全球門診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

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：

兒童超說明書用藥系統評價用藥安全

DOI：

10.7507/1672-2531.20120050

視頻：

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目的　系統評價國內外門診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歲門診兒童超說明書用藥研究，以Combieg工具評價研究質量，描述性分析各級醫療機構和各年齡段兒童超說明書用藥發生率、常見超說明書用藥種類及其構成比。
結果　共納入20個橫斷面研究，合計1 933 760例兒童，5 262 573條醫囑。結果顯示① 各級醫療機構門診超說明書用藥發生率：初級醫療機構19.5%（IQR 13.5%，24.5%），三級醫療機構26.0%（IQR 24.0%，35.0%）；② 各研究一致報告新生兒、嬰兒或青少年超說明書用藥發生率最高，年齡居中的普通兒童最低；③ 半數以上研究將呼吸系統用藥、全身用抗感染藥、感覺器官和皮膚用藥列為超說明書使用頻率前5位；④ 有“無兒童用藥信息”的超說明書用藥分類的研究提示該類超說明書用藥發生率最高，無該分類的研究提示超年齡用藥發生率最高。
結論　 ① 全球門診兒童超說明書用藥現象普遍存在，三級醫療機構發生率可能高于初級醫療機構，新生兒、嬰兒和青少年可能高于其他年齡組兒童；② 住院兒童超說明書用藥發生率可能高于門診；③ 呼吸系統用藥、全身用抗感染藥、感覺器官和皮膚用藥的超說明書使用常見；④ “無兒童用藥信息”的超說明書用藥和超年齡用藥較常見。建議將來的研究應重點關注兒童（或某年齡段兒童）藥物臨床試驗尚處空白的領域。

引用本文： 張伶俐,李幼平,梁毅,曾力楠,劉怡. 全球門診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(3): 305-313. doi: 10.7507/1672-2531.20120050 復制

