Introduction to Physiology

Introduction

Physiology is the study of the functions of living matter. It is concerned with how an organism performs its varied activities: how it feeds, how it moves, how it adapts to changing circumstances, how it spawns new generations. The subject is vast and embraces the whole of life. The success of physiology in explaining how organisms perform their daily tasks is based on the notion that they are intricate and exquisite machines whose operation is governed by the laws of physics and chemistry.

Although some processes are similar across the whole spectrum of biology—the replication of the genetic code for or example—many are specific to particular groups of organisms. For this reason it is necessary to divide the subject into various parts such as bacterial physiology, plant physiology, and animal physiology.

To study how an animal works it is first necessary to know how it is built. A full appreciation of the physiology of an organism must therefore be based on a sound knowledge of its anatomy. Experiments can then be carried out to establish how particular parts perform their functions. Although there have been many important physiological investigations on human volunteers, the need for precise control over the experimental conditions has meant that much of our present physiological knowledge has been derived from studies on other animals such as frogs, rabbits, cats, and dogs. When it is clear that a specific physiological process has a common basis in a wide variety of animal species, it is reasonable to assume that the same principles will apply to humans. The knowledge gained from this approach has given us a great insight into human physiology and endowed us with a solid foundation for the effective treatment of many diseases.

1. Type C: continuous reactions due to long-term drug use (neuroleptic-related tardive dyskinesia or analgesic nephropathy)

2. Type D: delayed reactions (alkylating agents leading to carcinogenesis, or retinoid-associated teratogenesis);

3. Type E: end-of-use reactions such as adrenocortical insufficiency following withdrawal of corticosteroids, or withdrawal
   There are between 30000 and 40000 medicinal products available directly or on prescription in the UK. A recent survey suggested that approximately 80% of adults take some kind of medication during any 2-week period. Exposure to drugs in the population is thus substantial, and the incidence of adverse reactions must be viewed in this context. Type A reactions are believed to be responsible for up to 3% of acute hospital admissions and 2%~3% of consultations in general practice. In hospital, clinically significant adverse reactions are estimated to complicate 10%~20% of all admissions, prolongin

4. C 型：由于长期使用药物引起的持续反应（与神经阻滞剂有关的迟发性运动障碍或镇痛性肾病）；

5. D 型：延迟反应（烷化剂导致致癌，或维甲酸相关致畸形）；

6. E 型：停用反应如停用皮质类固醇后肾上腺皮质功能不全，停用可乐定，苯二氮卓类，三环类抗抑郁药或 β-肾上腺素受体拮抗剂终止使用后的综合征。
   在英国，直接或处方药品有 30000 到 40000 种之间。最近的一项调查显示，大约 80% 的成年人在任何 2 周的时间内服用某种药物。因此，人群中的药物暴露量很大，必须从这个角度来看待不良反应的发生率。A 型反应被认为是造成急性住院的高达 3%，在一般实践中占 2%~3%。在医院中，临床上显着的不良反应估计使全部住院病人的 10%~20% 复杂化，延长住院时间，造成痛苦和可观的死亡人数以及浪费资源，是新生儿/老年人中最常见和最严重的，女

   drug reactions often occur early in therapy (during the first 1~10day).

   The drugs most commonly implicated are digoxin, antimicrobials, diurectics, potassium salt replacements, analgesics, sedatives and major tranquillizers, insulin, aspirin, glucocorticosteroids, antihypertensives and warfarin

   Factors involved in the etiology of adverse drug reactions can be classified

7. patient factors
   Intrinsic:

