Evaluation of the irritable bowel syndrome severity index in Japanese male patients with irritable bowel syndrome with diarrhea.
Evaluation of the irritable bowel syndrome severity index in Japanese male patients with irritable bowel syndrome with diarrhea.
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DOI：
10.1186/s13030-017-0092-x
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发表时间：
2017
影响因子：
2.1
通讯作者：
Fukudo S
中科院分区：
文献类型：
--
作者：
Ida M;Nishida A;Akiho H;Nakashima Y;Matsueda K;Fukudo S
先前的研究表明，雷莫司琼是一种5 - 羟色胺 - 3受体拮抗剂，可全面改善男性腹泻型肠易激综合征（IBS - D）患者的肠易激综合征症状。然而，除了整体评估外，评估“具有临床意义的改善，重点关注患者的主要诉求以及主要肠易激综合征症状的严重程度”也被认为是很重要的。我们进行了一项随机、安慰剂对照的IV期初步研究，以探索和检验能够对男性腹泻型肠易激综合征患者使用雷莫司琼进行此类评估的疗效变量。
我们对2009年6月至2009年12月期间在日本25个中心就诊的115名符合罗马III标准的男性腹泻型肠易激综合征门诊患者进行了一项前瞻性研究。经过一周的基线期后，受试者分别接受每日一次5μg雷莫司琼（n = 47）或安慰剂（n = 51）治疗，持续12周。为了评估“重点关注主要肠易激综合征症状严重程度的具有临床意义的改善”，使用了日本版肠易激综合征严重程度指数（IBSSI - J）。
在最后一次评估时，雷莫司琼5μg组的IBSSI - J总分较基线的变化为 - 133.5 ± 110.72，安慰剂组为 - 108.2 ± 94.44（P = 0.228）。除第1个月外，雷莫司琼5μg组和安慰剂组之间IBSSI - J较基线至少降低50%的应答率差异超过10%。在第2个月，雷莫司琼5μg组对整体肠易激综合征症状缓解的整体评估月度应答率与安慰剂组相比有统计学显著改善（44.4%对18.4%，P = 0.012）。在第12周，整体评估应答组中IBSSI - J总分降低≥50%的患者比例为24/37（64.9%），无应答组为18/54（33.3%）。
在将IBSSI - J用于腹泻型肠易激综合征药物的临床试验之前，还需要进一步的研究。然而，这项研究表明，整体评估的应答与IBSSI - J的改善相关，这提示整体评估反映了腹泻型肠易激综合征患者症状严重程度的改善。（Clinicaltrials.gov编号：NCT00918411，2009年6月9日注册）
Previous studies have indicated that ramosetron, a 5-hydroxytryptamine-3 receptor antagonist, achieves global improvement in irritable bowel syndrome (IBS) symptoms in male patients with IBS with diarrhea (IBS-D). However, in addition to global assessment it was deemed important to assess “clinically meaningful improvements, focusing on the patient’s chief complaint and the severity of major IBS symptoms”. We performed a randomized, placebo-controlled, phase IV pilot study to explore and examine efficacy variables that allow such evaluation of ramosetron in male patients with IBS-D. We performed a prospective study of 115 male outpatients with IBS-D (according to the Rome III criteria), from June 2009 to December 2009 at 25 centers in Japan. After a one-week baseline period, subjects received either 5 μg of ramosetron (n = 47) or placebo (n = 51) once daily for 12 weeks. To evaluate “clinically meaningful improvements focusing on the severity of major IBS symptoms,” the Japanese version of the IBS severity index (IBSSI-J) was used. Change in IBSSI-J overall score from baseline was −133.5 ± 110.72 in the ramosetron 5 μg group and −108.2 ± 94.44 in the placebo group (P = 0.228) at the last evaluation point. Differences in responder rates for at least a 50% reduction from baseline in IBSSI-J between the ramosetron 5 μg group and the placebo group were over 10%, except Month 1. The monthly responder rate for global assessment of relief of overall IBS symptoms in the ramosetron 5 μg group showed a statistically significant improvement compared to placebo at the second month (44.4% vs 18.4%, P = 0.012). The proportion of patients who had a ≥ 50% reduction in IBSSI-J overall score was 24/37 (64.9%) in the responder group on global assessment and 18/54 (33.3%) in the non-responder group at Week 12. Further examination will be needed before IBSSI-J can be used in clinical trials of agents for IBS-D. However, this study revealed that response on global assessment was correlated with improvement in the IBSSI-J, suggesting that global assessment reflects improvement of the symptom severity of patients with IBS-D. (Clinicaltrials.gov ID: NCT00918411 Registered 9 June 2009).