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The Patient Jul 2024Compared with early stages (eBC) metastatic BC (mBC) is incurable. In mBC, aggressive treatment may increase the duration of survival but may also cause severe treatment...
INTRODUCTION
Compared with early stages (eBC) metastatic BC (mBC) is incurable. In mBC, aggressive treatment may increase the duration of survival but may also cause severe treatment side effects. A better understanding how patients with BC value different aspects of drug therapy might improve treatment effectiveness, satisfaction and adherence. This systematic review aims to identify and summarise studies evaluating patient preferences for drug therapy of BC and to compare preferences of patients with eBC and mBC.
METHODS
The systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The electronic databases PubMed and Web of Science were searched on 22 June 2023. All studies published to this point were considered. Original studies reporting patient preferences on BC drug therapy determined by any type of choice experiment were eligible. A narrative synthesis of the effect measures presented as relative importance ratings, trade-offs (required benefit to make a therapy worthwhile) or monetary values of the treatment attributes was reported for each study. Risk of bias assessment for individual studies was performed using the checklist for observational studies from the STROBE Statement and the checklist from 'Conducting Discrete Choice Experiments to Inform Healthcare Decision Making: A User's Guide'. The study protocol was registered at the PROSPERO database (CRD42022377031).
RESULTS
A total of 34 studies met the inclusion criteria were included in the analysis evaluating the preferences of patients with eBC (n = 18), mBC (n = 10) or any stage BC (n = 6) on, for example, chemotherapy, endocrine therapy, hormonal therapy or CKD4/6-inhibitors using different types of choice experiments. Regardless of the stage, most patients valued treatment effectiveness in terms of survival gains higher than potential adverse drug reactions (ADRs). Treatment cost, mode of administration, treatment regimen and monitoring aspects were considered as least important treatment attributes. In addition, preferences concerning 16 different types of ADRs were described, showing high heterogeneity within BC stages. Yet, comparable results across BC stages were observed.
CONCLUSIONS
Regardless of the stage, patients with BC consistently valued survival gains as the most important attribute and were willing to accept the risk of potential ADRs. Incorporating patient preferences in shared decision making may improve the effectiveness of interventions by enhancing adherence to drug therapy in patients suffering from BC.
Topics: Humans; Patient Preference; Breast Neoplasms; Female; Neoplasm Staging; Antineoplastic Agents; Neoplasm Metastasis
PubMed: 38451419
DOI: 10.1007/s40271-024-00679-6 -
BMJ Open Mar 2024To compare the efficacy and safety of different anti-vascular endothelial growth factor (VEGF) agents combined with different delivery methods for neovascular glaucoma... (Meta-Analysis)
Meta-Analysis
Comparative efficacy and safety of different anti-VEGF agents combined with different delivery methods for neovascular glaucoma: a systematic review and Bayesian network meta-analysis.
OBJECTIVE
To compare the efficacy and safety of different anti-vascular endothelial growth factor (VEGF) agents combined with different delivery methods for neovascular glaucoma (NVG).
DESIGN
Systematic review and Bayesian network meta-analysis (NMA).
DATA SOURCES
PubMed, Embase, Cochrane Library, Web of Science, ClinicalTrials.gov, ISRCTN and Chinese databases including the China National Knowledge Infrastructure, China Science Periodical Database (Wanfang Database), VIP Journal Integration Platform and China Biology Medicine Database were searched from inception to 5 September 2022.
ELIGIBILITY CRITERIA
We included randomised controlled trials (RCTs) that investigated the treatment of NVG using different anti-VEGF agents combined with various methods of drug administration, without any language limitations. All patients included underwent panretinal laser photocoagulation and there were no restrictions on prior glaucoma surgery.
DATA EXTRACTION AND SYNTHESIS
Two independent reviewers extracted data and assessed the risk of bias. Random-effect Bayesian NMA was conducted to compare the efficacy and safety and rank priority of anti-VEGF regimens. The source of heterogeneity and the related factors affecting the stability of the results were also explored. CINeMA (Confidence in Network Meta-Analysis) was used to assess the certainty of evidence.
