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GBZ 57-2019 English PDF (GB Z57-2008, GB Z57-2002)

GBZ 57-2019_English: PDF (GBZ57-2019)
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GBZ 57-2019English180 Add to Cart 0--9 seconds. Auto-delivery Diagnosis of occupational asthma Valid GBZ 57-2019
GBZ 57-2008English160 Add to Cart 0--9 seconds. Auto-delivery Diagnostic criteria of occupational asthma Obsolete GBZ 57-2008
GBZ 57-2002English519 Add to Cart 4 days [Need to translate] Diagnostic Criteria of Occupational Asthma Obsolete GBZ 57-2002


BASIC DATA
Standard ID GBZ 57-2019 (GBZ57-2019)
Description (Translated English) Diagnosis of occupational asthma
Sector / Industry National Standard
Classification of Chinese Standard C60
Classification of International Standard 13.100
Word Count Estimation 16,194
Date of Issue 2019
Date of Implementation 2019-07-01

BASIC DATA
Standard ID GBZ 57-2008 (GBZ57-2008)
Description (Translated English) Diagnostic criteria of occupational asthma
Sector / Industry National Standard
Classification of Chinese Standard C60
Classification of International Standard 13.100
Word Count Estimation 19,173
Date of Issue 2008-06-06
Date of Implementation 2008-12-01
Older Standard (superseded by this standard) GBZ 57-2002
Quoted Standard GBZ 188; GB/T 16180
Drafting Organization Shanghai Pulmonary Hospital, Tongji University (Shanghai occupational disease hospital)
Regulation (derived from) ?Health-Communication [2008] 12
Summary This standard provides guidelines for the diagnosis and treatment principles of occupational asthma. This standard applies to occupational allergens cause the diagnosis and treatment of asthma.

BASIC DATA
Standard ID GBZ 57-2002 (GBZ57-2002)
Description (Translated English) Diagnostic Criteria of Occupational Asthma
Sector / Industry National Standard
Classification of Chinese Standard C60
Classification of International Standard 13.1
Word Count Estimation 13,168
Date of Issue 2002/4/8
Date of Implementation 2002/6/1
Regulation (derived from) Health-Communication [2008] 12


GBZ 57-2019 GBZ NATIONAL OCCUPATIONAL HEALTH STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 13.100 C 60 Replacing GBZ 57-2008 Diagnosis of occupational asthma ISSUED ON: JANUARY 30, 2019 IMPLEMENTED ON: JULY 01, 2019 Issued by: National Health Commission of the PRC Table of Contents Foreword ... 3  1 Scope ... 5  2 Normative references ... 5  3 Terms and definitions ... 5  4 Diagnostic principles ... 6  5 Diagnosis ... 6  6 Treatment principles ... 7  7 Instructions for the correct use of this Standard ... 8  8 Laboratory sensitizer bronchial provocation test and job-site bronchial provocation test ... 8  9 Sensitizer-specific IgE antibody detection-enzyme-linked immunosorbent assay (ELISA) ... 8  10 Specific sensitizer skin test ... 8  Appendix A (Informative) Instructions for the correct use of this Standard ... 9  Appendix B (Normative) Laboratory sensitizer bronchial provocation test and job-site bronchial provocation test ... 13  Appendix C (Informative) Sensitizer-specific IgE antibody detection-enzyme- linked immunosorbent assay (ELISA) ... 17  Appendix D (Informative) Specific sensitizer skin test ... 20  Foreword Clause 5 of this Standard is mandatory. The rest are recommended. According to the Code of Occupational Disease Prevention of PRC, this Standard is developed. This Standard is drafted in accordance with the rules given in GB/T 1.1-2009. This Standard replaces GBZ 57-2008 “Diagnostic criteria of occupational asthma”. As compared with GBZ 57-2008, the main changes are as follows: - ADD terms and definitions; - Expand the definition of occupational asthma and ADD reactive airway dysfunction syndrome; - REVISE the diagnostic principles; - REVISE the diagnosis of occupational asthma and delete the grading; - REVISE part of Appendix A; - The index of Fractional exhaled nitric oxide is added to the positive reaction standards of job-site bronchial provocation test; - Delete appendixes “non-specific bronchial provocation test”, “exercise challenge test”, and “sensitizer-specific IgE antibody detection-enzyme- labelled fluorescence immunoassay (FEIA)”. Drafting organizations of this Standard: Shanghai Pulmonary Hospital, Tongji University (Shanghai Occupational Disease Prevention and Treatment Hospital), Guangdong Province Hospital for Occupational Disease Prevention and Treatment, The Second Hospital of Heilongjiang Province, West China Fourth Hospital, Sichuan University. Main drafters of this Standard: Zhang Jingbo, Sun Daoyuan, Chen Jiabin, Zhao Liqiang, Song Li, Yang Huimin, Hu Yinghua. The previous editions of this Standard were released as follows: - GB 16377-1996; - GBZ 57-2002; Diagnosis of occupational asthma 1 Scope This Standard specifies the principles of diagnosis and treatment of occupational asthma. This Standard applies to the diagnosis and treatment of occupational asthma. 