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Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. WS 288-2017: Diagnosis for pulmonary tuberculosis Status: Valid WS 288: Historical versions
Basic dataStandard ID: WS 288-2017 (WS288-2017)Description (Translated English): Diagnosis for pulmonary tuberculosis Sector / Industry: Health Industry Standard Classification of Chinese Standard: C59 Word Count Estimation: 24,240 Date of Issue: 2017-11-09 Date of Implementation: 2018-05-01 Older Standard (superseded by this standard): WS 288-2008 Regulation (derived from): State-Health-Communication (2017) 25 Issuing agency(ies): National Health and Family Planning Commission of the People's Republic of China WS 288-2017: Diagnosis for pulmonary tuberculosis---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.(Pulmonary tuberculosis diagnostic criteria) ICS 11.020 C 59 WS People's Republic of China health industry standards Replace WS 288-2008 Diagnosis of tuberculosis Diagnosis for pulmonary tuberculosis 2017-11-09 Published 2018-05-01 implementation People's Republic of China National Health and Family Planning Commission released ForewordThis standard "Chapter 3 ~ Chapter 5" is a mandatory clause, the rest are recommended terms. This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces WS 288-2008 "diagnostic criteria for tuberculosis." This standard compared with WS 288-2008, the main changes are as follows. - Added fluorescent staining microscopy, liquid culture medium examination, molecular biology examination (see 3.4.1 and 3.4.2); - Revised conditions for diagnosis of tuberculosis (increase in molecular biology test results) (see 5.3); - Increase of interferon-gamma release test (see 3.4.4.2); - increased bronchoscopy and tracheal, bronchial tuberculosis microscopic findings (see 3.5); - An increase of tuberculosis pathology (see Appendix C) - Added diagnosis of non-tuberculous mycobacterium tuberculosis (see E.2 in Appendix E); - Added diagnostic features for tuberculosis in children (see 3.2.1 and 3.3.1). This standard was drafted. China Center for Disease Control and Prevention, Capital Medical University, Beijing Chest Hospital, Capital Medical University North Beijing Children's Hospital, the People's Liberation Army No. 309 Hospital. The main drafters of this standard. Wang Lixia, into poetry, Zhou Lin, Zhao Yanlin, Gao Mengqiu, early Nai Hui, Zhou Xinhua, Wang Xiexiu, Zhao Shunying, Tu Dehua, Lin Minggui, Li Liang, Li Qi, Li Ning, Wu Xueqiong, Liu Ergyong, Lai Yuji, Wang Shengfen, Wang Qian, Ma Yan. This standard replaces the standards previously issued as follows. - GB 15987-1995; - WS 288-2008. Diagnosis of tuberculosis1 ScopeThis standard specifies the basis for the diagnosis of tuberculosis, diagnostic principles, diagnosis and differential diagnosis. This standard applies to all types of medical and health institutions at all levels and their medical staff on the diagnosis of tuberculosis.2 Terms and definitionsThe following terms and definitions apply to this document. 2.1 Pulmonary tuberculosis Tuberculosis occurs in lung tissue, trachea, bronchi and pleura. Tuberculosis etiology see Appendix A. 2.2 Mycobacterium tuberculosis Mycobacterium tuberculosis for short, is the pathogen of human tuberculosis. Mycobacterium tuberculosis is elongated or slightly curved shape, blunt bacilli at both ends, Length 1μm ~ 4μm, width 0.3μm ~ 0.6μm.3 diagnostic basis3.1 Epidemiology history History of exposure to tuberculosis patients. 