“从脾论治”ITP 的临床试验方案设计特色与评价
首发时间:2015-06-15
摘要:重点介绍"脾不统血"所致免疫性血小板紫癜"从脾论治"临床试验方案设计,并评价设计特色。该方案以免疫性血小板减少性紫癜患者为研究对象,采用多中心、前瞻性、中央随机对照试验方法,并按照药物临床试验管理规范(GCP)进行临床试验,客观评价"从脾论治"免疫性血小板减少性紫癜的临床疗效。方案特色主要有:①在突出中医药理论与中医特色前提下,以行业公认的患者外周血小板计数为终点观察指标,以中医证候与出血症状为特色指标,综合评价从脾论治免疫性血小板紫癜的有效性。②方案设计具有科学性和临床实用价值,并体现了行业的公认性。
关键词: 中西医结合 免疫性血小板减少性紫癜 从脾论治 临床实验方案
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Evaluation and Features of Clinical Trials Program in Treating Immune Thrombocytopenic Purpura from Spleen in TCM
Abstract:To introduce the clinical trials program of treated Immune Thrombocytopenic Purpura (ITP) caused by failure of Spleen in governing blood from Spleen according to TCM theory, and to evaluate the features of this program. To objectively evaluate the clinical efficacy of treating ITP from Spleen in TCM, in this program, ITP patients as the object of study, multi-center, prospective, central randomization controlled as trial method, Good Clinical Practice (GCP) as management standard. In this program, to comprehensively evaluate the clinical efficacy of treating ITP from Spleen in TCM, platelet counts in ITP patients' peripheral blood as end points, TCM syndromes and bleeding as special points. All above features are on the premise of outstanding TCM theory and the characteristics of TCM. This program is scientific and utility in clinical practice, could be recognized in the medical field。
Keywords: Integrated Traditional and Western Medicine Immune Thrombocytopenic Purpura Treated ITP from Spleen in TCM Clinical trial program
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No.4643012405731431****
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