鎮痙薬臭化シメトロピウム(DA3177)の上部尿路結石に伴う疼痛に対する第3相臨床試験 : 臭化ブチルスコポラミン錠を対照薬とした二重盲検群間比較試験

Abstract

1)DA3177(D群) 112例, 臭化ブチルスコポラミン(B群) 111例のうち有効性評価例数はD群97例, B群101例の計198例であった. 2)患者印象は「よくきいた」以上が, D群68.7%, B群53.5%であった. 3)疼痛改善度は「中等度改善」以上が, D群69.1%, B群60.4%であり, D群はB群に比し, 高い改善率が認められた. 4)全般改善度は「中等度改善」以上が, D群70.1%, B群61.4%であった. 5)概括安全度は「安全性に問題なし」が, D群91.5%, B群93.3%であり, 2群間に有意差は認められなかった. 6)「有用」以上の有用率が, D群68.7%, B群60.4%であり, D群はB群に比し, 高い有用率が認められた

A double-blind study was conducted to evaluate the efficacy, safety and usefulness of cimetropium bromide (DA3177) in the patients with pain caused by upper urinary calculus at a daily dose of 75 mg t.i.d. (Group D, 97 patients) in comparison with scopolamine butylbromide at a daily dose of 60 mg t.i.d. (Group B, 101 patients). According to patient's impression, the rate of "moderately improved" or better was significantly higher in Group D (68.7%) than in Group B (53.5%; Wilcoxon 2 sample test: p = 0.0044). For pain, the rate of "moderately improved" or better was 69.1% in Group D and 60.4% in Group B. In global improvement, the rate of "moderately improved" or better was significantly higher in Group D (70.1%) than in Group B (61.4%; Wilcoxon 2 sample test: p = 0.0469). The rate of "no problem in safety" showed no significant difference between Group D (91.5%) and Group B (93.3%). Adverse reactions occurred in 8.5% in Group D and 6.7% in Group B. The major adverse reactions were "dry mouth", "abdominal distension", "constipation" and "nausea". The rate of "useful" or better was 68.7% in Group D, and 60.4% in Group B. In conclusion, DA3177 was confirmed to be a useful drug for patient with pain caused by upper urinary calculus.