Welcome to visit Zhongnan Medical Journal Press Series journal website!

Home Articles Vol 33,2024 No.4 Detail

Establishment and application of drug use evaluation criteria of recombinant human prourokinase

Published on Apr. 29, 2024Total Views: 248 times Total Downloads: 391 times Download Mobile

Author: ZHUANG Zhihe 1# QIN Qin 2# CAI Huiya 3 MA Tianyu 1 WANG Runqiu 4 XIANG Qian 5 ZHANG Jinhua 6

Affiliation: 1. Department of Pharmacy, Xilin Gol League Central Hospital, Xilin Gol 026000, Inner Mongolia Autonomous Region, China 2. Department of Pharmacy, Luxian People's Hospital, Luzhou 646000, Sichuan Province, China 3. Department of Pharmacy, Zhangzhou Second Hospital, Zhangzhou 363199, Fujian Province, China 4. Department of Clinical Nutrition, Xilin Gol League Central Hospital, Xilin Gol 026000, Inner Mongolia Autonomous Region, China 5. Department of Pharmacy, Peking University First Hospital, Beijing 100034, China 6. Department of Pharmacy, Fujian Maternity and Child Health Care Hospital, Fuzhou 350001, China

Keywords: Recombinant human prourokinase Drug use evaluation Standard rules Rational drug use Adverse drug reaction

DOI: 10.12173/j.issn.1005-0698.202312031

Reference: ZHUANG Zhihe, QIN Qin, CAI Huiya, MA Tianyu, WANG Runqiu, XIANG Qian,ZHANG Jinhua.Establishment and application of drug use evaluation criteria of recombinant human prourokinase[J].Yaowu Liuxingbingxue Zazhi,2024, 33(4):371-380.DOI: 10.12173/j.issn.1005-0698.202312031.[Article in Chinese]

  • Abstract
  • Full-text
  • References
Abstract

Objective  To establish the drug use evaluation (DUE) criteria of recombinant human prourokinase (rhPro-UK), and to provide reference for the rational clinical application of rhPro-UK.

Methods  Based on the drug instructions of rhPro-UK, DUE standard rules were established by referring to relevant guidelines, expert consensus, authoritative literature and expert consultation. The medical records of hospitalized patients treated with rhPro-UK from January 2019 to May 2022 in Xilin Gol League Central Hospital were evaluated by retrospective investigation. The effectiveness of rhPro-UK was evaluated based on clinical outcome, and its safety was evaluated based on the incidence and severity of adverse reactions.

Results  A total of 230 cases were included, and 4 cases fully met the evaluation criteria (medication indication, medication process, medication results), accounting for 1.74%. There were 226 patients (98.26%) with irrational drug use, mainly manifested in two aspects of drug indication and drug process ( administration mode and dosage). Treatment was effective in 221 patients, with an overall effective rate of 96.09%; 139 patients experienced adverse reactions, with an incidence rate of 60.43%.

Conclusion  The clinical use of rhPro-UK in our hospital is irrational in the indication of medication and the process of medication, and the establishment of the DUE standard rules of rhPro-UK can provide a reference to standardize the clinical application of rhPro-UK and promote its rational use.

Full-text
Please download the PDF version to read the full text: download
References

1.国家卫生计生委合理用药专家委员会, 中国药师协会. 急性ST段抬高型心肌梗死溶栓治疗的合理用药指南(第2版)[J]. 中国医学前沿杂志(电子版), 2019, 11(1): 40-65. DOI: 10.12037/YXQY.2019.01-07.

2.国家药品监督管理局. 注射用重组人尿激酶原(普佑克®)说明书[DB/OL]. (2021-04-28) [2023-03-15]. https://zy.yaozh.com/instruct/sms20220223/37.pdf.

3.Jiang WL, Xiong XS, Du XH, et al. Safety and efficacy study of prourokinase injection during primary percutaneous coronary intervention in acute ST-segment elevation myocardial infarction[J]. Coron Artery Dis, 2021, 32(1): 25-30. DOI: 10.1097/MCA.0000000000000898.

4.Huang D, Qian JY, Liu ZJ, et al. Effects of intracoronary pro-urokinase or tirofiban on coronary flow during primary percutaneous coronary intervention for acute myocardial infarction: a multi-center,placebo-controlled, single-blind,randomized clinical trial[J]. Front Cardiovasc Med, 2021, 8: 710994. DOI: 10.3389/fcvm.2021.710994.

5.林东升, 傅广, 何仲春, 等. 冠状动脉内联合应用重组人尿激酶原和替罗非班对行急诊PCI的STEMI患者心肌血流灌注的影响[J]. 临床心血管病杂志, 2021, 37(3): 215-219. [Lin DS, Fu G, He ZC, et al. Effects of intracoronary low-dose recombinant human prourokinase and tirofiban on myocardial perfusion in STEMI patients with primary PCI[J]. Journal of Clinical Cardiology, 2021, 37(3): 215-219.] DOI: 10.13201/j/issn.1001-1439.2021. 03.006.

