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Efficacy and safety of lubiprostone for the treatment of functional constipation in Chinese adult patients: A multicenter, randomized, double-blind, placebo-controlled trial

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单位: [1]Sun Yat Sen Univ, Dept Gastroenterol, Affiliated Hosp 1, 58 Zhongshan II Rd, Guangzhou 510080, Guangdong, Peoples R China [2]Zhejiang Univ, Sir Run Run Shaw Hosp, Dept Gastroenterol, Sch Med, Hangzhou, Zhejiang, Peoples R China [3]Xi An Jiao Tong Univ, Dept Gastroenterol, Affiliated Hosp 1, Xian, Shaanxi, Peoples R China [4]Huazhong Univ Sci & Technol, Tongji Hosp, Dept Gastroenterol, Tongji Med Coll, Wuhan, Hubei, Peoples R China [5]Southern Med Univ, Nanfang Hosp, Dept Gastroenterol, Guangzhou, Guangdong, Peoples R China [6]Qingdao Univ, Dept Gastroenterol, Affiliated Hosp, Qingdao, Shandong, Peoples R China [7]Cent South Univ, Dept Gastroenterol, Xiangya Hosp 3, Changsha, Hunan, Peoples R China [8]Shandong Univ, Dept Gastroenterol, Qilu Hosp, Jinan, Shandong, Peoples R China [9]Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Dept Gastroenterol, Wuhan, Hubei, Peoples R China [10]Chinese Acad Med Sci, Peking Union Med Coll Hosp, Dept Gastroenterol, Beijing, Peoples R China [11]Nanchang Univ, Dept Gastroenterol, Affiliated Hosp 2, Nanchang, Jiangxi, Peoples R China [12]Gen Hosp Western Theater Chinese Peoples Liberat, Dept Gastroenterol, Chengdu, Sichuan, Peoples R China [13]Jilin Univ, Dept Gastroenterol, Bethune Hosp 1, Changchun, Jilin, Peoples R China [14]China Med Univ, Dept Gastroenterol, Hosp 1, Shenyang, Liaoning, Peoples R China [15]Peking Univ, Dept Gastroenterol, Peoples Hosp, Beijing, Peoples R China [16]Capital Med Univ, Beijing Friendship Hosp, Dept Gastroenterol, Beijing, Peoples R China [17]Fudan Univ, Zhongshan Hosp, Dept Gastroenterol, Shanghai, Peoples R China [18]Cent South Univ, Xiangya Hosp, Dept Gastroenterol, Changsha, Hunan, Peoples R China [19]Cent South Univ, Dept Gastroenterol, Xiangya Hosp 2, Changsha, Hunan, Peoples R China
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关键词: adult Chinese patients functional constipation lubiprostone randomized placebo-controlled trial

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Objectives Functional constipation is a gastrointestinal disorder prevalent around the world. Lubiprostone is the first locally acting type-2 chloride channel activator to be used for treating constipation. This study aimed to evaluate the efficacy and safety of lubiprostone in Chinese adults with functional constipation. Methods This was a multicenter, randomized, double-blind, placebo-controlled study. Patients with functional constipation were randomized to receive either lubiprostone (24 mcg twice daily) or placebo for 4 weeks. The primary end-point was the frequency of spontaneous bowel movements (SBMs) during the first week of treatment. The secondary end-points included the median time of the first SBM, SBM frequency at weeks 2, 3 and 4, weekly response rate of SBMs, the stool consistency score and average number of complete spontaneous bowel movements (CSBMs) per week. Results In total, 259 patients were randomized, with 130 in the lubiprostone group and 129 in the placebo group. SBM frequency was higher in the lubiprostone group (4.88 +/- 4.09/wk) than that in the placebo group (3.22 +/- 2.01/wk) at week 1 (P < 0.0001). SBM frequency was also higher in the lubiprostone group at weeks 2, 3 and 4. The average number of CSBMs and the stool consistency score in the lubiprostone group were significantly higher than that in the placebo group at each week. No drug-related serious adverse events (AEs) occurred. The most commonly reported AE was nausea. Conclusion Lubiprostone was superior to placebo in treating Chinese patients with functional constipation, together with good safety profile.

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出版当年[2020]版:
大类 | 4 区 医学
小类 | 4 区 胃肠肝病学
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 胃肠肝病学
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出版当年[2019]版:
Q4 GASTROENTEROLOGY & HEPATOLOGY
最新[2023]版:
Q3 GASTROENTEROLOGY & HEPATOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2019版] 出版当年五年平均 出版前一年[2018版] 出版后一年[2020版]

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第一作者单位: [1]Sun Yat Sen Univ, Dept Gastroenterol, Affiliated Hosp 1, 58 Zhongshan II Rd, Guangzhou 510080, Guangdong, Peoples R China
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