scholarly journals Newer-generation antihistamines and the risk of adverse events in children: a systematic review

2020 ◽  
Author(s):  
Michael Miligkos ◽  
Maria Dakoutrou ◽  
Eleni Statha ◽  
Nikoletta Theochari ◽  
Ilektra Antonia Mavroeidi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Pediatric Population ◽  
Indirect Evidence ◽  
Allergic Diseases ◽  
Tolerability Profile ◽  
Eligibility Criteria ◽  
Safety Parameters ◽  
Comparative Safety

Background: H1-antihistamines (AHs) are widely used for the treatment of allergic diseases, being one of the most commonly prescribed classes of medications in Pediatrics. Newer-generation AHs are associated with fewer adverse effects compared to first-generation. However, their relative harms in the pediatric population still need scrutiny. Methods: We performed a systematic review of randomized controlled trials (RCTs) which included comparisons of safety parameters between an orally administered newer-generation AH with another AH (first- or second- generation), montelukast or placebo in children aged≤12 years. We searched MEDLINE and CENTRAL, independently extracted data on study population, interventions, adverse events (AEs) and treatment discontinuations, and assessed the methodological quality of the included RCTs using the Cochrane’s risk of bias tool. Results: Fourty-five RCTs published between 1989 and 2017 met eligibility criteria. The majority of RCTs included school-aged children with allergic rhinitis and had a follow-up period of up to a month. Four RCTs reported serious AEs in patients receiving a newer-generation AH, but only two patients experienced a possibly drug-related serious AE. The occurrence of AEs, drug-related AEs and treatment discontinuations due to AEs varied between RCTs. Most AEs reported were of mild intensity. Indirect evidence indicates that cetirizine is more sedating than the other newer-generation AHs. Conclusion: Our findings confirm that newer-generation AHs have a favorable safety and tolerability profile. However, we could not draw firm conclusions regarding the comparative safety profile of the newer-generation AHs due to the paucity of head-to-head RCTs, variation in definitions and reporting of AEs, and short follow-up duration.

scholarly journals Potential of biomarkers during pharmacological therapy setting for postmenopausal osteoporosis: a systematic review

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Filippo Migliorini ◽  
Nicola Maffulli ◽  
Filippo Spiezia ◽  
Giuseppe Maria Peretti ◽  
Markus Tingart ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Postmenopausal Osteoporosis ◽  
Randomized Clinical Trials ◽  
Type I Collagen ◽  
Therapy Monitoring ◽  
Pharmacological Therapy ◽  
Type I ◽  
Gastrointestinal Adverse Events

Abstract Background Biochemical markers of bone turnover (BTMs), such as the bone alkaline phosphatase (bALP), procollagen type I N propeptide (PINP), serum cross-linked C-telopeptides of type I collagen (bCTx), and urinary cross-linked N-telopeptides of type I collagen (NTx), are used to manage therapy monitoring in osteoporotic patients. This systematic review analyzed the potential of these BMTs in predicting the clinical outcomes in terms of BMD, t-score, rate of fractures, and adverse events during the therapy setting in postmenopausal osteoporosis. Methods All randomized clinical trials (RCTs) reporting data on biomarkers for postmenopausal osteoporosis were accessed. Only articles reporting quantitative data on the level of biomarkers at baseline and on the outcomes of interest at the last follow-up were eligible. Results A total of 36,706 patients were retrieved. Greater values of bALP were associated with a greater rate of vertebral (P = 0.001) and non-vertebral fractures (P = 0.0001). Greater values of NTx at baseline were associated with a greater rate of adverse events at the last follow-up (P = 0.02). Greater values of CTx at baseline were associated with a greater rate of adverse events leading to discontinuation (P = 0.04), gastrointestinal adverse events (P = 0.0001), musculoskeletal adverse events (P = 0.04), and mortality (P = 0.04). Greater values of PINP at baseline were associated with greater rates of gastrointestinal adverse events (P = 0.02) at the last follow-up. Conclusion The present analysis supports the adoption of BMTs during pharmacological therapy setting of patients suffering from osteoporosis. Level of evidence I, systematic review of RCTs

scholarly journals Commonly Reported Adverse Events Associated With Pediatric Immunotherapy: A Systematic Review From the Children’s Oncology Group

