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Evidence-Based Medicine A CKD patient with dyslipidemia Reported by R2 陳苡揚 Instructed by Dr. 董淳武.

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Presentation on theme: "Evidence-Based Medicine A CKD patient with dyslipidemia Reported by R2 陳苡揚 Instructed by Dr. 董淳武."— Presentation transcript:

1 Evidence-Based Medicine A CKD patient with dyslipidemia Reported by R2 陳苡揚 Instructed by Dr. 董淳武

2 Our Patient 40 歲微胖婦女身高 :150 公分, 體重 :60 公斤,(BMI:26.7 Kg/m2) 慢性腎臟疾病 (GFR: 20.2 ml/min) 血壓 :135/85 mmHg, 呼吸每分鐘 14 下, 雙下肢並無水腫 ;

3 Hemogram Hb: 10 g/dl, Hct: 31%. Urinalysis Protein (+), RBC: 2/HPF, WBC:3/HPF. Our Patient

4 Biochemistry: Uric acid: 6.0 mg/dl Triglyceride: 180 mg/dl Total cholesterol: 225 mg/dl HDL: 40 mg/dl LDL: 140 mg/dl AC sugar: 100 mg/dl Electrolyte: Cr: 3.5 mg/dl Na: 138 mEq/L K: 4.0 mEq/L Alb: 4.0 g/dl Ca: 8.8 mg/dl P: 4.8 mg/dl

5 由於膽固醇異常, 此婦人向你詢問是否需要使用藥物, 就算要 自費使用也沒關係. 請問你會提供什麼樣的建議給這位病患 ?? Our Patient

6 5As of EBM Ask : ask an answerable question Acquire : track down the best evidence Appraisal : validity, impact, applicability Apply : to patient’s problem Audit : effectiveness

7 Ask an answerable question Patient : CKD, Predialysis Dyslipidemia Proteinuria Intervention : Lipid lowering medication Comparison : Without lipid lowering medication Outcome : All cause mortality Renal outcome

8 Acquire track down the best evidence Guideline Primary journal or database Secondary journal or database

9 Acquire track down the best evidence Guideline Primary journal or database Secondary journal or database

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17 Published Guideline GuidelineCountryYear Stage of CKD LipidTreatment KDOQIUSA2003Stage 3,4,5 1.LDL LDL > TG > 200 & non-HDL > TLC 2.TLC+low dose statin 3.TLC+low dose statin CARIAustralia2005CKD P’t TC > 166 LDL > 100 TG > 200 Initiate statin if LDL > 100

18 Other Guidelines EBPG (2002) : Dialysis patient BRA (2002) : Dialysis patient CSN (2005) : No guideline available

19 Ask an answerable question Patient : CKD, Predialysis Dyslipidemia Proteinuria Intervention : Statin Comparison : Without statin Outcome : All cause mortality Renal outcome

20 Acquire track down the best evidence Guideline Primary journal or database Secondary journal or database

21 Secondary Database

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26 1. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. - Level 1a 2. HMG CoA reductase inhibitors (statins) for kidney transplant recipients. - Level 1a 3. HMG CoA reductase inhibitors (statins) for dialysis patients. - Level 1a 4. Effect of pitavastatin on urinary liver-type fatty-acid-binding protein in patients with nondiabetic mild chronic kidney disease. - Level 2b 5. A randomized trial of the effect of statin and fibrate therapy on arterial function in CKD. - Level 1b 6. Acute effect of simvastatin on inflammation and oxidative stress in chronic kidney disease. - Level 2b

27 1. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. - Level 1a 2. HMG CoA reductase inhibitors (statins) for kidney transplant recipients. - Level 1a 3. HMG CoA reductase inhibitors (statins) for dialysis patients. - Level 1a 4. Effect of pitavastatin on urinary liver-type fatty-acid-binding protein in patients with nondiabetic mild chronic kidney disease. - Level 2b 5. A randomized trial of the effect of statin and fibrate therapy on arterial function in CKD. - Level 1b 6. Acute effect of simvastatin on inflammation and oxidative stress in chronic kidney disease. - Level 2b

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29 Acquire track down the best evidence Guideline Primary journal or database Secondary journal or database

30 Primary Database

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36 Appraisal Validity, Impact, aPplicability 想要回答什麼問題 是否有遺漏重要文獻 選擇的文獻是否適當 選擇的文獻能有效回答問題 各研究的結果是否相似

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38 V.S.

