处方模式的变化作为血管紧张素转换酶抑制剂药物不良反应的潜在标志物。
Change in prescription pattern as a potential marker for adverse drug reactions of angiotensin converting enzyme inhibitors.
作者信息
Mahmoudpour Seyed Hamidreza, Asselbergs Folkert W, de Keyser Catherine E, Souverein Patrick C, Hofman Albert, Stricker Bruno H, de Boer Anthonius, Maitland-van der Zee Anke-Hilse
机构信息
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Universiteitsweg 99, David de Wied Building, 3508 TB, Utrecht, The Netherlands.
Department of Cardiology, Division Heart and Lungs, University Medical Center Utrecht, 3508 GA, Utrecht, The Netherlands.
出版信息
Int J Clin Pharm. 2015 Dec;37(6):1095-103. doi: 10.1007/s11096-015-0159-3. Epub 2015 Jul 10.
BACKGROUND
Angiotensin converting enzyme inhibitors (ACEIs) are among the most frequently prescribed groups of medications. ACEI-induced adverse drug reactions (ADRs) are the main reason to discontinue or switch ACEI treatment. ADRs information is not available in prescription databases. OBJECTIVE :To identify a proxy for ACEI-induced ADRs in prescription databases.
SETTING
The Rotterdam Study is an ongoing prospective cohort study that started in 1990 in the Netherlands and has included 14,926 subjects aged 45 years or older.
METHODS
All ACEI starters from 2000 to 2011 were identified using prescription data within the Rotterdam Study. Participants were classified into 4 mutually exclusive groups: continuing, discontinuing, switching to angiotensin receptor blockers (ARBs), and switching to other antihypertensives. For categorization, the maximum time-interval between two prescription periods was set at 3 and 6 months. Subsequently, primary care physician files were searched and clinical events were classified as definite ADRs, probable ADRs, possible ADRs and definite non-ADRs. Finally the accuracy of different prescription patterns as indicators of ADRs was evaluated. Main outcome measure Positive predictive values (PPVs), negative predictive values (NPVs), sensitivity and specificity of the prescription patterns of the 4 groups were calculated.
RESULTS
Totally, 1132 ACEI starters were included. The PPV for a definite ADR was 56.1 % for switchers to ARB, while the PPVs for switchers to other antihypertensives, and discontinuation were 39.5 and 19.5 %, respectively. After including probable ADRs and possible ADRs, PPVs for switchers to ARB increased to 68.3 and 90.5 %. A 6-month interval gave slightly higher PPVs compared to a 3-month interval (maximum 6.1 % higher). The differences in NPVs between 3 and 6-months interval groups were approximately 1.0 %.
CONCLUSIONS
Switching ACEIs to ARBs is the best marker for ACEI-induced ADRs in prescription databases.
背景
血管紧张素转换酶抑制剂（ACEI）是最常被处方的药物类别之一。ACEI引起的药物不良反应（ADR）是停止或更换ACEI治疗的主要原因。处方数据库中没有ADR信息。目的：在处方数据库中确定ACEI引起的ADR的替代指标。
设置
鹿特丹研究是一项正在进行的前瞻性队列研究，于1990年在荷兰开始，纳入了14926名45岁及以上的受试者。
方法
利用鹿特丹研究中的处方数据确定2000年至2011年期间所有开始使用ACEI的患者。参与者被分为4个相互排斥的组：持续用药、停药、换用血管紧张素受体阻滞剂（ARB）和换用其他抗高血压药物。为了进行分类，两个处方期之间的最大时间间隔设定为3个月和6个月。随后，查阅初级保健医生的档案，将临床事件分类为明确的ADR、可能的ADR、可疑的ADR和明确的非ADR。最后，评估不同处方模式作为ADR指标的准确性。主要结局指标计算4组处方模式的阳性预测值（PPV）、阴性预测值（NPV）、敏感性和特异性。
结果
总共纳入了1132名开始使用ACEI的患者。换用ARB的患者中明确ADR的PPV为56.1%，而换用其他抗高血压药物和停药的患者的PPV分别为39.5%和19.5%。纳入可能的ADR和可疑的ADR后，换用ARB的患者的PPV分别增至68.3%和90.5%。与3个月的间隔相比（最高高6.1%），6个月的间隔给出的PPV略高。3个月和6个月间隔组之间的NPV差异约为1.0%。
结论
在处方数据库中，将ACEI换用ARB是ACEI引起的ADR的最佳标志。
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