中国创新性艾滋病疫苗已完成Ⅰ期临床试验
2011年03月23日 00:39 来源：中国新闻网
中新社北京3月22日电 (记者 孙自法)“十一五”期间，中国16个国家科技重大专项之一的“艾滋病和病毒性肝炎等重大传染病防治”紧密结合传染病防控实践，已初步建立具有举国体制特征的传染病科技支撑体系，突破一批关键技术，产生一批产品，新发突发传染病应急能力显著增强。
“十一五”国家重大科技成就展提供的信息披露，中国创新性艾滋病疫苗已完成Ⅰ期临床试验，申报2项(Ⅰ期、Ⅱ期)临床试验，取得可预防猴对抗病毒攻击的临床前研究结果，建成了3个疫苗评价平台和产学研相结合的中国艾滋病疫苗联盟。同时，已建立适合中国国情且符合国际标准的全自动、高通量核酸血筛检测体系及多种HIV检测试剂盒。
针对艾滋病、病毒性肝炎和肺结核的治疗难点，“艾滋病和病毒性肝炎等重大传染病防治”专项建立中国最大的症候研究数据库，筛选出20多个中医、中西医结合治疗方案，采用循证医学的理念和方法，开展多中心临床研究，观察逾万例病例。结果显示，中医药治疗可调节免疫功能，提高抗病毒治疗效果，降低毒副作用，改善生存质量，明显降低重型肝炎等病死率。
该专项对乙肝免疫预防策略的大样本、系统全面的研究表明，目前中国人群乙肝感染率已降至7.18%，5岁以下人群乙肝携带率降至1%以下；重型乙肝治疗方案进一步优化，新型难治性丙肝治疗方案使抗病毒治疗应答率较西方国家提高15%以上；成功研制出16种新型乙肝或丙肝诊断试剂，其中10种已获准上市，性能达到或超过国际主流试剂水平。
通过实施“艾滋病和病毒性肝炎等重大传染病防治”专项，中国建立传染病实验室监测技术平台并开展病原谱监测研究，在流感大流行期间迅速建立了甲型H1N1流感快速诊断方法，制备出10余万人份检测试剂，及时发往中国国内各网络实验室，并向周边国家与地区提供检测试剂，为中国及时发现确诊第一例传入病例奠定基础。覆盖中国内地31个省份的传染病实验室监测网络开展病毒学研究，已阐明中国甲型H1N1流感的病原学特征，为疫苗的及早研发提供技术支持和保障。
“艾滋病和病毒性肝炎等重大传染病防治”专项还研制出生物采样侦检车，该车具有生物采样、空气预警和快速检测等多种功能，其机动性好、功能配套，适合城市街道生物采样与生防侦检作业。同时，防治重大传染病规模化现场流行病学和干预研究方面，旨在覆盖2000万人群的示范区已创建传染病综合信息管理体系，打造出社区防治网。(完)
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| 图示∶2010年12月即将出版的《中国特色医疗金鉴》登载的刘君主任及其机构 |
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China's innovative AIDS vaccine clinical trials have been completed Ⅰ
At 00:39 on March 23, 2011 Source: China News
China news agency, Beijing, March 22 (Reporter Sun Zifa) - "Eleventh Five-Year" period, China's 16 major projects, one of the national science and technology, "AIDS and viral hepatitis and other major infectious diseases" in close connection with infectious diseases prevention and control practice, has initially established a nationwide system of infectious diseases and technology support system features, breaking number of key technologies, resulting in a number of products, emerging infectious disease emergency response capacity has markedly increased.
"Eleventh Five-Year" National Key Science and Technology Exhibition to provide disclosure of information, innovation in China Ⅰ AIDS vaccine clinical trials have been completed, return two (Ⅰ, Ⅱ, period) clinical trials, the monkey made against virus attacks can prevent pre-clinical results, and built a three vaccine evaluation platform and a combination of research of Chinese AIDS vaccine alliance. Meanwhile, China's national conditions has been established in line with international standards and fully automated, high-throughput nucleic acid blood screening test system and a variety of HIV test kits.
For AIDS, viral hepatitis and tuberculosis treatment difficult, "AIDS and viral hepatitis and other major infectious diseases," a symptom of a special study to establish the largest database of screened more than 20 traditional Chinese medicine, Integrative Medicine program, the use of evidence-based medicine ideas and methods and conduct multi-center clinical research, observation Yu Wan cases. The results showed that Chinese medicine treatment can regulate immune function, improve the effectiveness of antiviral therapy, reduced side effects and improve quality of life, severe hepatitis was significantly lower mortality rate.
The specific strategy for the prevention of hepatitis B immunization of large samples, systematic and comprehensive study shows that the current prevalence of hepatitis B in Chinese population has dropped to 7.18%, 5 years of hepatitis B carrier rate to 1% or less; severe hepatitis B treatment was further optimized, new refractory hepatitis C treatment response rate to antiviral therapy compared with Western countries increased by 15% or more; successfully developed a new type of hepatitis B or C of 16 kinds of diagnostic reagents, of which 10 species have been approved for marketing, performance, meet or exceed the level of the international mainstream reagents.
Through the implementation of "major infectious diseases such as AIDS and viral hepatitis prevention and control" projects, China has established laboratory surveillance of infectious pathogen spectrum of technology platforms and conduct monitoring studies of influenza during a pandemic influenza A H1N1 influenza rapid establishment of a rapid diagnostic method, prepared more than 10 million copies of test reagents, promptly sent to the network of laboratories in China, neighboring countries and regions to provide test kits for the Chinese to discover the first case of confirmed imported cases lay the foundation. Covering 31 provinces in Mainland China infectious disease surveillance network of virology laboratories has been to clarify the etiology of influenza H1N1 Influenza Chinese characteristics, the early development of the vaccine to provide technical support and protection.
"AIDS and viral hepatitis and other major infectious diseases" special also developed a biological sample detector car, the car has a biological sample, air early warning and rapid detection and other functions, and its mobility, and functional support for the city streets of biological Sampling and biocontrol detector operation. Meanwhile, the prevention of major infectious diseases field scale epidemiological and intervention studies, designed to cover 20 million people in the demonstration area of infectious diseases have created comprehensive information management system, to create a community prevention and control network. (End)
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