2 Normative references The following documents are indispensable for the application of this document. For the dated references, only the editions with the dates indicated are applicable to this document. For the undated references, the latest edition (including all the amendments) are applicable to this document. GB/T 16180 Standard for identify work ability - Gradation of disability caused by work-related injuries and occupational diseases 3 Terms and definitions The following terms and definitions apply to this document. 3.1 Occupational asthma Chronic inflammatory disease of the airway involving a variety of cells including eosinophils, mast cells, T lymphocytes, neutrophils, smooth muscle cells, airway epithelial cells, and other cellular components, which is caused by contact with certain chemical substances in occupational activities. It is accompanied by variable airflow limitation and airway hyperresponsiveness. Occupational asthma in this Standard includes occupational sensitizer-induced asthma and occupational reactive airway dysfunction syndrome. 3.2 Occupational sensitizer-induced asthma Chronic inflammatory disease of the airway characterized by intermittent attack of wheezing, shortness of breath, chest tightness, or cough, etc. caused by inhalation of sensitizers in occupational activities, with a period of incubation. 3.3 Occupational reactive airway dysfunction syndrome Chronic airway neurogenic inflammatory disease with cough, wheezing, and 5.1.7 If 5.1.1+5.1.2+5.1.3 or 5.1.2+5.1.3+5.1.4 or 5.1.1+5.1.2+5.1.5 or 5.1.1+5.1.2+5.1.6 are met, occupational sensitizer-induced asthma can be diagnosed. 5.2 Occupational reactive airway dysfunction syndrome The following conditions shall be met at the same time: a) There is an exact occupational inhalation history of large doses of irritant chemicals in a short period of time; b) After contact, mucosal irritation symptoms such as shedding tears, pharyngalgia, cough, etc. appear immediately; c) Within 24 h after inhalation, bronchial asthma symptoms appear. The duration of the symptoms is longer than 3 months; d) Pulmonary function test shows reversible obstructive ventilation function disturbance or non-specific airway hyperresponsiveness; e) There is no history of diseases of respiratory system such as chronic bronchitis and chronic obstructive pulmonary disease. 6 Treatment principles 6.1 Therapeutic principles 6.1.1 After the diagnosis of occupational asthma is established, the patient shall be removed from the original occupational activity environment as soon as possible, to avoid and prevent the relapse of asthma. 6.1.2 Patients with acute asthma attacks shall be relieved for symptoms as soon as possible, relieved for airflow limitation and hypoxemia. The main pharmacotherapy methods are repeated inhalation of fast-acting β2 receptor agonists, oral or intravenous glucocorticoids, inhalation of anticholinergic drugs, and intravenous aminophylline, etc. Patients with severe asthma attacks and acute respiratory failure, if necessary, shall be treated with mechanical ventilation. 6.1.3 For long-term therapy of asthma, according to the severity of the disease, an appropriate therapeutic regimen shall be selected. The goal is to achieve and maintain symptom control, maintain normal activity level, and maintain normal pulmonary function as much as possible. 6.2 Other treatment Appendix A (Informative) Instructions for the correct use of this Standard A.1 Occupational sensitizer or irritant chemical is one of the pathogenic factors of bronchial asthma. Compared with common asthma, occupational sensitizer- induced asthma has no difference in pathological changes, clinical manifestations, pulmonary function changes, therapy, etc. The pathogenesis is mainly sensitizer-induced mechanism, but other mechanisms are often mixed. Respiratory inhalation is the main contact route for occupational sensitizer- induced asthma and the starting position for stimulating the immune response. A.2 Case data show that individual chemicals can, through skin contact, cause occupational sensitizer-induced asthma, such as occupational sensitizer- induced asthma caused by skin contact with latex. If epidemiological investigations, toxicological studies indicate that other chemicals can also cause sensitizer-induced asthma by skin contact, occupational asthma can be diagnosed. A.3 Case data show that occupational sensitizer-induced asthma often occurs in the 6 months to 10 years of contact with sensitizers. The shortest is 2 months. A.4 Patients with occupational sensitizer-induced asthma, before the onset of the disease, may develop allergic rhinitis symptoms such as running nose, nasal itching, nasal congestion, and sneezing. Therefore, when there are frequent attacks of nasal congestion, nasal itching, thin nasal discharge, continuous sneezing, and other symptoms, the possibility of occupational asthma shall be tracked. A.5 In the early and middle stages of occupational sensitizer-induced asthma, the occurrence and development of asthma symptoms are closely related to sensitizer exposure. Typical occupational asthma patients often develop asthma attacks during work or a few hours after work. The symptoms are more pronounced on the first day of the workday. On weekends, holidays, or after leaving the workplace, asthma