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~~卡介苗與結核病防治 ~~
社團法人中華民國防癆協會第一胸腔病防治所 索 任 醫 師
DOTS The recommended strategy for TB
control
卡介苗預防接種
BCG Vaccine
卡介苗預防接種在防癆工作的意義
卡介苗 Bacillus
Calmette-Guerin
Heimbeck
Effectiveness
of BCG Vaccination
Bacille
Calmette-Guerin Vaccine Strains
卡介苗接種
針頭位置 (肌肉, 皮下,
皮內 注射)
Local Complication
at Vaccination Site
Glandular
Abscess
嬰兒淋巴腺腫大人數統計
BCG Keloid 卡介苗蟹足腫
Factors
Affecting Local Reaction after BCG Vaccination
嚴重卡介苗併發症
Announcement
of WHO on BCG vaccination
嬰兒卡介苗接種率與
結核病死亡率(0-4歲)
Administration summary: BCG vaccine
Criteria for Discontinuation of
Universal BCG Vaccine
結核菌素
結核菌素皮膚試驗
結核菌素反應硬結大小分布
(2001)
Factors Causing
Decreased Ability to Respond to Tuberculin (1)
Factors
Causing Decreased Ability to Respond to Tuberculin (2)
結核菌素測驗之用途
結核菌素測驗陽性率
金門縣 0-11歲兒童結核菌素反應分布
卡介苗製造
DOTS
= 最有效的結核病防治策略
DOTS= 最有效的結核病防治策略
 政府承諾：保障持續周全的結核病防治動力。
因症就診，痰塗片鏡檢。
標準短程治療與DOT。
規則而不中斷地供應所有必要的抗結核藥物。
標準化的記錄及報告系統以評估整體成效。
卡介苗預防接種
卡介苗預防接種 1974 前全球已接種15億劑卡介苗.
1974 WHO 推動全球 Expanded Programme on Immunization (EPI) 後,
每年約 1 億人接種卡介苗.
初次接種
新生兒：出生體重2500克以上之健康新生兒，出生24小時後直接接種。
嬰幼兒：各鄉鎮巿區衛生所定期門診辦理直接接種。
國小入學兒童：沒有卡介苗疤者，先予結核菌素皮膚試驗，若反應陰性，則給予卡介苗初次接種。
BCG
Vaccine
BCG Vaccine--Summary of WHO position
paper -1
結核菌 Mycobacterium tuberculosis (Mtb),
結核病的病原菌, 是造成人類疾病和死亡的主要凶手, 尤其是在開發中國家.
全球的 TB 問題和貧窮緊密結合在一起, 而結核病的防治成敗, 關鍵問題在於公義和人權.
HIV/AIDS 的大流行伴隨著 TB 的同時流行, 已使許多地方的防治工作疲於奔命.
抗藥性結核菌的增加, 防治工作更加困難.
數十年來TB病人穩定下降, 然而近年許多已開發國家都面臨結核病人回升的挑戰.
Summary of WHO position paper -2
卡介苗 bacille Calmette–Guerin (BCG) vaccine 已存在80年以上,
是現今所有疫苗中用得最多也最廣的疫苗, 在推動兒童卡介苗接種的國家, 超過 80% 的新生兒和嬰幼兒都已接種過卡介苗.
卡介苗已證實對兒童的結核性腦膜炎和散播型結核病有保護效果.
卡介苗不能預防初次感染, 也不能預防潛伏感染的發病, 而結核病的發病才是社區中傳染結核菌的源頭.
因而卡介苗在預防結核菌傳染的效果有限.
Summary of WHO position paper -3
雖然新疫苗已在努力研發中, 但顯然在數年之間, 新疫苗仍不可能安全上市.
新疫苗正在研發的同時, 應鼓勵適當地運用卡介苗接種.
卡介苗已經證實對麻瘋的防治有效, 也對 Buruli ulcer (一種NTM造成的胃腸潰瘍) 有保護作用.
治療膀胱癌也有些作用.
Summary of WHO position paper -5
在結核病高負擔國家, 每個嬰兒都應在出生後盡早接種單一劑卡介苗.
即使在無症狀的 HIV 陽性嬰兒接種卡介苗也極少出現嚴重副作用, 所有健康新生兒都應接種卡介苗,
即使在HIV流行的地方也不例外.
