WordNet

place a new load on; "The movers reloaded the truck"

PrepTutorEJDIC

〈鉄砲〉‘に'弾丸を込め直す

Wikipedia preview

出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2017/09/06 18:23:39」(JST)

wiki en

[Wiki en表示]

Challenge–dechallenge–rechallenge (CDR) is a medical testing protocol in which a medicine or drug is administered, withdrawn, then re-administered, while being monitored for adverse effects at each stage. The protocol is used when statistical testing is inappropriate due to an idiosyncratic reaction by a specific individual, or a lack of sufficient test subjects and unit of analysis is the individual. During the withdraw phase, the medication is allowed to wash out of the system in order to determine what effect the medication is having on an individual.

Use in drug testing

CDR is one means of establishing the validity and benefits of medication in treating specific conditions^[1] as well as any adverse drug reactions. The Food and Drug Administration of the United States lists positive dechallenge reactions (an adverse event which disappears on withdrawal of the medication) as well as negative (an adverse event which continues after withdrawal), as well as positive rechallenge (symptoms re-occurring on re-administration) and negative rechallenge (failure of a symptom to re-occur after re-administration).^[2] It is one of the standard means of assessing adverse drug reactions in France.^[3]

Fluoxetine and suicide

Peter Breggin asserted that there was an association between fluoxetine (Prozac) use and suicidal ideation. While his research group were investigating the effectiveness and side effects of the medication, Breggin noticed that only certain individuals responded to the medication with increased thoughts of suicide, and used the challenge-dechallenge-rechallenge protocol in an effort to verify the link. Given the low occurrence rate of suicidality, statistical testing was considered inappropriate.^[4] Other researchers have similarly suggested that the CDR is useful for researching the adverse effect of suicidality while taking fluoxetine, and Eli Lilly adopted the protocol rather than randomized controlled trials when testing for increased risk of suicide.^[5] In addition to suicidality, akathisia is a reaction to medication which is suggested as amendable to a CDR protocol.^[6]^[7]

Clinical trials using a CDR protocol are also reported for clinicians attempting to assess the effects of a medication on patients.^[8] Detection of Dechallenge in spontaneous Reporting System ^[9]

Self-monitoring

CDR has been suggested as a means for patients to perform self-diagnosis, self-treatment and monitoring of their own reactions to medications.^[10]

References

^ Spitzer WO (1986). "Importance of valid measurements of benefit and risk". Med Toxicol. 1 Suppl 1: 74–8. PMID 3821430.
^ "Guideline for Adverse Experience Reporting for Licensed Biological Products: Definitions". Food and Drug Administration. Archived from the original on 2007-10-07. Retrieved 2008-03-15.
^ Begaud B (1984). "Standardized assessment of adverse drug reactions: the method used in France. Special workshop—clinical". Drug Inf J. 18 (3–4): 275–81. PMID 10268556. doi:10.1177/009286158401800314.
^ Breggin, Ginger Ross; Breggin, Peter Roger (1995). Talking back to Prozac: what doctors won't tell you about today's most controversial drug. New York: St. Martin's Paperbacks. ISBN 0-312-95606-1.
^ Maris, RWM (2002-10-04). "Suicide and Neuropsychiatric Adverse Effects of SSRI Medications: Methodological Issues". Philadelphia, Pennsylvania. Archived from the original on November 20, 2008. Retrieved 2008-03-15.
^ Healy D, Whitaker C (2003). "Antidepressants and suicide: risk-benefit conundrums". J Psychiatry Neurosci. 28 (5): 331–7. PMC 193979 . PMID 14517576.
^ Healy D (2003). "Lines of evidence on the risks of suicide with selective serotonin reuptake inhibitors". Psychother Psychosom. 72 (2): 71–9. PMID 12601224. doi:10.1159/000068691.
^ Rothschild AJ, Locke CA (1991). "Reexposure to fluoxetine after serious suicide attempts by three patients: the role of akathisia". J Clin Psychiatry. 52 (12): 491–3. PMID 1752848.
^ Banu AB, Alias Balamurugan SA, Thirumalaikolundusubramanian P (2014). "Detection of dechallenge in spontaneous reporting systems: A comparison of Bayes methods". Indian J Pharmacol. 46 (3): 277–80. doi:10.4103/0253-7613.132157.
^ Charlton BG (2005). "Self-management of psychiatric symptoms using over-the-counter (OTC) psychopharmacology: the S-DTM therapeutic model—Self-diagnosis, self-treatment, self-monitoring". Med. Hypotheses. 65 (5): 823–8. PMID 16111835. doi:10.1016/j.mehy.2005.07.013.

UpToDate Contents

全文を閲覧するには購読必要です。 To read the full text you will need to subscribe.

1. 全身化学療法に対する輸注反応 infusion reactions to systemic chemotherapy
2. 癌治療に用いられる治療用モノクローナル抗体に対する輸注反応 infusion reactions to therapeutic monoclonal antibodies used for cancer therapy
3. 小児におけるセリアック病のマネージメント management of celiac disease in children
4. トラスツズマブおよびその他の抗HER2薬の心毒性 cardiotoxicity of trastuzumab and other her2 targeted agents
5. 成人におけるセリアック病のマネージメント management of celiac disease in adults

English Journal

Experimental Infection and Response to Rechallenge of Alpacas with Middle East Respiratory Syndrome Coronavirus.

Crameri G, Durr PA, Klein R, Foord A, Yu M, Riddell S, Haining J, Johnson D, Hemida MG, Barr J, Peiris M, Middleton D, Wang LF.
Emerging infectious diseases.Emerg Infect Dis.2016 Jun 15;22(6). doi: 10.3201/eid2206.160007. [Epub ahead of print]
We conducted a challenge/rechallenge trial in which 3 alpacas were infected with Middle East respiratory syndrome coronavirus. The alpacas shed virus at challenge but were refractory to further shedding at rechallenge on day 21. The trial indicates that alpacas may be suitable models for infection a
PMID 27070733

Alopecia Areata After Vaccination: Recurrence with Rechallenge.

Chu CH1, Cheng YP1, Chan JL1.
Pediatric dermatology.Pediatr Dermatol.2016 Apr 13. doi: 10.1111/pde.12849. [Epub ahead of print]
Alopecia areata (AA) is the most common form of hair loss in children. We report the case of a child who had two episodes of AA after two different vaccines with complete hair regrowth between the episodes. This case supports the concept that vaccination might be a trigger for the development of AA
PMID 27071855

Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance: The GAUSS-3 Randomized Clinical Trial.

Nissen SE1, Stroes E2, Dent-Acosta RE3, Rosenson RS4, Lehman SJ5, Sattar N6, Preiss D7, Bruckert E8, Ceška R9, Lepor N10, Ballantyne CM11, Gouni-Berthold I12, Elliott M3, Brennan DM1, Wasserman SM3, Somaratne R3, Scott R3, Stein EA13; GAUSS-3 Investigators.
JAMA.JAMA.2016 Apr 3. doi: 10.1001/jama.2016.3608. [Epub ahead of print]
Importance: Muscle-related statin intolerance is reported by 5% to 20% of patients.Objective: To identify patients with muscle symptoms confirmed by statin rechallenge and compare lipid-lowering efficacy for 2 nonstatin therapies, ezetimibe and evolocumab.Design, Setting, and Participants: Two-stage
PMID 27039291