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Evidence-based medicine 指導醫師 董淳武 醫師 98.11.26 R2 王鼎堯.

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Presentation on theme: "Evidence-based medicine 指導醫師 董淳武 醫師 98.11.26 R2 王鼎堯."— Presentation transcript:

1 Evidence-based medicine 指導醫師 董淳武 醫師 R2 王鼎堯

2 Situation 60 歲的陳媽媽在十年前因為糖尿病腎病變併發尿毒症開始接受長期血液 透析治療。雙臂的人工廔管因為狹窄阻塞,已不能使用,所以在今年初 接受了右側股動靜脈人工廔管手術。 但是在一個月前開始產生反覆發燒現象,經檢查發現原來是才剛做沒多 久的股動靜脈人工廔管發生感染化膿的現象。在把人工廔管移除和 2 周 的抗生素治療之後,現在發燒和感染的現象都已經緩解。由於其左下肢 有嚴重的膕動脈粥狀動脈硬化現象併發壞疽,半年前已接受過膝下截肢 手術,所以主治醫師與外科醫師討論後,為避免加重其末端缺血情形, 並不建議在陳媽媽的左側股動靜脈做吻合或是置放人工廔管。 目前陳媽媽是經由右側內頸靜脈的「永久性」導管 (permanent catheter) 做透析治療。其實陳媽媽的血糖控制情形還可以,飯前血糖約略在 130 ~ 140 mg/dl , A1c:7.1%. 聽一起坐計程車來洗腎的王先生說,利用中心 靜脈導管來透析更容易會有感染的問題,陳媽媽聽了更煩惱了,因為她 很害怕再住院。她問查房的主治醫師它應該要如何去照顧她的中心靜脈 導管,或是洗腎室有甚麼特殊的措施可以避免讓她的中心靜脈導管發生 感染的問題?

3 Ask Patient who dialyzed through permanent catheters P Prophylactic antibiotics I Placebo or without antibiotics C Prevention of catheter related infection and other complication O 3

4 Evidence-Based Practice Tools Summary 4          Cochrane Library Cochrane Database of Systematic Reviews (Cochrane Reviews) Database of Abstracts of Reviews of Effects (Other Reviews - DARE)  PubMed MEDLINE - Systematic Reviews  BMJ Clinical Evidence DynaMed USPSTF Guidelines | AHRQ Evidence Reports | FPIN Clinical Inquiries included in Journal of Family Practice and American Family Physician Indexed in PrimeAnswersPrimeAnswers   PubMed Clinical Queries Cochrane Library Cochrane Central Register of Controlled Trials (Clinical Trials)  ACP Journal Club POEMS (Patient Oriented Evidence that Matters) BandolierBandolier | BestBETsBestBETs  Natural Medicines Comprehensive Database  PubMed National Guideline Clearinghouse  PrimeAnswers | Care Provider Toolkit 

5 5 Acquire The Cochrane Library (www.thecochranelibrary.com) Main search keywords: 1.H*emodialysis 2.Catheter* 3.Infection* Advanced Search: (Cochrane or meta-analysis or Systematic review)

6 Acquire Cochrane Database of Systematic Reviews (Cochrane Reviews) No related topics was found !

7 Acquire Database of Abstracts of Reviews of Effects (Other Reviews - DARE) 3 related topics was found !

8 Acquired Journal (1) Meta-analysis: Antibiotics for Prophylaxis against Hemodialysis Catheter–Related Infections Ann Intern Med. 2008;148:

9 Appraisal 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 9

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11 Appraisal Check List 1. PICO –P: Adults receiving long-term hemodialysis using a central venous catheter –I: Use of an antibiotic applied topically to the catheter exit site or instilled intraluminally into the catheter –C: With another or no antimicrobial agent –O: Catheter-related bloodstream infection rate or secondary outcomes of interest

12 2 . Is any study missed ? ① Database ? –MEDLINE (1966 through October 2007) –EMBASE (1980 through October 2007) –Cochrane Central Register of Controlled Trials (1996 through October 2007) ② Keywords? –Catheter-related bloodstream infection (searching for catheter-related bloodstream infection, bacteremia, or septicemia) –Dialysis (searching for renal dialysis) –Catheter (searching for indwelling catheter, catheterization, central venous catheter, or hemodialysis catheter)

13 Appraisal Check List ③ Reference list review: YES ④ Contact to Authors: YES ⑤ Unpublished studies: Eligible ⑥ Duplicate publications: Excluded ⑦ Language: regardless

14 Appraisal Check List 3.Publication Bias: –Using funnel plots, the Begg test (P=0.001) for asymmetry, and an Egger test (P=0.085) for trials of intraluminal antibiotics –No test for trials of topical antimicrobial agents ( ∵ small number of these studies) Funnel plot suggested an absence of publication of small studies that showed lesser benefits for intraluminal antibiotics than seen in the identified trials.