2020 ◽  
Vol 38 (1) ◽  
pp. 16-25
Author(s):  
Janice S. Withycombe ◽  
Aimee Carlson ◽  
Carly Coleman ◽  
Sharon L. Leslie ◽  
Micah Skeens ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Pediatric Oncology ◽  
Nursing Practice ◽  
Evaluation Criteria ◽  
Brentuximab Vedotin ◽  
Educational Materials ◽  
Eligibility Criteria ◽  
Assessment Development ◽  
Pediatric Cancers

Background: Immunotherapy is a new and promising approach to treating pediatric cancers. These types of therapies have unique mechanisms of action for identifying and fighting cancer, as compared with traditional chemotherapy, and therefore are associated with different therapy-related adverse events (AEs). The purpose of this systematic review was to review available evidence to: (a) identify commonly reported AEs associated with immunotherapy agents frequently used in pediatric oncology and (b) generate recommendations for nursing practice. Method: A clinical question was developed and used to guide the systematic literature review. Five immunotherapy agents (dinutuximab, blinatumomab, rituximab, inotuzumab ozogamicin, brentuximab vedotin) were selected for inclusion secondary to their high relevance to pediatric oncology. A literature search was conducted to locate articles published between January 1, 2003 and October 31, 2018. Results: Seventeen articles met eligibility criteria for inclusion and were evaluated using the Grading of Recommendations Assessment, Development, and Evaluation criteria. The most commonly reported AEs for the selected immunotherapy agents were identified and summarized. Strong recommendations are made for nurses to become familiar with the unique AE profiles associated with individual immunotherapy agents. Agent-specific recommendations for nursing practice regarding AEs associated with dinutuximab and rituximab were generated. Conclusions: Immunotherapy is rapidly emerging as an effective therapy for pediatric cancers. Nurses need to be aware of the breadth of agent-specific, immunotherapy-related AEs to appropriately monitor and manage patients receiving these therapies. Additional work is needed to confidently profile immunotherapy-related AEs in pediatric oncology and to develop agent-specific educational materials for patients/families.

scholarly journals Pediatric Pituitary Adenoma: Case Series, Review of the Literature, and a Skull Base Treatment Paradigm

2018 ◽  
Vol 79 (01) ◽  
pp. 091-114 ◽  
Author(s):  
Avital Perry ◽  
Christopher Graffeo ◽  
Christopher Marcellino ◽  
Bruce Pollock ◽  
Nicholas Wetjen ◽  
...  
Keyword(s):  
Systematic Review ◽  
Pituitary Adenoma ◽  
Skull Base ◽  
Pituitary Adenomas ◽  
Pediatric Population ◽  
Csf Leak ◽  
Persistent Disease ◽  
Treatment Paradigm ◽  
Surgical Cure

