Literature Analysis of 63 Cases of Adverse Drug Reactions Induced by Compound Fat-soluble Vitamin for Injection

Abstract

Abstract: Objective To explore the general characteristics of adverse drug reactions (ADRs) induced by compound fat-soluble vitamin for injection in order to provide references for rational and safe clinical drug use. Methods ADR cases induced by compound fat-soluble vitamin for injection reported in SinoMed and CNKI during 2000~Jul. 2017 were collected and analyzed statistically. Results Compound fat-soluble vitamin was used in clinic beyond the approved indications and immediate hypersensitivity occurred, which hurted multiple organs and systems including severe allergic reactions and anaphylactic shock. Conclusion Compound fat-soluble vitamin for injection should not be used with unreasonable indications. Medical staff should pay attention to the ADR induced by compound fat-soluble vitamin for injection. Drug manufacturers should strengthen the post-market monitoring of ADR. The domestic drug package inserts need to be further improved and revised.

Key words: compound fat-soluble vitamin, adverse drug reactions, literature, analysis

CLC Number:

R994.11

CUI Xiao-kang, WU Shi-fu, LI Yu-ji, TIAN Yue-jie, LU Chang-fei, ZHAI Shu-yue. Literature Analysis of 63 Cases of Adverse Drug Reactions Induced by Compound Fat-soluble Vitamin for Injection[J]. Chinese Journal of Pharmacovigilance, 2017, 14(11): 691-696.

References

[1] 田晓云, 徐欣昌, 吴晓阜.维生素类注射剂的严重不良反应[J].海峡药学杂志, 2015, 27(2):237-238.
[2] 易丹. 44例注射用脂溶性维生素不良反应文献分析[J]. 中国药物警戒, 2015, 12(3): 172-174.
[3] 高志强. 注射用脂溶性维生素(Ⅱ)致过敏性休克[J].药物不良反应杂志,2012, 14(1):56-57.
[4] 杨胜芬, 高宝丽, 徐艳春. 脂溶性维生素(I)致严重过敏反应[J].实用医学杂志,2013,29(15)：2432.
[5] 潘飞, 许东. 注射用脂溶性维生素(Ⅱ)过敏反应1例[J].中国药师,2012,15(12):1776-1777.
[6] 赵妍, 康红军, 王彬,等. 药物热的诊断思维(附二例报告)[J]. 临床误诊误治,2014, 27(1)：64-67.
[7] 史惠卿,雍小兰,胡婷婷.万古霉素致药物热的药学监护[J]. 西南军医,2013, 15(6)：643-645.
[8] Young E J, Fainstein V, Musher D M. Drug-induced fever: casesseen in the evaluation of unexplained fever in a general hospitalpopulation[J]. Rev Infect Dis, 1982, 4(1):69-77.
[9] Pleasants R A, Walker T R, Samuelson W M. Allergic reactions toparenteral beta- lactam antibiotics in patients with cystic fibrosis[J]. Chest, 1994, 106(4): 1124-1128.
[10] Johnson D H, Cunha B A. Drug fever[J]. Infect Dis Clin North Am, 1996 ,10(1): 85-91.
[11] 国家食品药品监督管理总局.药品不良反应信息通报（第43期）警惕维生素K1注射液的严重过敏反应[EB/OL]. (2011-11-26)[2017-10-19].http://www.sda.gov.cn/WS01/CL0078/67960.html.
[12] 梁雁, 鲁云兰. 儿童药物不良反应及相关因素[J].儿科药学杂志, 2008, 14 (3):9-11.
[13] 徐瑞琴, 冯喜英, 汪海燕. 患者应用头孢类药物不良反应与其过敏史相关性的调查[J]. 临床医学, 2009, 29(4):119-120.
[14] 张燕荣, 甄健存. 依据《药品不良反应信息通报》探讨避免药品不良反应发生的措施[J].中国医院药学杂志,2015,35(2):156-160.
[15] 周远华, 方海顺, 苏广海. 注射用脂溶性维生素(Ⅰ)与两种常用输液的配伍稳定性考察[J].中国药房, 2013, 16(4):573-576.
[16] 黄社文.注射用脂溶性维生素(Ⅱ)与常用输液配伍的稳定性考察[J].医学信息,2011, 24(3):992-993.
[17] 范静, 李相成, 李飞, 等. 注射用脂溶性维生（Ⅱ）/水溶性维生素与常用电解质配伍的稳定性考察[J]. 中国药房, 2017, 28(11):1478-1481.