15 4. Reviewer numbers: 2 reviewers independently evaluated articles for eligibility in a 2-stage procedure.

16 5. Quality Assesssment of Included Trials

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21 減少 68% 的 感染率 減少 78% 的感染率 無異質性

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25 Apply Both topical and intraluminal antibiotics reduced the rate of bacteremia as well as the need for catheter removal secondary to complications. Whether these strategies will lead to anti-microbial resistance and loss of efficacy over longer periods remains unclear.

26 Limitation The evidence base included only 16 trials Most had less than 6 months of follow- up Only one third of studies were blinded. Publication bias was evident.

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28 Acquire (2) A meta-analysis of hemodialysis catheter locking solutions in the prevention of catheter-related infection American Journal of Kidney Diseases, Vol 51, No 2 (February), 2008: pp

29 Appraisal Check List 1. PICO –P: Adults receiving long-term hemodialysis using a central venous catheter –I: Use antimicrobial lock solutions (ALSs) –C: Heparin only –O: CRI per 1,000 catheter-days

30 2 . Is any study missed ? ① Database ? –Cochrane Central Register of Controlled Trials –MEDLINE 1966 to 2005, –EMBASE (up to 2005 –CINAHL ② Keywords? – end stage renal disease – h(a)emodialysis, –catheter related bacter(a)emia –antibiotic lock(ing) solution

31 Appraisal Check List ③ Reference list review: YES ④ Contact to Authors: not mention ⑤ Unpublished studies: Eligible ⑥ Duplicate publications: Nil ⑦ Language: English only

32 Appraisal Check List 3.Publication Bias: Not mentioned 4. Reviewer numbers: –2 reviewers independently evaluated articles for eligibility in a 2-stage procedure. Differences were resolved by discussion

33 所收錄文章其中六篇被收錄 於第一篇 Systematic review

34 星星數代表 Jadad Score

35 並非使用抗生素

36 Using absolute risk reduction for each study, this translates to a number needed to treat (NNT) of 3 to prevent 1 CRI/100 catheter-days

37 高異質性

38 Apply This meta-analysis of randomized controlled trials supports the effectiveness of ALSs as a successful strategy to decrease the incidence of CRI in HD patients. All ALSs studied were effective in this way, and the overall number needed to treat to prevent 1 CRI was small.

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40 Acquire (3) Preventing haemodialysis catheter- related bacteraemia with an antimicrobial lock solution: a meta- analysis of prospective randomized trials Nephrol Dial Transplant (2008) 23: 1666–1672

41 Appraisal Check List 1. PICO –P: Adults receiving long-term hemodialysis using a central venous catheter –I: Use antimicrobial lock solutions (ALSs) –C: Heparin only –O: CRI per 1,000 catheter-days

42 2 . Is any study missed ? ① Database ? –Pubmed, from 1990 until March (same in below) –Medline –Web of Science –The Cochrane Library database –Major nephrology journals ② Keywords? – Dialysis, Catheter lock, Bacteraemia, Sepsis, Septicaemia, Infection and prophylaxis

43 Appraisal Check List ③ Reference list review: YES ④ Contact to Authors: YES ⑤ Unpublished studies: Exclude ⑥ Duplicate publications: Exclude ⑦ Language: Regardless

44 Appraisal Check List 3.Publication Bias: Funnel plot showed under-representation of small studies with a low or no effect. 4. Reviewer numbers: –Not mentioned, perhaps only one (group of) reviewer

45 Bleyer Saxena

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47 除了 Bleyer et al. 的 study 外其餘都 與第二篇的搜尋結果相同

48 無顯著差異

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50 Apply Catheter interdialytic locking with an ALS reduces the incidence of CRB. Achieved incidence of CRB in the ALS groups is similar to published reports from units with low CRB incidence Limit: follow-up of studies included in this meta-analysis does not exclude the onset of adverse events or bacterial resistance with longer use of ALS.