3.2 Clinical manifestations 3.2.1 Symptoms Cough, sputum ≥ 2 weeks, or bloody sputum or hemoptysis suspicious symptoms of tuberculosis. Most of the slow onset of tuberculosis, some patients without obvious symptoms, only found in the chest imaging examination. As the disease progresses, can be out Now cough, expectoration, sputum bloody or hemoptysis, some patients may have recurrent upper respiratory tract infection symptoms. Tuberculosis can also occur in the body Symptoms such as night sweats, tiredness, intermittent or prolonged afternoon fever, loss of appetite, weight loss, etc., female patients may be accompanied by menstrual disorders or amenorrhea. A small number of patients with sudden onset, there are high fever, some with varying degrees of dyspnea. Lesions in the pleura may have irritating cough, chest pain and breathing difficulties and other symptoms. Lesions occur in the trachea, bronchial irritation and more cough, longer duration, bronchial lymphatic fistula formation and break into the bronchial or Bronchial stenosis, there may be wheezing or breathing difficulties. A small number of patients may be associated with tuberculous hypersensitivity syndrome, including. erythema nodosum, herpetic conjunctivitis/keratitis and so on. Children with tuberculosis can also show stunting, children with primary tuberculosis may be due to tracheal or bronchial lymph nodes swollen oppression trachea or bronchus Tubal, or lymph node - bronchial fistula, wheezing symptoms often appear. When combined with extrapulmonary tuberculosis, there may be the corresponding symptoms of organs involved. 3.2.2 signs Early lung signs are not obvious, when the lesion is involved in a large range, the local percussion was dull, auscultation and tubular breath sounds can be heard, the combined flu Dye or combined bronchiectasis, can be heard and wet rales. Lesions involving the trachea, bronchi, causing local stenosis, auscultation can be heard and fixed, limited wheezing, when caused by atelectasis, Can be manifested tracheal displacement to the affected side, ipsilateral thoracic collapse, intercostal space narrowing, percussion for the voiced or real sound, auscultatory breath sounds weakened or disappeared. Lesions involving the pleura, early in the affected side can be heard and pleural friction sound, with the increase of pleural effusion, ipsilateral thoracic full, intercostal space increased Wide tracheal shift to the contralateral side, percussion was voiced to real sound, auscultatory breath sounds weakened to disappear. Pleural effusion may occur when effusion decreases or disappears Thickening, adhesions, tracheal displacement to the affected side, ipsilateral thoracic collapse, intercostal space narrowing, respiratory movement is limited, percussion dullness, auscultation of breathing Weak tone. Primary pulmonary tuberculosis may be accompanied by superficial lymph nodes, disseminated hematogenous disseminated tuberculosis may be associated with hepatosplenomegaly, fundus choroid nodules, children with May be accompanied by skin miliary rash. 3.3 chest imaging examination 3.3.1 Primary pulmonary tuberculosis Primary pulmonary tuberculosis is mainly manifested as primary lesion and intrathoracic lymphadenopathy, or simple thoracic lymphadenopathy. Primary lung in children Tuberculosis can also be manifested as empty, caseous pneumonia and bronchial tuberculosis caused by bronchial lymphatic fistula. 3.3.2 Hematogenous disseminated tuberculosis Acute hematogenous disseminated tuberculosis showed uniform distribution of both lung size and density of the shadow of the miliary; subacute or chronic hematogenous spread Pulmonary tuberculosis diffuse lesions, mostly located in the upper middle of the two lungs, different sizes, the density range, there may be integration. Children acute blood smear Pulmonary tuberculosis is sometimes only manifested as ground glass-like shadow, infiltration of infants and young children around the miliary lesions obvious, fuzzy edge, easy to fusion. 