Santucci L, Fiorucci S, Chiucchiù S, Sicilia A, Bufalino L, Morelli A
Istituto di Gastroenterologia ed Endoscopia Digestiva, University of Perugia, Italy.
Dig Dis Sci. 1992 Dec;37(12):1825-32. doi: 10.1007/BF01308075.
The acute gastroduodenal mucosa injury and gastric potential difference (GPD) drops provoked by 14-day administration of 20 mg/day of a new piroxicam formulation (piroxicam-beta-cyclodextrin), 20 mg/day standard piroxicam and 100 mg/day indomethacin were evaluated and compared in a randomized, double-blind, placebo-controlled study carried out on 64 volunteers. Endoscopic examinations, performed after 14-day treatment, demonstrated that piroxicam-beta-cyclodextrin was less gastrolesive (mean endoscopic score +/- SE = 0.56 +/- 0.2) than either piroxicam (2.06 +/- 0.5) or indomethacin (2.25 +/- 0.5) (p < 0.01). The drop in GPD after a single dose of the assigned drug was considerably greater for piroxicam and indomethacin than for piroxicam-beta-cyclodextrin (p < 0.01), which registered similar values to placebo. Since GPD is an expression of the anatomo-functional integrity of the gastric barrier, the results indicate that piroxicam-beta-cyclodextrin exerts less direct acute damage on the gastric mucosa. Therefore, when administered short-term, piroxicam-beta-cyclodextrin appears to be less gastrolesive than either indomethacin or the standard piroxicam formulation.
在一项针对64名志愿者开展的随机、双盲、安慰剂对照研究中，对连续14天每天服用20毫克新的吡罗昔康制剂（吡罗昔康-β-环糊精）、每天服用20毫克标准吡罗昔康以及每天服用100毫克吲哚美辛所引发的急性胃十二指肠黏膜损伤和胃电位差（GPD）下降情况进行了评估和比较。在14天治疗后进行的内镜检查表明，吡罗昔康-β-环糊精的胃损伤性（平均内镜评分+/-标准误=0.56+/-0.2）低于吡罗昔康（2.06+/-0.5）或吲哚美辛（2.25+/-0.5）（p<0.01）。单次服用指定药物后，吡罗昔康和吲哚美辛导致的GPD下降幅度明显大于吡罗昔康-β-环糊精（p<0.01），吡罗昔康-β-环糊精的GPD下降值与安慰剂相似。由于GPD是胃屏障解剖学功能完整性的一种表现，结果表明吡罗昔康-β-环糊精对胃黏膜的直接急性损伤较小。因此，短期给药时，吡罗昔康-β-环糊精的胃损伤性似乎低于吲哚美辛或标准吡罗昔康制剂。
