The two sister disciplines of clinical pharmacology and clinical pharmacy were newly emerging disciplines in the 1960s. Penetration between peripheral disciplines is particularly prominent among them, making it difficult for medical workers to distinguish. Although both belong to the category of pharmacy, each has its own research purpose and focus.
Clinical pharmacology is a discipline that studies the law of interactions between drugs and the human body. It is not only the final comprehensive stage in pharmacological research, but also a new branch of pharmacology. The main feature that distinguishes it from basic pharmacology research is that clinical pharmacology research is carried out in the human body. Clinical pharmacology research is one of the most important contents in evaluating new drugs.
Early clinical pharmacology can be simply regarded as “testing with humans”, and the direct observation of pharmacological effects with humans is an example of Lind’s treatment of scurvy sailors with lemon oranges in 1747. However, when clinical pharmacology was formally proposed as a discipline, it should be counted from 1947. In 1974, Professor Gold from the United States held a lecture on clinical pharmacology at Cornell University, thus ushering in a new era of clinical science. In the following 20 years, due to the development of the chemical synthesis industry, the number of new drugs increased sharply.
Species differences (including differences between human races, and differences between humans and animals) are a relatively important content in clinical pharmacology. Species differences make clinical pharmacology not support the direct promotion of a drug that has passed animal experiments into the clinic. Even between different races, because of the existence of species differences, it is not appropriate to directly use the drug on different races. . For example, the pupil dilation effect of ephedrine is the strongest in white people, followed by yellow people, and almost no black people. In particular, the occurrence of thalidomide (thalidomide) incident in West Germany in the 1960s made clinical pharmacology research really attract the attention of relevant administrative departments and medical scientific circles in many countries, and thus established its role in new drug research. Reasonable location.
Main tasks of clinical pharmacology research in new drug evaluation
1. Observing the curative effect and toxic and side effects of new drugs on people, and studying the laws of transport and transformation of new drugs in the human body. This kind of research is carried out under the guidance of an experienced clinical pharmacologist in a hospital with advanced equipment after the approval of the relevant national authority. In recent years, the extensive application of mathematics, physics, chemistry and electronic technology has made the evaluation of pharmacodynamics (physiological indicators such as ECG, EEG, respiration, etc.; biochemical indicators such as changes in camppg concentration, etc.) to a microscopic level. The application of gas chromatography, high performance liquid chromatography, radioimmunity and other technologies has solved the problem of drug microanalysis that could not be solved in the past, and finally obtained a drug in vivo kinetic parameter. In this way, the standards and methods for measuring the quality of medicines are transferred from outside the human body to the inside of the human body. It has made a big step in the evaluation of the pharmacodynamics and pharmacokinetics of new drugs. This task is mainly accomplished through Phase I-III clinical studies.
2. Long-term in-depth clinical observation of the efficacy and toxic and side effects of new drugs is a regular work in clinical pharmacology research. Purposeful, planned and organized evaluation of the long-term efficacy and adverse reactions of a drug in a group of patients is the main form of the fourth phase of clinical research. For example, from 1961 to 1966, the American Diabetes Research Group collected a total of 1027 patients from 12 universities in Nengjia cooperation to observe the prevention of vascular complications during the development of diabetes. The results found that the patients in the tolbutamide group had cardiovascular mortality. Significantly higher than other drug groups, so in 1969 to stop using tolbutamide. The US FDA has a special drug use experience department responsible for collecting reports of side effects of new drugs on the market (including spontaneous reports from medical staff in various places). In my country, there are scattered reports of the drug experience of clinicians and pharmacists or the occasional adverse reactions of a certain drug. Such an organized, purposeful and large-scale Phase IV clinical study still lags behind that of developed countries.
Different from related studies
Main Difference Between Clinical Pharmacology and Clinical Pharmacy
(1) Research objects The work in these two fields has been very active in recent years. Because the research objects are people, a cautious attitude should be taken, especially in the evaluation of new drugs.
