2013年—2017年我国六市口服抗凝药在呼吸系统疾病中的应用情况分析
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摘要
目的了解2013年—2017年北京、广州、上海、成都、沈阳、郑州6个城市72所医院口服抗凝药在呼吸系统疾病中的应用现状及发展趋势。方法通过各医院信息系统,2013年1月—2017年12月对北京、广州、上海、成都、沈阳、郑州6个城市各12所医院每季度随机抽取10个工作日的门诊处方及住院医嘱的电子信息,汇总后纳入《医院处方分析项目》处方数据库。筛选出使用了口服抗凝药的处方,再通过人工筛选将诊断中有呼吸系统疾病相关诊断的处方提取出来作为研究对象。以用药金额、处方数量、处方日剂量(prescribed daily dose,PDD)、限定日剂量(defined daily dose,DDD)对口服抗凝药物在呼吸系统疾病中应用情况进行统计分析。结果 2013年—2017年,在呼吸系统相关疾病中,华法林钠处方数量依次为4 769、5 747、7 549、7 261、7 151张,虽一直排列第一,但自2015年后逐年降低,华法林钠用药金额构成比从2013年的32.52%逐年降低至2017年的5.03%。新型口服抗凝药在5年间处方数量构成比及用药金额构成比均逐年升高。华法林钠、达比加群酯、利伐沙班、阿哌沙班PDD/DDD分别为0.41、0.73、0.68、0.33。存在超说明书适应证及禁忌证使用的情况。结论我国上述6个城市72所医院口服抗凝药物5年间处方数量构成比仍以华法林为主,临床医生在制定药物治疗方案时充分考虑用药安全、有效、经济性后作出了综合判断。
Objective To realize the application status and development trend of oral anticoagulant drugs used in respiratory diseases in 72 hospitals in 6 cities from the year 2013 to 2017. Methods From January 2013 to December2017, we randomly selected the electronic information from 10 working days per quarter in 6 cities including Beijing,Guangzhou, Shanghai, Chengdu, Shenyang, and Zhengzhou, with 12 hospitals in each city, and summarized the information into the prescription database of the hospital prescription analysis project. Through the hospital information system, we screened out the information of outpatient prescriptions and inpatient medical records which used oral anticoagulants. The prescriptions with respiratory diseases related-diagnosis were selected as the research objects by manual screening. The application of oral anticoagulant drugs used in respiratory diseases was statistically analyzed by drug amount, prescription amount, prescribed daily dose(PDD), and defined daily dose(DDD). Results From 2013 to2017, the number of warfarin sodium prescriptions was successively 4 769, 5 747, 7 549, 7 261, and 7 151, which had been always ranked the first in the five years, but decreased year by year since 2015. The proportion of warfarin sodium drug use amount decreased year by year from 32.52% in 2013 to 5.03% in 2017. The proportion of prescription and drug consumption sum of new oral anticoagulants increased year by year in the past five years. The PDD/DDD of warfarin sodium, dabigatran etexilate, rivaroxaban, and apixaban were 0.41, 0.73, 0.68, and 0.33, respectively. There were off lable use of new oral anticoagulants. Conclusions Warfarin still dominates the proportion of oral anticoagulants prescribed in the 72 hospitals in the 6 cities in the five years. The clinicians have made a comprehensive judgment after fully considering the safety, effectiveness, and economy of drug use when formulating drug treatment programs.
