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European Journal of Clinical Nutrition Jul 2015To investigate all the available evidence assessing the effect of nutrition intervention on patients with chyle leakage and its effectiveness at reducing the need for... (Review)
Review
BACKGROUND/OBJECTIVES
To investigate all the available evidence assessing the effect of nutrition intervention on patients with chyle leakage and its effectiveness at reducing the need for surgical intervention.
SUBJECTS/METHODS
A systematic review was undertaken of all English language studies using MEDLINE, Cinahl and Web of Science from January 1980 to September 2013. Case series were included because of limited available evidence. Exclusion criteria included animal studies, pediatrics and studies without nutritional intervention. Assessment of study quality was included. Because of the heterogeneity of the data, no meta-analysis was performed.
RESULTS
Thirty-one articles were identified for analysis, all of which were retrospective case series studies. The data within these studies were greatly limited. A total of 550 subjects were identified from these studies, 72% of whom had a chyle leak successfully resolved without surgical intervention. However, there was no significant difference between the type of dietary intervention and the rate of resolution (χ(2)=11.14, P=0.08).
CONCLUSIONS
Although there is evidence to suggest that nutrition may have a role in the management of patients with chyle leakage, it is not possible to determine which dietary methods are most effective. More research is required before any guidelines for best practice can be established.
Topics: Adult; Anastomotic Leak; Caprylates; Chyle; Diet, Fat-Restricted; Food, Formulated; Humans; Lymphatic System; Malnutrition; Paraneoplastic Syndromes; Parenteral Nutrition, Total; Precision Medicine; Triglycerides
PubMed: 25920423
DOI: 10.1038/ejcn.2015.48 -
Vaccines Nov 2023Aluminium adjuvants are commonly used in vaccines to boost the effects of vaccination. Here, we assessed the benefits and harms of different aluminium adjuvants vs.... (Review)
Review
Concentrations, Number of Doses, and Formulations of Aluminium Adjuvants in Vaccines: A Systematic Review with Meta-Analysis and Trial Sequential Analysis of Randomized Clinical Trials.
Aluminium adjuvants are commonly used in vaccines to boost the effects of vaccination. Here, we assessed the benefits and harms of different aluminium adjuvants vs. other aluminium adjuvants or vs. the same aluminium adjuvant at other concentrations, administered a different number of doses, or at different particle sizes used in vaccines or vaccine excipients. We conducted a systematic review with meta-analysis and Trial Sequential Analysis to assess the certainty of evidence with Grading of Recommendations Assessment, Development and Evaluation (GRADE). We obtained data from major medical databases until 20 January 2023 and included 10 randomized clinical trials of healthy volunteers. The comparisons assessed higher vs. lower aluminium adjuvant concentrations; higher vs. lower number of doses of aluminium adjuvant; and aluminium phosphate adjuvant vs. aluminium hydroxide adjuvant. For all three comparisons, meta-analyses showed no evidence of a difference on all-cause mortality, serious adverse events, and adverse events considered non-serious. The certainty of evidence was low to very low. None of the included trials reported on quality of life or proportion of participants who developed the disease being vaccinated against. The benefits and harms of different types of aluminium adjuvants, different aluminium concentrations, different number of doses, or different particle sizes, therefore, remain uncertain.
PubMed: 38140168
DOI: 10.3390/vaccines11121763 -
Human Vaccines & Immunotherapeutics 2015Because of the age-related immune system decline, 2 potentiated influenza vaccines were specifically licensed for the elderly: Fluad(®), an MF59-adjuvanted vaccine... (Comparative Study)
Comparative Study Review
Because of the age-related immune system decline, 2 potentiated influenza vaccines were specifically licensed for the elderly: Fluad(®), an MF59-adjuvanted vaccine administered intramuscularly (IM-MF59), and Intanza 15 mcg(®), a non adjuvanted vaccine administered intradermally (ID). The objective of this paper was to conduct a systematic review of studies that evaluated antibody responses in the elderly following immunization with IM-MF59 or ID vaccines. The two potentiated vaccines induced immune responses satisfying, in most instances, the European Medicine Agency immunogenicity criteria, both against vaccine antigens and heterovariant drifted strains. Considering pooled data reported in the articles analyzed and papers directly comparing the 2 vaccines, the antibody responses elicited by IM-MF59 and ID were found to be generally comparable. The use of IM-MF59 and ID vaccines can be proposed as an appropriate strategy for elderly seasonal influenza vaccination although further studies are required for a more complete characterization of the 2 vaccines.