3.3.3 secondary tuberculosis Secondary pulmonary tuberculosis chest image performance varied. The main manifestations of light patches, nodules and cable shadow, or showed tuberculoma or isolated empty Hole; severe cases can be manifested as lobar infiltration, cheese pneumonia, multiple cavity formation and bronchial disseminated; repeated extension of the progress of those who may have lung Damage, destruction of lung tissue volume reduction, multiple thick fibers inside its walls, secondary bronchiectasis, or associated with multiple calcifications, adjacent lung Pull the door and mediastinum shift shift, thoracic collapse, pleural thickening adhesions, compensatory emphysema appears in other lung tissue and old and new bronchus Disseminated lesions and so on. 3.3.4 trachea, bronchial tuberculosis Trachea and bronchial tuberculosis mainly manifested as irregular tracheal or bronchial wall thickening, stenosis or obstruction, narrow bronchial distal lung group Weave may appear secondary atelectasis or consolidation, bronchiectasis and other parts of the bronchial disseminated lesions. 3.3.5 Tuberculous pleurisy Tuberculous pleurisy is divided into dry pleurisy and exudative pleurisy. Dry pleurisy is an early inflammatory response to the pleura, usually without noticeable Imaging performance; exudative pleurisy mainly for pleural effusion, and pleural effusion can be manifested as a small amount or a large amount of free fluid, or there Limited to any part of the chest fluid, slow absorption often associated with thickened pleural adhesions can also evolve into pleural tuberculosis and empyema. 3.4 laboratory tests 3.4.1 Bacteriological examination Check the method in Appendix B. The test results are as follows. a) smear microscopy positive; b) Mycobacterium culture positive, strain identified as Mycobacterium tuberculosis complex. 3.4.2 Molecular Biology examination Mycobacterium tuberculosis nucleic acid test positive. 3.4.3 tuberculosis pathology examination Tuberculosis histopathological changes in Appendix C. 3.4.4 Immunological examination 3.4.4.1 Tuberculin skin test, moderately or strongly positive (see Appendix D). 3.4.4.2 γ-interferon release test positive. 3.4.4.3 Mycobacterium tuberculosis antibody positive. 3.5 bronchoscopy Bronchoscopy can be directly observed tracheal and bronchial lesions, can also suction secretions, brush and biopsy.4 diagnostic principlesThe diagnosis of tuberculosis is based on etiology (including bacteriology, molecular biology), combined with epidemiological history, clinical manifestations, chest Video, related auxiliary examination and differential diagnosis, make a comprehensive analysis to make a diagnosis. Pathogenic, pathological findings as a basis for diagnosis. Diagnosis of tuberculosis in children, in addition to sputum etiology check, but also pay attention to the etiology of gastric juice examination.5 diagnostic5.1 suspected cases Where one of the following items. a) have any one of 3.3; b) children under 5 years of age. with 3.2 at the same time have any of 3.1, 3.4.4.1, 3.4.4.2. 5.2 Clinical diagnosis of cases The differential diagnosis of other lung diseases, in line with one of the following items. a) Have any of 3.3 and 3.2; b) Have any of 3.3 and 3.4.4.1; c) have any one of 3.3 and 3.4.4.2; d) have any of 3.3 and 3.4.4.3; e) have any of the 3.3 and extrapulmonary histopathology confirmed as tuberculosis; f) With 3.3.4 and 3.5 can be diagnosed as tracheobronchial tuberculosis; g) With 3.3.5 and pleural effusion as exudate, adenosine deaminase increased, with 3.4.4.1, 3.4.4.2, 3.4.4.3 either Article who can be diagnosed as tuberculous pleurisy; h) Clinical diagnosis of tuberculosis in children should also have the following two. 1) Have any one of 3.3 and 3.2; 2) Have any of 3.4.4.1, 3.4.4.2. 5.3 confirmed cases 5.3.1 sputum smear-positive pulmonary tuberculosis diagnosis Where one of the following items. a) 2 sputum specimens smear acid-fast bacilli test in line with 3.4.1.a who; b) 1 sputum smear specimens acid-fast bacilli in line with 3.4.1.a, also have any of the 3.3; c) One sputum smear Acid-fast bacilli test in accordance with 3.4.1.a, and one sputum specimen Mycobacterium culture complying with 3.4.1.b. 5.3.2 Only Mycobacterium Isolates and Culture Positive pulmonary tuberculosis diagnosis In line with any of 3.3, at least 2 copies of sputum smear negative and mycobacterial culture in line with 3.4.1.b who. 5.3.3 molecular biology test positive pulmonary tuberculosis diagnosis Meet any one of 3.3 and 3.4.2. 