胃間隔手術可能促進第二型糖尿病肥胖病患疾病消退


  January 23, 2008 — 一項初期、沒有雙盲的隨機分派研究結果顯示,相較於接受傳統減重方式與糖尿病控制病患,罹患第二型糖尿病的肥胖病患,接受胃間隔手術可以減去更多體重,且糖尿病消退的可能性更高;這項研究結果發表於1月23日的美國醫學會期刊上。
  
  澳洲墨爾本大學摩納許大學的John B. Dixon博士表示,透過胃部手術來維持持續且顯著的減重效果,從未在治療第二型糖尿病肥胖患者身上正式檢驗過,許多觀察性研究結果顯示這有顯著好處,但這些研究一般是侷限於嚴重肥胖的受試者,據我們所知,目前並沒有已經發表的隨機分派研究。
  
  這項研究的目的在於評估,相較於傳統減重方式與糖尿病控制,以外科手術減重的方式是否與血糖控制有關,且可以降低對降血糖藥物的需求。
  
  從2002年12月到2006年12月之間,60位在過去兩年內被診斷罹患第二型糖尿病的肥胖病患(身體質量指數>30且<40 kg/m2),這些病患從社區中被收納到澳洲大學肥胖研究中心已確立的治療計畫中,受試者被隨機分派到強調透過生活型態改變來減重的傳統糖尿病治療、或是以腹腔鏡可調整型胃間隔手術加上糖尿病傳統照護。
  
  主要試驗終點包括第二型糖尿病消退,以空腹血糖值低於126 mg/dl(7.0 mmol/L)以及沒有降血糖藥物治療下糖化血紅素(HbA1c)值低於6.2%定義;次要試驗終點為以意向分析進行體重以及代謝症候群相關組成。
  
  60位收納進入研究的病患中有55位(92%)完成兩年的後續追蹤;在手術組中,22位(73%)病患第二型糖尿病消退,其中有4位(13%)是傳統治療組,手術組的第二型糖尿病消退相對風險為5.5(95%信賴區間為2.2-14.0)。
  
  兩年時,接受外科手術組平均體重下降20.7% ± 8.6%,控制組則是1.7% ± 5.2%(P<.001);第二型糖尿病的消退與減重有關(R2 = 0.46;P<.001),這兩組都沒有發生嚴重的併發症。
  
  作者寫道,被隨機分派到接受外科手術的受試者比較可能透過減重程度較多,而達到第二型糖尿病的消退;這些研究結果應該在較大型的、收納對象種類更多的、以及更長期的療效研究檢驗;在闡釋外科手術與減重的長期利益時必須小心,這項研究代表支持在治療第二型糖尿病肥胖患者時,應該早點考慮手術減重的強烈證據。
  
  這項試驗的限制包括,受試者侷限於那些最近被診斷罹患第二型糖尿病的;胃間隔手術團隊對於胃間隔手術有豐富的經驗、對於其他機構的應用程度可能有限;偵測安全性或是試驗終點的統計力量不足,例如死亡率或是心血管疾病事件;後續追蹤僅限制在兩年;且有5位病患未完成後續追蹤。
  
  作者們的結論是,這項研究的一個重要發現是,體重下降的程度,而不是減重方法,顯然是肥胖受試者血糖控制改善與糖尿病消退的主要動力;這有很重要的應用且顯示密集的減重治療相較於單純生活型態改變,可能是處理糖尿病更好的第一步;這項研究結果顯示,少數病患體重下降少於10%且糖尿病消退,這樣的程度有重要的健康益處。
  
  這項研究由摩納許大學贊助,該大學接受Allergan Health公司不受限制的資金,該公司提供未收費的腹腔鏡可調整型胃間隔瓣(Allergan Health公司)以及腹腔鏡接口(Applied Medical公司);部分作者表示與國家健康與醫學研究局、Allergan Health公司、諾華藥廠、禮來藥廠、諾和諾德藥廠、賽諾菲安萬特藥廠、Alphapharm公司以及/或是亞培藥廠有許多資金上的往來。
  
  在隨後的主編評論中,來自西雅圖密西根大學的David E. Cummings醫師與David R. Flum醫師稱這些發現是"清楚且突出的"。
  
  他們寫道,政策與健康照護相關領導人致力於研究外科手術介入的費用與風險,但這必須與不採取手術介入使糖尿病消退所帶來的費用與風險比較;要釐清這些問題需要時間與資源,但在糖尿病研究的領域中,透過研究以手術介入治療糖尿病所開始獲得的經驗,可能是自從胰島素發明之後最深切的,因此,未來對病患來說是光明的。
  
  Cummings與Flum醫師表示與國家健康機構、Tyco、楊森藥廠、Autosuture公司、Allergan公司、羅氏藥廠、Storz公司、GI Dynamics公司、Amylin公司以及/或是Power Medical Interventions公司有不同經濟上的往來。

Gastric Banding Surgery May He

By Laurie Barclay, MD
Medscape Medical News

January 23, 2008 — Obese patients with type 2 diabetes who had gastric banding surgery lost more weight and had a higher likelihood of diabetes remission than did patients who used conventional methods for weight loss and diabetes control, according to a preliminary, unblended, randomized controlled trial reported in the January 23 issue of the Journal of the American Medical Society.

