某医院老年住院病人康艾注射液超说明书用药情况分析
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摘要
目的分析康艾注射液超说明书使用情况,为促进临床合理用药提供参考。方法利用医院HIS信息系统,调取某院2015年1月至2017年7月所有长期医嘱中使用康艾注射液的老年(≥60岁)病人,共1 148例,采用随机数字表法抽取574例,其中男性366例,女性208例,医嘱共779条。根据临床诊断对照药品说明书及相关文献对适应证、给药剂量、给药方法、给药途径、溶媒选择、配伍等方面进行评价。结果调查住院病例574份,其中214例(37. 28%) 282条医嘱(36. 20%)存在超说明书用药情况。其中超适应证用药135例(23. 52%) 169条医嘱(21. 78%),给药剂量不足17例(2. 96%) 33条医嘱(4. 24%),超疗程4例(0. 70%) 4条医嘱(0. 51%),混合配伍27例(4. 70%) 36条医嘱(4. 62%),超溶媒类型及用量31例(5. 40%) 38条医嘱(4. 88%)。结论老年病人使用康艾注射液超说明书用药现象明显,主要表现在疗程随意性大、超适应证用药,给药剂量不足,溶媒选择不适宜等。应加强干预措施,尤其是在老年病人这一特殊群体的临床治疗中更应确保其规范合理使用。
Objective To probe into prescription with off-label drug application of Kang'ai Injection in elderly patients,so as to provide references for rational drug use. Methods A total of 1148 cases of elderly patients who used Kang'ai Injection follow prescription in our hospital from Jan. 2015 to Jul. 2017 were enrolled by HIS system. 574 cases were selected by random number table,with 366 male and 208 female,779 cases of prescriptions. Based on the diagnosis,instruction and relevant reference,the indication,dosage,administration,the solvent and compatibility were evaluated. Results There were 282 prescriptions and 214 elderly patients of off-label drug application in the 574 cases. The main categories of off-label drug use were indication( 135,23. 52%),dosage( 17,2. 96%),course of treatment( 4,0. 70%),solvent types( 31,5. 40%) and solvent volume( 38,4. 88%). Conclusion Off-label drug application of Kang'ai Injection occurs commonly. It is necessary and urgent for us to establish and improve safe drug application in elderly patients.
Objective To probe into prescription with off-label drug application of Kang'ai Injection in elderly patients,so as to provide references for rational drug use. Methods A total of 1148 cases of elderly patients who used Kang'ai Injection follow prescription in our hospital from Jan. 2015 to Jul. 2017 were enrolled by HIS system. 574 cases were selected by random number table,with 366 male and 208 female,779 cases of prescriptions. Based on the diagnosis,instruction and relevant reference,the indication,dosage,administration,the solvent and compatibility were evaluated. Results There were 282 prescriptions and 214 elderly patients of off-label drug application in the 574 cases. The main categories of off-label drug use were indication( 135,23. 52%),dosage( 17,2. 96%),course of treatment( 4,0. 70%),solvent types( 31,5. 40%) and solvent volume( 38,4. 88%). Conclusion Off-label drug application of Kang'ai Injection occurs commonly. It is necessary and urgent for us to establish and improve safe drug application in elderly patients.
引文
[1]中国药理学会治疗药物监测研究专业委员会药品风险管理学组.超说明书用药专家共识[J].药物不良反应杂志,2015,17(2):101-103.
[2]王学谦,龚宏霞,林洪生,等.康艾注射液在肿瘤姑息治疗中的临床研究现状[J].世界中医药,2015,10(8):1264-1269.
[3]国家统计局.中华人民共和国2014年国民经济和社会发展统计公报[J].中国统计,2015(3):6-14.
[4]宋吉华.老年人服用西药的用药原则[J].世界最新医学信息文摘:电子版,2013(18):224-224. DOI:10. 3969/j. issn. 1671-3141. 2013. 18. 168.
[5]中华人民共和国国家卫生和计划生育委员会.关于进一步加强中药注射剂生产和临床使用管理的通知[z]. 2008-12-24.
[6] FAIRMAN KA,CURTISS FR. Regulatory actions on the off-label use of prescription drugs:ongoing controversy and contradiction in2009 and 2010[J]. J Manag Care Pharm,2010,16(8):629-639.
[7]王力剑,金锋,樊若曦,等.康艾注射液不良反应/事件报告分析[J].中国药物警戒,2016,13(10):609-613.
[8]袁珍娥,郭清文,朱淑萍,等.病区医嘱中药注射剂不合理应用分析[J].现代诊断与治疗,2013,24(13):2980-2981.
[9]梁晓美.康艾注射液与5种输液配伍的稳定性[J].医药导报,2013,32(6):805-806.
[10]秦丽莉,郝东霞,刘亚丽.中药注射剂不合理使用情况分析[J].中国药物与临床,2017,17(3):357-359.
[11]蔡德珺,蒋晓松,林高. 90例康艾注射液联合化疗治疗晚期结肠癌的有效性[J].北方药学,2015,12(8):184-184.
[12]张丽娜,汪园园,邱超平,等.康艾注射液联合FOLFIRI方案治疗结直肠癌的Meta分析[J].中国当代医药,2017,24(13):4-8.
[13]张丹,吴嘉瑞,刘施,等.基于Meta分析的康艾注射液辅助治疗结直肠癌临床评价研究[J].药物流行病学杂志,2017,26(11):751-756.
[14]张丹,刘施,吴嘉瑞.康艾注射液联合化疗治疗胃癌的系统评价[J].药物流行病学杂志,2016,25(8):486-492.