39 想要回答什麼問題 Cochran e Statin for people with CKD not requiring dialysis V BMJEffect of statins with CKDX

40 重要的資料庫相關研究的參考文獻 向專家請教,特別是尚未刊載的研究 不只限於英文資料 是否有遺漏重要文獻

41 Potentially relevant articles MedLine : 146 EMBase : 367 Cochrane : 70 Total : 583 Full text analysis : 62 Included : 28(58 report) Complete : 26(52 report) Ongoing : 2(6 report) Studied excluded : 521 Search overlap; Not RCT/review article; RCT, outcome not appropriate; Duration < 8wks Studied excluded : 4 Non RCT/ review article : 3 Duration < 8 wks : 1

42 Medline: Pre-Dialysis : 146 Dialysis : 32 Transplant : 68 EMBase: Pre-Dialysis : 367 Dialysis : 67 Transplant : 118 Cochrane: Pre-Dialysis : 38 Dialysis : 14 Transplant : 19 Full text analysis : 68 Pre-Dialysis : 146 Dialysis : 32 Transplant : trial, 54 comparison, P’t Pre-Dialysis : 26 Dialysis : 11 Transplant : 17 Excluded : 801 Search overlap : 104 Not RCT/review : 693 Duration < 8wks : 4 Excluded : 16 Duplicate reports Duration < 8wks Non RCT

43 是否有遺漏重要文獻 Text book Unpublished trial Not english only Expert CochraneVVunclearV BMJVVVV

44 選擇的文獻是否適當 CochraneBMJ Inclusion 1. RCT, quasi RCT 2.Statin to Placebo/No/ Statin 3.CKD - KDOQI a.Stage 3,4 b.Stage 1,2 + Proteinuria 4.Baseline Cr > 1.4mg/dl 5.Duration > 8wks 1. RCT, quasi RCT 2. Statin to Placebo/No/Statin 3. CKD - KDOQI a. RRT b. Stage 3-5 c. Stage 1,2 + Proteinuria 4. Baseline Cr > 1.4mg/dl 5. Duration > 8wks Exclusion 1. ESRD 2.Impaired liver function 3.Elevated CPK 4.Combination treatment 1. Undefined “renal impairment” 2. Impaired liver function 3. Elevated CPK 4. Combination treatment Outcome Rhabdomyolysis Double of serum Cr Allograft rejection

45 文獻能有效回答問題 Allocation concealment Adequate(A) Unclear(B) Inadequate(C) Blinding Investigator Participants assessor Analysis Intention-to- treat analysis Yes No No stated Follow up% of excluded

46 文獻能有效回答問題

47 各研究結果是否相似 Forest Plot

48 各研究結果是否相似 Forest Plot Cochran chi-square ( Cochran Q ) Definite heterogeneity : P < 0.05 Possible heterogeneity : No Statical significant, Q/df > 1 Heterogeneity unlikely : No Statical significant, Q/df < 1

49 All Cause Mortality CV Renal outcome GFR Proteinuria Apply to patient’s problem Cochrane BMJ Cochrane BMJ

50 Cochrane

51 Others

52 Conclusion Statins have benefit in improving mortality Statins can improving proteinuria but can’t ameliorate the progression of the GFR 建議病患可以使用低劑量的 Statin

53 For your attention

54 Q & A Meta-analysis versus Clinical trial ? quasi - Randomized control trial ? Heterogeneity of studies ? MESH term ? Level of evidence of guidelines ?

55 All Cause Mortality

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57 CV Mortality

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59 Renal - CrCl

60 Renal Proteinuria


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