51 Tunneled catheters’ outcome optimization among diabetics on dialysis through antibiotic-lock placement Kidney International (2006) 70, 1629–1635

52 PICO of this study P: Diabetics dialyzed through tunneled-cuffed catheters I: ‘locked’ with cefotaxime/heparin C: filled with standard heparin only O: prevention of thrombotic and infectious complication-related morbidity and mortality

53 Appraisal Patient: Include criteria: All the diabetic ESRD patients were eligible for the study if they required insertion of a TCC (SC or IJC) for the maintenance or initiation of HD between March 2002 and February 2003 at our Tertiary Care Center Reinsertion of a TCC through a new access site were also included

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55 Appraisal Exclude criteria: Active sepsis/receiving prolonged (more than 7 days) antibiotic therapy (oral/parenteral) Allergy to cephalosporins Patients who could not be randomized within three dialysis sessions of new TCC insertion Had the exchange over guidewire of a TCC through the same exit site

56 Appraisal Intervention: Group I with cefotaxime–heparin lock (cefotaxime, 10 mg/ml and heparin, 5000 U/ml) Comparison: Group II with standard heparin lock (5000 U/ml)

57 Appraisal Outcome: Thrombosis: inability to use the catheter at a blood flow of 200 ml/min; No respond to intraluminal thrombolysis with t-plasminogen activator. Catheter infection: growth of ≥15 colony-forming units (by semiquantitative roll- plate technique)

58 Catheter exit-site infection: –Positive (semi-)quantitative culture of the drainage material with local signs of inflammation. Catheter-related bloodstream infections (CRBSI): –The same organism (i.e. identical species, antibiogram) from a quantitative culture of the distal segment of catheter and from the blood

59 Randomize quality The randomization was performed using sequentially numbered, opaque, sealed envelopes. The sequence of interventions was obtained from a computer-generated random number list to ensure the concealment of the patient’s assignment to a particular group.

60 Baseline Drop out rate/ ITT

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62 Masking Double blind Patient: randomized, consealment All the authors/investigators, including microbiologists and HD staff involved in the study, were blinded to the patient’s allocation to the treatment groups

63 Enough sample? The sample size:110 TCCs (55 in each group) Calculated to be of power to detect 30% difference in the two treatments at a one-sided 0.05 level of significance Based on baseline risk of 2.5 CRBSI episodes/1000 catheter days α error: 5% / β error: 70%

64 Result

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69 effectiveness Thrombosis Event (+)Event (-)Total ALS74451 Heparin EER = 7 / 51 = 13.7 % CER = 21 / 58 = 36.2 % RR = EER / CER = 37.8 % RRR = (CER – EER) / CER = 62.2 % ARR = CER – EER = 22.5 % NNT = 1 / ARR = 4 ( 每 4 人,就有一人的導管可以減少栓塞的機會)

70 effectiveness RR = EER / CER = 42.4% RRR = (CER – EER) / CER = 57.6 % ARR = CER – EER = 2.12 /1000 catheter-days NNT = 1 / ARR = 472 ( 每 472 catheter-days 可減少一次 CRBSI) CRBSI Events Catheter x days CRBSI/1000 catheter days ALS (EER) Heparin (CER)

71 effectiveness Exit site infections Event (+)Event (-)Total ALS94251 Heparin94958 EER = 9 / 51 = 17.6 % CER = 9 / 58 = 15.5 % 然而結果無統計上的意義

72 effectiveness TCC FAILURE in 365 days Event (+)Event (-)Total ALS Heparin EER = 11 / 51 = 21.6 % CER = 36 / 58 = 62.1 % RR = EER / CER = 34.8 % RRR = (CER – EER) / CER = 65.2 % ARR = CER – EER = 40.5 % NNT = 1 / ARR = 2 ( 每 2 個人,就有一人的導管能在一年內減少失效 的風險)

73 effectiveness CRBSI-associated mortality Event (+)Event (-)Total ALS54549 Heparin EER = 5 / 49 = 9.8 % CER = 11 / 47 = 23.4 % RR = EER / CER = 41.9 % RRR = (CER – EER) / CER = 58.1 % ARR = CER – EER = 13.6 % NNT = 1 / ARR = 7 ( 每 7 個人,就有一人能避免因導管感染而死亡)

74 Thanks for your listening & comment


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