反応源性、反応性
- 関
- reactive、reactivity、responsive、responsiveness
WordNet
- readily reacting or replying to people or events or stimuli; showing emotion; "children are often the quickest and most responsive members of the audience"
- containing or using responses; alternating; "responsive reading"; "antiphonal laughter" (同)antiphonal
- participating readily in reactions; "sodium is a reactive metal"; "free radicals are very reactive"
- reacting to a stimulus; "the skin of old persons is less reactive than that of younger persons" (同)responsive
- responsive to stimulation (同)reactivity
- the quality of being responsive; reacting quickly; as a quality of people, it involves responding with emotion to people and events
- ready susceptibility to chemical change
PrepTutorEJDIC
- すぐ反応する,共鳴しやすい;応答する
- 反作用の;化学反応を示す…反動的な
- 反作用,反応 / 反動的傾向
Wikipedia preview
出典(authority):フリー百科事典『ウィキペディア(Wikipedia)』「2015/02/24 01:12:09」(JST)
[Wiki en表示]
In clinical trials, the term reactogenicity refers to the property of a vaccine of being able to produce common, “expected” adverse reactions, especially excessive immunological responses and associated signs and symptoms—fever, sore arm at injection site, etc. (Much less frequently, the term has also been applied to therapeutic drug trials.) Other manifestations of reactogenicity typically assessed in such trials include bruising, redness, induration, and swelling.
The term reactogenicity was coined by the US Food and Drug Administration (FDA). Typically, reactogenicity is seen in the presence of an adjuvant (chemical additive intended to enhance the recipient's immune response to the vaccine antigen), but can also occur with non-adjuvanted vaccines. Reactogenicity describes immediate short-term reactions to vaccines, not long term sequelae. Assessments of reactogenicity are carried out to evaluate the safety and usability of an experimental vaccine (see Investigational New Drug). It is unclear whether a higher degree of reactogenicity to a vaccine actually correlates with more severe adverse events, such as would require hospitalization or be life-threatening. Occasionally they do, but this could be an accidental concurrence. After many years of assessing large databases relating to these events, the FDA has not been able to make any such association.
Formal definitions
The US National Institutes of Health (NIH) has provided the following “definition of reactogenicity” in a suggested template for clinical trials protocols:[1]
Reactogenicity events are adverse events that are common and known to occur for the intervention/investigational product being studied and should be collected in a standard, systematic format using a graded scale based on functional assessment or magnitude of reaction. Provide a definition of expected vs. unexpected AEs and local vs. systemic events, based on the risk profile of the intervention/investigational product. This information is found on the CIB or package insert. Typically, reactogenicity adverse events are solicited and collected on diary cards or a reactogenicity case report form.
Example of a functional scale for assessing reactogenicity or other parameters not specifically listed in the toxicity table:
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- 0 = Absence of the indicated symptom
- 1 = Mild (awareness of a symptom but the symptom is easily tolerated)
- 2 = Moderate (discomfort enough to cause interference with usual activity)
- 3 = Severe (incapacitating; unable to perform usual activities; requires absenteeism or bed rest)
- 4 = Life-threatening
References
- ^ NIH (2004), [glrce.org/docs/NIH%20Clinial%20trial%20protocol%20template.doc DIMD Protocol Template].
UpToDate Contents
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English Journal
- A trivalent, inactivated influenza vaccine (Vaxigrip®): summary of almost 50 years of experience and more than 1.8 billion doses distributed in over 120 countries.
- Haugh M1, Gresset-Bourgeois V2, Macabeo B2, Woods A2, Samson SI2.
- Expert review of vaccines.Expert Rev Vaccines.2017 May 10:1-20. doi: 10.1080/14760584.2017.1324302. [Epub ahead of print]
- PMID 28460594
- Vaccine profile of herpes zoster (HZ/su) subunit vaccine.
- Cunningham AL1, Heineman T2.
- Expert review of vaccines.Expert Rev Vaccines.2017 May 9. doi: 10.1080/14760584.2017.1329012. [Epub ahead of print]
- PMID 28486850
- Passive enhanced safety surveillance for Vaxigrip and Intanza 15 µg in the United Kingdom and Finland during the northern hemisphere influenza season 2015/16.
- Bricout H1, Chabanon AL1, Souverain A1, Sadorge C1, Vesikari T2, Caroe TD3.
- Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin.Euro Surveill.2017 May 4;22(18). pii: 30527. doi: 10.2807/1560-7917.ES.2017.22.18.30527.
- PMID 28494843
Japanese Journal
- 臨床研究・症例報告 乾燥弱毒生麻疹風疹混合ワクチン(MRワクチン)の副反応の検討(第2報)2期接種における2社(武田,阪大微研)製品の副反応の比較
- 臨床研究・症例報告 乾燥弱毒生麻疹風疹混合ワクチン(MRワクチン)の副反応の検討(第1報)1期接種における2社(武田,阪大微研)製品の副反応の比較
- A combined liqid Hib (PRP-OMPC). hepatitis B. diphtheria, tetanus and whole-cell pertussis vaccine : controlled studies of immunogenicity and reactogenicity
Related Links
- reactogenicity (rē-ak-tō-je-nĭ-sĭ'tē), State of being able to produce adverse reactions. reactogenic (rē-ak″tŏ-jen′ik) [ react(ion) + -genic] Capable of producing a physiologic response, as a vaccine that elicits an antibody response. ...
- The definition information for reactogenicity is provided by Stedman's. You can search our medical dictionary here. Stedman's, part of Lippincott Williams & Wilkins, provides a comprehensive line of health-science publications for ...
Related Pictures
★リンクテーブル★
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- react、reaction、reactive、reactivity、reactogenicity、respond、response、responsiveness、responsivity
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- 英
- responsiveness、reactivity、reactogenicity、responsive、reactive
- 関
- 応答性、反応、反応源性
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- reactive、reactivity、reactogenicity、responsive、responsivity
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- 関
- reactivity、reactogenicity、responsive、responsiveness
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- reactive、reactogenicity、responsive、responsiveness