Chue Pierre, Jones Barry, Taylor Cindy C, Dickson Ruth
University of Alberta Hospital, Edmonton, Alberta.
Can J Psychiatry. 2002 Oct;47(8):771-4. doi: 10.1177/070674370204700809.
This pilot study investigates the dissolution profile, tolerability, and acceptability of an orally disintegrating olanzapine tablet in patients with schizophrenia.
Eleven patients with schizophrenia stabilized on oral olanzapine (mean dosage 12.7 mg daily [SD5.2]) were given an orally disintegrating olanzapine tablet, rather than their usual tablet, daily for 7 days. At each visit, visual assessments were made for elapsed time to initial disintegration (every 15 seconds) and complete disintegration (every 1 minute). At the end of the study, patients completed a drug-acceptance questionnaire.
The mean time to initial disintegration was 15.78 seconds, and mean time to complete disintegration was 0.97 minutes. All patients found the orally disintegrating tablet acceptable and expressed positive comments. Nonserious clinically significant adverse events, asthenia, purpuric rash, headache, depression, and insomnia (preexisting, except for asthenia and insomnia) were reported in 3 patients.
The orally disintegrating olanzapine tablet disintegrates rapidly and is a well-tolerated and acceptable alternative to standard olanzapine tablets in patients with schizophrenia.
本初步研究调查了口服崩解型奥氮平片在精神分裂症患者中的溶出度、耐受性和可接受性。
11名口服奥氮平病情稳定的精神分裂症患者（平均日剂量12.7毫克[标准差5.2]），连续7天每日服用口服崩解型奥氮平片而非其常用片剂。每次访视时，对初始崩解（每15秒）和完全崩解（每1分钟）的经过时间进行视觉评估。研究结束时，患者完成一份药物接受情况问卷。
初始崩解的平均时间为15.78秒，完全崩解的平均时间为0.97分钟。所有患者均认为口服崩解片可接受并给出了积极评价。3名患者报告了非严重的具有临床意义的不良事件，即乏力、紫癜性皮疹、头痛、抑郁和失眠（除乏力和失眠外，均为既往存在）。
口服崩解型奥氮平片崩解迅速，对于精神分裂症患者而言，是一种耐受性良好且可接受的标准奥氮平片替代药物。