[15]狄剑士,关雅萍,毕经旺,等.康艾注射液联合化疗对胃癌疗效的Meta分析[J].中国肿瘤生物治疗杂志,2013,20(4):468-474.
[16]吕行,宁鹏,赵强,等.康艾注射液联合放化疗方案治疗对中晚期食管癌免疫功能的影响[J].中医药导报,2014,20(14):36-38.
[17]王伟华,陈前,江道文.康艾注射液联合放疗治疗中晚期食管癌的临床研究[J].现代药物与临床,2014,29(9):1032-1035.
[18]张宏博,单丽珠,张洁,等.康艾注射液联合化疗对胰腺癌患者免疫功能的影响[J].山西中医,2013,29(9):23-24.
[19]栾尚峰,范雯,吕登钦.康艾注射液对晚期胰腺癌患者生存质量的影响[J].医学综述,2011,17(1):153-155.
[20]张鹤,单丽珠,张洁,等.康艾注射液联合化疗治疗胰腺癌癌因性疲劳[J].中国中西医结合外科杂志,2012,18(5):438-440.
[21]武俊平,陈婷婷,宋文华,等.康艾注射液联合多西他赛及泼尼松治疗激素抵抗性前列腺癌的临床效果及安全性[J].临床误诊误治,2018,31(3):81-84.
[22]林雪颖.康艾注射液超说明书用药情况调查及合理性分析[J].今日药学,2017,27(2):134-136.
[23] VENTOLA CL. Off-label drug information:regulation,distribution,evaluation,and related controversies[J]. PT,2009,34(8):428-440.
[24]刘利军,肖龙华,李睿,等.超说明书用药认识问题及管理对策研究[J].中国医院用药评价与分析,2014,14(4):361-364.
[2]王学谦,龚宏霞,林洪生,等.康艾注射液在肿瘤姑息治疗中的临床研究现状[J].世界中医药,2015,10(8):1264-1269.
[3]国家统计局.中华人民共和国2014年国民经济和社会发展统计公报[J].中国统计,2015(3):6-14.
[4]宋吉华.老年人服用西药的用药原则[J].世界最新医学信息文摘:电子版,2013(18):224-224. DOI:10. 3969/j. issn. 1671-3141. 2013. 18. 168.
[5]中华人民共和国国家卫生和计划生育委员会.关于进一步加强中药注射剂生产和临床使用管理的通知[z]. 2008-12-24.
[6] FAIRMAN KA,CURTISS FR. Regulatory actions on the off-label use of prescription drugs:ongoing controversy and contradiction in2009 and 2010[J]. J Manag Care Pharm,2010,16(8):629-639.
[7]王力剑,金锋,樊若曦,等.康艾注射液不良反应/事件报告分析[J].中国药物警戒,2016,13(10):609-613.
[8]袁珍娥,郭清文,朱淑萍,等.病区医嘱中药注射剂不合理应用分析[J].现代诊断与治疗,2013,24(13):2980-2981.
[9]梁晓美.康艾注射液与5种输液配伍的稳定性[J].医药导报,2013,32(6):805-806.
[10]秦丽莉,郝东霞,刘亚丽.中药注射剂不合理使用情况分析[J].中国药物与临床,2017,17(3):357-359.
[11]蔡德珺,蒋晓松,林高. 90例康艾注射液联合化疗治疗晚期结肠癌的有效性[J].北方药学,2015,12(8):184-184.
[12]张丽娜,汪园园,邱超平,等.康艾注射液联合FOLFIRI方案治疗结直肠癌的Meta分析[J].中国当代医药,2017,24(13):4-8.
[13]张丹,吴嘉瑞,刘施,等.基于Meta分析的康艾注射液辅助治疗结直肠癌临床评价研究[J].药物流行病学杂志,2017,26(11):751-756.
[14]张丹,刘施,吴嘉瑞.康艾注射液联合化疗治疗胃癌的系统评价[J].药物流行病学杂志,2016,25(8):486-492.
[15]狄剑士,关雅萍,毕经旺,等.康艾注射液联合化疗对胃癌疗效的Meta分析[J].中国肿瘤生物治疗杂志,2013,20(4):468-474.
[16]吕行,宁鹏,赵强,等.康艾注射液联合放化疗方案治疗对中晚期食管癌免疫功能的影响[J].中医药导报,2014,20(14):36-38.
[17]王伟华,陈前,江道文.康艾注射液联合放疗治疗中晚期食管癌的临床研究[J].现代药物与临床,2014,29(9):1032-1035.
[18]张宏博,单丽珠,张洁,等.康艾注射液联合化疗对胰腺癌患者免疫功能的影响[J].山西中医,2013,29(9):23-24.
[19]栾尚峰,范雯,吕登钦.康艾注射液对晚期胰腺癌患者生存质量的影响[J].医学综述,2011,17(1):153-155.
[20]张鹤,单丽珠,张洁,等.康艾注射液联合化疗治疗胰腺癌癌因性疲劳[J].中国中西医结合外科杂志,2012,18(5):438-440.
[21]武俊平,陈婷婷,宋文华,等.康艾注射液联合多西他赛及泼尼松治疗激素抵抗性前列腺癌的临床效果及安全性[J].临床误诊误治,2018,31(3):81-84.
[22]林雪颖.康艾注射液超说明书用药情况调查及合理性分析[J].今日药学,2017,27(2):134-136.
[23] VENTOLA CL. Off-label drug information:regulation,distribution,evaluation,and related controversies[J]. PT,2009,34(8):428-440.
[24]刘利军,肖龙华,李睿,等.超说明书用药认识问题及管理对策研究[J].中国医院用药评价与分析,2014,14(4):361-364.