544例精神障碍住院患者抗抑郁药超说明书用药调查
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摘要
目的调查我院精神障碍住院患者中抗抑郁药的超说明书用药情况,为制订合理的超说明书用药策略提供基础数据。方法采用回顾性调查研究方法,分层抽样法筛选出2017年1月1日至2017年12月31日我院使用抗抑郁药的出院精神疾病患者544例,应用自编住院患者用药信息调查表,以CFDA药品说明书作为判定依据,从适应症、给药剂量、给药人群3个方面进行超说明书用药判定。结果我院精神障碍住院患者中抗抑郁药的超说明书用药率为44. 3%,超适应症用药率32. 2%、超剂量用药率12. 7%、超人群用药率2. 4%;精神分裂症、神经症性疾病(躯体化障碍、应激相关障碍、分离(转换)性障碍)、非器质性失眠症、器质性精神障碍、精神活性物质所致精神障碍的超适应症用药率为100. 0%,焦虑障碍的超适应症用药率也较高(84. 4%);抗抑郁药的超人群使用体现在儿童青少年和老年人群中。结论我院抗抑郁药超说明书用药现象较普遍,以超适应症用药最多见,提示应加强医院用药规范管理及探讨超说明书用药的合理性。
Objective To investigate the off-label use of antidepressants in 544 inpatients with mental disorders of our hospital,and provide the basic data for formulating the rational strategy of off-label use. Methods W ith a retrospective study,a total of 544 discharged psychiatric patients from January 1,2017 to December 31,2017 who used antidepressants were selected by stratified sampling method. W e used the self-designed questionnaire to investigate the medication information of these inpatients,and judged the off-label use of antidepressants from three aspects: indications,dosage and population,according to the CFDA drug directions. Results The total usage rate of the off-label prescribing of antidepressants was 44. 3%. The usage rate of over-indication was 32. 2%. The usage rate of over-dosage was 12. 7% and the usage rate of over-population was 2. 4%. The usage rate of over-indication was 100. 0% in schizophrenia,neurotic disorders( somatoform disorders,stress-related disorders,dissociative( conversion) disorders),non-organic insomnia,organic disorders and mental disorders caused by psychoactive substances. The usage rate of over-indication in anxiety disorder was84. 4%. The over-population use of antidepressants was reflected in children,adolescents and the elderly. Conclusion Off-label use of antidepressants was a common phenomenon in our hospital,and the over-indication use was the most. It suggests us to strengthen the standardized management of drug use and discuss the rationality of off-label use.
Objective To investigate the off-label use of antidepressants in 544 inpatients with mental disorders of our hospital,and provide the basic data for formulating the rational strategy of off-label use. Methods W ith a retrospective study,a total of 544 discharged psychiatric patients from January 1,2017 to December 31,2017 who used antidepressants were selected by stratified sampling method. W e used the self-designed questionnaire to investigate the medication information of these inpatients,and judged the off-label use of antidepressants from three aspects: indications,dosage and population,according to the CFDA drug directions. Results The total usage rate of the off-label prescribing of antidepressants was 44. 3%. The usage rate of over-indication was 32. 2%. The usage rate of over-dosage was 12. 7% and the usage rate of over-population was 2. 4%. The usage rate of over-indication was 100. 0% in schizophrenia,neurotic disorders( somatoform disorders,stress-related disorders,dissociative( conversion) disorders),non-organic insomnia,organic disorders and mental disorders caused by psychoactive substances. The usage rate of over-indication in anxiety disorder was84. 4%. The over-population use of antidepressants was reflected in children,adolescents and the elderly. Conclusion Off-label use of antidepressants was a common phenomenon in our hospital,and the over-indication use was the most. It suggests us to strengthen the standardized management of drug use and discuss the rationality of off-label use.
引文
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[2]广东省药学会.药品未注册用法专家共识[S]. 2010-03-18.
[3]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. DOI:10. 3969/j. issn. 1672-2531. 2012.04. 010.
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[5]贾海玲,张萍,王健,等. 2002~2012年间河北省抑郁障碍患者药物使用情况调查[J].临床精神医学杂志,2017,27(3):185-187. DOI:10. 3969/j. issn.1005-3220. 2017. 03. 013.
[6] Wong J,Motulsky A,Abrahamowicz M,et al. Off-label indications for antidepressants in primary care:descriptive study of prescriptions from an indication based electronic prescribing system[J]. BMJ,2017,356:j603.DOI:10. 1136/bmj. j603.
[7]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.
[8]贾晓妮,权伟,陈建波,等. CFDA和FDA标准下我院精神专科药物超适应证使用比较分析[J].中国药房,2017,28(14):1899-1903. DOI:10. 6039/j. issn.1001-0408. 2017. 14. 08.
[9] Czaja AS,Valuck R. Off-label antidepressant use in children and adolescents compared with Young adults:extent and level of evidence[J]. Pharmacoepidemiol Drug Saf,2012,21(9):997-1004. DOI:10. 1002/pds.3312.
[10] Lee E,Teschemaker AR,Johann-Liang R,et al. Off-label prescribing patterns of antidepressants in children and adolescents[J]. Pharmacoepidemiol Drug Saf,2012,21(2):137-144. DOI:10. 1002/pds. 2145.
