苓桂术甘汤治疗代谢综合征的配方颗粒与传统饮片随机对照盲态评价临床研究方案

摘要

目的：：评价苓桂术甘汤配方颗粒与传统饮片治疗代谢综合征的有效性和安全性。方法：采用随机、对照、盲态评价、等效性临床研究设计方法，拟将280例受试者随机分为配方颗粒剂组和传统饮片水煎剂组，通过16周的治疗，观察胰岛素抵抗指数，空腹血糖、代谢综合征指标组分及安全性指标等在组间的分布差异，评价苓桂术甘汤配方颗粒与传统饮片治疗代谢综合征的疗效和安全性是否相同。结论：本研究采用随机对照、盲态评价、等效性设计的方法，同时规范合并用药与饮食锻炼的要求，能够较好的控制患者个体因素和不同医生诊疗差异的影响，提高临床研究的规范性和科学性，保证研究结果的可靠性和可信性，验证配方颗粒的疗效及安全性，为配方颗粒的临床合理应用提供依据。%Objective:To evaluate the efficacy and safety of Linggui Zhugan granules and slices in the treatment of metabolic syn-drome. Methods:A randomized,controlled research were conducted with 280 subjects who are randomly divided into Linggui Zhu-gan granules group and Linggui Zhugan slices group. During16 weeks of treatment,insulin resistance index,fasting blood glucose, metabolic syndrome components and safety indicators are observed, and the safety differences were concluded between the two groups. Conclusion:By adopting a randomized,controlled,evaluation on grouping unknown,equivalence clinical study,as well as standardized drug combination and exercise with diet,the standardization and scientificity of the research can be ensured. This can guarantee the reliability and credibility of outcomes and verify the clinical effect and safety of traditional Chinese medicine ( TCM) granules. It provides evidence for the clinical application of TCM granules.