Journal Club
Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ,
Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G,
Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver
National Institute of Child Health and Human Development Maternal-Fetal Medicine
Units Network.
A multicenter, randomized trial of treatment for mild gestational diabetes.
N Engl J Med. 2009 Oct 1;361(14):1339-48.
Lasserson DS, Glasziou P, Perera R, Holman RR, Farmer AJ.
Optimal insulin regimens in type 2 diabetes mellitus: systematic review and metaanalyses.
Diabetologia. 2009 Oct;52(10):1990-2000. Epub 2009 Jul 31.
2009年10月8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
■症例1■ 30歳 女性
■来院目的■ 妊娠中の血糖管理
■既往歴■ 鬱病(28歳より治療中),出産歴は経妊,経産ともなし。
■生活習慣■ 喫煙と飲酒はしない
■家族歴■ 特記事項なし
■現病歴■
当院精神科通院中。妊娠13週より近くの産婦人科医院を通院し妊娠19週の75gブドウ糖
負荷試験で空腹時血糖値128mg/dl, 282mg/dl, 258mg/dlであった。血糖コントロール目的
で妊娠20週で当科に紹介された。
■服薬■
塩酸マプロチリン100mg (ルジオミール錠 10mg 10 T), レボメプロマジン5mg (ヒルナミン
錠 5mg 1 T), セチプチリンマレイン酸塩6mg (テシプール錠 1mg 6 T), フルニトラゼパム
4mg (サイレース錠 2mg 2 T), ブロマゼパム4mg (レキソタン錠 2mg 2 T),以上1日量
■初診時現症■
身長 155cm、体重 82.2kg 来院時血圧 118/73mmHg
眼瞼結膜は貧血・黄疸無く,身体所見に異常は認めない。
■来院時(19週)検査所見■
血球数;RBC 451万/mm3, WBC 9400/m3, Hb 13.3g/dL, Hct 40.1%, Plt 24.8×104 /μl
尿検査;糖 (-), 蛋白 (-), ケトン体 (-)
生化学;T.P. 6.5g/dL, Alb 3.6g/dL., AST 17 I.U./l, ALT 10 I.U./l, T-Cho 199 mg/dl,
HDL 82 mg/dl, TG 132 mg/dl, BUN 6 mg/dl, Crn 0.4 mg/dl, Na 135 mEq/l, K 4.0
mEq/l, Cl 103 mEq/l, PG 137 mg/dl (随時), HbA1c 7.1 %, グリコアルブミン 16.1 %
眼底;異常なし
■問題1■
妊娠前は糖尿病がなく妊娠を契機に血糖が上昇してきた症例です。
妊娠継続と出産を強く希望されております。産婦人科医の判断は
現時点では胎児に異常はなく妊娠継続は可能としています。
次のうち初診時の説明として妥当なものはどれか
a. 予想される奇形率は5~17%です。妊娠を継続し、出産に
至った場合でも周産期の合併症の危険性は一般の2倍程度、帝王
切開になる可能性は20%程度と高くなります。
b. 妊娠中に血糖が上がると児が大きくなりすぎてしまうので治
療が必要です。児への影響が無く、安全に治療できるインスリン
で治療しましょう。
c. 体重は7kgの増加までは問題ありません。妊娠中なので充
分な栄養を摂り、体重を減らさないように注意してください。
d. 内服薬が多いので,児に影響が出る可能性があります。このま
までは授乳も出来ませんので一度中止して様子をみて無理なよう
なら中絶も考えましょう。
■問題2■
25週で受診した際のデータを示す。
体重 86.5kg
血圧 128/78mmHg
尿検査;糖 (-), 蛋白 (-), ケトン体 (-)
生化学;T.P. 6.2g/dL, Alb 3.4g/dL., AST 14 I.U./l, ALT 10 I.U./l, T-Cho 220 mg/dl,
HDL 80 mg/dl, TG 222 mg/dl, BUN 8 mg/dl, Crn 0.5 mg/dl, Na 137 mEq/l, K 4.0
mEq/l, Cl 102 mEq/l, PG 86 mg/dl (随時), HbA1c 6.1 %, グリコアルブミン 10.5 %
治療内容
ノボラピッド(60-50-50- 0)
ノボリンN ( 0- 0- 0-10)
SMBGでは空腹時100mg/dl以下、食後2時間血糖120mg/dl以下が達成できている。
正しい対応はどれか
a. 血糖は改善しており、特に問題は無いことから単位数を変えずに引き続き
外来で治療する。
b. 週数が進むにつれてインスリン量は増えるため、食後血糖が120mg/dlを超
えるようならインスリンを増やすように指導する。
c. 体重が増えすぎており、胎児死亡の危険性があるため入院のうえ食事とイ
ンスリンを調整する。
d. 体重増加は過食とインスリン過剰が原因なのでインスリンを減らして外来
で治療する。
■問題1■
■問題2■
Gestational diabetes is also diagnosed based on plasma glucose values
measured during the OGTT. Blood glucose levels are checked four
times during the test. If your blood glucose levels are above normal at
least twice during the test, you have gestational diabetes. Table shows
the above-normal results for the OGTT for gestational diabetes.
