Parsons R L
Clin Pharmacokinet. 1977 Jan-Feb;2(1):45-60. doi: 10.2165/00003088-197702010-00004.
There is a considerable range in the dose of many drugs that is required to produce a given pharmacological effect in an individual patient. This individual variation in dose requirement is sometimes reflected in the wide scatter in the steady state plasma concentration that follows the same oral dose of a drug given to any group of subjects. Such individual differences are largely due to variation in the rate of elimination of drugs. Gastrointestinal disease may also alter oral dose requirements by producing variation in both the amount and rate of drug absorption. These changes may be reflected in the plasma concentration/time curve that follows an oral dose. The amount of drug abosorbed is simultaneously affected by many factors. These include the physicochemical properties of the drug and the physiological factors that operate within the gut, as well as the presence of other substances such as food, or interaction with other drugs in the gut. The availability of the drug within the intestinal lumen is largely governed by its dissolution characteristics, particularly factors which can interfere with dissolution of the drug product in the gut. Physiological factors within the gut that affect oral drug absorption include gastric emptying rate and intestinal motility, the pH of the gastrointestinal fluids, the activity of gastrointestinal drug metabolising enzymes (e.g. monoamine oxidase and dopa decarboxylase) or drug metabolising bacteria and the surface area of the gut. Many factors affect gastric emptying. These include disease, surgery and other drugs. A change in the rate of gastric emptying alters the rate of drug delivery from the stomach to the duodenum and upper small intestine. This may profoundly alter the plasma concentration/time curve that follows oral administration of many drugs. For some drugs, proximal jejunal disease may reduce, delay or increase the apparent amount of drug absorbed. Reduced absorption of an antibiotic leads to a fall in the peak plasma concentration. If the peak falls below the minimum inhibitory concentration for a particular organism then therapeutic failure may occur, if it is assumed that the peak plasma concentration is all important for antimicrobial activity. Excessive drug absorption may lead to drug toxicity. Abnormal drug absorption is a feature of lower small intestinal conditions such as Crohn's disease. This suggests that drug absorption is not confined to the jejunum but continues throughout the small intestine. It is not always possible to predict the pattern of drug malabsorption from a knowledge of the physicochemical and pharmacokinetic properties of the drug and the pathophysiology of the disease. The rate and amount of drug absorbed be one patient may differ from that in another patient with the same condtion. Although these differences reflect normal individual variation, they are also related to the extent and activity of disease at the time of study...
在个体患者中,产生特定药理作用所需的许多药物剂量存在相当大的范围。剂量需求的这种个体差异有时反映在给予任何一组受试者相同口服剂量药物后稳态血浆浓度的广泛离散上。这种个体差异很大程度上归因于药物消除速率的变化。胃肠道疾病也可能通过导致药物吸收量和吸收速率的变化来改变口服剂量需求。这些变化可能反映在口服剂量后的血浆浓度/时间曲线上。药物吸收量同时受到许多因素的影响。这些因素包括药物的物理化学性质、肠道内起作用的生理因素,以及其他物质(如食物)的存在或与肠道内其他药物的相互作用。药物在肠腔内的可利用性在很大程度上取决于其溶解特性,特别是那些会干扰药物制剂在肠道内溶解的因素。影响口服药物吸收的肠道内生理因素包括胃排空速率和肠道蠕动、胃肠液的pH值、胃肠药物代谢酶(如单胺氧化酶和多巴脱羧酶)或药物代谢细菌的活性以及肠道表面积。许多因素会影响胃排空。这些因素包括疾病、手术和其他药物。胃排空速率的改变会改变药物从胃输送到十二指肠和上段小肠的速率。这可能会深刻改变许多药物口服给药后的血浆浓度/时间曲线。对于某些药物,空肠近端疾病可能会减少、延迟或增加药物的表观吸收量。抗生素吸收减少会导致血浆峰浓度下降。如果峰浓度降至特定生物体的最低抑菌浓度以下,那么如果假设血浆峰浓度对抗菌活性至关重要,就可能会发生治疗失败。药物吸收过多可能会导致药物毒性。药物吸收异常是诸如克罗恩病等下段小肠疾病的一个特征。这表明药物吸收不仅限于空肠,而是在整个小肠中持续进行。仅根据药物的物理化学和药代动力学性质以及疾病的病理生理学知识,并不总是能够预测药物吸收不良的模式。一名患者的药物吸收速率和吸收量可能与患有相同病症的另一名患者不同。虽然这些差异反映了正常的个体变异,但它们也与研究时疾病的程度和活性有关……