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Research
of Traditional Chinese Medicine(TCM) micro
ecological
preparation and its clinical application for
AIDS
with intestine as the target organ
与非洲国家合作项目建议书
Proposal
of Project collaboration with African countries
项目建议单位:Project
proposal unit
中国科学院遗传与发育生物学研究所
Institute of Genetic and Developmental Biology,
CAS
中国疾病预防控制中心性病艾滋病预防控制中心
Chinese
centre for disease control and prevention, Venereal disease and AIDS
control and prevention centre.
中国人民解放军第304医院全军烧伤研究所
Chinese
People’s Liberation Army 304th Hospital
一、 国际艾滋病研究最新发现:近80% HIV在肠道组织内
Recent International research discovered: nearly
80% HIV locates in the intestinal tract tissue
多年来科学界一直以为血液里携带了最大量的HIV,但2004年美国科学家在临床上证实了近80% HIV在肠道组织内,血液内的病毒载量仅占2%-5%。HIV进入人体后攻击的主要目标是淋巴细胞,肠道是淋巴组织和淋巴结、淋巴细胞最丰富的地方,因此集聚了非常多的HIV,艾滋病患者真正的毒库在肠道。
It was believed for many years in the scientific
field that majority of HIV was carried in the blood stream; however,
in 2004 the American scientists from clinical study proved that nearly
80% HIV was in the tissue of intestinal tract, and only 2%-5% flowing
in the blood. After the virus entering into the human body, the main
attacking target are the lymph cells; intestinal tract is a place where
many lymphatic tissue, lymph node and lymph cells are located, therefore,
many HIV gathers in it. The real major virus-storeroom for the AIDS
patients is their intestinal tract.
专家指出,由此能解释男同性恋感染艾滋病的风险很高,因为“肛交”直接接触HIV最密集的区域,一旦有伤口破损,高浓度的病毒就可能进入健康人的体内,造成感染。
The experts indicate, thereby it can explain
the reason why the male homosexual has a high risk of getting infected
with the AIDS virus, as during ‘anal sex’ they have direct physical
contact with HIV dense area. Once where a wound broken, many virus could
get into the healthy body, therefore to result in the infection.
非洲的一项治疗也佐证了这一发现,当地对艾滋病儿童施于抗生素,抑制肠道炎症的发展,由此降低了HIV的繁殖速度,使艾滋病孩的死亡率下降了20%。
美国华盛顿大学朱托夫教授指出:这提示了肠道是治疗艾滋病的重要靶点,今后锁定艾滋病人肠道寻找治疗药物将是必然的方向。
A medical treatment in Africa provided another
proof, that the AIDS child was given the antibiotics for restraining
from worsening of intestinal inflammations, simultaneous it cause HIV
multiplication rate reduced, and the mortality of AIDS child dropped
20%.
Professor ZHU Tuofu from The University of Washington once indicated:
this found suggested that the intestinal tract is the significant target
for AIDS treatment, and focusing on the intestinal tract of AIDS patient
and thereafter finding the therapeutic remedy would be the inevitable
direction for future study.
二、中国科学院遗传发育所在肠道中药微生态制剂研究领域已取得国际先进水平的成果,为“以肠道为靶器官的艾滋病中药微生态制剂研究”提供了重要的科研基础
The institute of Genetic and Developmental Biology,
CAS has achieved the advanced international level in research of Traditional
Chinese Medicine (TCM) micro ecological preparation for regulating the
intestinal tract, and provided the significant foundation for scientific
research regarding “TCM micro ecological preparation with intestinal
tract as target organ for AIDS”.
1.“胡萝卜素肠道微生态调节剂研究”达到国际先进水平
中国科学院遗传与发育生物学研究所与中国人民解放军第304医院、中国医学科学院肿瘤医院肿瘤研究所、卫生部食品卫生监督检验所、中国科学院生物物理研究所开展多学科联合攻关,使“胡萝卜素肠道微生态调节剂研究”取得重大进展。
1. “The research and development of Natural
carotene enriched extract for regulating healthy intestinal micro-ecology”
has achieved the advanced level in international
The institute of Genetic and Developmental Biology, CAS with Chinese
People’s Liberation Army 304th hospital, Cancer Institute (hospital),
CAMS, Institute of Food Safety Control and Inspection, Ministry of Public
Health, and Institute of Biophysics, CAS carried out multi-disciplinary
research collaboration and the remarkable achievement was made in research
of natural carotene enriched extract for regulating intestinal microecologic
health.