Background Pediatric pituitary adenoma is a rare skull base neoplasm, accounting for 3% of all intracranial neoplasms in children and 5% of pituitary adenomas. Compared with pituitary tumors in adults, secreting tumors predominate and longer disease trajectories are expected due to the patient age resulting in a natural history and treatment paradigm that is complex and controversial. Objectives The aims of this study were to describe a large, single-institution series of pediatric pituitary adenomas with extensive long-term follow-up and to conduct a systematic review examining outcomes after pituitary adenoma surgery in the pediatric population. Methods The study cohort was compiled by searching institutional pathology and operative reports using diagnosis and site codes for pituitary and sellar pathology, from 1956 to 2016. Systematic review of the English language literature since 1970 was conducted using PubMed, MEDLINE, Embase, and Google Scholar. Results Thirty-nine surgically managed pediatric pituitary adenomas were identified, including 15 prolactinomas, 14 corticotrophs, 7 somatotrophs, and 4 non-secreting adenomas. All patients underwent transsphenoidal resection (TSR) as the initial surgical treatment. Surgical cure was achieved in 18 (46%); 21 experienced recurrent/persistent disease, with secondary treatments including repeat surgery in 10, radiation in 14, adjuvant pharmacotherapy in 11, and bilateral adrenalectomy in 3. At the last follow-up (median 87 months, range 3–581), nine remained with recurrent/persistent disease (23%).Thirty-seven publications reporting surgical series of pediatric pituitary adenomas were included, containing 1,284 patients. Adrenocorticotropic hormone (ACTH)-secreting tumors were most prevalent (43%), followed by prolactin (PRL)-secreting (37%), growth hormone (GH)-secreting (12%), and nonsecreting (7%). Surgical cure was reported in 65%. Complications included pituitary insufficiency (23%), permanent visual dysfunction (6%), chronic diabetes insipidus (DI) (3%), and postoperative cerebrospinal fluid (CSF) leak (4%). Mean follow-up was 63 months (range 0–240), with recurrent/persistent disease reported in 18% at the time of last follow-up. Conclusion Pediatric pituitary adenomas are diverse and challenging tumors with complexities far beyond those encountered in the management of routine adult pituitary disease, including nuanced decision-making, a technically demanding operative environment, high propensity for recurrence, and the potentially serious consequences of hypopituitarism with respect to fertility and growth potential in a pediatric population. Optimal treatment requires a high degree of individualization, and patients are most likely to benefit from consolidated, multidisciplinary care in highly experienced centers.

Flow redirection endoluminal device (FRED) for treatment of intracranial aneurysms: A systematic review

2021 ◽  
pp. 159101992110279
Author(s):  
Muhammad Waqas ◽  
Rimal H Dossani ◽  
Modhi Alkhaldi ◽  
Jocelyn Neveu ◽  
Justin M Cappuzzo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Intracranial Aneurysms ◽  
Flow Diverter ◽  
Complication Rates ◽  
Mesh Terms ◽  
Aneurysm Occlusion ◽  
Occlusion Rate ◽  
Layered Flow ◽  
Comparative Safety

Introduction The Flow Redirection Endoluminal Device (FRED; MicroVention) is a dual-layered flow diverter used for the treatment of intracranial aneurysms. The objective of this systematic review was to compile device-related safety and effectiveness data. Methods The literature from January 1, 2013 to April 30, 2021 was searched for studies describing use of the FRED for intracranial aneurysm treatment irrespective of aneurysm location and morphology. The review included anterior and posterior circulation ruptured and unruptured saccular, fusiform or dissection, and blister aneurysms. MeSH terms related to “flow re-direction endoluminal device” and “FRED for aneurysms” were used. Data related to indication, complications, and rates of aneurysm occlusion were retrieved and analyzed. Results Twenty-two studies with 1729 intracranial aneurysms were included in this review. Overall reported morbidity was 3.9% (range 0–20%). Overall procedure-related mortality was 1.4% (range 0–6%). Complication rates fell into 5 categories: technical (3.6%), ischemic (3.8%), thrombotic or stenotic (6%), hemorrhagic (1.5%), and non-neurological (0.8%). The aneurysm occlusion rate between 0 and 3 months (reported in 11 studies) was 47.8%. The occlusion rate between 4 and 6 months (reported in 14 studies) was 73.8%. Occlusion rates continued to increase to 75.1% at 7–12 months (reported in 10 studies) and 86.6% for follow-up beyond 1 year (reported in 10 studies). Conclusion This review indicated that the FRED is a safe and effective for the treatment of intracranial aneurysms. Future studies should directly compare the FRED with other flow diverters for a better understanding of comparative safety and effectiveness among the different devices.

scholarly journals A Systematic Review of Pediatric and Adult In-Flight Medical Emergencies

2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Christina Sul ◽  
Sherif M. Badawy
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Health Outcomes ◽  
Pediatric Population ◽  
Air Travel ◽  
Serious Adverse Events ◽  
Significant Events ◽  
Medical Emergencies ◽  
The Subject

