Future direction of medical care system for patients with infectious disease and the new infectious diseases control law in Japan--centering around a category 1 hospital

As of April 1, 1999, the new Infectious Diseases Control Law became effective in Japan. Under the new law, there are three types of category for medical care systems such as "Specified Infectious Disease Medical Hospital", "Category 1 Infectious Disease (Ebola virus hemorrhagic fever, Marburg disease, Lassa fever, Crimean-Congo hemorrhagic fever and plague) Designated Hospital" and "Category 2 Infectious Disease (Cholera, Sigellosis, Typhoid fever, Paratyphoid fever, Poliomyelitis and Diphtheria) Designated Hospital". In these categories, "Category 1 Infectious Disease Designated Hospital" should be designated by prefectural governments, one hospital per prefecture. Recently some papers indicated that (1) whether each government should arrange a category 1 hospital, (2) whether strict isolation with precautions against airborne spread including negative air pressure with anterior-room should be required, (3) plague is not a dangerous disease and the patient with plague is not required of Category 1 hospital but Category 2 hospital for medical care and infection control. The purpose of this article is, including a counterargument for these opinion, to summarize the point of view for the new medical care system under the new law and to search for the future medical care system in Japan. First of all, medical care for patients with infectious diseases should not be a special one but the extension of the general one. Second, we understand that one of the purposes for Category 1 hospital is the core hospital concerning the therapy, pre/post education and research for infectious diseases in each prefectures. Third, the constructive standard for Category 1 hospital should be a strict one including negative air pressure rooms with an anterior-room and an outside hall, and the air should not be recirculated. Under the big chance of enforcement of this new Infectious Diseases Control Law in Japan, we should try to restruct about medical care system for patients with infectious diseases in a long-range plan.     

The new Tuberculosis Control Program of Japan

The 1951 Tuberculosis Control Law of Japan was amended extensively and has been in effect since April, 2005. The revision of the National Tuberculosis Program (NTP) is to respond to the tremendous changes that have occurred during the last 50 years in tuberculosis epidemiology and in the environment in tuberculosis control implementation. In this review, the main points and framework of the revisions were summarized and the perspective of the development of new technical innovations relevant to each area of the revised TB control legislation is discussed. Also, challenges of Japan's NTP in the recent future are discussed, including the controversies over the proposed abolishment of the Tuberculosis Control Law. 1. IMMUNIZATION: In the revision of NTP, the BCG vaccination of elementary school and junior-high school entrants was discontinued. In order to strengthen the early primary vaccination for infants, the new Law has adopted the direct vaccination scheme omitting tuberculin testing prior to immunization. This program is implemented to young babies, i.e., less than six months old, as defined by the decree. It is a heavy responsibility for the municipalities to ensure the high coverage of immunization when the period of legal vaccination is rather strictly limited practically to the fourth to sixth months after birth. The safe direct vaccination is another new challenge where appropriate management of the Koch's phenomenon or similar reactions should be warranted. 2. CHEMOPROPHYLAXIS: Though unfortunately suspended for some legal reason currently, the expansion and improvement of chemoprophylaxis, or treatment of latent tuberculosis infection, to cover anyone with higher risk of clinical development of TB would have a tremendous effect in Japan, especially since 90% of patients who developed TB were infected tens of years ago. The technical innovations in diagnosis of TB infection such as QuantiFERON will be very helpful. Development of new drugs or drug regimens for this purpose is also expected. 3. CASE DETECTION: The "indiscriminate" screening scheme in the periodic mass health examination has been replaced with a selective one. Only subjects aged 65 or older are eligible for the screening, supplemented with selected occupational groups who are considered to become source of infection, should they develop tuberculosis, such as health-care providers and school teachers. Local autonomies are also responsible for offering screening to the socio-economic high-risk populations, such as homeless people, slum residents, day laborers, and/or workers in small businesses, as decided by the autonomies at their disposal. Another important mode of active case-finding, i.e., contact investigation has been legally enforced so that anybody cannot refuse to be examined by the Health Center. This investigation service will be greatly enhanced by such new technologies as DNA fingerprinting of TB bacilli and a new diagnostic of TB infection. Regarding the clinical service of the symptomatic patients that detect 75% of new cases currently will be improved in its quality by introducing an external quality assurance system of commercial bacteriological laboratory services. 4. TREATMENT AND PATIENT SUPPORT: The revised NTP clearly states the government's responsibility for treating TB patients in close cooperation with a doctor, in the framework of the DOTS Japan version. While the development of new anti-tuberculosis drugs will be realized in the near future, Japan still has to overcome the issues of improper practice of treatment, as well as the government's slow process for approving drugs to be used for multi-drug resistant TB and non-tuberculous mycobacterioses, such as quinolones, macrolides and others. 5. PREFECTURAL TB CONTROL PLAN: In order to respond to the specific issues of tuberculosis problem in the respective prefectures in terms of epidemiology or in available resources, the Law requests every prefecture to develop and implement its own TB control plan. The rather abruptly proposed argument of abolishing Tuberculosis Control Law and merging the NTP to Infectious Disease Control Law threatens us with the government's premature departure from active commitment in the tuberculosis control. This reminds us of the United States' remarkable experience of the tuberculosis resurgence in the late 1980's and early 1990's, after 15 years of abandonment of the governmental efforts during 1970s.     