RESULTS
Our analysis included 17 RCTs involving a total of 1311 eyes from 1228 patients. We examined five different treatment regimens, which used three different anti-VEGF drugs. The following treatments showed a significant decrease in intraocular pressure (IOP) compared with the control group at 1 month after glaucoma surgery: simultaneous intravitreal and intracameral injection of conbercept (ICCIVC) (mean difference (MD)=-11.56, 95% credible interval (CrI) -20.8 to -2.24), intravitreal injection of conbercept (MD=-8.88, 95% CrI -13.93 to -3.78), intravitreal injection of ranibizumab (MD=-7.62, 95% CrI -10.91 to -4.33) and intravitreal injection of bevacizumab IVB) (MD=-5.51, 95% CrI -10.79 to -0.35). The surface under the cumulative ranking curve (SUCRA) analysis indicated that ICCIVC (82.0%) may be the most effective regimen in reducing IOP. In terms of safety, there were no statistically significant differences among the interventions. According to the SUCRA analysis, ICCIVC (68.0%) was considered the safest choice with the fewest complications. Subgroup and meta-regression analyses showed that mean age was the main source of heterogeneity. Sensitivity analysis demonstrated the robustness of the study results.
CONCLUSION
ICCIVC was more effective and safer than other anti-VEGF regimens for NVG. Simultaneous intravitreal and intracameral injection was found to be the best route of administration, and conbercept was found to be the superior drug selection when compared with ranibizumab and bevacizumab.
PROSPERO REGISTRATION NUMBER
CRD42022309676.
Topics: Humans; Glaucoma, Neovascular; Bevacizumab; Network Meta-Analysis; Ranibizumab; Vascular Endothelial Growth Factors; Glaucoma
PubMed: 38443085
DOI: 10.1136/bmjopen-2023-080103 -
Heliyon Mar 2024Diabetes mellitus (DM) is one of the fastest-growing diseases worldwide; however, its pathogenesis remains unclear. Complications seriously affect the quality of life of... (Review)
Review
CONTEXT
Diabetes mellitus (DM) is one of the fastest-growing diseases worldwide; however, its pathogenesis remains unclear. Complications seriously affect the quality of life of patients in the later stages of diabetes, ultimately leading to suffering. Natural small molecules are an important source of antidiabetic agents.
OBJECTIVE
Astragaloside IV (AS-IV) is an active ingredient of Astragalus mongholicus (Fisch.) Bunge. We reviewed the efficacy and mechanism of action of AS-IV in animal and cellular models of diabetes and the mechanism of action of AS-IV on diabetic complications in animal and cellular models. We also summarized the safety of AS-IV and provided ideas and rationales for its future clinical application.
METHODS
Articles on the intervention in DM and its complications using AS-IV, such as those published in SCIENCE, PubMed, Springer, ACS, SCOPUS, and CNKI from the establishment of the database to February 2022, were reviewed. The following points were systematically summarized: dose/concentration, route of administration, potential mechanisms, and efficacy of AS-IV in animal models of DM and its complications.
RESULTS
AS-IV has shown therapeutic effects in animal models of DM, such as alleviating gestational diabetes, delaying diabetic nephropathy, preventing myocardial cell apoptosis, and inhibiting vascular endothelial dysfunction; however, the potential effects of AS-IV on DM should be investigated.
CONCLUSION
AS-IV is a potential drug for the treatment of diabetes and its complications, including diabetic vascular disease, cardiomyopathy, retinopathy, peripheral neuropathy, and nephropathy. In addition, preclinical toxicity studies indicate that it appears to be safe, but the safe human dose limit is yet to be determined, and formal assessments of adverse drug reactions among humans need to be further investigated. However, additional formulations or structural modifications are required to improve the pharmacokinetic parameters and facilitate the clinical use of AS-IV.
PubMed: 38439832
DOI: 10.1016/j.heliyon.2024.e26863 -
Actas Dermo-sifiliograficas May 2024Topical and intralesional (IL) treatments may be considered the first-line therapy in patients with hidradenitis suppurativa (HS); however, the evidence supporting their...
BACKGROUND AND OBJECTIVE
Topical and intralesional (IL) treatments may be considered the first-line therapy in patients with hidradenitis suppurativa (HS); however, the evidence supporting their use is limited. The aim of our review is to evaluate the efficacy and safety profile of topical and IL treatments in patients with HS.
MATERIALS AND METHODS
We designed a systematic review of the current medical literature available following the PICO(T) method. And including all types of studies (Study type [T]) of individuals with HS of any sex, age, and ethnicity (Population [P]) who received any topical or IL treatment for HS (Intervention [I]) compared to placebo, other treatments, or no treatment at all (Comparator [C]), and reported efficacy and/or safety outcomes (Outcomes [O]). Two outcomes were defined: quality of life and the no. of patients with, at least, one adverse event. The search was conducted in the Cochrane Library, MEDLINE, and Embase databases; study selection was performed based on pre-defined criteria. The risk of bias was determined in each study.