symptoms can be alleviated. If the worker, during work or a few hours after work, develops repeated attack of wheezing, shortness of breath, cough, and other symptoms, and has medical records; or there are two or more workmates (same type of work or same post) proof materials proving that the patients often develop cough, chest tightness, asthma symptoms during work or a few hours after work and develop repeated attacks, it can be considered that occupational contact is associated with Appendix B (Normative) Laboratory sensitizer bronchial provocation test and job-site bronchial provocation test B.1 Laboratory sensitizer bronchial provocation test B.1.1 Conditions and requirements for subjects B.1.1.1 During the test, asthma symptoms have been alleviated. There is no wheezing in the auscultation of the lungs. B.1.1.2 Before the test, subjects have a FEV1≥70 % of the predicted value. Under close observation, some patients may be relaxed to FEV1>60 % of the predicted value. B.1.1.3 Subjects with cardiac and (or) pulmonary insufficiency, aortic aneurysm, recent myocardial infarction or cerebrovascular accident, uncontrolled hypertension, hyperthyroidism, pregnancy, and recent upper respiratory tract infection (< 2 weeks), etc. are not suitable for the test. Subjects who are allergic to certain strong sensitizers (such as penicillin, etc.) or have had a history of hypersensitivity (such as anaphylactic shock) are also not suitable for the test. B.1.1.4 Drugs to be discontinued a) Discontinuation of inhaled short-acting β2-receptor agonist or anticholinergic drugs for 6h, oral short-acting β2-receptor agonist or theophylline drugs for 12h, long-acting or sustained-release dosage form drugs for 24 h; b) Discontinuation of inhaled glucocorticoids for 12 h, oral glucocorticoids for 48 h; c) Discontinuation of antihistamines for 48h; d) Other drugs, such as β-receptor blockers, barbiturates, benzodiazepines, etc., can reduce the tolerance to the activator; and shall be discontinued 48h before the measurement. B.1.1.5 6h before the measurement, it shall avoid drinking coffee, strong tea, and alcoholic beverages. 2h before the measurement, it shall avoid vigorous exercise or cold air inhalation. B.1.3.2 If there are obvious symptoms and signs after the provocation, such as chest tightness, shortness of breath, sharp cough, lung wheezing, etc., the upper value shall be relaxed. If FEV1 drops by more than 10%, it can be judged as positive. B.1.4 Matters needing attention B.1.4.1 There is still a potential danger in the process of provocation test. The sensitizer inhalation concentration should not be too high, so as to avoid the irritative reaction. At the same time, the indications and contraindications shall be strictly controlled. The operation specification shall be strictly followed. The technician who performs the operation must be proficient in the operation procedures. The examination room shall be provided with bronchodilator, oxygen, and other first-aid medicines. B.1.4.2 In view of the fact that this test requires certain equipment and technical conditions, during the test, individual cases may be overreacted, so this test shall be carried out in a hospital with conditions. B.1.4.3 It is not advisable to give hints before or during the test that the subject should not be too nervous. B.2 Job-site bronchial provocation test B.2.1 Pre-test preparation and basic conditions Same as B.1.1. B.2.2 Method B.2.2.1 Before the test, the value of the basic Fractional exhaled nitric oxide (FeNO) is measured. Within the 1st hour after entering the job site, every 15 min, the ventilation function (FEV1) is measured once. The 2nd hour, every 0.5 h, the ventilation function is measured once. According to the situation, it is possible to stay at the site for 1 h~2 h. B.2.2.2 After disengagement, every 1 h, the pulmonary function is measured once. The clinical symptoms and signs shall be paid attention to and recorded. Continuous observation for at least 8 h. 24 h, it shall be measured again. FeNO after the test shall also be measured. B.2.2.3 If pulmonary function indices are significantly reduced, and there are respiratory symptoms and signs, the provocation test can be terminated; the bronchodilator can be inhaled. The recovery of pulmonary function indices shall be observed. Appendix C (Informative) Sensitizer-specific IgE antibody detection-enzyme-linked immunosorbent assay (ELISA) C.1 Principle The basis of enzyme-linked immunosorbent assay is the immobilization of antigen or antibody and the enzyme labelling of antigen or antibody. The antigen or antibody bound to the surface of solid phase support retains its immunological activity. The enzyme-labelled antigen or antibody retains both its immunological activity and the activity of the enzyme. In the measurement, the known specific antigen is first immobilized on the surface of solid phase support to form a solid phase antigen. The sample to be tested is added. Then the enzyme-labelled antibody is added, so that an antigen-antibody to be tested- labelled antibody complex is formed on the solid phase