GB 15987-1995 Diagnostic criteria and management principles for infectious pulmonary tuberculosis
Some standard content:
National Standard of the People's Republic of China
Diagnostic criteria and principles of managementof infectious pulmonary tuberculosis1 Subject content and scope of application
This standard specifies the diagnostic criteria and management principles of infectious pulmonary tuberculosis. GB15987--1995
This standard applies to the clinical and laboratory diagnosis of infectious pulmonary tuberculosis in health and epidemic prevention and medical care institutions at all levels. 2 Confirmation
Tuberculosis is a chronic infectious disease caused by Mycobacterium tuberculosis, which can affect all organs of the body, especially pulmonary tuberculosis. Pulmonary tuberculosis patients who excrete bacteria in sputum are infectious pulmonary tuberculosis, which is the source of infection for the spread and prevalence of tuberculosis in society and is the primary control target. 2.1 Two sputum specimens are positive for acid-fast bacilli or isolated and cultured mycobacteria. 2.2 Chest X-ray shows signs of pulmonary tuberculosis. 3 Treatment principles
3.1 Patients with infectious pulmonary tuberculosis produce micro-droplets containing tuberculosis bacilli when coughing, sneezing, talking loudly, etc., which can float indoors with air currents and cause the spread of tuberculosis. Patients should be discouraged from coughing or sneezing at people, and should cover their mouths and noses with handkerchiefs, masks, etc. when coughing, and should not spit anywhere. Sputum can be sterilized by burning, boiling, or chemical drugs. In addition, strengthening indoor air circulation, sunlight and ultraviolet radiation, and using anti-tuberculosis drugs to treat patients can effectively reduce and prevent the spread of tuberculosis. 3.2 Close contacts of patients with infectious pulmonary tuberculosis (especially children) should be examined, including tuberculin tests and chest X-ray examinations. According to different situations, corresponding prevention and control measures such as BCG vaccination, preventive treatment, and follow-up should be adopted. 3.3 Treatment
3.3.1 Principles
3.3.1.1 Early stage: Newly diagnosed patients with positive sputum must be treated in time, and patients with re-treatment who are excreting sputum should also be treated early. 3.3.1.2 Combination: Two or more anti-tuberculosis drugs must be used in combination to treat tuberculosis to ensure efficacy and prevent the development of drug resistance. 3.3.1.3 Appropriate dosage: Appropriate therapeutic dose can avoid the side effects caused by excessive doses and the disadvantages of drug resistance caused by insufficient doses to ensure efficacy.
3.3.1.4 Regularity: Regular and timely medication within the prescribed course of treatment is the most important key to the success of chemotherapy. The medication should be taken strictly in accordance with the number of doses and intervals (such as daily or every other day) specified in the chemotherapy regimen to avoid omissions or interruptions. 3.3.1.5 Full course: Completing the full course of medication according to the prescribed course of treatment is a prerequisite for ensuring efficacy. Interruption of treatment before the full course of treatment will lead to treatment failure and increase the recurrence rate.
4 Cure judgment
According to the prescribed chemotherapy regimen, the prescribed course of treatment is completed, and the sputum bacteria test turns negative (the sputum bacteria are negative for two consecutive months in the last two months of the course of treatment) for cure. Approved by the State Administration of Technical Supervision on December 15, 1995 and implemented on July 1, 1996
5 Follow-up
GB15987-1995
5.1 Patients who use effective chemotherapy and take medication regularly for a full course of treatment and the sputum bacteria turn negative do not need to be followed up regularly. Patients can be asked to come to the follow-up clinic if they have respiratory symptoms.
If the sputum bacteria turn negative, but it is not certain whether the patient takes medication regularly, follow-up can be conducted for 1 to 2 years. 5. 2
A1 Patients with first-time infectious pulmonary tuberculosis
GB15987—1995
Appendix A
Treatment plan
(Supplement)
A six-month short-term plan based on the combination of isoniazid, rifampicin and pyrazinamide is adopted. A1.1 Intensive period: streptomycin (or ethambutol), isoniazid, rifampicin and pyrazinamide once a day for two months; continuation period: isoniazid and rifampicin once a day for four months. A1.2 Intensive period: streptomycin (or ethambutol), isoniazid, rifampicin and pyrazinamide once a day for two months; continuation period: isoniazid and rifampicin three times a week for four months. A1.3 Intensive period: streptomycin (or ethambutol), isoniazid, rifampicin and pyrazinamide are taken every other day for two months; continuation period: isoniazid and rifampicin are taken every other day for four months. A2 Patients with retreated infectious pulmonary tuberculosis
A2.1 Patients with retreated infectious pulmonary tuberculosis or relapsed patients who failed treatment due to irregular initial treatment can adopt the 1.1 plan in the initial treatment plan for infectious pulmonary tuberculosis, adopt supervised chemotherapy, and ensure regular medication. If the sputum bacteria have not turned negative at the end of the 6-month course of treatment, the continuation period can be extended for two months.