Objective To realize the application status and development trend of oral anticoagulant drugs used in respiratory diseases in 72 hospitals in 6 cities from the year 2013 to 2017. Methods From January 2013 to December2017, we randomly selected the electronic information from 10 working days per quarter in 6 cities including Beijing,Guangzhou, Shanghai, Chengdu, Shenyang, and Zhengzhou, with 12 hospitals in each city, and summarized the information into the prescription database of the hospital prescription analysis project. Through the hospital information system, we screened out the information of outpatient prescriptions and inpatient medical records which used oral anticoagulants. The prescriptions with respiratory diseases related-diagnosis were selected as the research objects by manual screening. The application of oral anticoagulant drugs used in respiratory diseases was statistically analyzed by drug amount, prescription amount, prescribed daily dose(PDD), and defined daily dose(DDD). Results From 2013 to2017, the number of warfarin sodium prescriptions was successively 4 769, 5 747, 7 549, 7 261, and 7 151, which had been always ranked the first in the five years, but decreased year by year since 2015. The proportion of warfarin sodium drug use amount decreased year by year from 32.52% in 2013 to 5.03% in 2017. The proportion of prescription and drug consumption sum of new oral anticoagulants increased year by year in the past five years. The PDD/DDD of warfarin sodium, dabigatran etexilate, rivaroxaban, and apixaban were 0.41, 0.73, 0.68, and 0.33, respectively. There were off lable use of new oral anticoagulants. Conclusions Warfarin still dominates the proportion of oral anticoagulants prescribed in the 72 hospitals in the 6 cities in the five years. The clinicians have made a comprehensive judgment after fully considering the safety, effectiveness, and economy of drug use when formulating drug treatment programs.
引文
1董军,刘寅.抗凝药物的进展及临床应用.中华老年心脑血管病杂志, 2013, 15(12):1333-1335.
2黄海彬,卢晓霞,邱倩倩,等.抗凝药物临床应用的研究进展.海峡药学, 2013, 25(6):1-4.
3任小婵,罗选娟,杨欢,等.新型口服抗凝药的临床应用研究进展.中华全科医学, 2018, 16(4):615-619, 666.
4World Health Organization. Introduction to drug utilization research 2003. Oslo, Norway:2003. http://apps.who.Int/medicinedocs/en/d/Js4876e/7.html.
5陈新谦,金有豫,汤光.新编药物学. 17版.北京:人民卫生出版社, 2011:536-537.
6罗文苹.新型口服抗凝药在治疗血栓栓塞性疾病中的研究进展.重庆:重庆医科大学, 2015.
7杜昕,郭伟.新型口服抗凝药是否可以取代华法林用于静脉血栓栓塞症抗凝治疗.中国血管外科杂志:电子版, 2016, 8(3):178-182.
8中华医学会心血管病学分会,中国老年学学会心脑血管病专业委员会.华法林抗凝治疗的中国专家共识.中华内科杂志, 2013,52(1):76-82.
9何培根,闵新文,郑芳,等.华法林钠药理作用影响因素与华法林钠用药监护.医药导报, 2011(5):668-671.
10Rieder MJ, Reiner AP, Gage BF, et al. Effect of VKORC1haplotypes on transcriptional regulation and warfarin dose. N Engl J Med, 2005, 352(22):2285-2293.
11徐建华,邹颖.胺碘酮可增强华法林的抗凝作用分析.南通大学学报:医学版, 2012, 32(3):243-244.
12张先龙.新型口服抗凝药物阿哌沙班.中华关节外科杂志:电子版, 2014(4):543-546.
13Kearon C, Akl EA, Ornelas J, et al. Antithrombotic therapy for VTE disease:CHEST guideline and expert panel report. Chest,2016, 149(2):315-352.
14中国健康促进基金会血栓与血管专项基金专家委员会,中华医学会呼吸病学分会肺栓塞与肺血管病学组,中国医师协会呼吸医师分会肺栓塞与肺血管病工作委员会.医院内静脉血栓栓塞症防治与管理建议.中华医学杂志, 2018, 98(18):1383-1388.
15Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace, 2016, 18(11):1609-1678.
16马军,吴一龙,秦叔逵,等.肿瘤相关静脉血栓栓塞症的预防与治疗中国专家指南(2015版).中国肿瘤临床, 2015, 43(20):979-991.
17中华人民共和国卫生部.处方管理办法.(2007-02-14)[2018-12-11 ]. http://www.gov.cn/flfg/2007-03/13/content_549406.htm.
