WS 291-2008Diagnosis for leprosy (English PDF)
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Issued by
National Health Commission
Level / Type
National · Mandatory
Issue date
March 6, 2018
Implementation date
August 1, 2018
Scope
WS 291-2008 (Diagnosis for leprosy) is available as an English-translated PDF.
WS 291-2008 — This standard specifies the diagnostic basis, diagnostic principles, diagnosis and differential diagnosis of leprosy. This standard applies to the diagnosis of leprosy in various types of medical and health institutions and their medical staff at all levels.
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Document preview — WS 291-2008
National Standard of the People's Republic of China
- ICS
- 11.020
- Classification
- C 59
- Replacing
- WS 291-2008
Issued by: National Health Commission
Contents
- Foreword
- 1 Scope
- 2 Terms and definitions
- 3 Diagnosis basis
- 3.1 New patient diagnosis basis
- 3.2 Diagnosis of leprosy patients
- 3.3 Diagnosis basis for relapsed patients
- 4 Diagnostic principles
- 5 Diagnosis
- 5.1 New patient diagnosis criteria
- 5.2 Diagnostic criteria for leprosy response
- 5.3 Diagnostic criteria for patients with recurrence
- 6 Differential diagnosis
Foreword
Chapter 5 of this standard is mandatory and the rest are recommended.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces WS 291-2008 "Diagnostic Standards for Leprosy".
Compared with WS 291-2008, the main technical changes of this standard are as follows.
- Revised the Diagnostic Basis section (see Chapter 3, Chapter 3 of the 2008 edition);
- Removed the original damage biopsy histological examination clause (see 3.1.3.2 of the 2008 edition);
- increased the histological examination of skin damage (see 3.2.2);
- Added diagnostic criteria for leprosy response (see 5.2);
- Deleted the MDT program and treatment (see Table D.2 of the 2008 edition);
- Revised the clinical cure (clinical inactivity) standard section (see F.2);
- Increased the method of inoculation of M. vaginalis by mouse footpad (see Appendix G).
This standard was drafted. China Center for Disease Control and Prevention, Leprosy Control Center, Guangdong Provincial Center for Dermatology and Venereology, Jiangsu Province Prevention and Control Center, Shanghai Dermatology Hospital.
1 Scope
This standard specifies the diagnostic basis, diagnostic principles, diagnosis and differential diagnosis of leprosy.
This standard applies to the diagnosis of leprosy in various types of medical and health institutions and their medical staff at all levels.
2 Terms and definitions
The following terms and definitions apply to this document.
Mycobacterium leprosy mycobacterium leprae; ML Leprosy Intracellular parasites, positive for acid-fast staining, arranged in bundles or clustered, have special properties for Schwann cells and reticuloendothelial cells Affinity.
Acid-fast bacillus anti-fast bacillus; AFB when dyeing by Ziehl-Neelsen method, the bacteria can be red-dyed red by carbolic acid, and can not be acidized under the specified conditions after coloring.
Decolorized bacilli. Acid-fast bacilli include M. leprae, Mycobacterium tuberculosis and some other mycobacteria.
Bacterial morphology index the sum of the complete bacteria of each part (coating film) divided by the sum of the whole bacteria and non-intact bacteria of each part (coating film), generally as a percentage table Show.
Bacterial density index when the skin tissue fluid smear is examined, the sum of the density of the leprosy bacteria of each of the bacteria-detecting parts (coating film) and the spot of the investigation (coating film) the ratio of the totals (the result is one digit after the decimal point).
Leprosy endemic area in the county (district), there are areas where there are new leprosy patients in the local resident population within 3 years.
Leprosy nodular erythema nodosum leprosum; ENL an acute or subacute hypersensitivity reaction of the body to ML antigen in patients with leprosy during chronic disease is the main cause of leprosy type II response to be expressed, belongs to the antigen-antibody complex type hypersensitivity reaction with complement involvement.
Leproy reaction
In patients with leprosy, the original skin lesions suddenly appear red, swollen or new skin lesions, or severe peripheral nerve swelling Pain, new disability, called type I (reverse) reaction; or leprosy nodular erythema, iritis, lymphadenitis, orchitis or hair the case where some or all of the heat is expressed is called a type II reaction.
Early case patient at early stage Newly diagnosed cases with short duration (generally within 1 year) and no disability or irreversible nerve damage.
Advanced patient at advanced stage Newly diagnosed cases with long-term (more than 2 years) lesions with extensive or severe disability and/or nerve damage.