1.	NLM (2010), MeSH NLM Controlled Vocabulary. [2011-09-13] Aavailable from: http://www.ncbi.nlm.nih.gov/mesh/68056687.
2.	張伶俐, 李幼平. 基于風險與責任, 促進中國兒童合理用藥的思考. 中國循證醫學雜志, 2011, 11(9): 983-984.
3.	張伶俐, 李幼平, 梁毅, 等. 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, (2): 176-187.
4.	張伶俐, 李幼平, 胡蝶, 等. 四川大學華西第二醫院2010年住院患兒超說明書用藥情況調查. 中國循證醫學雜志, 2012, (2): 161-167.
5.	International Conference on Harmonisation; guidance on E11 clinical investigation of medicinal products in the pediatric population; availability. Notice. Federal Register, 2000, 78493-78494.
6.	Crombie I: The pocket guide to critical appraisal London: BMJ Publishing Group, 1996.
7.	Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics, 1977, 33(1): 159-174.
8.	WHO. ATC. [2012-02-01] Available from: http: //www.whocc.no/atc/structure_and principles/.
9.	Schirm E, Tobi H, de Jong-van den Berg LTW. Risk Factors for Unlicensed and Off-Label Drug Use in Children Outside the Hospital. Pediatrics, 2003, 111(2): 291-295.
10.	Schirm E, Tobi H, de Jong-van den Berg LTW. Unlicensed and off label drug use by children in the community: cross sectional study. BMJ, 2002, 324(7349): 1312-1313.
11.	W `t Jong G, Eland IA, Sturkenboom MCJM, et al. Unlicensed and off label prescription of drugs to children: population based cohort study. BMJ, 2002, 324(7349): 1313-1314.
12.	Dick A, Keady S, Mohamed F, et al. Use of unlicensed and off-label medications in paediatric gastroenterology with a review of the commonly used formularies in the UK. Aliment Pharmacol Ther, 2003, 17(4): 571-575.
13.	McIntyre J, Conroy S, Avery A, et al. Unlicensed and off label prescribing of drugs in general practice. Arch Dis Child, 2000, 83(6): 498-501.
14.	Horen B, Montastruc J, Lapeyre-Mestre M, et al. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol, 2002, 54(6): 665-670.
15.	Chalumeau M, Treluyer JM, Salanave B, et al. Off label and unlicensed drug use among French office based paediatricians. Arch Dis Child, 2000, 83(6): 502-505.
16.	Olsson L, Kimland E, Pettersson S, et al. Paediatric drug use with focus on off-label prescriptions in Swedish outpatient care – a nationwide study. Acta Paediatrica, 2011, 100(9): 1272-1275.
17.	Ufer M, Rane M, Karlsson A, et al. Widespread off-label prescribing of topical but not systemic drugs for 350, 000 paediatric outpatients in Stockholm. Eur J Clin Pharmacol, 2003, 58(11): 779-783.
18.	Moral es-Carpi C, Estañ L, Rubio E, et al. Drug utilization and off-label drug use among Spanish emergency room paediatric patients. Eur J Clin Pharmacol, 2010, 66(3): 315-320.
19.	Pandolfini C, Campi R, Clavenna A, et al. Italian paediatricians and off-label prescriptions: Loyal to regulatory or guideline standards? Acta Pædiatrica, 2005, 94(6): 753-757.
20.	Lass J, Irs A, Pisarev H, et al. Off label use of prescription medicine s in children in outpatient setting in Estonia is common. Pharmacoepidemiology & Drug Safety, 2011, 20(5): 474-481.
21.	Bücheler R, Schwab M, Mörike K, et al. Off label prescribing to children in primary care in Germany: retrospective cohort study. BMJ, 2002, 324(7349): 1311-1312.
22.	Sturkenboom M, Felisi M, Manfredi C, et al. Paediatric status and off-label use of drugs in children in Italy, United Kingdom and the Netherlands. Pharmaceuticals Policy and Law, 2009, 11(1-2): 51–59.
23.	Lifshitz M, Gavrilov V, Grossman V, et al. Unapproved Prescription Practices in Primary Pediatric Clinics in Israel: A Prospective Analysis. Current Therapeutic research, 2002, 63(12): 830-837.
24.	Gavrilov V, Lifshitz M, Levy J, et al. Unlicensed and Off-Label Medication Use in a General Pediatrics Ambulatory Hospital Unit in Israel. Isr Med Assoc J, 2000, 2(8): 595-597.
25.	Phan H, Leder M, Fishley M, et al. Off-Label and Unlicensed Medication Use and Associated Adverse Drug Events in a Pediatric Emergency Department. Pediatric Emergency Care, 2010, 26(6): 424-430.
26.	王海瀅, 劉芳. 北京大學第三醫院兒科門診超說明書用藥調查與分析.中國醫院用藥評價與分析, 2011, 11(2): 184-186.
27.	張伶俐, 李幼平, 黃亮, 等. 四川大學華西第二醫院兒科門診處方超藥品說明書用藥情況調查. 中國循證醫學雜志, 2011, 11(10): 1120-1124.
28.	薛麗萍, 汪琪. 兒科超說明書用藥的調查分析.中國藥房, 2008, 19(4): 315-31.
29.	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.
30.	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.
31.	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.
32.	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.
33.	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.
34.	Jain SS, Bavdekar SB, Gogtay NJ, et al. Off-label drug use in children. Indian J Pediatr, 2008, 75(11): 1133-1136.
35.	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.
36.	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.
37.	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.
38.	Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr, 2005, 164(9): 552-558.
39.	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.
40.	‘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.
41.	Allergy&AsthmaNetwork. [2012-02-01] http: //www.aanma.org/faqs/welcome-to-precious-breathers/respiratory-diseases/.
42.	WHO. [2012-02-10] http: //www.who.int/infectious-disease-report/pages/textonly.html.

