Journal Club 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 2012 年 3 月 29 日 8:30-8:55 ８階 医局 Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. N Engl J Med Mar 26. [Epub ahead of print]

減量手術 245 件 （内訳） 腹腔鏡下胃バイパス手 術 143 件 腹腔鏡下袖状胃切除術 58 件 ラップバンド手術 17 件 腹腔鏡下 BPD/DS 27 件 その他 胃内バルーン挿入術 7件7件 Laparoscopic Roux en Y Gastric Bypass: LRYGB Laparoscopic Gastric Banding BIB Before After Dr. Kasama

胃バイパス術バンディング術減量手術全体 超過体重減少率 1 ） 61.60%47.50%61.20% 平均体重減少ｋｇ 1 ） 43.5kg28.6kg39.7kg 術死率 1 ） 0.50%0.10% 術後合併症率 2 ） 7.90%7.20% 再手術率 2 ） 1.10%5.30% 満足しない減量の率 2 ） 1.00%13.00% 糖尿病治癒率／改善率 1 ） 83.7% / 93.2%47.9% / 80.8%76.8% / 86.0% 高血圧治癒率／改善率 1 ） 67.5% / 87.2%43.2% / 70.8%61.7% / 78.5% 高脂血症改善率 1 ） 96.90%58.90%79.30% 睡眠時無呼吸改善率 1 ） 94.80%68%83.60% 1) Bariatric surgery: a systematic review and meta-analysis. Buchwald H, Avidor Y, Braunwald E et al: JAMA : ) Brazil Sao Paulo Gastro Obeso Center での同一スタッフによる腹腔鏡下胃バイパス 術 :2012 人、腹腔鏡下バンディング術 1174 人の検討（ 2005 年 IFSO 発表）

A meta-analysis from University of California, Los Angeles reports the following weight loss at 36 months Biliopancreatic diversion - 53 kg Roux-en-Y gastric bypass (RYGB) - 41 kg Open - 42 kg Laparoscopic - 38 kg Adjustable gastric banding - 35 kg Vertical banded gastroplasty - 32 kg Sleeve gastrectomy ? Biliopancreatic diversion Roux-en-Y gastric bypass Sleeve gastrectomy with duodenal switch Adjustable gastric banding Vertical banded gastroplasty

JAMA. 2012;307(1):56-65 スウェーデンで肥満患者を対象に、肥満手術と心血管イベントの関連を非無作為化前向 き対照試験（ SOS 試験）で検証。心血管死は手術群 2010 人中 28 人、通常治療群 2037 人中 49 人で、肥満手術と心血管死の減少に関連が見られた（調整後ハザード比 0.47 ）。 初発心血管イベントは手術群 199 人、通常治療群 234 人で発生が見られた。

/nejmoa nejm.org the Bariatric and Metabolic Institute (P.R.S., S.A.B., S.T., B.A.), the Endocrinology Institute (S.R.K.), the Heart and Vascular Institute (K.W., C.E.P., S.E.N.), and the Lerner Research Institute ( J.P.K.), Cleveland Clinic, Cleveland; and the Veterans Affairs Boston Healthcare System, Brigham and Women’s Hospital, and Harvard Medical School — all in Boston (D.L.B.).

Background Observational studies have shown improvement in patients with type 2 diabetes mellitus after bariatric surgery.

Methods In this randomized, nonblinded, single-center trial, we evaluated the efficacy of intensive medical therapy alone versus medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy in 150 obese patients with uncontrolled type 2 diabetes. The mean (±SD) age of the patients was 49±8 years, and 66% were women. The average glycated hemoglobin level was 9.2±1.5%. The primary end point was the proportion of patients with a glycated hemoglobin level of 6.0% or less 12 months after treatment.

Subgroups Stratified by BMI, Age, Duration of Diabetes, and Insulin Use

Use of Insulin for Patients on Maximum Oral Agents and GLP-1 Agonist Therapy

Figure 1. Changes in Measures of Diabetes Control from Baseline. Values for change in glycated hemoglobin (Panel A), change in fasting plasma glucose (Panel B), the average number of diabetes medications (Panel C), and change in body-mass index (BMI) (Panel D) were plotted at 3, 6, 9, and 12 months. Least-square means and standard errors from a repeated measures model are plotted for glycated hemoglobin, average number of medications, and BMI; medians and interquartile ranges are plotted for fasting plasma glucose. P values are for the comparison between each surgical group and the medical-therapy group and were calculated from a repeated-measures model that considers data over time.

Gastric bypass vs. intensive medical therapy Sleeve gastrectomy vs intensive medical Gastric bypass vs sleeve gastrectomy

* All P values in the footnotes were calculated on the basis of the 12- month data with the medical-therapy group as the comparator. Data for the 12-month analysis were missing for two patients in the medical- therapy group and for one patient in the gastric- bypass group. ACE denotes angiotensin- converting enzyme, and ARB angiotensin- receptor blocker. † P< ‡ Injectable agents include insulin. § P<0.05 for the categorical comparison of the number of medications. ¶ P<0.01.

* Patients may have had more than one event. Seven patients in the medical-therapy group withdrew immediately after randomization. One patient in the sleeve- gastrectomy group had anemia before withdrawing from the study before surgery. † Hypoglycemic episodes were self- reported. Patients were classified according to whether they reported at least one episode of hypoglycemia during the follow-up period. ‡ Anemia was defined as a hemoglobin level of less than 11.5 g per deciliter for women and less than 13.0 g per deciliter for men. § Excessive weight gain was defined as an increase of more than 5% over the baseline value.

Results Of the 150 patients, 93% completed 12 months of follow-up. The proportion of patients with the primary end point was 12% (5 of 41 patients) in the medical therapy group versus 42% (21 of 50 patients) in the gastric-bypass group (P = 0.002) and 37% (18 of 49 patients) in the sleeve-gastrectomy group (P = 0.008). Glycemic control improved in all three groups, with a mean glycated hemoglobin level of 7.5±1.8% in the medical-therapy group, 6.4±0.9% in the gastric- bypass group (P<0.001), and 6.6±1.0% in the sleeve-gastrectomy group (P = 0.003). Weight loss was greater in the gastric-bypass group and sleeve-gastrectomy group (−29.4±9.0 kg and −25.1±8.5 kg, respectively) than in the medical-therapy group (−5.4±8.0 kg) (P<0.001 for both comparisons). The use of drugs to lower glucose, lipid, and blood-pressure levels decreased significantly after both surgical procedures but increased in patients receiving medical therapy only. The index for homeostasis model assessment of insulin resistance (HOMA-IR) improved significantly after bariatric surgery. Four patients underwent reoperation. There were no deaths or life- threatening complications.

Conclusions In obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone. Further study will be necessary to assess the durability of these results. (Funded by Ethicon Endo-Surgery and others; ClinicalTrials.gov number, NCT )

Message 手術による治療が肥満患者にはよさそうなのだ が．．． The success of various types of bariatric surgery suggests that they should not be seen as a last resort. Such procedures might well be considered earlier in the treatment of obese patients with type 2 diabetes.