Tuberculosis as a zoonosis

There are more than 700 different kinds of major zoonosis. Among them, tuberculosis is important, since mycobacteriosis, including tuberculosis, is common among non-human primates and ruminants. Although the natural host of tubercle bacilli is human, many kinds of animals are susceptible to Mycobacterium spp., including Mycobacterium bovis and other non-tuberculous Mycobacteria. In Japan, the prevalence of the recurrent infection between human and pet animals leads to increasing trends of, and mycobacteriosis of exhibition animals sometimes present a severe problem in a zoo. International standards for the control of infections caused by animals and foods are established by the Office International des Epizooties (OIE), which was founded in 1927. Member nations are required to ensure the protection of human and animal life and health on the basis of the international standards. Owing to the standards, animal diseases have been relatively well controlled in Japan. For example, the occurrence of bovine tuberculosis in dairy cattle is extremely limited, and the incidence rate of human tuberculosis in imported laboratory monkeys is quite low. At present, there is the political plan that the Tuberculosis Prevention Law will be incorporated into the Infectious Diseases Control Law without consideration of the notification procedures of the infected animals or certification of non-affected animals. Not only veterinarians but also physicians should be aware of this problem.     

Development of vaccination policy in Japan: current issues and policy directions

Until November 2001, eight vaccinations had been offered to Japanese children on a routine basis; namely, diphtheria-tetanus-pertussis, polio, measles, rubella, Japanese encephalitis, and BCG. The 2001 amendment of the Immunization Law introduced an influenza vaccine for the elderly population. This paper reviews the progress of the immunization program in the broader context of infectious disease control in Japan. There are two recent major policy changes in the field of infectious disease control in Japan. One is the strengthening and revitalization of the infectious disease control program, particularly surveillance, by the enactment of new 1999 legislation entitled "Law concerning the Prevention of Infectious Diseases and Patients with Infectious Diseases". The other major policy change is a review of existing immunization programs and the amendment of the Immunization Law in 2001. In this article, the present routine vaccination program, as well as the recent amendments to the law, are described. Current policy issues are then discussed, including polio vaccination after the WHO "Zero Polio" announcement in the Western Pacific Region in 2000; strategies for changes in measles, rubella, tuberculosis, and influenza control; as well as adverse reaction monitoring/surveillance and feedback for improving vaccine safety. Finally, the future prospects of intended/planned changes in the vaccination policy are considered.     

Human rights of patients and tuberculosis prevention

The Act for Prevention and Medical Treatment of Patients of Infectious Diseases in Japan was revised in December 2006. Through this revise of the act, the articles for the measures against Bio-terrors were incorporated into the act, and the idea of respect of human rights of patients surely took root into the act. At the same time, the Tuberculosis Prevention Act was abolished and the articles of this act were partly revised and incorporated into the Act for Prevention and Medical Treatments of Patients of Infectious Diseases. The procedural rights of tuberculoses patients and the role of jurists in the procedure of tuberculosis prevention were consolidated. It is desirable that dialogues between jurists and those who are engaged in tuberculosis prevention should be accelerated by these legislations.     

