Song C W, Chun H J, Kim C D, Ryu H S, Choe J G, Hyun J H
Department of Internal Medicine and Nuclear Medicine, Institute of Digestive Disease and Nutrition, Korea University, College of Medicine, Seoul, Korea.
Korean J Intern Med. 1998 Feb;13(1):15-21. doi: 10.3904/kjim.1998.13.1.15.
Levosulpiride is the levo-enantiomer of sulpiride, a well-known antiemetic, antidyspeptic and antipsychotic drug. This study was undertaken to investigate the effects of levosulpiride on dyspeptic symptoms and gastric motor function in a group of patients with functional dyspepsia showing delayed gastric emptying.
Forty two eligible patients were entered into a 3 week, double-blind randomized comparison of 25mg of levosulpiride or placebo t.i.d.. Symptom assessment and gastric scintigraphy following the intake of scrambled egg sandwich, were performed in each patient before and after treatment.
The improvement of symptom score in levosulpiride group was higher than the placebo group (p < 0.05). We assessed global efficacy, which was excellent in 1 (6%), good 11 (65%), fair 4 (24%), nil 1 (6%) of those receiving levosulpiride, and fair 9 (60%), nil 5 (33%), poor 1 (6%) of those receiving placebo. Levosulpiride tended to be more effective than placebo in relieving the dyspeptic symptoms especially in the subgroups of dysmotility-like (p < 0.05) and nonspecific (p < 0.05) as compared to other subgroups (p = 0.16). The reduction of gastric emptying time after levosulpiride treatment was more marked than Placebo group (p < 0.05). We found a significant correlation between changes of symptom score and gastric emptying time (r = 0.47, p = 0.01). No serious adverse effects were reported after administration of either levosulpiride or placebo. Only two patients reported mild somnolence during levosulpiride administration.
Levosulpiride is effective and well tolerated in patients with functional dyspepsia accompanied by delayed gastric emptying. Its efficacy may be related to its action on the gastric motor function by improving the delayed gastric emptying.
左舒必利是舒必利的左旋对映体，舒必利是一种知名的止吐、抗消化不良和抗精神病药物。本研究旨在调查左舒必利对一组胃排空延迟的功能性消化不良患者的消化不良症状和胃运动功能的影响。
42名符合条件的患者进入为期3周的双盲随机对照试验，分别服用25mg左舒必利或安慰剂，每日3次。在治疗前后，对每位患者进行症状评估，并在摄入炒蛋三明治后进行胃闪烁扫描。
左舒必利组的症状评分改善高于安慰剂组（p<0.05）。我们评估了总体疗效，接受左舒必利治疗的患者中，1例（6%）疗效极佳，11例（65%）良好，4例（24%）一般，1例（6%）无效；接受安慰剂治疗的患者中，9例（60%）一般，5例（33%）无效，1例（6%）较差。与其他亚组相比，左舒必利在缓解消化不良症状方面往往比安慰剂更有效，尤其是在动力障碍样亚组（p<0.05）和非特异性亚组（p<0.05）中（p=0.16）'。左舒必利治疗后胃排空时间的缩短比安慰剂组更明显（p<0.05）。我们发现症状评分变化与胃排空时间之间存在显著相关性（r=0.47，p=0.01）。服用左舒必利或安慰剂后均未报告严重不良反应。只有两名患者在服用左舒必利期间报告有轻度嗜睡。
左舒必利对伴有胃排空延迟的功能性消化不良患者有效且耐受性良好。其疗效可能与其通过改善胃排空延迟对胃运动功能的作用有关。