[11]杨荣梅,王艳涛.某精神专科医院2015年门诊药房超说明书用药处方分析[J].中国药房,2016,27(11):1466-1468.
[12]周舟,王魁元,胡群英,等.度洛西汀短期治疗精神分裂症的增效作用及对认知损害变化的影响[J].中国新药与临床杂志,2017,36(5):287-291. DOI:10.14109/j. cnki. xyylc. 2017. 05. 011.
[13]徐莉,陈云峰,秦天星,等.舍曲林对阿立哌唑治疗阴性症状为主精神分裂症的增效作用[J].全科医学临床与教育,2015,13(4):372-375. DOI:10. 13558/j. cnki. issn1672-3686. 2015. 04. 004.
[14] Coskun M,Zoroglu S. Clozapine induced obsessions treated with sertraline in an adolescent with schizophrenia[J]. Klinik Psikofarmakoloji Bulteni,2009,19(2):155-158.
[15]王锋锐,甘春连,叶百维.抗抑郁药辅助治疗精神分裂症伴焦虑抑郁症状的疗效研究[J].现代诊断与治疗,2018,29(19):3129-3130.
[16]胡昌清,史晓宁,丰雷,等.艾司西酞普兰对精神分裂症认知功能的改善作用[C]//中华医学会第十三次全国精神医学学术会议论文集.济南:中华医学会精神医学分会委员会,2015:257-258.
[17] Jonville-Béra AP,Béra F,Autret-Leca E. Are incorrectly used drugs more frequently involved in adverse drug reactions A prospective study[J]. Eur J Clin Pharmacol,2005,61(3):231-236. DOI:10. 1007/s00228-004-0881-6.
[2]广东省药学会.药品未注册用法专家共识[S]. 2010-03-18.
[3]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. DOI:10. 3969/j. issn. 1672-2531. 2012.04. 010.
[4] Stephenson CP,Karanges E,McGregor IS. Trends in the utilisation of psychotropic medications in Australia from2000 to 2011[J]. Aust N Z J Psychiatry,2013,47(1):74-87. DOI:10. 1177/0004867412466595.
[5]贾海玲,张萍,王健,等. 2002~2012年间河北省抑郁障碍患者药物使用情况调查[J].临床精神医学杂志,2017,27(3):185-187. DOI:10. 3969/j. issn.1005-3220. 2017. 03. 013.
[6] Wong J,Motulsky A,Abrahamowicz M,et al. Off-label indications for antidepressants in primary care:descriptive study of prescriptions from an indication based electronic prescribing system[J]. BMJ,2017,356:j603.DOI:10. 1136/bmj. j603.
[7]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.
[8]贾晓妮,权伟,陈建波,等. CFDA和FDA标准下我院精神专科药物超适应证使用比较分析[J].中国药房,2017,28(14):1899-1903. DOI:10. 6039/j. issn.1001-0408. 2017. 14. 08.
[9] Czaja AS,Valuck R. Off-label antidepressant use in children and adolescents compared with Young adults:extent and level of evidence[J]. Pharmacoepidemiol Drug Saf,2012,21(9):997-1004. DOI:10. 1002/pds.3312.
[10] Lee E,Teschemaker AR,Johann-Liang R,et al. Off-label prescribing patterns of antidepressants in children and adolescents[J]. Pharmacoepidemiol Drug Saf,2012,21(2):137-144. DOI:10. 1002/pds. 2145.
[11]杨荣梅,王艳涛.某精神专科医院2015年门诊药房超说明书用药处方分析[J].中国药房,2016,27(11):1466-1468.
[12]周舟,王魁元,胡群英,等.度洛西汀短期治疗精神分裂症的增效作用及对认知损害变化的影响[J].中国新药与临床杂志,2017,36(5):287-291. DOI:10.14109/j. cnki. xyylc. 2017. 05. 011.
[13]徐莉,陈云峰,秦天星,等.舍曲林对阿立哌唑治疗阴性症状为主精神分裂症的增效作用[J].全科医学临床与教育,2015,13(4):372-375. DOI:10. 13558/j. cnki. issn1672-3686. 2015. 04. 004.
[14] Coskun M,Zoroglu S. Clozapine induced obsessions treated with sertraline in an adolescent with schizophrenia[J]. Klinik Psikofarmakoloji Bulteni,2009,19(2):155-158.
[15]王锋锐,甘春连,叶百维.抗抑郁药辅助治疗精神分裂症伴焦虑抑郁症状的疗效研究[J].现代诊断与治疗,2018,29(19):3129-3130.
[16]胡昌清,史晓宁,丰雷,等.艾司西酞普兰对精神分裂症认知功能的改善作用[C]//中华医学会第十三次全国精神医学学术会议论文集.济南:中华医学会精神医学分会委员会,2015:257-258.
[17] Jonville-Béra AP,Béra F,Autret-Leca E. Are incorrectly used drugs more frequently involved in adverse drug reactions A prospective study[J]. Eur J Clin Pharmacol,2005,61(3):231-236. DOI:10. 1007/s00228-004-0881-6.