Sánchez-Torralvo Francisco José, Vázquez-Pedreño Luis, Gonzalo-Marín Montserrat, Tapia María José, Lima Fuensanta, García-Fuentes Eduardo, García Pilar, Moreno-Ruiz Javier, Rodríguez-Cañete Alberto, Valdés Sergio, Olveira Gabriel
Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, 29010 Malaga, Spain.
Departamento de Medicina y Dermatología, Facultad de Medicina, University of Malaga, 29010 Malaga, Spain.
J Clin Med. 2022 Apr 11;11(8):2126. doi: 10.3390/jcm11082126.
Background: Intragastric injection of botulinum toxin A (BT-A) has been shown to be effective for weight loss up to six months after administration, according to previous studies. Our objective was to determine, in patients on bariatric surgery waiting lists, the effect of BT-A on weight loss in the pre- and postoperative period and to analyse if there are different responses based on Body Mass Index (BMI). Methods: We performed a follow-up analysis of the IntraTox study, which included 46 patients on bariatric surgery waiting lists in a single-centre, randomised, double-blind, placebo-controlled clinical trial. The treatment group received intragastric BT-A, whereas the control group received physiological saline solution. The one-time procedure was performed at the time of diagnostic endoscopy 7−8 months before surgery. Weight loss was evaluated at admission and after 4 and 12 weeks from the bariatric surgery. Our analysis was stratified by BMI at randomisation. Results: weight loss percentage on the day of surgery, with respect to the initial visit, was −4.5 ± 3.9% for the control group vs. −7.6 ± 4.2%, for the treatment group (p = 0.013). Weight loss percentage tended to remain greater in the treatment group one month after the intervention (−12.7 ± 4.7% vs. −15.2 ± 4.6%, p = 0.07) and become similar three months after (−21.6 ± 4.7% vs. −21.6 ± 4.6%). After stratifying by BMI, only patients with BMI over 50 kg/m2 allocated to the treatment group obtained a greater weight loss at the end of the trial, the day of surgery, and one month after, compared with the placebo group (−4.9 ± 4.9%, −10.8 ± 5.3% and −17.1 ± 3.8% vs. −0.1 ± 2.6%, −4.3 ± 3.2% and −12.8 ± 4.1%, respectively (p < 0.05). Conclusions: intragastric injection of BT-A is effective to achieve significant weight loss, especially in extreme obesity. Its use before bariatric surgery enhances perioperative weight loss.
根据以往研究，胃内注射A型肉毒杆菌毒素（BT-A）在给药后长达六个月内对体重减轻有效。我们的目的是确定在接受减肥手术等候名单上的患者中，BT-A在术前和术后对体重减轻的影响，并分析基于体重指数（BMI）是否存在不同反应。方法：我们对IntraTox研究进行了随访分析，该研究在一项单中心、随机、双盲、安慰剂对照临床试验中纳入了46名接受减肥手术等候名单上的患者。治疗组接受胃内BT-A，而对照组接受生理盐水溶液。一次性操作在手术前7-8个月的诊断性内镜检查时进行。在入院时以及减肥手术后4周和12周评估体重减轻情况。我们的分析按随机分组时的BMI进行分层。结果：与治疗组相比，对照组在手术当天相对于初次就诊时的体重减轻百分比为-4.5±3.9%，而治疗组为-7.6±4.2%（p=0.013）。干预后一个月，治疗组的体重减轻百分比倾向于保持更高（-12.7±4.7%对-15.2±4.6%，p=0.07），三个月后变得相似（-21.6±4.7%对-21.6±4.6%）。按BMI分层后，与安慰剂组相比，仅分配到治疗组的BMI超过50kg/m²的患者在试验结束时、手术当天和一个月后体重减轻更多（分别为-4.9±4.9%、-10.8±5.3%和-17.1±3.8%对-0.1±2.6%、-4.3±3.2%和-12.8±4.1%，p<0.05）。结论：胃内注射BT-A有效地实现了显著的体重减轻，尤其是在极度肥胖患者中。在减肥手术前使用可增强围手术期体重减轻。
