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백신 부작용과 인과관계의 분석
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백신 부작용과 인과관계의 분석.hwp
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백신 부작용과 인과관계의 분석.hwp
[Size :
46 Kbyte
]
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자료설명
(1) 잠재적 인과성에 대한 판단(Potential causality)
잠재적 인과성을 판단하기 위하여 백신과 부작용 사이에 통계적으로 유...
잠재적 인과성을 판단하기 위하여 백신과 부작용 사이에 통계적으로 유...
본문/내용
(1) 잠재적 인과성에 대한 판단(Potential causality)
잠재적 인과성을 판단하기 위하여 백신과 부작용 사이에 통계적으로 유의한 관련성이 있는지를 수집된 자료로 분석한다. 즉 보고된 증상이 백신에 의하여 일어날 잠재성이 있는가를 판단하기 위해서는 다음 사항들에 대해서 검토를 하여야 한다.1) 인과성의 강도(Strength of association)
접종자와 비접종자 사이에서 이상 반응이 나타난 빈도를 비교하여 비교위험도(relative risk또는 odd ratio)가 1.0이하이면 백신의 인과성이 없다. 비교위험도가 높으면 높을수록 백신 부작용을 설명하는데 있어서 한가지 분석 치우침(analytic bias)만으로 설명이 어렵다2) 분석 치우침 또는 편향(Analytic bias)
인과성을 평가하는데 있어서 체계적 오차를 뜻하는데 통상 4가지 유형이 있다. 자료의 선택 치우침(selection bias), 정보 치우심(information bias), 혼란 치우침(confounding bias), 역인과성 치우침(reverse causality bias)을 들 수 있다3) 생물학적 성분(Biologic gradient)
일반적으로 백신은 접종량이 많을수록, 접종횟수가 많을수록 부작용의…(생략)4) 통계적 유의성(Statistical significance)
참고문헌
1) Hinman AR. Public health considerations. In: Plotkin SA, Mortimer EA, editors, Vaccine. Philadelphia: WB Saunders, 1988;587-611.
2) Chen RT. Special methodological issues in pharmacoepidemiology studys of vaccine safety. In: Strom BL, editor. Pharmacoepidemiology, Chichester. John Wiley and Sons, 1994;581-94.
3) Baraff LJ, Manclark CR, Cheny JD, Christenson P, Marcy SM. Analyses of adverse reactions to diphtheria and tetanus toxoids and pertussis vaccine by vaccine lot, endotoxin content, pertussis vaccine potency and percentage of mouse weight gain. Pediatr Infect Dis J 8:502-7, 1989.
4) Baraff LJ, Cody CL, Cheny JD. DTP-associated reactions: an analysis by injection site, manufacturer, prior reactions, and dose. Pediatrics 73:31-6, 1984.
5) Church JA. Richards W. Recurrent abscess formation following DTP immunizations: association with hypersensitivity to tetanus toroid. Pediatrics 75:899-900, 1985.
6) Miller E, Goldacre M, Pugh S. et al. Risk of aseptic meningitis after measles, mumps, and rubella vaccine in UK children. Lancet 341:979-82, 1993.
7) Edsall G, Elliott MW, Peebles TC, Levine L, Eldred MC. Excessive use of tetanus toroid boosters. JAMA 202:111-3, 1967.
8) Institute of Medicine. Report of committee to review and epidemiologic syudy of neuologic illness and vaccination in children. Washington DC: Institute of Medicine, 1990.
9) Kramer MS, Lane DA. Causal propositions in clinical research and practice. J Clin Epidemiol 45:639-49, 1992.
10) Lane D. A probabilists view of causality assessment. D겨g Information Journal 18:323-30, 1984.
11) Stratton KR, Howe CJ, Johnston RE. Adverse events associated with childhood vaccines. Washington DC: National Academy Press, 1994;19-33.
12) Lane DA, Kramer MS, Hutchinson TA, Jones JK, Naranjo C. The causality assessment of adverse drug reactions using a Bayesian approach. J Pharma Med 2:265-8, 1987.
13) Finichel GM, Lane DA, Livengood JR, Horwitz SJ, Menkes JH, Schwartz JF. Adverse events following immunization: assessing probability of causation. Pediatr Neurol 5:287-90, 1989.
14) Centers for Disease Control. Vaccine Adverse Event Reporting System-United States. MMWR 41:730-3, 1990,
15) Chen RT, Rastogi SC, Mullen JR, et al. The Vaccine Adverse Event Reporting System(VAERS). Vaccine 12:542-250, 1994.
2) Chen RT. Special methodological issues in pharmacoepidemiology studys of vaccine safety. In: Strom BL, editor. Pharmacoepidemiology, Chichester. John Wiley and Sons, 1994;581-94.
3) Baraff LJ, Manclark CR, Cheny JD, Christenson P, Marcy SM. Analyses of adverse reactions to diphtheria and tetanus toxoids and pertussis vaccine by vaccine lot, endotoxin content, pertussis vaccine potency and percentage of mouse weight gain. Pediatr Infect Dis J 8:502-7, 1989.
4) Baraff LJ, Cody CL, Cheny JD. DTP-associated reactions: an analysis by injection site, manufacturer, prior reactions, and dose. Pediatrics 73:31-6, 1984.
5) Church JA. Richards W. Recurrent abscess formation following DTP immunizations: association with hypersensitivity to tetanus toroid. Pediatrics 75:899-900, 1985.
6) Miller E, Goldacre M, Pugh S. et al. Risk of aseptic meningitis after measles, mumps, and rubella vaccine in UK children. Lancet 341:979-82, 1993.
7) Edsall G, Elliott MW, Peebles TC, Levine L, Eldred MC. Excessive use of tetanus toroid boosters. JAMA 202:111-3, 1967.
8) Institute of Medicine. Report of committee to review and epidemiologic syudy of neuologic illness and vaccination in children. Washington DC: Institute of Medicine, 1990.
9) Kramer MS, Lane DA. Causal propositions in clinical research and practice. J Clin Epidemiol 45:639-49, 1992.
10) Lane D. A probabilists view of causality assessment. D겨g Information Journal 18:323-30, 1984.
11) Stratton KR, Howe CJ, Johnston RE. Adverse events associated with childhood vaccines. Washington DC: National Academy Press, 1994;19-33.
12) Lane DA, Kramer MS, Hutchinson TA, Jones JK, Naranjo C. The causality assessment of adverse drug reactions using a Bayesian approach. J Pharma Med 2:265-8, 1987.
13) Finichel GM, Lane DA, Livengood JR, Horwitz SJ, Menkes JH, Schwartz JF. Adverse events following immunization: assessing probability of causation. Pediatr Neurol 5:287-90, 1989.
14) Centers for Disease Control. Vaccine Adverse Event Reporting System-United States. MMWR 41:730-3, 1990,
15) Chen RT, Rastogi SC, Mullen JR, et al. The Vaccine Adverse Event Reporting System(VAERS). Vaccine 12:542-250, 1994.
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