support. After adding enzyme substrate and chromogen, color is generated. The degree of color generation is expressed by the absorbance (A) value. The measured A value is correlated with the level of the sensitizer to be tested. C.2 Equipment Porous polystyrene board (universal 96-pore board, 12×8 pores), micropipette, enzyme-labelled immunoassay instrument, PH test paper, thermostat, refrigerator, wash bottle, wet box, common glassware, etc. C.3 Reagents C.3.1 Currently, various ELISA tests have commercialized special kits, including reaction plates coated with goat anti-human IgE, serial standards (0 U/mL, 10 U/mL, 100 U/mL, 500 U/mL), and quality control serum; enzyme (HRP) labelled anti-human IgE monoclonal antibody; buffer solution, stop buffer, etc. C.3.2 Dedicated labelling enzyme: Horse-radish peroxidase (HRP) is most commonly used to label various antibodies. C.3.3 Commonly-used enzyme substrates and chromogens: HRP substrate is H2O2 (or urea peroxide), which requires hydrogen donor to participate in the catalysis. The latter is mostly a reductive dye, which reacts to form a dark or fluorescent oxidative dye. There are many chromogens (hydrogen donors) available for HRP. Commonly used are o-phenylenediamine (OPD), 3,3’,5,5’- Appendix D (Informative) Specific sensitizer skin test D.1 Intracutaneous test D.1.1 Selection of skin test solution D.1.1.1 Sensitizer skin test solution: SELECT a standardized skin test solution. D.1.1.2 Skin test control solution and purpose: In order to obtain an accurate skin test result, a skin test is performed with both positive and negative controls. The positive control solution is histamine dihydrochloride at a concentration of 0.017mg/mL or histamine diphosphate at a concentration of 0.028 mg/mL, which is equivalent to a 0.01 mg/mL histamine substrate. The purpose of using a positive control solution: a) JUDGE the positive degree of sensitizer skin test: USE positive control solution caused papule as the standard “scale” to determine the positive degree of sensitizer skin test. b) Determine the level of skin reactivity of the subjects: Due to age, physical condition, and region, the skin’s reactivity is not the same. For example, the skin reactivity of the elderly is poor; and the reaction of the positive control is also weak. c) Observe the inhibitory effect of drugs: When the positive control solution shows negative reaction, it indicates that the skin test result is likely to be inhibited by certain drugs, such as antihistamines, thus the skin test result is invalid. Only when the positive control solution shows positive reaction, it indicates that the skin test is not affected by drug inhibition or other factors, and the skin test result is valid. The negative control solution is usually normal saline or sensitizer diluted preservation solution. The negative control solution shows negative reaction. If the patient is highly sensitive, a false positive reaction may appear. At this time, the skin test positive reaction produced by the sensitizer is not clinically significant. D.1.2 Operation procedures D.1.2.1 The skin of the subject’s forearm palmaris is disinfected using 75% alcohol. When disinfecting, do not apply it repeatedly. Do not use iodine tincture b) People with obvious dermatographism should not be skin tested; c) Before the test, STOP taking the antihistamine drugs. When the conditions permit, it shall stop taking adrenal glucocorticoid; d) The antigen used shall be sterile and of appropriate concentration; e) The test operation shall be accurate. Do not be bleeding; f) After injection, do not press and rub the wheal; g) Attention shall be paid to systemic reaction. First-aid medicines shall be provided. D.2 Prick test D.2.1 Selection of skin test solution D.2.1.1 Sensitizer skin test solution: same as D.1.1.1. D.2.1.2 Skin test control solution and purpose: The concentration of histamine dihydrochloride or histamine diphosphate used in the positive control solution is 100 times that of the intracutaneous test, which is equivalent to 1mg/mL histamine substrate. The purpose of using the control solution is the same as D.1.1.2. D.2.2 Operation procedures D.2.2.1 The test area disinfection is the same as that of intracutaneous test. D.2.2.2 Apply a drop of sensitizer skin test solution or control solution to the skin test site. USE a pricking needle to prick in the center of the skin where the skin test solution is dripped. The method of pricking is: USE a pricking needle to vertically and gently press down on the skin for 1s; and quickly LIFT the needle; 2min~3min, WIPE the skin test solution. If multiple sensitizer pricks are performed at the same time, each pricking site shall be separated by more than 3cm. D.2.3 Observation and judgment D.2.3.1 About 15 min after pricking, the reaction results are observed. Observe whether there is a papule at the pricking site and the papule size. In the next 10min~15min, it is observed several times. If the papule increases, RECORD the latter reaction. If it is reduced, RECORD the previous reaction. D.2.3.2 Observation method: same as D.1.3.2. ......


