Edelman S, Ng-Mak D S, Fusco M, Ashton D, Okerson T, Liu Q, Jin J, Dixon J B
University of California, San Diego, Veterans Affairs Medical Center, San Diego, CA, USA.
Diabetes Obes Metab. 2014 Oct;16(10):1009-15. doi: 10.1111/dom.12313. Epub 2014 Jun 9.
The 5-year, open-label, prospective, observational helping evaluate reduction in obesity (HERO) study (N = 1106) examines efficacy and safety of the LAP-BAND AP(®) laparoscopic adjustable gastric band (LAGB) in obese patients. This interim analysis assessed the control of type 2 diabetes (T2D), 1 year after the implantation of the LAGB.
Baseline T2D was defined by chart review or use of antidiabetic medications or haemoglobin A1c (HbA1c) ≥ 7.0%. Control of T2D at 1 year was defined as A1c <7.0% (with or without antidiabetic medications).
After 1 year, 187 of 273 patients with T2D at baseline had adequate data available to assess T2D status, of which 135 patients (72.2%) achieved target control of T2D compared with 42.8% control rate at baseline. Independent predictors of achieving target control at 1 year included the following: (i) shorter diabetes duration odds ratio (OR) 0.914 [95% confidence interval (CI), 0.839, 0.995, p = 0.038], (ii) not using insulin therapy OR 0.16 (95% CI, 0.06, 0.47, p < 0.001) and (iii) greater mean % weight loss OR 1.176 (95% CI, 1.093, 1.266, p < 0.001). Patients using insulin at baseline were 84% less likely to achieve control of T2D after 1 year; each additional year of diabetes at baseline reduced the likelihood of good control by 9%; and each 1% of weight loss increases the likelihood of good control by 18%. Rates of device-related adverse events and reoperations were low and were not significantly different between patients with and without baseline T2D at 1 year.
Greater % weight loss, not using insulin therapy, and shorter disease duration predicted increased likelihood of target control of T2D, 1 year after implantation of the LAGB.
为期5年的开放标签、前瞻性观察性帮助评估肥胖症减轻情况（HERO）研究（N = 1106），旨在研究LAP - BAND AP（®）腹腔镜可调节胃束带（LAGB）在肥胖患者中的疗效和安全性。这项中期分析评估了LAGB植入1年后2型糖尿病（T2D）的控制情况。
通过病历审查、使用抗糖尿病药物或血红蛋白A1c（HbA1c）≥7.0%来定义基线T2D。1年时T2D的控制定义为A1c <7.0%（无论是否使用抗糖尿病药物）。
1年后，273例基线时患有T2D的患者中有187例有可用于评估T2D状态的充分数据，其中135例患者（72.2%）实现了T2D的目标控制，而基线时的控制率为42.8%。1年时实现目标控制的独立预测因素包括：（i）糖尿病病程较短，优势比（OR）为0.914 [95%置信区间（CI），0.839，0.995，p = 0.038]，（ii）未使用胰岛素治疗，OR为0.16（95% CI，0.06，0.47，p < 0.001），以及（iii）平均体重减轻百分比更大，OR为1.176（95% CI，1.093，1.266，p < 0.001）。基线时使用胰岛素的患者1年后实现T2D控制的可能性降低84%；基线时糖尿病病程每增加1年，良好控制的可能性降低9%；体重每减轻1%，良好控制的可能性增加18%。与器械相关的不良事件和再次手术的发生率较低，1年时基线有T2D和无T2D的患者之间无显著差异。
LAGB植入1年后，体重减轻百分比更大、未使用胰岛素治疗以及病程较短预示着T2D目标控制的可能性增加。
