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一项多中心、随机、交叉研究比较了奥氮平口崩片与普通口服片剂在患者中的偏好。

Patients' preference for olanzapine orodispersible tablet compared with conventional oral tablet in a multinational, randomized, crossover study.

机构信息

Department of Psychiatry and Psychotherapy, Semmelweis University, Budapest, Hungary.

出版信息

World J Biol Psychiatry. 2010 Oct;11(7):894-903. doi: 10.3109/15622975.2010.505663.

Abstract

OBJECTIVES

The aim of this study was to compare patients' preference for olanzapine orodispersible tablet (ODT) with oral conventional tablet (OCT).

METHODS

A 12-week randomized, crossover, multinational, open-label study was conducted to estimate the proportion of patients preferring ODT or OCT. Outpatients with stable schizophrenia on OCT monotherapy were randomly assigned 1:1 to ODT or OCT. Compliance and drug attitude were measured using the Drug Attitude Inventory (DAI-10) and Medication Adherence Form (MAF) scales; tolerability and safety by Association for Methodology and Documentation in Psychiatry (AMDP-5) questionnaire and adverse event summary.

RESULTS

A total of 175 patients answered a preference question: 106 (61%) preferred ODT and 48 (27%) preferred OCT (P<0.001 adjusted for treatment sequence); 21 (12%) expressed no preference. There was no significant change in DAI-10 with either formulation. MAF was above 75% in 94% vs. 93% of patients on ODC and OCT, respectively. Compliance as measured by tablet count was above 98% on both formulations. The adverse event profiles did not differ between formulations. Mean weight increase over 6 weeks on ODT was 0.8 kg and on OCT was 0.6 kg.

CONCLUSIONS

Given the importance of patients' preference for treatment planning and success, the ODT formulation should be routinely considered as a treatment option.

摘要

目的

本研究旨在比较奥氮平口崩片(ODT)与口服普通片(OCT)的患者偏好。

方法

一项为期 12 周的随机、交叉、多国、开放性研究,旨在估计患者对 ODT 或 OCT 的偏好比例。接受 OCT 单药治疗的稳定精神分裂症门诊患者按 1:1 随机分配至 ODT 或 OCT 组。采用药物态度量表(DAI-10)和用药依从性量表(MAF)评估依从性和药物态度;采用精神病学方法和文献协会(AMDP-5)问卷和不良事件总结评估耐受性和安全性。

结果

共有 175 名患者回答了偏好问题:106 名(61%)患者更喜欢 ODT,48 名(27%)患者更喜欢 OCT(P<0.001,调整了治疗顺序);21 名(12%)患者表示无偏好。两种制剂的 DAI-10 均无显著变化。MAF 分别在 94%和 93%的 ODC 和 OCT 患者中超过 75%。两种制剂的药物计数均超过 98%。两种制剂的不良事件谱无差异。ODT 组在 6 周内的平均体重增加 0.8 公斤,OCT 组为 0.6 公斤。

结论

鉴于患者对治疗计划和成功的偏好的重要性,ODT 制剂应常规考虑作为一种治疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/671e/2981076/d812e30890e6/swbp11-894-f1.jpg

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