Friedenberg Frank K, Palit Amiya, Parkman Henry P, Hanlon Alexandra, Nelson Deborah B
Section of Gastroenterology, Temple University School of Medicine, Philadelphia, PA 19140, USA.
Am J Gastroenterol. 2008 Feb;103(2):416-23. doi: 10.1111/j.1572-0241.2007.01676.x. Epub 2007 Dec 5.
Observational data suggest that intrapyloric injection of botulinum toxin A (BoTN/A) reduces symptoms and accelerates gastric emptying in idiopathic and diabetic gastroparesis. Our purpose was to determine whether botulinum toxin improves symptoms to a significantly greater extent than placebo. An additional objective was to determine whether there is an acceleration of gastric emptying after injection.
A single-institution, randomized, double-blind, placebo-controlled trial* was done. Eligible patients had a Gastroparesis Cardinal Symptom Index score > or = 27 with randomization to intrapyloric botulinum toxin, 200 U (units), or saline placebo. Reassessment of symptoms and repeat gastric emptying scan at 1-month follow-up were done.
Thirty-two patients were randomized to botulinum toxin (N = 16) and placebo (N = 16). At 1-month follow-up, 37.5% randomized to botulinum toxin and 56.3% randomized to placebo achieved improvement as defined by this study. There were no identifiable clinical predictors of response. The botulinum toxin group demonstrated improvement in gastric emptying; however, this was not superior to placebo. No serious adverse events were attributable to botulinum toxin.
Intrapyloric injection of botulinum toxin improves gastric emptying in patients with gastroparesis, although this benefit was not superior to placebo at 1 month. Also, in comparison to placebo, symptoms do not improve significantly by 1 month after injection. Overall, we are unable to recommend botulinum toxin therapy for widespread use in the treatment of delayed gastric emptying until more data are available.
观察性数据表明，幽门内注射A型肉毒杆菌毒素（BoTN/A）可减轻特发性和糖尿病性胃轻瘫患者的症状并加速胃排空。我们的目的是确定肉毒杆菌毒素是否比安慰剂能更显著地改善症状。另一个目的是确定注射后胃排空是否加速。
进行了一项单中心、随机、双盲、安慰剂对照试验*。符合条件的患者胃轻瘫主要症状指数评分≥27，随机分为幽门内注射200单位肉毒杆菌毒素或生理盐水安慰剂组。在1个月随访时重新评估症状并重复进行胃排空扫描。
32例患者被随机分为肉毒杆菌毒素组（N = 16）和安慰剂组（N = 16）。在1个月随访时，根据本研究定义，随机接受肉毒杆菌毒素治疗的患者中有37.5%病情改善，随机接受安慰剂治疗的患者中有56.3%病情改善。没有可识别的反应临床预测因素。肉毒杆菌毒素组胃排空有所改善；然而，并不优于安慰剂组。没有严重不良事件可归因于肉毒杆菌毒素。
幽门内注射肉毒杆菌毒素可改善胃轻瘫患者的胃排空，尽管在1个月时这种益处并不优于安慰剂。此外，与安慰剂相比，注射后1个月症状没有显著改善。总体而言，在获得更多数据之前，我们无法推荐广泛使用肉毒杆菌毒素疗法来治疗胃排空延迟。