In-flight medical emergencies (IMEs) are acute onboard events of illnesses or injuries with potential immediate risk to a passenger’s short- or long-term health, or life. IMEs are significant events that are related to public safety concerns. With the increasing amount of annual air travel every year, it is expected that the number of encountered IMEs will continue to grow. Thus, it will be critical to develop and implement appropriate measures to manage IMEs with the best possible outcome. Despite the fact that most IMEs are self-limited with no serious adverse events, serious IME can lead to death, disability, or other unfavorable health outcomes, particularly as a result of suboptimal medical care. In this article, we systematically reviewed the published up-to-date evidence on the subject of in-flight emergencies with a specific focus on pediatric population.

scholarly journals Promoting activity, Independence and stability in early dementia (PrAISED): a, multisite, randomised controlled, feasibility trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Sarah E. Goldberg ◽  
◽  
Veronika van der Wardt ◽  
Andy Brand ◽  
Clare Burgon ◽  
...  
Keyword(s):  
Adverse Events ◽  
Falls Prevention ◽  
Feasibility Trial ◽  
Moderate Intensity ◽  
Eligibility Criteria ◽  
Intervention Delivery ◽  
Link Type ◽  
Early Dementia ◽  
Randomised Controlled

Abstract Background We tested the feasibility of delivering and evaluating a complex therapy intervention which aimed to promote activity and independence for people with early dementia (PrAISED). Feasibility questions were on: recruitment, randomisation, intervention delivery, adherence and withdrawals, level of supervision required, adverse events, data collection and sample size assumptions. Methods We conducted a three-arm, multi-site, single-blind, randomised controlled feasibility trial. Eligibility criteria were aged 65 years or older, diagnosed mild dementia or mild cognitive impairment, able to walk without human help, and communicate in English, no co-morbidities that prevented participation in cognitive assessment and capacity to give consent. Participants were recruited from Memory Assessment Service clinics and the ‘Join Dementia Research’ register. Patient participants were randomised 1:1:1 to a high intensity supervision PrAISED intervention, moderate intensity supervision PrAISED intervention or brief falls prevention assessment and advice (control). The PrAISED intervention aimed for participants to complete three hours of PrAISED exercises a week for 12 months. It included individualised activity and exercise plans and supervised exercises with regular re-assessment and progression, and was delivered by occupational therapists, physiotherapists and rehabilitation support workers. Primary efficacy outcome was the Disability Assessment for Dementia (DAD), measured after 12 months. Secondary outcomes included physical activity, quality of life, mood, cognition, strength, balance, rate of falls, frailty and carer strain. Falls and activity were ascertained by monthly diary. Results Between September 2016 and March 2017 we recruited 60 patient participants and 54 carer participants from two sites. Forty-nine patient participants completed a follow-up interview. Feasibility outcomes were mostly satisfactory, including recruitment and retention, intervention delivery and data completeness for most scales used. We could not maintain blinding of researchers at follow-up and experienced difficulties collecting data using some questionnaires and devices. Participants only completed a mean 77 (moderate supervision) and 71 (high supervision) minutes per week of PrAISED exercises over 12 months. We recorded 19 adverse events, none serious and related to the intervention. Conclusion We conclude that with some adjustments to the trial protocol, it is feasible to deliver the PrAISED intervention and conduct a trial. Trial registration ClinicalTrials.gov: NCT02874300 (first posted 22nd August 2016), ISRCTN: 10550694 (date assigned 31st August 2016).

scholarly journals Impact of surgical maxillomandibular advancement upon pharyngeal airway volume and the apnoea–hypopnoea index in the treatment of obstructive sleep apnoea: systematic review and meta-analysis

2019 ◽  
Vol 6 (1) ◽  
pp. e000402 ◽  
Author(s):  
Maria Giralt-Hernando ◽  
Adaia Valls-Ontañón ◽  
Raquel Guijarro-Martínez ◽  
Jorge Masià-Gridilla ◽  
Federico Hernández-Alfaro
Keyword(s):  
Systematic Review ◽  
Obstructive Sleep Apnoea ◽  
Meta Analysis ◽  
Sleep Apnoea ◽  
Eligibility Criteria ◽  
Pharyngeal Airway ◽  
Maxillomandibular Advancement ◽  
Subsequent Decrease ◽  
Obstructive Sleep

