360例严重药品不良反应和药物相互作用的分析

Analysis of Severe Adverse Drug Reactions and Drug Interactions in 360 Cases

关键词:  真实世界  严重药品不良反应  药物相互作用  老年患者  合理用药

Key words:  real-world  serious adverse drug reaction  drug-drug interactions  elderly patients  rational use of drugs

摘要:

目的 通过对真实世界中严重药品不良反应(serious adverse drug reaction，SADR)和药物-药物相互作用(drug-drug interactions，DDIs)的分析与评价，获得DDIs相关SADR的临床证据，为临床合理用药提供参考。方法 收集2011年1月—2020年12月上报至国家药品不良反应监测中心的SADR报告，采用UpToDate中的Lexi-Interaction^®软件对SADR中≥2种药物进行分析，评判是否存在潜在DDIs，并对可能由其导致的药品不良反应进行统计分析。结果 360例SADR中男性稍多于女性(50.83% vs 49.17%)，平均年龄(65.27±14.71)岁，≥65岁患者占56.39%。构成比最高的药物为心血管系统用药，累及器官以胃肠系统损害为主，而阿司匹林是导致SADR例次最多的药物。在含≥2种可疑药物的150例SADR中，存在潜在DDIs的有64例，占42.67%；而发生实际DDIs有42例，占28%，其中2例属于X级，16例属于D级，且多数(71.43%)报告是由相加的药效学相互作用所致。阿司匹林是潜在DDIs和实际DDIs中最常见的药物，而实际DDIs中最常涉及的药物组合为阿司匹林/氯吡格雷，其中胃肠道出血是最常见的SADR。结论 应关注药物相互作用对SADR的影响，优化处方用药，特别是老年人群，依据潜在DDIs的结果，合理选用治疗药物，同时加强心血管系统药物和重点人群的监测，保障用药安全。

Abstract:

OBJECTIVE To analyze and evaluate serious adverse drug reaction(SADR) and drug-drug interactions(DDIs) in the real-world, so as to obtain the clinical evidence of DDIs-related SADR, and to provide a reference for rational clinical use. METHODS The SADR reports reported to the National Adverse Drug Reaction Monitoring Center from January 2011 to December 2020 were collected, and Lexi-Interaction^® software in UpToDate was used to analyze ≥2 drugs in SADR to evaluate whether there were potential DDIs. And the possible adverse drug reactions caused by DDIs were statistically analyzed. RESULTS Among the 360 cases of SADR, males were slightly more than females(50.83% vs 49.17%), the mean age was (65.27±14.71) years old, and 56.39% were ≥65 years old. Cardiovascular agents were the most common implicated pharmacological group, and the gastrointestinal system was the most frequently affected system, and aspirin was the most frequently reported drug. Among 150 cases of SADR with at least two suspected drugs, 64 cases had potential DDIs, while 42 cases had clinically significant DDIs, of which only 16 and 2 cases of SADR were caused by actual DDIs in category D and X, respectively. The majority of reports(71.43%) were caused by additive pharmacodynamic interactions. Aspirin was the most common drug in both potential DDIs and actual DDIs, while aspirin and clopidogrel was the most commonly involved drug pair in actual DDIs, with gastrointestinal bleeding being the most common SADR. CONCLUSION Attention should be paid to the influence of drug interactions on SADR, and prescription should be optimized, especially in the elderly population. According to the results of potential DDIs, therapeutic drugs should be rationally selected. Meanwhile, monitoring of cardiovascular drugs and key populations should be strengthened to ensure drug safety.