5-Azacytidine and Decitabine Monotherapies of Myelodysplastic Disorders

2005 ◽  
Vol 39 (10) ◽  
pp. 1700-1709 ◽  
Author(s):  
Jim R Kuykendall
Keyword(s):  
Clinical Trials ◽  
Data Extraction ◽  
Supportive Therapy ◽  
Clinical Effectiveness ◽  
Data Sources ◽  
Hypomethylating Agents ◽  
Medline Search ◽  
Study Selection ◽  
Response To Chemotherapy ◽  
Leukemia Treatment

OBJECTIVE: To review and differentiate the pharmacology, toxicology, pharmacokinetics, and results of major clinical trials of 5-azacytidine (5-AzaC) and 5-aza-2'-deoxycytidine (decitabine) therapy of myelodysplastic disorders. DATA SOURCES: A PubMed/MEDLINE search was conducted (1966–October 2004) using the following terms: DNA methylation, myelodysplastic disorders, 5-azacytidine, and 5-aza-2'-deoxycytidine (decitabine). Additional data sources included bibliographies from identified articles and manufacturer information. STUDY SELECTION AND DATA EXTRACTION: Clinical trials for the treatment of various malignancies by hypomethylating agents were selected from data sources. All published, major clinical trials evaluating 5-AzaC or decitabine in myelodysplastic disorders and transformed myeloid leukemia treatment were included. DATA SYNTHESIS: Myelodysplastic disorders are a group of bone marrow stem cell hyperplasias and dysplasias that result in ineffective hematopoiesis. Myelodysplastic disorders and transformed leukemia have poor prognosis and minimal response to chemotherapy. DNA hypomethylating agents have been shown to improve overall response rates (increased neutrophil, leukocyte, and platelet counts), time to leukemic progression, and quality of life compared with supportive therapy. The incidence of the most common adverse effects (nausea, vomiting, myelosuppression) can be reduced by low-dose, continuous, or extended-interval infusion. CONCLUSIONS: Since appropriate dosing schedules of decitabine are being investigated, comparison of the clinical effectiveness of 5-AzaC and decitabine would be premature at this time. DNA hypomethylating agents show promise as monotherapies of myelodysplastic disorders and transformed leukemia and may be useful as a component of combination chemotherapy of various malignancies.

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.

Respiratory Syncytial Virus Immune Globulin Intravenous

1997 ◽  
Vol 31 (1) ◽  
pp. 83-88 ◽  
Author(s):  
Todd L Wandstrat
Keyword(s):  
Clinical Trials ◽  
Respiratory Syncytial Virus ◽  
Immune Globulin ◽  
Data Extraction ◽  
Safety Data ◽  
Infants And Children ◽  
Medline Search ◽  
Study Selection ◽  
Syncytial Virus ◽  
In Infants And Children

OBJECTIVE: To review the clinical data detailing the use of respiratory syncytial virus immune globulin intravenous (RSV—IGIV) in infants and children. DATA SOURCES: A MEDLINE search (1990–1996) was used to identify all publications that dealt with RSV—IGIV clinical trials, pharmacology, and pharmacokinetics in infants and children. Bibliographies of articles were also used. STUDY SELECTION: All abstracts and clinical trials were reviewed. DATA EXTRACTION: Study design, population, efficacy, and safety data were retained. DATA SYNTHESIS: RSV—IGIV is an immunoglobulin product with serum neutralizing titers against RSV. It has been shown to reduce hospital stay, admissions, intensive care unit admissions, and mechanical ventilation days in infants and children with RSV pneumonia or bronchiolitis who are younger than 24 months of age and were born prematurely, or have bronchopulmonary dysplasia. RSV—IGIV is well tolerated by infants and children. CONCLUSIONS: RSV—IGIV is an effective prophylactic agent against serious RSV disease in select groups of infants and children.

Efficacy and Toxicity of Amphotericin B Liposomal and Lipid Formulations

1995 ◽  
Vol 11 (3) ◽  
pp. 99-104 ◽  
Author(s):  
Jay P Rho ◽  
Jennifer H Cupo
Keyword(s):  
Clinical Trials ◽  
Amphotericin B ◽  
English Language ◽  
Fungal Infections ◽  
Data Sources ◽  
Pertinent Literature ◽  
Medline Search ◽  
Study Selection ◽  
Novel Method ◽  
Lipid Formulations

Objective: To review the efficacy and toxicity of amphotericin B liposomal and various lipid formulations with conventional amphotericin B desoxycholate. Data Sources: Pertinent literature was identified via a MEDLINE search. Study Selection: English-language clinical trials. Conclusions: The incorporation of amphotericin B into liposomes or lipid formulations appears to be a novel method of administering amphotericin B for the treatment of serious systemic fungal infections for patients who have either failed therapy with, or are intolerant to, conventional amphotericin B desoxycholate.

