Transcript 20120105NovelAlgorithmCCU

Journal Club
Nerenberg KA, Goyal A, Xavier D, Sigamani A, Ng J, Mehta SR, Díaz R,
Kosiborod M, Yusuf S, Gerstein HC; for the RECREATE Investigators.
Piloting a Novel Algorithm for Glucose Control in the Coronary Care Unit:
The RECREATE (REsearching Coronary REduction by Appropriately
Targeting Euglycemia) trial.
Diabetes Care. 2012 Jan;35(1):19-24. Epub 2011 Nov 10.
2012年1月5日 8:30-8:55
８階 医局
埼玉医科大学 総合医療センター 内分泌・糖尿病内科
Department of Endocrinology and Diabetes,
Saitama Medical Center, Saitama Medical University
松田 昌文
Matsuda, Masafumi
インスリン治療については：
病棟血糖管理マニュアル
理論と実践 (第1版増補)
本書は血糖管理の理論を詳説し、臨床症例を通じ
て理論をいかに実践に結びつけるかを述べたマ
ニュアルで、好評の第1版（2008年刊行）の増補版。
診断基準の改訂、CSIIや持効型インスリンの普及
など、糖尿病診療情勢の変化に対応。さらに、マ
ニュアルの利便性の向上を図り、研修医・看護師な
ど医療スタッフの理解促進のため「血糖管理のポイ
ント」、および実際の運用例として「簡易血糖管理マ
ニュアル」を追加。
Surgical ICUでのインスリン強化療法による
死亡率減少
CONVENTIONAL TREATMENT (N=783)
INTENSIVE TREATMENT (N=765)
Male sex — (%) 557 (71) vs 544 (71)
Age — yr
62.2±13.9 vs 63.4±13.6
N Engl J Med 2001;345:1359-67.
重症入院患者へのインスリン治療：死亡率
（無作為ランダム化研究のメタ解析）
35 publications, n=8478
Ref.15 of the current article
The NICE-SUGAR Study
Investigators. N Engl J
Med 2009;360:1283-1297
the 1Population Health Research Institute McMaster University, Hamilton, Ontario, Canada; the 2Department of
Medicine, Emory University, Atlanta, Georgia; the 3Department of Pharmacology, St. John’s Medical School,
Bangalore, India; the 4Department of Pharmacology, St. John’s Research Institute, Bangalore, India; the
5Department of Medicine, McMaster University, Hamilton, Ontario, Canada; the 6Etudios Cardiologica Latin
America, Rosario, Argentina; the 7Mid-America Heart and Vascular Institute of Saint Luke’s Hospital and the
Department of Medicine, University of Missouri, Kansas City, Missouri; and the 8Department of Clinical
Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.
Diabetes Care 35:19–24, 2012
OBJECTIVE
Elevated glucose levels are common after an
acute myocardial infarction (AMI) and increase
the risk of death. Prior trials of glucose control
after AMI have been inconsistent in their ability
to lower glucose levels and have reported
mixed effects on mortality. We developed a
paper-based glucose-lowering algorithm and
assessed its feasibility and safety in the setting
of AMI.
RESEARCH DESIGN AND METHODS
A total of 287 participants with an acute ST
segment elevation myocardial infarction
(STEMI) and a capillary glucose level ≧8.0
mmol/L were randomly allocated to glucose
management with intravenous glulisine insulin
using this algorithmin the coronary care unit
(CCU), followed by once-daily subcutaneous
insulin glargine for 30 days versus standard
glycemic approaches. The primary outcome
was a difference in mean glucose levels at 24
h. Participants were followed for clinical
outcomes through 90 days.
Figure 1 RECREATE trial flow diagram.
Table 1 Baseline patient characteristics and AMI management
182mg/dl
1.14mg/dl
176mg/dl
1.14mg/dl
The Killip classification is a system used in individuals with an acute myocardial
infarction (heart attack), in order to risk stratify them. Individuals with a low Killip
class are less likely to die within the first 30 days after their myocardial infarction
than individuals with a high Killip class.
Killip class I includes individuals with no clinical signs of heart failure.