Amendment of tuberculosis prevention law and prospect of tuberculosis control program

Tuberculosis Control Law, which provides a legal basis for national tuberculosis control, was amended in 2004 and entered into force on April 1, 2005. As it is more than half a century since its initial enactment, the law has been drastically amended based on some of the relatively new important ideas such as up-to-date scientific evidence, recent epidemiological conditions of tuberculosis, decentralization and respect for human rights. Japan has once seen a time when considerable part of producing population were affected with tuberculosis which caused severe infliction on the whole Japanese society including economical damage. With progress in medical technology such as development of chemotherapy and improvement of sanitary conditions, there was a major decline in incidence rate and death rate during the 1960s and 1970s. However, the decrease in TB incidence began to stagnate in the 1980s, partly explained by aging of the overall society and worsening of the urban tuberculosis conditions. Since then, there has been a discussion on review of national tuberculosis control program, and the increase in the number of tuberculosis patients in 1997, which happened for the first time in 38 years, precipitated the process. In 1999, 'Tuberculosis Emergency Declaration' was announced by the Minister of Health, which led to emergency national tuberculosis survey in 2000, and based on the result came forward the Recommendation on Comprehensive Review of National Tuberculosis Plan. Main ideas and spirits of the Recommendation were taken full account of during the process of the amendment of the law and were mostly reflected on the final outcome. Five key elements include; Establishment of National Tuberculosis Fundamental Guideline and Prefectural Tuberculosis Prevention Plan, Review on TB screening, Review on BCG vaccination policy, Promotion of a Japanese version of DOTS, Review on Tuberculosis Advisory Committee 1. Establishment of National Tuberculosis Fundamental Guideline and Prefectural Tuberculosis Prevention Plan With a view to establishing a comprehensive plan in the context of local tuberculosis situation, it was deemed to be necessary for both the central government and local governments to set out a detailed and comprehensive plan that may supplement the newly amended law. Prior to the amendment of Tuberculosis Prevention Law, it was made obligatory in the amended Infectious Diseases Control Law for the central government to establish National Fundamental Guideline and for local governments to establish Prefectural Prevention Plan. 2. Review on TB Screening With a view to promoting early detection of tuberculosis, tuberculosis screening system was totally reviewed to be turned into more effective and efficacious means for the purpose. Previously, all people above 19 years of age were to be screened annually for tuberculosis with chest X-ray. By this means, however, only 1,600 tuberculosis patients were detected out of 20,000,000 people screened which means the detection rate is 0.0067%. Thorough analysis was made to identify who would benefit from regular X-ray screening in terms of detection of tuberculosis patients and was decided to be those who have certain risk factors to develop tuberculosis such as the elderly and socio-economically challenged people and those who, once develops tuberculosis, may easily infect others such as school teachers, healthcare workers and such. Also the procedure of contact trace was reviewed and in highly required cases, compulsory examination implemented by health care officers has become a choice. 3. Review on BCG vaccination policy Previously national BCG policy included BCG vaccination for young children who tested negative on tuberculin skin test before they become 4 years old. However due to low sensitivity of tuberculin skin test and resulting too many of false-positive cases, the estimated number of unnecessary chemoprophylaxis was thought to be more than justifiable. Also, as regards the timing for vaccination, it was'thought of as best to give BCG vaccination before one gets infected, which may happen even before 4 years of age. For reasons above, new national BCG policy include direct BCG vaccination for infants younger than 6 months of age. 4. Promotion of a Japanese version of DOTS DOTS (Directly Observed Treatment, Short-course) is, needless to say, a tuberculosis control policy advocated worldwide by World Health Organization (WHO) since early 1990s. Japan has a long history of supporting tuberculosis patients through various activities by health care workers such as home-visit follow-up, although it is worthwhile to note that in a newly amended law there is a reference to having patients take medicine in the law itself as direction by a doctor or a director of the public health care center. 5. Review on Tuberculosis Advisory Committee The Tuberculosis Advisory Committee is a regional commi- ttee that gives advice on issues such as treatment of tuberculosis and hospitalization order based on the law. The amendment includes review on committee members to select at least one committee member from non-medical staff from the perspective of human rights protection. We acknowledge this time's amendment of the law is a significant step forward in the history of national tuberculosis control and it is our sincere hope that this will eventually lead to great improvement of national tuberculosis condition.     