GBZ 57-2008 GBZ OCCUPATIONAL HEALTH STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 13.100 C60 Replacing GBZ 57-2002 Diagnostic criteria of occupational asthma ISSUED ON. JUNE 06, 2008 IMPLEMENTED ON. DECEMBER 01, 2008 Issued by. Ministry of Health of PRC Table of Contents Foreword ... 3  1 Scope ... 4  2 Normative references ... 4  3 Principles of diagnosis ... 4  4 Specific allergen test ... 4  5 Criteria for diagnosis and grading ... 5  6 Principles of treatment ... 6  7 Instructions for correct use of this standard ... 6  Appendix A (Informative) Instructions for correct use of this standard ... 7  Appendix B (Normative) Non-specific bronchial provocation test (Determination of responsiveness after airway inhalation of acetylcholine/histamine) ... 10  Appendix C (Normative) Motion excitation test ... 18  Appendix D (Normative) Allergen bronchial provocation test ... 20  Appendix E (Normative) Testing of allergen-specific IgE antibody - Fluorescent enzyme immunoassay (FEIA) ... 23  Appendix F (Normative) Testing of allergen-specific IgE antibody - Enzyme- linked immunosorbent assay (ELISA) ... 25  Appendix G (Normative) Specific-allergen skin test ... 27  Diagnostic criteria of occupational asthma 1 Scope This standard specifies the diagnostic criteria and principles of treatment for occupational asthma. This standard applies to the diagnosis and treatment of asthma caused by occupational allergens. 2 Normative references The provisions in following documents become the provisions of this standard through reference in this standard. For the dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this standard; however, parties who reach an agreement based on this standard are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies. GBZ 188 Technical specifications for occupational health surveillance GB/T 16180 Standard for identify work ability - Gradation of disability caused by work-related injuries and occupational diseases 3 Principles of diagnosis According to the exact occupational allergen exposure history, asthma history, clinical manifestations, combined with the results of specific allergen test, with reference to the survey data of on-site occupational hygiene, perform comprehensive analysis to exclude asthma or respiratory diseases which are due to other causes, then make diagnosis. 4 Specific allergen test The specific allergen tests referred to in this standard include. a) Bronchial provocation test at the work site (see Appendix D); b) Bronchial provocation test of laboratory allergen (see Appendix D); c) Allergen-specific IgE antibody testing (see Appendix E or Appendix F); c) Concurrent pneumothorax, mediastinal emphysema or pulmonary heart disease, etc. 6 Principles of treatment 6.1 Principles of treatment 6.1.1 After the confirmation of occupational asthma through diagnosis, the corresponding person shall be removed from the original occupational activity environment as soon as possible, to avoid and prevent the recurrence of asthma. 6.1.2 The effectiveness of treatment for an acute asthma attack depends on the severity of the attack and the response to the treatment. The purpose of treatment is to relieve symptoms as soon as possible, to relieve airflow limitation and hypoxemia. Drugs and usage are mainly the repeated inhalation of fast- acting β2-receptor agonists, oral taking or intravenous glucocorticoids, inhalation of anticholinergic drugs, intravenous aminophylline. For those with severe asthma attacks with acute respiratory failure, use the mechanical ventilation treatment if necessary. 6.1.3 For the treatment of asthma of chronic duration, it shall select appropriate treatment plan according to the severity of the disease, the main principle is anti-inflammatory and symptomatic treatment. It emphasizes the long-term use of one or more asthma control drugs, such as inhaled corticosteroids, long- acting β2-receptor agonists, oral cysteinyl leukotriene receptor antagonists, sustained-release theophylline, etc. It may use the oral glucocorticoids of minimum controlled dosage if necessary. 6.1.4 The treatment in the relieving period is mainly based on anti-inflammatory. The purpose of treatment is to control chronic inflammation of the airway and to prevent acute attacks of asthma. The drugs inhaled are mainly inhaled glucocorticoids. 6.2 Other treatment 6.2.1 After relieving the asthma, it may arrange other work. For patients of severe asthma, it may assign work appropriately according to their health status. 6.2.2 If labor capacity assessment is required, it shall be handled in accordance with GB/T 16180. 7 Instructions for correct use of this standard See Appendix A. relieved naturally after leaving the occupational allergen or relieved quickly through treatment, but it can recur after re-exposure. A.5 Diagnostic grading is judged comprehensively based on the frequency of asthma attacks (wheezing, shortness of breath, chest tightness, coughing, etc.) after separation from allergens and standardized treatments, the effects on activities and sleep, the laboratory tests such as increased airway resistance. Acute asthma attacks can occur at all grades, but acute attacks only represent the severity of the disease at a certain episode. Therefore, the severity of the acute attacks of asthma cannot be used as a grading index. A.6 The atypical clinical manifestation of asthma means that there is no obvious wheezing or signs at the time of attack. Chronic cough is the main or only clinical manifestation, which is mostly irritating cough. It is a special form of asthma, called “cough variant asthma”. Its case physiological changes, like asthma, are also persistent airway inflammation and airway hyperresponsiveness. A.7 Refractory asthma has a broad meaning, which is characterized by clinically