若資源許可，對母親為HIV陽性的嬰兒接種卡介苗後，最好長期觀察，萬一免疫機能急速惡化導致全身卡介苗感染時，得以及早治療。WER
2004; 79:27-38
卡介苗預防接種在防癆工作的意義
卡介苗預防接種在防癆工作的意義
藉由卡介苗的人工感染，讓健康宿主的細胞型免疫在約 8
週後，發展出對結核菌的特異免疫力。
日後再接觸到結核菌抗原，宿主可在 48-72 小時內活化吞噬細胞，足以殺滅入侵的結核菌。
卡介苗的預防效力，須靠正常的免疫力及時活化吞噬細胞，才能抵抗結核菌的侵犯。
能減少兒童的結核病及結核死亡。但無法有效阻止結核菌的傳染。
 卡介苗
Bacillus
Calmette-Guerin
卡介苗 Bacillus Calmette-Guerin
患結核性乳房炎的乳牛取到牛乳（含大量牛型結核菌 M. bovis）。
以含馬鈴薯片、牛膽汁和甘油組成的培養基。
每 3 週繼代培養 1 次，經過 13 年共 230 次的繼代培養，減毒成功的牛型結核菌，命名為卡介苗。
Milk of a cow with tuberculous mastitis
Potato slice, Bovine bile, Glycerol
Subculture every 3 weeks for over 13 years (total 230
cultures)
1908 Calmette and Guerin,
於培養基中加入小牛膽汁，對牛型結核菌繼代培養，進行減毒。
1921 Bacille Calmette-Guerin (BCG) 卡介苗
1922 Weill-Halle first gave BCG by mouth to infants in
Paris. (在巴黎率先採用口服方式給嬰兒接種)
1923 Heimbeck, subcutaneous injection (皮下接種)
1927 Wallgren, intracutaneous injection (皮內接種)
Heimbeck
Student Nurses at the Ullevial Hospital in Oslo
Heimbeck Student Nurses at the
Ullevial Hospital in Oslo
1924-26
62/185 (34%) of tuberculin-negative vs.
3/152 (2%) of tuberculin-positive nurses developed
tuberculosis.
1927-34
27/436 (6%) of tuberculin-positive
79/463 (17%) of tuberculin-negative
42/95 (44%) refuse BCG vaccination
37/368 (10%) accepted BCG vaccination
developed tuberculosis.
Olaf Scheel and Johannes Heimbeck:
Heimbeck and Scheel pioneered giving the vaccine via
injection and to adults.
These projects have been criticised for being based on
voluntary inclusion and not being conducted as randomised
control trials.
The results were so convincing, however, that they led to
the launch of the Norwegian BCG programme shortly after
World War II. Scheel and Heimbeck' efforts were also of
great importance for the use of the BCG vaccine in other
countries.
Effectiveness
of BCG Vaccination
Effectiveness of BCG Vaccination
卡介苗預防結核病的成效
Colditz GA et al. Efficacy of BCG vaccination in the prevention of
tuberculosis. Meta-analysis of the
published literature. JAMA
1994; 271:698-702.
Bacille
Calmette-Guerin
Vaccine Strains
Bacille Calmette-Guerin Vaccine
Strains
卡介苗接種
卡介苗接種
凍晶乾燥卡介苗 Tokyo 172 菌株0.05mg/0.1ml
皮內接種接種位置 初次接種：左上臂三角肌中央
追加接種：距第一個卡介苗疤下約1.5cm處
禁忌結核病疑似患者細胞性免疫機能不全者，如AIDS急性熱病、全身或局部皮疹、痳疹等
針頭位置
(肌肉, 皮下, 皮內 注射)
針頭位置 (肌肉, 皮下, 皮內 注射)
| BCG
Vaccination - Week 0 |
BCG
Vaccination - Week 4-6 |
BCG
Vaccination - Week 4-6 |
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 |
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| BCG
Vaccination - Week 6 |
免疫控制期
Controlled by CTM and DTH
|
BCG
Vaccination - Scar |
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Local
Complication at Vaccination Site
接種部位的局部併發症
Local Complication at Vaccination Site
接種部位的局部併發症
Koch‘s phenomenon 柯霍氏反應
The accelerated reaction 加速型反應 Local abscess 局部膿瘍
Large or indolent ulcers 大而持久的潰瘍
Glandular
Abscess
Glandular Abscess
A late complication, usually occurring
between the 3rd and 6th month.
Factors influencing the incidence of glandular abscess after
BCG vaccination
strength of vaccination
methods of vaccination
age of the vaccinated person
the site of vaccination
臺灣省歷年卡介苗評價嬰兒淋巴腺腫大人數統計
臺灣省歷年卡介苗評價嬰兒淋巴腺腫大人數統計
BCG
Keloid
卡介苗蟹足腫
BCG Keloid 卡介苗蟹足腫&卡介苗蟹足腫疤痕調查
卡介苗蟹足腫疤痕調查
Factors
Affecting Local Reaction after BCG Vaccination
Factors Affecting Local Reaction after
BCG Vaccination
Strength of vaccination 卡介苗力價
Number of bacilli vaccinated 接種的活菌數目
Depth of vaccination 接種深度 Presence of immunity 免疫力
Site of vaccination 接種位置
嚴重卡介苗併發症
嚴重卡介苗併發症 全身性卡介苗感染症
卡介苗骨髓炎
Announcement
of WHO on BCG vaccination
Announcement of WHO on BCG
vaccination
Re-vaccination of BCG is not recommended as there has been
no proof on its efficacy, and to repeat vaccination more
than 3 times is never recommended in any occasion.
Tuberculin skin test results should not be used to select
subjects for BCG re-vaccination as there is little relation
between post-vaccination TR and the protective immunity.
In countries with high incidence and/or prevalence of TB,
BCG vaccination should be done as early as possible after
birth, and in any case, within the first year of life.
WHO.Global tuberculosis programme and
global programme on vaccines.
Statement on BCG revaccination for prevention of
tuberculosis.