Endemic tropical diseases: comtemporary health problem due to abandoned diseases in the developing world

There are two kinds of infectious diseases in the world; diseases being paid attention and neglected diseases. The former diseases include HIV/AIDS, tuberculosis and malaria, the latter group include many parasitic, fungal, bacterial and some of viral infections. "Neglected Infectious Diseases", which have been renamed as Endemic Tropical Diseases by WHO, are endemic in the developing world are not newly appeared diseases, but diseases affecting humans in these decades. In fact, DALYs for several diseases in the category are big enough; more than 300 millions for soil-transmitted helminthiasis, 5 millions for lymphatic filariasis, 4-5 millions for schistosomiasis and so forth. However, those diseases were not recognized as serious health problems because of socio-economical and/or scientific reasons. Furthermore, those diseases are no fatal in the acute phases; therefore, no big attention is raised by policy makers in the world. From the view point of basic medical sciences, however, there is no enough reason for neglecting the issues of those diseases: no improved diagnostics and therapeutics have been developed in spite of the urgent necessities in endemic areas. Considering those situations, WHO has started to take action for solving the problems since beginning of the 21st century. Recently, many of developed countries are recognizing that the imbalanced input of human and financial resources only for 3 major infectious diseases, HIV/AIDS, tuberculosis and malaria, and then, various international schemes for supporting research on Neglected diseases. DNDi, Drugs for Neglected Diseases initiative, is one of the examples and it's scope is only focusing on drug development for Neglected diseases. African trypanosomiasis is one of Neglected diseases and causing serious health problem both for humans and domestic animals in Africa. No safe and effective medicine has been available but a drug with serious side effects is only the drug of choice even nowadays. Under the grant support from DNDi, a Japanese group is developing a new drug, ascofuranone, for African trypanosomiasis without any detectable side effects. Developing new prophylactic drugs for schistosomiasis and new diagnostic tools for lymphatic filariasis are underway under the support of grant for Neglected or Re-emerging infectious diseases in Japan. Considering that issues of "Neglected Infectious Diseases" are urgent to be solved and also are challenging for modern medicine and medical sciences, researchers in the developed countries including Japan should make efforts to promote more active researches in this field.     

Reform of Japan's NTP and its technical perspectives

The 1951 Tuberculosis Control Law of Japan is now faced with tremendous changes that have occurred during the last 50 years in tuberculosis epidemiology and in the environment in tuberculosis control implementation. The law is also challenged with the shift of the paradigm for the National Tuberculosis (TB) Programme. In order to respond properly to these changes, the Tuberculosis Panel of the Health Science Council of the Ministry of Health, Labor and Welfare submitted its report for the amendment of the law in March 2002. Based on this report, a new Tuberculosis Control Law was passed in Parliament last June, and related decrees of the Cabinet and the Ministry are now being revised in preparation for it's enactment in April 2005. In this special lecture, the main points and framework of the revisions were discussed with the perspective of the development of new technical innovations relevant to each area of the revised TB control legislation. 1. Case detection. There will be a shift from the current "indiscriminate" screening scheme to a selective one regarding periodic mass health examination. Only subjects aged 65 or older will be eligible for the screening, supplemented with selected occupational groups who are considered to be at a higher risk of TB, or may be a danger to others if they develop TB, such as health-care providers and school teachers. In addition, local autonomies are responsible for offering screening to the socio-economic high-risk populations, such as homeless people, slum residents, day laborers, and/or workers in small businesses. This means that the efforts of the autonomies are critical for the new system to be effective. The extra-ordinary examination will be limited to only the patient's contacts, and will be mandatory for those contacts so they cannot refuse to be examined by the Health Center. The public services used in the contact investigations will be greatly facilitated by such new technologies as DNA fingerprinting of TB bacilli and a new diagnostic of TB infection using whole-blood interferon-gamma determination (QuantiFERON). The quality of clinical diagnosis and monitoring of treatment should also be improved by introducing an external quality assurance system of commercial laboratory services. 2. Chemoprophylaxis. Although not explicitly defined in the new legislation, the expansion and improvement of chemoprophylaxis to cover anyone with any risk of clinical development of TB would have a tremendous effect in Japan, especially since 90% of patients who developed TB were infected tens of years ago. These technical innovations in diagnosis of TB infection will be very helpful. Development of new drug regimens for the preventive treatment is also badly needed. 3. Immunization. Prior to the amendment of the Law, the BCG vaccination of students entering primary and junior high schools has been already abandoned. In order to encourage the early primary vaccination for infants, the new Law will adopt the direct vaccination scheme in which babies will be given the BCG vaccine without tuberculin testing. This program will be implemented safely, only if it is given to young babies, e.g., less than one year old, as defined by the decree. It is essential to maintain the high level of vaccination coverage under the new program. The autonomy may encounter difficulty mobilizing client babies shortly after their birth (only one year, as compared with the current four years). To avoid the possible, though very rare, adverse health effects due to the vaccination of infected babies, careful questioning should be conducted regarding the risk of exposure to infection prior to vaccination. A ready course of treatment and examinations for abnormal reactions after vaccination (Koch's phenomenon) is also warranted. 4. Treatment and patient care: The revised Law clearly states the governmental responsibility for treating TB patients in close cooperation with a doctor. This is an important legal basis for the expansion of the DOTS Japan version. While the development of new anti-tuberculosis drugs will be realized in the near future, Japan still has to overcome the issue of improper practice of treatment, as well as the government's slow process for approving new drugs to be used for multi-drug resistant TB and non-tuberculous mycobacterioses. 5. Prefectural TB Control Plan: In order to resolve the problems specific to the respective prefectures in terms of epidemiological parameters or available resources, the new Law requests every prefecture to develop its own TB control plan. In order for the new TB Control Law to be effective, strong government commitment supported by technological innovation is mandatory. It is for that reason that the Japanese Society of Tuberculosis should aggressively join the global movement to stop TB along with the general public of Japan.     