Table Gestational Diabetes: Above-Normal
Results for the Oral Glucose Tolerance Test
When
Plasma Glucose Result (mg/dL)
Fasting
At 1 hour
95 or higher
180 or higher
At 2 hours
155 or higher
At 3 hours
140 or higher
Frequency of Primary Outcomes across the Glucose Categories
Category
FPG
1hPG
2hPG
1
74 or less
105 or less
90 or less
2
79
132
108
3
84
155
125
4
89
171
139
5
94
193
157
6
99
211
177
7
100 or more
212 or more
178 or more (mg/dl)
The HAPO Study Cooperative Research Group. N Engl J Med 2008;358:1991-2002
the Department of Obstetrics and Gynecology at Ohio State University, Columbus (M.B.L.); the Eunice Kennedy Shriver National
Institute of Child Health and Human Development, Bethesda, MD (C.Y.S.); George Washington University Biostatistics Center,
Washington, DC (E.T.); the Departments of Obstetrics and Gynecology at Brown University, Providence, RI (M.W.C.); University of
Texas Health Science Center at Houston, Houston (S.M.R.); University of Texas Southwestern Medical Center, Dallas (B.C.); Columbia
University, New York (R.J.W.); University of Utah, Salt Lake City (M.W.V.); University of Alabama at Birmingham, Birmingham (D.J.R.);
University of North Carolina, Chapel Hill ( J.M.T.); Drexel University, Philadelphia (A.S.); Case Western Reserve University, Cleveland
(P.C.); Wake Forest University Health Sciences, Winston- Salem, NC (M.H.); University of Texas Medical Branch, Galveston (G.S.,
G.B.A.); University of Pittsburgh, Pittsburgh (K.Y.L.); Wayne State University, Detroit (Y.S.); Northwestern University, Chicago (A.M.P.);
and Oregon Health and Science University, Portland ( J.E.T.).
N Engl J Med 2009;361:1339-48.
AIM
It is uncertain whether
treatment of mild gestational
diabetes mellitus improves
pregnancy outcomes.
Method
Women who were in the 24th to 31st week of
gestation and who met the criteria for mild
gestational diabetes mellitus (i.e., an abnormal result
on an oral glucose-tolerance test but a fasting
glucose level below 95 mg per deciliter [5.3 mmol
per liter]) were randomly assigned to usual prenatal
care (control group) or dietary intervention, selfmonitoring of blood glucose, and insulin therapy, if
necessary (treatment group). The primary outcome
was a composite of stillbirth or perinatal death and
neonatal complications, including
hyperbilirubinemia, hypoglycemia, hyperinsulinemia,
and birth trauma.
Figure 1.
Screening, Enrollment, Random
Assignment, and Follow-up of
the Study Participants.
To convert the values for
glucose to millimoles per liter,
multiply by 0.05551. OGTT
denotes oral glucose tolerance
test.
•Plus–minus values are
means ±SD. Only alcohol
use was significantly
different between study
groups (P=0.04). OGTT
denotes oral glucosetolerance test.
† Race or ethnic group was
self-reported.
‡ The body-mass index is
the weight in kilograms
divided by the square of the
height in meters.
