阿加曲班注射液治疗急性缺血性脑卒中致消化道出血的不良反应分析

doi:10.19803/j.1672-8629.20240435

摘要/Abstract

摘要： 目的探讨阿加曲班治疗急性缺血性脑卒中（AIS）致消化道出血的不良反应、药师干预结果并文献研究。方法临床药师对北京某三甲医院神经内科2020年1月1日至2023年12月31日使用阿加曲班治疗AIS,出现消化道出血的患者进行药学服务,并分析出血原因、治疗过程、不良反应转归。同时检索中国知网、万方数据、维普网和PubMed阿加曲班治疗AIS的相关文献,分析其安全性。结果使用阿加曲班注射液的AIS及短暂性脑缺血发作（TIA）患者共196例,引起的消化道出血情况15 例（7.65％）;出血严重程度：13例仅为潜血阳性,对原患疾病影响不明显,2例为活动性出血,延长了住院时间。经药师干预,给予停药及质子泵抑制剂（PPIs）等治疗后情况均好转,对原患疾病进程影响不明显。检索得到的7篇有关阿加曲班治疗AIS安全性的文献,总计纳入1 070例患者。其中6篇文献显示,阿加曲班组消化道出血1例,发生率0.45%,对照组消化道出血3例,发生率1.36%;1篇将消化道出血列在其他出血事件中,数据统计后并没有增加其他出血事件的概率。结论应用阿加曲班治疗AIS可能引起消化道出血的不良反应,但一般出血量较少,预后良好,对AIS治疗影响较小;既往研究也表明,阿加曲班不会增加患者消化道出血的风险。

关键词: 急性缺血性脑卒中, 阿加曲班, 注射液, 消化道出血, 凝血酶抑制剂, 质子泵抑制剂, 安全性, 药品不良反应

Abstract: Objective To investigate the adverse reactions of argatroban in the treatment of acute ischemic stroke (AIS) leading to gastrointestinal bleeding and the results of pharmacist interventions. Methods Clinical pharmacists provided pharmaceutical care for patients with gastrointestinal bleeding who had used argatroban for AIS treatment between 2020 and 2023. The causes of bleeding, courses of treatment, and outcomes of adverse drug reaction (ADR) were analyzed. CNKI, Wanfang, VIP and PubMed were searched for related literature on treatment of AIS with argatroban before the safety of this drug was analyzed. Results There were a total of 196 patients with AIS and transient ischemic attack (TIA) who had used argatroban injections. Gastrointestinal bleeding caused by argatroban was observed in 15 cases (an incidence rate 7.65 %). Thirteen patients were only positive for occult blood, which had no significant effect on the primary disease, and two patients had active bleeding that prolonged hospitalization. After pharmacist interventions, such as drug withdrawal and the use of proton pump inhibitors (PPIs), the conditions were improved, and the progression of the primary disease was not obviously affected. Seven articles about the safety of argatroban therapy for AIS were retrieved, with a total of 1070 patients enrolled. Six articles showed that one patient had gastrointestinal bleeding in the argatroban group (an incidence rate 0.45%) while 3 had gastrointestinal bleeding in the control group (an incidence rate 1.36%). One article categorized gastrointestinal bleeding as other bleeding events, and the data showed no increase in the rate of other bleeding events. Conclusion The treatment of AIS with argatroban may cause gastrointestinal bleeding that is usually minimal, with a good prognosis, and has little effect on AIS treatment. Previous studies have also suggested that argatroban does not increase the risk of gastrointestinal bleeding in patients.

Key words: Acute Ischemic Stroke, Agatroban, Injection, Gastrointestinal Bleeding, Thrombin Inhibitor, Proton Pump Inhibitor, Safety, Adverse Drug Reactions

中图分类号:

R972
R994.11

赵秋月, 卫红涛, 李丹丹, 闫安, 邸宣. 阿加曲班注射液治疗急性缺血性脑卒中致消化道出血的不良反应分析[J]. 中国药物警戒, 2025, 22(1): 88-92.

ZHAO Qiuyue, WEI Hongtao, LI Dandan, YAN An, DI Xuan. Adverse Reactions of Argatroban in the Treatment of Ischemic Stroke Leading to Gastrointestinal Bleeding[J]. Chinese Journal of Pharmacovigilance, 2025, 22(1): 88-92.

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https://zgywjj.magtechjournal.com/CN/Y2025/V22/I1/88

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