尿管結石に伴う疹痛に対するHSR-902(チアトン)の臨床的有用性 --二重盲検法による比較試験--

Abstract

尿管結石症患者180例を対象として, HSR-902(チアトン(R))の鎮痛効果臭化ブチルスコポラミンを対照薬剤として二重盲検法により検討した.HSR-902の疼痛改善度は77例中, 著明改善22例, 中等度改善21例であった.対照薬剤は84例中, 著明改善12例, 中等度改善31例であった.HSR-902は疼痛改善度や全般改善度で対照薬剤との間に有意差はなかったが, 有用度判定では対照薬剤に比して有意差を認め(P<0.05), 疼痛推移においても対照薬剤に比し速やかな疼痛改善度効果を認めた(P<0.01).HSR-902における副作用は83例中1例も認めなかったが, 一方, 対照薬剤には87例中2例認めた

The clinical efficacy and safety of HSR-902 (tiquidium bromide, Thiaton) in patients with spastic pain caused by ureteral stones were evaluated in a double blind comparative trial. A daily dose of 30 mg HSR-902 or 60 mg butylscopolamine bromide as a control drug was orally administered for 7 days. With either drug marked improvement of spastic pain was observed. The time to obtain relief from spastic pain and utility rating were significantly more excellent with HSR-902 than with butylscopolamine bromide. With all other parameters used no significant difference was observed between the two drugs. Mild adverse effects such as abdominal discomfort and constipation were observed in 2 of the 87 cases in the butylscopolamine bromide group but none of the 83 cases in the HSR-902 group. Taking efficacy and safety of the treatment into consideration, no significant difference was observed in usefulness between the two drugs, and we were able to confirm the usefulness of HSR-902 for relief from spastic pain caused by ureteral stones.