康荣荣通口服液用于功能性便秘:一个多中心,安慰剂控制的II期试验
Luqing Zhao1, Xiaohong Sun2, Lei Zhu3
1Digestive Disease Center, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.
概括
康荣荣通口服液 (CROL) 有效地治疗缺陷类型的成年人的功能性便秘. 每天6克的剂量显著改善了肠道排便,并且耐受性很好.
科学领域:
- 胃肠病学 胃肠病学
- 传统中国医药 传统中国医药
- 临床药理学 临床药理学
背景情况:
- 功能性便秘 (FC) 是一种常见的胃肠道疾病.
- 缺乏症类型FC是传统中医 (TCM) 诊断中的特定亚型.
- 对FC的新型治疗剂的评估对于改善患者的治疗结果至关重要.
研究的目的:
- 评估Congrong Runtong口服液 (CROL) 在被诊断为缺乏症类型功能性便秘的成年患者的疗效和安全性.
- 为了比较CROL在两种不同剂量 (3g/day和6g/day) 与安慰剂的治疗反应.
- 评估二次结果,包括排便频率,便一致性和患者报告的症状.
主要方法:
- 进行了一项多中心,双盲,安慰剂控制的随机临床试验.
- 180名成年参与者符合罗马四号和TCM缺乏FC的标准.
- 参与者被随机分配,接受CROL (3g或6g/天) 或安慰剂8周,治疗反应是主要结果.
主要成果:
- 与安慰剂 (18.6%) 相比,每天6g的CROL组 (60.7%) 的治疗响应率显著更高 (p < 0.0001).
- 每天3克的CROL组也显示了统计学上显著的响应率 (35.0%) 与安慰剂 (p = 0.044) 相比.
- 每周完全自发性肠道排便 (CSBMs) 在每天6g的CROL (p = 0.001) 与安慰剂相比显著增加. 与治疗相关的不良事件在各组中低且可比.
结论:
- 康荣荣通口服液 (CROL) 在治疗成年人缺乏症类型功能性便秘方面表现出显著的疗效.
- 6g/天的CROL剂量似乎比3g/天的剂量更有效.
- 对于这种患者群体来说,CROL是一种安全且耐受良好的治疗选择.
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