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目的:探索穿琥宁注射剂不良反应发生的流行病学特点。方法:通过系统检索1979~2015年文献,采集穿琥宁注射剂不良反应详细个案报告,在此基础上应用Microsoft Access构建数据库,进而以Clementine 12.0为数据挖掘平台,应用关联规则Apriori算法开展数据挖掘研究。结果:共纳入穿琥宁注射剂所致不良反应案例183例,其临床表现大致有8类,有过敏性休克58例,血液系统损害46例,皮肤损害35例,呼吸系统损害16例;其中有60例存在联合用药情况;46例不良反应发生在给药开始后5 min之内。置信度最高的关联规则是在“ADR发生时间段=0~5min and配液用量=250ml and配液浓度=5%”的情况下,88.24%的案例“不良反应临床表现=过敏性休克”;支持度最高的关联规则是“年龄段=20~29岁and配液浓度=5%”与“不良反应临床表现=过敏性休克”同时出现的案例占纳入ADR案例的12.57%。结论:穿琥宁注射剂不良反应的特点与不良反应发生时间、联合用药情况、配液种类、患者年龄等因素相关,尚需更大样本量的数据分析验证。
Objective: To explore the epidemiological characteristics of adverse reactions of Chuanhuning injection. Methods: Through systematically searching the literature from 1979 to 2015, we collected the detailed case reports of the adverse reactions of Chuanhuning injection. Based on this, the database was constructed by using Microsoft Access, and then the data mining research was carried out using the Apriori algorithm of association rules based on Clementine 12.0. Results: A total of 183 cases of adverse reactions caused by Chuanhuning injection were included. There were 8 clinical manifestations, including 58 cases of anaphylactic shock, 46 cases of hematological system damage, 35 cases of skin damage and 16 cases of respiratory system damage. Among them, 60 cases There was a combination of medication; 46 cases of adverse reactions occurred within 5 minutes after the start of administration. The association rule with the highest degree of confidence was 88.24% of the cases with ADR occurrence time = 0 ~ 5min and dosing volume = 250ml and dosing concentration = 5% “Clinical manifestations of adverse reactions = Allergic Shock ”; the most supportive association rules are “ age range = 20-29 years old and dosing concentration = 5% ”and “ adverse reactions clinical manifestations = anaphylactic shock ”the case of simultaneous account for the inclusion of ADR cases Of 12.57%. Conclusion: The characteristics of adverse reactions of Chuanhuning injection are related to the occurrence time of adverse reactions, the combination of drugs, the type of dosing solution, the age of patients and other factors, but a larger sample of data analysis and verification is needed.