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固定剂量复方制剂的风险

The danger of fixed drug combinations.

作者信息

Herxheimer H

出版信息

Int J Clin Pharmacol Biopharm. 1975 Jul;12(1-2):70-3.

PMID:1165144
Abstract

After the second world war a number of pharmaceutical firms which were not able to create new therapeutic substances by their own research, put a great number of fixed drug combinations on the market. Their number quickly increased, as the efficiency of these compounds required no legal proof and as, with appropriate propaganda, large profits could be earned. The number of firms doing this sort of production also increased, and in West Germany, for instance, more than 3/4 of all drugs on the official list are now fixed combinations. Our task is, therefore, to ask for regulations which limit fixed combinations to such preparation the efficiency of which has been shown and whose advantages more than outweigh their disadvantages. The advantages of these preparations are convenience to the patient, avoidance of potential mistakes made possible by too many drugs given on the same day and, perhaps, lower prices. The disadvantages are: 1. The individual optimum dose for a patient cannot be achieved, because in case of a change of dosis all components are changed. 2. Different components may have different duration of action. 3. Different components may have a different bioavailability. 4. Different components may interact. 5. Some components may create tolerance, others not. In many cases fixed combinations have been used to make drugs with poor efficiency financially viable by combining them with very efficient drugs. The existence of thousands of fixed combinations makes the drug market indiscernible and useless. They obscure the relatively few essential drugs and make it difficult for the doctor to find his way amongst the mass of offered medicaments. Few fixed combinations are justifiable. These are well known and they should be permitted as before. All others should be banned until it has been shown that their advantages are greater than their disadvantages.

摘要

第二次世界大战后,一些无法通过自身研究创造新治疗药物的制药公司,将大量固定药物组合投放市场。其数量迅速增加,因为这些化合物的疗效无需法律证明,而且通过适当的宣传,可以赚取巨额利润。从事这类生产的公司数量也增加了,例如在西德,官方清单上超过四分之三的药物现在都是固定组合。因此,我们的任务是要求制定相关规定,将固定组合限制在那些已证明有疗效且其优点远大于缺点的制剂上。这些制剂的优点包括方便患者、避免因同一天服用过多药物可能导致的潜在错误,以及或许能降低价格。缺点如下:1. 无法为患者实现个体最佳剂量,因为一旦剂量改变,所有成分都会改变。2. 不同成分的作用持续时间可能不同。3. 不同成分的生物利用度可能不同。4. 不同成分可能相互作用。5. 一些成分可能产生耐受性,而其他成分则不会。在许多情况下,固定组合被用于通过将低效药物与高效药物组合来使低效药物在经济上可行。数以千计的固定组合的存在使得药品市场难以辨别且毫无用处。它们掩盖了相对较少的基本药物,让医生在大量提供的药物中难以找到方向。很少有固定组合是合理的。这些是众所周知的,应该像以前一样允许使用。所有其他组合都应被禁止,直到证明其优点大于缺点。

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