Topics: Adjuvants, Immunologic; Aged; Aged, 80 and over; Antibodies, Viral; Humans; Influenza Vaccines; Influenza, Human; Injections, Intradermal; Injections, Intramuscular; Middle Aged; Polysorbates; Squalene
PubMed: 25714138
DOI: 10.1080/21645515.2015.1011562 -
Journal of Pharmaceutical Analysis May 2024The presence of -nitroso compounds, particularly -nitrosamines, in pharmaceutical products has raised global safety concerns due to their significant genotoxic and... (Review)
Review
The presence of -nitroso compounds, particularly -nitrosamines, in pharmaceutical products has raised global safety concerns due to their significant genotoxic and mutagenic effects. This systematic review investigates their toxicity in active pharmaceutical ingredients (APIs), drug products, and pharmaceutical excipients, along with novel analytical strategies for detection, root cause analysis, reformulation strategies, and regulatory guidelines for nitrosamines. This review emphasizes the molecular toxicity of -nitroso compounds, focusing on genotoxic, mutagenic, carcinogenic, and other physiological effects. Additionally, it addresses the ongoing nitrosamine crisis, the development of nitrosamine-free products, and the importance of sensitive detection methods and precise risk evaluation. This comprehensive overview will aid molecular biologists, analytical scientists, formulation scientists in research and development sector, and researchers involved in management of nitrosamine-induced toxicity and promoting safer pharmaceutical products.
PubMed: 38799236
DOI: 10.1016/j.jpha.2023.12.009 -
Critical Reviews in Food Science and... Nov 2023Essential oil nanoemulsion may have improved antibacterial properties over pure oil and can be used for food preservation. Ultrasonic cavitation is the most common... (Meta-Analysis)
Meta-Analysis
Essential oil nanoemulsion may have improved antibacterial properties over pure oil and can be used for food preservation. Ultrasonic cavitation is the most common mechanism for producing nanoemulsions, and the impact of processing parameters on droplet properties needs to be elucidated. A systematic literature search was performed in four databases (Science Direct, Web of Science, Scopus and PubMed), and 987 articles were found, 16 of which were eligible for the present study. A meta-analysis was performed to qualitatively assess which process parameters (power, sonication time, essential oil, and tween 80 concentration) can influence the final droplet size and polydispersity and how droplet size is associated with antibacterial activity. We observed that power, essential oil, and tween 80 concentrations added during processing are the critical variables for forming smaller droplets. Ratios of up to 3:1 (surfactant:oil) can produce droplets smaller than 180 nm with antibacterial properties superior to pure oil or isolated compounds. The improved properties of nanoemulsions are associated with the size and chemical composition of the droplet since the proportion of the hydrophobic core (EO) and the hydrophilic outer layer (Tween 80) directly influences the antibacterial mechanism of action.
Topics: Oils, Volatile; Polysorbates; Emulsions; Surface-Active Agents; Anti-Bacterial Agents
PubMed: 35900149
DOI: 10.1080/10408398.2022.2103089 -
Vaccine Jan 2017In the elderly, traditional influenza inactivated vaccines are often only modestly immunogenic, owing to immunosenescence. Given that adjuvantation is a means of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
In the elderly, traditional influenza inactivated vaccines are often only modestly immunogenic, owing to immunosenescence. Given that adjuvantation is a means of enhancing the immune response, the trivalent inactivated vaccine adjuvanted with MF59 (MF59-TIV) was specifically designed to overcome this problem. Considering that, for ethical reasons, the absolute effectiveness of an influenza vaccine in the elderly cannot be demonstrated in placebo-controlled studies, the present study aimed to assess the effectiveness of MF59-TIV in preventing influenza-related outcomes in the elderly.
METHODS
We conducted a systematic review of observational studies aimed at evaluating the effectiveness of MF59-TIV against influenza-related outcomes. Results of single studies were pooled whenever possible.
