27(13): 1059-1067.
15.	Di Paolo ER, Stoetter H, Cotting J, et al. Unlicensed and off-label drug use in a Swiss paediatric university hospital. Swiss Med Wkly, 2006, 136(13-14): 218-222.
16.	Lindell-Osuagwu L, Korhonen MJ, Saano S, et al. Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature. J Clin Pharm Ther, 2009, 34(3): 277-287.
17.	Craig JS, Henderson CR, Magee FA. The extent of unlicensed and off-label drug use in the paediatric ward of a district general hospital in Northern Ireland. Ir Med J, 2001, 94(8): 237-240.
18.	Conroy S, Choonara I, Impicciatore P, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. BMJ, 2000, 320(7227): 79-82.
19.	Lass J, Kaar R, Jogi K, et al. Drug utilisation pattern and off-label use of medicines in Estonian neonatal units. Eur J Clin Pharmacol, 2011, 67(12): 1263-1271.
20.	Payares MC, Pedrosa MJ, Salvador A, et al. Off-label use of medications in the paediatric and neonatal intensive care units. British Journal of Clinical Pharmacology, 2010, 70(2): 286-287.
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24.	Doherty DR, Pascuet E, Ni A, et al. Off-label drug use in pediatric anesthesia and intensive care according to official and pediatric reference formularies. Can J Anaesth, 2010, (12): 1078-1088.
25.	O'Donnell CP, Stone RJ, Morley CJ. Unlicensed and off-label drug use in an Australian neonatal intensive care unit. Pediatrics, 2002, 110(5): e52.
26.	Barr J, Brenner-Zada G, Heiman E, et al. Unlicensed and off-label medication use in a neonatal intensive care unit: a prospective study. Am J Perinatol, 2002, 19(2): 67-72.
27.	Santos DB, Clavenna A, Bonati M, et al. Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil. Eur J Clin Pharmacol, 2008, 64(11): 1111-1118.
28.	Carvalho PR, Carvalho CG, Alievi PT, et al. Prescription of drugs not appropriate for children in a Pediatric Intensive Care Unit. J Pediatr (Rio J), 2003, 79(5): 397-402.
29.	曾雪花, 周炳豐. 住院兒科藥品說明書之外用藥的調查分析. 中國醫藥導報, 2011, 8(6): 113-114.
30.	Bajcetic M, Jelisavcic M, Mitrovic J, et al. Off label and unlicensed drugs use in paediatric cardiology. Eur J Clin Pharmacol, 2005, 61(10): 775-779.
31.	Khdour MR, Hallak HO, Alayasa KS, et al. Extent and nature of unlicensed and off-label medicine use in hospitalised children in Palestine. Int J Clin Pharm, 2011, 33(4): 650-655.
32.	Bavdekar SB, Sadawarte PA, Gogtay NJ, et al. Off-label drug use in a Pediatric Intensive Care Unit. Indian J Pediatr, 2009, 76(11): 1113-1118.
33.	Jain SS, Bavdekar SB, Gogtay NJ, et al. Off-label drug use in children. Indian J Pediatr, 2008, 75(11): 1133-1136.
34.	Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr, 2005, 164(9): 552-558.
35.	Cuzzolin L, Atzei A, Fanos V. Off-label and unlicensed prescribing for new borns and children in different setting: a review of the literature and a consideration about drug safety. Expert Opin Drug Saf, 2006, 5(5): 703-718.