   Age: neonatal, infant and elderly

   Sex: hormonal environment

1. 拓展练习

在一定温度下1g粉体所吸附的气体体积(cm3)对气体压力绘图可得什么？

A. 吸附等量线 B. 吸附等温线 C. 吸附等压线 D. 吸附等体积线

答案：B

2. 拓展练习

植入片一般长度不大于多少？

A. 6mm B. 10mm C. 12mm D. 8mm

答案：D

3. 拓展练习

卡尔-费休(Karl-Fisher)提出测定水的方法是在哪一年？

A. 1955年 B. 1945年 C. 1925年 D. 1935年

答案：D

4. 拓展练习

得到的曲线即为校正曲线，该曲线是通过什么操作得到的？

A. 度对峰高度作图 B. 度对峰面积作图 C. 度对峰体积作图 D. 度对峰宽度作图

答案：B

5. 拓展练习

首先需要了解一种动物如何活动应该掌握什么知识？

A. 了解它的饮食习惯 B. 了解它的生活环境 C. 了解它的构成 D. 了解它的行为

答案：C

6. 拓展练习

治疗药物临测的英文缩写是？

A. TDM B. TDI C. TIR D. TDA

答案：A

7. 拓展练习

II 期临床试验研究确定这种新药是否对适当的疾病患者产生预期效果。这项研究必须在哪个国家的药物安全委员会提交临床前和 I 期临床试验研究结果后才能进行？

A. 英国 B. 德国 C. 美国 D. 法国

答案：A

8. 拓展练习

制药行业希望在产品最终上市后收回什么？

A. 研发成本 B. 开发成本 C. 生产成本 D. 制造成本

答案：B

9. 拓展练习

法国人创造了“药物警戒”的概念是在哪一年？

A. 1994年 B. 1984年 C. 1964年 D. 1974年

答案：D

10. 拓展练习

美国国会通过药品检查实验室、药品生产许可证等相关法案是在哪一年？

A. 1848 年 B. 1868 年 C. 1858 年 D. 1838 年

答案：A

11. 拓展练习

根据原文，Yugen Kaisha (Y.K.) 等于英语中的什么公司类型？

A. Limited liability company B. Limited company C. Limited partnership D. Public limited company

答案：A

12. 拓展练习

E7部分的研究主题是什么？

A. 对特定族群的支持的研究：神经病学 B. 对特定族群的支持的研究：心脏病学 C. 对特定族群的支持的研究：老人病学 D. 对特定族群的支持的研究：儿科

答案：C

13. 拓展练习

判例法被认为是法律渊源之一，与什么相对？

A. 刑法 B. 民法 C. 制定法 D. 商法

答案：C

14. 拓展练习

妊娠周期的英文是？

A. Duration of pregnancy B. Duration of lactation C. Duration of embryonic development D. Duration of fetal development

答案：A

15. 拓展练习

炎症性肠病(IBD)包括哪些疾病？

A. 溃疡性结肠炎(UC)和克罗恩病(CD) B. 溃疡性结肠炎(UC)和克罗恩病(CD)及特异性肠道炎症性疾病 C. 溃疡性结肠炎(UC)和非特异性肠道炎症性疾病 D. 克罗恩病(CD)和特异性肠道炎症性疾病

答案：A

16. 拓展练习

人的评价可以分为几个阶段？

A. 四个阶段 B. 五个阶段 C. 六个阶段 D. 三个阶段

答案：A

17. 拓展练习

儿童用药的独占权法规规定儿童用药可以获得多少个月的市场独占权？

A. 6个月 B. 8个月 C. 12个月 D. 5个月

答案：A

18. 拓展练习

GD-MS 作为唯一的高纯物质分析仪器在哪些地区得到广泛应用？

A. 中国，日本，美国 B. 亚洲，欧洲，美洲 C. 欧洲，俄罗斯，美国 D. 欧洲，日本，美国

答案：D

19. 拓展练习

GCG是哪个委员会的分支委员会？

A. ICH指导委员会 B. ICH执行委员会 C. ICH评估委员会 D. ICH监督委员会

答案：A

20. 拓展练习

通常采用高、中、低三种浓度的同一样品，每种浓度配制多少份，置冰箱冷冻？

A. 7～15份 B. 5～10份 C. 5～15份 D. 7～10份

答案：D

21. 拓展练习

粒细胞一巨噬细胞集落刺激因子的英文缩写是什么？

A. G-CSF B. GM-SSF C. GM-CSF D. GS-CSF

答案：C

1.

药物因素

药物相互作用

药品批次问题，保质期，错误配药

药物不良反应监测/监测药物警戒

药物安全性的评估是复杂的，监测药物不良反应的方法有很多。每一个都有自己的优点和缺点，没有一个单一的制度可以提供舆论期望的绝对安全。理想的方法是以高度的敏感性和特异性鉴别药物不良反应，并迅速做出反应。

它可以检测罕见但严重的药物不良反应，但不会被普通药物所淹没，其发生率将与易感因素一起量化。新药上市后必须持续监测，因为初步检测是不可避免的药物在人体内的药物开发虽然排除了许多不良影响，但不能识别不寻常的副作用。已经引入了多种早期检测方法来尽可能迅速地识别药物不良反应。

Early (Phase I/II) trials are important for assessing the tolerability and dose-response relationship of new therapeutic agents, However, these studies are very insensitive at detecting adverse reactions because they are performed on relatively few subjects (perhaps 200~300).This is illustrated by the failure to detect the serious toxicity of several drugs (practolol, benoxaprofen, temafloxacin ,felbamate, dextfenfluramine and fenfluramin, troglitazone) before marketing. However, phase III clinical trials can establish the incidence of common adverse reactions and relate this to therapeutic benefit. Analysis of the reasons given for dropping out of phase III trials is particularly valuable in establishing whether common events such as headache, constipation, lethargy or male sexual dysfunction are truly drug related. The Medical Research Council Mild Hypertension Study unexpectedly identified impotence as being more commonly associated with thiazide diuretics than with placebo or beta-adrenoreceptor antagonist therapy in this way.

The problem of adverse drug reaction recognition is much greater if the reaction resembles spontaneous disease in the population, such that physicians are unlikely to attribute the reaction to drug exposure, The numbers of patients that must be exposed to enable such reactions to be detected are probably greater than those quoted by more than one or two orders of magnitude.

I / II / III 期试验

早期（I / II 期）试验对于评估新型治疗药物的耐受性和剂量反应关系是重要的。然而，这些研究对于检测不良反应非常不敏感，因为它们是在相对较少的受试者（可能为 200-300）下进行的。这可以通过在销售前未检测到几种药物（普罗洛尔，苯氧丙酸，替马沙星，非氨酯，右芬氟拉明和芬氟拉明，曲格列酮）的严重毒性来说明。然而，III 期临床试验可以确定常见不良反应的发生率，并将其与治疗益处联系起来。对于剔除 III 期临床试验的原因的分析，对于确定头痛，便秘，嗜睡或男性性功能障碍等常见事件是否真正与药物有关是特别有价值的。 医学研究委员会轻度高血压研究出乎意料地发现，与安慰剂或 β-肾上腺素受体拮抗剂治疗相比，噻嗪类利尿剂更通常与阳痿相关。

如果反应类似于人群中的自发性疾病，则药物不良反应识别的问题更为严重，因此医生不太可能将反应归因于药物暴露。必须暴露以使得能够检测到这种反应的患者的数目可能大于那些超过一个或两个数量级的引用。

Lead compounds