A2.2 Patients with retreated treatment who failed regular initial treatment can adopt an eight-month chemotherapy plan. Intensive period: streptomycin, isoniazid, rifampicin, pyrazinamide, ethambutol, two months; continuation period: isoniazid, rifampicin, ethambutol, six months. A2.3 Chronic excretion patients (chronic infectious sources) can choose at least three main and backup anti-tuberculosis drugs that are still sensitive according to the tuberculosis drug sensitivity test, and the course of treatment is preferably 8~~10 months. A3 Main anti-tuberculosis drugs and dosage
Daily therapeutic dose
Isoniazid
Rifampicin
Pyrazinamide
Streptomycin
Ethambutol
Terminology
0. 45 ~~0. 6
5～10
20～30
Initial treatment: Anyone who falls into any of the following conditions is considered as initial treatment. A4.1
Intermittent therapy for adults
1. 5~2. 5
1. 0~1. 5
Main side effects
Peripheral neuritis, abnormal liver function
Allergic reaction, gastrointestinal reaction, abnormal liver functionJoint pain, gastrointestinal reaction, abnormal liver function
Hearing impairment, dizziness, allergic reaction
Optic neuritis
GB15987—1995
A4.1.1Newly discovered or known patients who have not started anti-tuberculosis treatment at the time of registration; A4.1.2Patients who have not completed the course of regular medication with the initial treatment regimen; A4.1.3Patients who have not received irregular chemotherapy for less than one month. A4.2Re-treatment: Any of the following conditions is considered retreatment. A4.2.1 Patients who have failed initial treatment;
A4.2.2 Patients whose sputum bacteria have re-tested positive after a full course of regular medication; A4.2.3 Patients who have undergone irregular chemotherapy for more than one month; A4.2.4 Patients who have lost or recovered smear-positive patients.
A4.3 Chronic excretors (chronic infectious sources) Patients who have been treated many times and have repeatedly used the above-mentioned main anti-tuberculosis drugs but whose sputum bacteria remain positive for more than two years. Appendix B
Sputum tuberculosis examination method
(Supplement)
Sputum tuberculosis examination should be conducted in a biosafety workbench or in a hood equipped with a filter device to exhaust to the outside. B1 Smear examination method
B1.1 Direct smear method
Sputum specimen: Collect about 3 to 5 mL of deep cough sputum specimen in a wide-mouth container. Use a broken bamboo stick or other object to pick up 0.1 mL of purulent sputum. Place it in the center of the slide and evenly smear it into an oval sputum film of 2cm×2.5cm, as shown in Figure B1. 2. 5cm -
After natural drying, stain and examine under a microscope.
The smear must be made with a clean, scratch-free new slide. One slide is used to smear one specimen, and the slide is used only once. B1.2 Sputum smear method for collecting bacteria
For sputum specimens, keep 5~10L of deep cough sputum specimens or 12~24h sputum specimens, and place them in a sterilized glass container (about 120mL). If the sputum volume is small and viscous, add an appropriate amount of distilled water (no more than 10mL), sterilize it in a high-pressure steam sterilizer at 0.105MPa for 20~25min, and cool it for collection of bacteria smears.
B1.2.1 Centrifugal bacteria smear method: Take 5-10mL (no more than 10mL) of the above-treated sputum into a 50mL centrifuge tube, add distilled water to 50mL, centrifuge at 3000r/min (1750g centrifugal force) for 30min, discard the supernatant, take the sediment for smear, dry naturally, and then stain for microscopic examination.
