Department for Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Division of Endocrinology and Diabetology, Department of Medicine II, University Hospital of Freiburg, Medical Faculty, University of Freiburg, Freiburg, Germany.
Surg Obes Relat Dis. 2018 Jun;14(6):769-779. doi: 10.1016/j.soard.2018.02.029. Epub 2018 Mar 9.
The endoscopic duodenal-jejunal bypass liner (DJBL) represents a novel temporary endoscopic approach for treatment of obesity-associated type 2 diabetes. Recent results from the German DJBL registry confirmed substantial positive metabolic effects of the DJBL in type 2 diabetes. However, the last Food and Drug Administration trial was stopped due to a high occurrence of hepatic abscesses (3.5%).
Here, we analyzed time courses of development of co-morbidities, nutritive changes, and occurrence of adverse events during the 1-year treatment phase with the DJBL in the German DJBL registry.
Sixty-six patients from the registry were analyzed for efficacy, safety, and nutritional status. Patient data sets were analyzed at implantation, 3 and 6 months after implantation, and at explantation visits.
Weight, body mass index, glycated hemoglobin, and low-density lipoprotein cholesterol primarily declined during the first 3 months after implantation, whereas systolic and diastolic blood pressure were predominantly reduced during the second half of the treatment phase. Severe DJBL-associated side effects were mainly documented at the explantation visit (intestinal obstruction [1.7%], dislocation [1.7%], and liver abscess [1.7%]). Measurements of serum concentrations of ferritin, albumin, vitamin B12, folic acid, 25-hydroxyvitamin D3 (25 OH-Vit-D3), and calcium provided suggestive evidence of a possible decrease of nutritional absorption of vitamins and trace elements by the DJBL.
The DJBL demonstrates high efficacy with substantial improvement of all parameters of the metabolic syndrome and the potential for reduction of comedications in overweight patients with type 2 diabetes. These registry results are important to optimize recommendations for adaptation of concomitant medication, surveillance of adverse events, nutritional status and supplementation, and adaptation of the implantation period of the DJBL.
内镜十二指肠空肠旁路管（DJBL）代表了一种治疗肥胖相关 2 型糖尿病的新型临时内镜方法。来自德国 DJBL 注册中心的最新结果证实了 DJBL 在 2 型糖尿病中具有显著的代谢积极作用。然而，由于肝脓肿的高发生率（3.5%），最后一次食品和药物管理局试验被停止。
在此，我们分析了德国 DJBL 注册中心在 DJBL 治疗 1 年期间合并症的发展过程、营养变化和不良事件的发生情况。
对注册中心的 66 例患者进行了疗效、安全性和营养状况分析。患者数据集在植入、植入后 3 个月和 6 个月以及植入后访视时进行分析。
体重、体重指数、糖化血红蛋白和低密度脂蛋白胆固醇主要在植入后 3 个月内下降，而收缩压和舒张压主要在治疗阶段的后半段下降。严重的 DJBL 相关副作用主要在植入后访视时记录（1.7%的肠梗阻、1.7%的脱位和 1.7%的肝脓肿）。铁蛋白、白蛋白、维生素 B12、叶酸、25-羟维生素 D3（25-OH-Vit-D3）和钙的血清浓度测量提供了暗示性证据，表明 DJBL 可能降低了维生素和微量元素的营养吸收。
DJBL 具有很高的疗效，可显著改善代谢综合征的所有参数，并有可能减少超重 2 型糖尿病患者的合并用药。这些注册结果对于优化对合并用药的建议、监测不良事件、营养状况和补充、以及调整 DJBL 的植入期非常重要。
