治 療 therapy
Post on 16-Jan-2016
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Therapy,
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(Therapy) systemic review,
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()????(intention-to-treat analysis)?(blind)??
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Data collectionEnd pointsData MonitoringStatistical analysis
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Entry, Randomization, and Follow-up of Patients in the Hypertension in the Very Elderly TrialBeckett NS et al. N Engl J Med 2008;358:1887-1898
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Baseline Characteristics of the PatientsBeckett NS et al. N Engl J Med 2008;358:1887-1898
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()
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() (9595% CI)
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5.3 (relative risk reduction, RRR) (relative benefit increase, RBI) (relative risk increase, RRI)
RRR
ARR
(NNT)
CRE
EER
CEREER/CER
CEREER
1/ARR
MRC
5.7%
4.3%
5.7%-4.3%/5.7%25%
5.7%-4.3%1.4%
1/1.4%72
0.000057%
0.000043%
0.000057%-0.000043%/0.000057%25%
0.000057%-0.000043%0.000014%
1/0.000014%7142857
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RRR(ARR)ARRRRRRRR NNT (Number Needed to Treat), NNH
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NNT (number need to treat)NNTNNT=1/ARR=1/CER-EERNNTNNH (number need to harm) =1/ARI ()
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Treatment EffectsOccurrence of diabetic retinopathy at 5 years among insulin-dependent diabetic in the DCCT trialUsual insulin regimen (CER: control event rate): 38%Intensive insulin regimen (EER: experimental event rate): 13%Risk Reduction (calculation): NNT Absolute risk reduction (ARR) = CER-EER= 38%-13% = 25%Relative risk reduction (RRR) = CER-EER/CER = 25%/38% =66%Number needed to treat (NNT) = 1/ARR = 1/25% = 4 patients NNT: The number of patients that need to be treated to prevent one bad outcome or get one good outcome.
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HarmThe proportion of patients with at least one episode of symptomatic hypoglycemiaUsual insulin regimen (CER: control event rate): 23%Intensive insulin regimen (EER: experimental event rate): 57%Risk Increase(calculation): NNH Absolute risk increase (ARI) =EER - CER = 57%-23% = 34% Relative risk increase (RRI) =EER-CER/CER = 57%-23%/ 23% = 148%Number needed to harm (NNH) = 1/ARI = 1/0.34 = 3 patients () NNH: The number of patients that need to be treated to cause one bad outcome (being harmed).
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NNT
Event rate
NNT
CER
EER
110-129 mmHg
Death, stroke, MI
13 %
1.4 %
1.5 years
8
90-109 mmHg
Death, stroke, MI
5.5 %
4.7 %
5.5 years
128
()
Death or major stroke
18 %
8 %
2 years
10
Donepezil (vs. placebo)
No functional decline
44 %
59 %
1 year
7
7()
Death or MI
16 %
12 %
24 months
24
Oral acetylcysteine (vs. placebo)
Contrast media-induced reduction in renal function
12 %
4 %
8 months
12
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Figure 1. Entry, Randomization, and Follow-up of Patients in the Hypertension in the Very Elderly Trial. Of the 461 patients who did not meet the protocol criteria, 229 did not meet the criteria on the basis of blood pressure, 18 on the basis of age, 61 on the basis of serum potassium level, 20 on the basis of serum creatinine level, 26 because they were receiving other antihypertensive treatment, and 107 for other reasons. The other administrative reasons for the censoring of data were death or retirement of a local investigator and change in national legislation as to where patients in clinical trials could be seen.Table 1. Baseline Characteristics of the Patients.
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