摘要
[目的]观察艽龙胶囊治疗肝胃郁热型功能性消化不良(FD)的安全性与有效性。[方法]采用开放、多中心临床试验方法,将44个临床研究机构随机入组的2 290例患者作为研究对象,给予口服艽龙胶囊,疗程4周。观察治疗前后症状积分、胃排空不透光标志物检测和各项安全性指标。[结果]中医症状疗效:全分析数据(FAS)集:显愈率56.96%,总有效率94.14%;符合方案的数据(PPS)集:显愈率58.29%,总有效率95.36%。胃排空疗效:临床总有效率FAS数据集36.36%,PPS集35.81%,治疗前排出支数<11支人群(治疗前异常)胃排空总有效率为FSA集17.71%,PPS集15.72%。[结论]艽龙胶囊治疗肝胃郁热型FD疗效确切,对各项主症及次症都有较好疗效,对有限病例胃排空试验有一定疗效,不良反应轻微且不常见或罕见。
[Objective]To inspect and evaluate the security and effectiveness of Jiaolong Cap- sule on functional dyspepsia with stagnation-heat in liver and stomach syndrome. [Methods]Fol- lowing the open and multi-center clinical trial methods ,2 290 cases from the 44 clinical research organizations at random were treated with Jiaolong capsule for 4 weeks. The symptom scores and the radio-opaque markers detection of gastric emptying and various safety indicators were ob- served before and after the treatment. [Results]FAS analysis showed that the apparently effective rate of TCM syndrome was 56. 96% and the total effective rate was 94. 14%. PPS analysis showed that the apparently effective rate was 58. 29% and the total effective rate was 95.36% . Total effective rate of gastric emptying was 36. 36% by FAS analysis and 35.81% by PPS analysis. The total curative rate of gastric emptying by FAS analysis was 17.71% and 15.72% by PP8 analysis. [Conclusion]Jiaolong Capsule has positive effects on functional dyspepsia with stagnation-heat in liver and stomach syndrome, apparent effect on the main syndromes and secondary syndromes, and certain effect on gastric emptying in some cases. Adverse reactions on digestive tract were not common or rare.
出处
《中国中西医结合消化杂志》
CAS
2012年第3期106-109,共4页
Chinese Journal of Integrated Traditional and Western Medicine on Digestion
基金
国家食品药品监督管理局临床研究资助课题(临床试验批件号:FDA2003S01855)
关键词
消化不良
功能性
肝胃郁热
艽龙胶囊
functional dyspepsia
stagnation-heat in liver and stomach syndrome
Jiaolongcapsule
