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奥氮平长效注射与利培酮长效注射治疗精神分裂症 12 个月的开放性标签研究:直接、探索性比较。

Treatment-completion rates with olanzapine long-acting injection versus risperidone long-acting injection in a 12-month, open-label treatment of schizophrenia: indirect, exploratory comparisons.

机构信息

Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.

出版信息

Int J Gen Med. 2012;5:391-8. doi: 10.2147/IJGM.S29052. Epub 2012 May 4.

Abstract

BACKGROUND

Little is known about the comparative effectiveness of atypical antipsychotics in long-acting injection formulation. Due to the absence of head-to-head studies comparing olanzapine long-acting injection and risperidone long-acting injection, this study was intended to make exploratory, indirect, cross-study comparisons between the long-acting formulations of these two atypical antipsychotics in their effectiveness in treating patients with schizophrenia.

METHODS

Indirect, cross-study comparisons between olanzapine long-acting injection and risperidone long-acting injection used 12-month treatment-completion rates, because discontinuation of an antipsychotic for any cause is a recognized proxy measure of the medication's effectiveness in treating schizophrenia. Following a systematic review of the literature, two indirect comparisons were conducted using open-label, single-cohort studies in which subjects were stabilized on an antipsychotic medication before depot initiation. The first analysis compared olanzapine long-acting injection (one study) with pooled data from nine identified risperidone long-acting injection studies. The second analysis was a "sensitivity analysis," using only the most similar studies, one for olanzapine long-acting injection and one for risperidone long-acting injection, which shared near-identical study designs and involved study cohorts with near-identical patient characteristics. Pearson Chi-square tests assessed group differences on treatment-completion rates.

RESULTS

Comparison of olanzapine long-acting injection data (931 patients) with the pooled data from the nine risperidone long-acting injection studies (3950 patients) provided almost identical 12-month treatment-completion rates (72.7% versus 72.4%; P = 0.87). When the two most similar studies were compared, the 12-month completion rate for olanzapine long-acting injection was significantly higher than for risperidone long-acting injection (81.3% versus 47.0%; P < 0.001). However, any conclusions drawn from this comparison may be limited by differences in the studies' geographic catchment areas.

CONCLUSION

Using treatment-completion rates as a proxy measure of medication effectiveness, olanzapine long-acting injection did not differ significantly from risperidone long-acting injection when including all eligible studies. However, the findings of this exploratory analysis should be interpreted with caution, considering the methodological limitations of these indirect, cross-study comparisons.

摘要

背景

关于长效注射制剂中,非典型抗精神病药物的比较疗效知之甚少。由于缺乏奥氮平长效注射与利培酮长效注射的头对头研究,本研究旨在对这两种非典型抗精神病药物的长效制剂进行探索性、间接、交叉研究比较,以评估它们在治疗精神分裂症患者方面的有效性。

方法

使用 12 个月的治疗完成率来进行奥氮平长效注射和利培酮长效注射的间接、交叉研究比较,因为任何原因停止使用抗精神病药物都是药物治疗精神分裂症有效性的公认替代指标。在对文献进行系统回顾后,进行了两项间接比较,使用了开放标签、单队列研究,其中受试者在开始使用长效注射前已经稳定地使用了一种抗精神病药物。第一项分析将奥氮平长效注射(一项研究)与从九项已确定的利培酮长效注射研究中汇总的数据进行比较。第二项分析是一项“敏感性分析”,仅使用最相似的研究,一项是奥氮平长效注射,一项是利培酮长效注射,它们具有几乎相同的研究设计,并涉及具有几乎相同患者特征的研究队列。采用 Pearson Chi-square 检验评估治疗完成率的组间差异。

结果

将奥氮平长效注射数据(931 例患者)与九项利培酮长效注射研究的汇总数据(3950 例患者)进行比较,12 个月的治疗完成率几乎相同(72.7%对 72.4%;P=0.87)。当比较两项最相似的研究时,奥氮平长效注射的 12 个月完成率明显高于利培酮长效注射(81.3%对 47.0%;P<0.001)。然而,从这项比较中得出的任何结论都可能受到研究地理范围差异的限制。

结论

使用治疗完成率作为药物有效性的替代指标,在纳入所有合格研究时,奥氮平长效注射与利培酮长效注射无显著差异。然而,考虑到这些间接、交叉研究比较的方法学限制,应该谨慎解释这项探索性分析的结果。

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