B1.2.2 Floating bacteria smear method: Take 5-10mL of the above-treated sputum into a 120mL glass bottle, add 20-30mL of distilled water (the total amount does not exceed one-third of the bottle volume), add 0.3mL of xylene, and oscillate on an oscillator for 10min (oscillator speed 240 times/min), take it out and put it flat on the table, add distilled water to fill the bottle mouth, let it stand for 10-15min, and cover the bottle mouth with a labeled slide. Let it stand for 15-20min, take out the slide and put it flat on the table, dry naturally, and then stain for microscopic examination. B1.3 Staining method
B1.3.1 Acid-fast staining method (Ziehl-Neelsen method) 310
B1.3.1.1 Preparation of stain
GB15987-1995
B1.3.1.1.1 Staining agent: Take 8g of alkaline fuchsin, dissolve it in 100ml of 95% alcohol, add 900ml of 5% carbolic acid, let it stand for 24h, then filter it for use.
B1.3.1.1.2 Decolorizing agent: 5% hydrochloric acid alcohol. B1.3.1.1.3 Counterstaining agent: Take 0.15g of methylene blue and dissolve it in 50ml of 95% alcohol. Add distilled water to 1000ml. B1.3.1.2 Staining steps
B1.3.1.2.1 Fix the sputum smear with flame and place it flat on the staining rack. B1.3.1.2.2 Add staining agent to cover the sputum film, heat it with low heat until the dye liquid shows steam, remove the flame, stain for 5~10min (do not let the dye liquid dry out), and wash with water.
B1.3.1.2.3 Add decolorizing agent to cover the sputum film, decolorize for 3~5min until there is no red color, and wash with water. B1.3.1.2.4 Add counterstain to cover the sputum film, directly smear and counterstain for 30 seconds, collect bacteria smear and counterstain for 1 to 3 minutes, wash with water, dry, and examine under a microscope. Sputum smear staining quality requirements: after smear staining, the sputum film is light blue or blue when observed with the naked eye, and there should be no red plaques, and the sputum film detachment is less than 10%. Under the microscope, the field of view and background are clear. In the field of view of the 100× objective lens on a light blue background, acid-fast bacteria appear as red rods, and other bacteria and cells appear blue.
B1.3.1.3 Microscopic examination and report
The report standard for the results seen under the microscope (eyepiece 10×, oil objective 100×) is as follows: B1.3.1.3.1 Count 100 fields of view under the microscope (observation time is not less than 4 minutes). If no acid-fast bacteria are found, continue to observe until 300 fields of view. If no acid-fast bacteria are found, report acid-fast bacteria negative (I). B1.3.1.3.2 If 1 to 2 acid-fast bacilli are found in 100 to 300 visual fields under microscopic examination, the patient shall be reported as suspected acid-fast bacilli (soil), or a new smear shall be made or another sputum sample shall be kept for reexamination.
B1.3.1.3.3 If 3 to 9 acid-fast bacilli are found in 100 visual fields under microscopic examination, the patient shall be reported as positive for acid-fast bacilli (1+). B1.3.1.3.4 If 1 to 9 acid-fast bacilli are found in 10 visual fields under microscopic examination, the patient shall be reported as positive for acid-fast bacilli (2+). B1.3.1.3.5 If 1 to 9 acid-fast bacilli are found in each visual field under microscopic examination, the patient shall be reported as positive for acid-fast bacilli (3+). B1.3.1.3.6 If more than 9 acid-fast bacilli are found in each visual field under microscopic examination, the patient shall be reported as positive for acid-fast bacilli (4+). The nature and quality of the sputum sample should be included in the sputum smear examination report. B1.3.1.4 Quality control requirements
To ensure the quality of sputum smear examination, a quality control system for indoor and inter-laboratory sputum smear examination should be established and improved. Indoor quality control should include sputum specimen collection, smear, staining standards and microscopic examination result review. Indoor quality control should be carried out daily and quality control charts should be drawn. Sputum smears are preserved for quality control inspection by the upper-level laboratory.
Inter-laboratory quality control is carried out regularly by the upper-level laboratory. The quality requirements for sputum smear microscopic examination results are that the sputum smear negative compliance rate is above 95%, the smear positive compliance rate is above 98%, and the total compliance rate is above 96.5%. False negatives are not allowed for positive sputum slices above "1+". B1.3.2 Fluorescein staining method (Auramine O method) B1.3.2.1 Preparation of dye
B1.3.2.1.1 Dye: Dissolve 0.01g of auramine in 10mL of 95% alcohol. Add 5% carbolic acid to 100mL. B1.3.2.1.2 Decolorizing agent: 3% hydrochloric acid alcohol. B1.3.2.1.3 Counterstain: 0.5% potassium permanganate aqueous solution. B1.3.2.2 Staining steps
B1.3.2.2.1 Flame fix the sputum smear and place it flat on the staining rack. B1.3.2.2.2 Add stain to cover the sputum film, stain for 10-15 minutes, and wash with water. B1.3.2.2.3 Add decolorizing agent to cover the sputum film, decolorize for 3-5 minutes until there is no yellow color, and wash with water. B1.3.2.2.4 Add counterstain to cover the sputum film, stain for 2 minutes, and wash with water. After drying, examine under a microscope. B1.3.2.3 Microscopic examination and report
GB 15987-1995
Acid-fast bacilli show yellow-green or silver-white fluorescence against a dark background. Fluorescence microscope examination, 20× objective lens for counting, 40× objective lens for observing the morphology of acid-fast bacilli, and 40× objective lens for counting. The bacterial morphology is clear and the judgment is accurate.