2.10
Relapsed patient
Complete the prescribed course of treatment, show normal efficacy, and clinical, bacterial or histopathology after clinical cure (clinical inactivity) Patients with evidence of disease reactivation.
3 Diagnosis basis
3.1 New patient diagnosis basis
3.1.1 History of epidemiology
3.1.1.1 Living in areas where leprosy is endemic, there has been close contact with untreated leprosy patients.
3.1.1.2 There are leprosy patients among relatives, neighbors or colleagues and have had close contact with them before they have been diagnosed.
3.1.2 Clinical manifestations
3.1.2.1 Clinical lesion performance
3.1.2.1.1 Skin damage is 1 to 5 pieces, with rash or plaque, dry surface, clear edges, numbness and sweating (see A.2.1 in Appendix A).
3.1.2.1.2 Skin damage is 6 or more, asymmetrically distributed, with rash or plaque, yellowish red, tan or reddish Star-shaped or immune area lesions. The surface of the skin lesion is dry or smooth, the edges are clear, and some skin lesions are numb and sweat.
3.1.2.1.3 Skin damage is frequent, widely distributed symmetrically, with a smooth surface and blurred edges. Light spots, invasive erythema, nodules, spots Block or diffuse infiltration. In the early cases, the skin lesions were normal or decreased, and the eyebrows were intact. In the advanced cases, the skin lesions disappeared and the eyebrows fell off.
3.1.2.2 Peripheral nerve damage performance
3.1.2.2.1 Single peripheral nerve trunks are large and hard, some patients are accompanied by eye, hand, foot or facial disfigurement (see A.2.2).
3.1.2.2.2 The peripheral nerve trunk is asymmetrical and coarse, the number is 2 or more, the texture is hard, and some patients are accompanied by nerve dryness or eyes, hands, Foot or facial disability.
3.1.2.2.3 Early no peripheral nerve trunk is thick. Late peripheral nerve trunks are mild or moderately symmetrical, soft, and the number is 2 or on, there are numbness and disability of the hands and feet.
3.1.3 Laboratory inspection
3.1.3.1 AFB is positive in one or more parts of routine skin examinations (see Appendix B).
3.1.3.2 Histological examination of skin lesions (see Appendix C).
a) Destruction of the epidermis basement membrane, leukocyte invasion into the epidermis, epithelioid cell granuloma in the dermis, and Lang Lang giant cells, granulomas Surrounded by dense lymphocytes, the nerve branches are destroyed and illegible. The granuloma is negative for acid-fast bacilli, and the S-100 protein is free.
Epidemtidal staining showed damaged nerve branches in the granuloma; cutaneous nerve examination showed intraneural inflammation or epithelioid cell granuloma.
b) There is a stenosis under the epidermis, "no infiltration zone", epithelial-like cell granuloma in the dermis, surrounded by sparse lymphocytes around the granuloma.
Langhan giant cells with little or no, granulomatous inner nerve branches are difficult to identify, granuloma is positive for acid-fast bacilli, bacterial density 1+~ 3+.
c) The epidermis is atrophied, and there is no obvious "no infiltration zone" under the epidermis. In the dermis, tissue cells and foam cell granuloma are seen, and lymphocytes are less or None, the nerve bundle membrane changes onion, and inflammatory cells infiltrate in the nerve branches. Acid-fast bacilli in granulomas and nerve branches Check positive, bacterial density is 4 or above.
3.1.4 Classification of leprosy
See Appendix D for the five-level classification of leprosy patients and the WHO combined chemotherapy classification.
3.2 Diagnosis of leprosy patients
3.2.1 Clinical manifestations
3.2.1.1 The patient's original skin lesions are suddenly red and swollen, and new skin lesions appear. In severe cases, blisters or shallow ulcers occur. The hands and feet are swollen. Skin lesion There is desquamation after it has subsided. Some patients have single or multiple peripheral nerve trunks swollen with varying degrees of pain or tenderness, or sudden claw-shaped hands, Distracted wrist, foot or facial paralysis.
3.2.1.2 Sudden erythema of sudden tenderness in the patient. In severe cases, there are blisters, pustules, bullae, necrosis, ulceration and crusting. a small number of patients There is erythema or necrotic erythema. Severe patients with fever, fatigue, anorexia, lymphadenitis, iridocyclitis, testes Some or all of the manifestations of inflammation, neuritis and arthritis.
