Barcelona Clínic Schizophrenia Unit (BCSU), Neuroscience Institute, Hospital Clínic de Barcelona, Barcelona, Spain.
Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Eur Psychiatry. 2020 Jul 16;63(1):e71. doi: 10.1192/j.eurpsy.2020.72.
Around 30% of patients with schizophrenia are considered treatment resistant (TRS). Only around 40% of TRS patients respond to clozapine. Long acting injectable antipsychotics could be a useful augmentation strategy for nonresponders.
We conducted a multicenter, observational, naturalistic, retrospective, 6-month mirror-image study to evaluate the efficacy and tolerability of clozapine and paliperidone palmitate association in 50 patients with TRS and other psychotic disorders. Clinical outcomes and side effects were systematically assessed.
Six months after starting the combined treatment, participants showed a significant relief of symptoms, decreasing the Brief Psychiatric Rating Scale total score from 18.32 ± 7.71 to 7.84 ± 5.16 (p < 0.001). The number of hospitalizations, the length of hospital stays and the number of visits to emergency services also decreased, while an increase of the functionality was observed (Personal and Social Performance total score increased from 46.06 ± 118.7 to 60.86 ± 18.68, p < 0.001). There was also a significant decrease in the number and severity of side effects with the combination therapy, decreasing the Udvalg for Kliniske Undersogelser total score from 10.76 ± 8.04 to 8.82 ± 6.63 (p = 0.004).
This study provides the first evidence that combining clozapine with paliperidone palmitate in patients with TRS and other psychotic disorders could be effective and safe, suggesting further research with randomized controlled trials of augmentation strategies for clozapine nonresponder patients.
Patients with psychotic disorders such as schizophrenia show a variable response to antipsychotic treatments. Around 30% of patients are considered treatment resistant, indicated by insufficient symptom control to at least two different drugs. In these resistant cases, clozapine should be indicated, as it has shown to be superior to other options. However, only 40% of patients respond to clozapine, being necessary to establish which treatments could best potentiate clozapine action. Combining clozapine with long acting injectable antipsychotics, and particularly paliperidone palmitate, could be a useful strategy. We conducted a multicenter study of 50 patients with treatment-resistant schizophrenia and other psychotic disorders comparing the efficacy and tolerability in the 6 month-period prior and after starting the clozapine and paliperidone palmitate association. Our study suggests that this combination could be effective and safer, laying the groundwork for future clinical trials with this combination.
大约 30%的精神分裂症患者被认为是治疗抵抗（TRS）。只有大约 40%的 TRS 患者对氯氮平有反应。长效注射抗精神病药可能是一种有用的增效策略，适用于无反应者。
我们进行了一项多中心、观察性、自然主义、回顾性、6 个月镜像研究，以评估 50 例 TRS 和其他精神病患者联合使用氯氮平和棕榈酸帕利哌酮的疗效和耐受性。系统评估了临床结果和副作用。
在开始联合治疗 6 个月后，患者的症状明显缓解，简明精神病评定量表总分从 18.32±7.71 降至 7.84±5.16（p<0.001）。住院次数、住院时间和急诊就诊次数也减少，而功能得到改善（个人和社会表现总分从 46.06±118.7 增加到 60.86±18.68，p<0.001）。联合治疗也显著减少了副作用的数量和严重程度，从 Udvalg for Kliniske Undersogelser 总分 10.76±8.04 降至 8.82±6.63（p=0.004）。
这项研究首次提供了证据，表明在 TRS 和其他精神病患者中联合使用氯氮平和棕榈酸帕利哌酮可能是有效和安全的，这表明需要进一步进行氯氮平无反应患者增效策略的随机对照试验。
患有精神分裂症等精神病的患者对抗精神病药物治疗的反应存在差异。大约 30%的患者被认为是治疗抵抗的，这表现为至少两种不同药物治疗后症状控制不足。在这些耐药病例中，应使用氯氮平，因为它已被证明优于其他选择。然而，只有 40%的患者对氯氮平有反应，因此需要确定哪种治疗方法最能增强氯氮平的作用。将氯氮平与长效注射用抗精神病药，特别是棕榈酸帕利哌酮联合使用，可能是一种有用的策略。我们进行了一项多中心研究，纳入了 50 例治疗抵抗性精神分裂症和其他精神病患者，比较了在开始氯氮平和棕榈酸帕利哌酮联合治疗前和治疗后 6 个月的疗效和耐受性。我们的研究表明，这种联合治疗可能是有效且更安全的，为未来的临床试验奠定了基础。