1. NLM (2010), MeSH NLM Controlled Vocabulary. [2011-09-13] Aavailable from: http://www.ncbi.nlm.nih.gov/mesh/68056687.
2. 張伶俐, 李幼平. 基于風險與責任, 促進中國兒童合理用藥的思考. 中國循證醫學雜志, 2011, 11(9): 983-984.
3. 張伶俐, 李幼平, 梁毅, 等. 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, (2): 176-187.
4. 張伶俐, 李幼平, 胡蝶, 等. 四川大學華西第二醫院2010年住院患兒超說明書用藥情況調查. 中國循證醫學雜志, 2012, (2): 161-167.
5. International Conference on Harmonisation; guidance on E11 clinical investigation of medicinal products in the pediatric population; availability. Notice. Federal Register, 2000, 78493-78494.
6. Crombie I: The pocket guide to critical appraisal London: BMJ Publishing Group, 1996.
7. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics, 1977, 33(1): 159-174.
8. WHO. ATC. [2012-02-01] Available from: http: //www.whocc.no/atc/structure_and principles/.
9. Schirm E, Tobi H, de Jong-van den Berg LTW. Risk Factors for Unlicensed and Off-Label Drug Use in Children Outside the Hospital. Pediatrics, 2003, 111(2): 291-295.
10. Schirm E, Tobi H, de Jong-van den Berg LTW. Unlicensed and off label drug use by children in the community: cross sectional study. BMJ, 2002, 324(7349): 1312-1313.
11. W `t Jong G, Eland IA, Sturkenboom MCJM, et al. Unlicensed and off label prescription of drugs to children: population based cohort study. BMJ, 2002, 324(7349): 1313-1314.
12. Dick A, Keady S, Mohamed F, et al. Use of unlicensed and off-label medications in paediatric gastroenterology with a review of the commonly used formularies in the UK. Aliment Pharmacol Ther, 2003, 17(4): 571-575.
13. McIntyre J, Conroy S, Avery A, et al. Unlicensed and off label prescribing of drugs in general practice. Arch Dis Child, 2000, 83(6): 498-501.
14. Horen B, Montastruc J, Lapeyre-Mestre M, et al. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol, 2002, 54(6): 665-670.
15. Chalumeau M, Treluyer JM, Salanave B, et al. Off label and unlicensed drug use among French office based paediatricians. Arch Dis Child, 2000, 83(6): 502-505.
16. Olsson L, Kimland E, Pettersson S, et al. Paediatric drug use with focus on off-label prescriptions in Swedish outpatient care – a nationwide study. Acta Paediatrica, 2011, 100(9): 1272-1275.
17. Ufer M, Rane M, Karlsson A, et al. Widespread off-label prescribing of topical but not systemic drugs for 350, 000 paediatric outpatients in Stockholm. Eur J Clin Pharmacol, 2003, 58(11): 779-783.
18. Moral es-Carpi C, Estañ L, Rubio E, et al. Drug utilization and off-label drug use among Spanish emergency room paediatric patients. Eur J Clin Pharmacol, 2010, 66(3): 315-320.
19. Pandolfini C, Campi R, Clavenna A, et al. Italian paediatricians and off-label prescriptions: Loyal to regulatory or guideline standards? Acta Pædiatrica, 2005, 94(6): 753-757.
20. Lass J, Irs A, Pisarev H, et al. Off label use of prescription medicine s in children in outpatient setting in Estonia is common. Pharmacoepidemiology & Drug Safety, 2011, 20(5): 474-481.
21. Bücheler R, Schwab M, Mörike K, et al. Off label prescribing to children in primary care in Germany: retrospective cohort study. BMJ, 2002, 324(7349): 1311-1312.
22. Sturkenboom M, Felisi M, Manfredi C, et al. Paediatric status and off-label use of drugs in children in Italy, United Kingdom and the Netherlands. Pharmaceuticals Policy and Law, 2009, 11(1-2): 51–59.
23. Lifshitz M, Gavrilov V, Grossman V, et al. Unapproved Prescription Practices in Primary Pediatric Clinics in Israel: A Prospective Analysis. Current Therapeutic research, 2002, 63(12): 830-837.
24. Gavrilov V, Lifshitz M, Levy J, et al. Unlicensed and Off-Label Medication Use in a General Pediatrics Ambulatory Hospital Unit in Israel. Isr Med Assoc J, 2000, 2(8): 595-597.
25. Phan H, Leder M, Fishley M, et al. Off-Label and Unlicensed Medication Use and Associated Adverse Drug Events in a Pediatric Emergency Department. Pediatric Emergency Care, 2010, 26(6): 424-430.
26. 王海瀅, 劉芳. 北京大學第三醫院兒科門診超說明書用藥調查與分析.中國醫院用藥評價與分析, 2011, 11(2): 184-186.
27. 張伶俐, 李幼平, 黃亮, 等. 四川大學華西第二醫院兒科門診處方超藥品說明書用藥情況調查. 中國循證醫學雜志, 2011, 11(10): 1120-1124.
28. 薛麗萍, 汪琪. 兒科超說明書用藥的調查分析.中國藥房, 2008, 19(4): 315-31.
29. 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.
30. 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.
31. 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.
32. 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.
33. 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.
34. Jain SS, Bavdekar SB, Gogtay NJ, et al. Off-label drug use in children. Indian J Pediatr, 2008, 75(11): 1133-1136.
35. 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.
36. 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.
37. 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.
38. Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr, 2005, 164(9): 552-558.
39. 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.
40. ‘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.
41. Allergy&AsthmaNetwork. [2012-02-01] http: //www.aanma.org/faqs/welcome-to-precious-breathers/respiratory-diseases/.
42. WHO. [2012-02-10] http: //www.who.int/infectious-disease-report/pages/textonly.html.

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全球門診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》

全球門診兒童超說明書用藥現狀的系統評價

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