3.2.2 Skin histology examination
3.2.2.1 The epidermis sees edema inside and outside the cell. Superficial dermal tissue edema, lymphatic vessel dilatation, vacuolization of epithelioid cell cytoplasm Sex, the distance between cells becomes larger, and fibrin-like degeneration occurs in collagen tissue. Severe cases of small focal necrosis.
3.2.2.2 Inflammatory foci of dermis and subcutaneous tissue, see full-thickness vasculitis of the arteries and veins. Intima and endothelial cells show significant swelling and lumen changes Fine and occluded. Infiltration of neutrophils, lymphocytes, eosinophils, etc. in various layers of the vessel wall and fibrin-like changes in the vessel wall Sex and red blood cell extravasation.
3.2.3 Classification of leprosy response and disability classification
See Appendix E for leprosy response classification and disability classification.
3.3 Diagnosis basis for relapsed patients
3.3.1 History of treatment
Complete anti-leprosy treatment (such as combination chemotherapy) for the prescribed course of treatment, showing normal efficacy, after clinical cure (clinical inactivity) There are also evidence of clinical, bacterial or histopathological disease reactivation.
The monitoring requirements and clinical cure (clinical inactivity) standards after completion of the prescribed course of treatment shall be carried out in accordance with the methods specified in Appendix F.
3.3.2 Clinical manifestations
New leprosy active skin lesions such as macules, papules, plaques, nodules and diffuse infiltration appear in the rash site or other areas.
But the skin lesions have no obvious tenderness and edema. Some patients have new peripheral nerve trunks, or new eye, hand, foot or facial disfigurement.
3.3.3 Laboratory inspection
3.3.3.1 Skin smear examination AFB, one of the following.
a) After the skin is turned over, the bacterial density of any part appears >= 2+;
b) After the skin is turned over, the re-appearance of any part or multiple sites is positive, and there are complete staining bacteria.
3.3.3.2 Histological examination of recurrent skin lesions, one of the following.
a) reproduce active pathological changes in active leprosy without significant tissue edema;
b) pathological tissue like tissue edema is not obvious, and any part of the skin is found to be >= 2+;
c) Pathological acid-fast staining, and complete staining bacteria.
3.3.3.3 The mouse footpad vaccination confirmed the presence of live bacteria (see Appendix G).
4 Diagnostic principles
According to epidemiological history, clinical manifestations, combined with laboratory tests (skin smear examination of AFB and tissue biopsy for leprosy-specific pathology) Make a comprehensive analysis to make a timely and accurate diagnosis.
5 Diagnosis
5.1 New patient diagnosis criteria
5.1.1 Suspected cases
Compliance with one of 3.1.2.1 or 3.1.2.2, with or without one of 3.1.1.
5.1.2 Clinical diagnosis cases
It also complies with one of 3.1.2.1 and one of 3.1.2.2, with or without one of 3.1.1.
5.1.3 Confirmed cases
Meets 5.1.1 or 5.1.2 and meets one of 3.1.3.
5.2 Diagnostic criteria for leprosy response
5.2.1 Clinical cases of leprosy reaction
Meet one or more of 3.2.1.
5.2.2 Confirmed cases of leprosy reaction
It also meets one or more of 3.2.1 and one or more of 3.2.2.
5.3 Diagnostic criteria for patients with recurrence
Meets 3.3.1, 3.3.2, and at the same time meets one of 3.3.3.
Clinically, the difference between recurrence and type I leprosy (reverse) response is given in Table E.2 in Appendix E.
6 Differential diagnosis
Clinically, there are many diseases that need to be identified with leprosy. Therefore, we should fully understand the clinical features of leprosy, master its diagnostic points and diagnosis.
Broken skills, combined with epidemiological history, laboratory findings and the need to identify the clinical features of the disease, through careful and comprehensive analysis can make a diagnosis of this disease. Skin diseases, neurological diseases, other diseases, and skin that need to be differentiated from leprosy can also be found in acid-fast bacilli See Appendix H for the disease.
Appendix A
(normative appendix) Clinical examination method A.1 Medical history inquiry and clinical damage examination Talk to the patient and their family to get a real history of leprosy. Mainly understand the exact name, age, address, Occupation, work unit and place of birth, whether it has been in the leprosy epidemic area, whether there is family history or contact history. Try to review the initial symptoms and their development During the birth time, the skin lesions have no itching, ant walking, acupuncture, burning and pain. With or without skin damage, eye, hand, foot feels diminished or mourned Loss, hand and foot weakness, paralysis and other movement disorders. Inquire about its duration and evolution, and master the whole process of seeking medical treatment, and outcome.
