Terevnikov Viacheslav, Stenberg Jan-Henry, Joffe Marina, Tiihonen Jari, Burkin Mark, Tchoukhine Evgueni, Joffe Grigori
Kellokoski Hospital, Kellokoski, Finland.
Hum Psychopharmacol. 2010 Aug;25(6):431-8. doi: 10.1002/hup.1137.
Adjunctive mirtazapine improved negative symptoms of schizophrenia in several studies. Recently, we found an improvement also in positive symptoms when mirtazapine was added to first generation antipsychotics (FGAs) in a 6 week randomized controlled trial (RCT). The short duration of that trial was its limitation. This study aimed to explore whether longer treatment is worthwhile.
Completers of the RCT (n = 39) received open-label add-on mirtazapine for additional 6 weeks. The Positive and Negative Syndrome Scale (PANSS) total score (primary outcome) and several other clinical parameters were measured prospectively.
During the open-label phase, significant improvement was achieved in all parameters, with an effect size of 0.94 (CI 95% = 0.45-1.43) on the primary outcome and an impressive additive antipsychotic effect. Patients who received mirtazapine during both phases demonstrated greater improvement in positive symptoms (29.6% versus 21.2%, p = 0.027) than those who received mirtazapine during open-label extension phase only.
These findings support our previous data on the additive antipsychotic effect of mirtazapine in FGAs-treated schizophrenia. Mirtazapine may be effective in other symptom domains, too. Longer duration of mirtazapine treatment may yield additional benefits. If these results will be confirmed in larger studies, add-on mirtazapine may become a feasible option in difficult-to-treat schizophrenia.
在多项研究中，辅助使用米氮平可改善精神分裂症的阴性症状。最近，我们在一项为期6周的随机对照试验（RCT）中发现，将米氮平添加到第一代抗精神病药物（FGA）中时，阳性症状也有所改善。该试验的持续时间较短是其局限性。本研究旨在探讨更长时间的治疗是否值得。
RCT的完成者（n = 39）接受了为期6周的开放标签附加米氮平治疗。前瞻性地测量了阳性和阴性症状量表（PANSS）总分（主要结局）和其他几个临床参数。
在开放标签阶段，所有参数均取得了显著改善，主要结局的效应大小为0.94（95%CI = 0.45 - 1.43），且抗精神病作用显著增强。在两个阶段都接受米氮平治疗的患者在阳性症状方面的改善（29.6%对21.2%，p = 0.027）比仅在开放标签延长期接受米氮平治疗的患者更大。
这些发现支持了我们之前关于米氮平在FGA治疗的精神分裂症中具有附加抗精神病作用的数据。米氮平在其他症状领域可能也有效。更长时间的米氮平治疗可能会带来额外的益处。如果这些结果在更大规模的研究中得到证实，附加米氮平可能成为难治性精神分裂症的一种可行选择。
