Li Xuelin, Tang Jinfa, Meng Fei, Li Chunxiao, Xie Yanming
The First Affiliated Hospital of Henan College of Pharmacy, Zhengzhou 450000, China.
Zhongguo Zhong Yao Za Zhi. 2011 Oct;36(20):2786-8.
To study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection.
Set down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis.
Study the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions.
The central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.
采用集中监测法、病历回顾法、文献研究法和自发报告法四种方法研究丹红注射液的不良反应，比较四种方法的差异，探索适合开展中药注射剂上市后安全性评价的方法。
制定集中监测法、病历回顾法、文献研究法四种方法的不良反应调查问卷，收集一定时期内的不良反应信息。采用自发报告法收集河南省自发报告系统中的丹红注射液不良反应信息。进行数据汇总和描述性分析。
采用集中监测法、病历回顾法、文献研究法和自发报告法四种方法研究丹红注射液的不良反应，不良事件发生率分别为0.993%、0.336%、0.515%、0.067%。发绀、心律失常、低血压、出汗、红斑、出血性皮炎、皮疹、烦躁、牙龈出血、牙痛、耳鸣、哮喘、转氨酶升高、便秘、疼痛等为新发现的不良反应。
集中监测法是开展中药注射剂上市后安全性评价的适宜方法，能客观反映临床使用的真实情况。
