Objective To establish the detailed rules for the drug use evaluation (DUE) of prothrombin complex concentrate (PCC) , and evaluate the use of PCC by weighted TOPSIS method to provide references for its clinical rational application.
Methods Based on the instructions of PCC and referring to relevant data, the DUE standard rules were established, and weighted TOPSIS method was used to evaluate the rationality of medication in the cases of in patients who used PCC from January 2021 to December 2021 in the Affiliated Hospital of Xuzhou Medical University.
Results A total of 121 cases were included, the relative weights of the three indicators were as follows: coagulation function, dosage, interval, course of treatment and, diagnosis, progress notes drug interaction, with the weights of 0.095 2, 0.091 3, 0.091 3, 0.091 3, 0.089 7, 0.084 1 and 0.081 7 respectively. There were 21 cases (17.36%) with reasonable medical records, 39 cases (32.23%) with basically reasonable medical records, and 61 cases (50.41%) with unreasonable medical records. The main unreasonable problems were manifested in indications, usage and dosage, and drug interaction.
Conclusion The DUE criteria of PCC established is more scientific, practical and feasible. The indications, usage, dosage, and drug interaction of PCC remain unreasonable criteria, and pharmaceutical intervention should be carried out to promote its rational use.
1.Hayes K, Fernando MC, Jordan V. Prothrombin complex concentrate in cardiac surgery for the treatment of coagulopathic bleeding[J]. Cochrane Database Syst Rev, 2022, 11(11): CD013551. DOI: 10.1002/14651858.CD013551.pub2.
2.Tanaka KA, Szlam F. Treatment of massive bleeding with prothrombin complex concentrate: argument for[J]. J Thromb Haemost, 2010, 8(12): 2589-2591. DOI: 10.1111/j.1538-7836.2010.04052.x.
3.Scharman CD, Shatzel JJ, Kim E, et al. Off-label use of 4-factor prothrombin complex concentrate is common despite[J]. Eur J Haematol, 2018, 101(3): 349-353. DOI: 10.1111/ejh.13105.
4.何冬黎, 李倩, 吕漫, 等. 达比加群酯药物利用评价标准的建立与回顾性分析[J]. 中国医院药学杂志, 2022, 42(11): 1142-1146. [He DL, Li Q, Lv M, et al. Estabelishment and retrospective analysis of the evaluation criterial for drug utilization of dabigatran[J]. China Journal of Hospital Pharmacy, 2022, 42(11) : 1142-1146.] DOI: 10.13286/j.1001-5213.2022.11.11.
5.陈琪峰. 加权TOPSIS法在医院医疗质量评价中的应用 [J]. 中医药管理杂志, 2020, 28(23): 168-169. [Chen QF. Estabelishment and retrospective analysis of the evaluation criterial for drug utilization of dabigatran[J]. Journal of Traditional Chinese Medicine Management, 2020, 28(23): 168-169.] DOI: 10.16690/j.cnki.1007- 9203.2020.23.082.
6.孙博, 刘勋, 张二锋, 等. 基于加权TOPSIS法的亚胺培南西司他丁药物利用评价[J]. 药物流行病学杂志, 2021, 30(12): 827-832. [Sun B, liu X, Zhang EF, et al. Evaluation of drug use evaluation of imipenem and cilastatin based on weighted TOPSIS method[J]. Chinese Journal of Pharmacoepidemiology, 2021, 30(12): 827-832.] DOI: 10.19960/j.cnki.issn1005-0698.2021.12.008.
7.中国心胸血管麻醉学会血液管理分会. 心血管手术患者血液管理专家共识[J]. 中国输血杂志, 2018, 31(4): 321-325. DOI: 10.13303/j.cjbt.issn.1004-549x.2018.04.001.
8.中华医学会血液学分会血栓与止血学组, 中国血友病协作组. 获得性血友病A诊断与治疗中国指南(2021年版)[J]. 中华血液学杂志, 2021, 42(10): 793-799. DOI: 10.3760/cma.j.issn.0253-2727.2021.10.001.
9.Erdoes G, Koster A, Ortmann E, et al. A European consensus statement on the use of four-factor prothrombin complex concentrate for cardiac and non-cardiac surgical patients[J]. Anaesthesia, 2021, 76(3): 381-392. DOI: 10.1111/anae.15181.
10.Tomaselli GF, Mahaffey KW, Cuker A, et al. 2020 ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants[J]. J Am Coll Cardiol, 2020, 76(5): 594-622. DOI: 10.1016/j.jacc.2020.04.053.
11.中华医学会神经外科学分会, 中国医师协会急诊医师分会, 国家卫生健康委员会脑卒中筛查与防治工程委员会, 等. 出凝血功能障碍相关性脑出血中国多学科诊治指南[J]. 中国急救医学, 2021, 41(8): 14. DOI: 10.3969/j.issn.1002-1949.2021.08.002.
12.焦瑞, 侯晓彤. 凝血酶原复合物在心脏外科术后出血中的应用[J]. 心肺血管病杂志, 2017, 36(6): 500-502. [Jiao R, Hou XT. Application of prothrombin complex in postoperative bleeding of cardiac surgery[J]. Journal of Cardiovascular & Pulmonary Diseases, 2017, 36(6): 500-502.] DOI: 10.3969/j.issn.1007-5062.2017.06.020.
