Linearity in Dose—Response from Zinc Lozenges in Treatment of Common Colds

1995 ◽  
Vol 11 (3) ◽  
pp. 110-122 ◽  
Author(s):  
George A Eby
Keyword(s):  
Dose Response ◽  
Common Cold ◽  
Data Extraction ◽  
Cold Treatment ◽  
Electric Circuit ◽  
Zinc Ion ◽  
Data Sources ◽  
Data Synthesis ◽  
Zinc Speciation

Objective: To test the hypothesis that major variations in daily zinc ion availability (ZIA) between lozenge formulations caused greatly differing results and to describe the biologically closed electric circuit between the mouth and nose. Data Sources: Data sources included clinical and in vitro reports, zinc speciation computations, and unpublished data from the original researchers and manufacturers. Data Extraction: Data were extracted to determine the composition and usage of lozenges and resultant changes in common cold duration. Lozenge ZIA values were determined from Zn2+ ion concentrations and oral contact time. Data Synthesis: Data synthesis disclosed that lozenges releasing Zn2+ ions at physiologic pH (positive ZIA values) shortened the duration of colds. Conversely, lozenges that released negatively charged zinc complexes (ZnLN−) at physiologic pH (negative ZIA values) lengthened the duration of colds. ZIA 100 lozenges reduced the duration of colds by 7 days. ZIA 0 lozenges had no effect. ZIA −55 lozenges lengthened the duration of colds by 4.4 days. Conclusions: The hypothesis is valid that major variations in ZIA from different zinc lozenge formulations used in clinical trials caused greatly differing results. A linear dose-response relationship exists between ZIA values of zinc lozenges and changes in duration of common colds. In agreement with in vitro activity, Zn2+ ions from lozenges inhibit replication of rhinoviruses, induce interferon release, and stabilize cell membranes in common cold treatment. Linearity in dose-response shows efficacy against common cold duration from clinically untested lozenges to be predictable on the basis of readily determined ZIA values of experimental lozenges.

scholarly journals Prioritising recommendations following analyses of adverse events in healthcare: a systematic review

2020 ◽  
Vol 9 (4) ◽  
pp. e000843
Author(s):  
Kelly Bos ◽  
Maarten J van der Laan ◽  
Dave A Dongelmans
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Data Extraction ◽  
Data Sources ◽  
Cochrane Library ◽  
High Quality ◽  
Data Synthesis ◽  
Study Selection ◽  
Personal Opinion ◽  
User Friendly

PurposeThe purpose of this systematic review was to identify an appropriate method—a user-friendly and validated method—that prioritises recommendations following analyses of adverse events (AEs) based on objective features.Data sourcesThe electronic databases PubMed/MEDLINE, Embase (Ovid), Cochrane Library, PsycINFO (Ovid) and ERIC (Ovid) were searched.Study selectionStudies were considered eligible when reporting on methods to prioritise recommendations.Data extractionTwo teams of reviewers performed the data extraction which was defined prior to this phase.Results of data synthesisEleven methods were identified that are designed to prioritise recommendations. After completing the data extraction, none of the methods met all the predefined criteria. Nine methods were considered user-friendly. One study validated the developed method. Five methods prioritised recommendations based on objective features, not affected by personal opinion or knowledge and expected to be reproducible by different users.ConclusionThere are several methods available to prioritise recommendations following analyses of AEs. All these methods can be used to discuss and select recommendations for implementation. None of the methods is a user-friendly and validated method that prioritises recommendations based on objective features. Although there are possibilities to further improve their features, the ‘Typology of safety functions’ by de Dianous and Fiévez, and the ‘Hierarchy of hazard controls’ by McCaughan have the most potential to select high-quality recommendations as they have only a few clearly defined categories in a well-arranged ordinal sequence.

Recovery and Return to Activity Following Exertional Heat Stroke: Considerations for the Sports Medicine Staff

2007 ◽  
Vol 16 (3) ◽  
pp. 163-181 ◽  
Author(s):  
Brendon P. McDermott ◽  
Douglas J. Casa ◽  
Susan W. Yeargin ◽  
Matthew S. Ganio ◽  
Lawrence E. Armstrong ◽  
...  
Keyword(s):  
Data Extraction ◽  
Heat Stroke ◽  
Data Sources ◽  
Exertional Heat Stroke ◽  
Data Synthesis ◽  
Residual Symptoms ◽  
Study Selection ◽  
Initial Care ◽  
Type Data ◽  
Return To Activity

Objective:To describe the current scientific evidence of recovery and return to activity following exertional heat stroke (EHS).Data Sources:Information was collected using MEDLINE and SPORTDiscus databases in English using combinations of key words, exertional heat stroke, recovery, rehabilitation, residual symptoms, heat tolerance, return to activity, and heat illness.Study Selection:Relevant peer-reviewed, military, and published text materials were reviewed.Data Extraction:Inclusion criteria were based on the article’s coverage of return to activity, residual symptoms, or testing for long-term treatment. Fifty-two out of the original 554 sources met these criteria and were included in data synthesis.Data Synthesis:The recovery time following EHS is dependent on numerous factors, and recovery length is individually based and largely dependent on the initial care provided.Conclusion:Future research should focus on developing a structured return-to-activity strategy following EHS.