RESULTS
We obtained a total of 11,363 references, 31 of which met the inclusion criteria. These studies included 1143 patients with HS, 62% of whom were women. A total of 10, 8, 6, 2, and 5 studies, respectively, evaluated the use of photodynamic therapy (PDT), glucocorticoids, resorcinol, topical antibiotics, and other interventions. Most articles were case series (n=25), with only five randomized clinical trials (RCTs) and one cohort study. RCTs showed improvement in disease activity with topical clindamycin and botulinum toxin (BTX) vs placebo, and PDT with methylene blue (MB) niosomal vs free MB; however, intralesional triamcinolone acetonide was not superior to placebo. The risk of bias was low in three RCTs and high in two RCTs.
CONCLUSION
The quality of evidence supporting the use of topical, or IL treatments is low. However, it supports the use of topical clindamycin, PDT, and BTX. Well-designed RCTs with standardized outcomes and homogeneous populations of patients and lesions are needed to support decision-making in the routine clinical practice.
Topics: Hidradenitis Suppurativa; Humans; Injections, Intralesional; Administration, Topical; Photochemotherapy; Treatment Outcome; Female; Randomized Controlled Trials as Topic; Male
PubMed: 38423507
DOI: 10.1016/j.ad.2024.02.024 -
The Journal of Hospital Infection May 2024Outpatient parenteral antimicrobial therapy (OPAT) has been expanding in recent years and serves as a viable solution in reducing the shortage of hospital beds. However,... (Review)
Review
Outpatient parenteral antimicrobial therapy (OPAT) has been expanding in recent years and serves as a viable solution in reducing the shortage of hospital beds. However, the wider implementation of OPAT faces numerous challenges. This review aimed to assess implementation barriers and facilitators of OPAT services. Studies describing barriers and facilitators of the OPAT service were retrieved from PubMed, Scopus, MEDLINE, EMBASE, CINAHL, Cochrane Library, Web of Science Proceedings, International Pharmaceutical Abstracts and PsycINFO. All types of study designs published in the English language were included. Studies that did not mention any barrier or facilitator, did not differentiate OPAT and inpatient, focused on specific antimicrobials or diseases, and made no distinction between parenteral and other treatments were excluded. Qualitative analysis was performed using the 'best-fit' framework approach and the Consolidated Framework for Implementation Research (CFIR). The review was PROSPERO registered (CRD42023441083). A total of 8761 studies were screened for eligibility and 147 studies were included. Problems in patient selection, lack of awareness, poor communication and co-ordination, lack of support, lack of structured service and inappropriate prescriptions were identified. OPAT provides safe, effective and efficient treatment while maintaining patients' privacy and comfort, resulting in less daily life disruption, and reducing the risk of infection. Satisfaction and preference for OPAT were very high. Initiatives in strengthening OPAT such as antimicrobial stewardship and telemedicine are beneficial. Challenges to and facilitators of OPAT were identified among patients, health professionals, OPAT service providers and healthcare administrators. Understanding them is crucial to designing targeted initiatives for successful OPAT service implementation.
Topics: Humans; Ambulatory Care; Anti-Infective Agents; Outpatients; Infusions, Parenteral
PubMed: 38423135
DOI: 10.1016/j.jhin.2024.02.006 -
International Journal of Nanomedicine 2024Addressing disorders related to the central nervous system (CNS) remains a complex challenge because of the presence of the blood-brain barrier (BBB), which restricts...
Addressing disorders related to the central nervous system (CNS) remains a complex challenge because of the presence of the blood-brain barrier (BBB), which restricts the entry of external substances into the brain tissue. Consequently, finding ways to overcome the limited therapeutic effect imposed by the BBB has become a central goal in advancing delivery systems targeted to the brain. In this context, the intranasal route has emerged as a promising solution for delivering treatments directly from the nose to the brain through the olfactory and trigeminal nerve pathways and thus, bypassing the BBB. The use of lipid-based nanoparticles, including nano/microemulsions, liposomes, solid lipid nanoparticles, and nanostructured lipid carriers, has shown promise in enhancing the efficiency of nose-to-brain delivery. These nanoparticles facilitate drug absorption from the nasal membrane. Additionally, the in situ gel (ISG) system has gained attention owing to its ability to extend the retention time of administered formulations within the nasal cavity. When combined with lipid-based nanoparticles, the ISG system creates a synergistic effect, further enhancing the overall effectiveness of brain-targeted delivery strategies. This comprehensive review provides a thorough investigation of intranasal administration. It delves into the strengths and limitations of this specific delivery route by considering the anatomical complexities and influential factors that play a role during dosing. Furthermore, this study introduces strategic approaches for incorporating nanoparticles and ISG delivery within the framework of intranasal applications. Finally, the review provides recent information on approved products and the clinical trial status of products related to intranasal administration, along with the inclusion of quality-by-design-related insights.