18中华人名共和国卫生部,国家中医药管理局,总后勤部卫生部.医疗机构药事管理规定.(2 0 1 1-1 1-3 0)[2 0 1 8-1 2-0 1].http://www.nhfpc.gov.cn/mohyzs/s3585/201103/51113.shtml.
19全国人民代表大会常务委员会.中华人民共和国侵权责任法.(2009-12-26)[2018-12-01]. http://www.gov.cn/flfg/2009-12 /26/content_1497435.htm.
20覃涛,樊荣,何纪毅.超说明书用药合法吗?.中国医院院长,2018(19):84-87.
2黄海彬,卢晓霞,邱倩倩,等.抗凝药物临床应用的研究进展.海峡药学, 2013, 25(6):1-4.
3任小婵,罗选娟,杨欢,等.新型口服抗凝药的临床应用研究进展.中华全科医学, 2018, 16(4):615-619, 666.
4World Health Organization. Introduction to drug utilization research 2003. Oslo, Norway:2003. http://apps.who.Int/medicinedocs/en/d/Js4876e/7.html.
5陈新谦,金有豫,汤光.新编药物学. 17版.北京:人民卫生出版社, 2011:536-537.
6罗文苹.新型口服抗凝药在治疗血栓栓塞性疾病中的研究进展.重庆:重庆医科大学, 2015.
7杜昕,郭伟.新型口服抗凝药是否可以取代华法林用于静脉血栓栓塞症抗凝治疗.中国血管外科杂志:电子版, 2016, 8(3):178-182.
8中华医学会心血管病学分会,中国老年学学会心脑血管病专业委员会.华法林抗凝治疗的中国专家共识.中华内科杂志, 2013,52(1):76-82.
9何培根,闵新文,郑芳,等.华法林钠药理作用影响因素与华法林钠用药监护.医药导报, 2011(5):668-671.
10Rieder MJ, Reiner AP, Gage BF, et al. Effect of VKORC1haplotypes on transcriptional regulation and warfarin dose. N Engl J Med, 2005, 352(22):2285-2293.
11徐建华,邹颖.胺碘酮可增强华法林的抗凝作用分析.南通大学学报:医学版, 2012, 32(3):243-244.
12张先龙.新型口服抗凝药物阿哌沙班.中华关节外科杂志:电子版, 2014(4):543-546.
13Kearon C, Akl EA, Ornelas J, et al. Antithrombotic therapy for VTE disease:CHEST guideline and expert panel report. Chest,2016, 149(2):315-352.
14中国健康促进基金会血栓与血管专项基金专家委员会,中华医学会呼吸病学分会肺栓塞与肺血管病学组,中国医师协会呼吸医师分会肺栓塞与肺血管病工作委员会.医院内静脉血栓栓塞症防治与管理建议.中华医学杂志, 2018, 98(18):1383-1388.
15Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace, 2016, 18(11):1609-1678.
16马军,吴一龙,秦叔逵,等.肿瘤相关静脉血栓栓塞症的预防与治疗中国专家指南(2015版).中国肿瘤临床, 2015, 43(20):979-991.
17中华人民共和国卫生部.处方管理办法.(2007-02-14)[2018-12-11 ]. http://www.gov.cn/flfg/2007-03/13/content_549406.htm.
18中华人名共和国卫生部,国家中医药管理局,总后勤部卫生部.医疗机构药事管理规定.(2 0 1 1-1 1-3 0)[2 0 1 8-1 2-0 1].http://www.nhfpc.gov.cn/mohyzs/s3585/201103/51113.shtml.
19全国人民代表大会常务委员会.中华人民共和国侵权责任法.(2009-12-26)[2018-12-01]. http://www.gov.cn/flfg/2009-12 /26/content_1497435.htm.
20覃涛,樊荣,何纪毅.超说明书用药合法吗?.中国医院院长,2018(19):84-87.