Department of Health Services Administration, China Medical University, Taichung, Taiwan2Min-Sheng General Hospital, Taoyuan, Taiwan3Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Taiwan.
Min-Sheng General Hospital, Taoyuan, Taiwan.
JAMA Surg. 2015 Dec;150(12):1117-24. doi: 10.1001/jamasurg.2015.2602.
It has been well recognized that metabolic surgery has short-term benefits for mildly obese patients with type 2 diabetes mellitus (T2DM), but how long these effects can be sustained is uncertain.
To compare the 5-year efficacy between gastrointestinal metabolic surgery and medical treatment on glycemic control and diabetes remission in patients with T2DM and body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) lower than 35.
DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study compares long-term outcomes for mildly obese patients with T2DM receiving metabolic surgery (n = 52) vs medical treatment (n = 299). The surgical group, enrolled from August 20, 2007, to June 25, 2008, and followed up through December 31, 2013, received standard sleeve gastrectomy (n = 19) or bypass (n = 33) procedures in a regional hospital. The medical group, selected from a nationwide community cohort that was recruited from August 27, 2003, to December 31, 2005, and followed up through December 31, 2012, was matched with the surgical group by age, BMI, and diabetes duration.
Glycated hemoglobin (HbA1c) reduction and prolonged complete and partial diabetes remission (defined as HbA1c <6.0% and 6.0%-6.5% of total hemoglobin [Hb; to convert to proportion of total Hb, multiply by 0.01], respectively, for those who were exempted from any antidiabetic drugs for 5 years).
At the end of the fifth year, the surgical group had a mean weight loss of 21.0% (from a mean [SD] BMI of 31.0 [2.4] to 24.5 [2.7]), their mean (SD) HbA1c decreased from 9.1% (2.1%) to 6.3% (1.1%) of total Hb, 18 participants (36.0%) had complete remission, 14 (28.0%) had partial remission, 1 (1.9%) died, and 1 (1.9%) had end-stage renal disease. In the same follow-up period in the medical group, 3 (1.2%) had complete remission, 4 (1.6%) had partial remission, 9 (3.0%) died, and 2 (0.7%) had end-stage renal disease; their mean HbA1c remained around 8% of total Hb (mean [SD], 8.1% [1.8%] of total Hb at baseline and 8.0% [1.6%] of total Hb at 5 years), and BMI also stayed similar (mean [SD], 29.1 [2.4] at baseline and 28.8 [2.6] at 5 years). The HbA1c reduction and complete and partial remission rates were all significantly larger in the surgical group as compared with the medical group (all P < .001). However, the mortality rate and end-stage renal disease incidence were not significantly different in these 2 comparison groups (P = .66 and .37, respectively).
For mildly obese patients with T2DM, the improvement in glycemic control from metabolic surgery lasts at least 5 years. However, the survival benefit and lifelong adverse outcomes require more than 5 years to be established.
重要性:人们已经充分认识到代谢手术对患有 2 型糖尿病(T2DM)的轻度肥胖患者具有短期益处,但这些效果能持续多久尚不确定。
目的:比较胃肠代谢手术和药物治疗对 BMI 低于 35 的 T2DM 患者血糖控制和糖尿病缓解的 5 年疗效。
设计、设置和参与者:这项回顾性队列研究比较了接受代谢手术(n = 52)和药物治疗(n = 299)的轻度肥胖 T2DM 患者的长期结局。手术组于 2007 年 8 月 20 日至 2008 年 6 月 25 日入组,并在 2013 年 12 月 31 日之前进行了标准的袖状胃切除术(n = 19)或旁路手术(n = 33)。药物组选自全国社区队列,于 2003 年 8 月 27 日至 2005 年 12 月 31 日招募,并在 2012 年 12 月 31 日之前进行了随访。该队列通过年龄、BMI 和糖尿病病程与手术组相匹配。
主要结局和测量:糖化血红蛋白(HbA1c)降低和糖尿病完全缓解和部分缓解的持续时间(定义为 HbA1c<6.0%和 6.0%-6.5%的总血红蛋白[Hb;转换为总 Hb 的比例,乘以 0.01],对于那些在 5 年内无需任何抗糖尿病药物的患者)。
结果:在第 5 年末,手术组的平均体重减轻了 21.0%(从平均[SD]BMI 31.0[2.4]降至 24.5[2.7]),平均(SD)HbA1c 从 9.1%(2.1%)降至 6.3%(1.1%)的总 Hb,18 名参与者(36.0%)完全缓解,14 名(28.0%)部分缓解,1 名(1.9%)死亡,1 名(1.9%)发生终末期肾病。在相同的随访期间,药物组有 3 名(1.2%)完全缓解,4 名(1.6%)部分缓解,9 名(3.0%)死亡,2 名(0.7%)发生终末期肾病;他们的平均 HbA1c 仍保持在总 Hb 的 8%左右(基线时的平均[SD]为 8.1%[1.8%],5 年后为 8.0%[1.6%]),BMI 也相似(基线时的平均[SD]为 29.1[2.4],5 年后为 28.8[2.6])。与药物组相比,手术组的 HbA1c 降低和完全缓解及部分缓解率均显著更大(均 P<0.001)。然而,这两个比较组的死亡率和终末期肾病发生率没有显著差异(P=0.66 和 P=0.37)。
结论和相关性:对于轻度肥胖的 T2DM 患者,代谢手术改善血糖控制的效果至少持续 5 年。然而,生存获益和终身不良结局需要超过 5 年的时间才能确定。