文档介绍：
中医药治疗胃癌贫血的临床试验方案设计
特色与评价#
杨璐,田劭丹,侯丽,陈信义**
5
10
(北京中医药大学东直门医院)
摘要:目的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。方
法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。结果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。结论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。
关键词:中西医结合;胃癌;贫血;临床试验方案
中图分类号:请查阅《中国图书馆分类法》
15
Evaluation and Features of Clinical Trials Program in
Treating Gastric Cancer Anemia with TCM
Yang Lu, Tian Shaodan, Hou Li, Chen Xinyi
(Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine)
20
25
30
35
Abstract:
Objective
To introduce the clinical trials design of Traditional Chinese Medicine in the treatment of anemia
in gastric cancer and to evaluate the programming features of this design.
Methods
In this trials, anemia patients with advanced gastric cancer as the object of study, A multi-center,
prospective, practical randomized controlled as trial method, through the standard (GCP) clinical
trial, objectively evaluating the clinical efficacy of Traditional Chinese Medicine in the treatment
of anemia in gastric cancer, and exploring the clinical mechanism in treatment of advanced gastric
cancer anemia according to reinforcing spleen and generating blood theory
Results
bining Chinese Traditional Medicine and western medicine laboratory indexes we
determine the clinical curative