慢性便秘症に対するルビプロストンの効果と副作用の検討 [in Japanese] Efficacy and Safety of Oral Lubiprostone in the Management of Chronic Constipation [in Japanese]
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目的：新規便秘治療薬であるルビプロストンの有効性と副作用について検討した．方法：慢性便秘症に対してルビプロストンを投与した133例（女性73例，平均65.0歳）を対象とした．投与開始から2週間観察してConstipation scoring system（CSS）の変化と副作用について検討した．成績：CSSの全8因子のうち，排便回数，排便困難，残便感，腹痛，排便時間，排便失敗回数の6因子が有意に減少し，合計点はベースラインの10.05から7.60に有意に改善した．55例（41.4％）に副作用を認め，36例（27.1％）が副作用のために内服を中止した．副作用としては悪心（24.1％）と下痢（16.5％）が多く，悪心の頻度は男性よりも女性で高かった．結論：ルビプロストンは排便回数を増加させ，便秘の諸症状を改善することが示された．女性は悪心を起こしやすいため，適応は慎重に判断すべきである．
This clinical study was performed to assess the efficacy and safety of lubiprostone in the treatment of chronic constipation in a general hospital. We prospectively enrolled 133 patients who received a 24 mcg lubiprostone capsule twice a day. All the patients had chronic constipation as defined by the Rome III criteria. Efficacy measures included change in constipation scoring system (CSS), incidence of treatment-related adverse events including nausea, and percentage of treatment discontinuation in the first two weeks after administration. The total score of CSS was significantly improved from 10.1 at baseline to 7.6 after 2 weeks. Among the 133 patients who took at least one dose of the study drug, 55 (41.4%) experienced at least one adverse event. Adverse events reported by ≥ 5% of patients overall were nausea (24.1%) and diarrhea (16.5%). Thirty-six patients (27.1%) withdrew from the study due to adverse events, of which 19 (14.3%) were due to nausea. The percentage of patients experiencing nausea was statistically and significantly higher among the women than the men. In conclusion, our results demonstrate that lubiprostone is effective in improving many chronic constipation related symptoms. Lubiprostone use is limited by the incidence of gastrointestinal side effects, most notably nausea.
- Nippon Daicho Komonbyo Gakkai Zasshi
Nippon Daicho Komonbyo Gakkai Zasshi 69(1), 6-10, 2016
The Japan Society of Coloproctology