中医药治疗胃癌贫血的临床试验方案设计特色与评价

Evaluation and features of clinical trials program of treating anemia in gastric cancer with traditional Chinese medicine

介绍中医药治疗胃癌贫血的临床试验方案设计,并评价此方案的设计特色。以晚期胃癌贫血患者为研究对象,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贫血的临床疗效,并探索运用健脾生血理论治疗晚期胃癌贫血的临床机制。将中医理论与西医实验室指标相结合,共同判断出中医药治疗胃癌贫血的临床疗效。中医药治疗胃癌贫血的临床试验方案具有科学性和临床实用性,并体现了中医理论与终点观察指标的国际同步化和公认性。

To introduce the clinical trials design of treating anemia in gastric cancer with traditional Chinese medicine and to evaluate the programming features of this design. In the trials, anemia patients with advanced gastric cancer as the object of study, a multi-center, prospective, practical randomized controlled trial as the research method. Through the standard （GCP） clinical trial, to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of anemia in gastric cancer objectively and explore the clinical mechanism in treatment of advanced gastric cancer anemia according to reinforcing spleen and generating blood theory. Determine the clinical curative effect of the treatment in gastric cancer anemia using traditional Chinese medicine by combining traditional Chinese medicine and western medicine laboratory indexes. The clinical trials protocol of traditional Chinese medicine in the treatment of gastric cancer anemia was scientific and clinical utility, and embodied the international synchronization and recognized of traditional Chinese medicine theory and the outcomes.