Wkly Epidemiol Rec 1995; 70:229-231
嬰兒卡介苗接種率與
結核病死亡率(0-4歲)
嬰兒卡介苗接種率與 結核病死亡率(0-4歲)
Criteria
for Discontinuation of
Universal BCG Vaccine
Criteria for Discontinuation of
Universal BCG Vaccine
An effective notification system is in
place
And either of the following:
Average annual notification rate of smear positive pulmonary
TB is less than 5/100,000 over the previous 5 years
Average annual notification rate of tuberculous meningitis
in children under 5 years of age is less than 1/10,000,000
in over the previous 5 years 台灣 0-4歲結核腦膜炎人數 2001:3,
2000:2, 1999:4
Average annual risk of tuberculous infection is less than
0.1%
Administration summary: BCG
vaccine
Administration summary: BCG vaccine
WHO_Immunization in Practice_a practical resource guide for
health workers_2004 update
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Type of
vaccine
|
Live
bacterial
|
|
Number
of doses
|
One
|
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Schedule
|
At or
as soon as possible after birth
|
|
Booster
|
None
|
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Contraindications
|
Symptomatic HIV infection
|
|
Adverse
reactions
|
Local
abscess, regional lymphadenitis; rarely, distant
spread to osteomyelitis, disseminated disease
|
|
Special
precautions
|
Correct
intradermal administration is essential. A
special syringe and needle is used for the
administration of BCG vaccine
|
|
Dosage
|
0.05ml
|
|
Injection site
|
Outer
upper left arm or shoulder
|
|
Injection type
|
Intradermal
|
|
Storage
|
Store
between 2°C–8°C
(vaccine maybe frozen for long-term storage but
not the diluent)
|
結核菌素
結核菌素PPD RT23 with Tween 80
2 tu/0.1ml (0.04mcg) Mantoux test (皮內試驗)
左前臂掌側中段 72小時後判讀 (48-96小時) 記錄硬結橫徑
TuberculinOld Tuberculin (OT)
Take six-weeks-old culture of tubercle bacilli in 5%
glycerin bouillon; evaporate it down to 1/10 of original
volume; kill the bacilli by heat and then filter.
Purified Protein Derivative (PPD)
extracted from old tuberculin the tuberculo-protein.
結核菌素皮膚試驗
結核菌素皮膚試驗 針頭位置 (肌肉, 皮下, 皮內 注射)
 
結核菌素反應硬結大小分布
(2001)
結核菌素反應硬結大小分布 (2001)PPD RT23 + tween80,
2TU, Mantoux test
Factors Causing Decreased
Ability
to Respond to Tuberculin (1)
Factors Causing Decreased Ability to
Respond to Tuberculin (1)
ATS. Am Rev Respir dis 1990;142:725-35
Factors related to the person being
tested
Infections
Viral (measles, mumps, chicken pox)
Bacterial (typhoid fever, brucellosis, typhus, leprosy,
pertussis, overwhelming tuberculosis, tuberculous pleurisy)
Fungal (south American blastomycosis)
Live virus vaccinations (measles, mumps, chicken pox)
Metabolic derangements (chronic renal failure)
Nutritional factors (severe protein depletion)
Diseases affecting lymphoid organs (Hodgkin’s disease,
lymphoma, chronic lymphocytic leukemia, sarcoidosis)
Drugs (corticosteroids and other immunosuppressive agents)
Age (newborns, elderly patients with “waned” sensitivity)
Recent or overwhelming infection with M. Tuberculosis
Stress (surgery, burns, mental illness, graft-versus-host
reactions)
Factors Causing Decreased Ability to
Respond
to Tuberculin (2)
Factors Causing Decreased Ability to
Respond to Tuberculin (2)
ATS. Am Rev Respir dis
1990;142:725-35.
Factors related to the tuberculin used
Improper storage (exposure to light and heat)
Improper dilution
Chemical denaturation
Adsorption (partially controlled by adding Tween 80)
Factors related to method of administration
Injection of too little antigen
Delayed administration after drawing into syringe
Injection too deep
Factors related to reading the test and recording results
Inexperienced reader
Conscious or unconscious bias
Error in recording
結核菌素測驗之用途
結核菌素測驗之用途
幫助診斷：未曾接種過卡介苗，而結核菌素測驗反應陽性者，表示曾被結核菌感染過。
結核病流行病學調查方法之一，由結核病感染率之高低，可瞭解結核病流行的情形。
作為檢查結核病接觸者方法之一，篩選已受感染者。
卡介苗接種後效果之評價。
結核菌素測驗陽性率
結核菌素測驗陽性率 台灣省國小一年級無卡介苗疤學童 61-90年度
註 : 1.70年度前為抽樣調查 , 72年度後為全面篩檢
2.測驗方法依Mantoux技術, 以1TU PPD RT-23測驗, 測驗結果硬結(induration)≧
10mm, 判定為陽性
結核年感染率 Annual Risk of TB Infection
61年 1.32%
72年 0.64%
90年 0.43%
金門縣 0-11歲兒童結核菌素反應分布
金門縣 0-11歲兒童結核菌素反應分布
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