Objective To establish the drug use evaluation (DUE) criteria for aspirin enteric-coated tablets and provide a reference for the rationally clinical application of aspirin enteric-coated tablets.
Methods DUE criteria for aspirin enteric-coated tablets were established from three aspects of indications, medications and medication results with reference to drug instructions of aspirin enteric-coated tablets, related guidelines, expert consensus and literature, and through Delphi method. A retrospective analysis was conducted to evaluate the medical records of patients who took aspirin enteric-coated tablets from January 2021 to June 2022 in Fuqing Hospital affiliated to Fujian Medical University.
Results A total of 1 071 medical records were included. 683 cases fully met the DUE criteria, with a rational rate of 63.77%. Irrational drug use mainly included inappropriate indications (6.26%), off-label drug use without approval (28.48%), contraindications (1.03%), inappropriate usage and dosage (1.68%), drug interactions with potential clinical significance (0.65%) and other inappropriate drug use (2.71%).
Conclusion The established DUE standard for aspirin enteric-coated tablets has strong scientific practicability and feasibility. The irrational rate of aspirin enteric-coated tablets in this hospital is high. Corresponding intervention measures should be formulated to ensure the safety of clinical medication.
1.刘杰. 阿司匹林药理作用的研究新进展[J].中国中医药现代远程教育, 2009, 7(1): 86-87. [Liu J. New research progress of aspirin pharmacological effects[J]. Modern Distance Education of Chinese Medicine, 2009, 7(1): 86-87.] DOI: 10.3969/j.issn.1672-2779.2009.01.059.
2.王聪, 史琛, 张玉. 甲磺酸阿美替尼药物利用评价标准的建立及应用[J]. 中国药师, 2022, 25(8): 1402-1405.[Wang C, Shi C, Zhang Y. Establishment and application of medication use evaluation criteria for almonertinib mesilate[J]. China Pharmacist, 2022, 25(8): 1402-1405.] DOI: 10.19962/j.cnki.issn1008-049X.2022.08.018.
3.中华医学会妇产科学分会妊娠期高血压疾病学组. 妊娠期高血压疾病诊治指南(2020)[J]. 中华妇产科杂志, 2020, 55(4): 227-238. DOI: 10.3760/cma.j.cn112141-20200114-00039.
4.中华医学会儿科学分会心血管学组, 中华医学会儿科学分会风湿学组, 中华医学会儿科学分会免疫学组, 等. 川崎病诊断和急性期治疗专家共识[J]. 中华儿科杂志, 2022, 60(1): 6-13. DOI: 10.3760/cma.j.cn112140-20211018-00879.
5.国家卫生计生委合理用药专家委员会, 中国药师协会. 冠心病合理用药指南(第2版)[J]. 中国医学前沿杂志(电子版), 2018, 10(6): 1-130. DOI: 10.12037/YXQY. 2018.06-01.
6.Lawton JS, Tamis-Holland JE, Bangalore S, et al. 2021 ACC/AHA/SCAI guideline for coronary artery revascularization: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines[J]. Circulation, 2022, 145(3): e4-e17. DOI: 10.1161/CIR.0000000000001039.
7.中华医学会外科学分会血管外科学组. 下肢动脉硬化闭塞症诊治指南[J]. 中华普通外科学文献(电子版), 2016, 10(1): 1-18. DOI: 10.3877/cma.j.issn.1674-0793. 2016.01.001.
8.中华医学会糖尿病学分会, 国家基层糖尿病防治管理办公室. 国家基层糖尿病防治管理手册(2022)[J]. 中华内科杂志, 2022, 61(7): 717-748. DOI: 10.3760/cma.j.cn112138-20220509-00350.
9.王树洪, 田银, 王瑞烈. 无原发疾病创伤性脾破裂行脾切除术后血小板计数的变化情况[J]. 当代医学, 2020, 26(36): 129-131. [Wang SH, Tian Y, Wang RL.Changes of platelet count after splenectomy with traumatic rupture of the spleen without primary disease[J]. Contemporary Medicine, 2020, 26(36): 129-131.] DOI: 10. 3969/j.issn.1009-4393.2020.36.050.
10.中国医师协会血管外科医师分会静脉学组. 常见静脉疾病诊治规范(2022年版)[J]. 中华血管外科杂志, 2022, 7(1): 12-29. DOI: 10.3760/cma.j.cn101411-20211218-00102.
