臨床場景(Clinical Scenario) 60 y/o女性農婦,20歲結婚後就跟著先生經營農場 ,主要種植柑橘和玉米。平時身體狀況不錯,只是 血中尿酸自30歲起就發現一直在9.0以上,因為沒有 症狀所以一直不管它。10年前開始左大腳趾關節腫 痛過幾次,每次吃個3天普拿疼後都會好。5年前開 始兩個膝蓋開始有酸痛現象,因此就不再從事搬運 農作物的工作,但仍然每天去巡視農場。最近因右 膝疼痛越來越厲害,影響走路而去看醫生,被診斷 為退化性關節炎(osteoarthritis)。在美國工作的親 戚寄了”維骨力” (glucosamine)給她,她來醫院請 教是否可吃,有沒有效? 會不會影響尿酸? 1 Patient’s concern 維骨力 (glucosamine)對於退化性關節炎 (osteoarthritis)有沒有疼痛緩解的效果? 維骨力 (glucosamine)會不會影響尿酸值? 2 臨床問題(PICO-I) P (Patient/Problem) I (Intervention) C (Comparison) O (Outcomes) Type Patients with knee osteoarthritis Glucosamine Placebo Pain management ■介入型 □病因型 □診斷型 □預後型 □頻率型 □現象型 6 臨床問題(PICO-II) P (Patient/Problem) I (Intervention) C (Comparison) O (Outcomes) Type Patients with knee osteoarthritis Glucosamine Placebo Adverse effects (uric acid...etc.) ■介入型 □病因型 □診斷型 □預後型 □頻率型 □現象型 7 搜尋策略 • 我們的「搜尋資源」包括: 8 搜尋策略,關鍵字 P Patients with osteoarthritis Key words Osteoarthritis I Glucosamine Key words Glucosamine C Key words O Placebo nil Pain management Key words 10 搜尋歷程 Syntheses Question type Study design Diagnostic test Prospective, blinded cross-sectional study comparing with gold standard 診斷性檢驗或檢查 Prognosis 預後 Etiology 病因 Therapy 治療 Prevention 預防 Cost effectiveness 成本效益 前瞻性、盲法、與黃金標準進行比較之斷面研究 Cohort study > Case control study > Caseseries study 世代研究> 病例對照研究> 病例系列研究 Cohort study > Case control study > Caseseries study 世代研究> 病例對照研究> 病例系列研究 Systematic review of randomized control trials> Randomised control trial (RCT) Randomised control trial (RCT) 隨機對照試驗 Economic analysis 經濟分析 11 搜尋結果 標題 摘要內文 資料庫 找到文章數量 符合PICO的文章數量 1 1 24 2 22 3 12 1 17 文章選定 Level of evidence: 1 Systemic review of RCTs 符合臨床問題 研究設計適當 有全文 (Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence) 18 文章選定 本篇研究內容 我們設計的PICO P Patients with osteoarthritis Yes I Glucosamine Yes C Placebo/NSAID Yes O Pain relief/Functional preservation/Toxicity Yes 19 嚴格評讀 Critical Appraisal Skills Program (CASP) Validity Importance Practice • 本篇系統回顧是否提出明確定義的問題? • 選擇收錄研究的標準是否適當? • 本篇回顧的搜尋策略是否可能有遺漏合適的臨床試驗? • 其所收錄的研究是否有效力的研究? • 若為meta-analysis,所收錄的研究是否有足夠的一致性可 以合併研究資料? • 研究結果呈現的適當性? 20 文獻評讀 CASP- Systematic review • 本篇系統回顧是否提出明確定義的問題? Yes To assess the effectiveness and toxicity of glucosamine in the pharmacological management of OA. Both symptomatic effectiveness and structural effectiveness (that is, delay in radiological progression of OA) were evaluated. 21 嚴格評讀 Validity CASP- Systematic review • 選擇收錄研究的標準是否適當? Yes The first criteria were used to screen all citations that involved glucosamine in the management of OA. The second criteria were used to identify those studies that met the following additional requirements: 1) RCTs evaluating the efficacy and toxicity of glucosamine in OA, 2) both placebo-based and comparative studies were eligible, 3) both single-blinded and double-blinded trials were eligible, 4) studies to be included in the quantitative portion of the review (meta-analysis) must have presented suitable quantitative data for pooling across trials, 5) studies that enrolled participants with OA at any body site were eligible with the only exception being studies that evaluated glucosamine in temporomandibular joint (TMJ) disorders, 6) only studies which evaluated glucosamine-only preparations were included (studies which evaluated combination products containing glucosamine in association with other active compounds, for example chondroitin, were excluded), 7) glucosamine could have been administered by any route. 22 嚴格評讀 Validity CASP- Systematic review • 本篇回顧的搜尋策略是否可能有遺漏合適的臨床試驗? Yes A MEDLINE search (1966 to November 1999) was used to identify all relevant RCTs for the first version of this Cochrane Review. For the second version of the Cochrane Review, all searches were updated (in January 2005). The same MEDLINE search strategy was extended for this updated version of the review (up to week 1, January 2008). MEDLINE In-Process and other non-indexed citations were also searched (January 2008); MEDLINE Daily Update was searched (January 2008). In addition, the Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Database of Systematic Reviews (CDSR) (The Cochrane Library), AmericanCollege of Physicians (ACP) JournalClub, andDatabase of Abstracts of Reviews of Effectiveness (DARE) were searched (up to January 2008); Allied and Complementary Medicine (AMED) was searched (1985 to January 2008); and EMBASE was searched (1980 to week 2, January 2008 23 嚴格評讀 Validity CASP- Systematic review • 其所收錄的研究是否具有效力(quality)? Yes Two review authors (TT and TP or LM) used the screening criteria to review all identified citations independently. All citations identified by either investigator were retrieved and analyzed for suitability. Authors of abstracts were contacted requesting the full manuscript, including the raw and final data incorporating the results. 24 嚴格評讀 Importance CASP- Systematic review • 結果呈現是否適當?主要的結果是什麼? Yes 25 嚴格評讀 Importance CASP- Systematic review • 結果呈現是否適當?主要的結果是什麼? Yes 26 嚴格評讀 Importance CASP- Systematic review • 結果呈現是否適當?主要的結果是什麼? Yes 27 嚴格評讀 Practice NNT;number needed to treat RR ARR RRR NNT 1.52 [ 1.20, 1.91 ] 17.5% 26.6% 6人 • 試驗終點是否為重要的臨床預後? Yes 28 臨床應用 10 × 10 100位病人使用葡萄糖 胺 有 17位 病 人 的 疼痛 指標Lequesne Index 獲得改善(NNT=6) A B 29 臨床應用 30 Evidence Systemic review of RCTs 35 35