Kamp Caroline Barkholt, Petersen Johanne Juul, Faltermeier Pascal, Juul Sophie, Sillassen Christina Dam Bjerregaard, Siddiqui Faiza, Andersen Rebecca Kjaer, Moncrieff Joanna, Horowitz Mark Abie, Hengartner Michael Pascal, Kirsch Irving, Gluud Christian, Jakobsen Janus Christian
Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, Copenhagen Ø, DK-2100, Denmark.
Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, DK-5000, Denmark.
BMC Psychiatry. 2025 Jan 22;25(1):67. doi: 10.1186/s12888-024-06396-6.
Mirtazapine is used to treat depression worldwide, and the effects of mirtazapine on depression rating scales are well-known. Our primary objective was to assess the risks of adverse events with mirtazapine for major depressive disorder.
We searched relevant sources from inception to 7 March 2024 for randomised clinical trials comparing mirtazapine versus placebo in adults with major depressive disorder. The primary outcomes were suicides or suicide attempts, serious adverse events, and non-serious adverse events. Data were synthesised using meta-analysis and Trial Sequential Analysis.
We included 17 trials randomising 2,131 participants to mirtazapine versus placebo. All results were at high risk of bias, and the certainty of the evidence was very low. The included trials assessed outcomes at a maximum of 12 weeks after randomisation. Meta-analysis and Trial Sequential Analysis showed insufficient information to determine the effects of mirtazapine on the risks of suicides or suicide attempts and serious adverse events. Meta-analyses showed that mirtazapine increased the risks of somnolence, weight gain, dry mouth, dizziness, and increased appetite but decreased the risk of headaches.
There is a lack of evidence on the effects of mirtazapine on suicides and serious adverse events. Mirtazapine increases the risks of somnolence, weight gain, dry mouth, dizziness, and increased appetite. Mirtazapine might decrease the risk of headaches. The long-term effects of mirtazapine are unknown.
CRD42022315395.
米氮平在全球范围内用于治疗抑郁症，其对抑郁评定量表的影响是众所周知的。我们的主要目标是评估米氮平治疗重度抑郁症时不良事件的风险。
我们检索了从开始到2024年3月7日的相关资料，以查找比较米氮平与安慰剂治疗成人重度抑郁症的随机临床试验。主要结局为自杀或自杀未遂、严重不良事件和非严重不良事件。使用荟萃分析和试验序贯分析对数据进行综合分析。
我们纳入了17项试验，将2131名参与者随机分为米氮平组和安慰剂组。所有结果都存在高偏倚风险，证据的确定性非常低。纳入的试验在随机分组后最多12周评估结局。荟萃分析和试验序贯分析表明，没有足够的信息来确定米氮平对自杀或自杀未遂风险以及严重不良事件的影响。荟萃分析表明，米氮平增加了嗜睡、体重增加、口干、头晕和食欲增加的风险，但降低了头痛的风险。
缺乏关于米氮平对自杀和严重不良事件影响的证据。米氮平增加了嗜睡、体重增加、口干、头晕和食欲增加的风险。米氮平可能会降低头痛的风险。米氮平的长期影响尚不清楚。
PROSPERO注册号：CRD42022315395。
Zotero 插件
