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

作者：Xiao, Ying Lian; Dai, Ning; He, Shui Xiang; Tian, De An; Liu, Si De; Tian, Zi Bin; Wang, Xiao Yan; Li, Yan Qing; Hou, Xiao Hua; Fang, Xiu Cai; Wen, Zhi Li; Zeng, Wei Zheng; Xu, Hong; Sun, Ming Jun; Liu, Yu Lan; Wu, Yong Dong; Shen, Xi Zhong; Liu, Xiao Wei; Liu, De Liang; Chen, Min Hu^*

来源：Journal of Digestive Diseases, 2021, 22(11): 622-629.

DOI：10.1111/1751-2980.13058

• adult Chinese patients
• functional constipation
• lubiprostone
• randomized placebo-controlled trial

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.

• 单位
  华中科技大学; 中国医学科学院北京协和医院; 吉林大学; 复旦大学; 青岛大学; 浙江大学; 中国医科大学; 北京大学; 西安交通大学; 南方医科大学; 南昌大学; 山东大学; 中山大学