1. NLM (2010), MeSH NLM Controlled Vocabulary. [2011-09-13] Aavailable from: http://www.ncbi.nlm.nih.gov/mesh/68056687.
2. International Conference on Harmonisation; guidance on E11 clinical investigation of medicinal products in the pediatric population; availability. Notice. Federal Register, 2000, 78493-4.
3. Crombie I. The pocket guide to critical appraisal London: BMJ Publishing Group; 1996.
4. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics, 1977, 33(1): 159-174.
5. Van den Berg H, Tak N. Licensing and labeling of drugs in a pediatric oncology ward. Br J Clin Pharmacol, 2011, 72(3): 474-481.
6. ‘t Jong GW, van der Linden PD, Bakker EM, et al. Unlicensed and off-label drug use in a paediatric ward of a general hospital in the Netherlands. Eur J Clin Pharmacol, 2002, 58(4): 293-297.
7. ‘t Jong GW, Vulto AG, de Hoog M, et al. A survey of the use of off-label and unlicensed drugs in a Dutch children’s hospital. Pediatrics, 2001, 108(5): 1089-1093.
8. Dessì A, Salemi C, Fanos V, et al. Drug treatments in a neonatal setting:focus on the off-label use in the first month of life. Pharm World Sci, 2010, 32(2): 120-124.
9. Dell'Aera M, Gasbarro AR, Padovano M, et al. Unlicensed and off-label use of medicines at a neonatology clinic in Italy. Pharm World Sci, 2007, 29(4): 361-367.
10. Pandolfini C, Impicciatore P, Provasi D, et al. Off-label use of drugs in Italy: a prospective, observational and multicentre study. Acta Paediatrica, 2002, 91(3): 339-347.
11. Conroy S, McIntyre J, Choonara I. Unlicensed and off-label drug use in neonates. Arch Dis Child Fetal Neonatal Ed, 1999, 80(2): F142-F145.
12. Turner S, Longworth A, Nunn AJ, et al. Unlicensed and off-label drug use in paediatric wards: prospective study. BMJ, 1998, 316(7128): 343-345.
13. Nguyen KA, Claris O, Kassai B, et al. Unlicensed and off-label drug use in a neonatal unit in France. Acta Paediatr, 2011, 100(4): 615-617.
14. Neubert A, Dormann H, Weiss J. The Impact of Unlicensed and Off-Label Drug Use on Adverse Drug Reactions in Paediatric Patients. Drug Safety, 2004, 27(13): 1059-1067.
15. Di Paolo ER, Stoetter H, Cotting J, et al. Unlicensed and off-label drug use in a Swiss paediatric university hospital. Swiss Med Wkly, 2006, 136(13-14): 218-222.
16. Lindell-Osuagwu L, Korhonen MJ, Saano S, et al. Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature. J Clin Pharm Ther, 2009, 34(3): 277-287.
17. Craig JS, Henderson CR, Magee FA. The extent of unlicensed and off-label drug use in the paediatric ward of a district general hospital in Northern Ireland. Ir Med J, 2001, 94(8): 237-240.
18. Conroy S, Choonara I, Impicciatore P, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. BMJ, 2000, 320(7227): 79-82.
19. Lass J, Kaar R, Jogi K, et al. Drug utilisation pattern and off-label use of medicines in Estonian neonatal units. Eur J Clin Pharmacol, 2011, 67(12): 1263-1271.
20. Payares MC, Pedrosa MJ, Salvador A, et al. Off-label use of medications in the paediatric and neonatal intensive care units. British Journal of Clinical Pharmacology, 2010, 70(2): 286-287.
21. Prandstetter C, Tamesberger M, Wagner O. Medical prescriptions to premature and newborn infants in an Austrian neonatal intensive care unit. Klin Padiatr, 2009, 221(5): 312-317.
22. Annicq A, Robeyst A, Segers N. Unlicensed and off-label use of medication at the department of paediatrics in the university hospital UZ Ghent. 2008, Tijdschrift voor Geneeskunde, 2008, 64(13): 677-688.
23. Eiland LS, Knight P. Evaluating the off-label use of medications in children. Am J Health Syst Pharm, 2006, 63(11): 1062-1065.
24. Doherty DR, Pascuet E, Ni A, et al. Off-label drug use in pediatric anesthesia and intensive care according to official and pediatric reference formularies. Can J Anaesth, 2010, (12): 1078-1088.
25. O'Donnell CP, Stone RJ, Morley CJ. Unlicensed and off-label drug use in an Australian neonatal intensive care unit. Pediatrics, 2002, 110(5): e52.
26. Barr J, Brenner-Zada G, Heiman E, et al. Unlicensed and off-label medication use in a neonatal intensive care unit: a prospective study. Am J Perinatol, 2002, 19(2): 67-72.
27. Santos DB, Clavenna A, Bonati M, et al. Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil. Eur J Clin Pharmacol, 2008, 64(11): 1111-1118.
28. Carvalho PR, Carvalho CG, Alievi PT, et al. Prescription of drugs not appropriate for children in a Pediatric Intensive Care Unit. J Pediatr (Rio J), 2003, 79(5): 397-402.
29. 曾雪花, 周炳豐. 住院兒科藥品說明書之外用藥的調查分析. 中國醫藥導報, 2011, 8(6): 113-114.
30. Bajcetic M, Jelisavcic M, Mitrovic J, et al. Off label and unlicensed drugs use in paediatric cardiology. Eur J Clin Pharmacol, 2005, 61(10): 775-779.
31. Khdour MR, Hallak HO, Alayasa KS, et al. Extent and nature of unlicensed and off-label medicine use in hospitalised children in Palestine. Int J Clin Pharm, 2011, 33(4): 650-655.
32. Bavdekar SB, Sadawarte PA, Gogtay NJ, et al. Off-label drug use in a Pediatric Intensive Care Unit. Indian J Pediatr, 2009, 76(11): 1113-1118.
33. Jain SS, Bavdekar SB, Gogtay NJ, et al. Off-label drug use in children. Indian J Pediatr, 2008, 75(11): 1133-1136.
34. Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr, 2005, 164(9): 552-558.
35. Cuzzolin L, Atzei A, Fanos V. Off-label and unlicensed prescribing for new borns and children in different setting: a review of the literature and a consideration about drug safety. Expert Opin Drug Saf, 2006, 5(5): 703-718.

《中國循證醫學雜志》

全球住院兒童超說明書用藥現狀的系統評價

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《中國循證醫學雜志》

全球住院兒童超說明書用藥現狀的系統評價

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