Transcript The Study: （研究效度）

精神科
實證期刊閱讀報告
EBM-style Journal Reading
報告人：R1 陳佳儒 Email: [email protected]
指導臨床教師：莫庚翰醫師/廖以誠醫師
日期：11/19/2009
地點：鹿東分院二樓會議室
Clinical Scenario （臨床情境）
 19歲男性，診斷為Psychotic disorder, NOS,
suspect schizophrenia.
 入院後主線用藥為paliperidone 9mg/day，
個案自訴被害想法及幻聽有減少。但四周後
精神症狀開始惡化，自言自語並出現怪異行
為。故劑量增加為12mg/day，但改善不顯著。
 與家屬討論後更換主線用藥為olanzapine
15mg/day，並轉往國泰醫院汐止分院繼續治
療。
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Clinical Uncertainty → PICO 問題
For first-episode psychosis, which
antipsychotics would significantly
reduce the severity of psychotic
symptoms?
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臨床個案的PICO
Patient / Problem
First-episode psychosis
Intervention
Antipsychotics
Comparison
Placebo
Outcome
Improvement of
PANSS score
Type of Question:
Treatment
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Search Terms & Strategy:
（搜尋關鍵字與策略）
 資料庫：Pubmed
 搜尋日期： 11/01/2009
 搜尋關鍵字與隅策略：
 #1 (Schizophrenia AND first episode patient) AND
((clinical[Title/Abstract] AND trial[Title/Abstract]) OR
clinical trials[MeSH Terms] OR clinical
trial[Publication Type] OR random*[Title/Abstract] OR
random allocation[MeSH Terms] OR therapeutic
use[MeSH Subheading])
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Best available evidence:
（挑選可獲得之最佳研究證據）
 Citation/s:
 Effectiveness of antipsychotics in first-episode
schizophrenia and schizophreniform disorder on
response and remission: An open randomized
clinical trial (EUFEST) Schizophrenia Research,
Volume 115, Issue 2, Pages 97-103 , Sep 2009
 Lead author's name :
 H. Boter, J. Peuskens, J. Libiger, W. Fleischhacker,
M. Davidson, S. Galderisi, R. Kahn
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The Study: （研究效度）- 1
 A total of 50 centers participated in 13 European countries
and Israel. Eligible patients were 18–40 years of age and met
DSM-IV criteria for schizophrenia, schizophreniform, or
schizoaffective disorder confirmed by the Mini International
Neuropsychiatric Interview Plus.
 Patients were excluded if:
1. more than 2 years had passed since the onset of positive
symptoms
2. any antipsychotic had been used exceeding 2 weeks in the
previous year or 6 weeks lifetime
3. patients had a known intolerance to one of the study drugs
4. patients met any of the contraindications for any of the study
drugs as mentioned in the (local) package insert texts.
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The Study: （研究效度）- 2
 Patients were randomized by a dedicated web
based online system to: haloperidol 1–4 mg/d,
amisulpride 200– 800 mg/d, olanzapine 5–20
mg/d, quetiapine 200–750 mg/d, or ziprasidone
40–160 mg/d.
 All study medications were administered orally
within the dose ranges at the treating
physician's discretion.
 The use of mood stabilizers, benzodiazepines,
antidepressants, and anticholinergics was
allowed and documented.
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The Study: （研究效度）- 3
 The following formula was used to calculate
response rates: ((PANSS baseline
−30)−(PANSS follow-up−30))×100/
(PANSSbaseline−30)
 Remission was defined as a score of mild or
less(≤3) on eight predefined PANSS items —
each maintained for at least 6 months:
delusions (P1), conceptual disorganization
(P2), hallucinatory behavior (P3), blunted affect
(N1), social withdrawal (N4), lack of
spontaneity (N6), mannerisms/ posturing (G5),
and unusual thought content(G9)
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The Study: （研究效度）- 2
 Level of Evidence: 1b
(multicenter, open randomized clinical trial)
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The Study: （研究效度）- 3
本篇文獻的PICO (T)
Patient /
Problem
Patients of first episode schizophrenia
and schizophreniform disorder
Intervention Atypical antipsychotics
Comparison Haloperidol
Outcome
Response and remission on PANSS score
Time
12 months
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The Evidence: （研究重要結果）- 1
 Of the 498 patients enrolled, 200 (40%)
were female, 162 (33%) were
antipsychotic naïve, 198 (40%) had
schizophreniform disorder, 35 (7%) had
schizoaffective disorder, and 265 (53%)
had schizophrenia.
 Higher proportions of patients on
haloperidol or amisulpride used
anticholinergic drugs (overall p<0.0001),
and higher proportions of patients on
olanzapine used antidepressants (overall
p<0.0001)
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The Evidence: （研究重要結果）- 2
 Patients with ≥50% response within 12
months:
36 (37%) for haloperidol
70 (67%) for amisulpride
70 (67%) for olanzapine
47 (46%) for quetiapine
44 (56%) for ziprasidone.
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The Evidence: （研究重要結果）- 3
 The number of patients who remitted
within 12 months
18 (17%) for haloperidol
42 (40%) for amisulpride
43 (41%) for olanzapine
25 (24%) for quetiapine
23 (28%) for ziprasidone.
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Comment & Discussion: -1
 Patients on a low dose of haloperidol were
less likely to respond or remit within 12
months when compared with patients on
amisulpride, olanzapine, or ziprasidone.
 The most important predictor of ≥50%
response and remission was the use of
amisulpride and olanzapine.
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Comment & Discussion: -2
 Psychiatrists with negative expectations
about haloperidol could have discontinued
treatment with haloperidol sooner.
 For remission, we assumed that nonremitters continued to be non-remitters at
missing observations
 For response, missing observations were
substituted by the LOCF method.
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回到臨床個案情境
Clinical bottom line 臨床決策底線
 For first episode schizophrenia, Patients on
amisulpride, olanzapine, and ziprasidone showed
higher response and remission rates when compared
with patients on low doses of haloperidol.
證據等級1b, 建議等級A
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References:
 Effectiveness of antipsychotic drugs in
first-episode schizophrenia and
schizophreniform disorder: an open
randomized clinical trial. Lancet 371,
1085–1097.
 Remission in schizophrenia: proposed
criteria and rationale for consensus. Am.
J. Psychiatry 162, 441–449..
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結 論 （標題 Title）
For first episode schizophrenia,
amisupride and olanzapine
revealed the most response and
remission rate
Kill or Update By（下次更新日期）:
May. 15, 2010
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