Tuberculosis control of urban areas in Japan

The rates of tuberculosis remain high in urban areas. The declining speed of tuberculosis incidence rate in urban areas has been slower than other areas. Efforts and resources to tuberculosis control must be concentrated on urban locations to eradicate tuberculosis in Japan. 1. Tuberculosis control in a public health center of urban area: Teru OGURA and Chiyo INOGUCHI (Toshima City, Ikebukuro Public Health Center, Tokyo Metropolitan) A wide range of TB control measures is implemented by public health centers, such as a patient registration, home-visit guidance, contact examination in urban areas. Directors of every health center have the direct responsibility for tuberculosis control measures in their jurisdiction. Ikebukuro is urban areas where there are many offices, shopping and amusement facilities. Urban people is often on the move looking for job, so public health centers are often not easy to carry out contact examinations as planned. In recent years, homelessness has been recognized as a growing urban social problem. Their incidence of tuberculosis is high. Special TB control program must be carried out in urban areas. 2. Tuberculosis Control in Tokyo Metropolitan: Kazumasa MATSUKI (Department of Infectious Diseases and Tuberculosis, Bureau of Public Health, Tokyo Metropolitan) There has been a steady decline in the TB wards. The beds for TB patients are running short and even smear positive TB cases cannot be put in a hospital without waiting several days. Staffs of an urban emergency department must protect tuberculosis infection by environmental controls of emergency room. Tokyo Metropolitan government supports the engineering improvements of emergency room to hospitals. Directly observed therapy for tuberculosis patients at a district has been implemented to complete their therapy. On DOT, a trained health worker observes the patient take anti-TB medication. 3. Usefulness of Molecular Epidemiologic approach on Tuberculosis Control: Atsushi HASE (Osaka City Institute Laboratory of Health and Environment) DNA fingerprinting establishes the genetic relatedness of Mycobacterium tuberculosis isolates and has become a powerful tool in tuberculosis epidemiology. To use DNA fingerprinting to assess the efficacy of current tuberculosis infection-control practices. Combining conventional epidemiologic techniques with DNA fingerprinting of M. tuberculosis can improve the understanding of how tuberculosis is transmitted. Patients were assigned to clusters based on mycobacterial isolates with identical DNA fingerprints. Clusters were assumed to have arisen from recent transmission. We analyzed M. tuberculosis isolates from patients reported to the tuberculosis registry by RFLP techniques. These results were interpreted along with demographic data. Patients infected with the same strains were identified according to their RFLP patterns, and patients with identical patterns were grouped in clusters. RFLP patterns of high incidence districts have more variations than other areas. This suggests that the source of tuberculosis infection are quite diverse and complicated. Tuberculosis patients may accumulate to high incidence districts from other places after infection. 4. Structure of High Incidence of Tuberculosis and Control Plan in Osaka City: Yoichi TATSUMI (Bureau of Infection Control, Osaka City Office) The case notification rate in Osaka City is the highest in Japan. That of all TB cases and smear positive TB cases was 1573 and 216 per 100,000 population in 1997 at Airin District in Osaka City. The main reason for this highest incidence rate is that there are many homeless people and it is a mobile population. Most of residents are daily laborers. They come from all over Japan and stay there, mainly in rented rooms, to look for jobs. Thousands of homeless people also live in tents on streets or in parks. We are making to new strategic plan to intensify tuberculosis control measures throughout the city. Osaka city government h     