Skin damage examination should be carried out under bright natural light and suitable temperature conditions. The focus of the examination is on the skin, mucous membranes and surrounding areas.
nerve. The inspection method and requirements are explained to the subject in advance to obtain the cooperation. Should be from head to toe, from front to back, at different angles and distances Separately, a detailed examination of the whole body is performed in order to clearly identify any lesion on the skin and include concealed parts as much as possible. Peripheral nerve examination Under the bilateral contrast, the thickness, shape, texture, uniformity, tenderness and radiation pain of the surrounding superficial nerves were examined. Pay attention to the presence or absence of neuroma, Nerve abscess or fibrosis.
A.2 Physical examination A.2.1 Examination of skin damage A.2.1.1 Type and form of skin damage such as macules, papules, plaques, nodules and infiltration, with or without "immune zone" or "satellite" damage.
A.2.1.2 Edge
Whether it is clear or not, whether it is infiltrated or raised. If it is ring-shaped, it is necessary to separately describe whether the inner and outer edges are clear. Pay special attention to large maps, the center is located near the edge of the normal skin color immune area lesion.
A.2.1.3 Number and size those with less skin lesions can count directly, and many can write mostly or hard to count. The size can be described in kind (such as miliary, soy or silver dollar size), it is also possible to measure the longitudinal and transverse diameters in units of cm.
A.2.1.4 Color and luster such as light, light red, tan or rose, etc.; whether the skin lesions are infiltrated, shiny, atrophic or dull.
A.2.1.5 rash surface High, flat or sunken, dry or juicy, smooth or rough, with or without scales, hair loss and "immune zone".
A.2.1.6 Distribution Clustering or not, limited or extensive, symmetrical or asymmetrical.
A.2.1.7 Hardness and activity Hard or soft, active or inactive.
A.2.1.8 Shallow sensation, investigation and pathological changes Skin damage is associated with shallow sensory disturbance, positive or negative detection, and specific pathological changes in leprosy.
A.2.2 Inspection of nerve damage A.2.2.1 Neuromorphological examination A.2.2.1.1 supraorbital nerve. the upper incision and the eyebrow arch are perpendicular to the forehead. Use both hands to hold the subject's ankle while checking, both thumbs Touch from the inside to the outside of the eyebrow to check for abnormal nerves and abnormal hardness.
A.2.2.1.2 Auricular nerve. 1/3 out of the posterior edge of the sternocleidomastoid muscle, subcutaneously obliquely inward and upward, and the muscle crosses behind the ear. an examination when the subject's head is later tilted and turned to the opposite side, it can be touched to check for nerve enlargement and abnormal hardness.
A.2.2.1.3 ulnar nerve. the proximal end of the carpal tunnel through the iliac crest, the proximal end of the elbow and the ulnar side of the transverse ligament of the wrist. The examinee will be closed at the time of examination.
The section is slightly flexed and abducted. The examiner holds the forearm in one hand and touches the ulnar nerve groove upwards in one hand. Or the left hand grasps the subject's hand in the transverse ligament of the wrist.
The proximal side of the ulnar carpal tunnel was touched to check for abnormal nerves and abnormal hardness.
A.2.2.1.4 Median nerve. During the examination, touch the wrist between the wrist and the palmar tendon muscle, pay attention to whether there is tenderness and observe whether the part is present or not.
swelling.
A.2.2.1.5 phrenic nerve. During the examination, touch the phrenic nerve between the sacral sulcus and the superficial temporal nerve at the lateral head of the humerus in the middle of the upper arm.
Check for abnormal nerves and abnormalities in hardness.
A.2.2.1.6 Common peroneal nerve. the inner edge of the biceps femoris muscle outside the axilla, and the posterior humeral head. During the examination, the knee of the subject is slightly flexed, since Touch the outside of the armpit to check for abnormal nerves and abnormal hardness.
A.2.2.1.7 sacral nerve. The upper end of the fistula (inward iliac and upper 1/3 of the heel) after the medial malleolus is examined for neurological coarseness and abnormal hardness.
A.2.2.1.8 cutaneous nerve. examination of skin lesions and cutaneous nerves in or near the numb area, with or without nerve enlargement and hardness.
A.2.2.2 Peripheral nerve function test A.2.2.2.1 Sensory function check A.2.2.2.1.1 Skin pain, touch temperature perception test. The sensory test has high specificity and low sensitivity, often subjective components, and needs to be obtained.
