Ninety-seven cases of adverse drug reaction caused by urinary kininogenase for injection

doi:10.19803/j.1672-8629.20240064

Abstract

Abstract: Objective To analyze the characteristics and patterns of adverse drug reaction (ADR) caused by urinary kininogenase for injection so as to provide reference for rational use of this drug. Methods A total of 97 cases of ADR related to urinary kininogenase for injection reported between 2020 and 2023 were collected. The basic data, types of ADR, clinical manifestations, involved systems-organs, and rationality of medication were analyzed. Results Among the 97 cases of ADR related to urinary kininogenase for injection, male patients outnumbered female ones (64 cases, 65.98%). The course of treatment ranged from one day to thirteen days. There were 85 patients treated with antihypertensive drugs or other cerebral infarction drugs. Most of these ADR occurred within 24 hours of the first use of drugs, and involved the cardiovascular, neurological/psychiatric, and digestive systems, with such clinical manifestations as decreased blood pressure, sweating, nausea and vomiting, most of them improved after drug withdrawal or symptomatic treatment. There were 29 cases of new ADR, 2 cases of severe ADR, and 1 case of new and severe ADR. In total, there were 14 cases of irrational medication. Conclusion There is the need to improve the ADR monitoring of urinany kininogenase for injection to ensure the safety of medications.

Key words: urinary kininogenase, injection, adverse drug reaction, safety, cardiovascular, neurological, digestive systems

CLC Number:

CHEN Chunyan, TANG Yingjie, ZHAO Haixia, PAN Huimin, ZHU Qingmei. Ninety-seven cases of adverse drug reaction caused by urinary kininogenase for injection[J]. Chinese Journal of Pharmacovigilance, 2024, 21(10): 1143-1147.

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References

[1] WANG YJ, LI ZX, GU HQ, et al.China Stroke Report 2020[J]. Chin J Stroke(中国卒中杂志), 2022, 17(5): 433-447.
[2] Emergency Medicine Branch of the Chinese Medical Association, Chinese Emergency Medicine Expert Consensus Group on Assessment and Intervention of Collateral Circulation in Acute Ischemic Stroke. Assessment and intervention of collateral circulation in acute ischemic stroke Chinese Emergency Medicine Experts' Consensus[J]. Chin J Emerg Med(中华急诊医学杂志), 2022, 31(10): 1310-1318.
[3] Chinese Medical Association.Guideline for primary care of ischemic stroke: practice version(2021)[J]. Chin J Gen Pract(中华全科医师杂志), 2021, 20(9): 947-958.
[4] The Cerebrovascular Disease Group of the Neurologist Branch of the Chinese Medical Doctor Association. Chinese expert consensus on clinical evaluation and treatment of ischemic penumbra in acute cerebral infarction[J]. Chin J Nerv Ment Dis(中国神经精神疾病杂志), 2021, 47(6): 324-335.
[5] XUE HY, YU ZY, LI J.Decipherment and consideration of 2019 edition of medicine list for national basic medical insuranc, employment injury insurance and maternity insurance[J]. Herald of Medicine(医药导报), 2020, 39(1): 1-9.
[6] CHAI DY, XU CY, KAN YF, et al.Literature analysis of adverse drug reactions caused by urinary kininogenase and clinical application monitoring process[J]. Henan Medicine Research(河南医学研究), 2023, 32(12): 2140-2144.
[7] National Health Commission. Measures for the administration of reporting and monitoring adverse drug reactions[EB/OL]. (2011-05-04)[2022-07-28]. http://www.nhc.gov. cn/wjw/bmgz/201105/b442a66fc52b4793a57160002ac2a1a9.shtml.
[8] GAO SY.China Health Statistics Yearbook of 2022(2022中国卫生健康统计年鉴)[M]. Beijing: China Union Medical University Publishing House, 2022: 283-303.
[9] CAMPBELL DJ.The kallikrein-kinin system in humans[J]. Clin Exp Pharmacol Physiol, 2001, 28(12): 1060-1065.
[10] ZHANG L, ZHU WY, SU KR.Evaluation of the effects of urinary kininogenase and ACEI on blood pressure[J]. International Medicine and Health Guidance News(国际医药卫生导报), 2019, 5(4): 4044-4047.
[11] FEI KX.Effects of edaravone and urinary kallidinogenase on nerve and cognitive function in patients with acute cerebral infarction[J]. Chinese Journal of Drug Abuse Prevention and Treatment(中国药物滥用防治杂志), 2023, 29(4): 661-663.
[12] HUANG YY, PENG RQ, ZHANG YY, et al.Clinical efficacy and safety of Edaravone right camphor combined with urinary kallindinogenase in the treatment of acute cerebral infarction[J]. Chin J of Clinical Rational Drug Use(临床合理用药), 2023, 16(18): 52-55.
[13] MA ZL, WANG F, LIU Y, et al.Meta-analysis of the efficacy and safety of Butylphthalide combined with urinary kallindinogenase in the treatment of acute cerebral infarction[J]. China Medical Herald(中国医药导报), 2023, 20(8): 74-78.
[14] WANG QL, LI Z, MA ZL, et al.Meta-analysis of the efficacy and safety of argatroban combined with urinary kallidinogenase in the treatment of acute cerebral infarction[J]. China Medical Herald(中国医药导报), 2023, 20(11): 71-75.
[15] CUI L, DING N, TIAN L, et al.The clinical efficacy of ginkgo biloba diterpenoid lactone glucosamine combined with urinary kallidinogenase in the treatment of acute cerebral infarction[J]. J Math Med(数理医药学杂志), 2023, 36(6): 440-445.
[16] YANG YP, GUO G, ZHANG LL.Effects of salvia ligustrazine combined with urinary kallindinogenase on cerebral hemodynamics and TLR4/NF-κB signal pathway level in elderly patients with acute ischemic stroke[J]. Hainan Med J(海南医学), 2021, 32(1): 26-30.
[17] NI J, YAO M, WANG LH.The effect of treatment duration with human urinary kallidinogenase on the efficacy and safety of acute ischemic stroke: a subgroup analysis of RESK study[J]. Chin J Neurol(中华神经科杂志), 2024, 57(3): 225-232.
[18] YIN H, LI R, ZHANG EC, et al.Analysis of anaphylactic shock in a patient with acute cerebral infarction caused by urinary kallidinogenase for injection[J]. Chin J Lab Diagn(中国实验诊断学), 2022, 26(3): 431-433.
[19] HEI MW.One case of paresthesia with anaphylactic shock induced by urinary kallidinogenase for injection[J]. Chinese Journal of Drug Application and Monitoring(中国药物应用与监测), 2021, 18(1): 67-69.
[20] NI J, YAO M, WANG LH, et al.Human urinary kallidinogenase in acute ischemic stroke: a single-arm, multicenter, phase IV study (RESK study)[J]. CNS Neuroscience and Therapeutics, 2021, 27(12): 1493-1503.