uncontrollable chronic symptoms, paroxysmal aggravation, persistent variable airway obstruction. Currently, refractory asthma is divided into three types. acute severe asthma (mainly including severe asthma and fatal asthma), unstable asthma (mainly including fragile asthma and nocturnal asthma), chronic persistent asthma (mainly including glucocorticoid-dependent asthma and glucocorticoid-resistant asthma). A.8 For those personnel that is exposed to occupational allergens, if the non- specific airway responsiveness test is characterized by airway hyperresponsiveness, with frequent episodes of rhinitis, nasal itching, runny sputum, continuous sneezing and other symptoms, it shall make close observation according to GBZ 188, to track the likelihood of occupational asthma. A.9 Diagnosis of this disease shall exclude the history of bronchial asthma which exists before work, meanwhile identify it together with upper respiratory tract infection, chronic obstructive pulmonary disease, cardiogenic asthma, exogenous allergic alveolitis and other diseases. A.10 Diagnostic naming of occupational asthma and its writing format Standardizing the naming format for diagnosis of occupational asthma is conducive to accumulating clinical data, determining the treatment effect, and is more conducive to comprehensive assessment of the illness status in the identification of disability grading of occupational disease. The standardizing principle of naming is, after diagnosis, indicating the grading of the severity of illness status, wherein the XX refers to the name of the exposed allergen. Its Appendix B (Normative) Non-specific bronchial provocation test (Determination of responsiveness after airway inhalation of acetylcholine/histamine) Histamine is the main inflammatory medium of asthma, which can stimulate contraction of bronchial smooth muscle, increase the permeability of microvascular. Acetylcholine is a synthetic derivative of acetylcholine in the neural medium, which can be combined with the cholinergic receptor on the bronchial smooth muscle, to stimulate the contraction of smooth muscle. The degree of response of the smooth muscle for the same dose of the two reagents is consistent; however, in some cases, it is not exactly the same. The response of patients of mild chronic obstructive pulmonary disease to histamine is stronger than acetylcholine; the response of the patients of bronchial asthma is same to both. In the use of larger doses, the side effects of acetylcholine is smaller than that of histamine. B.1 Adaptation disease B.1.1 Diagnosis to exclude or determine asthma. for patients with existing asthma symptoms, where the regular lung function is normal or close to normal, meanwhile the presence of asthma cannot be determined by other methods, if the result of this test is negative, the asthma can be ruled out. For other patients who have atypical symptoms, are mainly featured by cough or chest tightness, but the conventional lung function is normal, if the result of this test is positive, after ruling out the causes which may cause similar symptoms, it can be confirmed as the cough variant asthma. B.1.2 Differential diagnosis for asthma. The increased airway responsiveness is a more reliable indicator for diagnosis of asthma. Because the airway of patients of asthma is several or even dozens of times more responsive to certain drugs or irritants than normal personnel or patients who suffered from other lung and bronchial diseases, the results are more reliable. B.1.3 It can be used for epidemiological investigation of asthma and study of the pathogenesis of asthma. B.1.4 Evaluate the efficacy of asthma drugs. B.2 Conditions and requirements of subject B.2.1 The symptoms have been relieved during the test and there is no wheezing sound in the hearing. a power source, the pressure of compressed gas is 3.5 kg/cm2, the flow rate is 5 L/min, the nebulizer is loaded with 3 mL of saline, histamine or acetylcholine saline solution. b) Concentration of histamine (His) or acetylcholine (Mch). It can be prepared to the solution of the following concentration (mg/ml) to prepare for use. 0.03, 0.06, 0.125, 0.25, 0.50, 1.00, 2.00, 4.00, 8.00, 16.00, 32.00, in double increments. c) Determination steps. 1) The subjects rest for 15 min, take the sitting position, clamp the nose, determine FEV1 for 2 times, take the higher value as the base value. 2) First inhale saline; wear a hole mask or mouth-piece which is connected to the nebulizer; turn on the gas source to start atomization, the nebulizer must be upright, otherwise it will affect the amount of atomization. Use the natural frequency to conduct tidal breathing for 2 min; stop breathing, afterwards make FEV1 once at 30 s and 60 s, respectively. If the maximum value of FEV1 reduces 10% or more as compared with the base value of FEV1, the concentration of inhaled drugs shall start from low dose of 0.03 mg/min and cannot be simplified. The determination time of all FEV1 shall be completed within 3 min. 3) Inhalation of drugs. the method is same as above, starting from the low dose, in double increments. Determine the FEV1 once at 30 s and 60 s, respectively after each inhalation. Take the higher value. The interval of starting inhalation of adjacent two doses is 5 min, until the FEV1 drop value is ≥ 20% of the base value of FEV1 or the inhalation of the highest concentration. 4) At the end of the test, inhale the β2-receptor agonist for two sprays. 