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首页> 外文期刊>Therapeutic advances in psychopharmacology. >Amisulpride augmentation of clozapine for treatment-refractory schizophrenia: a double-blind, placebo-controlled trial
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Amisulpride augmentation of clozapine for treatment-refractory schizophrenia: a double-blind, placebo-controlled trial

机译：氯氮平氨磺必隆治疗难治性精神分裂症的双盲，安慰剂对照试验

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A second antipsychotic is commonly added to clozapine to treat refractory schizophrenia, notwithstanding the limited evidence to support such practice. The efficacy and adverse effects of this pharmacological strategy were examined in a double-blind, placebo-controlled, 12-week randomized trial of clozapine augmentation with amisulpride, involving 68 adults with treatment-resistant schizophrenia and persistent symptoms despite a predefined trial of clozapine. There were no statistically significant differences between the amisulpride and placebo groups on the primary outcome measure (clinical response defined as a 20% reduction in total Positive and Negative Syndrome Scale score) or other mental state measures. However, the trial under recruited and was therefore underpowered to detect differences in the primary outcome, meaning that acceptance of the null hypothesis carries an increased risk of type II error. The findings suggested that amisulpride-treated participants were more likely to fulfil the clinical response criterion, odds ratio 1.17 (95% confidence interval 0.40–3.42) and have a greater reduction in negative symptoms, but these numerical differences were not statistically significant and only evident at 12 weeks. A significantly higher proportion of participants in the amisulpride group had at least one adverse event compared with the control group (p = 0.014), and these were more likely to be cardiac symptoms. Treatment for more than 6 weeks may be required for an adequate trial of clozapine augmentation with amisulpride. The greater side-effect burden associated with this treatment strategy highlights the need for safety and tolerability monitoring, including vigilance for indicators of cardiac abnormalities, when it is used in either a clinical or research setting.
机译：尽管支持这种治疗的证据有限，但通常向氯氮平中添加第二种抗精神病药来治疗难治性精神分裂症。在一项双盲，安慰剂对照，为期12周的氨磺必利氯氮平增强随机试验中，对该药理策略的疗效和不良反应进行了检查，尽管已有氯氮平的既定试验，但其中有68名成年人具有治疗耐药性精神分裂症和持续症状。在主要结局指标（临床反应定义为阳性和阴性综合症状量表总分降低20％）或其他精神状态指标方面，氨磺必利和安慰剂组之间在统计学上无显着差异。但是，该试验尚处于征募阶段，因此没有足够的能力检测主要结果的差异，这意味着接受无效假设会增加II型错误的风险。研究结果表明，使用氨磺必利治疗的参与者更有可能符合临床反应标准，比值比为1.17（95％置信区间0.40–3.42），阴性症状的缓解程度更大，但这些数值差异在统计学上无统计学意义，仅是明显的在12周时。与对照组相比，氨磺必利组的参与者发生至少一种不良事件的比例更高（p = 0.014），并且这些人更可能是心脏症状。氯氨平联合氨磺必利的充分试验可能需要治疗6周以上。与这种治疗策略相关的更大的副作用负担凸显了对安全性和耐受性监测的需求，包括在临床或研究环境中使用时都要警惕心脏异常指标。

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