Analysis on 382 Cases of Medication and Drug Adverse Reactions of Protamine Sulfate Injection in a Hospital from 2015 to 2017

Abstract

Abstract: Objective To analyze the rational uses and adverse reactions of protamine sulfate injection in the clinic, and to provide references for rational drug use. Methods We conducted a retrospective review of 382 inpatients with application of protamine sulfate injection from January 2015 to February 2017 in a hospital, which were collected by China Hospital Pharmcovigilance System (CHPS), and analyzed the characters of the adverse drug reaction/event (ADR/ADE). Results There weren't obviously irrational medication orders except one case that the patient was treated with a single dose of 300 mg protamine sulfate. 8 cases of ADR were obtained, and they were mainly hypotension. And 2 cases of severe ADR were anaphylactic shock and myocardium inhibition. A new batch of the protamine sulfate and dose reduction had positive effects on preventing adverse reactions. Conclusion The use of protamine sulfate injection in this hospital was basically rational, and the ADRs were mainly hypotension. In order to assess the risk of medication and promote clinical rational use of drugs, medical staff should strengthen to write treatment details and actively report ADRs.

Key words: protamine sulfate injection, adverse drug reaction, rational use of drug

CLC Number:

R994.11

ZHAN Hai-yan, YANG Jian. Analysis on 382 Cases of Medication and Drug Adverse Reactions of Protamine Sulfate Injection in a Hospital from 2015 to 2017[J]. Chinese Journal of Pharmacovigilance, 2018, 15(1): 41-44.

References

[1] 国家药典委员会. 中华人民共和国药典(二部)2015年版[M]. 北京: 中国医药科技出版社, 2015: 1346-1347.
[2] 国家药典委员会. 临床用药须知化学药和生物制品卷2010年版[M]. 北京: 中国医药科技出版社, 2011: 498-499, 501-504.
[3] 邱立成, 朱金如, 李树军, 等. 鱼精蛋白毒性反应的临床表现与机制[J]. 中华胸心血管外科杂志, 2002, 18(3): 20-22.
[4] 吴红兵, 王志维, 程栋梁, 等. 心内直视手术中鱼精蛋白毒性反应的发生及处理[J].中国胸心血管外科临床杂志, 2007, 14(3): 230-231.
[5] 国家药品不良反应监测中心. 药品不良反应术语使用指南[S]. 监测与评价综[2016]77号.
[6] S.C.斯威曼, 李大魁, 金有豫, 等. 马丁代尔药物大典(原著第37版) [M]. 北京:化学工艺出版社, 2013:1253-1256, 1402.
[7] 国家基本药物临床应用指南和处方集编委会. 国家基本药物处方集(化学药品和生物制品)2012年版[M]. 北京: 人民卫生出版社, 2013: 354-356.
[8] 杨大明. 临床用药速查手册[M]. 南京: 江苏科学技术出版社, 2005: 549.
[9] Horrow J C.Protamine: A Review of its Toxicity[J]. Anesthesia & Analgesia, 1985, 64(3), 348-361.
[10] Mads N, Skov M J.Serious anaphylactic reactions due to protamine sulfate: a systematic literature review[J]. Basic and clinical pharmacology and toxicology, 2008, 103(2): 192-196.
[11] 王祖谦. 鱼精蛋白不良反应及其预防[J]. 国外医学, 麻醉学与复苏分册, 1998, 19(3): 172-174, 192.
[12] 陈青云, 华东, 郑和平. 氯化钙预防鱼精蛋白不良反应临床观察[J]. 罕少疾病杂志, 2013, 20(3): 37-41.
[13] 苏依丹, 汪正平, 陈猛, 等. 体外循环后鱼精蛋白不良反应的预防(附64例报告)[J]. 河北医科大学学报, 2003, 24(1): 19-21.
[14] 刘刚, 郑斯聚. 鱼精蛋白对抗肝素引起的不良反应[J]. 国外医学, 麻醉学与复苏分册, 1986, (1): 44-49.
[15] 中华医学会麻醉学分会. 2014版中国麻醉学指南与专家共识[M]. 北京: 人民卫生出版社,2014: 234-236.
[16] 林仙菊, 杨灵君. 不同途径注射鱼精蛋白不良反应的临床观察[J]. 浙江创伤外科, 2006, 11(6): 551-552.
[17] 卢玉平, 王朝仁, 王凤学. 静脉预注异丙肾上腺素预防鱼精蛋白不良反应的临床观察[J]. 临床麻醉学杂志, 2000, 16(8): 410-411.
[18] 庞宏宣, 林高翔. 预防心脏手术中使用鱼精蛋白不良反应的临床观察[J]. 华夏医学, 2006, 19(6): 1080-1082.
[19] 舒婷, 陈文戈, 侯永芳, 等. 基于HIS的哨点医院药物警戒系统的研究与应用[J]. 中国药房, 2017, 28(25): 3468-3471.