13.刘琳琳, 纪宏文. 凝血酶原复合物在心血管手术围术期的应用[J]. 北京医学, 2018, 40(6): 565-567. [Liu LL, Ji HW. The application of prothrombin complex in the perioperative period of cardiovascular surgery[J]. Beijing Medical Journal, 2018, 40(6): 565-567.] DOI: 10.15932/j.0253-9713.2018.06.024.
14.邢蓉, 朱裕林, 宋佳伟, 等. 基于加权TOPSIS法的美罗培南药物利用评价[J]. 中国新药与临床杂志, 2013, 32(5): 389-393. [Xing R, Zhu YL, Song W, et al. Evaluation on meropenem using based on weighted TOPSIS method[J]. Chinese Journal of New Drugs and Clinical Remedies, 2013, 32(5): 389-393.] https://kns.cnki.net/kcms2/article/abstract?v=3uoqIhG8C44YLTlOAiTRKgchrJ08w1e7xAZywCwkEEIQxZyWVZVupRTcOryc1jOXuqcceZP5tUdtH2h9BGTn8GOlp7dWYga2&uniplatform=NZKPT.
15.王桂凤, 李雪芹, 刘锐锋, 等. 基于加权TOPSIS法的利奈唑胺葡萄糖注射液药物利用评价[J]. 中国医院药学杂志, 2021, 41(23): 2464-2468. [Wang GF, Li XQ, Liu RF, et al. Evaluation of Drug Use of Linezolidinjection based on weighted TOPSIS method[J]. China Journal of Hospital Pharmacy, 2021, 41(23): 2464-2468.] DOI: 10.13286/j.1001-5213.2021.23.14.
16.杨万枝, 胡章海, 解雪峰, 等. 基于加权TOPSIS法的急性胰腺炎患者抗菌药物应用合理性评价 [J]. 中国医院用药评价与分析, 2021, 21(7): 853-857. [Yang WZ, Hu ZH, Xie XF, et al. Evaluation on Application Rationality of Antibiotics in Patients with Acute Pancreatitis Based on Weighted TOPSIS Method[J]. Evaluation and Analysis of Drug-Use in Hospitals of China, 2021, 21(7): 853-857.] DOI: 10.14009/j.issn.1672-2124.2021.07.018.
17.Pei L, Sun C, Lyu H, et al. Efficacy of prothrombin complex concentrate (PCC) versus fresh frozen plasma[J]. BMJ Open, 2022, 12(2): e051072. DOI: 10.1136/bmjopen-2021-051072.
18.Cho BC, Jung YH, DeMario VM, et al. On-label compared to off-label four-factor prothrombin complex concentrate use: a retrospective, observational study[J]. Transfusion, 2019, 59(8): 2678-2684. DOI: 10.1111/trf.15355.
19.Godier A, Susen S, Samama CM. Treatment of massive bleeding with prothrombin complex concentrate: argument against[J]. J Thromb Haemost, 2010, 8(12): 2592-2595. DOI: 10.1111/j.1538-7836.2010.04062.x.
20.Adkins BD, Shaim H, Abid A, et al. Four-factor prothrombin complex concentrate use for on-label versus off-label indications: a retrospective cohort study[J]. J Thromb Thrombolysis, 2023, 55(1): 74-82. DOI: 10.1007/s11239-022-02671-z.
21.Ferraris VA, Hochstetler M, Martin JT, et al. Blood transfusion and adverse surgical outcomes: The good and the bad[J]. Surgery, 2015, 158(3): 608-617. DOI: 10.1016/j.surg. 2015. 02. 027.
22.Cappabianca G, Mariscalco G, Biancari F, et al. Safety and efficacy of prothrombin complex concentrate as first-line treatment in bleeding after cardiac surgery. Crit Care[J]. Crit Care, 2016, 20: 5. DOI: 10.1186/s13054-015-1172-6.
23.Arnékian V, Camous J, Fattal S, et al. Use of prothrombin complex concentrate for excessive bleeding after cardiac[J]. Interact Cardiovasc Thorac Surg, 2012, 15(3): 382-389. DOI: 10.1093/icvts/ivs224.
24.Tibi P, McClure RS, Huang J, et al. STS/SCA/AmSECT/SABM Update to the Clinical Practice Guidelines on Patient Blood[J]. Ann Thorac Surg, 2021, 112(3): 981-1004. DOI: 10.1016/j.athoracsur.2021.03.033.
25.Spahn DR, Bouillon B, Cerny V, et al. The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition[J]. Crit Care, 2019, 23(1): 98. DOI: 10.1186/s13054-019-2347-3.
26.Marcos-Jubilar M, García Erce JA, Martínez-Calle N, et al. Safety and effectiveness of a prothrombin complex concentrate in approved and off-label indications[J]. Transfus Med, 2019, 29(4): 268-274. DOI: 10.1111/tme.12621.
27.Ansell J, Hirsh J, Hylek E, et al. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th edition)[J]. Chest, 2008, 133(6 Suppl): 160S-198S. DOI: 10.1378/chest.08-0670.
28.Dentali F, Marchesi C, Giorgi Pierfranceschi M, et al. Safety of prothrombin complex concentrates for rapid anticoagulation reversal of vitamin K antagonists. A meta-analysis[J]. Thromb Haemost, 2011, 106(3): 429-438. DOI: 10.1160/TH11-01-0052.
29.Bhatt HV, Subramaniam K. PRO: Prothrombin complex concentrate should be used in preference to fresh frozen plasma for hemostasis in cardiac surgical patients[J]. J Cardiothorac Vasc Anesth, 2018, 32(2): 1062-1067. DOI: 10.1053/j.jvca.2017.05.044.