RESULTS
Of the 1993 papers screened, 11 (6 case-control, 3 cohort and 2 prospective case-control) studies were identified. Hospitalization due to pneumonia/influenza and laboratory-confirmed influenza were reported in more than one study, while other outcomes (influenza-like illness, cardio- and cerebrovascular accidents) were investigated only by one study each. Pooled analysis of four case-control studies showed an adjusted MF59-TIV effectiveness of 51% (95% CI: 39-61%) against hospitalizations for pneumonia/influenza among community-dwelling seniors. Pooled results of the adjusted vaccine effectiveness against laboratory-confirmed influenza were also high (60.1%), although the 95% CI passed through zero (-1.3 to 84.3%). Other single community-based studies showed very high effectiveness of MF59-TIV in preventing hospitalizations for acute coronary [87% (95% CI: 35-97%)] and cerebrovascular [93% (95% CI: 52-99%)] events. MF59-TIV proved highly effective [94% (95% CI: 47-100%] in reducing influenza-like illness among institutionalized elderly. Furthermore, MF59-TIV displayed greater efficacy than non-adjuvanted vaccines in preventing hospitalizations due to pneumonia/influenza [adjusted risk ratio 0.75 (95% CI: 0.57-0.98)] and laboratory-confirmed influenza [adjusted odds ratio 0.37 (0.14-0.96)].
CONCLUSIONS
Our results suggest that MF59-TIV is effective in reducing several influenza-related outcomes among the elderly, especially hospitalizations due to influenza-related complications.
Topics: Adjuvants, Immunologic; Aged; Aged, 80 and over; Humans; Influenza Vaccines; Influenza, Human; Observational Studies as Topic; Polysorbates; Squalene; Treatment Outcome; Vaccines, Inactivated
PubMed: 28024956
DOI: 10.1016/j.vaccine.2016.12.011 -
European Journal of Pharmacology Jan 2015Intravenous immunoglobulins (IVIG) have been used for several licensed and off-label indications. Each IVIG product is a unique formulation of IgG and excipients, making... (Review)
Review
Intravenous immunoglobulins (IVIG) have been used for several licensed and off-label indications. Each IVIG product is a unique formulation of IgG and excipients, making them distinct products. How these differences impact on individual IVIG product efficacy and safety are not well established but can be investigated by head-to-head randomized controlled trials (RCT). A systematic review of head-to-head RCT comparing different formulations of IVIG, regardless of the target condition and outcomes investigated. Two reviewers screened 4084 citations retrieved from MEDLINE, Embase, Cochrane and LILACS, and 23 citations were fully-text evaluated. Eight trials were included. The clinical conditions, outcomes and risk of bias were assessed. Of the eight trials included only two investigated products that are currently on the market. One evaluated two Grifols brands used in patients with primary immunodeficiency and another evaluated two Baxter brands used in patients with chronic inflammatory demyelinating polyradiculoneuropathy. There were no differences between the formulations for the outcomes evaluated. In the other trials, either the manufacturers were acquired by other companies or the formulation was withdrawn from the market. As consequence, evidence concerning these products could not be considered. The quality of the studies was low, showing high risk of bias. Direct evidence about the different IVIGs is scarce and, at present, there is no scientific evidence that can be applied for a specific brand or formulation. Further comparative effectiveness studies are highly desirable for a better understanding of the differences in safety and efficacy of IVIGs.
Topics: Chemistry, Pharmaceutical; Humans; Immunoglobulins, Intravenous; Randomized Controlled Trials as Topic; Safety
PubMed: 25496751
DOI: 10.1016/j.ejphar.2014.11.033 -
Frontiers in Pharmacology 2022Cancer is an important cause of morbidity and mortality worldwide, irrespective of the level of human development. Globally, it was estimated that there were 19.3...
Cancer is an important cause of morbidity and mortality worldwide, irrespective of the level of human development. Globally, it was estimated that there were 19.3 million new cases of cancer and almost 10 million deaths from cancer in 2020. The importance of prevention, early detection as well as effective cancer therapies cannot be over-emphasized. One of the important strategies in cancer therapy is targeted drug delivery to the specific tumor sites. Nanogels are among the several drug delivery systems (DDS) being explored as potential candidates for targeted drug delivery in cancer therapy. Nanogels, which are new generation, versatile DDS with the possession of dual characteristics of hydrogels and nanoparticles have shown great potential as targeted DDS in cancer therapy. Nanogels are hydrogels with a three-dimensional (3D) tunable porous structure and a particle size in the nanometre range, from 20 to 200 nm. They have been visualized as ideal DDS with enormous drug loading capacity, and high stability. Nanogels can be modified to achieve active targeting and enhance drug accumulation in disease sites. They can be designed to be stimulus-responsive, and react to internal or external stimuli such as pH, temperature, light, redox, thus resulting in the controlled release of loaded drug. This prevents drug accumulation in non-target tissues and minimizes the side effects of the drug. Drugs with severe adverse effects, short circulation half-life, and easy degradability by enzymes, such as anti-cancer drugs, and proteins, are suitable for delivery by chemically cross-linked or physically assembled nanogel systems. This systematic review summarizes the evolution of nanogels for targeted drug delivery for cancer therapy over the last decade. On-going clinical trials and recent applications of nanogels as targeted DDS for cancer therapy will be discussed in detail. The review will be concluded with discussions on safety and regulatory considerations as well as future research prospects of nanogel-targeted drug delivery for cancer therapy.
