PDF(Pubmed)
Abstract：
UNASSIGNED: Mood stabilisers and other psychotropic drugs can lead to serious adverse drug events (ADEs). However, the incidence remains unknown. We aimed to (a) determine the incidence of serious ADEs in patients with bipolar or schizoaffective disorders, (b) explore the role of lithium exposure, and (c) describe the aetiology.
UNASSIGNED: This study is part of the LiSIE (Lithium-Study into Effects and Side Effects) retrospective cohort study. Between 2001 and 2017, patients in the Swedish region of Norrbotten, with a diagnosis of bipolar or schizoaffective disorder, were screened for serious ADEs to psychotropic drugs, having resulted in critical, post-anaesthesia, or intensive care. We determined the incidence rate of serious ADEs/1,000 person-years (PY).
UNASSIGNED: In 1,521 patients, we identified 41 serious ADEs, yielding an incidence rate of 1.9 events per 1,000 PY. The incidence rate ratio (IRR) between ADEs with lithium present and causally implicated and ADEs without lithium exposure was significant at 2.59 (95% CI 1.20-5.51; p = 0.0094). The IRR of ADEs in patients <65 and ≥65 years was significant at 3.36 (95% CI 1.63-6.63; p = 0.0007). The most common ADEs were chronic lithium intoxication, oversedation, and cardiac/blood pressure-related events.
UNASSIGNED: Serious ADEs related to treatment of bipolar (BD) or schizoaffective disorder (SZD) were uncommon but not rare. Older individuals were particularly at risk. The risk was higher in individuals exposed to lithium. Serum lithium concentration should always be checked when patients present with new or unclear somatic symptoms. However, severe ADEs also occurred with other mood stabilisers and other psychotropic drugs.
UNASSIGNED: This study is part of the LiSIE (Lithium-Study into Effects and Side Effects) retrospective cohort study. Between 2001 and 2017, patients in the Swedish region of Norrbotten, with a diagnosis of bipolar or schizoaffective disorder, were screened for serious ADEs to psychotropic drugs, having resulted in critical, post-anaesthesia, or intensive care. We determined the incidence rate of serious ADEs/1,000 person-years (PY).
UNASSIGNED: In 1,521 patients, we identified 41 serious ADEs, yielding an incidence rate of 1.9 events per 1,000 PY. The incidence rate ratio (IRR) between ADEs with lithium present and causally implicated and ADEs without lithium exposure was significant at 2.59 (95% CI 1.20-5.51; p = 0.0094). The IRR of ADEs in patients <65 and ≥65 years was significant at 3.36 (95% CI 1.63-6.63; p = 0.0007). The most common ADEs were chronic lithium intoxication, oversedation, and cardiac/blood pressure-related events.
UNASSIGNED: Serious ADEs related to treatment of bipolar (BD) or schizoaffective disorder (SZD) were uncommon but not rare. Older individuals were particularly at risk. The risk was higher in individuals exposed to lithium. Serum lithium concentration should always be checked when patients present with new or unclear somatic symptoms. However, severe ADEs also occurred with other mood stabilisers and other psychotropic drugs.
摘要：
■情绪稳定剂和其他精神药物可导致严重的药物不良事件（ADE）。然而,发病率仍然未知。我们旨在（a）确定双相情感障碍或分裂情感障碍患者中严重ADE的发生率，(b)探讨锂暴露的作用，和(c)描述病因。
■本研究是LiSIE（影响和副作用的锂研究）回顾性队列研究的一部分。在2001年至2017年之间，瑞典Norrbotten地区的患者，诊断为双相情感障碍或分裂情感障碍，对精神药物的严重ADE进行了筛查，导致了至关重要的，麻醉后,或重症监护。我们确定了严重ADE的发病率/1,000人年（PY）。
■在1,521名患者中，我们确定了41个严重的ADE,产生每1000PY1.9个事件的发生率。存在锂和有因果关系的ADE与没有锂暴露的ADE之间的发生率比（IRR）为2.59（95％CI1.20-5.51；p=0.0094）。<65岁和≥65岁患者的ADE的IRR为3.36（95％CI1.63-6.63；p=0.0007）。最常见的ADE是慢性锂中毒，过度镇静,和心脏/血压相关事件。
■与双相情感障碍（BD）或分裂情感障碍（SZD）治疗相关的严重ADE并不常见，但并不罕见。老年人尤其处于危险之中。暴露于锂的个体的风险更高。当患者出现新的或不清楚的躯体症状时，应始终检查血清锂浓度。然而,其他情绪稳定剂和其他精神药物也会出现严重的ADE。
■本研究是LiSIE（影响和副作用的锂研究）回顾性队列研究的一部分。在2001年至2017年之间，瑞典Norrbotten地区的患者，诊断为双相情感障碍或分裂情感障碍，对精神药物的严重ADE进行了筛查，导致了至关重要的，麻醉后,或重症监护。我们确定了严重ADE的发病率/1,000人年（PY）。
■在1,521名患者中，我们确定了41个严重的ADE,产生每1000PY1.9个事件的发生率。存在锂和有因果关系的ADE与没有锂暴露的ADE之间的发生率比（IRR）为2.59（95％CI1.20-5.51；p=0.0094）。<65岁和≥65岁患者的ADE的IRR为3.36（95％CI1.63-6.63；p=0.0007）。最常见的ADE是慢性锂中毒，过度镇静,和心脏/血压相关事件。
■与双相情感障碍（BD）或分裂情感障碍（SZD）治疗相关的严重ADE并不常见，但并不罕见。老年人尤其处于危险之中。暴露于锂的个体的风险更高。当患者出现新的或不清楚的躯体症状时，应始终检查血清锂浓度。然而,其他情绪稳定剂和其他精神药物也会出现严重的ADE。