Natalizumab for the Treatment of Multiple Sclerosis and Crohn's Disease

2005 ◽  
Vol 39 (11) ◽  
pp. 1833-1843 ◽  
Author(s):  
Kendra A Keeley ◽  
Michael P Rivey ◽  
Douglas R Allington
Keyword(s):  
Multiple Sclerosis ◽  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Bowel Disease ◽  
Randomized Clinical Trials ◽  
Case Reports ◽  
Data Extraction ◽  
Data Sources ◽  
Medline Search ◽  
Inflammatory Bowel

OBJECTIVE To review the pharmacology, pharmacokinetics, safety, and pivotal clinical trials for natalizumab in the treatment of multiple sclerosis (MS) and inflammatory bowel disease. DATA SOURCES A PubMed/MEDLINE search was conducted (1966–June 2005), and information was obtained from Iowa Drug Information Services. Additional data sources included meeting abstracts, bibliographies from identified articles, and information from the manufacturer. STUDY SELECTION AND DATA EXTRACTION Studies and review articles examining natalizumab were evaluated. All published, randomized clinical trials evaluating natalizumab in MS and IBD were included in this review. DATA SYNTHESIS Natalizumab is the first drug in a new class of agents called selective adhesion molecule inhibitors. It has shown promising results in MS and inflammatory bowel disease and appears superior compared with current therapies in reducing relapse rates. However, 3 recent, confirmed case reports of progressive multifocal leukoencephalopathy (PML) create concern about natalizumab's use in combination with existing therapies or in undefined patient subgroups. Natalizumab was voluntarily withdrawn from the market in March 2005 while the drug's safety is further evaluated. CONCLUSIONS Although long-term efficacy and safety of natalizumab have not been established, available data indicate that it is a novel drug for patients with MS or inflammatory bowel disease. Analysis of its possible association with PML will determine the risk–benefit evaluation and eventual place in therapy for natalizumab.

Zolpidem: Distinct from Triazolam?

1997 ◽  
Vol 31 (5) ◽  
pp. 625-632 ◽  
Author(s):  
Bob L Lobo ◽  
William L Greene
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Memory Impairment ◽  
English Language ◽  
Data Extraction ◽  
Residual Effects ◽  
Data Synthesis ◽  
Medline Search ◽  
Study Selection ◽  
Pertinent Information

OBJECTIVE: TO review the literature that compares Zolpidem with triazolam, with an emphasis on efficacy and safety in humans. DATA SOURCES: Information was retrieved from a MEDLINE search (1983–1996) of the English-language literature using the terms triazolam and zolpidem. STUDY SELECTION: Reports of clinical trials comparing the safety and efficacy of zolpidem and triazolam were included in this review. DATA EXTRACTION: Data were evaluated according to study design, efficacy, and adverse effects. Pertinent information was selected and the data synthesized into a review format. DATA SYNTHESIS: Zolpidem and triazolam have similar pharmacokinetic and pharmacodynamic effects in humans. Clinical trials have shown that usually recommended, equipotent dosages of zolpidem and triazolam do not differ with respect to pharmacokinetics, efficacy, tolerability, residual effects, memory impairment, rebound insomnia, abuse potential, or other adverse effects. CONCLUSIONS: Zolpidem offers no distinct therapeutic advantage over triazolam for the treatment of insomnia.

Acute Management of Cancer-Related Hypercalcemia

1996 ◽  
Vol 30 (5) ◽  
pp. 507-513 ◽  
Author(s):  
Marie A Chisholm ◽  
Anthony L Mulloy ◽  
A Thomas Taylor
Keyword(s):  
Clinical Trials ◽  
English Language ◽  
Data Extraction ◽  
Symptomatic Relief ◽  
Gallium Nitrate ◽  
Medline Search ◽  
Patients With Cancer ◽  
Study Selection ◽  
Life Threatening ◽  
Acute Hypercalcemia

OBJECTIVE: TO review the pathogenesis and pharmacologic treatment of acute hypercalcemia associated with malignancy. DATA SOURCES: A MEDLINE search (1966 to 1995) of the English-language literature pertaining to acute hypercalcemia was performed. Additional literature was obtained from reference lists of articles identified through the search. STUDY SELECTION AND DATA EXTRACTION: All articles discussing the etiology and medical management of cancer-related acute hypercalcemia were considered in the review. Clinical trials reporting efficacy and safety of antihypercalcemic agents were also included. Information selected in the review was based on the discretion of the authors. DATA SYNTHESIS: Hypercalcemia is a life-threatening disorder associated with malignancy. It occurs in approximately 10–20% of patients with cancer. A variety of medications have been used in the management of hypercalcemia including bisphosphonates, calcitonin, furosemide, gallium nitrate, glucocorticoids, NaCl 0.9%, and plicamycin. Each of these agents has been reviewed with consideration of pharmacologic mechanism of action, evaluation of clinical trials, recommended dosages, efficacy, safety, cost, and role in treating cancer-related acute hypercalcemia. CONCLUSIONS: Immediate management of cancer-related acute hypercalcemia to prevent death and provide symptomatic relief is warranted. Severity determined by symptoms, calcium concentrations, and the overall status of the patient are important considerations in selecting appropriate therapy. Although the specific role of individual agents may vary, hydration remains the cornerstone of therapy. NaCl 0.9%, calcitonin, and Pamidronate disodium have established roles as dominant first-line agents for the management of acute hypercalcemia associated with malignancy.