The examination should be completed within 24 hours after fluorescent staining. If it needs to be kept overnight, the sputum smear should be stored in a dark place and the examination should be completed the next day. The results of fluorescence microscope 20× objective lens microscopy should be reported according to the following standards: B1.3.2.3.130 No acid-fast bacilli are found in the field of view, and the acid-fast bacilli are reported as negative (-). B1.3.2.3.230 19 acid-fast bacilli are found in the field of view, and the number of acid-fast bacilli is reported. The results of re-staining or smear re-examination should be reported by the acid-fast staining method (see B1.3.1).
B1.3.2.3.330 10 to 100 acid-fast bacilli are found in the field of view, and the acid-fast bacilli are reported as positive (1+). B1.3.2.3.4 If an average of 1 to 10 acid-fast bacilli are found in each field of view, the test is reported as positive (2+). B1.3.2.3.5 If an average of 11 to 200 acid-fast bacilli are found in each field of view, the test is reported as positive (3+). B1.3.2.3.6 If an average of more than 200 acid-fast bacilli are found in each field of view, the test is reported as positive (4+). B2 Mycobacterium Culture Method
B2.1 Culture Medium
B2.1.1 Modified Roche Medium
Ingredients:
Monosodium glutamate (more than 95%)
Potassium dihydrogen phosphate
Magnesium sulfate
Magnesium citrate
Distilled water
Potato starch
Whole egg liquidwww.bzxz.net
2% malachite green
1000mL
Preparation method: After the salt components are dissolved, add potato starch and mix well. Boil in a boiling water pot for 30-40 minutes (shake from time to time to prevent clotting) until it becomes a paste. After cooling, add 1000mL of fresh whole egg liquid filtered through sterile gauze and mix. Add 20mL of 2% malachite green, mix well, and dispense into test tubes (18mm×180mm). Add 7mL of culture medium to each test tube. The height of the culture medium slope should be two-thirds of the bottom of the test tube. Put it in the serum coagulator for coagulation. When the temperature in the coagulator reaches 90℃, put the sub-test tubes in, preferably in two layers. When the temperature in the coagulator reaches 85-90℃, start the timer, take it out after coagulation for 1-1.5h, let it cool, put it in a 4℃ refrigerator for standby after the sterility test, and use it within one month. The prepared culture medium has bright color, smooth and moist surface, certain toughness and acid-base buffering capacity. B2.1.2 Sodium pyruvate culture medium
The ingredients are the same as the modified Roche culture medium, remove glycerol, add 1.6g of sodium pyruvate, adjust pH7.2 with 10% sodium hydroxide, add 4g of glucose, and the rest is the same as the modified Roche culture medium preparation method.
B2.1.3 Acidic Roche culture medium
The ingredients are the same as the modified Roche culture medium, increase the potassium dihydrogen phosphate to 14g, and the rest is the same as the modified Roche culture medium preparation method. B2.1.43% Ogawa medium
Ingredients:
Potassium dihydrogen phosphate
Sodium glutamate
Distilled water
Whole egg liquid
2% malachite green
100 mL
Preparation method, same as modified Roche medium. Egg disinfection method:
GB159871995
Fresh eggs are washed with tap water, scrubbed with soapy water, and wiped with 75% alcohol for disinfection after drying. Pour the egg liquid into a sterilized graduated sugar porcelain cup under aseptic operation, filter it into the culture medium with sterilized gauze, add 2% malachite green, mix well, dispense and solidify. B2.2 Pretreatment method
B2.2.1 Alkali treatment method (for acidic Roche culture medium and 3% Ogawa culture medium) B2.2.1.12% sodium hydroxide, take 2g sodium hydroxide, dissolve in 80ml, add water to 100ml after it is completely dissolved in distilled water. B2.2.1.2 Treatment method, take 1mL of sputum specimen and add 2~~4ml of 2% sodium hydroxide, incubate at room temperature for 30min, shake 2~3 times during this period to promote sputum liquefaction.