5) Calculation of test results. The threshold of high responsiveness of airway is expressed in PC20FEV1 or PD20FEV1, abbreviated as PC20 and PD20, wherein PC20 is the drug excitation concentration when the drop value of FEV1 is equal to the 20% of the base value of FEV1; PD20 is the cumulative dose of the drug excitation when the drop value of FEV1 is equal to 20% of the base value of FEV1. PC20 = Cologarithm [logC1 + (logC2 - logC1) (20 - R1) / (R2 - R1)] C2 = The last drug concentration inhaled C1 = The penultimate drug concentration. equivalent products have the same effect, it can use these equivalent products. the startup of instrument. First inhale the saline. Afterwards after inhaling the atomization agent of each concentration for 1 min, automatically turn to the next dose, meanwhile automatically draw the response curve of dose. After inhaling the saline, the determined Rrs is the control value. The cumulative dose of inhaled drugs when the Rrs after inhaling drug increases 2 times higher than the control value is defined as the threshold of high responsiveness of airway, which represents the sensitivity of airway’s reaction. The rising slope of curve represents the responsiveness. In addition, it may also use the airway conductivity (Grs) as an indicator of airway responsiveness, Grs = 1/Rrs. It can draw the Grs curve on the coordinate graph of the dose response curve. For the Grs, the inflection point at the startup of drop of the horizontal line which represents the control value is D minutes, which is the threshold of high responsiveness of the airway, represents the minimum dose of acetylcholine when this threshold is reached, indicates the sensitivity of the airway’s reaction; the descending slope SGrs of the Grs represents the responsiveness, SGrs = ΔGrs / Δt, wherein t is the time. The unit of calculation of dose is as below. in case of tidal breathing, the inhalation of atomization solution of 1 mg/mL concentration for 1 min is equal to 1 U. For normal person, in case of inhalation of the solution of the above range of concentration, even it reaches the highest concentration, it will not result in reaction, which can be distinguished from the high airway responsiveness. B.4 Precautions B.4.1 Although the excitation test of histamine and acetylcholine is relatively safe, there is still a potential danger. The concentration of allergens inhaled shall not be too high, so as not to produce stimulating reaction. At the same time, it shall master the indications and contraindications, operate strictly in accordance with the operating norms. The technicians who implement operations must be familiar with the operating norms, meanwhile check the laboratory, where there must be equipped with bronchodilators, oxygen and other emergency drugs. B.4.2 The normal value and abnormal value of the drug test may overlap, so the test results shall not be treated too mechanically. If His PC20 or Mch PC20 is ≤ 4 mg, the reliability of the diagnosis is very high; if 4 mg < Mch PC20 ≤ 16 mg, there may be false positive or false negative in this range. The clinical manifestation of the patient can be referred to when making judgement, for example, the more clinical basis of asthma, even if the PC20 value is relatively larger, the higher the reliability of diagnosing asthma. B.4.3 In view of the need for certain equipment and technical conditions in this test, in the test process, an overreaction may occur in individual cases, so this test shall be carried out in a hospital with conditions. B.4.4 It should not provide hints before or during the test, the subject shall not puncture test, or the allergen infusion concentration of skin ridge (+) in the skin ridge test, or the 200 protein nitrogen units/mL, or the allergen concentration of 10-5 ~ 10-3 (W/V) can be used as a reference for the concentration of inhaled allergen, which is incremented by 10 times proportion based on this concentration, the time interval of inhalation is above 10 min. D.1.2.3 Before the test, determine the index of the lung function. The determination of FEV1 has been widely used in clinical practice and is the best reproducible index in lung function tests. Therefore, FEV1 is the most commonly-used index for assessing the specific bronchial provocation test. As the base value, the difference between the two results of FEV1 is not more than 5%; if a certain dilution is added into the allergen, before inhaling the allergen, it shall also perform the test after inhaling the dilution, as the control value, the change of which shall not exceed 10% of the base value. D.1.2.4 The time interval between observations shall not be longer than 15 min ~ 30 min within the first 1 hour after inhalation. In addition to closely observing the response within 2 h after inhalation of allergens, it shall also pay attention to the observation of delayed or bidirectional reactions which occur within 4 h ~ 6 h. Therefore, the total observation time shall reach to 24 h. D.1.3 Positive reaction criteria D.1.3.1 The result is judged not PC20 but PC15, that is, the concentration of allergen infusion (extraction) which causes a 15% drop in FEV1 is used to indicate the airway responsiveness. D.1.3.2 If there are obvious symptoms and signs after the stimulation, such as chest tightness, shortness of breath, cough, lung wheezing, etc., the upper value shall be relaxed, more than 10% can be judged as positive. D.1.4 Precautions. Same as B.4. D.2 Bronchial provocation test at work site D.2.1 Pre-test preparation and basic conditions. Same as B.2. D.2.2 Methods D.2.2.1 Within 1 hour after entering the work site, determine the ventilation function (FEV1) once every 15 minutes; after 1 h, determine the ventilation function once every 0.5 hour. According to the situation, it can stay at the site for 1 h ~ 2 h. D.2.2.2 After keeping away from exposure, determine the lung function once every 1 h, pay attention to record the clinical symptoms and signs. Make continuous observation for at least 8 h. It shall make determination again at 24 Appendix E (Normative) Testing of allergen-specific IgE antibody - Fluorescent enzyme immunoassay (FEIA) E.1 