血管紧张素转化酶抑制剂/血管紧张素受体拮抗剂类药品不良反应/事件报告分析

Adverse Drug Reactions/Events Induced by ACEI/ARB

目的分析血管紧张素转换酶抑制剂(ACEI)/血管紧张素受体拮抗剂(ARB)类药品不良反应/事件的发生特点及规律,为临床安全、合理用药提供参考。方法对深圳市2014年1月1日至2017年12月31日间上报的32 068份药品不良反应/事件(ADR/AE)报告筛选出怀疑ACEI/ARB类药物的病例报告进行统计分析,共筛选出83例怀疑ACEI类药物、68例怀疑ARB类药物所致的ADR/AE报告。结果两类药物所致ADR/AE男女比例无明显差异,年龄大者更易发生ADR/AE(ACEI≥40岁占89.16%,ARB≥40岁占89.71%);两类药物所致ADR/AE均多发生在1~7 d内(ACEI、ARB分别为72.29%、85.29%);ACEI类ADR/AE以呼吸系统多见(60.19%),ARB类ADR/AE涉及系统-器官及不良反应表现多样化,以神经系统多见(30.48%),且新的(ARB 15.88%,ACEI 7.77%)及严重的(ARB 6.54%,ACEI 2.91%)不良反应所占比例更高;ACEI类药物ADR/AE中,培哚普利(36.89%)、贝那普利(21.36%)、依那普利(21.36%)报告较多,ARB报告多为缬沙坦(42.06%)、厄贝沙坦(28.04%)及氯沙坦(17.76%);ACEI和ARB导致的ADR/AE均较轻微,易于好转和治愈。结论临床医师和药师在患者开始使用ACE I/ARB类药物一周内,应加强关注其不良反应,密切监测呼吸系统及神经系统等不良反应,及时鉴别、干预两类药物所致的不良反应,避免严重ADR/AE的发生。

Objective To analyze the regularities and characteristics of adverse drug reactions/events(ADR/AE) caused by angiotensin converting enzyme inhibitors(ACEIs) and angiotensin receptor blockers(ARBs) in order to provide reference for rational drug use in the clinic. Methods Cases of ADR/AE caused by ACEI and ARB were screened and analyzed statistically from a total of 32 068 cases of ADR/AE reported in Shenzhen between 2014.1.1 and 2017.12.31. Eighty-three cases of ADR/AE caused by ACEI and 63 caused by ARB were screened out. Results There was no significant difference between males and females in the incidence of ADRs/ADEs caused by the two types of drugs, but the elders were more vulnerable to ADR/AE(for ACEI, those≥40 years old accounted for 89.16% of the cases, compared with 89.71% for ARB). The onset time of most ADR/AE associated with ACEI(72.29%) and ARB(85.29%) was within 1 to 7 days after oral medicine. The main manifestations of adverse effects by ACEI involved the respiratory system(60.19%). The involved organs/systems and manifestations by ARB outnumbered those of ACEI, and adverse drug reactions associated with the nervous system(30.48%) were common. New(ARB 15.88% vs ACEI 7.77%) and serious(ARB 6.54% vs ACEI 2.91%) ADRs/ADEs caused by ARB accounted for a high proportion. The ADRs/ADEs were related to six drug categories, respectively. The top three drug categories of ACEI were perindopril(36.89%), benapril(21.36%), and enapril(21.36%), compared with valsartan(42.06%), irbesartan(28.04%) and losartan(17.76%) for ARB. Most of the manifestations of adverse effects by ACEI and ARB were mild and had good prognosis. Conclusion Clinicians and clinical pharmacists should be alert to ADR/ADE induced by ACEI and ARB within a week of administration. ADR/AE caused by the two kinds of drugs should be distinguished and intervened in as early as possible in order to prevent serious ADR/AE.