Lembo T, Wright R A, Bagby B, Decker C, Gordon S, Jhingran P, Carter E
Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
Am J Gastroenterol. 2001 Sep;96(9):2662-70. doi: 10.1111/j.1572-0241.2001.04128.x.
Bowel urgency is one of the most bothersome symptoms for nonconstipated IBS patients. The efficacy of alosetron in control of bowel urgency and Global Improvement of IBS symptoms were evaluated in a multicenter double-blind, randomized, placebo-controlled study.
Female IBS patients with lack of satisfactory control of bowel urgency were randomized 2:1 to alosetron 1 mg twice daily or placebo treatment groups. The primary endpoint was the proportion of days with satisfactory control of bowel urgency during the 12-wk treatment period and 2-wk follow-up period. Secondary endpoints included IBS Global Improvement (responder defined as patient-reported moderate or substantial improvement in IBS symptoms) and improvements in bowel function (stool frequency, consistency, and sensation of incomplete evacuation).
A total of 801 women were randomized to the alosetron (n = 532) or placebo groups (n = 269). Physicians classified 98% of patients with diarrhea-predominant IBS. Patients treated with alosetron had a significantly greater proportion of days with satisfactory control of urgency compared to placebo for the treatment period (73% vs 57%, p < 0.001). A significantly greater number of patients treated with alosetron were IBS Global Improvement responders compared to placebo at week 12 (76% vs 44%, p < 0.001). IBS Global Improvement responders had more days with satisfactory control of urgency at week 12 (88% vs 48%) as well as firmer stools, fewer stools/day, and fewer days with incomplete evacuation compared with nonresponders. Alosetron-treated patients showed improvements in bowel functions compared to placebo-treated patients. Constipation was the most commonly reported adverse event.
对于无便秘的肠易激综合征（IBS）患者而言，肠道急迫感是最困扰他们的症状之一。在一项多中心、双盲、随机、安慰剂对照研究中，评估了阿洛司琼控制肠道急迫感及改善IBS整体症状的疗效。
肠道急迫感缺乏满意控制的女性IBS患者按2:1随机分为阿洛司琼每日两次、每次1毫克治疗组或安慰剂治疗组。主要终点是在12周治疗期和2周随访期内肠道急迫感得到满意控制的天数比例。次要终点包括IBS整体改善情况（应答者定义为患者报告IBS症状有中度或显著改善）以及肠道功能改善情况（大便频率、稠度和排便不尽感）。
共有801名女性被随机分入阿洛司琼组（n = 532）或安慰剂组（n = 269）。医生将98%的患者归类为腹泻型IBS。在治疗期，与安慰剂相比，接受阿洛司琼治疗的患者肠道急迫感得到满意控制的天数比例显著更高（73%对57%，p < 0.001）。在第12周时，与安慰剂相比，接受阿洛司琼治疗的IBS整体改善应答者显著更多（76%对44%，p < 0.001）。与无应答者相比，IBS整体改善应答者在第12周时肠道急迫感得到满意控制的天数更多（88%对48%），大便更成形，每日排便次数更少，排便不尽的天数更少。与安慰剂治疗的患者相比，阿洛司琼治疗的患者肠道功能有所改善。便秘是最常报告的不良事件。