6.张正光, 肖成祖, 胡显文, 等. 国产重组人尿激酶原的药效学、药理学和毒理学研究[J]. 中国科学: 生命科学, 2011, 41(10): 1024-1029. [Zhang ZG, Xiao CZ, Hu XW, et al. Overwiew of investigation of pharmacodynamics, pharmacology, and toxicology of domestic human prourokinase[J]. Scientia Sinica (Vitae), 2011, 41: 1024-1029.] DOI: 10.1360/052011-593.

7.Afanasjeva J, Burk M, Cunningham FF, et al. ASHP Guidellines on medication-use evaluation[J]. Am J Health Syst Pharm, 2021, 78(2): 168-175. DOI: 10.1093/ajhp/zxaa393.

8.袁浩宇, 林勇, 胡明, 等. 药物利用评价标准建立的方法探讨及实践[J]. 中国药房, 2010, 21(22): 2101-2104. [Yuan HY, Lin Y, Hu M, et al. Exploration on the method for establishment of DUE standard and practical study[J]. China Pharmacy, 2010, 21(22): 2101-2104.] DOI: CNKI: SUN:ZGYA.0.2010-22-036.

9.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.iss-n.0253-3758.2019.10.003.

10.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.

11.姚朱华, 陈湾湾, 曹明英, 等. 注射用重组人尿激酶原治疗急性ST段抬高型心肌梗死的疗效和安全性及影响因素分析[J]. 中国全科医学, 2016, 9: 1061-1066. [Yao ZH, Chen WW, Cao MY, et al. Efficacy and safety of injection of recombinant human prourokinase in the treatmentof acute ST-segment elevation myocardial infarction and influencing factors[J]. Chinese General Practice, 2016, 19(9): 1061-1066.] DOI: 10.3969/j.issn. 1007-9572.2016.09.016.

12.中华医学会心血管病学分会心力衰竭学组, 中国医师协会心力衰竭专业委员会中华心血管病杂志编辑委员会. 中国心力衰竭诊断和治疗指南2018[J]. 中华心血管病杂志, 2018, 46(10): 760-789. DOI: 10.3760/cma.j.issn.0253-3758.2018.10.004

13.中华医药生物技术协会药物性肝损伤防治技术专业专业委员会, 中华医学会肝病学分会药物性肝病学组. 中国药物性肝损伤诊治指南[J]. 中华肝脏病杂志, 2023, 31(4): 355-384. DOI: 10.3760/cma.j.cn501113-20230419-00176.

14.颜红兵, 向定成, 刘红梅, 等. ST段抬高型急性心肌梗死院前溶栓治疗中国专家共识[J]. 中国介入心脏病学杂志, 2018, 26(4): 181-190. [Yan HB, Xiang DC, Liu HM, et al. Chinese expert consensus on pre-hospital thrombolytic therapy for ST segment elevation acute myocardial infarction[J]. Chinese Journal of Interventional Cardiology, 2018, 26(4): 181-190.] DOI: 10.3969/j.issn. 1004-8812.2018.04.001.

15.林小娟, 黄小红, 黄涓涓, 等. 利伐沙班药物利用评价标准的建立与应用[J]. 中国现代应用药学, 2020, 37(20): 2543-2548. [Lin XJ, Huang XH, Huang JJ, et al. Establishment and application of drug yse evaluation standard of rivaroxaban[J]. Chinese Journal of Modern Applied Pharmacy, 2020, 37(20): 2543-2548.] DOI: 10. 13748/j.cnki.issn1007-7693.2020.20.020.

16.李小东, 居靖, 李令培, 等. 阿替普酶治疗急性缺血性脑卒中药物利用评价标准的建立与应用[J]. 中国药师, 2021, 24(7): 323-326. [Li XD, Ju J, Li LP, et al. Establishment and application of evaluation criteria for the utilization of alteplase in the treatment of acute ischemic stroke[J]. China Pharmacist, 2021, 24(7): 323-326.] DOI: 10.19962/j.cnki.issn1008-049X.2021.07.023.

17.Fan G, Wu XG, Jiao WP, et al. Safety and efficacy of intracoronary recombinant human prourokinase administration in patients with acute myocardial infarction and ST-segment elevation: A meta-analysis of randomized controlled trials[J]. Exp Ther Med, 2023, 25(1): 40. DOI: 10.3892/etm.2022.11739.

18.Geng YX, Zhao LY, Wang Y, et al. Competency model for dentists in China: Results of a Delphi study[J]. PLoS One, 2018, 13(3): e0194411. DOI: 10.1371/journal.pone. 0194411.