Nonthrombocytopenic Purpura Associated Sequentially with Nifedipine and Diltiazem

1992 ◽  
Vol 26 (9) ◽  
pp. 1089-1090 ◽  
Author(s):  
Margaret Kuo ◽  
Nancy Winiarski ◽  
Serafino Garella
Keyword(s):  
Adverse Effect ◽  
Channel Blocker ◽  
Case Reports ◽  
Data Extraction ◽  
Data Sources ◽  
Cutaneous Vasculitis ◽  
Laboratory Studies ◽  
Pertinent Literature ◽  
Data Synthesis ◽  
Purpuric Rash

OBJECTIVE: To report the case of a patient who developed nonthrombocytopenic purpura sequentially following the administration of nifedipine and diltiazem. DATA SOURCES: Case reports, MEDLINE review of pertinent literature, and review of relevant studies. DATA EXTRACTION: Data were extracted from direct patient observation and review of laboratory studies and published reports. DATA SYNTHESIS: Nonthrombocytopenic purpura secondary to cutaneous vasculitis is a known, although rare, adverse effect of nifedipine. It has not been reported in association with diltiazem. We report the case of a 75-year-old woman in whom a purpuric rash demonstrated by biopsy to be attributable to cutaneous vasculitis developed in the course of nifedipine therapy. The rash disappeared after discontinuation of the drug; however, it recurred when diltiazem therapy was initiated. CONCLUSIONS: Nonthrombocytopenic purpura may be associated with diltiazem as well as with nifedipine. When this adverse effect occurs following administration of a calcium-channel blocker, caution is advised in using other agents of the same class.

Isoniazid-Associated Psychosis: Case Report and Review of the Literature

1993 ◽  
Vol 27 (2) ◽  
pp. 167-170 ◽  
Author(s):  
Karen A. Pallone ◽  
Morton P. Goldman ◽  
Matthew A. Fuller
Keyword(s):  
Case Report ◽  
English Language ◽  
Case Reports ◽  
Data Extraction ◽  
Data Sources ◽  
Review Of The Literature ◽  
Data Synthesis ◽  
Medline Search ◽  
Study Selection ◽  
Language Literature

Objective To describe a case of isoniazid-associated psychosis and review the incidence of this adverse effect. Data Sources Information about the patient was obtained from the medical chart. A MEDLINE search of the English-language literature published from 1950 to 1992 was conducted and Index Medicus was manually searched for current information. Study Selection All case reports describing isoniazid-associated psychosis were reviewed. Data Extraction Studies were evaluated for the use of isoniazid, symptoms of psychosis, onset of symptoms, and dosage of isoniazid. Data Synthesis The case report is compared with others reported in the literature. The incidence of isoniazid-associated psychosis is rare. Conclusions The mechanism of isoniazid-associated psychosis is uncertain. It appears that isoniazid was associated with the psychosis evident in our patient and in the cases reviewed.

Weight Gain Associated with Cinnarizine

1992 ◽  
Vol 26 (7-8) ◽  
pp. 928-930 ◽  
Author(s):  
Joaquin Navarro-Badenes ◽  
Inocencia Martínez-Mir ◽  
Vicente Palop ◽  
Elena Rubio ◽  
Francisco J. Morales-Olivas
Keyword(s):  
Weight Gain ◽  
Food Intake ◽  
Randomized Trials ◽  
Case Reports ◽  
Data Extraction ◽  
Data Sources ◽  
Initial Weight ◽  
Data Synthesis ◽  
Previous Level ◽  
The Mean

OBJECTIVE: To report four cases of cinnarizine-induced weight gain. DATA SOURCES: Case reports from a local obesity center and review articles. DATA EXTRACTION: Data were abstracted from spontaneous comments made by patients to one of the authors, who was a doctor at the clinic, and reviewed by the remaining authors. DATA SYNTHESIS: We reviewed the cases of four women, aged 50–57 years without endocrine or metabolic pathologies, that showed weight gain associated with the intake of cinnarizine for one to two years. No other drugs usually were administered during the period in which the women gained weight, although in two cases cinnarizine was associated with dihydroergocristine in the same medicine (Clinadil). The mean weight increase was 6.25 kg (range 4–10). The increases do not appear to be related to whether the patients' initial weight was ideal or excessive. The weight gain was always associated with increased appetite and food intake. One patient discontinued cinnarizine treatment and her weight returned to its previous level. CONCLUSIONS: Cinnarizine is a piperazine derivative used in the treatment of vertigo and in the prophylaxis of migraine. In contrast to related drugs, data about cinnarizine are scarce because randomized trials of cinnarizine have been inconclusive. Our observations indicate that cinnarizine may cause weight gain, as observed with other drugs in the same class.