Continuing challenge of infectious diseases in India

In India, the range and burden of infectious diseases are enormous. The administrative responsibilities of the health system are shared between the central (federal) and state governments. Control of diseases and outbreaks is the responsibility of the central Ministry of Health, which lacks a formal public health department for this purpose. Tuberculosis, malaria, filariasis, visceral leishmaniasis, leprosy, HIV infection, and childhood cluster of vaccine-preventable diseases are given priority for control through centrally managed vertical programmes. Control of HIV infection and leprosy, but not of tuberculosis, seems to be on track. Early success of malaria control was not sustained, and visceral leishmaniasis prevalence has increased. Inadequate containment of the vector has resulted in recurrent outbreaks of dengue fever and re-emergence of Chikungunya virus disease and typhus fever. Other infectious diseases caused by faecally transmitted pathogens (enteric fevers, cholera, hepatitis A and E viruses) and zoonoses (rabies, leptospirosis, anthrax) are not in the process of being systematically controlled. Big gaps in the surveillance and response system for infectious diseases need to be addressed. Replication of the model of vertical single-disease control for all infectious diseases will not be efficient or viable. India needs to rethink and revise its health policy to broaden the agenda of disease control. A comprehensive review and redesign of the health system is needed urgently to ensure equity and quality in health care. We recommend the creation of a functional public health infrastructure that is shared between central and state governments, with professional leadership and a formally trained public health cadre of personnel who manage an integrated control mechanism of diseases in districts that includes infectious and non-infectious diseases, and injuries.     

传染病防治药物临床试验信息管理平台的构建

目的 按照药物临床试验质量管理规范(good clinical practice,GCP)标准,建立传染病防治药物临床试验信息管理平台。方法 按照GCP的临床试验规则,采用J2EE技术、Struts和Hibernate的三层体系架构及数据库技术,构建传染病防治药物临床信息管理平台。结果 建立了包括电子数据采集系统、临床试验数据系统、GCP项目管理系统和中央随机化管理系统在内的传染病药物临床信息管理平台。结论 使用传染病防治药物临床信息管理平台,显著增强了临床试验质量控制,为建立符合国际规范的传染病防治药物评价体系,准确评价药物的疗效和安全性奠定了基础。     

Tuberculosis diagnostics and biomarkers: needs, challenges, recent advances, and opportunities

Tuberculosis is unique among the major infectious diseases in that it lacks accurate rapid point-of-care diagnostic tests. Failure to control the spread of tuberculosis is largely due to our inability to detect and treat all infectious cases of pulmonary tuberculosis in a timely fashion, allowing continued Mycobacterium tuberculosis transmission within communities. Currently recommended gold-standard diagnostic tests for tuberculosis are laboratory based, and multiple investigations may be necessary over a period of weeks or months before a diagnosis is made. Several new diagnostic tests have recently become available for detecting active tuberculosis disease, screening for latent M. tuberculosis infection, and identifying drug-resistant strains of M. tuberculosis. However, progress toward a robust point-of-care test has been limited, and novel biomarker discovery remains challenging. In the absence of effective prevention strategies, high rates of early case detection and subsequent cure are required for global tuberculosis control. Early case detection is dependent on test accuracy, accessibility, cost, and complexity, but also depends on the political will and funder investment to deliver optimal, sustainable care to those worst affected by the tuberculosis and human immunodeficiency virus epidemics. This review highlights unanswered questions, challenges, recent advances, unresolved operational and technical issues, needs, and opportunities related to tuberculosis diagnostics.     

Infectious diseases as a Canadian subspecialty, with projections to the year 2000

Infectious diseases is a relatively new subspecialty in Canada. During the past decade, however, important advances have been made. These include the formation of the Canadian Infectious Diseases Society and the development of the first Royal College of Physicians and Surgeons examinations in the subspecialty of infectious diseases. The majority of Canadians training for practice in the field of infectious diseases are now enrolled in programs in Canada. Despite predictions in the United States of an excess of physicians who specialize in infectious diseases, such a situation has not occurred in Canada. More physicians with training in infectious diseases will be required in Canada in the next decade to fill positions in patient care, microbiology (for individuals with both clinical and laboratory training), research, epidemiology and infection control, programs related to human immunodeficiency virus infections, geographic and international medicine, the pharmaceutical industry, and education and administration. In Canada, the extent to which infectious diseases physicians are involved in these areas varies from that in the United States. This review suggests a continued need for physicians with appropriate training in infectious diseases.     

