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實證醫學競賽
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D30008 黃詩涵
OUTLINE - 6A
Analysis 臨床場景分析
Ask 提出臨床問題
Acquire 搜尋最有用的資料
Appraisal 嚴格評讀文獻
Apply 應用到病人身上
Audit 自我評估
2
1
ANALSIS
臨床場景分析
3
CLINICAL SCENARIO
老王因為兩膝疼痛被診斷有骨關節炎
(osteoarthritis) ,進聽說葡萄糖胺 (glucasamine)
對於減少膝蓋疼痛頗有效果,並不會比非類固消
炎劑差,是真的嗎 ?
患者的考量問題
1. 在骨關節炎的患者,使用葡萄糖胺,相較於
NSAID ,對減少膝蓋疼痛的療效差異。
2. 在骨關節炎的患者,使用葡萄糖胺,相較於
NSAID 所產生的副作用差異 ?
背景資訊
6
相關知識
疾病說明:
Osteoarthritis (OA) was previously thought to be a normal consequence of
aging, thereby leading to the term degenerative joint disease. However, it is
now realized that OA results from a complex interplay of multiple factors,
including joint integrity, genetics, local inflammation, mechanical forces, and
cellular and biochemical processes.
常見病因、危險因子 / 機轉:
OA is linked to one or more factors, such as aging, occupation, trauma, and
repetitive, small insults over time. These associations are strongest for OA of
the knee and hand and are less strong for the hip.
相關知識
常見治療方法 / Indication :
治療效果:
8
2
ASK
提出臨床問題
Patient > Intervention > Comparison > Outcome
9
• PICO – 1
在骨關節炎的患者,使用葡萄糖胺,相較於
NSAID ,對減少膝蓋疼痛的療效差異。
Intervention Glucosamine
Comparison NSAID
Clinical outcomes
Outcome (Quality of life, Pain, Progression)
■ 治療 / 預防 □診斷 □危害 / 病因 □預後
Type of Question
□其他
• PICO – 2
在骨關節炎的患者,使用葡萄糖胺,
• 相較於 NSAID 所產生的副作用差異 ?
Intervention Glucosamine
Comparison NSAID
Ref.
Users' Guides to the Medical Literature: A Manual for
Evidence-Based Clinical Practice2nd Edition. Gordon
Guyatt, Drummond Rennie, Maureen O. Meade, and 12
Deborah J. Cook. 2008, ISBN: 978-0-07-159036-5
3
ACQUIRE
搜尋最有用的資料
MeSH Term Integrated with Search Strategy
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MeSH EXAMPLE
14
SEARCH STRATEGY
資料庫資源:■ ACCESSSS ■Cochrane Library ■PubMed ■Dynamed
P I C O
knee “Glucosamine” “NSAID” 1. Quality of life
osteoarthritis [Mesh] [Mesh] 2. Pain
3. Progression
Rate
6S MODEL
DiCenso A, Bayley L, Haynes RB. Accessing preappraised evidence: fine-tuning the 5S model into a 6S 16
model. ACP J Club 2009;151:JC3-2, JC3-3. Reproduced by EVMS Brickell Medical Sciences Library
PUBMED SEARCH
17
18
19
N = 10 N = 11 N = 27
搜尋文獻共 48 篇
不符合 PICO
排除
重複文章 N=42
品質不佳
文章較舊
其他國語言
6篇
20
Pubmed
RTC+systematic review, 2015
1. Efficacy and safety of glucosamine, diacerein, and NSAIDs in osteoarthritis
knee: a systematic review and network meta-analysis. (2015)
3. A clinical study on glucosamine sulfate versus combination of glucosamine non RCT, not Glucosamine vs
sulfate and NSAIDs in mild to moderate knee osteoarthritis. (2012) NSAID, research was too old
Cochrane
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Impact Factor: 1.68 Ranking: 84/124
22
Patient
Systemic Review
25
Yes Can‘t tell No
1. Did the review address a clearly
focused question? V
本篇論文
情境
與情境相同
Mid-year-old man
P with knee O
osteoarthritis
I Glucosamine O
C NSAID O
O Clinical outcomes O
26
Yes Can‘t tell No
2. Did the authors look for the right
type of papers? V
31
Yes Can‘t tell No
4. Did the review’s authors do enough
to assess the quality of the included V
studies?
Muller FH U U Y Y Y Y
Noack W U U Y Y Y Y
Rindone JP
U U Y U Y U Did not mention about ITT
Pelletier JP Y Y Y N Y Y
Reginster JY Y Y Y N N Y
Dougados M Y Y Y N Y Y
Pavelka K Y Y Y N Y Y
Braham R N N Y Y Y Y
Cibere J Y Y Y Y Y Y
33
Yes Can‘t tell No
4. Did the review’s authors do enough
to assess the quality of the included V
studies?
> 2 Assessor O
Valid criteria O
34
Yes Can‘t tell No
5. If the results of the review have
been combined, was it reasonable to V
do so?