1-1从胡萝卜中高效提取胡萝卜素获重大突破,超高胡萝卜素含量浓缩汁率先在中国实现工业化生产并具有自主知识产权。
1-1 the great break through was achieved in
high abstraction of the natural carotene from carrot, and the concentrated
extract with highly carotene contained was first actualized & produced
in industrial production in China, with possessed of its independent
intellectual property.
1-2在国际上首先发现:“胡萝卜素肠道微生态调节剂”可高效解决益生菌的厌氧生存环境和增殖因子补给,受试者口服7日肠道中双歧杆菌可增殖120倍,属国际领先技术。
1-2 first found in international: our “Natural
carotene enriched extract for regulating intestinal microecologic health
” can highly sustain the anaerobic surviving environment and supply
the breeding factors for beneficial bacterium; after the testees orally
taking it for 7 days, the bifidobacterium in their intestinal track
was increased to 120 times, which is the international leading technology.
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| 125ml“胡萝卜素微生态营养液”于2004年6月实现了工业化生产
125ml “Natural Carotene enriched extract
for regulating intestinal micro-ecologic health” was implemented
industrial production in June 2004
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1-3在国际上首先发现:“胡萝卜素肠道微生态调节剂”可显著保护肠道机械性屏障、生物学屏障和免疫学屏障,可有效防止肠缺血再灌注损伤所致内毒素血症的发生,并能显著减少肠缺血再灌注损伤的动物死亡率。
1-3 first found in international: our “Natural
Carotene enriched extract for regulating intestinal microecologic health”
can notably protect mechanical barrier, biological barrier and immune
barrier of intestinal tract; can effectively prevent from the endotoxemia
caused by injury of the intestinal ischemia reperfusion; and also remarkably
decreased the mortality of testing animal in relation with intestinal
ischemia reperfusion injury”
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| 胡萝卜微生态营养液可有效保护肠黏膜
注射MTX48小时后,灌喂胡萝卜汁组小鼠的小肠绒
毛高度及受损脱落情况(左图)与对照组(右图)有显著性差异
‘Natural carotene enriched extract for regulating
intestinal micro-ecologic health’ can effectively protect the
intestinal mucosa
48 hours after Injected MTX(methotrexate), comparison of villi
height and damage condition in the small intestine between the
extract fed rats (left) and normal rats (right).
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“胡萝卜素肠道微生态调节剂”已于2000年和2004年成功应用于悉尼奥运会和雅典奥运会中国国家队备战训练和奥运比赛,对运动健儿的肠道健康发挥了重要作用。
Our “Natural carotene enriched extract for regulating
intestinal microecologic health” was successfully used for China national
team during 2000 Sydney and 2004 Athens Olympic games in competition
and preparation training; it contributed significantly in supporting
the national athletes by having a regulated healthy microecologic environment
in their intestine.
2.在国家奥运攻关中,针对肠缺血造成的运动性腹泻、腹痛的中药微生态制剂取得重大进展
2. In national Olympiad-oriented research, TCM
micro ecological preparation with aiming at exercise-related diarrhea
and bellyache caused by ischemia of intestine, has achieved the significant
development.
运动可引起内脏血流的重新分配。在极限运动时,无论训练有素者或是缺乏训练者,肠道血流可减少80%。上述原因是造成我国体能类运动员运动性腹泻/腹痛、血便及由此导致运动能力下降的重要诱因之一,是影响我国体能类竞技项目成绩提高的重要“瓶颈”。
Sports motions can cause the redistribution
of viscera blood flow. During extreme exercise motions, no matter the
professional athletes or the amateurish exerciser, blood flow could
reduce 80% in intestinal tract. The above is one of the main reason
of causing our national physical ability class athletes exercise-related
diarrhea/bellyache, and bloody stool, therefore, resulted in their physical
ability fade; and which is also the ‘choke point’ and restrain on the
potential improvement in physical ability class items in Olympic Games.
目前国内外尚无特效药物可对运动性腹泻对症治疗,运动员服用黄连素、整肠生、易蒙停、诺氟沙星等药物基本无效。
Currently there is no effective therapeutic
medicine for exercise-related diarrhea in China, and the medicines such
as Berberine, Entrocoordinatibiogen:E.C.B, Loperamide Hydrochloride,
Norfloxacin had little affects for the athletes suffering from it.