§ To convert the values for
glucose to millimoles per
liter, multiply by 0.05551.
Results
A total of 958 women were randomly assigned to a study
group — 485 to the treatment group and 473 to the control
group. We observed no significant difference between groups
in the frequency of the composite outcome (32.4% and 37.0%
in the treatment and control groups, respectively; P = 0.14).
There were no perinatal deaths. However, there were
significant reductions with treatment as compared with usual
care in several prespecified secondary outcomes, including
mean birth weight (3302 vs. 3408 g), neonatal fat mass (427
vs. 464 g), the frequency of large-for-gestational age infants
(7.1% vs. 14.5%), birth weight greater than 4000 g (5.9% vs.
14.3%), shoulder dystocia (1.5% vs. 4.0%), and cesarean
delivery (26.9% vs. 33.8%). Treatment of gestational diabetes
mellitus, as compared with usual care, was also associated
with reduced rates of preeclampsia and gestational
hypertension (combined rates for the two conditions, 8.6% vs.
13.6%; P = 0.01).
Conclusion
Although treatment of mild gestational
diabetes mellitus did not significantly
reduce the frequency of a composite
outcome that included stillbirth or
perinatal death and several neonatal
complications, it did reduce the risks of
fetal overgrowth, shoulder dystocia,
cesarean delivery, and hypertensive
disorders.
(ClinicalTrials.gov number, NCT00069576.)
Message
妊娠糖尿病の場合にきちんと血糖管理する介入
は大切である。
肥満の妊婦さんが増えているので注意!
Division of Public Health and Primary Care, University of Oxford, Rosemary Rue
Building, Old Road Campus, Headington, Oxford OX3 7LF, UK
Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism,
University of Oxford, Oxford, UK
Diabetologia (2009) 52:1990–2000
Aim
We compared the effect of
biphasic, basal or prandial
insulin regimens on glucose
control, clinical outcomes and
adverse events in people with
type 2 diabetes.
Method
We searched the Cochrane Library,
MEDLINE, EMBASE and major
American and European conference
abstracts for randomised controlled
trials up to October 2008. A
systematic review and metaanalyses were performed.
change in HbA1c (%)
change in fasting SMBG
change in weight (kg)
Fig. 2 a–c Biphasic vs basal
WMD, weighted mean difference
change in HbA1c (%)
change in fasting SMBG
change in weight (kg)
Fig. 2 d–f Prandial vs basal
WMD, weighted mean difference
Results
Twenty-two trials that randomised 4,379 patients were
included. Seven trials reported both starting insulin dose and
titration schedules. Hypoglycaemia definitions and glucose
targets varied. Meta-analyses were performed pooling data
from insulin-naive patients. Greater HbA1c reductions were
seen with biphasic and prandial insulin, compared with basal
insulin, of 0.45% (95% CI 0.19–0.70, p=0.0006) and 0.45% (95%
CI 0.16–0.73, p=0.002), respectively, but with lesser
reductions of fasting glucose of 0.93 mmol/l (95% CI 0.21–
1.65, p=0.01) and 2.20 mmol/l (95% CI 1.70–2.70, p<0.00001),
respectively. Larger insulin doses at study end were reported
in biphasic and prandial arms compared with basal arms. No
studies found differences in major hypoglycaemic events, but
minor hypoglycaemic events for prandial and biphasic insulin
were inconsistently reported as either higher than or
equivalent to basal insulin. Greater weight gain was seen with
prandial compared with basal insulin (1.86 kg, 95% CI 0.80–
2.92, p=0.0006).
Conclusion
Greater HbA1c reduction may be
obtained in type 2 diabetes when
insulin is initiated using biphasic or
prandial insulin rather than a basal
regimen, but with an unquantified risk
of hypoglycaemia. Studies with longer
follow-up are required to determine the
clinical relevance of this finding.
Message
インスリンは血糖を下げる目的ならば、食後追加分
泌補充は大切だが、低血糖に注意!
しかし、HbA1cや空腹時血糖を目標に追加分泌
を増やせば、当然低血糖は起こるのが当たり
前!
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問題1 - 埼玉医科大学総合医療センター 内分泌・糖尿病内科