■胆胰转流伴十二指肠开关(DS)后的长期随访结果很少。
■为了比较体重减轻,健康结果,严重肥胖患者Roux-en-Y-胃旁路术(RYGB)和DS手术后10年或更长时间的生活质量-也就是说,体重指数(BMI;以千克体重除以米的平方身高计算)为50至60。
■这项开放标签的随机临床试验在瑞典和挪威的2个学术减肥中心进行。从2006年3月1日至2007年8月31日,纳入60例BMI为50至60的患者。数据从2022年8月12日至2023年1月25日进行了分析。
■腹腔镜RYGB或腹腔镜DS。
■主要结果是10年或更长时间后BMI的变化。次要结果包括人体测量,脂质和血糖分布,骨密度,不良事件,胃肠道症状,和健康相关的生活质量。
■原始60例患者中有48例(80%)在中位数为12(范围,9-13)岁(平均[SD]年龄,48.0[6.0]岁;35名妇女[73%])。在后续行动中,RYGB的平均BMI降低为11.0(95%CI,8.3-13.7),DS的平均BMI降低为20.3(95%CI,17.6-23.0),组间平均差异为9.3(95%CI,5.4-13.1;P<.001)。RYGB的总体重减轻为20.0%(95%CI,15.3%-24.7%),DS的总体重减轻为33.9%(95%CI,27.8%-40.0%)(P=.001)。平均血脂水平,除了高密度脂蛋白胆固醇和血红蛋白A1c,随访期间DS组改善更多。两组的骨量从5年减少到10年,DS后10年骨量较低。生活质量评分(与肥胖相关的问题量表和36项简短形式的健康调查)在10年的各组之间具有可比性。DS后不良事件总数较高(RYGB为135vs97;P=0.02)。DS组中更多的患者出现了维生素缺乏症(RYGB为21比11;P=.008),包括25-羟基维生素D缺乏症(DS为19比RYGB为9;P=.005)。DS组29例患者中有4例(14%)出现了严重的蛋白质-热量营养不良,其中3人(10%)接受了修正手术。
■在这项随机临床试验中,DS后BMI降低更大,但RYGB在10年内的风险状况更好。对于BMI为50至60的患者,与RYGB相比,DS的胆道胰腺改道可能不是更好的手术策略。
■ClinicalTrials.gov标识符:NCT00327912。
UNASSIGNED: Results from long-term follow-up after biliopancreatic diversion with duodenal switch (DS) are scarce.
UNASSIGNED: To compare weight loss, health outcomes, and quality of life 10 years or more after Roux-en-Y-gastric bypass (RYGB) and DS surgery in patients with severe obesity-that is, a body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 50 to 60.
UNASSIGNED: This open-label randomized clinical trial was conducted at 2 academic bariatric centers in Sweden and Norway. Sixty patients with a BMI of 50 to 60 were included from March 1, 2006, to August 31, 2007. Data were analyzed from August 12, 2022, to January 25, 2023.
UNASSIGNED: Laparoscopic RYGB or laparoscopic DS.
UNASSIGNED: The main outcome was change in BMI after 10 or more years. Secondary outcomes included anthropometric measures, lipid and glycemic profiles, bone mass density, adverse events, gastrointestinal tract symptoms, and health-related quality of life.
UNASSIGNED: Forty-eight of the original 60 patients (80%) were assessed after a median of 12 (range, 9-13) years (mean [SD] age, 48.0 [6.0] years; 35 women [73%]). At follow-up, the mean BMI reductions were 11.0 (95% CI, 8.3-13.7) for RYGB and 20.3 (95% CI, 17.6-23.0) for DS, with a mean between-group difference of 9.3 (95% CI, 5.4-13.1; P < .001). Total weight loss was 20.0% (95% CI, 15.3%-24.7%) for RYGB and 33.9% (95% CI, 27.8%-40.0%) for DS (P = .001). Mean serum lipid levels, except high-density lipoprotein cholesterol and hemoglobin A1c, improved more in the DS group during follow-up. Bone mass was reduced for both groups from 5 to 10 years, with lower bone mass after DS at 10 years. Quality-of-life scores (Obesity-Related Problem Scale and the 36-Item Short Form Health Survey) were comparable across groups at 10 years. The total number of adverse events was higher after DS (135 vs 97 for RYGB; P = .02). More patients in the DS group developed vitamin deficiencies (21 vs 11 for RYGB; P = .008) including 25-hydroxyvitamin D deficiency (19 for DS vs 9 for RYGB; P = .005). Four of 29 patients in the DS group (14%) developed severe protein-caloric malnutrition, of whom 3 (10%) underwent revisional surgery.
UNASSIGNED: In this randomized clinical trial, BMI reduction was greater after DS, but RYGB had a better risk profile over 10 years. Biliopancreatic diversion with DS may not be a better surgical strategy than RYGB for patients with a BMI of 50 to 60.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT00327912.