(2) If the research scope of clinical pharmacology is purely new drug evaluation, it is undoubtedly the scope of clinical pharmacology. However, like the new use of old drugs and the mechanism of action of traditional Chinese medicine, such as the study of prostaglandin levels in the amniotic fluid of Rivanol during labor induction; the comparison of urinary 17-hydroxycorticosteroids in the treatment of rheumatoid arthritis by Tripterygium wilfordii; the old drug phenytoin sodium The determination of pharmacokinetic parameters in normal healthy human body, such as digoxin, gentamicin, etc., should be the content of clinical pharmacology. Because it is an evaluation of an old drug, the trial does not need to be approved by the authority, but some trials are less thorough in terms of reporting. Such as the description of normal health without routine physical examination and necessary laboratory examination and dietary control.
(3) Scope of clinical pharmacy The discussion of clinical pharmacy centered on rational drug use is very lively and the content is quite extensive. Such as prescription analysis; summarizing rational drug use; pharmacists go deep into clinical practice and share similar drug regimens with doctors; act as drug consultation; pharmacokinetics tests, etc.
(IV) Differences between the two As far as pharmacokinetic tests are concerned, it is generally believed that the main difference between clinical pharmacology and clinical pharmacy is that the main test subjects were normal healthy people, and every drug for systemic use on the market should have a pharmacokinetic profile. Kinetic data. The test objects of the latter are patients, especially those with poor liver and kidney functions. The tested drugs are mainly limited to a few drugs with low therapeutic index and nonlinear kinetic characteristics, and the elimination constant in vivo is related to the dose.
Main Functions of Clinical Pharmacology Staff
(1) Responsible for clinical pharmacology research of new drugs The clinical pharmacology base of the Ministry of Health should actively undertake the clinical pharmacology research of a drug, and technically has the responsibility to guide and assist clinical hospitals in various regions to carry out and conduct clinical trials and verifications of new drugs. It is also responsible for formulating clinical research plans, organizing clinical trials, and jointly completing new drug clinical research tasks approved by the Ministry of Health or the health departments and bureaus of provinces, autonomous regions, and municipalities directly under the Central Government with hospitals designated by the health departments and bureaus of all provinces, autonomous regions, and municipalities directly under the Central Government. After the clinical research is over, a scientific summary report is written and sent to the research and development unit and copied to the Ministry of Health and the health departments and bureaus of relevant provinces, autonomous regions and municipalities directly under the Central Government.
(2) Clinical re-evaluation of the produced drugs. Each clinical pharmacology base should actively carry out the re-evaluation of the marketed drugs of a certain type of drugs, and treat the drugs with inaccurate curative effect, adverse reactions or other reasons that endanger people’s health according to the hygiene standards. According to the actual situation of the unit, conduct social surveys, collect data, combine experimental research, analyze and adjust, and make scientific conclusions. Submit comments to the Ministry of Health and the Health Department and Bureau.
(3) Responsible for drafting the clinical trial indicators and evaluation principles of various drugs. Each clinical pharmacology base is responsible for drafting the requirements, contents and observation indicators and clinical evaluation principles of various drugs for clinical trials and clinical verification, so that the clinical research of various drugs can meet the Standardized requirements.
(4) Guide the clinical rational drug use to carry out adverse drug reaction monitoring and improve the level of drug treatment. When carrying out clinical pharmacology research, each clinical base should accumulate experience in the safe and effective use of new and old drugs, make scientific summaries at any time, carry out tasks such as epidemiology of adverse drug reactions and drug abuse, and have the responsibility to guide doctors. Rational drug use.
(5) Provide clinical pharmacology training for doctors who conduct clinical research on new drugs, and designate doctors in hospitals with conditions to conduct clinical trials of new drugs to hold training courses at least once a year, and small training courses can also be held by specialties. Other clinical pharmacology bases can also gradually create conditions to hold training courses for local clinical pharmacology backbones. The bases can be connected horizontally, communicate with each other, and gradually write unified clinical pharmacology lecture notes, so that the training level can be continuously improved.
(6) Carry out professional consultation on clinical pharmacology and exchange of information and intelligence. Each clinical pharmacology base should actively carry out clinical pharmacology consultation, and units with conditions should be open to the society. For drugs with a narrow therapeutic range, blood concentration monitoring should be carried out in the unit to provide a scientific basis for clinical treatment, and every effort should be made to ensure that the drug is safe and effective. Information exchange should be carried out between bases, which is an extremely important means to promote the development of clinical pharmacology work.
(7) To undertake temporary tasks and temporary clinical pharmacology tasks assigned by the Ministry of Health and the Department of Health.