1 / 21

精 神 科 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

精 神 科 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading. 報告人： 林政曄 Email:146102@cch.org.tw 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 .

topaz
Download Presentation

精 神 科 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 精 神 科實 證 期 刊 閱 讀 報 告EBM-style Journal Reading 報告人： 林政曄 Email:146102@cch.org.tw 指導臨床教師：鄭怡君醫師 日期：2012/07/19 地點：精神科討論室

  2. 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

  3. Clinical Uncertainty → PICO 問題 If antidepressant agent decreases urinary symptoms like frequency and urgency in depressive patient ?

  4. 臨床個案的PICO Type of Question＆: Therapy

  5. 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 #2Serotonin #1and#2 34

  6. 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 1 0 0 , 3 3 7 – 3 4 5 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

  7. 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

  8. The Study: （研究效度）- 2

  9. 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.

  10. 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).

  11. The Study: （研究效度）- 12本篇文獻的PICO (T)

  12. The Evidence: （研究重要結果）-1

  13. The Evidence: （研究重要結果）-2

  14. 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

  15. 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.

  16. 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.

  17. 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.

  18. 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

  19. References: • 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 • 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 • 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

  20. 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

  21. 敬請指教

More Related