J Clin Psychiatry:艾司凯明鼻腔喷雾剂加口服抗抑郁剂治疗耐药性抑郁症的安全性良好

2021-04-10 MedSci原创 MedSci原创

艾司凯明鼻腔喷雾剂联合新型口服抗抑郁剂(OAD)已批准用于治疗耐治性抑郁症(TRD),但是有研究显示艾司凯明鼻腔喷雾剂的诸多副作用,为明确艾司凯明鼻腔喷雾剂联合OAD治疗TRD的长期安全性和有效性,研

艾司凯明鼻腔喷雾剂联合新型口服抗抑郁剂(OAD)已批准用于治疗耐治性抑郁症(TRD),但是有研究显示艾司凯明鼻腔喷雾剂的诸多副作用,为明确艾司凯明鼻腔喷雾剂联合OAD治疗TRD的长期安全性和有效性,研究人员进行了一项3期、开放标签、多中心研究,研究结果已发表于J Clin Psychiatry。

研究于2015年10月至2017年10月进行。纳入TRD(DSM-5诊断为重度抑郁症且对≥2种OAD治疗无反应)的患者。在为期4周的诱导(IND)阶段,每周给药2次,每周或隔周给药1次;对治疗有反应的患者,每周或隔周给药1次,进入为期48周的优化/维持(OP/MAINT)阶段,给药1次,给药1次。

 

结果,共有802名患者入组;进入IND阶段的779名患者中,有580名(74.5%)完成治疗,进入OP/MAINT阶段的603名患者中,有150名(24.9%)完成治疗。常见的治疗突发不良事件(TEAEs)为头晕(32.9%)、解离(27.6%)、恶心(25.1%)和头痛(24.9%)。76名患者(9.5%)因TEAEs而停用艾司他明。55名患者(6.9%)出现严重的TEAEs。大多数TEAE发生在给药日,严重程度为轻度或中度,并在当天解决。研究过程中,有两例死亡报告,均与艾司他明无关。

患者的认知能力在基线后得到改善或保持稳定。没有出现间质性膀胱炎或呼吸抑制的病例。治疗中出现短暂的分离症状,一般在服药后1.5小时内缓解。Montgomery-Åsberg抑郁评定量表总分在IND阶段有所下降,且在OP/MAINT阶段维持(从各阶段基线到终点的平均[SD]变化:IND,-16.4[8.76];OP/MAINT,0.3[8.12])。

综上所述,该研究结果表明,长期使用艾司他明鼻腔喷雾剂联合新的OAD疗法治疗的安全良好,而且在TRD患者中,可以持续改善其抑郁症状。

 

原始出处:

 

Ewa Wajs, et al., Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression: Assessment of Long-Term Safety in a Phase 3, Open-Label Study (SUSTAIN-2). J Clin Psychiatry. 2020 Apr 28;81(3):19m12891. doi: 10.4088/JCP.19m12891.

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    2021-04-12 mnda
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