Ticket 27

1. Basic principles and methods of testing new medicinal substances. The concepts of "placebo" and "blind" control. The ethical side of prescribing a placebo.

Principles of clinical research of new drugs: • Selection of a homogeneous population of patients; • Exact e-z b-no and a similar severity of the disease; • Control group b-n; • Similar dosage of drugs; • Pharmacokinetic research; • Choice of sensitivities of the effects typical for the given island;

• Quantification of effects; • Sufficient research volume for static processing; • Use of "placebo" and "double-blind method" research; • Comparison with reference drugs of this group; • Simultaneous research of new and reference drugs; • Compliance with ethical principles.

1. In the double-blind method, neither the patient nor the doctor conducting the study knows which drug the patient is receiving. This is known only to the head of the test. This method eliminates the possibility of a doctor or patient's prejudice against a new drug, their prediction of the results of treatment, etc., which may affect the assessment of the effectiveness of the drug. However, when planning the trial, measures must be taken to ensure that the drug is quickly identified by the attending physician, if the patient's interests so require.

2. In a single "blind" trial, the patient is not aware of the treatment with a new drug, but the researcher is aware of it. It is believed that such a test is almost always less satisfactory than a double-blind test, and the small gain in convenience is unlikely to compensate for the potential loss in learning precision.

3. The most often used in practice, "open test", in which both the researcher and the patient know the method of treatment. Often open testing is the only possible method. They should not be less specific than double-blind testing, provided that the principle of random sampling and stratification is applied. When researching new drugs, testing should be limited.

• Placebo - a substance with no apparent medicinal properties, used to simulate a drug in studies where the estimated effect may be distorted by the patient's belief in the efficacy of the drug, or to improve the patient's well-being in the absence of a more effective drug.

However, the use of a placebo is ethically acceptable (even in the presence of effective therapy) in cases: 1) when the use of a placebo is absolutely necessary to assess the effectiveness or safety of a medical method; 2) when patients will not be at additional risk of serious or irreversible harm because a medical method is being studied for a minor illness.

2. Non-steroidal anti-inflammatory drugs (Non-narcotic analgesics) Classification. The mechanism of their anti-inflammatory, analgesic, antipyretic action. Indications for use. Side effects. Contraindications Comparative assessment of drugs.

• fur acts: they inhibit type 3 cyclooxygenase. They inhibit the formation of mediators of pain, inflammation, and fever.

• indications: headache; myalgia; neuralgia; arthralgia; fever; postoperative pain

• side effects: anemia; thrombocytopenia, agranulocytosis; leukopenia; skin rashes; itching; angioedema.

• contraindications: - Hypersensitivity to paracetamol, hepatic and renal failure; - When using rectal suppositories, inflammatory diseases of the rectal mucosa are contraindications.

In terms of analgesic and antipyretic effectiveness, paracetamol roughly corresponds to aspirin. Unlike aspirin, it has no damaging effect on the gastric mucosa and does not affect platelet aggregation