复方脑肽节苷脂注射液30000例上市后临床安全性医院集中监测分析  

Centralized hospital monitoring analysis of clinical safety of 30000 cases of Compound Cerebropeptide Ganglioside Injection after the market

作　　者：苍爱军[1] 王雨[1] 谭安军 陈霞[3] 丁玲 韩冠英 范广俊[6] 孙玲 杭桂华 杨康 徐圣秋 朱丹 张瑞萍 王延虹[13] 张彦忠[14] 卢守四 CANG Aijun;WANG Yu;TAN Anjun;CHEN Xia;DING Ling;HAN Guanying;FAN Guangjun;SUN Ling;HANG Guihua;YANG Kang;XU Shengqiu;ZHU Dan;ZHANG Ruiping;WANG Yanhong;ZHANG Yanzhong;LU Shousi(Pharmacy Department of Liaoning Provincial People's Hospital,Liaoning Shenyang 110016,China;Pharmacy Department of Yongchuan District Traditional Chinese Medicine Hospital,Chongqing 402160,China;Pharmacy Department of Fuling Central Hospital,Chongqing 408099,China;Pharmacy Department of Jiangjin District Central Hospital,Chongqing 402260,China;Pharmacy Department of First Affiliated Hospital of Jinzhou Medical College,Liaoning Jinzhou 121012,China;Pharmacy Department of Second Affiliated Hospital of Dalian Medical University,Liaoning Dalian 116023,China;Municipal Dongfang,Lianyungang City Hospital Pharmacy Department,Jiangsu Lianyungang 222042,China;Pharmacy Department of Taizhou Second Hospital,Jiangsu Taizhou 225309,China;Pharmacy Department of Wuxi Eighth People's Hospital,Jiangsu Wuxi 214011,China;Pharmacy Department of Xuzhou First People's Hospital,Jiangsu Xuzhou 221002,China;Pharmacy Department of Qiqihar Traditional Chinese Medicine Hospital,Heilongjiang Qiqihar 161099,China;Pharmacy Department of Luoyang First People's Hospital,Henan Luoyang 471002,China;Department of Pharmacy,Fifth Affiliated Hospital of Zhengzhou University,Henan Zhengzhou 450052,China;Pharmacy Office of The Third Affiliated Hospital of Xinxiang Medical College,Henan Xinxiang 453003,China;Pharmacy Department of Beijing Boai Hospital,Beijing 100068,China)

机构地区：[1]辽宁省人民医院药学部,沈阳110016 [2]重庆市永川区中医院药学部,重庆402160 [3]重庆市涪陵中心医院药学部,重庆408099 [4]重庆市江津区中心医院药学部,重庆402260 [5]锦州医学院附属第一医院药学部,辽宁锦州121012 [6]大连医科大学第二附属医院药剂科,辽宁大连116023 [7]连云港市市立东方医院药学部,江苏连云港222042 [8]泰州第二医院药剂部,江苏泰州225309 [9]无锡市第八人民医院药剂科,江苏无锡214011 [10]徐州市第一人民医院药学部,江苏徐州221002 [11]齐齐哈尔市中医医院药学部,黑龙江齐齐哈尔161099 [12]洛阳市第一人民医院药剂科,河南洛阳471002 [13]郑州大学第五附属医院药学部,河南郑州450052 [14]新乡医学院第三附属医院药学办公室,河南新乡453003 [15]北京博爱医院药剂科,北京100068

出　　处：《中国医院药学杂志》2023年第15期1705-1709,共5页Chinese Journal of Hospital Pharmacy

摘　　要：目的:监测分析复方脑肽节苷脂注射液上市后应用于30000例患者的临床安全性。方法:采用前瞻性、非对照的临床研究设计方法,选取2020年4月至2021年4月全国不同区域的46家二级甲等以上医院中至少接受1次复方脑肽节苷脂注射液治疗的30000例患者作为监测对象,通过监测其临床基本资料、用药信息以及药物不良反应等评价复方脑肽节苷脂注射液的安全性。结果:30000例复方脑肽节苷脂注射液治疗期间不良事件发生率为8.85%(2655/30000),其中105例(0.35%)不良事件经研究判断为药物不良反应,其中轻度79例(0.263%)、中度26例(0.087%),未见重度不良反应。不同疾病患者药物不良反应发生率分别为:老年性痴呆患者1.250%、创伤性周围神经损伤患者0.906%、其他诊断患者0.360%、缺血性脑卒中患者0.333%、出血性脑卒中患者0.307%、颅脑损伤患者0.266%、脊髓损伤患者0.198%。药物不良反应类型主要集中在胃肠系统疾病、皮肤及皮下组织类疾病,分别为36、24例。不同医院等级、有无其他药物食物过敏史、是否首次使用、是否存在不合理用药的患者药物不良反应发生率比较差异有统计学意义(P<0.05)。接受复方脑肽节苷脂注射液治疗的患者4.29%痊愈、81.59%好转、13.84%无明显变化、0.27%病情加重、0.02%死亡;治疗期间发生药物不良反应的105例患者75.24%好转、24.76%病情无明显变化。结论:复方脑肽节苷脂注射液整体不良反应发生率较低,且不良反应症状均为已知或注射剂常见不良反应,不良反应发生率可能与不合理用药等因素有关。临床应加强用药管理,以提高用药安全性。OBJECTIVE To monitor and analyze the clinical safety of Compound Cerebropeptide Ganglioside Injection in 30000 patients after the market.METHODS A prospective,and uncontrolled clinical study design method was used to select patients who received at least one Compound Cerebropeptide Ganglioside Injection at 46 hospitals in different regions of the country from May 2020 to May 2021 as monitoring objects,and the safety of Compound Cerebropeptide Ganglioside Injection was re-evaluated by monitoring their basic clinical data,drug information and adverse drug reactions.RESULTS The incidence of adverse events in 30000 cases of Compound Cerebropeptide Ganglioside Injection during treatment was 8.85%(2655/30000),of which 105 cases(0.35%)of adverse events were judged to be adverse drug reactions by the study.Seventy-nine cases(0.263%)had mild adverse drug reactions,26 cases(0.087%)had moderate adverse drug reactions,and no severe adverse reactions were found.The incidence of adverse drug reactions in patients with different diseases were 1.250% in patients with senile dementia,0.906% in patients with traumatic peripheral nerve injury,0.360% in patients with other diagnoses,0.333% in patients with ischemic stroke,0.307% in patients with hemorrhagic stroke,0.266% in patients with craniocerebral injury,and 0.198% in patients with spinal cord injury.Adverse drug reactions were mainly concentrated in gastrointestinal system diseases,skin and subcutaneous tissue diseases,with 36 cases and 24 cases respectively.There were statistically significant differences(P<0.05)in the incidence of adverse drug reactions among patients with different hospital grades,with or without a history of allergy to other drugs,whether it was used for the first time and whether there was irrational drug use.4.29% of patients who received Compound Cerebropeptide Ganglioside Injection were cured,81.59% improved,13.84% had no significant changes,0.27% had worsened conditions,and 0.02% died.75.24% of the 105 patients with adverse drug reactions during treat

关 键 词：复方脑肽节苷脂注射液 缺血性脑卒中 上市后安全性再评价 

分 类 号：R971[医药卫生—药品]