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.

scholarly journals Clinical effectiveness of convalescent plasma in hospitalized patients with COVID-19: a systematic review and meta-analysis

2021 ◽  
Vol 15 ◽  
pp. 175346662110280
Author(s):  
Roberto Ariel Abeldaño Zuñiga ◽  
Ruth Ana María González-Villoria ◽  
María Vanesa Elizondo ◽  
Anel Yaneli Nicolás Osorio ◽  
David Gómez Martínez ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Clinical Improvement ◽  
Data Extraction ◽  
Meta Analysis ◽  
Clinical Effectiveness ◽  
Risk Of Bias ◽  
Hospitalized Patients ◽  
Low Risk ◽  
Controlled Clinical Trials

Aims: Given the variability of previously reported results, this systematic review aims to determine the clinical effectiveness of convalescent plasma employed in the treatment of hospitalized patients diagnosed with COVID-19. Methods: We conducted a systematic review of controlled clinical trials assessing treatment with convalescent plasma for hospitalized patients diagnosed with SARS-CoV-2 infection. The outcomes were mortality, clinical improvement, and ventilation requirement. Results: A total of 51 studies were retrieved from the databases. Five articles were finally included in the data extraction and qualitative and quantitative synthesis of results. The overall risk of bias in the reviewed articles was established at low-risk only in two trials. The meta-analysis suggests that there is no benefit of convalescent plasma compared with standard care or placebo in reducing the overall mortality and the ventilation requirement. However, there could be a benefit for the clinical improvement in patients treated with plasma. Conclusion: Current results led to assume that the convalescent plasma transfusion cannot reduce the mortality or ventilation requirement in hospitalized patients diagnosed with SARS-CoV-2 infection. More controlled clinical trials conducted with methodologies that ensure a low risk of bias are still needed. The reviews of this paper are available via the supplemental material section.

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.

Leukotriene-Receptor Antagonists and 5-Lipoxygenase Inhibitors in Asthma

1993 ◽  
Vol 27 (7-8) ◽  
pp. 898-903 ◽  
Author(s):  
Julie S. Larsen ◽  
Edward P. Acosta
Keyword(s):  
Clinical Trials ◽  
English Language ◽  
Data Extraction ◽  
Background Information ◽  
Receptor Antagonists ◽  
Lipoxygenase Inhibitors ◽  
Medline Search ◽  
Leukotriene Receptor Antagonists ◽  
Patient Tolerance ◽  
Leukotriene Receptor

OBJECTIVE: To familiarize readers with a potentially new class of compounds for treating asthma. Background information on leukotrienes is provided in addition to an indepth review of pertinent clinical trials. DATA SOURCES: Information was obtained from controlled clinical trials, abstracts, and review articles identified through a MEDLINE search of English-language articles. STUDY SELECTION: Emphasis was placed on early clinical trials that showed some benefit with these compounds as well as more recent studies using newer agents that produced more promising results. DATA EXTRACTION: Information regarding leukotriene biochemistry was extracted from basic science research and data from human studies were evaluated by the authors according to patient selection, study design, methodology, and therapeutic response. DATA SYNTHESIS: Leukotrienes have a pathophysiologic role in asthma. Two distinct but pharmacologically similar classes of leukotriene inhibitors are currently being clinically evaluated. These are leukotriene receptor antagonists and 5-lipoxygenase inhibitors. Early clinical trials with these agents yielded unfavorable results primarily because of lack of drug potency and selectivity, poor patient tolerance, and possibly the route of administration. Subsequent studies with more potent and selective agents have further implicated leukotrienes as biochemical mediators in asthma and, consequently, have shown promising clinical outcomes with respect to pulmonary function testing and patient tolerance. CONCLUSIONS: Advancements in the pathogenesis of asthma are beginning to define a role for the leukotrienes. Although more studies are needed to assess the efficacy of leukotriene inhibitors, recent clinical trials using leukotriene-receptor antagonists and 5-lipoxygenase inhibitors indicate a potential for the expansion of therapeutic regimens currently used in the treatment of asthma.

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