大连医科大学硕士研究生试卷 药学院2010级专业外语(包括答案)

这个当时是药理学跟微生物与生化药学专业共用的哦

大连医科大学硕士研究生试卷

2010 年级专业外语试卷

学号姓名

命题单位：药学院教研室：临床药理教研室主任审核签字：

阅卷人：

Drug-drug Interactions ( DDI )

The desirable and undesirable effects of a drug are related to its concentration at various sites of action, which is usually related to the blood or tissue concentration of the drug. The blood or tissue concentrations resulting from a dose are determined by the drug’s absorption, distribu tion, metabolism, and excretion (ADME). Elimination of a drug or its active metabolites occurs either by metabolism to an inactive metabolite that is excreted, or by direct excretion of the drug or active metabolites. The kidneys and liver are responsible for most drug excretion. Drug interactions related to metabolism and excretion are well-recognized, but effects related to transporters are being documented with increasing frequency and are, therefore, important to consider in drug development.

The overall objective of interaction studies for a new drug is to determine:

●whether any interactions are sufficiently large to necessitate a dosage adjustment of the drug itself or of the drugs with which it might be used,

●whether any interactions calls for additional therapeutic monitoring, or

●whether there should be a contraindication to concomitant use when lesser measures cannot mitigate risk.

In some instances, understanding how to adjust a dose or dosage regimen in the presence of an interacting drug, or how to avoid drug-drug interactions, may allow marketing of a drug that would otherwise have an unacceptable level of risk. In a few cases, consequences of an interaction have led to the conclusion that the drug could not be marketed safely. In almost all of these cases, that conclusion was strengthened by the availability of alternative drugs with lower risks for interactions. Several drugs have been withdrawn from the market because of significant drug interactions that led to QT prolongation and Torsades de Pointes (TdP) arrhythmias, after warnings in drug labels did not adequately manage the risk of drug interactions.

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Dalian Medical University

这个当时是药理学跟微生物与生化药学专业共用的哦

答案：药物的期望效应和不良反应与药物在不同作用部位的浓度有关，通常是血液和组织中的药物浓度。一定剂量给药后血液和组织中的药物浓度是由药物的吸收，分布，代谢，排泄（ADME）决定的。药物或活性代谢产物的消除有两种方式，或者被代谢为无活性的代谢物排出体外，或者直接排泄。肾脏和肝脏负责大多数药物的排泄。人们已经充分认识到药物相互作用与代谢和排泄相关密切相关，但是，有关转运蛋白的影响也越来越频繁的报道，因此在药物开发中应重点考虑。治疗性蛋白制剂可被靶细胞表面受体识别，内吞进细胞，并被溶酶体降解，从而特异性消除。

对新药进行相互作用研究的全部目的，是确定潜在的相互作用强度，从而采取以下措施规避风险：

∙调整新药自身或可能合用的药物的给药剂量；

∙进行治疗药物检测；

∙设立合用药禁忌。

正常情况下，即便一种药物具有某种无法接受的风险，只要了解在相互作用药物存在时如何调节剂量或给药方案，避免DDI，那么这种药物即可上市销售。只有很少情况下，存在相互作用风险会导致药物退出市场；几乎所有的这种情况，都是出现了更安全、相互作用风险更少的替代药物。有几种药物，在说明书中提出警告仍不能有效控制药物相互作用风险后，退出了市场；这些药物可导致QT间期延长和尖端扭转型心律失常（TdP），存在显著的药物相互作用。

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Dalian Medical University