国家重大传染病防治项目-中医药干预艾滋病免疫重建研究项目启动


  国家重大传染病防治项目-中医药干预艾滋病免疫重建研究项目启动

  2009年07月12日00:01  来源:人民网

  人民网北京7月11日电(记者王君平)艾滋病病毒侵入人体后,主要侵犯免疫系统,导致机体细胞免疫缺陷,造成各种机会性感染和肿瘤,以致最后衰竭死亡。免疫系统的状态与HIV感染的形成和发展密切相关。国家重大传染病防治项目――“中医药干预对艾滋病免疫重建的研究”项目今日在京启动。

  课题负责人中国中医科学院广安门医院院长王阶说,无论在HAART治疗开始前,还是治疗中,免疫功能的存在和恢复是决定预后的关键。重建HIV/AIDS患者的免疫功能,可以使得病情长期稳定,进一步提高现有治疗手段的疗效,从而改善HIV/AIDS患者的预后。

  艾滋病全称为获得性免疫缺陷综合征,该病由感染人免疫缺陷病毒而引起,导致被感染者免疫功能的部分或完全丧失,继而发生多系统、多器官、多病原体的复合感染和肿瘤等。截至今年6月30日我国累计报告HIV感染者和艾滋病病人252748例,其中艾滋病病人73071例,累计治疗48551例。艾滋病已经严重危害人民群众身体健康,成为我国当前重大公共卫生问题和社会问题。

  目前,包括被动输入HIV特异的抗体或细胞,细胞因子调节免疫等免疫疗法正在研发阶段,在临床上尚未获得肯定的结果。理想的免疫治疗药物应该能够根据机体免疫功能状态适时适度的发挥免疫活化或免疫抑制的作用。

  王阶认为,艾滋病属于中医“疫病”、“伏气瘟病”、“虚劳”、“五劳损伤”等范畴。在中医学的整体观和辨证论治指导下,近年来开展的临床研究,特别是中国中医科学院与坦桑尼亚合作,进行了大量的中医辨证论治的尝试,中药在提高患者免疫功能,改善症状等方面取得了较好的临床效果。发挥中医药优势,运用中药扶正等方法,研发具有多靶点、双向调节作用的中药复方制剂以重建HIV/AIDS患者的免疫功能,将是中医药的防治艾滋病研究的重要突破口之一。

  本课题以既往研究成果为基础,依据国家重大传染病防治项目要求及项目主管部门相关规定,经多个专业领域的专家反复论证,制定了“中医药干预对艾滋病免疫重建的研究”临床试验方案。通过现代医学的临床及实验技术,利用循证医学及现代临床流行病学的相关方法,在充分体现中医整体观和辨证论治前提下,客观评价中医药干预对艾滋病免疫重建的临床有效性与安全性,为形成证据确凿、可供推广、广泛认可的艾滋病免疫重建的中医综合治疗方案提供依据。

  课题联合了中国医学科学院药用植物研究所、云南省艾滋病关爱中心、中国人民解放军第302医院、中国医学科学院药用植物研究所、中国医学科学院实验动物研究所、北京世纪康医药科技开发有限公司共六家在国内艾滋病领域研究具有影响的单位,特别是肖培根院士、曾毅院士等全国著名专家对本课题的指导和参与、实现了强强联合,保证了研究的权威性和先进性。

  王阶介绍说,项目的特色与创新主要有:项目采用实验室检测指标与临床特征相结合进行中医辨证分型,研究艾滋病的正虚或正虚毒盛证候,有利于艾滋病中医证候的规范化量化诊断;严格的质量控制,中医综合治疗对艾滋病患者免疫重建的影响,采用前瞻性多中心随机双盲设计,在国内外亦为领先水平;对艾滋病正虚与正虚毒盛的证候与艾滋病分子免疫指标的相关研究,在国内未见报道。与国际接轨的临床研究模式,聘请中立的第三方机构(CRO机构)进行项目管理工作,采用北京大学第一医院医学统计室的中央随机系统进行患者的随机分组,聘请国内外著名统计学、循证医学专家全程参与;建立艾滋病中医治疗网站并进行实时更新,普及艾滋病防治知识,为广大患者提供在线服务平台,同时促进学术交流,加快创新人才队伍的培养。

     

Infectious disease prevention and control of major national projects - pharmaceutical intervention in immune reconstitution of AIDS research project to start

At 0:01 on July 12, 2009 Source: People's Network

Beijing, July 11 (Xinhua王君平) HIV into the human body, the major violations of the immune system, leading to defects in cellular immunity, resulting in a variety of opportunistic infections and tumors, resulting in the death of the last failure. The status of the immune system and HIV infection is closely related to the formation and development. The state's major infectious diseases prevention and control project - "Chinese medicine intervention on the study of immune reconstitution of AIDS" project to start today in Beijing.