Mental Tools for Thinking About DNA Technologies in New Ways

2002 ◽  
Vol 126 (3) ◽  
pp. 263-265
Author(s):  
Robert Root-Bernstein ◽  
Michele Root-Bernstein
Keyword(s):  
Creative Thinking ◽  
Data Extraction ◽  
Data Sources ◽  
Biomedical Science ◽  
Biomedical Sciences ◽  
Data Synthesis ◽  
Recognition Pattern ◽  
The Arts ◽  
Study Selection ◽  
Pattern Forming

Abstract Objective.—To investigate the nature of creative thinking in biomedical science with specific applications to molecular pathologies and DNA technologies. Data Sources.—Accounts of breakthroughs and inventions contained in autobiographies, biographies, interviews, and archival sources. Study Selection.—Discoveries that have altered, or may yet alter, basic textbook accounts of biomedical sciences for which appropriate data sources exist. Data Extraction.—Approximately 1000 data sources were analyzed, both within appropriate sciences and in other creative fields, such as the arts. Data Synthesis.—The current analysis is based on a framework described in our previous book, Sparks of Genius, which outlines a general approach to understanding creative thinking. Conclusions.—Creative thinking in all disciplines depends on a common mental “toolkit” that consists of 13 fundamental tools: observing, imaging, abstracting, pattern recognition, pattern forming, analogizing, body thinking, empathizing, dimensional thinking, modeling, playing, transforming, and synthesizing. Scientists recognize and solve problems by observing data that break the patterns established by theories; exploring a system by creating an abstract model with which they can play; and transforming data into feelings, sounds, and other forms that create surprising analogies to already-understood principles. The result of such personal thinking is knowledge combined with sensation and emotion—feeling and understanding synthesized into complete awareness. We illustrate some of these modes of thinking with reference to recent breakthroughs in DNA-related areas and suggest ways in which the use of “tools for thinking” can increase the probability of making further discoveries in the biomedical sciences.

Identification of Risk Factors for Exertional Heat Illness: A Brief Commentary on Genetic Testing

2007 ◽  
Vol 16 (3) ◽  
pp. 222-226 ◽  
Author(s):  
Sheila Muldoon ◽  
Rolf Bunger ◽  
Patricia Deuster ◽  
Nyamkhishig Sambuughin
Keyword(s):  
Risk Factors ◽  
Genetic Testing ◽  
Sports Medicine ◽  
Data Extraction ◽  
Data Sources ◽  
Hereditary Diseases ◽  
Heat Illness ◽  
Data Synthesis ◽  
Exertional Heat Illness ◽  
Type Data

Objective:This commentary discusses known links between Exertional Heat Illness (EHI), Malignant Hyperthermia (MH), and other hereditary diseases of muscle. Genetic and functional testing is also evaluated as measures of fitness to return to duty/play.Data Sources:Reviews and research articles from Sports Medicine, Applied Physiology, and Anesthesiology.Data Extraction:Detailed comparisons of existing literature regarding clinical cases of EHI and MH and the potential utility of genetic testing, specifically the ryanodine receptor (RYR1) gene and other genes related to disorders of skeletal muscle.Data Synthesis:EHI is a complex disorder wherein physiological, environmental, and hereditary factors interact to endanger an individual’s ability to maintain thermal homeostasis.Conclusions:Individuals’ genetic background is likely to play an important role, particularly when EHI recurs. Recurrent EHI has been associated with MH and other genetic disorders, highlighting the importance of identification and exclusion of individuals with known high risk factors.

Predisposing Risk Factors on Susceptibility to Exertional Heat Illness: Clinical Decision-Making Considerations

2007 ◽  
Vol 16 (3) ◽  
pp. 204-214 ◽  
Author(s):  
Michelle Cleary
Keyword(s):  
Relative Risk ◽  
High Risk ◽  
Data Extraction ◽  
Heat Stroke ◽  
Data Sources ◽  
Heat Illness ◽  
Potential Health ◽  
Data Synthesis ◽  
Exertional Heat Illness ◽  
Type Data

