芪龙颗粒治疗难治性特发性血小板减少性紫癜临床设计和实施

【作者】 李万辉；

【导师】 孙颖立； 陈信义；

【作者基本信息】 北京中医药大学 ， 中西医结合临床内科， 2008， 博士

【摘要】 常规应用糖皮质激素和脾脏切除术可使70%以上的特发性血小板减少性紫癜(ITP)患者血小板数量稳定在安全水平,约30%患者使用这些措施无效,这部分患者即属于难治性特发性血小板减少性紫癜(RITP)范围。RITP具有效果差、易反复等特征,故治疗非常棘手。药物联合是RITP治疗的一大特点,但文献报道疗效差异很大,且治疗周期较长,停药后复发率高,不良反应明显,药物毒副作用导致的危害可能高于疾病本身,同时,部分药物价格昂贵,使相关的治疗费用上扬,也限制了临床应用。中西医结合治疗RITP前景可观。联合中医药治疗,可使RITP患者外周血小板计数维持在安全水平,并且改善临床症状,提高患者生活质量。但是,就中医药临床研究而言,存在①辨证论治无明显规律可寻;②临床研究客观性、真实性和可重复性有待提高;③安全性研究有待深入等不足,难以真正体现中医药的内在价值。通过长期的临床观察,我们提出“气虚血瘀”是RITP的主要病机,并拟定了“益气活血”的治则,为了客观地证实芪龙颗粒治疗“气虚血瘀”型RITP的临床疗效,我们在国内首次采用了目前公认最先进的随机对照试验(RCT)设计思路,严格临床病例纳入、排除标准及疗效评估标准,并制定临床病例报告表,进行多中心临床观察。本课题因此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)。课题目前尚未完成,在具体的临床试验工作中,我们遇到了一些问题和不足,同时也在解决问题中逐渐完善自我,芪龙颗粒治疗RITP的客观临床疗效有待在课题完成后进一步揭示。更多还原

【Abstract】 Idiopathic thrombocytopenic purpura (ITP) is an autoimmune disease characterized by low platelets and bleeding,about one thrid of adults with ITP do not respond to standard doses of corticosteroids and aplenectomy and require anther therapy to raise their platelet count, those patients belong to Refractory Idiopathic thrombocytopenia purpura(RITP). The treatment of RITP is barely effective and some patients will relapse within given period.At present, multiple treatments play a more important method in RITP of adult, but response rates are low, or long treatment periods, or high relapse rate,or serious side effects against their use. However, the goal of treatment for patients with ITP is not to cure the RITP, but raise the platelet count high enough levels to prevent bleeding using the least toxic therapy. So the integration of traditional and western medicine is one of promising treatments for RITP.Through the integration of traditional and western medicine, paitents of RITP can maintain a high level of platelet count and improve clinic symptom ,but there are some lacks in traditional Chinese medicine clinic test, such as absencing rules of the treatment based on syndrome differentiation, less objectivity, authernicity and long term security.In the theory of traditional Chinese medicine, blood stasis due to qi deficiency is the essential mechanism of RITP. According to the pathogens, the treatment is supplementing qi, promoting blood circulation for removing blood stasis. we use Qi Long granule as therapy medicine, set a randomized controlled trials (RCTs) to evaluate clinic curative effect of RITP,which is the first time we do this job in traditional Chinese medicine of RITP. So this study is authorized self-determination innovated study in traditional Chinese medicine in 2005 by the fund of medicine development in Beijing (number: SF-2005-031) .At present, the study is not accomplished, wo met a lot of problems in the clinic test and at the same time we improve ourslves, which make our study more scientific and external, In 2009 we can finish the study and report the clinic curative effect of Qi Long granule for RITP.更多还原