Killip class II includes individuals with rales or crackles in the lungs, an S3, and
elevated jugular venous pressure.
Killip class III describes individuals with frank acute pulmonary edema.
Killip class IV describes individuals in cardiogenic shock or hypotension (measured
as systolic blood pressure lower than 90 mmHg), and evidence of peripheral
vasoconstriction (oliguria, cyanosis or sweating).
Yale大学プロトコール／若干の修正
Diabetes Care 27:461, 2004 を改変
しろうと！
mM mg/dl
6.5
117
7.0
126
8.3
149
8.9
160
10.8
194
12.5
225
14.7
265
mM
mg/dl
3.9
70
4.9
88
6.5
117
4.9
88
8.8
158
7.2
130
9.4
169
12.2
220
11.0
198
16.5
297
Diabetes Mellitus Insulin Glucose Infusion in
Acute Myocardial Infarction (DIGAMI): Benefit of
Tight Glycemic Control in No Insulin – Low Risk Cohort
Total Cohort
No Insulin – Low Risk
0.7
0.7
p = .0111
p = .004
n=314
0.6
0.6
0.5
Control
0.4
n=306
0.3
0.2
Insulin-glucose
Infusion
0.1
1
2
3
4
Years in Study
n=133
0.4
Control
0.3
0.2
n=139
0.1
0
0
Mortality
Mortality
0.5
5
0
0
Insulin-glucose
Infusion
1
2
3
4
Years in Study
5
Malmberg K, et al. BMJ. 1997;314:1512-1515.
Glucose Control Summary
(All subjects Kameda Medical Center 2006-2008)
Running time (hours)
Average glucose infusion rate (g/hr)
Average insulin infusion rate (U/hr)
BG at start (mg/dl)
Average glucose conc (mg/dl)
BG reached (mg/dl)　ALL
BG reached (mg/dl)　Ca rdi a c di s ea s es &
ISI-delta (mg/dl per hr per U)
IRI-absolute [last] (U/hr)
good BG [80-120mg/dl]　(hours，%)
fair BG [70-180mg/dl]　(hours，%)
high BG [>180mg/dl]　(hours，%)
low BG [<70mg/dl]　(hours，%)
serious hypoglycemia　[<50mg/dl]
OB
19764
4.5 ± 5.4
2.1 ± 2.2
221 ± 193
142 ± 64
127 ± 46
108 ± 29
46 ± 16
0.6 ± 2.3
8119 ,
41.1
16287 ,
82.4
3161 ,
16.0
320 ,
1.6
6 cases
Partly presented at the 44th EASD, Sep. 8-11, 2008, Rome, Italy, Diabetologia 51(Supplement 1): S440, 2008
RESULTS
At 24 h, the mean glucose level was 1.41mmol/L
(95%CI 0.69–2.13) lower in the insulin (6.53 vs.
7.94mmol/L). Differences in glucose levels were
maintained at 72 h and 30 days. A total of 22.7%
of the insulin group versus 4.4% of the standard
group had biochemical hypoglycemia (with
neither signs nor symptoms) in the CCU because
of lower glycemic goals. However, there were no
differences in symptomatic hypoglycemia or
clinical outcomes between the groups.
CONCLUSIONS
A paper-based insulin algorithm targeting
glucose levels of 5.0–6.5 mmol/L (90–117
mg/dL) can be feasibly implemented in the
CCU. A cardiovascular outcomes trial using
this approach can determine whether
targeted glucose lowering improves patient
outcomes.
Message/Comments
まぁNovelと言っているが、基本的にはYale大学プロト
コールを簡略化した感じ。
一定の方法で慣れてくるとだいたいあまり低血糖は普
通起さないとは感じるが、23%は多すぎ！
差はまぁともかく？？？
例）もし-15%死亡が異なるとすると
心筋梗塞で9%しか死なないと仮定すると、
１００人心筋梗塞で血糖管理で９人死ぬか８人死ぬか
の１人の差にしかならない！
でも、90%死ぬとすると90人死ぬか76人死ぬか14人の差
になる。