基于OpenFDA的环硅酸锆钠不良反应真实世界研究

目的:通过对环硅酸锆钠上市后的不良事件报告数据进行挖掘与分析,为其临床安全用药提供依据。方法:采用报告比值比法和比例报告比值法对2018年5月至2021年12月期间美国食品药品监督管理局公共数据公开项目(OpenFDA)中的环硅酸锆钠不良事件报告中的不良反应数据进行风险信号挖掘。挖掘得到的信号使用国际医学用语词典的首选系统器官分类和首选术语进行统计分类和分析。结果:检索到环硅酸锆钠相关不良事件报告508份,挖掘到34个具有临床参考价值的不良反应风险信号,主要涉及胃肠系统疾病、心脏系统疾病、代谢和营养失调、肾脏及泌尿系统疾病、各种肌肉骨骼及结缔组织疾病、皮肤及皮下组织类疾病、血管疾病、全身性疾病及给药部位各种反应、各类检查9个系统器官。发现环硅酸锆钠除说明书载入的不良反应外,还存在充血性心力衰竭、血钙降低、蛋白尿、死亡、腹水、心衰、多器官功能障碍综合征等15个说明书未提及的阳性风险信号。结论:临床应用环硅酸锆钠时,除药品说明书中已提到的不良反应外,还需密切关注其说明书未提及不良反应的风险,避免对患者造成损害。

Real-world study on the adverse reactions of sodium zirconium cyclosilicate based on OpenFDA

OBJECTIVE To mine and analyze the postmarketing adverse reaction data of sodium zirconium cyclosilicate, so as to provide basis for clinical safe drug use.METHODS The report ratio method (ROR) and proportional report ratio method (PRR) were used to mine the risk signals of adverse reaction report data of sodium zirconium cyclosilicate in the public data disclosure project of the U.S. Food and Drug Administration (OpenFDA) from May 2018 to December 2021. The mined signals were statistically classified and analyzed by using the preferred system organ classification (SOC) and preferred term (PT) in the International Dictionary of Medical Terms.RESULTS Totally 508 adverse reaction reports related to sodium zirconium cyclosilicate were retrieved, and 34 adverse reaction risk signals with clinical reference value were excavated, mainly involving gastrointestinal diseases, cardiac diseases, metabolic and nutritional disorders, kidney and urinary diseases, various musculoskeletal and connective tissue diseases, skin and subcutaneous tissue diseases, vascular diseases, systemic diseases, various reactions at the administration sites, and 9 system organs examined. It was found that in addition to the adverse reactions contained in the manual, sodium zirconium cyclosilicate also had 15 positive risk signals not mentioned in the manual yet, such as congestive heart failure, decreased blood calcium, proteinuria, death, ascites, heart failure and multiple organ dysfunction syndrome.CONCLUSION In addition to the adverse reactions mentioned in the drug instruction, the risk of adverse events not mentioned in the instruction should be paid close attention, so as to avoid damage to patients.