标题：上海金山地区利伐沙班出凝血异常药物不良反应/事件临床分析

      作者：王敏 1，杨雪光 2，徐蓉 3，王欢良 4，何兴美 5，刘茜 6    王敏 1，杨雪光 2，徐蓉 3，王欢良 4，何兴美 5，刘茜 61.上海市金山区亭林医院药剂科，上海 201500；2.上海市金山区朱泾镇卫生服务中心药剂科，上海 201500；3.上海市金山区金卫镇卫生服务中心药剂科，上海 201500；4.上海市金山区亭林镇卫生服务中心药剂科，上海 201500；5.上海市金山区漕泾镇卫生服务中心药剂科，上海 201500；6.上海市金山区市场监督管理局药品化妆品安全监管科，上海 201500

      卷次： 2023年34卷8期

      【摘要】 目的 分析上海金山地区利伐沙班出凝血异常药物不良反应/事件(ADR/E)，为提高临床用药的合理性、安全性提供相关依据。方法 回顾性分析2009年7月至2021年12月上海金山地区上报的63例利伐沙班出凝血异常ADR/E的报告资料，统计分析所有患者的年龄、性别、利伐沙班出凝血异常ADR/E的发生时间、部位、严重程度及治疗转归等临床资料。结果 63例利伐沙班出凝血异常ADR/E患者中，女性占36.51%，男性占63.49%，其中60岁及以上占77.78%；用药后30 d内利伐沙班出凝血异常ADR/E的发生率为79.37%，其中用药后0~7 d内利伐沙班出凝血异常ADR/E的发生率最高，为53.97%；利伐沙班出凝血异常ADR/E的发生部位主要集中在胃肠道出血(44.44%)和脑出血(25.40%)；常见不良事件评价标准(CTCAE) Version 5.0分级结果显示：3级及以上的利伐沙班出凝血异常ADR/E占 38.10%，其中胃肠道出血占 75.00%；临床采用常规治疗方案者占 50.79%，治疗后恢复者占84.13%。结论 临床需高度重视利伐沙班出凝血异常ADR/E，给患者用药过程中加强持续监测，并加强对患者及其家属有关利伐沙班出凝血异常ADR/E的宣传教育，尤其是学会识别胃肠道出血的相关症状，进一步提高临床用药的安全性。
      【关键词】 利伐沙班；出凝血异常；药物不良反应/事件；高龄；胃肠道出血；安全性
      【中图分类号】 R96 【文献标识码】 A 【文章编号】 1003—6350（2023）08—1156—04

Clinical analysis of adverse drug reactions/events of rivaroxaban coagulation abnormalities in Jinshan District ofShanghai.
WANG Min 1, YANG Xue-guang 2, XU Rong 3, WANG Huan-liang 4, HE Xing-mei 5, LIU Qian 6. 1.Departmentof Pharmacy, Shanghai Jinshan District Tinglin Hospital, Shanghai 201500, CHINA; 2.Department of Pharmacy, ShanghaiJinshan District Zhujing Town Health Service Center, Shanghai 201500, CHINA; 3.Department of Pharmacy, ShanghaiJinshan District Jinwei Town Health Service Center, Shanghai 201500, CHINA; 4.Department of Pharmacy, ShanghaiJinshan District Tinglin Town Health Service Center, Shanghai 201500,CHINA; 5.Department of Pharmacy, ShanghaiJinshan Caojing Town Health Service Center, Shanghai 201500, CHINA; 6.Department of Drug and Cosmetic SafetySupervision, Shanghai Jinshan District Market Supervision and Administration Bureau, Shanghai 201500, CHINA
【Abstract】 Objective To analyze the adverse drug reactions/events (ADR/E) of rivaroxaban coagulation ab-normalities in Jinshan District of Shanghai, and to provide relevant basis for improving the rationality and safety ofclinical medication. Methods The data of 63 cases of ADR/E with abnormal coagulation of rivaroxaban reportedfrom July 2009 to December 2021 in Jinshan District of Shanghai were retrospectively analyzed, and the clinical dataof all patients were statistically analyzed, such as age, gender, occurrence time, location, severity and treatment out-come. Results Among the 63 patients with ADR/E of abnormal coagulation with rivaroxaban, there were 36.51%of female, 63.49% of male, of which 77.78% were 60 years old or older. The incidence of ADR/E with abnormal co-agulation of rivaroxaban was 79.37% within 30 days after administration, and the highest incidence of ADR/E withabnormal coagulation of rivaroxaban was 53.97% within 0-7 days after administration. The occurrence sites of ADR/E of abnormal coagulation with rivaroxaban were mainly gastrointestinal hemorrhage (44.44%) and cerebral hemor-rhage (25.40%). The Common Adverse Events Evaluation criteria (CTCAE) Version 5.0 grading results showed thatADR/E of rivaroxaban grade 3 and above was 38.10%, among which gastrointestinal bleeding accounted for 75.00%.Clinically, 50.79% of patients received conventional treatment, and 84.13% of patients recovered after treatment.Conclusion Clinical attention should be paid to ADR/E with abnormal coagulation of rivaroxaban, and continuousmonitoring should be strengthened in the process of medication. Publicity and education of ADR/E with abnormal coagu-lation of rivaroxaban should be also strengthened to patients and their families, especially the recognition of the symp-toms of gastrointestinal bleeding, so as to further improve the safety of clinical medication.
      【Key words】 Rivaroxaban; Abnormal coagulation; Adverse drug reactions/events; Old age; Gastrointestinalbleeding; Safety