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本文引用的文献

1
Clinical pharmacology. Possible clinical importance of genetic differences in drug metabolism.临床药理学。药物代谢中基因差异可能具有的临床重要性。
Br Med J (Clin Res Ed). 1981 Aug 22;283(6290):537-42. doi: 10.1136/bmj.283.6290.537.
2
Trade names or approved names. Part III. Special cases. Combination products.商品名或批准名。第三部分。特殊情况。组合产品。
Postgrad Med J. 1974 Feb;50(580):103-6. doi: 10.1136/pgmj.50.580.103.
3
Report of a workshop on fixed-ratio drug combinations.固定剂量复方药物研讨会报告
Eur J Clin Pharmacol. 1975 Feb 28;8(2):149-54. doi: 10.1007/BF00561565.

固定剂量复方药物的药理学评估:讨论文件

Pharmacological appraisal of fixed-dose combination medicines: discussion paper.

作者信息

Snell E S

出版信息

J R Soc Med. 1982 Jun;75(6):457-63. doi: 10.1177/014107688207500615.

DOI:10.1177/014107688207500615
PMID:7086795
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1437979/
Abstract

Combination medicines can offer advantages over single products and over multiple drug regimes; at present they account for about one-third of medicines used in general practice and one-fifth in hospital. The alleged disadvantages of such products are mostly theoretical or doctrinal, with the strongest being an objection to the fixed ratio of the ingredients. Nearly all medicines are a formulated mixture of several chemicals and a single active ingredient may be metabolized to a variety of substances with different therapeutic and toxic effects. Hence, the basis of this main objection must be to the fixed ratio of the properties of the multiple ingredients. However, most single drugs, as well as most physiological substances, induce a range of different actions in the body in fixed ratio. Homeostasis is achieved through multicomponent pathways and as such may have advantages in the quality of control compared with the use of any single effector; the same principle may apply pharmacologically in the long-term stabilization of functions such as blood pressure and blood sugar. Thus, discrimination against combination medicines per se on these pharmacological grounds is questionable and should not be allowed to hamper a potentially useful area of therapeutic research. Some recent combination products have provided notable advances in therapeutics and suggest that this could be extended in ways that would not involve the cost and lengthy development of new single-chemical entities.

摘要

复方药物相较于单一产品和多种药物联用方案具有优势;目前,它们在全科医疗用药中约占三分之一,在医院用药中约占五分之一。此类产品所谓的劣势大多是理论性或原则性的,其中最主要的是对成分固定比例的反对。几乎所有药物都是几种化学物质的配方混合物,单一活性成分可能会代谢成具有不同治疗和毒性作用的多种物质。因此,这一主要反对意见的依据必定是多种成分性质的固定比例。然而,大多数单一药物以及大多数生理物质都会在体内以固定比例引发一系列不同的作用。稳态是通过多组分途径实现的,因此与使用任何单一效应器相比,在控制质量方面可能具有优势;同样的原理在药理学上可能适用于血压和血糖等功能的长期稳定。因此,基于这些药理学理由对复方药物本身进行歧视是值得怀疑的,不应阻碍这一潜在有用的治疗研究领域。最近的一些复方产品在治疗方面取得了显著进展,并表明这可以在不涉及新单一化学实体的成本和漫长研发过程的情况下得到扩展。