芪龙颗粒治疗难治性血小板减少性紫癜临床设计
首发时间:2009-04-02
摘要:为了客观、科学地观察芪龙颗粒的临床疗效,我们设计了芪龙颗粒治疗难治性血小板减少性紫癜的随机双盲、对照、多中心的临床观察方案。本课题被首都医学发展基金批准为2005年度中医临床研究自主创新课题(课题编号:SF-2005-031)。具体设计包括病例选择标准、研究方法、观测指标、临床疗效评定、不良事件观察、质量控制、数据管理、统计处理、医学医学伦理要求九个部分内容。
关键词: 芪龙颗粒 难治性血小板减少性紫癜 临床设计
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Clinical Design for Qi Long Granule on Treating Refractory Idiopathic Thrombocytopenia Purpura
Abstract:In order to objectively observe the clinic therapeutic effective of Qi Long granule in a scientific way, we designed a multicentre randomized double-blind controlled clinical trail of Qi Long granule on treating refractory idiopathic thrombocytopenia purpura (RITP). This study had been authorized self-determination innovated study in traditional Chinese medicine in 2005 by the fund of medicine development in Beijing (number:SF-2005-031). In detail, the study included 9 parts, which were inclusive criteria, research method, observation index, clinical outcome evaluation, adverse event monitoring, quality control, data management, statistical processing, requirements of medical ethics.
Keywords: Qi Long granule refractory idiopathic thrombocytopenia purpura clinical design
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No.3101740573123865****
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