| 药物的不良反应 |
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Difference,
Definition, side Effects, Adverse Drug Event ?
Adverse
Drug Reaction ?
Definition and
Difference, Adverse Drug Events are unexpected, severe Side Effects
associated with Drugs,
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wikipedia 的定义 |
An adverse drug reaction (abbreviated ADR) is
a term to describe the unwanted, negative consequences
sometimes associated with the use of
medications.
It is more precise than, and usually preferred in the
medical field, over the term "side-effect"
as these purported "side"-effects may sometimes be
therapeutically-useful.
While ADR is probably the most precise term to describe the
concept, it is not widely used in the community since it may
be perceived as
jargon
and because of the negative-associations with the term "drug".
Alternative terms with equivalent meaning to ADR include:
side-effect,
adverse event, adverse effect, etc.
（原文） |
but
Adverse Drug Reactions are
unexpected, severe Side Effects caused by Drugs.
Adverse Events -
Adverse Reactions
An
Adverse Drug Reaction (ADR)
is an unwanted or harmful Side Effect
experienced following the administration of a drug or
combination of drugs and is suspected to be related to the drug.
For
Britain's Medical Control Agency (MCA),
the reaction may be a known Side Effect
of the drug or it may be a new previously unrecognized
Adverse Drug Reaction.
For the purposes of
Food and Drug Administration (FDA)
reporting, generally it is considered a reaction that is
unexpected in intensity or in kind - distinct from expected
Side Effects.
To be perfectly exact, "Adverse
Reaction" and "Adverse
Event" are not synonymous.
"Adverse Drug
Event" (ADE)
implies that the event may be coincidental, whereas "Adverse
Drug Reaction" implies that
the event was caused by the drug in question.
In the United States,
Adverse Drug Events are
reported through the
MedWatch system. Anyone can file such a report, and as
the name implies, it is not necessary to be of the opinion that
the drug in question caused the event. In the
United Kingdom, the analogous
Adverse Drug Event Report
is called a Yellow Card.
药物不良反应事件是指药品治疗过程中出现的不利临床事件，便该事件未必与药物有因果关系。
不良事件所包含临床新出现的偶然事件及药物不良反应。
1.超过常规使用剂量引起的中毒反应，为ADE.
2.合格药品因非药物成分因素差异引起的不利后果，为ADR。
而由不合格药品（药品质量问题）引起的不良事件，为ADE。
3.在一种新药或药品的新用途的临床试验中，其治疗剂量尚未确定是时，所有有害而非所期望的、与药品应用有因果关系的反应，也应视为药物的不良反应。
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