目的评价内镜下胃转流支架系统对肥胖患者体重和肥胖相关代谢指标的疗效，并评估设备的安全性。
方法选取2021年3月至2022年10月全国多中心随机对照试验中于首都医科大学附属北京友谊医院行胃转流支架治疗的14例肥胖患者进行亚组分析。患者入组后行内镜下胃转流支架置入术，12周后经内镜取出，取出后继续随访至36周。主要评价入组12周、24周和36周患者的多余体重减少率、总体重减少率、胰岛素抵抗、转氨酶、血脂和尿酸的变化，以及设备的安全性。
结果14例患者中男9例、女5例，年龄（34.3±7.4）岁，初始体重（104.8±13.9）kg。2例患者因不能耐受消化道不良反应提前取出支架，其余12例患者完成了随访，12周、24周和36周多余体重减少率分别为34.4%±25.5%、39.1%±37.5%和27.3%±40.8%；总体重减少率分别为8.7%±6.2%、10.1%±10.2%和8.3%±13.8%。胰岛素抵抗的稳态模型评估基线水平为7.03±3.59，12周时为4.81±3.71（与基线相比 P=0.022），24周时为4.17±2.77（与基线相比 P=0.002），36周时为4.66±3.58（与基线相比 P=0.016）。丙氨酸转氨酶（alanine aminotransferase，ALT）在基线、12周、24周和36周分别为48（21~124）U/L、39（14~96）U/L、27（10~86）U/L和32（16~113）U/L，ALT下降在24周、36周差异均有统计学意义（与基线相比 P=0.009， P=0.026）。天冬氨酸转氨酶（aspartate aminotransferase，AST）在基线、12周、24周和36周分别为30（20~62）U/L、24（15~72）U/L、22（11~56）U/L和26（13~74）U/L，AST下降在24周差异有统计学意义（与基线相比 P=0.018）。而血脂、尿酸的变化无统计学意义（ P>0.05）。唯一的严重不良事件是在支架取出过程中发生1例食管黏膜撕裂，经内镜下金属夹成功夹闭治疗。所有患者无器械移位、急性胰腺炎或肝脓肿等发生。
结论胃转流支架系统短期内具有良好的减重效果，且相对安全，还可以改善胰岛素抵抗和肝酶。
ObjectiveTo evaluate the efficacy and safety of a gastric bypass stent system for weight loss and obesity-associated metabolic parameters.
MethodsA sub-analysis of a multicenter randomized control trial was conducted on data of 14 obese patients who were implanted the gastric bypass stent system under endoscopy in Beijing Friendship Hospital, Capital Medical University from March 2021 to October 2022. The device was removed after 12 weeks and the patients were followed up for 36 weeks. Outcomes included changes in excess weight loss (EWL), total weight loss (TWL), insulin resistance, liver enzymes, lipids and uric acid at 12, 24 and 36 weeks, and the safety of the device.
ResultsAmong the 14 patients, there were 9 males and 5 females, aged 34.3±7.4 years, with an initial body weight of 104.8±13.9 kg. Stents were removed in advance in 2 patients because of intolerable adverse reactions of the digestive tract. The remaining 12 patients completed follow-up, and their EWL was 34.4%±25.5% at 12 weeks, 39.1%±37.5% at 24 weeks, and 27.3%±40.8% at 36 weeks. TWL was 8.7%±6.2%, 10.1%±10.2% and 8.3%±13.8%, respectively. The levels of homeostasis model assessment of insulin resistance (HOMA-IR) at 12 weeks (4.81±3.71, P=0.022), 24 weeks (4.17±2.77, P=0.002) and 36 weeks (4.66±3.58, P=0.016) were statistically significant compared with baseline (7.03±3.59). The levels of alanine aminotransferase (ALT) were 48 (21-124) U/L, 39 (14-96) U/L, 27 (10-86) U/L and 32 (16-113) U/L at baseline, 12 weeks, 24 weeks and 36 weeks, respectively, and the changes of ALT were statistically significant at 24 weeks and 36 weeks ( P=0.009, P=0.026 compared with baseline). The levels of aspartate aminotransferase (AST) were 30 (20-62) U/L, 24 (15-72) U/L, 22 (11-56) U/L and 26 (13-74) U/L at baseline, 12 weeks, 24 weeks and 36 weeks, respectively, and the change of AST was significant at 24 weeks ( P=0.018 compared with baseline). However, the changes of uric acid and serum lipid were not statistically significant ( P>0.05). The only severe adverse event was esophageal mucosal laceration during the process of explantation, which was successfully treated with endoscopic clips. There was no device migration, acute pancreatitis or hepatic abscess.
ConclusionThe gastric bypass stent system, relatively safe, has a good short-term weight loss effect and improves insulin resistance and liver enzymes.
周艳华,张倩,张澍田,等. 内镜下胃转流支架系统治疗肥胖的疗效和安全性分析[J]. 中华消化内镜杂志,2024,41(01)：18-24.
DOI:10.3760/cma.j.cn321463-20230912-00377版权归中华医学会所有。
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除非特别声明，本刊刊出的所有文章不代表中华医学会和本刊编委会的观点。
周艳华：撰写文章、病例信息收集；张倩：医学统计指导；张澍田：文章指导及修改；李鹏：内镜操作、文章指导及修改
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