内镜下注射肉毒毒素治疗单纯性肥胖的临床研究

Endoscopic injection of botulinum toxin for the treatment of obesity:a pilot study in China

目的研究内镜下胃壁注射A型肉毒毒素(BTX-A)治疗单纯性肥胖的有效性和安全性。方法10例单纯性肥胖患者为解放军总医院消化内科2008年12月至2009年3月收治患者,体重指数(BMI)28.6～46.41,随机分为2组,200U组内镜下胃窦、胃体、胃底共注射BTX-A200U,300U组胃窦、胃体、胃底共注射BTX-A300U。治疗前和治疗后1周、4周、12周分别对进食量、体重、BMI、胃半排空时间等进行随访。结果所有患者治疗后进食量较治疗前明显减少(P<0.05),至12周时仍较为明显;治疗后胃固体半排空时间均延长,且较治疗前差异有统计学意义(P<0.05);治疗后体重和BMI呈下降趋势,12周时体重减轻3～10kg,平均体重由(96.85±26.70)kg降至(91.10±26.15)kg(P<0.05),BMI由35.42±6.9降至33.31±6.92(P<0.05)。300U组BMI减少较200U组明显(P<0.05),但其余指标两组间相比差异无统计学意义。无明显不良反应发生。结论内镜下注射BTX-A能减慢胃排空、减少进食量,减轻体重,有望成为减肥治疗新手段。

Objective To investigate the safety and efficacy of botulinum toxin A injected into the gastric wall for the treatment of obesity. Methods 10 patients with simple obesity （ BMI 28.6 - 46.41 kg/m^2 ） were randomized into, 2 groups. In 200 U group,200 U BTX-A were injected endoscopically into the antrum,fundus and ganstric body. In 300 U group ,300 U BTX-A were injected were injected into the same sites. Food intake, body weight, BMI and semi-gastric emptying time were recorded before injection and 1 week,4 weeks and 12 weeks after the treatment. Results All patients reported reduced food intake 12 weeks after the injection（ P 〈 0.05 ）. The semi-gastric solid emptying time were significant longer than before the treatment（ P 〈0. 05 ）. Body weight and BMI decreased after the treatment. The average body weight reduced from （96. 85 ±26.7）kg to （91. 1 ±26. 15）kg at 12 weeks（with the weight loss of 3 - 10 kg） （P 〈0. 05） and BMI reduced from 35.42 ± 6. 9 to 33.31 ± 6. 92 （ P 〈 0. 05） There were no differences between the two groups except BMI. No clinically significant side effects were observed. Conclusion Endoscopic injection of BTX-A can reduce food intake and delay gastric emptying. It appears to be a new safe choice for weight loss of obese patients.