Coss-Adame E, Remes-Troche J M, Flores Rendón R, Tamayo de la Cuesta J L, Valdovinos Díaz M A
Departamento de Gastroenterología y Laboratorio de Motilidad Gastrointestinal, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Laboratorio de Fisiología Digestiva y Motilidad Gastrointestinal, Instituto de Investigaciones Médico-Biológicas, Universidad Veracruzana, Veracruz, Veracruz, Mexico.
Rev Gastroenterol Mex (Engl Ed). 2024 Jan-Mar;89(1):70-79. doi: 10.1016/j.rgmxen.2023.05.006. Epub 2023 May 22.
Chronic idiopathic constipation (CIC) negatively impacts quality of life and increases healthcare costs. Lubiprostone stimulates the secretion of intestinal fluid, in turn facilitating the passage of stools and alleviating associated symptoms. Lubiprostone has been available in Mexico since 2018, but its clinical efficacy has not been studied in a Mexican population.
To evaluate the efficacy of lubiprostone, assessed by changes in spontaneous bowel movement (SBM) frequency after one week of treatment with 24 μg oral lubiprostone (b.i.d.), as well as its safety, over four weeks of treatment.
Randomized, double-blind, placebo-controlled study on 211 adults with CIC in Mexico.
The increase in SBM frequency, after one week of treatment, was significantly higher in the lubiprostone group than in the placebo group (mean: 4.9 [SD: 4.45] vs. 3.0 [3.14], p = 0.020). Secondary efficacy endpoints revealed a significantly higher proportion of SBM frequency/week in the lubiprostone group at weeks 2, 3, and 4. There was a better response within 24 h after the first dose with lubiprostone vs. placebo (60.0% vs. 41.5%; OR: 2.08, CI95%: [1.19, 3.62], p = 0.009) and the lubiprostone group also had significant improvement, with respect to straining, stool consistency, abdominal bloating, and Satisfaction Index. The main adverse events were gastrointestinal disorders in 13 (12.4%) lubiprostone-treated subjects and 4 (3.8%) control subjects.
Our data confirm the efficacy and safety of lubiprostone for the treatment of CIC in a Mexican population. Lubiprostone treatment induces relief from the most bothersome symptoms associated with constipation.
慢性特发性便秘（CIC）对生活质量有负面影响，并增加医疗成本。鲁比前列酮可刺激肠液分泌，进而促进粪便排出并缓解相关症状。鲁比前列酮自2018年起在墨西哥上市，但尚未在墨西哥人群中研究其临床疗效。
评估口服24μg鲁比前列酮（每日两次）治疗一周后，通过自发排便（SBM）频率变化评估鲁比前列酮的疗效及其在四周治疗期内的安全性。
对墨西哥211名患有CIC的成年人进行随机、双盲、安慰剂对照研究。
治疗一周后，鲁比前列酮组的SBM频率增加显著高于安慰剂组（均值：4.9[标准差：4.45]对3.0[3.14]，p=0.020）。次要疗效终点显示，在第2、3和4周时，鲁比前列酮组每周SBM频率的比例显著更高。与安慰剂相比，鲁比前列酮在首剂后24小时内有更好的反应（60.0%对41.5%；比值比：2.08，95%置信区间：[1.19，3.62]，p=0.009），并且鲁比前列酮组在用力排便、粪便稠度、腹胀和满意度指数方面也有显著改善。主要不良事件为13名（12.4%）接受鲁比前列酮治疗的受试者和4名（3.8%）对照受试者出现胃肠道疾病。
我们的数据证实了鲁比前列酮在墨西哥人群中治疗CIC的疗效和安全性。鲁比前列酮治疗可缓解与便秘相关的最困扰症状。