11.中华医学会血液学分会白血病淋巴瘤学组.原发性血小板增多症诊断与治疗中国专家共识(2016年版)[J].中华血液学杂志, 2016, 37(10): 833-836. DOI: 10.3760/cma.j.issn.0253-2727.2016.10.001.
12.中华医学会神经病学分会, 中华医学会神经病学分会脑血管病学组. 中国急性缺血性脑卒中诊治指南2018[J]. 中华神经科杂志, 2018, 51(9): 666-682. DOI: 10.3760/cma.j.issn.1006-7876.2018.09.004.
13.中华医学会心血管病学分会, 中华心血管病杂志编辑委员会. 急性ST段抬高型心肌梗死诊断和治疗指南(2019)[J]. 中华心血管病杂志, 2019, 47(10): 766-783. DOI: 10.3760/cma.j.issn.0253-3758.2019.10.003.
14.中国医师协会急诊医师分会, 国家卫健委能力建设与继续教育中心急诊学专家委员会, 中国医疗保健国际交流促进会急诊急救分会. 急性冠脉综合征急诊快速诊治指南(2019)[J]. 中华急诊医学杂志, 2019, 28(4): 421-428. DOI: 10.3760/cma.j.issn.1671-0282.2019.04.003.
15.中华医学会心血管病学分会介入心脏病学组, 中国医师协会心血管内科医师分会血栓防治专业委员会, 中华心血管病杂志编辑委员会. 中国经皮冠状动脉介入治疗指南(2016)[J]. 中华心血管病杂志, 2016, 44(5): 382-400. DOI: 10.3760/cma.j.issn.0253-3758.2016.05.006.
16.张宾, 郝呈泉. 长期服用阿司匹林的不良反应及防治措施[J]. 中外医学研究, 2011, 9(12): 40. [Zhang B, Hao CC. The adverse reactions and prevention measures of long-term use of aspirin[J]. Chinese and Foreign Medical Research, 2011, 9(12): 40.] DOI: 10.3969/j.issn.1674-6805.2011.12.032.
17.《中国血栓性疾病防治指南》专家委员会. 中国血栓性疾病防治指南[J]. 中华医学杂志, 2018, 98(36): 2861-2888. DOI: 10.3760/cma.j.issn.0376-2491.2018.36.002.
18.李素琼. 利拉鲁肽药物利用评价标准的构建和应用 [D]. 昆明: 昆明医科大学, 2022.
19.甘念, 罗敏, 吴丽芬. 基于德尔菲法与层次分析法构建儿科门诊护理质量评价体系[J]. 护理实践与研究, 2021, 18(10): 1573-1576. [Gan N, Luo M, Wu LF. Constructing an evaluation system of pediatric outpatient nursing quality based on Delphi method and analytic hierarchy process method[J]. Nursing Practice and Research, 2021, 18(10): 1573-1576.] DOI: 10.3969/j.issn.1672-9676.2021.10.045.
20.陈翠, 郝建玲, 陶红, 等. 德尔菲专家咨询法在构建个人防护技巧核心指标核查表中的应用[J]. 解放军医院管理杂志, 2020, 27(6): 507-510, 515. [Chen C. Hao JL, Tao H, et al. Application of Delphi method in core indicators checklist construction of personal protective skills[J]. Hospital Administration Journal of Chinese People's Liberation Army, 2020, 27(6): 507-510, 515.] DOI: 10.16770/J.cnki.1008-9985.2020.06.003.
21.Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions[J]. Clin Pharmacol Ther, 1981, 30(2): 239-245. DOI: 10.1038/clpt.1981.154.
22.刘凌云. 《医院处方点评管理规范(试行)》执行中的难点及对判定标准的探讨[J]. 中国医院用药评价与分析, 2016, 16(1): 107-110. [Liu LY. Difficulties in implementation of Management Standards for Hospital Prescription Evaluation (Trial) and exploration of evaluation criteria[J]. Evaluation and Analysis of Drug Use in Chinese Hospitals, 2016, 16(1): 107-110.] DOI: 10.14009/j.issn. 1672-2124.2016.01.038.
23.刘艳杰, 李琳, 吴烨青. 《医院处方点评管理规范(试行)》执行中存在问题的思考[J]. 中国药业, 2013, 22(8): 70-71. [Liu YJ, Li L, Wu YQ. Thingking on the problems in implementation of Management Standards for Hospital Prescription Evaluation (Trial) [J]. China Pharm, 2013, 22(8): 70-71.] DOI: 10.3969/j.issn.1006-4931.2013.08.042.
