| 杜雪亭,高玲娜,孙红爽,等.致心律失常不良反应药物信号的检测与评价[J].安徽医药,2023,27(1):207-212. |
| 致心律失常不良反应药物信号的检测与评价 |
| Detection and evaluation of drug signals of arrhythmic adverse reactions |
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| DOI：10.3969/j.issn.1009-6469.2023.01.045 |
| 中文关键词: |
| 英文关键词: Drug-related side effects and adverse reactions Arrhythmic Detection Mining Adverse drug reaction reporting systems ADR signal |
| 基金项目:河北省医学科学研究课题计划( 20211195) |
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| 摘要点击次数: 830 |
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| 中文摘要: |
| 目的检测和评价致心律失常药品不良反应( adverse drug reaction，ADR)药物信号，为临床安全用药提供参考。方法收集 2004年第 1季度至 2020年第 4季度美国食品药品监督管理局不良事件报告系统自发呈报系统中接收到的致心律失常 ADR信号，采用比例报告比法( proportional reporting ratios，PRR)和报告比值比法( proportional reporting odds ratio，ROR)对进行信号检测，分析 ADR报告中对应病人的基本信息(包括性别、年龄、上报年份、上报国家、严重 ADR)和安全警告信号。结果收集到的 65 536份 ADR报告中，排除重复，保留首要怀疑药物和伴随药物的 ADR报告有 20 401份。除性别未知和年龄缺失的 ADR报告外，纳入报告病人的性别分布女性稍高于男性(9 918比 8 401)，年龄范围 50～75岁比例较高，其余分布较均衡，上报数量最多的年份分别是 2005年、 2011年、 2012年、 2018年和 2019年，主要上报国家为美国、德国等。严重的 ADR报告有 11 158份(占 54.7％)“住院或住院时间延长”为主，导致死亡占 16.88%。共挖掘得到 ADR信号 478个，累及心血管系统( 122个)、内分泌系统(48个)、以，抗精神病( 43个)、神经系统( 32个)、抗感染( 22个)、呼吸系统( 22个)、血液系统( 17个)、抗肿瘤( 16个)等 19个系统用药。致心律失常 ADR信号频数排序前 10位的药物分别为罗非考昔(频数 1 795)、罗非昔布(频数 1 792)、对乙酰氨基酚(频数 1 393)、左甲状腺素(频数 912)、美托洛尔(频数 879)、缬沙坦(频数 805)、罗格列酮(频数 798)、丙氧酚(频数 776)、呋塞米(频数 687)、氢氯噻嗪(频数 635)。头孢噻吩信号强度值最高，对乙酰氨基酚次之。结论心血管系统、抗精神 |
| 英文摘要: |
| Objective To detect and evaluate the drug signals of arrhythmic adverse drug reaction (ADR), and to provide reference for clinical safe drug use.Methods Arrhythmogenic ADR signals received from the spontaneous notification system of the US FDAAdverse Event Reporting System from the first quarter of 2004 to the fourth quarter of 2020 were collected. Proportional reporting oddsratio (ROR) and proportional reporting Odds ratio (PRR) were used to detect signals. The basic information (including gender, age, reporting year, reporting country, serious ADR) and safety warning signals of corresponding patients in ADR reports were analyzed.Re? sults Of the 65 536 ADR reports collected, there were 20 401 ADR reports that retained the primary suspected drug and concomitantdrug excluding duplication. Except for the ADR reports with unknown gender and age loss, the gender distribution of included patientswas slightly higher in females than in males (9 918 vs. 8 401), and the proportion of age range from 50 to 75 years old was relativelyhigh. The rest of the distribution was more balanced. The most reported years were 2005, 2011, 2012, 2018 and 2019, and the main reporting countries were the United States and Germany. There were 11 158 serious ADR reports (54.7%), mainly "hospitalization or prolonged hospitalization", 16.88% in death. A total of 478 ADR signals were obtained, involving 19 systems such as cardiovascular system (122), endocrine system (48), antipsychotic system (43), nervous system (32), anti-infective system (22), respiratory system (22), blood system (17), and anti-tumor system (16). The top 10 drugs in the ranking of arrhythmia induced ADR signal frequency were rofecoxib (frequency 1 795), rofecoxib (frequency 1 792) and acetaminophen (frequency 1 393), levothyroxine (frequency 912), metoprolol(frequency 879), valsartan (frequency 805), rolitazone (frequency 798), propofol (frequency 776), furosamide (frequency 687), hydrochlorothiazide (frequency 635). The signal intensity of cephalothiophene was the highest, followed by acetaminophen.Conclusions Cardiovascular system, antipsychotic system, nervous system, anti-infective system, respiratory system, blood system, anti -tumor druginduced arrhythmia safety risk is higher. When taking medicine, we should be vigilant, early detection and timely discontinue medicine, and actively give symptomatic treatment to reduce the harm of drug-induced adverse reactions. |
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