"Significant sustained weight loss achieved using bariatric surgery has never been formally investigated as a treatment for type 2 diabetes in obese participants," write John B. Dixon, MBBS, PhD, from Monash University in Melbourne, Australia, and colleagues. "Several observational studies suggest substantial benefit, but these have generally been restricted to severely obese participants; to our knowledge, there have been no published randomized controlled trials."

The aim of this study was to evaluate whether surgically induced weight loss was associated with better glycemic control and with less need for diabetes medications than were traditional approaches to weight loss and diabetes control.

From December 2002 through December 2006, 60 obese patients (body mass index >30 and <40 kg/m2) with type 2 diabetes diagnosed in the past 2 years were recruited from the general community to established treatment programs at the University Obesity Research Center in Australia. Participants were randomly assigned to conventional diabetes therapy emphasizing weight loss by lifestyle change or to conventional diabetes care with laparoscopic adjustable gastric banding surgery.

The primary endpoints included remission of type 2 diabetes, defined as fasting glucose level less than 126 mg/dL (7.0 mmol/L) and glycated hemoglobin (HbA1c) value lower than 6.2% in the absence of glycemic therapy. Secondary endpoints were weight and components of the metabolic syndrome, and analysis was by intent-to-treat.

Two-year follow-up was completed by 55 (92%) of the 60 patients enrolled. In the surgical group, 22 of the patients (73%) had remission of type 2 diabetes, as did 4 patients (13%) in the conventional-therapy group, yielding a relative risk of remission for the surgical group of 5.5 (95% confidence interval, 2.2 – 14.0).

At 2 years, mean weight loss was 20.7% ± 8.6% in the surgical group and 1.7% ± 5.2% in the conventional-therapy group (P < .001). Remission of type 2 diabetes was associated with weight loss (R2 = 0.46; P < .001), as well as with lower HbA1c levels at baseline (combined R2 = 0.52; P < .001). Neither group developed any serious complications.

"Participants randomized to surgical therapy were more likely to achieve remission of type 2 diabetes through greater weight loss," the authors write. "These results need to be confirmed in a larger, more diverse population and have long-term efficacy assessed.... While caution is required in interpreting the longer-term benefits of surgery and weight loss, this study presents strong evidence to support the early consideration of surgically induced loss of weight in the treatment of obese patients with type 2 diabetes."

Study limitations include participation restricted to those with a recent diagnosis of type 2 diabetes; extensive experience of the bariatric surgical team with the gastric banding procedure, limiting generalizability to other institutions; insufficient power for safety or to detect differences in hard endpoints, such as mortality or cardiovascular events; duration of follow-up limited to 2 years; and missing follow-up data in 5 patients.

"An important finding of this study is that degree of weight loss, not the method, appears to be the major driver of glycemic improvement and diabetes remission in obese participants," the authors conclude. "This has important implications, as it suggests that intensive weight-loss therapy may be a more effective first step in the management of diabetes than simple lifestyle change. This study shows that few participants achieved remission with a body weight loss of less than [10%], a level expected to produce important health benefits."

This study was funded by Monash University, which received an unrestricted grant from Allergan Health. The manufacturers provided the laparoscopic adjustable gastric bands (Allergan Health) and the laparoscopic ports (Applied Medical) without charge. Some of the authors report various financial arrangements with the National Health and Medical Research Council, Allergan Health, Novartis, Eli Lilly, Novo Nordisc, Sanofi Aventis, Alphapharm, and/or Abbott Australia.

In an accompanying editorial, David E. Cummings, MD, and David R. Flum, MD, MPH, from the University of Washington, Seattle, call these findings "clear and striking."

"Policy and health care leaders are grappling with the costs and risks of surgical interventions, which must be balanced against the costs and risks of not taking advantage of surgically induced diabetes remission, in the face of an expanding pandemic," they write. "Addressing these issues requires time and resources, but in this era of advanced diabetes research, the insights already beginning to be gained by studying surgical interventions for diabetes may be the most profound since the discovery of insulin. As a result, the future looks brighter for patients."

Dr. Cummings and Dr. Flum report various financial arrangements with the National Institutes of Health, Tyco, Johnson & Johnson, Autosuture, Allergan, Roche, Storz, GI Dynamics, Amylin, and/or Power Medical Interventions.

JAMA. 2008;299(3):316–323, 341–343.

    
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