PubMed: 36160424
DOI: 10.3389/fphar.2022.874510 -
American Journal of Rhinology & Allergy 2014Cilia in the human respiratory tract play a critical role in clearing mucus and debris from the airways. Their function can be affected by a number of drugs or other... (Review)
Review
BACKGROUND
Cilia in the human respiratory tract play a critical role in clearing mucus and debris from the airways. Their function can be affected by a number of drugs or other substances, many of which alter ciliary beat frequency (CBF). This has implications for diseases of the respiratory tract and nasal drug delivery. This article is a systematic review of the literature that examines 229 substances and their effect on CBF.
METHODS
MEDLINE was the primary database used for data collection. Eligibility criteria based on experimental design were established, and 152 studies were ultimately selected. Each individual trial for the substances tested was noted whenever possible, including concentration, time course, specific effect on CBF, and source of tissue.
RESULTS
There was a high degree of heterogeneity between the various experiments examined in this article. Substances and their general effects (increase, no effect, decrease) were grouped into six categories: antimicrobials and antivirals, pharmacologics, human biological products, organisms and toxins, drug excipients, and natural compounds/other manipulations.
CONCLUSION
Organisms, toxins, and drug excipients tend to show a cilioinhibitory effect, whereas substances in all other categories had mixed effects. All studies examined were in vitro experiments, and application of the results in vivo is confounded by several factors. The data presented in this article should be useful in future respiratory research and examination of compounds for therapeutic and drug delivery purposes.
Topics: Animals; Anti-Infective Agents; Biomedical Research; Cilia; Drug Delivery Systems; Humans; Respiratory Mucosa; Respiratory Tract Diseases
PubMed: 25514481
DOI: 10.2500/ajra.2014.28.4092 -
PloS One 2021The vaginal microbiota in bacterial vaginosis (BV) typically has low abundance of lactic acid producing lactobacilli. Lactic acid has properties that may make it...
OBJECTIVE
The vaginal microbiota in bacterial vaginosis (BV) typically has low abundance of lactic acid producing lactobacilli. Lactic acid has properties that may make it effective for treating BV and/or restoring an optimal lactobacillus-dominated vaginal microbiota. We conducted a systematic review to describe the effect of intravaginal lactic acid-containing products on BV cure, and their impact on vaginal microbiota composition (PROSPERO registration: CRD42018115982).
METHODS
PubMed, Embase and OVID were searched from inception to November 2019 to identify eligible studies. Included studies evaluated an intravaginal lactic acid-containing product and reported BV cure using established diagnostic methods, and/or vaginal microbiota composition using molecular methods. Studies were independently screened and assessed, and the proportion of women cured post-treatment was calculated. Study results were described in a qualitative manner.
RESULTS
We identified 1,883 articles and assessed 57 full-texts for eligibility. Seven different lactic acid-containing products were evaluated and differed with respect to excipients, lactic acid concentration and pH. Most studies had medium or high risk of bias. Three trials compared the efficacy of a lactic acid-containing product to metronidazole for BV cure. One study found lactic acid to be equivalent to metronidazole and two studies found lactic acid to be significantly inferior to metronidazole. Two studies included a control group receiving a placebo or no treatment. One reported lactic acid to be superior than no treatment and the other reported lactic acid to be equivalent to placebo. Lactic acid-containing products did not significantly impact the vaginal microbiota composition.
CONCLUSION
There is a lack of high-quality evidence to support the use of lactic acid-containing products for BV cure or vaginal microbiota modulation. However, adequately powered and rigorous randomised trials with accompanying vaginal microbiota data are needed to evaluate the efficacy of lactic acid as a BV treatment strategy.
Topics: Administration, Intravaginal; Female; Humans; Lactic Acid; Microbiota; Publication Bias; Risk; Vagina; Vaginosis, Bacterial
PubMed: 33571286
DOI: 10.1371/journal.pone.0246953