中医药治疗胃癌合并高凝状态的临床试验方案设计特色与评价

The Evaluation and Features of Clinical Trial Protocol Design for Traditional Chinese Medicine Therapy in Gastric Cancer with Hypercoagulable State

目的:介绍中医药治疗胃癌合并高凝状态的临床试验方案,并评价方案的设计特色。方法:以晚期胃癌合并高凝状态患者为研究对象,采用多中心、前瞻性、实用性随机对照试验方法,通过规范(GCP)临床试验,客观评价中医药治疗胃癌合并高凝状态的临床疗效,通过分析相关指标,探索运用益气活血理论治疗晚期胃癌合并高凝状态的临床机制。结果:运用中医"气虚血瘀"理论,结合现代实验室相关指标,共同判断中医药治疗胃癌合并高凝状态的临床疗效与效应机制。结论:中医药治疗胃癌合并高凝状态的临床试验方案具有临床实用性和科学性,在中医理论指导下,临床表现与实验室客观指标相结合,为今后的临床推广和行业公认奠定基础。

Objective： To introduce clinical trial protocols for traditional Chinese medicine therapy in gastric cancer with hypercoagulable state and to evaluate the design features of this protocol. Methods： The advanced gastric cancer patients with hypercoagulable state were taken as subjects in multi-centered,prospective,pragmatic randomly controlled trial conducted in accordance with the guidelines of Good Clinical Practice（GCP）. Relevant indexes and indicators were analyzed to objectively evaluate the efficacy of traditional Chinese medicine therapy for gastric cancer complicated with hypercoagulable state and to explore its clinical mechanism according to the tonifying qi and activating blood circulation theory. Results： Combined with modern laboratory indicators,the theory of ＂qi deficiency and blood stasis＂was applied to determine the clinical efficacy and effect mechanism of traditional Chinese medicine therapy for patients with gastric cancer with hypercoagulable state. Conclusion： This clinical trial protocol for traditional Chinese medicine therapy in treating gastric cancer complicated with hypercoagulable state is scientific and applicable by integrating clinical symptoms and objective laboratory indicators under the guidance of Chinese medicine theory and it lays a foundation for future clinical application and professional acknowledgement.