Topics: Administration, Intranasal; Blood-Brain Barrier; Brain; Drug Delivery Systems; Lipids; Liposomes; Nanoparticles; Nasal Mucosa
PubMed: 38414526
DOI: 10.2147/IJN.S439181 -
Sports Medicine (Auckland, N.Z.) May 2024Iron deficiency in athletes is initially treated with a nutritional intervention. If negative iron balance persists, oral iron supplementation (OIS) can be used. Despite... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Iron deficiency in athletes is initially treated with a nutritional intervention. If negative iron balance persists, oral iron supplementation (OIS) can be used. Despite the recent proposal for a refinement of treatment strategies for iron-deficient athletes, there is no general consensus regarding the actual efficiency, dosage, or optimal regimen of OIS.
OBJECTIVE
The aim of this meta-analysis was to evaluate to what extent OIS affects blood iron parameters and physical performance in healthy adult athletes.
METHODS
PubMed, Web of Science, PEDro, CINAHL, SPORTDiscus, and Cochrane were searched from inception to 2 November 2022. Articles were eligible if they satisfied the following criteria: recruited subjects were healthy, adult and physically active individuals, who used exclusively OIS, irrespective of sex and sports discipline.
EXCLUSION CRITERIA
simultaneous supplementation with iron and any other micronutrient(s), intravenous iron supplementation or recent exposure to altitude acclimatisation. The methodological quality of included studies was assessed with the PEDro scale, the completeness of intervention reporting with the TIDieR scale, while the GRADE scale was used for quality of evidence synthesis. The present study was prospectively registered in PROSPERO online registry (ID: CRD42022330230).
RESULTS
From 638 articles identified through the search, 13 studies (n = 449) were included in the quantitative synthesis. When compared to the control group, the results demonstrated that OIS increases serum ferritin (standardized mean difference (SMD) = 1.27, 95% CI 0.44-2.10, p = 0.006), whereas blood haemoglobin (SMD = 1.31, 95% CI - 0.29 to 2.93, p = 0.099), serum transferrin receptor concentration (SMD = - 0.74, 95% CI - 1.89 to 0.41, p = 0.133), and transferrin saturation (SMD = 0.69, 95% CI - 0.84 to 2.22, p = 0.330) remained unaltered. Following OIS, a trend of small positive effect on VO (SMD = 0.49, 95% CI - 0.09 to 1.07, p = 0.086) was observed in young healthy athletes. The quality of evidence for all outcomes ranged from moderate to low.
CONCLUSIONS
Increase in serum ferritin concentration after OIS was evident in subjects with initial pre-supplementation serum ferritin concentration ≤ 12 µg/l, while only minimal, if any effect, was observed in subjects with higher pre-supplementation serum ferritin concentration. The doses of OIS, that induced a beneficial effect on hematological parameters differed from 16 to 100 mg of elementary iron daily, over the period between 6 and 8 weeks. Shorter supplementation protocols have been shown to be ineffective.
Topics: Humans; Dietary Supplements; Randomized Controlled Trials as Topic; Iron; Athletes; Ferritins; Administration, Oral; Athletic Performance; Hemoglobins; Anemia, Iron-Deficiency
PubMed: 38407751
DOI: 10.1007/s40279-024-01992-8 -
International Journal of Oncology Apr 2024Lung cancer represents a marked global public health concern. Despite existing treatment modalities, the average 5‑year survival rate for patients with patients with... (Review)
Review
Lung cancer represents a marked global public health concern. Despite existing treatment modalities, the average 5‑year survival rate for patients with patients with lung cancer is only ~20%. As there are numerous adverse effects of systemic administration routes, there is an urgent need to develop a novel therapeutic strategy tailored specifically for patients with lung cancer. Non‑invasive aerosol inhalation, as a route of drug administration, holds unique advantages in the context of respiratory diseases. Nanoscale materials have extensive applications in the field of biomedical research in recent years. The present study provides a comprehensive review of the classification, applications summarized according to existing clinical treatment modalities for lung cancer and challenges associated with inhalable micron/nanoparticle drug delivery systems (DDSs) in lung cancer. Achieving localized treatment of lung cancer preclinical models through inhalation is deemed feasible. However, further research is required to substantiate the efficacy and long‑term safety of inhalable micron/nanoparticle DDSs in the clinical management of lung cancer.
