Microsoft PowerPoint EBM 臨床藥學部第七組最終版(3)-3.ppt

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1 實證醫學文獻查證競賽 臨床藥學部參賽組別 : 第七組陳成桃 葉爵榮 金秦瑩 年第一次 EBM 活動競賽規則 每組發表時間以 10 分鐘為限, 由評審團進行評分 使用單槍投射器進行發表, 並能於 20 公尺處看清楚為原則 8 分鐘時響鈴兩短聲,10 分鐘時以響鈴一長聲做為提醒, 超過 10 分鐘者應立即停止發表 簡報大綱建議 1. 形成 PICO 的內容 2. 呈現搜尋資料的策略 使用資料庫及搜尋結果 3. 文獻評讀 4. 以去學術化術語的方式 (plain language) 回答病人的問題 5. 比較透過 EBM 的介入方式與傳統介入方式之醫療照護品質之差異 情境一 一位 54 歲外觀無恙之停經後婦女最近在一次遊園活動中接受了足踝部位之骨質疏鬆檢查, 結果骨密度指數為 -2.6 SD, 負責檢查的人員告知婦人有骨質疏鬆症並向婦人推銷骨質疏鬆症藥物 這位女士返家後上網找到一些有關骨質疏鬆症之資料並來到本院門診, 她並無其他共病存在, 首先提及不太瞭解骨質疏鬆症是如何診斷的, 是否足踝部位之骨密度檢查就能確定她有骨質疏鬆症, 是否應做一比較精確的檢查來確定診斷? 情境一 若不治療會有何種後果, 會不會影響生命安全? 如果要治療用何種方式或何種藥物較為恰當? 這些藥物是否會有副作用? 她聽說有 副甲狀腺素 (PTH), 雙磷酸鹽 (bisphosphonates), 補骨挺疏 (strontium ranelate) 等藥物效果很好, 不知如何選擇 你答應她壹週後向她說明 What are the patient s concern? 1 是否足踝部位之骨密度檢查就能確定她有骨質疏鬆症? 2 是否應做一比較精確的檢查來確定診斷? 3 若不治療會有何種後果, 會不會影響生命安全? 4 這些藥物是否會有副作用? 5 她聽說有 副甲狀腺素 (PTH), 雙磷酸 (bisphosphonates), 補骨挺疏 (strontium ranelate) 等藥物效果很好, 如果要治療用何種方式或何種藥物較為恰當?

2 Five Steps of EBM 1 Ask a Clinical Question? 2 Tracking down the best Evidence 3 Critically Appraise Evidence 4 Apply to your patient 5 Evalution Step 1. Ask a Clinical Question? 一位 54 歲接受了足踝部位之骨質疏鬆檢查, 結果骨密度指數為 -2.6 SD, 是否應做一比較精確的檢查來確定診斷? 是否需治療? 治療使用何種藥物較為恰當? 藥物是否會有副作用? PICO 型式 : 治療性 關鍵字 P A 54-year-old postmenopausal woman R/O Osteoporosis Osteoporosis,postmenopausal I C Pharmacological therapy Non Pharmacological therapy Therapy (Bisphosphonates, PTH, Strontium Ranelate, SERMs, Calcitonin, Estrogen, Calcium, Vitamin D) Exercise, Placebo Step 2. Tracking down the best Evidence O Treatment effect Fracture, Treatment effect, Effectiveness, Cost-effectiveness Search Databases Systems Summaries Synopses Syntheses Studies Secondary database Primary database The Taiwanese Osteoporosis Association 骨質疏鬆症之診斷原則 骨質密度 (bone mineral density, BMD) 之測定, 以中軸型的雙能量 X 光吸收儀 (dual-energy X-ray absorptiometry, DEXA) 為準 定量超音波儀器或其它部位之雙光子或單光子吸光檢查 ( 周邊骨質密度測定儀 ), 在目前只宜當做初步篩檢的工具 ; 若發現異常, 則應以上述 DEXA 施行髖骨或腰椎檢查來確認

3 Harrison National Guideline Clearinghouse Osteoporosis and Postmenopausal Management of Osteoporosis in postmenopausal women To employ lifestyle practices Indications for treatment: (1) T scores below -2.5 in the absence of risk factors (2) T scores -1.0 to -2.5 if other risk factors present (3) Prior vertebral or hip fracture Treatment recommendations are based on both efficacy data and clinical parameters. Bisphosphonates are the first-line drugs for treating postmenopausal woman with osteoporosis Osteoporosis and postmenopausal Overview of the management of osteoporosis in postmenopausal

4 Drug Choose Grade Bisphosphonates First-line therapy Grade 2B Raloxifene Who cannot tolerate Grade 2B bisphosphonates PTH therapy At least one fragility fracture who are unable to tolerate any of the available bisphosphonates Grade 2B Strontium Ranelate An effective and welltolerated therapy for women with established osteoporosis Search Databases Cochrane Library Pub Med Osteoporosis and postmenopausal and therapy and fracture women AND osteoporosis AND treatments AND effectiveness 搜尋結果 (Ann Interm Med, 2008) (Level:1a)