Objective:To present strategies for identifying predisposing conditions, susceptibility, and incidence reduction for the most common exertional heat illnesses (EHI): heat cramps, heat exhaustion, and most importantly, heat stroke.Data Sources:A comprehensive literature review of MEDLINE and 1996 to 2006, including all retrospective, controlled studies of EHI risk using the following keywords: exertional heat illness risk, exertional heat stroke risk, and exercise-induced dehydration risk. Search limits included the following: English language, published in the last 10 years, clinical trial, meta-analysis, practice guideline, randomized controlled trial, review, and humans. A manual review was conducted of relevant position statements and book chapters including the reference lists.Data Extraction:To evaluate the quality of the empirical studies to be included in this review, each study must have scored at least 17/22 or 77% of items included when reporting a randomized trial using the CONSORT checklist.Data Synthesis:Many cases of EHI are preventable and can be successfully treated if the ATC® identifies individuals at increased relative risk and implement appropriate prevention strategies. The ability to objectively identify individuals at increased relative risk of EHI and to provide appropriate monitoring is critical in EHI prevention and reduction of repeated incidents of EHI.Conclusions:For any heat illness prevention program to be effective, greater attention and continued observation is needed for athletes at high risk for EHI. For many athletic teams or programs, because of the sheer numbers and associated catastrophic injury potential, health care professionals must implement a system by which high-risk individuals are monitored during activity with the highest level of vigilance for prevention of EHI.

FDA Policy on Unapproved Drug Products: Past, Present, and Future

2005 ◽  
Vol 39 (7-8) ◽  
pp. 1260-1264 ◽  
Author(s):  
Renu Chhabra ◽  
Mary E Kremzner ◽  
Brenda J Kiliany
Keyword(s):  
Data Extraction ◽  
Drug Regulation ◽  
Data Sources ◽  
Federal Regulations ◽  
Data Synthesis ◽  
Safety And Efficacy ◽  
Drug Products ◽  
The Past ◽  
Study Selection ◽  
History Of

OBJECTIVE To review the history of drug regulation by the Food and Drug Administration (FDA) as it relates to unapproved drugs and FDA policy, along with the FDA's efforts to avoid future incidents by amending and enforcing those policies that are already in place. DATA SOURCES Data from FDA history documents, FDA guidances, Code of Federal Regulations Title 21, and presentations by the FDA's Office of Compliance were gathered. STUDY SELECTION AND DATA EXTRACTION All information identified from the data sources was evaluated, and all information deemed relevant was included for this review. DATA SYNTHESIS Contrary to popular belief, there are drugs on the market that have not been evaluated for safety or efficacy by the FDA. For almost a century, the FDA has taken action against public health threats posed by unapproved drug products, and today's drugs and vaccines are required to demonstrate both safety and efficacy prior to marketing. The FDA has taken great strides to ensure the welfare of Americans by reacting to disasters that have occurred in the past and being proactive by setting regulations that will prevent such catastrophes from occurring in the future. CONCLUSIONS The FDA recognizes that drug regulation is an ongoing process and that, although we have come a long way, there is still much to be done.

Predicting Inhibitory Drug—Drug Interactions and Evaluating Drug Interaction Reports Using Inhibition Constants

2005 ◽  
Vol 39 (6) ◽  
pp. 1064-1072 ◽  
Author(s):  
Kenneth A Bachmann ◽  
Jeffrey D Lewis
Keyword(s):  
Cytochrome P450 ◽  
Drug Interaction ◽  
Drug Interactions ◽  
Web Sites ◽  
Case Reports ◽  
Data Extraction ◽  
Data Sources ◽  
Study Selection ◽  
Inhibitory Drug

OBJECTIVE: To review the use of inhibitory constants (Ki) determined from in vitro experiments in the prediction of the significance of inhibitory drug—drug interactions (DDIs). DATA SOURCES: Searches of MEDLINE (1966—August 2004) and manual review of journals, conference proceedings, reference textbooks, and Web sites were performed using the key search terms cytochrome P450, drug—drug interaction, inhibition constant, and Ki. STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data sources were evaluated, and information deemed relevant was included for this review. DATA SYNTHESIS: The cytochrome P450 isoenzymes factor prominently in the explanation of numerous DDIs. Although the regulation of these enzymes by one drug can affect the pharmacokinetics of other drugs, the consequences may not necessarily be significant either in terms of pharmacokinetic or clinical outcomes. Yet, many DDI monographs originate as unconfirmed case reports that implicate the influence of one drug on the CYP-mediated metabolism of another, and these often uncorroborated mechanisms can eventually become regarded as dogma. One consequence of this process is the overprediction of potentially important DDIs. The pharmaceutical industry, Food and Drug Administration, and pharmaceutical scientists have developed a strategy for predicting the significance of inhibitory DDIs at the earliest possible stages of drug development based on a new chemical entity's Ki value, determined in vitro. CONCLUSIONS: We suggest that the use of Ki values of drugs purported to behave as CYP inhibitors be incorporated in the assessment of case reports that ascribe DDIs to inhibition of metabolism of one drug by another.

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