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抗精神病药物治疗首发或复发精神分裂症患者的疗效和安全性比较:一项真实世界观察性研究。

Comparative effectiveness and safety of antipsychotic drugs in patients with schizophrenia initiating or reinitiating treatment: A Real-World Observational Study.

机构信息

Département de Psychiatrie et Neurosciences, Université Laval, Québec City, Québec, Canada.

Groupe de Recherche PRIMUS, Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke (CRCHUS), Sherbrooke, Québec, Canada.

出版信息

Acta Psychiatr Scand. 2022 May;145(5):456-468. doi: 10.1111/acps.13413. Epub 2022 Mar 1.

DOI:10.1111/acps.13413
PMID:35158404
Abstract

OBJECTIVE

To compare the effectiveness and safety of various second-generation antipsychotics (SGAs), newer oral and long-acting injectable (LAI) SGAs, and first-generation antipsychotics (FGAs) treatments in patients with schizophrenia or schizoaffective disorder (SCZ).

METHODS

This retrospective cohort study included medical administrative information for patients with a diagnosis of SCZ living in Quebec (Canada), initiating or reinitiating at least one antipsychotic (AP) drug (with a clearance baseline period of 12 months without any APs). Effectiveness was defined by a reduced risk of hospitalization for mental disorder and discontinuation, and safety by a reduced risk of all-cause death and hospitalization for non-mental disorder, 2 years after AP initiation or reinitiation. Cox proportional hazard models were used to estimate the events associated with different antipsychotics compared with oral olanzapine.

RESULTS

The study cohort included 19,615 patients initiating or reinitiating an antipsychotic drug between January 2006 and December 2015. Results showed better effectiveness of clozapine (adjusted HR 0.36, 95% CI 0.30-0.42, p < 0.0001) and LAI SGAs (adjusted HR 0.56, 95% CI 0.51-0.61, p < 0.0001) compared with oral olanzapine when adding discontinuation to hospitalizations for mental disorder as a composite measure of effectiveness, as opposed to oral FGAs (adjusted HR 1.36, 95% CI 1.27-1.46, p < 0.0001) and LAI FGAs (adjusted HR 1.22, 95% CI 1.12-1.32, p < 0.0001). Most APs were as safe as oral olanzapine.

CONCLUSION

The effectiveness of LAI SGAs and clozapine appears to justify their use and are as safe as a recognized treatment (oral olanzapine) in Quebec (Canada).

摘要

目的

比较第二代抗精神病药物(SGAs)、新型口服和长效注射(LAI)SGAs 与第一代抗精神病药物(FGAs)治疗精神分裂症或分裂情感障碍(SCZ)患者的疗效和安全性。

方法

这是一项回顾性队列研究,纳入了在魁北克(加拿大)居住并诊断为 SCZ 的患者的医疗行政信息,这些患者至少开始或重新开始使用一种抗精神病药物(AP)(在没有任何 AP 的情况下,有 12 个月的清除基线期)。有效性定义为精神障碍住院和停药风险降低,安全性定义为全因死亡和非精神障碍住院风险降低,在 AP 起始或重新起始后 2 年。使用 Cox 比例风险模型来估计与口服奥氮平相比,不同抗精神病药物相关的事件。

结果

研究队列纳入了 19615 例在 2006 年 1 月至 2015 年 12 月期间开始或重新开始使用抗精神病药物的患者。结果表明,与口服奥氮平相比,氯氮平(调整后的 HR 为 0.36,95%CI 为 0.30-0.42,p<0.0001)和 LAI SGAs(调整后的 HR 为 0.56,95%CI 为 0.51-0.61,p<0.0001)的疗效更好,当将精神障碍住院和停药作为有效性的综合指标时,而不是口服 FGAs(调整后的 HR 为 1.36,95%CI 为 1.27-1.46,p<0.0001)和 LAI FGAs(调整后的 HR 为 1.22,95%CI 为 1.12-1.32,p<0.0001)。大多数 AP 与口服奥氮平一样安全。

结论

LAI SGAs 和氯氮平的疗效似乎证明了它们的使用是合理的,并且在魁北克(加拿大)与公认的治疗方法(口服奥氮平)一样安全。

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