BackgroundA systematic review was carried out on the effect of surgical maxillomandibular advancement (MMA) on pharyngeal airway (PA) dimensions and the apnoea–hypopnoea index (AHI) in the treatment of obstructive sleep apnoea (OSA), with the aim of determining whether increased PA in the context of MMA is the main factor conditioning the subsequent decrease in AHI.MethodsA search was made of the PubMed, Embase, Google Scholar and Cochrane databases. A total of 496 studies were identified. The inclusion criteria were a diagnosis of moderate to severe OSA, MMA success evaluated by polysomnography, reporting of the magnitude of MMA achieved, PA increase and a minimum follow-up of 6 months.ResultsFollowing application of the eligibility criteria, eight articles were included. Metaregression analysis showed MMA to significantly increase both pharyngeal airway volume (PAV) (mean 7.35 cm3 (range 5.35–9.34)) and pharyngeal airway space (mean 4.75 mm (range 3.15–6.35)) and ensure a final AHI score below the threshold of 20 (mean 12.9 events/hour).ConclusionsAlthough subgroup analysis showed MMA to be effective in treating OSA, more randomised trials are needed to individualise the required magnitude and direction of surgical movements in each patient, and to standardise the measurements of linear and nonlinear PAV parameters.

scholarly journals Synovial Sarcoma of the Nerve—Clinical and Pathological Features: Case Series and Systematic Review

Neurosurgery ◽  
2019 ◽  
Vol 85 (6) ◽  
pp. E975-E991 ◽  
Author(s):  
Stephen Shelby Burks ◽  
Ross C Puffer ◽  
Iahn Cajigas ◽  
David Valdivia ◽  
Andrew E Rosenberg ◽  
...  
Keyword(s):  
Systematic Review ◽  
Statistical Analysis ◽  
Synovial Sarcoma ◽  
Tumor Size ◽  
Clinical Course ◽  
Case Reports ◽  
Case Series ◽  
Pathological Features ◽  
Eligibility Criteria

Abstract BACKGROUND Synovial sarcoma of the nerve is a rare entity with several cases and case series reported in the literature. Despite an improved understanding of the biology, the clinical course is difficult to predict. OBJECTIVE To compile a series of patients with synovial sarcoma of the peripheral nerve (SSPN) and assess clinical and pathological factors and their contribution to survival and recurrence. METHODS Cases from 2 institutions collected in patients undergoing surgical intervention for SSPN. Systematic review including PubMed and Scopus databases were searched for related articles published from 1970 to December 2018. Eligibility criteria: (1) case reports or case series reporting on SSPN, (2) clinical course and/or pathological features of the tumor reported, and (3) articles published in English. RESULTS From patients treated at our institutions (13) the average follow-up period was 3.2 yr. Tumor recurrence was seen in 4 cases and death in 3. Systematic review of the literature yielded 44 additional cases with an average follow-up period of 3.6 yr. From pooled data, there were 10 recurrences and 7 deaths (20% and 14%, respectively). Adjuvant treatment used in 62.5% of cases. Immunohistochemical markers used in diagnosis varied widely; the most common are the following: Epithelial membrane antigen (EMA), cytokeratin, vimentin, cluster of differentiation (CD34), and transducin-like enhancer of split 1 (TLE1). Statistical analysis illustrated tumor size and use of chemotherapy to be negative predictors of survival. No other factors, clinically or from pathologist review, were correlated with recurrence or survival. CONCLUSION By combining cases from our institution with historical data and performing statistical analysis we show correlation between tumor size and death.