5 Step 3. Critical appraisal Evidence Is the systematic review valid Are the result Important? Can the results help me? 1 Is this a systematic review of high-quality studies which are relevant to your question? **Comparative Effectiveness of Treatments to prevent fractures in men and women with low Bone Density or Osteoporosis. **Randomized, double-blind, placebo controlled, with concealed allocation. **Level:1a 2 Does the methods section adequately describe: (a) finding and including all relevant trials? (b) assessing their individual validity? 3 Are the studies consistent, both clinically and statistically? ** The author searched Medline, ACP, Cochrane, for relevant randomized controlled trials published between **The groups of patients, interventions and outcome measures were similar enough to merit combining their results. ** Two independent reviews abstracted all information and data using standardized data abstraction forms, with a third reviewer verifying. Are the Valid results of this systematic review important? **Measure of efficacy: RR **Measure the benefits and harm of the therapy: NNT **Precise are these results: 95% CI Drug NNT Bisphosphonates Alendronate 16 Relative Risk (95% CI) Etidronate 12 Ibandronate 40 Pamidronate 20 Risedronate 14 Zoledronic acid 48 Estrogen Estrogen 14 PTH PTH 11 Favors treatment SERMs Raloxifene 15 Favors Control

6 Can you apply this valid, important evidence from a systematic review in caring for your patient? 1. Is your patient so different from those in the study that its results cannot apply? 2. Treatment feasible in your patient in your setting? 3. Do you and your patient have a clear assessment of their values and preferences? No 4. Are they met by this regimen and its consequences? Drug Dose Primary Prevention Alendronate 10 mg/day Etidronate 400 mg/day Risedronate 5 mg/day Clinically important reduction in vertebral fractures No clinically or statistically important benefit No statistically significant reductions in vertebral and nonvertebral fracture. Secondary Prevention Clinically important and statistically significant reduction in vertebral, nonvertebral, hip, and wrist fractures. Clinically important and statistically significant reduction in vertebral fractures. Clinically important and statistically significant reduction in vertebral, nonvertebral, and hip fractures Cochrane Database Syst Rev 2008 Jan 23;(1):CD001155, CD004523, and CD Health economics In women with low BMD without previous fractures, treatment with alendronate or risedronate appeared to be cost effective across countries (UK, US, Denmark). (From:The cost effectiveness of bisphosphonates for The prevention and treatment of osteoporosis: a structured review of the literature. Pharmacoeconomics. 2007;25(11): review) Drug Bisphosphonate Alendronate ( 如 Fosamax ) Raloxifene hydrochloride ( 如 Evista 60mg Tablets) Teriparatide ( 如 Forteo 注射劑 ) 骨質疏鬆症 治療藥物健保給付範圍 健保給付範圍 (1) 停經後婦女或男性因骨質疏鬆症引起之脊椎壓迫性骨折或髖骨骨折病患 (2) 血清肌酸酐 (serum creatinine) 小於或等於 1.6mg/dl 的患者 1. 停經後婦女因骨質疏鬆症引起之脊椎壓迫性骨折或髖骨骨折病患 2. 每日最大劑量 60mg 1. 適用於因嚴重骨質疏鬆症而造成二個 ( 含 ) 以上脊椎或一個髖骨骨折之患者 2. 使用期限不得逾 18 個月 drug Bisphosphonates adverse reactions Esophageal and gastric irritation TSGH Osteoporosis Drug 分類學名商品名價錢外觀 Raloxifene (a SERM) Parathyroid hormone (PTH) Estrogen plus progestin therapy (EPT). Calcitonin Calcium Vitamin D Strontium Ranelate increase in vasomotor symptoms muscle cramps and infrequent hypercalcemia, nausea, and dizziness increased risk of breast cancer, stroke, coronary heart disease, thromboembolic events, and dementia Nausea, local inflammation, and flushing of the face or hands gastrointestinal (GI) adverse effects (i.e., gaseousness, constipation). Doses higher than 2,000 IU/day may introduce risks such as hyper-calciuria and hypercalcemia gastrointestinal disturbances, headache, diarrhea Management of osteoporosis in postmenopausal women: 2006 position statement of The North American Menopause Society. Menopause 2006 May-Jun;13(3): Bisphosphonat es ALENDRONATE SODIUM, CHOLECALCIFE ROL FOSAMAX PLUS TAB 70MG 健保價 :262 1 tab per week Month:1048 元 Estrogens Raloxifene Evista 60 mg 健保價 : tab per day Month:1210 元 others Strontium Ranelate Parathyroid Calcitonin Miacalcic 200IU Nasal Spray PROTOS 2 GM 自費 : patch per day Month:2116 元 Parathyroid Teriparatide FORTEO INJ 250 MCG/ML 3 ML 健保價 :1946 Per 2 week Month:3892 元 健保價 :15766 per month Month:15766 元

7 1. 足踝部位的骨密度檢查, 只能當作初步篩檢工具, 建議您找骨科醫師做進一步檢查 2. 停經後婦女, 骨質易流失, 建議您平常飲食需攝取足夠鈣質與維生素 D 適度運動也有助於減少骨質流失 3. 若經醫生評估後, 需藥物治療, 目前是以雙磷酸鹽類為主, 此類藥物除了少數腸胃道不適, 在安全性及療效上都是可以放心的