19.彭贵琴, 刘文华, 唐宗伟, 等. 基于德尔菲法构建我国癌痛规范化药学服务的指标体系[J]. 药物流行病学杂志, 2021, 30(8): 562-566. [Peng GQ, Liu WH, Tang ZW, et al. Construction of an index system of standardized pharmaceutical care for cancer pain in China: A delphi study[J]. Chinese Journal of Pharmacoepidemiology, 2021, 30(8): 562-566.] DOI: 10.19960/j.cnki.issn1005-0698. 2021.08.013.

20.原国家食品药品监督管理局药品安全监管司, 国家药品不良反应监测中心. 药品不良反应报告和监测工作手册[S]. 2012.

21.薛逸非, 李光耀, 张弨. 临床超说明书用药的分析[J]. 中国临床药理学杂志, 2021, 37(17): 2360-2363. [Xue YF, Li GY, Zhang C, et al. Analysis of clinical off-label drug use[J]. The Chinese Journal of Clinical Pharmacology, 2021, 27(17): 2360-2363.] DOI: 10.13699/j.cnki. 1001-6821.2021.17.028.

22.Zhang YR, Huang ZQ. Efficacy analysis of recombinant human pro-urokinase combined with percutaneous coronary intervention in the treatment of acute ST-segment elevation myocardial infarction[J]. WRSJ, 2021, 7(11): 310-314. DOI: 10.6911/WSRJ.202111_7(11).0045.

23.张镭, 谭玲, 陆进. 超说明书用药专家共识[J]. 药物不良反应杂志, 2015, 17(2): 101-103. [Zhang L, Tan L, Lu J. Expert consensus on off-label drug use[J]. Adverse Drug Reactions Journal,2015, 17(2): 101-103.] DOI: 10.3760/cma.j.issn.1008-5734.2015.02.011.

24.广东省药学会. 医疗机构超药品说明书用药管理专家共识[J]. 中国现代应用药学, 2017, 34(3): 436-438. DOI: 10.13748/j.cnki.issn1007-7693.2017.03.031.

25.田彩霞, 田云霞, 薛伟珍, 等. 重组人尿激酶原联合替罗非班治疗急性ST段抬高型心肌梗死急诊PCI的疗效观察[J]. 中西医结合心脑血管病杂志, 2021, 19(8): 1406-1408. [Tian CX, Tian YX, Xue WZ, et al. Curative effect of recombinant human urokinase combined with Tirofiban in the treatment of acute ST-segment elevation myocardial infarction by emergency PCI[J]. Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease, 2021, 19(8): 1406-1408.] DOI: 10.12101/j.issn.1672-1349.2021.08.042.

26.张帅, 王要鑫, 刘洁云. 重组人尿激酶原联合比伐芦定治疗急性ST段抬高型心肌梗死PCI术中无复流/慢血流的临床疗效[J]. 中西医结合心脑血管病杂志, 2022, 20(4): 763-765. [Zhang S, Wang YX, Liu JY. Clinical efficacy of recombinant human urokinase combined with bivarudine in the treatment of acute ST-segment elevation myocardial infarction without reflow/slow flow after PCI[J]. Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease, 2022, 20(4): 763-765.] DOI: 10.12102/j.issn.1672-1349.2022.04.041.

27.白文楼, 陈涛, 孟存良, 等. 比伐芦定联合重组人尿激酶原对老年急性心肌梗死患者直接PCI术后慢血流/无复流的影响及安全性[J]. 临床心血管病杂志, 2019, 35(7): 595-599. [Bai WL, Chen T, Meng LC, et al. Effect and safety of bivalrudine combined with recombinant human prourokinase on slow/no-refolw after emergency PCI in elderly patients with acute myocardial infarction[J]. Journal of Clinical Cardiology, 2019, 35(7): 595-599.] DOI: 10.13201/j.issn.1001-1439.2019.07.004.

28.曾敬, 张小群, 温春兰, 等. 比伐芦定联合替罗非班用于急性心肌梗死急诊PCI术的疗效及出血风险评估[J]. 中国药业, 2018, 27(17): 40-42. [Zeng J, Zhang XQ, Wen CL, et al. Effect and bleeding risk assessment of bivalirudin combined with tirofiban used in emergency percutaneous coronary intervention for patients with acute myocardial infarction[J]. China Pharmaceuticals, 2018, 27(17): 40-42.] DOI: 10.3969/j.issn.1006-4931.2018.17.011.

29.0n of myocardial markers in patients with acute myocardial infarction and their relationship with prognosis[J]. Chinese Journal of Clinical Pathologist, 2020, 12(2): 95-99.] DOI: 10.3969/j.issn.1674-7151. 2020.02.009.

Popular papers
Last 6 months