5.3.4 Pulmonary histopathology Positive pulmonary tuberculosis diagnosis 3.4.3 meet. 5.3.5 trachea, bronchial tuberculosis diagnosis Where one of the following items. a) with 3.5 and trachea, bronchial pathological examination in line with 3.4.3; b) have 3.5 and tracheal, bronchial secretions etiological examination, in line with 3.4.1.a or 3.4.1.b or 3.4.2. 5.3.6 Diagnosis of tuberculous pleurisy Where one of the following items. a) with 3.3 and pleural effusion or pleural pathology examination in line with 3.4.3; b) have 3.3 and pleural effusion pathology, in line with 3.4.1.a or 3.4.1.b or 3.4.2.6 differential diagnosisSymptoms, signs and imaging findings of tuberculosis are similar to many chest diseases. In the diagnosis of tuberculosis, attention should be paid to other diseases Do not (see E.1), including identification of non-tuberculous mycobacterium tuberculosis (see E.2). Identified non-TB Mycobacterium non-tuberculosis Mycobacterium tuberculosis treatment. AA Appendix A. (Informative) Tuberculosis etiology A.1 Mycobacterium tuberculosis morphology and staining characteristics Mycobacterium tuberculosis slender slightly curved, clustered branched proliferation. Because of its cell wall contains a lot of lipids, not easy to color, Nissl acid-resistant stain was red, sterile hair and flagella, do not form spores (cells), is now proven capsule. Single, double, or in clusters. On artificial media, due to the different bacteria, strains and environmental conditions, there may be a variety of forms, such as approximately spherical, rod-shaped or filamentous. In electricity Microscopic observation of its complex structure. the micro-capsule, the three-tier structure of the cell shell, cytoplasmic membrane, cytoplasm, body, ribosome and the intermediate nuclei constitute. The typical Mycobacterium tuberculosis morphology is slender slightly curved or straight, blunt bacilli at both ends, length 1 μm ~ 4 μm, width 0.3μm ~ 0.6 μm, single scattered, sometimes X, Y-shaped or cords. Sputum specimens smear after acid-fast staining at 100 times the biological microscope can be see. Mycobacterium tuberculosis in vitro and in vivo by penicillin, cycloserine or lysozyme induced cell wall peptidoglycan synthesis, isoniazid Affect the synthesis of mycolic acid, macrophages phagocytosis Mycobacterium tuberculosis lysozyme role can destroy peptidoglycan, can lead to it into L-type, Granular or filamentous. A.2 Mycobacterium tuberculosis culture characteristics Mycobacterium tuberculosis is an obligate aerobic bacteria, high nutritional requirements, the optimum pH of 6.5 to 6.8 is appropriate, slow growth, the initial separation of nutrition Rich medium. Roche solid medium commonly used, containing egg yolk, glycerol, potato, inorganic salts and malachite green. Malachite green can be suppressed System of bacteria growth, easy separation and long-term culture. Yolk contains lipid growth factor that stimulates growth. According to the number of inoculation, usually 2 weeks ~ 4 Colonies can be seen weeks of growth. Colonies on solid medium were grayish-white, dry and granular, prominent uplift, rough surface shrinkage, cauliflower-like Colonies. In liquid medium, a coarse wrinkled membrane forms on the liquid surface and the medium remains clear. If added Tween 80 in the medium, can make tuberculosis Bacillus evenly dispersed growth, usually 1 week ~ 2 weeks to grow. Clinical specimen examination liquid culture several times higher than the positive rate of solid culture. bacteria Body slender slightly curved bacilli, stained red by acid-fast staining. Particularly strong resistance to dry, acid and alkali have a strong resistance, easy to produce Resistance mutations and L-type bacteria. A.3 Mycobacterium tuberculosis biochemical characteristics Mycobacterium tuberculosis does not ferment sugar, can produce catalase. Mycobacterium tuberculosis is generally thought of as human, cow-type, non-human Island type. Human type and bovine fungi