Topics: Humans; Administration, Inhalation; Drug Delivery Systems; Drug-Related Side Effects and Adverse Reactions; Lung; Lung Neoplasms; Nanoparticle Drug Delivery System
PubMed: 38391039
DOI: 10.3892/ijo.2024.5626 -
Microbial Biotechnology Feb 2024Inhalation is the preferred route of delivery for anti-asthma and chronic obstructive pulmonary disease (COPD) drugs. The use of this route has demonstrated efficacy in... (Review)
Review
Inhalation is the preferred route of delivery for anti-asthma and chronic obstructive pulmonary disease (COPD) drugs. The use of this route has demonstrated efficacy in these and other conditions, it offers rapid onset of action, and is associated with minimal systemic exposure, thereby reducing the risk of adverse effects. Therefore, the current brief covers an interesting collection of inhaler action modes, shedding light on their molecular mechanisms and clinical applications for anti-asthma, COPD and antibacterial inhalation therapy. Hence, not only enriches our understanding of inhalation therapy molecular intricacies but also provides a comprehensive overview of the evolving landscape in clinical and antibacterial inhalation therapy. In doing so, it underscores the pivotal role of microbiology and biotechnology in advancing therapeutic approaches that harness the power of inhalation.
Topics: Humans; Administration, Inhalation; Anti-Bacterial Agents; Nebulizers and Vaporizers; Pulmonary Disease, Chronic Obstructive
PubMed: 38387963
DOI: 10.1111/1751-7915.14419 -
American Journal of Cardiovascular... Mar 2024oral anticoagulant (DOAC) agents are becoming the anticoagulation strategy of choice for most clinical risks for which they are indicated. However, residual uncertainty... (Meta-Analysis)
Meta-Analysis
Comparative Effectiveness and Safety of Direct Oral Anticoagulants Compared with Warfarin in Patients with Low Bodyweight who have Atrial Fibrillation: A Systematic Review and Meta-analysis.
INTRODUCTION
oral anticoagulant (DOAC) agents are becoming the anticoagulation strategy of choice for most clinical risks for which they are indicated. However, residual uncertainty remains regarding their use in preventing stroke in patients with low bodyweight [< 60 kg or body mass index (BMI) < 18 kg/m]. We have carried out pooled systematic analyses of published studies to determine the efficacy and safety of these agents compared with warfarin in stroke prevention in patients with low bodyweight.
METHODS
We carried out a comprehensive search of electronic databases from inception to June 2023 for eligible studies reporting on the efficacy and safety of direct oral anticoagulants versus warfarin in patients with atrial fibrillation who had low bodyweight. These include PubMed, EMBASE, the Cochrane Database of Systematic Reviews, the Science Citation Index, and the Database of Abstracts of Reviews of Effectiveness. Using the random effects model, derived pooled odd ratios (with their corresponding confidence intervals) of mortality outcomes in patient cohorts exposed to direct oral anticoagulants versus warfarin in patients with atrial fibrillation who had low bodyweight.
RESULTS
Nine studies (n = 159,514 patients) were included in our meta-analysis. DOAC analogs were associated with lower stroke recurrence compared with warfarin [odds ratio (OR) 0.66, 95% confidence interval (CI) 0.49-0.9]; however, there was no significant difference in the composite outcome (OR 0.81, 95% CI 0.59-1.09) and mortality (OR 0.82, 95% CI 0.48-1.41). Additionally, DOAC analogs showed a significant reduction in major bleeding events by 30% compared with warfarin (OR 0.70, 95% CI 0.62-0.80).
CONCLUSION
In this pooled meta-analytical synthesis of studies comprising both real-world and randomized controlled data, the use of DOAC analogs in patients with atrial fibrillation and low bodyweight (< 60 kg or BMI < 18 kg/m) was associated with a significant reduction in risks of stroke and major bleeding compared with patient cohorts stabilized on warfarin-based therapy. There was uncertainty regarding the composite outcome and mortality point estimate between these two anticoagulation strategies. This finding helps to resolve the uncertainty associated with the use of DOACs in this cohort. Additionally, it suggests the need for confirmatory non-inferiority randomized controlled trials evaluating DOACs versus warfarin in this cohort of patients.
Topics: Humans; Warfarin; Atrial Fibrillation; Anticoagulants; Stroke; Hemorrhage; Administration, Oral
PubMed: 38386247
DOI: 10.1007/s40256-024-00628-6