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26 THE JOURNAL OF TAIWAN PHARMACY Vol.28 No.2 Jun. 30 2012
先呈現過渡/維持期(BL【TR】)基準點及過渡期/維持期內的PANSS平均總分,然後呈現雙盲期(BL【DB】) 基準點及雙盲期內的PANSS平均總分。PANSS=Positive and negative Syndrome Scale,活性與負性症狀評量表;ITT=intent-to-treat:意圖治療;LOCF=last observation carried forward,最後觀察值評估;TR=transition,過渡;MA= maintenance,維持,DB=double-blind,雙盲;BL=baseline,基準點
安慰劑組審查約是295天至441天的資料,Sustenna®組審查的是第220天至第407天的資料
分數變化為正,表示有改善。根據ANCOVA模型,以治療組別(安慰劑以及Sustenna®25、100與125mg eq.)和國家為因子。基準點數值為共變數,P值針對PANSS總分(主要療效指標)和PSP(關鍵次要療效指標)以及與安慰劑相較的各種不同劑量進行多重調整,使用以Dunnett-Bonferroni為基礎的平行手們方法。PSP= Personal and Social Performance Scale,個人及社會表現量表。
LOCF分析(BD、BO、無DB/Sustenna®組):當依IDMC建議中止雙盲試驗時,直接進入OLE期的過渡/維持期患者;安慰劑/Sustenna:患者在雙盲期隨機分配至安慰劑,在OLE期則接受Sustenna®/ Sustenna®組:在雙盲期接受隨機分配至Sustenna®組並繼續進入OLE期的患者)。PANSS=Positive and negative Syndrome Scale,活性與負性症狀評量表。OLE= open-label extension,開放式延伸。DB=double-blind,雙盲。LOCF=last observation carried forward,最後觀察值評估。IDMC=Independent Data Monitoring Committee,獨立數據監測委員會。
安慰劑組審查約是172天至313天的資料,Sustenna®組審查的是第119天至第280天的資料
30 THE JOURNAL OF TAIWAN PHARMACY Vol.28 No.2 Jun. 30 2012
6. Cleton et al: Assessment of the dose proportionality of paliperidone palmitate 25, 50, 100 and 150 mg eq., a new long-acting injectable antipsychotic, following adminis-tration in the deltoid or gluteal muscles. Poster presented at ASCPT, April 2-5 2008, Orlando, USA [Available upon request: insert local medical information contact details. Please update with data from manuscript when published]
* 建議每個月一次之劑量** 可根據患者的耐受性及/或療效,調整為較低或較高的劑量
第28卷第2期Jun. 30 2012
精神分裂症藥物 — Paliperidone Palmitate 之剖析
藥學雜誌 第111冊 31
Analysis of Schizophrenia Drug — Paliperidone Palmitate
Chen-Ting Ku
Tsaoyun Psychiatric Center, Department of Health
Abstract
In Taiwan, about 10 million people with schizophrenia, patients with schizophrenia often relapse 2-5 years after diagnosis. This period is a critical period, and will lead to recurrence of disease worsening. Therefore, to avoid the early recurrence of disease progression will help break the cycle, carried out during this critical period of treatment, the influence of the disease may be even more late in the course of the intervention period.
Knowledge of disease-free patients in the case of a sense of disorder, medication compliance is often poor, easy to interrupt drug use relapse of acute symptoms, increased force hospital treatment, the patients functional damage, disease continues to worsen.
A new generation of antipsychotic drugs can block the D 2 dopamine and 5-HT2A receptor, in addition to the symptoms of schizophrenia (positive, negative, cognitive and emotional symptoms) have a wide effect, and the incidence of side effects than traditional antipsychotic drugs is low.
U.S. Food and Drug Administration has approved Sustenna 2009 for the treatment of schizophrenia, Sustenna also in April 2011 by the competent national authority — the Department of Health's pharmaceutical license application process; this will benefit the domestic pharmaceutical schizophrenia patients, once a month to provide a new long-acting antipsychotics, for schizophrenia patients, early use of long-acting antipsychotics (long-acting treatment), to avoid early relapse, reduce disease progression and improve patient "Personal and social function" (PSP, personal and social performance), reconstruction of the patient's future.
7. Hough et al: Paliperidone palmitate maintenance treat-ment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Schizophr Res 2010; 116: 107-117.
8. Gopal et al: A 52-week open-label study of the safety and tolerability of paliperidone palmitate in patients with schizophrenia. J Psychopharmacol 2010 Jul 8. [Epub
ahead of print] DOI: 10.1177/0269881110372817.9. Pandina et al: A randomized, placebo-controlled study to
assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophre-nia. J Clin Psychopharmacol 2010; 30: 235-244.