本项研究将现代肠道微生态学理论、肠屏障学理论和传统中医药学“整体观”和“辩证施治”理论有机结合,充分发挥“微生态制剂”和“中药复方制剂”两种制剂在肠屏障方面的各自独特优势,从而有效地解决了体能类运动项目肠道应激反应(腹泻/腹痛)复杂的临床运动医学难题。
Our research integrated the complimentary intestinal
micro ecology theory, intestinal barrier disciplinary theory and TCM
‘Holistism’ & ‘Treatment based on differential diagnosis’, combined
the usage of ‘TCM formulated preparation’ and ‘Carotene enriched extract
for regulating intestinal microecologic health’ in order to have both
unique advantageous effects upon intestinal mucosa. Hence, the research
effectively solved the difficulty in sports clinical medicine regarding
the intestinal tract stress responds (diarrhea/bellyache) during physical
ability class competition.
中药复方制剂“止泻消痛片”在奥运备战和比赛期间应用,对于急性水泻可做到8小时见效,24小时后恢复训练的高效临床应用效果,得到了国家体育总局医疗专家组的充分肯定。
TCM formulated preparation ‘Anti diarrhea &
contusion Tablet’ was used for the athletes in the period of Olympic
Games competition and preparation. For treating acute watery diarrhea,
the positive effect was gained after taking it 8 hours, and the athletes
returned to training after 24 hours. This TCM preparation has been highly
recognized by the Medical Expert Group of Central Administration of
Sport of China.
Anti diarrhea & contusion Tablet
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用于中国国家队2004雅典奥运会备战训练和奥运比赛肠道功能调节剂
Used as functional therapy for intestinal
disorders by Chinese national sports team during 2004 Athens Olympic
Games and the period of preparation
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三、本项研究的目的将已有预防肠道功能紊乱和治疗运动性急性水泻的研究成果应用于艾滋病人的临床实验研究
3. The purpose of this research is to conduct
the research of clinical experiment on AIDS patients based upon using
above researched achievements in preventing intestinal tract dysfunction
and acute exercise-related watery diarrhea.
艾滋病患者死亡总数中,因机会感染导致腹泻而死亡的人数约占总死亡人数的1/3,因此,此项研究在非洲有重大意义。
Among the total mortality of AIDS patients,
1/3 died of diarrhea caused by opportunity infects, therefore, this
research has significant meaning in Africa.
1.中国方面与非洲国家组成多学科联合攻关课题组的单位及分工
1. China uniting with African countries to form
a multi-disciplinary research group and organize the research participation
units
中国方面参加单位:
Participating Units from China:
中国科学院遗传与发育生物学研究所
The institute of Genetic and Developmental Biology,
CAS
总体设计,负责以肠道为靶器官的艾滋病中药微生态制剂研制及机理研究
Construction of general plan, and responsible
for the research and development of Traditional Chinese Medicine micro-ecological
preparation for AIDS disease and its Mechanism research with aiming
at the intestinal tract as target organ.
中国疾病预防控制中心性病艾滋病预防控制中心
Chinese centre for disease control and prevention,
Venereal disease and AIDS control and prevention centre.
负责临床应用总体设计和临床应用研究,负责艾滋病人血液指标及肠道微生态学检测研究,其中包括:粪便中双歧杆菌、 乳杆菌、拟杆菌、肠杆菌、肠球菌、产气荚膜梭菌数量的检测。
Responsible for constructional planning of clinical
application research, and its implementation, along with the examination
studies on intestinal tract micro ecology and hematological attributes
of AIDS patients, which including the quantitative tests of Bifidobacterium,
Lactobacillus, Bacteroides, Enterobacter, Escherichia coli and cl.perfringen
in feces.
中国人民解放军第304医院(全军烧伤研究所)
Chinese People’s Liberation Army 304th Hospital
负责艾滋病人肠屏障通透性、HIV及肠毒素移位检测研究
Responsible for the examination studies on HIV,
toxic replacement and permeability of the AIDS patient’s intestinal
barrier.
血浆内毒素水平定量检测:生理情况下,由于宿主有完整的肠粘膜机械屏障,肠道菌群的微生态平衡及健全的免疫防御系统,肠道细菌/内毒素一般不易发生移位。细菌移位的发生机制主要包括三个方面,即肠粘膜屏障功能丧失、肠道菌群生态学异常及宿主免疫功能抑制。大量的研究揭示,在各种危重临床情况下均可发生肠道细菌移位与内毒素血症,通过检测血浆内毒素水平可了解肠屏障功能状态。
Quantitative test of endotoxin (LPS) level:
Under normal physiological condition of a host(body) who has complete
intestinal mucosa as mechanical barrier, with balanced gut bacterial
flora and healthy immune system, the intestinal bacteria / endotoxin
commonly do not replace within its gut. Bacterial replacement happens
primarily with three conditions: lost function of intestinal mucosa,
ecological abnormality of bacteria flora in the intestine, or the inhabitation
of host’s immune system. Many research revealed that intestinal bacterial
replacement and endotoxemia can occur under various clinic critical
conditions, and intestinal mucous function condition can be understood
by through LPS test.
