PDF(Pubmed)
Abstract：
OBJECTIVE: This study aimed to verify the real-world efficacy and safety of quetiapine fumarate extended-release tablets (Bipresso® 50 mg and 150 mg; marketing authorization holder is KYOWA Pharmaceutical Industry Co., Ltd., Osaka, Japan) in patients with bipolar depression.
METHODS: We performed a post-marketing surveillance with an observation period of 12 weeks.
RESULTS: In the safety analysis group (n = 345), adverse drug reactions (ADRs) occurred in 111 patients (32.17%). The most common ADRs (>1%) were somnolence in 55 patients (15.94%), akathisia in 11 (3.19%), dizziness in 10 (2.90%), weight increase in 6 (1.74%), thirst in 5 (1.45%), and hypersomnia, constipation, and nausea in 4 patients each (1.16%). The only severe ADR was one patient of suicidal ideation, and \"longer time since the onset of the first episode\" (p = 0.011) and \"presence of complications\" (p < 0.001) were identified as significant risk factors for the occurrence of ADRs. In the efficacy analysis group (n = 265), the average changes from baseline in the total Montgomery-Åsberg Depression Rating Scale (MADRS) score were -7.3 ± 8.8, -12.2 ± 10.7, -16.8 ± 12.7, and -13.2 ± 12.7 points after 4, 8, and 12 weeks, and at the last evaluation, respectively. The mean MADRS total score decrease had no significant association with maximum daily dose, diagnosis, and presence or absence of prior or concomitant treatment for bipolar disorder with mood stabilizers/antipsychotics/antidepressants.
CONCLUSIONS: The efficacy of quetiapine fumarate extended-release tablets was confirmed in clinical practice, and no new safety concerns or risks were identified.
METHODS: We performed a post-marketing surveillance with an observation period of 12 weeks.
RESULTS: In the safety analysis group (n = 345), adverse drug reactions (ADRs) occurred in 111 patients (32.17%). The most common ADRs (>1%) were somnolence in 55 patients (15.94%), akathisia in 11 (3.19%), dizziness in 10 (2.90%), weight increase in 6 (1.74%), thirst in 5 (1.45%), and hypersomnia, constipation, and nausea in 4 patients each (1.16%). The only severe ADR was one patient of suicidal ideation, and \"longer time since the onset of the first episode\" (p = 0.011) and \"presence of complications\" (p < 0.001) were identified as significant risk factors for the occurrence of ADRs. In the efficacy analysis group (n = 265), the average changes from baseline in the total Montgomery-Åsberg Depression Rating Scale (MADRS) score were -7.3 ± 8.8, -12.2 ± 10.7, -16.8 ± 12.7, and -13.2 ± 12.7 points after 4, 8, and 12 weeks, and at the last evaluation, respectively. The mean MADRS total score decrease had no significant association with maximum daily dose, diagnosis, and presence or absence of prior or concomitant treatment for bipolar disorder with mood stabilizers/antipsychotics/antidepressants.
CONCLUSIONS: The efficacy of quetiapine fumarate extended-release tablets was confirmed in clinical practice, and no new safety concerns or risks were identified.
摘要：
目的：本研究旨在验证富马酸喹硫平缓释片（Bipresso®50mg和150mg；上市许可持有人为KYOWAPharmaceuticalIndustryCo.，Ltd.,大阪,日本）双相抑郁症患者。
方法：我们进行了为期12周的上市后监测。
结果：在安全性分析组（n=345）中，111例(32.17%)患者发生药物不良反应(ADR)。最常见的不良反应（>1%）是55例患者的嗜睡（15.94%），11例（3.19%），头晕10（2.90%），体重增加6（1.74%），口渴5（1.45%），和失眠症，便秘,恶心患者各4例(1.16%)。唯一的严重不良反应是一名有自杀意念的患者，和“自首次发作以来的时间较长”（p=0.011）和“存在并发症”（p<0.001）被确定为ADR发生的重要危险因素。在疗效分析组（n=265）中，在第4、8和12周之后，蒙哥马利-奥斯贝格抑郁量表（MADRS）总分与基线的平均变化分别为-7.3±8.8、-12.2±10.7、-16.8±12.7和-13.2±12.7分，在最后一次评估中，分别。平均MADRS总分下降与最大日剂量没有显著关联，诊断,以及是否存在使用情绪稳定剂/抗精神病药/抗抑郁药治疗双相情感障碍的先前或同时治疗。
结论：富马酸喹硫平缓释片的临床疗效得到证实，没有发现新的安全问题或风险。
方法：我们进行了为期12周的上市后监测。
结果：在安全性分析组（n=345）中，111例(32.17%)患者发生药物不良反应(ADR)。最常见的不良反应（>1%）是55例患者的嗜睡（15.94%），11例（3.19%），头晕10（2.90%），体重增加6（1.74%），口渴5（1.45%），和失眠症，便秘,恶心患者各4例(1.16%)。唯一的严重不良反应是一名有自杀意念的患者，和“自首次发作以来的时间较长”（p=0.011）和“存在并发症”（p<0.001）被确定为ADR发生的重要危险因素。在疗效分析组（n=265）中，在第4、8和12周之后，蒙哥马利-奥斯贝格抑郁量表（MADRS）总分与基线的平均变化分别为-7.3±8.8、-12.2±10.7、-16.8±12.7和-13.2±12.7分，在最后一次评估中，分别。平均MADRS总分下降与最大日剂量没有显著关联，诊断,以及是否存在使用情绪稳定剂/抗精神病药/抗抑郁药治疗双相情感障碍的先前或同时治疗。
结论：富马酸喹硫平缓释片的临床疗效得到证实，没有发现新的安全问题或风险。