传染病防治药物临床试验管理系统的建立

目的 建立具有自主知识产权的传染病防治药物临床试验管理系统,为传染病防治药物的研发提供技术保障。方法 本系统严格按照药品临床试验管理规范要求的业务流程和标准,基于J2EE开发平台,使用了BioKnow-UAP框架体系,运用Struts、Hibernate等架构技术和Oracle数据库存储数据。结果 本系统建立了标准化的临床试验评价手段和体系,并构建了严密的质量控制体系,保证临床评价数据管理的可靠性,健全了高效的人员培训体系,使药物临床研究更加符合人体生物医学研究伦理学要求,能够承担传染病防治药物的Ⅰ-Ⅳ期临床试验研究。结论 本系统成功构建了符合药品临床试验管理规范及适于传染病防治药物研究的临床试验评价体系,具有较高的实用价值。     

Importance of National Institute of Infectious Diseases and Institutes of Public Health on control of infectious diseases in the new century

As the incidence of infectious diseases has recently decreased, we are faced with new problems, such as emerging and re-emerging infectious diseases, food poisoning, zoonosis, and bio-terrorism. In light of these new conditions, the National Institute of Infectious Diseases, the Local Institutes of Public Health, public health offices, and other medical organization must maintain close relationship in order to protect the health and safety of the citizens.     

Reaching the limits of tuberculosis prevention among foreign-born individuals: a tuberculosis-control program perspective.

Analysis of whether assiduous implementation of American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America guidelines for targeted testing and treatment of latent tuberculosis infection could have prevented any of 223 cases of active tuberculosis in foreign-born persons in San Francisco during the period 2002-2003. We report that 62% of these cases were not preventable and conclude that a further reduction in the incidence of tuberculosis among foreign-born persons will be modest without modification of current guidelines.     

Update: prevention and treatment of tuberculosis

Tuberculosis remains one of the leading infectious disease killers globally. A significant reservoir of infected individuals and disease activity remains, particularly in the countries of the world which have the least economic resources to treat latent and active disease. This has set the stage, over the decades, for the development of multi-drug resistant isolates now easily spread around the world with increased trans-national migration.Tuberculosis treatment and control requires a global approach with international organizations such as the World Health Organization (WHO), and the International Union Against Tuberculosis and Lung Disease (IUATLD) overseeing National Tuberculosis Control Programs and seeking financial support from governmental as well as non-governmental sources. Directly Observed Therapy Short Course (DOTS) and DOTS Plus remain the cornerstones in the treatment of drug sensitive and drug resistant diseases respectively.Research activity should focus in developing early diagnostic tools and drugs which would be able to effectively treat tuberculosis cases for shorter periods of time in the new millennium.     

Professional challenges and opportunities in clinical microbiology and infectious diseases in Europe

The two closely linked specialties of clinical microbiology and infectious diseases face important challenges. We report the consensus of clinical microbiologists and infectious disease physicians assembled by the European Society for Clinical Microbiology and Infectious Diseases. Both specialties have different training requirements in different European countries and are not universally recognised as professions. The specialties are rapidly evolving as they adapt to the changing demands within hospital practice, including the need to deal with emerging infections, rapidly increasing internationalisation, and immigration. Clinical microbiology needs to develop and master technological advances such as laboratory automation and an avalanche of new methods for rapid diagnostics. Simultaneously, the pressure for concentration, amalgamation, and out-sourcing of laboratory services is ever-increasing. Infectious disease physicians have to meet the professional challenge of subspecialisation and the continual need to find new niches for their skills. Despite these challenges, each of these specialties continues to thrive in Europe and will enjoy important opportunities over the next few years. The recently formed European Centre for Disease Prevention and Control in Stockholm, Sweden, will increase demands in areas of surveillance of infectious diseases and antimicrobial resistance on both specialties.     