Direct comparisons of continuous outcomes were measured at the end of each study between
glucosamine versus placebo and diacerein versus placebo and were then pooled using an
unstandardized mean difference (UMD). Heterogeneity of the mean difference across
studies was checked using the Q statistic, and the degree was quantified using the I 2 statistic. If
heterogeneity was present (P value <0.10 or the I 2 > 25%), the UMD was estimated using a random effects
model; otherwise, a fixed-effects model was applied.
For dichotomous outcomes, a relative risk (RR) of adverse reactions of treatment comparisons
at the end of each study was estimated and pooled. Heterogeneity was assessed using the same
method as mentioned previously. If heterogeneity was present, the DerSimonian and Laird method [10]
was applied for pooling; otherwise, the fixed-effects model by inverse variance method was applied. Meta-
regression was applied to explore the source of heterogeneity (for example, mean age, percentage of
females, bone mass index (BMI), Kellgren-Lawrence grading, duration of OA) if data was available.
Publication bias was assessed using contour-enhanced funnel plots [11,12] and Egger tests [13].
For indirect comparisons, network meta-analyses were applied to assess all possible effects of
treatment measured at different times if summary data were available for pooling [14-16]. A linear
regression model weighted by inverse variance was applied to assess the treatment effects with
35
adjustment for study effects and time for continuous outcomes. For adverse events, a mixed-effect Poisson
regression was applied to assess treatment effects [15].
Yes Can‘t tell No
6. What are the overall results of the
review? V
● pain VAS
● total WOMAC scores
● subWOMAC scores
Primary ● Lequesne algofunctional
Outcome index
● Joint space width
including pain, stiffness, and
function
36
The mean VAS was −0.90 (95% CI: −1.67, −0.14) units
signifi- cantly lower in glucosamine than in NSAIDs
(Table 2).
37
38
Yes Can‘t tell No
7. How precise are the results?
V
39
Yes Can‘t tell No
8. Can the results be applied to the
local population? V
40
Yes Can‘t tell No
9. Were all important outcomes
considered? V
● Pain VAS
● Total WOMAC scores
Outcome ● SubWOMAC scores
● Lequesne algofunctional index
● Joint space width
Including pain, stiffness, and function
41
Yes Can‘t tell No
10. Are the benefits worth the harms
and costs? V
42
評讀總表
1. Did the study address a clearly focused issue?
2. Was the cohort recruited in an acceptable way?
3. Do you think all the important, relevant studies
were included?
4. Did the review’s authors do enough to assess the
quality of the included studies?
5. If the results of the review have been combined,
was it reasonable to do so?
6. What are the overall results of the review?
7. How precise are the results?
8. Can the results be applied to the local population?
9. Were all important outcomes considered?
10. Are the benefits worth the harms and costs?
43
評讀偏誤
1. NSAID 的項目、頻次、使用方式?
44
• 證據等級
45
5
APPLY & AUDIT
應用到病人身上 & 自我評估
46
1. 我們和研究中的病人是否非常不
同,而不能應用此結果?
24/27 of the studies included OA of the knee
由於病人資訊不足,因此假定病人為體重正常且超過 42 歲之中年男
子,又題目寫最近聽說,合理假設老王被診斷 OA 已超過 1.6 年,因此
符合我們資料中的範圍。
• 這樣的治療是否有提供?
Yes, 如 OSAMINE 250MG
• 經濟考量?
與非類固醇消炎止痛藥相比,一樣都有超級大包裝,
價格相對昂貴但是副作用相對較少,較難以比較使用 NSAID 的經濟考量
48
由於每個人對疼痛
的感受不同,使用
止痛藥 / 葡萄糖胺的
習慣也不同,因此
較難以比較價格
49
3. 我們的病人使用 Glucosamine 替
代 NSAID 治療骨關節炎可能從治療
中得到什麼好處或壞處?
好處 壞處
● Glucosamine 有較少的副 ● 使用 glucosamine 顯著較
作用 NSAID 更好之處未明
● Glucosamine 對疼痛的改
善較 NSAID 顯著
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4. 對於我們要預防的結果及我們所提供
的治療,病人的價值觀和期望值為何?
Contexual Features
Quality of Life
社會環境因素
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用病人能理解的語言提供建議
王先生您好,目前有臨床證據支持硫酸鹽葡萄糖胺可以改善退化性
關節炎所產生的疼痛。但是並沒有研究告訴我們市面上時常提及的
「潤滑關節,保護骨頭」的效果。另外,維骨力和非類固醇消炎藥在
疼痛緩解上也沒有顯著的差別,目前對他們的長期作用並沒有進一步
了解。不過葡萄糖胺也沒有什麼特別需要擔心的副作用,所以如果已
經買了的話就先吃吧。只是市售葡萄糖胺相關產品有可能含有許多不
明添加物,在購買的時候請小心。
由於健保已經取消維骨力的給
付,在價錢上會比非類固醇消炎藥稍
貴一點。但考量到非類固醇消炎藥可
能造成的腸胃道不適,建議還是使用
葡萄糖胺更適合。
52
THANKS FOR YOUR ATTENTION