注射用益气复脉(冻干)安全性医院集中监测研究
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摘要
目的:分析注射用益气复脉(冻干)临床应用中不良反应(ADR)发生特征和发生率。方法:采用回顾性医院集中监测方法,利用合理用药监测系统对2017年1月-2017年11月使用注射用益气复脉(冻干)的住院患者进行监测。监测内容为患者的一般信息、诊断信息、用药信息、不良反应/事件信息等。结果:2 476例患者中发生ADR 31例,发生率为1. 25%,以全身性损害和皮肤及其附件损害最为常见,主要表现为皮疹、皮肤瘙痒、寒战、高热等;严重ADR 5例,新的ADR 16例; 31例患者中男性14例,女性17例;患者用药1～7 d内发生ADR最多。结论:注射用益气复脉(冻干) ADR发生率属常见,以老年人为主,临床应密切监测其不良反应发生。
OBJECTIVE To analyze the adverse drug reactions( ADRs) characteristic and calculate the ADRs incidence of YiqiFumai Injection( freeze-dried) in clinical application. METHODS All the records of inpatients using Yiqi Fumai Injection( freeze-dried) from January 2017 to November 2017 were retrospectively analyzed by intensive monitoring in the hospital. The main contents ofmonitoring were observed by Prescription Automatic Screening System,including general information,diagnosis,medication,and ad-verse reaction/event of patients. RESULTS Totally 31 cases of ADRs in 2 476 patients were reported,with an incidence of 1. 25%.The most common ADRs happened over whole body,in skin and its appendages. The main presentations of ADRs were rash,skin itch-ing,rigors,hyperpyrexia,etc. Five severe and 16 new ADRs were reported,respectively. There were 14 male patients with ADRs and17 female patients with ADRs. The ADRs generally occurred within a week after onset of therapy. CONCLUSION All the above re-sults show that Yiqi Fumai Injection( freeze-dried) ADRs mainly occurr in elderly patients. The adverse reactions of patients should becarefully monitored.
OBJECTIVE To analyze the adverse drug reactions( ADRs) characteristic and calculate the ADRs incidence of YiqiFumai Injection( freeze-dried) in clinical application. METHODS All the records of inpatients using Yiqi Fumai Injection( freeze-dried) from January 2017 to November 2017 were retrospectively analyzed by intensive monitoring in the hospital. The main contents ofmonitoring were observed by Prescription Automatic Screening System,including general information,diagnosis,medication,and ad-verse reaction/event of patients. RESULTS Totally 31 cases of ADRs in 2 476 patients were reported,with an incidence of 1. 25%.The most common ADRs happened over whole body,in skin and its appendages. The main presentations of ADRs were rash,skin itch-ing,rigors,hyperpyrexia,etc. Five severe and 16 new ADRs were reported,respectively. There were 14 male patients with ADRs and17 female patients with ADRs. The ADRs generally occurred within a week after onset of therapy. CONCLUSION All the above re-sults show that Yiqi Fumai Injection( freeze-dried) ADRs mainly occurr in elderly patients. The adverse reactions of patients should becarefully monitored.
引文
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[9]Wang GQ,Liao X,Xie YM.Core elements of safety monitoring report of medicines(Chinese patent medicines)[J].China J Chin Matet Med(中国中药杂志),2016,41(24):4483-4487.
[10]Yang Y,Zhan SY.Analysis of Necessity and Feasibility in Studies of Post-marketing Drug Safety Active Surveillance Based on Big Data[J].Chin J Pharmacoepid(药物流行病学杂志),2016,25(7):403-404.
[11]Luo H,Liu JP.Application of the Data-capture System that Integrates with Hospital electronic Health Records in Pharmacovigilance[J].Drug Eval(药品评价),2012,9(2):40-43.
[12]Lv F,Ye ZL,Li DK,et al.Compatible stability of Yiqi Fumai lyophilized injection with fructose injection[J].Tianjin J Tradit Chin Med(天津中医药),2013,30(3):175-178.
[2]Liu WS,Wang BH.Clinical research progress of Yiqi Fumai Injection[J].Hunan J Tradit Chin Med(湖南中医杂志),2016,32(1):194-196.
[3]Ma N,Hou YZ,Wang XL,et al.Literature-based study of adverse effects of Yi-Qi-Fu-Mai sterile powder[J].Chin J New Drugs(中国新药杂志),2015,24(10):1197-1120.
[4]Guo JH,Gao WF,Jia SJ.Meta-analysis of adverse reaction induced by Shengmai Injection[J].Pharmacol Clin Chin Mater Med(中药药理与临床),2013,29(6):168-171.
[5]Chian Food and Drug Administration.Precaution severe allergic reactions of Shengmai Injection[R].Notification of adverse drug reactions(药品不良反应信息通报),2012(44).
[6]Jiang JJ,Xie YM.Discussion on establishment of quality control system for intensive hospital monitoring on traditional Chinese medicine injections[J].China J Chin Mater Med(中国中药杂志),2012,37(18):2689-2691.
[7]Li Y,Wu J,Li X,et al.Preliminary Safety Evaluation for Clinical Application of Shengmai Injection[J].Chin Pharm(中国药房),2013,24(16):1504-1507.
[8]Tao LN,Zhang Y,Zhang SX,et al.Centralized Monitoring of Clinical Use and Adverse Reaction of Xueshuantong Injection(Freeze-dried)Post-marketing in the Hospital[J].Chin J Pharmacoepid(药物流行病学杂志),2017,26(4):268-271.
[9]Wang GQ,Liao X,Xie YM.Core elements of safety monitoring report of medicines(Chinese patent medicines)[J].China J Chin Matet Med(中国中药杂志),2016,41(24):4483-4487.
[10]Yang Y,Zhan SY.Analysis of Necessity and Feasibility in Studies of Post-marketing Drug Safety Active Surveillance Based on Big Data[J].Chin J Pharmacoepid(药物流行病学杂志),2016,25(7):403-404.
[11]Luo H,Liu JP.Application of the Data-capture System that Integrates with Hospital electronic Health Records in Pharmacovigilance[J].Drug Eval(药品评价),2012,9(2):40-43.
[12]Lv F,Ye ZL,Li DK,et al.Compatible stability of Yiqi Fumai lyophilized injection with fructose injection[J].Tianjin J Tradit Chin Med(天津中医药),2013,30(3):175-178.