The cooperation of examiners can reflect objective results. Before the examination, explain the purpose, method and requirements of the examination to the examinee patiently and meticulously. First in normal Test on the skin, so that the patient can understand the method of examination, and then point it to the closed eyes or cover the eyes with the object, indicating the feeling of the tested part.
what. The skin lesions were compared with the corresponding normal skin, and their expressions and responses were observed to determine the credibility of the test results. When the subject If the thought is not concentrated or the inspection result is uncertain, it should be retested. It should be noted that not all leprosy lesions must have sensory impairments.
In the early LL end patients, the erythema of the trunk and the diffuse infiltration of the face were not obvious.
A.2.2.2.1.1.1 Pain. Take two pins or needles, and use the tip or blunt tip to stimulate the normal skin and the corresponding lesions alternately.
Let the subject answer whether it is "spike" or "blunt", or "pain" and "no pain." Normal people can answer clearly and observe their expression and presence or absence.
Avoid stimulating movements; those with hypoalgesia are unclear or slow to respond to "tip" and "blunt"; those with pain loss are indistinct, blunt, or no pain, only feeling touched.
A.2.2.2.1.1.2 Tactile. Lightly touch the normal skin and the corresponding skin lesions with cotton wool or soft feather at the end of the cotton swab.
The person feels that the object touches in time, indicating the number of times the site is touched or the order in which the answer is reached. Those with normal touch, pointing to the test site or reporting no False; those who are declining, most of them are pointing, the report is not allowed or the response is slow; those who are lost cannot be pointed or reported. Hand and foot protective sensation should be used with beads Tip check.
A.2.2.2.1.1.3 Temperature sense (cold and heat sensation). use two test tubes, one for cold water (about 10 °C), one for hot water (about 50 °C), with two the lower end of the test tube is alternately tested for normal skin and corresponding lesions to understand its sensitivity to cold and heat. Most of the losers answered incorrectly or late Slow; the loser can not distinguish between cold and hot test tubes.
A.2.2.2.2 Motion function check A.2.2.2.2.1 Contrast examination, record the muscle strength of the muscles affected by the affected nerve, determine the resistance of each innervating muscle, with or without 瘫痪 or shrinking.
A.2.2.2.2.1.1 Face. Observe facial nerve dysfunction by squatting, frowning, closing eyes, whistling and tooth decay. Order the examiner closes his eyes to see if the upper and lower eyelids can be closed and whether there is any valgus; if it cannot be closed, the distance (mm) of the cleavage should be measured and recorded.
A.2.2.2.2.1.2 Hand. Determine the presence or absence of dysfunction of the upper limb nerves (ulnar nerve, median nerve, and radial nerve). Observe the finger abduction, inside Receiving, the situation and strength of the thumb palm side abduction, palm, fist, wrist dorsiflexion.
A.2.2.2.2.1.3 Foot. Observe the dorsiflexion, varus, valgus of the subject's foot, as well as the condition and strength of the flexion and toe, and examine the lower limbs.
There are no dysfunctions in the sacral nerve and the posterior tibial nerve.
A.2.2.2.3 Autonomic nerve function test Check for signs of sweating at the lesion, and whether the tripartite reaction in the histamine test is complete.
A.2.2.2.4 Judgment of disability in the event of a disability, it should be recorded using the WHO Level 0 to 2 disability classification method (see Exhibit E.3).
A.2.3 Examination of eye diseases all types of leprosy patients are often accompanied by primary or secondary eye disease, and attention should be paid to eye examination. Mainly pay attention to whether the eyebrows and eyelashes are off Fall; presence or absence of trichiasis, blinking and closed eyes. Whether the cornea feels normal, whether the eyes have pain, photophobia or foreign body sensation. Check for cornea White spot, ulcer or turbidity, sclera congestion. Is there a leprosy, whether the iris texture is clear, whether the pupil is regular, and the response to light is Whether it is sensitive, whether the intraocular pressure is increased, etc.
A.2.4 Other inspections Especially in the case of advanced and advanced patients (MB), ear, nose, pharynx, larynx, lymph nodes and internal organs should be examined.
A.3 Clinical trials
Whether the peripheral nerve function is damaged, or in the skin lesions or numbness, through the histamine test, sweat test and the vertical muscle test Test. However, these tests are not specific. They can also be abnormal in peripheral nerve diseases or trauma. Some patients with early leprosy can also be normal.
Should, be noted to exclude.
Appendix B
(normative appendix) Skin smear method (Ziehl-Neelsen acid-fast staining method) B.1 Skin smear B.1.1 Selecting the smear Skin smear smear, generally take 4 to ...
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