9735例舒血宁注射液安全性医院集中监测研究  

Intensive hospital monitoring study on safety of 9735 cases of Shuxuening Injection

作　　者：曲阳 马玄静 李清华 李和林 赵晓晨 孙兴华[1] 张淼 陈宏 QU Yang;MA Xuan-jing;LI Qing-hua;LI He-lin;ZHAO Xiao-chen;SUN Xing-hua;ZHANG Miao;CHEN Hong(Department of Clinical Research,the Second Affiliated Hospital of Heilongjiang Traditional Chinese Medicine University,Harbin 150001,China;Department of General Practice,Taihang Community Health Service Center,High-tech Zone,Shijiazhuang 050000,China;Department of Cardiovascular Medicine,Chengde Longhua Hospital of Traditional Chinese Medicine,Chengde 067000,China;Research Group of Chinese Medicine Injection Safety Reevaluation of China Association of Chinese Materia Medica,Beijing 100101,China;Project Department,Beijing Kangpaixing Pharmaceutical Technology Development Co.,Ltd.,Beijing 100000,China;Institute of Clinical Chinese Medicine,Heilongjiang Academy of Traditional Chinese Medicine(Heilongjiang Provincial Hospital of Traditional Chinese Medicine),Harbin 150036,China)

机构地区：[1]黑龙江中医药大学附属第二医院临床研究部,黑龙江哈尔滨150001 [2]石家庄高新区太行社区卫生服务中心全科医疗科,河北石家庄050000 [3]河北省承德市隆化县中医医院心血管内科,河北承德067000 [4]中国中药协会中药注射剂安全性再评价研究课题组,北京100101 [5]北京康派星医药科技开发有限公司项目部,北京100000 [6]黑龙江省中医药科学院(黑龙江省中医医院)中医临床研究所,黑龙江哈尔滨150036

出　　处：《中草药》2023年第10期3253-3260,共8页Chinese Traditional and Herbal Drugs

基　　金：科技部科技重大专项—示范性新药临床评价技术平台建设(2018ZX09734-002-004);黑龙江中医药大学中药临床疗效与安全性评价工程中心资助项目(2017SEC01)。

摘　　要：目的 通过安全性医院集中监测研究,探索舒血宁注射液在真实世界使用过程中可能存在的不良反应及其影响因素,并发现未知或罕见的不良反应。方法 采用药品安全性医院集中监测方法,观察2016年8月—2020年10月注册登记的39家医疗机构所有使用舒血宁注射液9735例患者,用药期间不良事件/反应发生情况,采用单因素和多因素方法分析舒血宁注射液药物不良反应发生率及其影响因素。结果 9735例患者在使用舒血宁注射液过程中共有256例发生不良事件,不良事件发生率为2.63%,其中23例患者发生的36例次不良反应经三级专家判定与舒血宁注射液有关,舒血宁注射液药物不良反应发生率0.236%,总体不良反应发生率属于偶见范围。所有不良反应均为一般不良反应,无严重不良反应及非预期不良反应发生。36例次不良反应按照系统分类依次为全身性疾病及给药部位各种反应8例次、胃肠系统损伤7例次、各类神经系统损害6例次、心血管系统疾病6例次、皮肤及皮下组织类疾病5例次,咳嗽、咳痰、肢体疼痛、静脉炎各1例次。单因素及多因素Logistic回归分析,用药3~5 d和6 d及以上发生不良反应的风险分别较用药3 d以下降低86%、99.6%;合并高同型半胱氨酸血症、首次使用舒血宁注射液、用药时长、单次注射持续时间及合并使用川芎嗪类、氨茶碱类注射液对不良反应发生的影响均有统计学意义(P<0.05),提示为危险因素。结论 舒血宁注射液在临床使用中不良反应发生率低,安全性良好,并提示合并高同型半胱氨酸血症、首次使用舒血宁注射液、用药时长、单次注射持续时间及合并使用川芎嗪类、氨茶碱类注射剂时应特别注意安全风险。Objective To explore the possible adverse reactions and influencing factors of Shuxuening Injection(舒血宁注射液)in the real world,and to find unknown or rare adverse reactions through safety hospital centralized monitoring study.Methods From August 2016 to October 2020,9735 patients who used Shuxuening Injection in 39 medical institutions were registered by hospital centralized monitoring method of drug safety.Adverse events/reactions during medication were observed and recorded.Univariate and multivariate methods were used to analyze the incidence and influencing factors of adverse drug reactions in Shuxuening Injection.Results A total of 256 adverse events occurred in 9735 patients during the use of Shuxuening Injection,and the incidence of adverse events was 2.63%.Among them,36 adverse events occurred in 23 patients were judged to be related to Shuxuening Injection by thirdlevel experts,and the incidence of adverse drug reactions of Shuxuening Injection was 0.236%.The overall incidence of adverse reactions was in the occasional range.All ADRs were general adverse reactions,and no serious adverse reactions and unexpected adverse reactions occurred.According to the systematic analysis,the 36 adverse reactions were systemic diseases and various reactions at the administration site(eight cases),gastrointestinal system injury(seven cases),nervous system damage(six cases),cardiovascular system diseases(six cases),skin and subcutaneous tissue diseases(five cases),cough,expectoration,limb pain,and phlebitis(one case each).Univariate and multivariate logistic regression analysis showed that the risk of adverse reactions for 3—5 d and more than 6 d were reduced by 86%and 99.6%,respectively,compared with those for less than 3 d.The effects of combined hyperhomocysteinemia,first use of Shuxuening Injection,duration of medication,duration of single injection,combined use of Ligustrazine and Aminophylline injections on the occurrence of adverse reactions were statistically significant(P<0.05),suggesting that they w

关 键 词：舒血宁注射液 中药注射剂 医院集中监测 不良反应 安全风险 

分 类 号：R285.64[医药卫生—中药学]