Botulinum toxin a for the treatment of delayed gastric emptying
Botulinum toxin a for the treatment of delayed gastric emptying
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DOI：
10.1111/j.1572-0241.2007.01676.x
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发表时间：
2008-02-01
影响因子：
9.8
通讯作者：
Nelson, Deborah B.
中科院分区：
文献类型：
--
作者：
Friedenberg, Frank K.;Palit, Amiya;Nelson, Deborah B.
背景技术背景：观察数据表明，幽门内注射肉毒杆菌毒素A（BoTN/A）可减轻特发性和糖尿病性胃轻瘫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更能显著改善症状。另一个目的是确定是否有一个注射后胃排空的加速。方法：一个单机构，随机，双盲，安慰剂对照试验 * 完成。符合条件的患者胃轻瘫主要症状指数评分>= 27，随机接受幽门内肉毒杆菌毒素、200 U（单位）或生理盐水安慰剂。症状的重新评估和重复胃排空扫描在1个月follow-up.Results：32例患者被随机分配到肉毒杆菌毒素（N = 16）和安慰剂（N = 16）。在1个月的随访中，37.5%随机分配到肉毒杆菌毒素组和56.3%随机分配到安慰剂组的患者达到了本研究定义的改善。没有可识别的临床反应预测因子。肉毒杆菌毒素组表现出胃排空的改善;然而，这并不上级安慰剂。没有严重的不良事件归因于肉毒杆菌toxin.CONCLUSIONS：幽门内注射肉毒杆菌毒素改善胃轻瘫患者的胃排空，虽然这种好处是没有上级安慰剂在1个月。此外，与安慰剂相比，注射后1个月症状没有显著改善。总的来说，在获得更多数据之前，我们不能推荐肉毒杆菌毒素治疗广泛用于治疗胃排空延迟。
BACKGROUND: 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.METHODS: A single-institution, randomized, double-blind, placebo-controlled trial* was done. Eligible patients had a Gastroparesis Cardinal Symptom Index score >= 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.RESULTS: 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.CONCLUSIONS: 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 I 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.