薬理と治療

Abstract

We conducted a postmarketing surveillance（PMS）study to investigate the safety and effectiveness of sodium hyaluronate solution（MucoUp）as a submucosal injectate during endoscopic mucosal resection（EMR）or endoscopic submucosal dissection（ESD）for gastric or colon tumor by using a central registration system. Out of 898 registered patients, 856 were included in the safety and effectiveness analyses. Adverse reactions were reported in 16 patients（1.9％）in total, which were comparable to that reported in the clinical trial（2.5％）. Most of adverse reactions were haemorrhage in 11 patients（1.3％）and there were no reported shock and hypersensitivity, which were focused on the study as important events. Assessment of en bloc complete resection showed that the tumor was completely removed in 451（93.6％）of 482 patients with gastric tumor and 294（78.6％）of 374 patients with colon tumor. Assessment of the ease of mucosal resection revealed that the resection was rated easy or extremely easy in 389 patients（80.7％）with gastric tumor and 300 patients （80.2％）with colon tumor. The results were comparable to those of the clinical trial. Thus, the PMS study revealed no significant problem in the incidence rate or character of reported adverse reactions and showed a high en bloc complete resection rate and simplicity of mucosal resection. The study comfirmed that MucoUp was a useful infusion solution for EMR and ESD.