二胺氧化酶(DAO)活性:DAO是人类和哺乳动物小肠粘膜上层绒毛中具有高度活性的细胞内酶,其活性与粘膜细胞的核酸和蛋白合成密切相关,可反映小肠粘膜的完整性和损伤程度。
Activity of Diamine oxidase (DOA): DOA is the
highly active endoenzyme in the microvilli of small intestine of human
and other mammal, which activity has crucial correlation with nucleic
acids and protein synthesize within mucous cells and also reflects the
completion or trauma level of small intestinal mucosa.
D-乳酸含量测定:业已证明,D-乳酸由胃肠道固有细菌产生,且哺乳动物体内无快速代谢它的酶系统,血液中D-乳酸水平升高可能反映肠粘膜屏障功能的异常。我们研究发现,急性肠缺血再灌注可致肠粘膜屏障破坏,
使门、体循环D-乳酸水平显著升高, 其含量与小肠粘膜损害密切相关。因此, D-乳酸可作为新的血浆标志物应用于急性肠粘膜损害的早期诊断。
Determination of D-lactic acid content
It is proved that D-lactic acid is produced by inherent bacteria in
the gastrointestinal(GI) tract. In mammal body there is no enzymic system
to fast metabolize D-lactic acid; therefore, the increase of D-lactic
acid level in blood can reflect the functional abnormality of the intestinal
mucosa. Our research found that acute intestinal ischemia reperfusion
can cause the damage of intestinal mucosa, but the D-lactic acid level
increased obviously in portal-systemic circulation, and its content
has close correlation with small intestinal mucosa damage. Hence, D-lactic
acid can be the new blood plasma indicator for early diagnosis of acute
intestinal mucosa damage.
2.与非洲国家艾滋病研究机构及医院合作,将胡萝卜素肠道微生态调节剂和中国草药止泻制剂在非洲艾滋病高发区和腹泻高发区进行人群临床应用研究
2. To collaborate with the hospitals and the
institutes of AIDS research in African countries, to carry out a public
clinical application research of using “Carotene enriched extract for
regulating intestinal microecologic health” and “TCM Anti-diarrhea Preparation”
for Diarrhea and AIDS high occurring areas in Africa.
2-1胡萝卜素肠道微生态调节剂和中国草药止泻制剂已在中国进行了安全性评价并用于运动员和亚健康人群。
2-1 “Carotene enriched extract for regulating
intestinal microecologic health” and TCM Anti-diarrhea Preparation”
have been safety approved and used for the national athletes and the
people with subhealth condition in China.
2-2以上两种制剂在与非洲合作的艾滋病医院进行临床应用实验,目标人群为艾滋病腹泻者,研究此两种制剂对艾滋病腹泻者的有效性,实验人数20人,男女各半,自身对照。
2-2 To conduct the clinical application research
of using above remedy and extract in the African collaboration hospitals,
that the experimental target group are AIDS patients with diarrhea condition,
thereafter to carry out the research for the effectiveness of these
two treatments upon Aids patients with diarrhea condition. The experimental
objects are 20 people in total with equal numbers of male and female,
the comparison data of the condition will be taken from the objects
before experiment and after treatments.
上述两种制剂均是以肠道为靶器官,若将其应用于艾滋病感染的腹泻者,有可能除对改善艾滋病患者临床症状发挥积极作用,还可能对HIV感染者的免疫功能有重要影响,可能对提高CD4细胞计数作用、增加CD4/CD8比值、延缓HIV病毒复制发挥积极作用。
Above two treatments are all focusing on the
intestinal tract as target organ,if applied on AIDS patients with diarrhea
condition, it may contribute positive effect in the clinical symptom
improvement of AIDS patients, and may also have crucial influence of
their immune function. Furthermore, the treatment may have positive
function upon the count of CD4 cells, increasing CD4/CD8 Ratio, and
restraining the HIV multiplication.
2-3在2-2取得良好治疗效果的基础上,进一步扩大实验人群并开展制剂与艾滋病患者肠屏障相关的病理研究。
2-3 Based upon the positive results gained from
above treatment, the experimental group may be expanded farther and
the further pathological researches can be carried out in relation with
treatment (using remedy & extract) and intestinal mucosa of AIDS
patient.
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