Project Leader of China Academy of Traditional Chinese Medicine Hospital Guang'an Men band Wang said that both before the start of HAART treatment, or treatment, the existence of immune function and prognosis of recovery is the key to the decision. Reconstruction of HIV / AIDS patient's immune function, can make long-term, stable condition, to further improve the efficacy of existing treatments in order to improve HIV / AIDS prognosis of patients.

AIDS-wide known as the acquired immunodeficiency syndrome, the disease by the human immunodeficiency virus infection caused by, resulting in immune function have been infected with the partial or complete loss of, and subsequent multi-system, multi-organ, multi-complex pathogens, such as infections and tumors. As of June 30 this year, China reported a total of HIV infections and 252,748 cases of AIDS patients, of which 73,071 cases of AIDS patients, a total of 48,551 cases of treatment. AIDS has been seriously endanger people's health, and has become a major public health problem and social problems.

At present, including the passive input HIV-specific antibodies or cells, cytokines, such as regulation of the immune phase of immunotherapy being developed, clinical results have not been positive. Immunotherapy ideal drug should be able to function in accordance with timely immune moderate or immune activation play a role in immunosuppression.

Wang bands that AIDS belongs to Chinese medicine, "disease", "V gas blast", "虚劳", "Five injured workers," and so on. In the overall concept of Chinese medicine and syndrome differentiation, under the guidance of clinical research carried out in recent years, in particular, China Academy of Traditional Chinese Medicine in cooperation with Tanzania to carry out a large number of Traditional Chinese Medicine Treatment of attempts in patients with Chinese medicine in improving immune function, improve symptoms, such as to achieve a more good clinical results. Advantage to play a traditional Chinese medicine, the use of methods such as traditional Chinese medicine Fuzheng, research and development with multi-target, two-way regulation of Chinese medicine compound preparation to rebuild the HIV / AIDS patient's immune function, will be the study of Chinese medicine in the fight against AIDS one of the important breakthrough.

Subject to the basis of previous research results, according to the state's major infectious diseases prevention and control projects and project requirements of the relevant provisions of the competent authorities, after a number of professional experts in the field repeatedly argued that the development of a "Chinese medicine intervention on the immune reconstitution of AIDS research," clinical trials program. Modern medicine through clinical and experimental techniques, the use of evidence-based medicine and clinical epidemiology related to modern methods, fully embodied in the concept of Chinese medicine and syndrome differentiation overall premise, the objective evaluation of Chinese medicine intervention on the immune reconstitution of AIDS clinical efficacy and safety of and evidence for the formation for the promotion, widely recognized immune reconstitution of AIDS Chinese medicine provide the basis for comprehensive treatment program.

The subject of the Chinese Academy of Medical Sciences Joint Medicinal Plant Research Institute, Yunnan AIDS Care Center, the People's Liberation Army No. 302 Hospital, Chinese Academy of Medical Sciences Institute of Medicinal Plant, Chinese Academy of Medical Sciences Institute of Laboratory Animal, Beijing Century Pharmaceutical Technology and Culture Development Co., Ltd. A total of six areas of the domestic AIDS research unit, in particular, Bacon Academy Xiao, Zeng Yi, the National Academy of Sciences and other leading experts on the subject of guidance and participation, to achieve a strong joint, and ensuring the authority and nature study.

Wang said order, the project features and innovations include: the project targets the use of laboratory tests and clinical characteristics of combining syndrome differentiation to study AIDS is real or is empty Sheng poisoning syndromes and is conducive to the TCM Syndrome AIDS standardized quantitative diagnosis; strict quality control, integrated traditional Chinese medicine treatment of AIDS patients the impact of immune reconstitution, the use of forward-looking, multi-center randomized, double-blind design, at home and abroad for leading level; of AIDS is false and is true of drug-sheng Syndromes of Molecular Immunology and AIDS-related indicators of research, not been reported in China. In line with international standards of clinical research model, to employ a neutral third party agencies (CRO organization) to carry out project management work, the use of Peking University First Hospital of Medical Statistics of the central room system randomized patients randomized to employ well-known statistics, full participation of experts in evidence-based medicine; the establishment of Chinese medicine treatment of AIDS and to conduct real-time Web site updates, universal access to AIDS prevention and control knowledge, as the majority of patients with online services platform, while promoting academic exchanges, and to speed up the cultivation of innovative talents.

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