24.Stanworth SJ, Dowling K, Curry N, et al. Haematological management of major haemorrhage: a British Society for Haematology guideline[J]. Br J Haematol, 2022, 198(4): 654-667. DOI: 10.1111/bjh.18275.
25.2019阿司匹林在心血管疾病一级预防中的应用中国专家共识写作组. 2019阿司匹林在心血管疾病一级预防中的应用中国专家共识[J]. 中华心血管病杂志(网络版), 2019, 2(1): 1-5. DOI: 10.3760/cma.j.issn.2096- 1588.2019.1000020.
26.Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: a report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines[J]. Circulation, 2019, 140(11): e596-e646. DOI: 10.1161/CIR.0000000000000678.
27.中华医学会心血管病学分会, 中国康复医学会心脏预防与康复专业委员会, 中国老年学和老年医学会心脏专业委员会, 等. 中国心血管病一级预防指南基层版[J]. 中华心血管病杂志, 2023, 51(4): 343-363. DOI: 10.3760/cma.j.cn112148-20230106-00014.
28.Wang X, Wang H, Zheng Q, et al. Outcomes associated with 50 mg/d and 100 mg/d aspirin for the prevention and management of cardiovascular disease in chinese elderly: single-center interim analysis of a multicenter, prospective, observational study[J]. Int J Gen Med, 2022, 15: 7089-7100. DOI: 10.2147/IJGM.S384375.
29.中华人民共和国国家卫生健康委员会. 流行性感冒诊疗方案(2020年版)[J]. 全科医学临床与教育, 2020, 18(12): 1059-1063. DOI: 10.13558/j.cnki.issn1672-3686. 2020.012.002.
30.张秋霞, 王玉玲. 小剂量肠溶阿司匹林致肾损害16例分析[J]. 药物不良反应杂志, 2004, 6(2): 82-84. [Zhang QX, Wang YL. 16 cases of renal damage caused by low-dose enteric-coated aspirin[J]. Journal of Adverse Drug Reaction, 2004, 6(2): 82-84.] DOI: 10.3969/j.issn.1008- 5734.2004.02.003.
31.Tanrikulu AM, Ozben B, Koc M, et al. Aspirin resistance in patients with chronic renal failure[J]. J Nephrol, 2011, 24(5): 636-46. DOI: 10.5301/JN.2011.6259.
32.孙云. 阿司匹林与布洛芬相互作用对阿司匹林心血管保护作用的影响[J]. 中国保健营养, 2016, 26(30): 41-41, 42. [Sun Y. The effect of aspirin and ibuprofen on the cardiovascular protective effect of aspirin[J]. China Health Care & Nutrition, 2016, 26(30): 41-41, 42.] DOI: 10.3969/j.issn.1004-7484.2016.30.051.
33.孙海燕. 基于FDA不良事件数据库阿司匹林相关痛风和高尿酸血症不良事件分析[J]. 药学研究, 2022, 41(12): 838-840. [Sun HY. Analysis of aspirin related gout and hyperuricaemia adverse events based on FDA adverse event database[J]. Journal of pharmaceutical Research, 2022, 41(12): 838-840.] DOI: 10.13506/j.cnki.jpr.2022.12.014.
34.谢成钧. 1例服用阿司匹林致痛风发作的案例分析[J]. 世界最新医学信息文摘, 2017, 17(68): 184. [Xie CJ. A case study of gout attack induced by aspirin[J]. World Latest Medicine Information, 2017, 17(68): 184.] DOI: 10.19613/j.cnki.1671-3141.2017.68.096.
35.周琳, 石磊, 石焱. 小剂量阿司匹林对老年糖尿病患者血尿酸水平影响[J]. 临床军医杂志, 2019, 47(10): 1132-1133. [Zhou L, Shi L, Shi Y. Effect of low-dose aspirin on blood uric acid in elderly diabetic patients[J]. Clinical Journal of Medical Officers, 2019, 47(10): 1132-1133.] DOI: 10.16680/j.1671-3826.2019.10.42.
36.杜忠东, 谢利剑, 刘世平, 等. 阿司匹林在川崎病治疗中的儿科专家共识[J]. 中国当代儿科杂志, 2022, 24(6): 597-603. [Du ZD, Xie LJ, Liu SP, et al. Pediatric consensus on aspirin in the treatment of Kawasaki disease[J]. Chineses Journal of Contemporary Pediatrics, 2022, 24(6): 597-603.] DOI: 10.7499/j.issn.1008-8830. 2203190.