Department of Gastroenterological Surgery, Gastroenterological Center, Cancer Institute Hospital, Japanese Foundation for Cancer Research, and Department of Gastrointestinal Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
Gastrointest Endosc. 2011 May;73(5):932-41. doi: 10.1016/j.gie.2010.12.013. Epub 2011 Feb 26.
GI peristalsis during GI endoscopy commonly requires intravenous or intramuscular injection of antispasmodic agents, which sometimes cause unexpected adverse reactions.
Our ultimate goal was to evaluate whether the antiperistaltic effect of L-menthol-based preparations facilitates endoscopic examinations in a clinical setting.
Multicenter, randomized, double-blind, placebo-controlled study.
Six Japanese referral centers.
A total of 87 patients scheduled to undergo upper GI endoscopy were randomly assigned to receive 160 mg of L-menthol (n=45) or placebo (n=42). Both treatments were sprayed endoscopically on the gastric mucosa. The degree of gastric peristalsis was assessed by an independent committee.
The proportion of subjects with no peristalsis 90 to 135 seconds after administration and at the end of the endoscopic examination (complete suppression of gastric peristalsis). Other outcomes were the proportion of subjects with no or mild peristalsis (adequate suppression of gastric peristalsis) and the ease of intragastric observation as evaluated by the endoscopist who performed the procedure.
Gastric peristalsis was completely suppressed in 35.6% (21.9, 51.2) of the L-menthol group compared with only 7.1% (1.5, 19.5) of the placebo group (P<.001). In the L-menthol group, 77.8% (62.9, 88.8) (35/45 subjects) of the subjects had no or mild peristalsis at the completion of endoscopy. Minor peristalsis interfered with intragastric examination in only 1 of these 35 patients (2.9%). The incidence of adverse events did not differ significantly between the groups (P=.512).
Small sample size.
During upper GI endoscopy, L-menthol sprayed on the gastric mucosa significantly suppresses peristalsis with minimal adverse drug reactions compared with placebo. (
NCT00742599.).
在胃肠内镜检查过程中，胃肠道蠕动通常需要静脉或肌肉注射抗痉挛药物，但这些药物有时会引起意想不到的不良反应。
我们的最终目标是评估基于 L-薄荷醇的制剂的抗蠕动作用是否有利于临床内镜检查。
多中心、随机、双盲、安慰剂对照研究。
六家日本转诊中心。
共 87 名计划接受上消化道内镜检查的患者被随机分为 L-薄荷醇组（n=45）和安慰剂组（n=42），每组接受 160mg L-薄荷醇或安慰剂。两种治疗方法均在内镜下喷洒于胃黏膜上。由独立委员会评估胃蠕动程度。
给药后 90 至 135 秒和内镜检查结束时无蠕动的患者比例（完全抑制胃蠕动）；其他观察指标包括无或轻度蠕动的患者比例（充分抑制胃蠕动）以及操作内镜的内镜医生评估的胃内观察的难易程度。
L-薄荷醇组完全抑制胃蠕动的比例为 35.6%（21.9%，51.2%），安慰剂组仅为 7.1%（1.5%，19.5%）（P<.001）。在 L-薄荷醇组中，内镜检查结束时 77.8%（62.9%，88.8%）（35/45 例）的患者无或轻度蠕动。在这 35 例患者中，仅有 1 例（2.9%）轻度蠕动干扰胃内检查。两组不良反应发生率无显著差异（P=.512）。
样本量小。
与安慰剂相比，L-薄荷醇喷洒在胃黏膜上可显著抑制蠕动，且药物不良反应最小。（临床试验注册号：NCT00742599）。
