The Study: (研究效度)
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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: 林政曄
Email:[email protected]
指導臨床教師:鄭怡君醫師
日期:2012/07/19
地點:精神科討論室
Clinical Scenario (臨床情境)
A 29 years old female admitted due to depressed mood,
outside wandering since 1 week before admission.
She presented with depressed mood, reference delusion,
delusional atmosphere, illogical thinking and multiple somatic
complain.
Obvious urinary tract symptoms such as urgency and
frequency.
Family history: Sister schizophrenia
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Clinical Uncertainty → PICO 問題
If antidepressant agent decreases urinary
symptoms like frequency and urgency in
depressive patient ?
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臨床個案的PICO
Patient / Problem
Depressive patient with
urgency and frequency
Intervention
Antidepressant
Comparison
Placebo
Outcome
Improvement of frequency
Type of Question&: Therapy
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Search Terms & Strategy:
(搜尋關鍵字與策略)
資料庫:PubMed
搜尋日期: 2012/07/10
搜尋關鍵字與策略:
Search #1 Overactive bladder
Search #2 Serotonin
#1 and #2 34
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Best available evidence:
(挑選可獲得之最佳研究證據)
Citation/s:
Duloxetine compared with placebo for
treating women with symptoms of
overactive bladder
2 0 07 B J U I N T E R N A T I O N A L
100,337–345
Lead author's name :
William D. Steers, Sender Herschorn*, Karl J. Kreder, Kate Moore, Kris
Strohbehn,Ilker Yalcin§ and Richard C. Bump§for the Duloxetine OAB
Study Group
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The Study: (研究效度)- 1
Inclusion criteria:
12-week, randomized, placebo-controlled, double-blind, 30 study
centres
women aged ≥ 18 years
predominant symptoms of OAB for ≥ 3 consecutive months
Exclusion criteria:
a postvoid residual urine volume (PVR) of >100 ml
a mean 24-h total voided volume of ≥3 L
documented on a 2-day frequency-volume chart (FVC)
a positive urine culture (>100 000 colony-forming units/mL) or four or more UTIs during the year
regular use of medications for OAB symptoms within a month
any previous use of duloxetine
continence surgery within 6 months or any major surgery within 3 months of enrolment
pelvic organ prolapse greater than ICS Stage II
Any nonpharmacological intervention (e.g. electrical stimulation, bladder training,
continence devices) within 3 months of enrolment
pelvic floor muscle training that had not been stable for 3 months or would not remain stable during the
trial
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The Study: (研究效度)- 2
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The Study: (研究效度)- 3
A significantly higher proportion of patients in the placebo than in the duloxetine
group completed the study (78% vs 59%, P< 0.001), the result of a significantly higher
discontinuation rate because of AEs in the duloxetine than in the placebo group.
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The Study: (研究效度)- 4
Efficacy analyses considered one primary efficacy variable, the
change in the number of voiding episodes/24-h (VE24, reflecting
the overall effect of treatment on frequency)
Secondary variables
Mean daytime (awake hours) VI (reflecting the frequency symptom with the
greatest effect while awake)
number of UI episodes/24 h (UIE)
the mean volume per void (functional bladder capacity),
number of continence pads used/24 h
number of nocturic (sleep hours) episodes/24h (reflecting the frequency
symptom with the greatest effect while asleep).
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The Study: (研究效度)- 12本篇
文獻的PICO (T)
Patient /
Problem
Patients with overactive bladder and
urodynamic detrusor overactivity
Intervention
Duloxetine 80mg for 4 weeks and 120mg
for another 8 weeks
Comparison Placebo
Outcome
Decrease in voiding episode, and increase
in daytime voiding interval
Time
12 weeks
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The Evidence: (研究重要結果)-1
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The Evidence: (研究重要結果)-2
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The Evidence: (研究重要結果)-3
There were significant treatment differences favouring duloxetine
over placebo
decreases in VE24
increases in mean daytime VI,
decreases in UIE overall
Of patients whose mean VI were < 2 h on the FVC completed
before randomization, 48.2% of duloxetine-treated and 21.3% of
placebo-treated patients had VIs of ≥ 2 h during treatment
(P<0.001).
Level of Evidence: 2b
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Comment & Discussion: -1
The positive efficacy results in the present study differ
from the negative results in three earlier phase 2
duloxetine clinical trials, completed between 1995 and
1997.
The lack of response to duloxetine in these trials was
probably the result of the low doses used.
The short duration of active treatment and relatively
few patients might also contribute to the differences.
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Comment & Discussion: -2
This implied that any benefit of duloxetine might
require higher drug exposures.
Thus, in the present proof-of-concept study we
increased the dose of duloxetine from 40-mg twice
daily (the optimally effective dose for SUI) to 60-mg
twice daily after 4 weeks, to be certain that, had
efficacy not been apparent at 4 weeks, it was not
because of an inadequate dose.
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Comment & Discussion: -3
Figure 3A,B suggests some progressive improvement
in VE24 and daytime VI between visit 4 (when
patients were taking duloxetine 80 mg/day) and visits
5 and 6 (when patients were taking duloxetine 120
mg/day).
This could be a result of progressive improvement
over time or could reflect enhanced efficacy at the
higher dose of duloxetine.
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回到臨床個案情境
Clinical bottom line 臨床決策底線
In patient with depression and overactive
bladder, Duloxetine decrease in voiding
episode, and increase in daytime voiding
interval
證據等級 2b 建議等級:B
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References:
1.
Cardozo L, Drutz HP, Baygani SK, Bump RC, for the Duloxetine Severe
UI Study Group. Pharmacological treatment of women awaiting surgery
for stress urinary incontinence. Obstet Gynecol 2004; 104: 511–9
2.
Hurley DJ, Turner CL, Yalcin I, Viktrup L, Saygani SK. Duloxetine for the
treatment of stress urinary incontinence: an integrated analysis of safety.
Eur J Obstet Gynecol Reprod Biol 2006; 125: 120–8
3.
Lubeck DP, Prebil LA, Peeples P, Brown JS. A health related quality of
life measure for use in patients with urge urinary incontinence: a
validation study. Qual Life Res 1999; 8: 337–44
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結 論 (標題 Title)
Duloxetine was better than placebo for
treating women with ‘wet’ and ‘dry’
symptoms of overactive bladder
associated with detrusor overactivity.
Kill or Update By(下次更新日期):
Jan. 19, 2013
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