《中国学校结核病防控指南(2020 年版) 》重点问题解读与思考

学生是我国结核病防治工作的重点人群,学校结核病防控是校内传染病防控工作的重点、难点和热点。 为加强新形势下的学校结核病控制工作,国家卫生健康委、教育部制定下发了《中国学校结核病防控指南( 2020 年版)》。 本文针对该指南中学校结核病防控策略和措施、入学健康体检结核病筛查、学校结核病预警响应、接触者筛查和处置以及学生患者诊疗质量控制和管理等一些重点问题进行了解读和思考,为日常学校结核病防控工作提供参考。     

Tuberculosis and human rights

Tuberculosis (TB) patients must be hospitalized while the smear of sputum is positive because TB spreads through air. Cooperation of a patient is important in order to complete the treatment of TB. However, a small number of patients are noncooperative for the treatment and may sometimes refuse it. At this symposium, we discussed about whether we could restrict the human rights of noncooperative TB patients. Although the patients' human rights must be protected, we also have to protect the human rights of people who may receive TB infection. The balance of the both people's rights is fully considered in the TB control policy. It is epoch-making that the TB society took up the theme about the human rights' restriction of TB patients. Five speakers presented their papers from each position. There were presentations about the scientific evidence of isolation, the actual cases, the situation of the United States, and the legal view on the human rights' restriction of TB patients. The present situation and the legal problems in Japan became clear at this symposium. We need further discussion about the human rights' restriction of TB patients for the revision of the Tuberculosis Protection Act and have to obtain the national consensus on it. 1. The evidence for isolation: Emiko TOYODA (International Medical Center of Japan) To determine appropriate periods of respiratory isolation, available biological, clinical, and epidemiological issues and data were studied. Although absolute lack of infectiousness requires consecutive culture negative and it takes too long and impractical periods. There seems to be no established evidence for noncontagiousness after 2 to 3 weeks effective treatment. Practically conversion to 3 negative consecutive smear results may used as a surrogate for noninfectiousness, even though a small risk of transmission still be present. Chemical isolation has been more important and administration with DOT should be indicated to keep compliance. 2. Discontinued hospitalization in tuberculosis patient: Yoshiko KAWABE (National Hospital Organization Tokyo National Hospital) We investigated the background of tuberculosis patients who entered our hospital in 11 years from 1993 to 2003 and discontinued hospitalization. Out of 4,126 cases 76 cases (1.8 %) discontinued hospitalization. We classify three groups. One is self discharged group who leaved hospital without permission. Second is obligatory discharged group who were displaced for some trouble. Third is transferred group who were transferred to another hospital including mental hospital that have ward for tuberculosis. Major reasons were drinking during hospitalization, violence, roam because of dementia and major backgrounds were repeatedly noncompliant patients, homeless people, and suffering from senile dementia. We concluded we need some legal intervention for few cases who cannot continue hospitalization. 3. Tuberculosis control policy and human rights in public health center: Keiko FUJIWARA (Infection Diseases Control Division, Public Health Bureau, City of Yokohama) It is required for a success of the tuberculosis control policy to consider human rights. Patients' human rights should be respected, and surrounding people's human rights should also be respected. We sometimes see a tuberculosis patient who cannot continue tuberculosis treatment. A society as a whole has to share the recognition of tuberculosis as a social illness. The completion of tuberculosis treatment is not only the benefit of individual, but also it is very important as social defense. When we revise the tuberculosis control policy, we should think about both protecting a society from tuberculosis and protecting tuberculosis patients' human rights and obtain national consensus. 4. The mandatory TB control policy in the US: Hidenori MASUYAMA (Shibuya Dispensary, Japan Anti-TB Association) The mandatory TB control policy in the US was discussed. If the mandatory health policy would be applied, the following three criteria of human rights must be satisfied. 1. The health of others will be adversely affected without a mandatory program. 2. The mandatory program is the least restrictive alternative. 3. The mandatory program is implemented equitably without purposeful bias. For example, the mandatory DOT could not satisfy these criteria. Before applying the mandatory TB control policy in Japan, the TB patient's autonomy and social cooperation of TB therapy need to be considered. 5. Tuberculosis and guarantee of human rights: Shigeru TAKAHASHI (Graduate School of Law, Hitotsubashi University) In modern administrative Law the relations between Governments and peoples are regarded not as the facing relationships between Governments and the peoples, who submit to the interventions by Government, but as the triangle relationships between Governments, the peoples who submit to the interventions by Governments and the peoples who enjoy benefits from the interventions by Governments. When we make a new design of the Tuberculosis Protection Act, we must at first take considerations of the human rights of the tuberculosis patients from the view points of due Process of Law. And we must also take considerations of the human rights of the peoples who are threatened with the risks of tuberculosis infection.