Corinaldesi R, Stanghellini V, Tosetti C, Rea E, Corbelli C, Marengo M, Monetti N, Barbara L
Institute of Internal Medicine and Gastroenterology, University of Bologna, Italy.
Eur J Clin Pharmacol. 1993;44(5):429-32. doi: 10.1007/BF00315538.
The aim of this study was to determine the optimal dosage regimen of cisapride for the treatment of idiopathic gastroparesis. We studied 17 patients with documented idiopathic gastroparesis in a three-way, cross-over, double-blind study with three 4-day treatment periods separated by at least 3 days without treatment. In each period, the patients were preloaded with cisapride (10 mg tid) for three days. On the fourth day (the test day) they took either 10 mg or 20 mg before breakfast and placebo before lunch (1 x 10 mg), (1 x 20 mg), or 10 mg before breakfast and 10 mg before lunch (2 x 10 mg). The medications were taken 30 min before meals. Gastric emptying of solids (99mTc-sulphur colloid) was measured at lunch time under basal conditions and during each treatment period. Plasma concentrations of cisapride were determined before the breakfast dose, before the lunch dose, and at 1, 2, 3, 4 and 5 h after. The greatest acceleration in gastric emptying occurred with the 2 x 10 mg regimen. Although the single morning dose of 20 mg also significantly accelerated gastric emptying (P = 0.05), the reduction was not as substantial. Plasma concentrations of cisapride were significantly higher after 2 x 10 mg than after 1 x 20 mg or 1 x 10 mg. There was a significant relation between cisapride plasma concentrations and changes in gastric emptying. Peak concentrations of cisapride greater than 60 ng.ml-1 were invariably associated with acceleration of gastric emptying. We conclude that cisapride 10 mg tid before meals is the optimal dose for the treatment of idiopathic gastroparesis.
本研究的目的是确定西沙必利治疗特发性胃轻瘫的最佳给药方案。我们对17例确诊为特发性胃轻瘫的患者进行了一项三向、交叉、双盲研究，研究包括三个为期4天的治疗期，期间至少有3天不进行治疗。在每个治疗期，患者先服用西沙必利（10毫克，每日三次）三天。在第四天（测试日），他们在早餐前服用10毫克或20毫克，午餐前服用安慰剂（1×10毫克）、（1×20毫克），或者早餐前服用10毫克，午餐前服用10毫克（2×10毫克）。药物在饭前30分钟服用。在午餐时间的基础状态下以及每个治疗期测量固体（99mTc-硫胶体）的胃排空情况。在早餐剂量前、午餐剂量前以及之后1、2、3、4和5小时测定西沙必利的血浆浓度。2×l0毫克给药方案使胃排空加速最明显。虽然单次晨起20毫克剂量也显著加速了胃排空（P = 0.05），但加速程度不如前者。2×10毫克给药后西沙必利的血浆浓度显著高于1×20毫克或1×10毫克给药后。西沙必利血浆浓度与胃排空变化之间存在显著相关性。西沙必利峰值浓度大于60纳克·毫升-1时总是与胃排空加速相关。我们得出结论，饭前服用西沙必利10毫克，每日三次是治疗特发性胃轻瘫的最佳剂量。