Principles The allergen is covalently bound to the solid phase carrier of ImmunoCAP, a three-dimensional poly-cellulose plate. Add the patient’s serum to cause specific binding of the antigen-antibody. After washing away the free IgE, add the enzyme-labeled anti-IgE antibody. After incubation, wash away the unbound enzyme-labeled anti-IgE, then incubate the ImmunoCAP together with the substrate. After the reaction is terminated, test the fluorescence intensity. The stronger the fluorescence intensity, the higher the content of specific IgE in the sample. Based on the World Health Organization (WHO)’s IgE reference 75/502, draw the standard curve. From the and the fluorescence intensity, it can derive the IgE concentration in the sample. E.2 Instruments Fully automatic in-vitro immunodiagnostic instrument ImmunoCAP 100/ImmunoCAP 2504. The instrument can automatically perform all steps of the testing analysis, meanwhile automatically print the results of the test after the analysis is completed. E.3 Reagents E.3.1 Dedicated testing reagents Total IgE, specific IgE (about 600 species of allergens in more than 10 categories such as pollen, dust mites, food, microorganisms); E.3.2 Dedicated system reagents Enzyme, calibration solution, curve control solution, CAP for calibration, etc.; E.3.3 General system reagents Substrate solution (development solution), stop buffer, wash solution, etc. 4 Note. Fully-automatic in-vitro immunodiagnostic instrument ImmunoCAP 100/ImmunoCAP 250 is the trade name of the product supplied by the supplier. This information is given to facilitate users of this standard and does not imply recognition of the product. If other equivalent products have the same effect, it can use these equivalent products. Appendix F (Normative) Testing of allergen-specific IgE antibody - Enzyme-linked immunosorbent assay (ELISA) F.1 Principles The known specific antigen is first immobilized on the surface of the solid-phase carrier, to form a fixed-phase antigen. Add the sample to be tested, then add the enzyme-labeled antibody, to form an antigen-tested antibody-labeled antibody complex on the solid-phase carrier. After adding the enzyme substrate and the chromogen, it develops color and the degree of coloration is expressed by the absorbance (A), the measured A value is correlated with the level of the allergen to be tested. F.2 Equipment Porous polystyrene plate (the commonly-used plate is 96-hole plate, 12 × 8 holes), micro-pipette, enzyme-labeled immunoassay instrument, pH test paper, incubator, refrigerator, washing bottle, wet box, commonly-used glass instruments, etc. F.3 Reagents Currently, various ELISA tests have commercial dedicated kits, including the coated goat anti-human IgE reaction plate, series of standard substances (0 U/mL, 10 U/mL, 100 U/mL, 500 U/mL) and quality control serum; enzyme (HRP) labeled anti-human IgE monoclonal antibody; buffer solution, stop buffer, etc. F.3.1 Enzyme dedicated for labeling. The horse-radish peroxidase (HRP) is most commonly-used to label various antibodies. F.3.2 Commonly-used enzyme substrates and chromogens. The substrate of HRP is H2O2 (or hydrogen peroxide), which requires hydrogen donors to participate in the catalysis. The latter are mostly reducing dyes. Through reaction, it produces dark or fluorescent oxidizing dyes. There are many chromogens (hydrogen donors) available for HRP. The commonly-used chromogens are o-phenylenediamine (OPD), 3,3',5,5'-tetramethylbenzidine (TMB), tetramethylbenzidine sulfate (TMBS), etc. H2O2 (or hydrogen peroxide) and chromogen are often mixed prior to testing. F.3.3 Coating buffer (pH 9.6 carbonate buffer solution). Add distilled water into 0.16 g of Na2CO3 and 0.29 g of NaHCO3 to dissolve it, add water to 100 mL, Appendix G (Normative) Specific-allergen skin test G.1 Intracutaneous test G.1.1 Selection of skin test solution G.1.1.1 Test solution of allergen skin It shall select the standardized skin test solution. G.1.1.2 Control solution and purpose for skin test In order to obtain an accurate skin test result, when performing the skin test, it shall establish the positive and negative controls at the same time. The positive control solution uses the histamine dihydrochloride at a concentration of 0.017 mg/mL or the histamine diphosphate at a concentration of 0.028 mg/mL, which is equivalent to a 0.01 mg/mL histamine substrate. The purpose of using a positive control solution. 1) Judge the positive degree of the allergen skin test. Use the papule which is caused by the positive control solution as the standard “scale” to judge the positive degree of the allergen skin test; 2) Determine the intensity of the skin responsiveness of the skin tester. Due to different age, physical condition and geographical area, the skin responsiveness is not always the same. For example, the skin responsiveness of the elderly is poor, the responsiveness of the positive control is also weak. 3) Observe the inhibitory effect of the drug. When the positive control solution presents negative reaction, it indicates that the skin test result is likely to be inhibited by certain drugs, such as antihistamines, thus the skin test result is invalid. Only when the positive control solution presents positive reaction, it indicates that the skin test is not affected by drug inhibition or other factors, thus the skin test result is valid. The negative control solution is usually selected from physiological saline or allergen diluted preservation solution. The negative control solution presents negative reaction. If the patient is highly sensitive, it is possible to have a false positive reaction. At this time, the positive reaction of skin test as produced by the allergen is not clinically significant. ......

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