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药物的风险效益分析:从生物统计学家角度的基本考量与要求。甲氧苄啶与磺胺甲恶唑联合用药评估中的问题。

Risk-benefit analyses of drugs: fundamental considerations and requirements from the point of view of the biometrician. Problems in the assessment of the combination of trimethoprim with sulfamethoxazole.

作者信息

Hasford J, Victor N

机构信息

Institut für Medizinische Dokumentation, Statistik und Datenverarbeitung der Universität, Heidelberg.

出版信息

Infection. 1987;15 Suppl 5:S236-40. doi: 10.1007/BF01643196.

DOI:10.1007/BF01643196
PMID:3501772
Abstract

Risk-benefit analyses are a prerequisite for a rational decision about therapies, e.g. drugs. Ingredients of a risk-benefit analysis are: 1. quality and quantity of the benefit; 2. quality and quantity of the harm; 3. benefit and harm of the natural history of the disease; 4. benefit and harm of therapeutic alternatives; 5. commensurability of harm and benefit; 6. consideration of all types of adverse drug reactions together. The available evidence was not suitable for a sound risk-benefit analysis of the use of trimethoprim-sulfamethoxazole. However, there seems to be enough evidence to restrict the use of trimethoprim-sulfamethoxazole in diseases with a benign prognosis and/or when there are therapeutic alternatives with a smaller risk/benefit ratio. Reliable rules for risk-benefit analyses have to be developed and the necessary information has to be gained also in methodologically sound phase IV research.

摘要

风险效益分析是对治疗方法(如药物)做出合理决策的前提条件。风险效益分析的要素包括:1. 效益的质量和数量;2. 危害的质量和数量;3. 疾病自然史的效益和危害;4. 治疗替代方案的效益和危害;5. 危害与效益的可比性;6. 综合考虑各类药物不良反应。现有证据不适用于对甲氧苄啶 - 磺胺甲恶唑使用进行完善的风险效益分析。然而,似乎有足够的证据限制在预后良好的疾病中使用甲氧苄啶 - 磺胺甲恶唑,和/或在存在风险/效益比更小的治疗替代方案时使用。必须制定可靠的风险效益分析规则,并且还必须在方法学上合理的IV期研究中获取必要信息。

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Risk-benefit analyses of drugs: fundamental considerations and requirements from the point of view of the biometrician. Problems in the assessment of the combination of trimethoprim with sulfamethoxazole.药物的风险效益分析:从生物统计学家角度的基本考量与要求。甲氧苄啶与磺胺甲恶唑联合用药评估中的问题。
Infection. 1987;15 Suppl 5:S236-40. doi: 10.1007/BF01643196.
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本文引用的文献

1
Double-blind trial to compare ampicillin, cephalexin, co-trimoxazole, and trimethoprim in treatment of urinary infection.比较氨苄西林、头孢氨苄、复方新诺明和甲氧苄啶治疗尿路感染的双盲试验。
Br Med J. 1972 Jun 17;2(5815):673-6. doi: 10.1136/bmj.2.5815.673.