在查中检测2种超低容量肠道制剂的腺瘤检测率和耐受性:一个非劣质随机对照试验
Anna Serradesanferm1, Isabel Torá-Rocamora2, Àngels Pozo1
1Department of Preventive Medicine and Epidemiology, Hospital Clinic of Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; ISGlobal, Barcelona, Spain.
与酸 (SPMC) 配合的硫酸与酸 (SPMC) 显示,与1L聚乙烯糖醇加上酸盐 (1L-PEGA) 相比,腺瘤检测率 (ADR) 不低. 在结直肠癌查中,SPMC为肠道清洁提供了更好的安全性和耐受性.
科学领域:
- 胃肠病学 胃肠病学
- 结肠直肠癌查 结肠直肠癌查
- 临床试验 临床试验
背景情况:
- 腺瘤检测率 (ADR) 对结直肠癌 (CRC) 查有效性至关重要.
- 肠道清洁的质量显著影响ADR.
- 有限的数据存在于非常低剂量的肠道清洁产品对ADR的影响.
研究的目的:
- 为了比较腺瘤检测率 (ADR),使用两个不同的非常低剂量的肠道清洁产品.
- 在基于免疫化学便隐性血液测试 (iFOBT) 的查计划中,评估1L的聚乙烯甘醇加上甲酸盐 (1L-PEGA) 与酸与酸 (SPMC) 的硫酸.
- 评估肠道准备的质量,安全性和耐受性作为次要结果.
主要方法:
- 进行了一项随机,并行,非劣等性临床试验.
- 年龄在50-69岁的参与者,iFOBT结果呈阳性,接受了早晨结肠镜检查.
- 被试被随机分配,接受1L-PEGA或SPMC用于肠道清洁.
主要成果:
- 在SPMC (56.5%) 和1L-PEGA (53.7%) 之间的聚合ADR中没有发现显著差异,表明SPMC的非劣势性.
- 1L-PEGA显示出优越的肠道准备质量 (96.2%与89.2%,P<.001).
- SPMC的安全性和耐受性显著提高,不良事件较少.
结论:
- 在结直肠癌查中,酸与酸 (SPMC) 的硫酸盐对1L聚乙烯糖醇加上酸 (1L-PEGA) 的ADR没有劣势.
- 尽管1L-PEGA的制备质量更好,但SPMC提供了更好的安全性,耐受性和参与者满意度.
- 在CRC查计划中,SPMC是肠道清洁的可行替代方案.
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