B2.2.2 Acid treatment method (for improved Roche culture medium and sodium pyruvate culture medium) B2.2.2.12% sulfuric acid solution, take 2mL of concentrated sulfuric acid and slowly add it to 90ml of distilled water, add water to 100ml. B2.2.2.2 Treatment method, take 1mL of sputum specimen and add 2~~4ml of 2% sulfuric acid, incubate at room temperature for 30min, shake (or use a sputum crusher to break up the sputum) 2~3 times during this period to promote sputum liquefaction.
B2.3 Inoculation method
Mix the sputum after digestion and take 0.1mL with a sterile capillary pipette. Slowly and evenly inoculate on the slope of each culture medium. Inoculate two culture media for each sputum specimen. After inoculation, place in a 37℃ incubator for culture. B2.4 Results and Reports
After inoculation, bacterial growth should be observed weekly. Positive growth should be reported at any time after verification by smear staining. If no bacterial growth is observed after 8 weeks of culture, the mycobacterial culture should be reported as negative (if species identification is required, bacterial growth should be observed 3 days and 7 days after inoculation, and then observed weekly until 8 weeks).
Culture results should be reported according to the following standards:
If no colony growth is observed after 8 weeks of culture, the mycobacterial culture should be reported as negative (一). If less than 20 colonies grow on the slant of the culture medium, the mycobacterial positive and colony count should be reported. If the colonies on the slant of the culture medium grow dispersedly and occupy less than 1/4 of the slant, the mycobacterial positive should be reported (1+). If the colonies on the slant of the culture medium grow dispersedly and occupy less than 1/2 of the slant, the mycobacterial culture should be reported as positive (2+). If the colonies on the slant of the culture medium grow densely or partially fused and occupy less than 3/4 of the slant, the mycobacterial positive should be reported (3→). If the colonies on the slant of the culture medium grow densely and are distributed like bacterial mosses, and occupy the entire slant, all are reported as mycobacterium positive (4+). B2.5 Report on culture medium contamination
When observing the growth of mycobacteria, if non-mycobacterial growth is found, report the growth of contaminating bacteria. When the contamination rate is higher than 5%, it indicates that the sterilization treatment during the preparation of the culture medium or the digestion liquid treatment is poor, and the operation procedures should be carefully checked. The degree of contamination is reported according to the following standards:
B2.5.1 If the growth of contaminating bacteria occupies less than 1/4 of the slant of the culture medium, report (C1+). B2.5.2 If the growth of contaminating bacteria occupies less than 1/2 of the slant of the culture medium, report (C2+). B2.5.3 If the growth of contaminating bacteria occupies less than 3/4 of the slant of the culture medium, report (C3+). B2.5.4 If the growth of contaminating bacteria occupies the entire slant of the culture medium, report (C4+). B2.5.5 If the culture medium liquefies, report (IQ). 313
GB15987—1995
Appendix C
Diagnosis of Negative Active Pulmonary Tuberculosis
(Reference)
Sputum specimen smear microscopy acid-fast bacilli examination or isolation culture method examination is negative for more than two times. ct
Chest X-ray shows signs of active pulmonary tuberculosis. With symptoms such as cough, sputum, fatigue, chest tightness and shortness of breath, chest pain, low-grade fever, loss of appetite, bloody sputum or hemoptysis, weight loss, menstrual disorders, etc. Five units of tuberculin (OT or PPD-T) are injected intradermally for 72 hours, and the diameter of the local induration reaction is ≥5mm. Pulmonary pathological specimens (surgery, fiberoptic bronchoscopy, lung puncture, etc.) are pathologically diagnosed as tuberculosis lesions. With a. C1, C2, or with one of C3 to C4 at the same time. b. C1 and C5.
Can be diagnosed.
Additional Notes:
This standard was proposed by the Ministry of Health of the People's Republic of China. This standard was drafted by the Beijing Tuberculosis and Chest Tumor Research Institute. The main drafters of this standard were Li Zhengmin, Zhu Wenhu, and Pan Yuxuan. This standard was interpreted by the Ministry of Health's technical coordination unit, the Ministry of Health's Infectious Disease Supervision and Management Office. 314
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