morphological similar to all have strong virulence in guinea pigs, but the pathogenicity of human-type bacteria in rabbits than bovine-type bacteria is weak. Human type Mycobacterium tuberculosis can synthesize niacin, nitrate reduction, thiophene-2-carboxylic acid hydrazide resistance, Mycobacterium bovis do not have the above characteristics. Human type And cow-type strains, neutral red test were positive, non-toxic strains, the neutral red-negative and loss of cord-like growth. Hot catalase test on the difference knot Mycobacterium tuberculosis and non-TB Mycobacterium is of great significance. Mycobacterium tuberculosis most tentase test positive, and hot catalase test negative, non Mycobacterium tuberculosis is positive in most of the two tests. Hot catalase test test method is to place the concentrated bacterial suspension heated to 68 ℃ water bath for 20 min, Then add H2O2. Observe whether there is a bubble, bubble-positive. Bovine Mycobacterium tuberculosis can be used to drink non-sterile lead-bearing cow milk Since the onset of intestinal tuberculosis infection. Under the microscope are acid-fast bacilli, slender slightly curved, sometimes see people fonts, Y-shaped branches, the growth of culture by biochemical tests Can identify the type of bacteria. A.4 Mycobacterium tuberculosis resistance Mycobacterium tuberculosis is resistant to acids, alkalis, the natural environment and dryness but is sensitive to damp-heat, alcohol and ultraviolet light and to anti-tuberculosis drugs Easy to produce drug resistance. Mycobacterium tuberculosis cell wall contains lipid, it is sensitive to ethanol. 75% alcohol 5 min ~ 30 min death, Liquid heating 62 ℃ ~ 63 ℃, 30 min death. Mycobacterium tuberculosis is sensitive to ultraviolet light and can be killed by direct sunlight for 2 h to 7 h. UV can be used for tuberculosis patients clothes, books and other disinfection. Mycobacterium tuberculosis in the dry sputum can survive for 6 months to 8 months, easy to develop resistance to anti-tuberculosis drugs. Mycobacterium tuberculosis resistance Force and the presence of organic matter in the environment are closely related, such as sputum can enhance the resistance of Mycobacterium tuberculosis. Because most disinfectants can make sputum The protein coagulation, wrapped around the bacteria, so that bacteria are not easily killed. 5% carbolic acid can kill Mycobacterium tuberculosis 30 min after no sputum, Need to sputum 24h; 5% to the Soviet Union without sputum 5 minutes to kill Mycobacterium tuberculosis, sputum when required 1 h ~ 2 h. Mycobacterium tuberculosis is resistant to acid (3% HCl or 6% H2SO4) or base (4% NaOH) and is not affected for 15 min. Available in points Used to deal with contaminated samples of bacteria and digested specimens of viscous material. Mycobacterium tuberculosis 1. 13,000 malachite green arrived Resistance, added to the medium can inhibit the growth of bacteria. Mycobacterium tuberculosis streptomycin, isoniazid, rifampicin, cycloserine, ethambutol, Kanamycin, aminosalicylic acid and other sensitive, but prone to long-term drug resistance. A.5 Mycobacterium tuberculosis variability Mycobacterium tuberculosis variability includes. a) Variability of drug resistance. Mycobacterium tuberculosis is more susceptible to anti-tuberculosis drugs, resulting in more resistant strains and poor treatment difficult. b) Toxicity variation. toxic M. bovis is cultured in medium containing glycerol, bile and potato and passaged 230 times, It took 13 years to obtain an attenuated live strain, BCG, which is currently widely used in the prevention of human tuberculosis. A.6 Mycobacterium tuberculosis pathogenicity Mycobacterium tuberculosis does not produce internal and external toxins. Its pathogenicity may be due to bacterial proliferation in the tissue cells caused by inflammation, bacteria into The toxicity of metabolites and metabolites is related to the immune damage caused by the body components. 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