Imatinib Long Term Effects (ILTE) Study: An Independent, International Study in CML Patients.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1099-1099
Author(s):  
Carlo Gambacorti-Passerini ◽  
Dong-Wook Kim ◽  
François-Xavier Mahon ◽  
Giuseppe Saglio ◽  
Fabrizio Pane ◽  
...  
Keyword(s):  
Adverse Events ◽  
International Study ◽  
Imatinib Treatment ◽  
Long Term Effects ◽  
First Line ◽  
Eligibility Criteria ◽  
Serious Adverse Events ◽  
Second Cancers

Abstract Imatinib is an effective first line therapy for chronic myeloid leukemia (CML) and has substantially changed its biological and clinical behavior. Durable complete cytogenetic responses (CCyR) were reported in the majority of patients, with a rather benign side effect profile, despite the ‘off target’ inhibition of several other kinases, including Kit, PDGFR and Lck. Since available information is largely based on industry-sponsored trials and long-term field studies are lacking, the ILTE study was conceived as an industryindependent, academic, multicenter trial supported by the Italian Drug Safety Agency (AIFA). ILTE is an international study on a retrospective cohort and includes 31 centers in Europe, North/South America, Africa and Asia; therefore it is uniquely positioned to present a global picture of imatinib long-term effects. Consecutive patients with Ph+ CML who started imatinib between 01 September 1999 and 31 December 2004 were eligible if they were in Complete Cytogenetic Response (CCyR) after two years of imatinib treatment. Study endpoints were survival, serious adverse events (SAE, including second cancers), toxicities not qualifying as SAE (NSAE) but judged by the referring physician as substantially impacting quality of life, loss of CCyR, and development of PCR negativity. A total of 957 patients were enrolled, 92% of which met eligibility criteria. The median age of eligible patients was 50 (range 15–92) years; 59% of patients were males and the median follow-up was 3.1 years (excluding the first 2 years of treatment). As of Dec. 31 2007, 2564 person years were available for analysis. Eleven deaths were observed (only 3 of them caused by relapsed CML), with a standardized rate of 0.4/100 person years and an observed/expected ratio of 0.48 (95% CI = 0.24–0.85). One-hundred SAE were recorded (rate 3.9/100 person years, most frequent type “heart failure”), with 21% being considered related to imatinib. Second cancers were documented in 28 patients (rate 1.1/100 person years), with an observed/expected ratio of 1.27 (95% CI = 0.84–1.84). Among the 576 NSAE recorded (0.65/patient) the most frequent types were “edema, cramps, skin fragility, diarrhea”; 71% of them were related to imatinib. A total of 12 patients (1.4 %) discontinued imatinib because of toxicities during the period of observation. Thirty-four patients lost CCyR, corresponding to a rate of 1.4/100 person years (1.0 in patients with imatinib as first-line treatment, 1.5 in patients who were treated with imatinib >6 months after diagnosis), with stable or increasing rates over time. Finally, 214 patients (24.5%) developed durable (> 1 year) PCR negativity. In conclusion, the first report from ILTE shows that CML patients on imatinib die unfrequently of CML related causes, do not appear to have substantially higher second cancer rates than the general population, have mortality rates lower than expected in an age/sex matched population and do not show new types of imatinib-related adverse events. They also experience a low but steady rate of loss of CCyR and develop PCR negativity in approximately ¼ of cases. Follow-up and further analysis are ongoing. (Presented on behalf of the ILTE Investigators group)

Custo-efetividade da telemedicina no acompanhamento de asmáticos: revisão sistemática

2019 ◽  
Vol 17 (2) ◽  
Author(s):  
Marcela Da Silva Souza ◽  
Carolina Barbosa Souza Santos ◽  
Raimeyre Marques Torres ◽  
Mayara Sousa Silva ◽  
Ana Carla Carvalho Coelho ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Cost Effectiveness ◽  
Asthma Management ◽  
Review Of The Literature ◽  
Eligibility Criteria ◽  
The Cost ◽  
Made In

Aim: systematic review of the literature on the cost-effectiveness of telemedicine in the follow-up of asthmatics. Method: Systematic review of the PUBMED / MEDLINE, LILACS and Cochrane Central databases. Articles published in English, Portuguese or Spanish were considered in the period from 2005 to 2018 according to the PRISMA guidelines. Results: A total of 1363 articles were identified, of which 59 were read in their entirety. Only five met the eligibility criteria, and all were made in European countries and totaled 2,497 participants. The interventions were performed by nurses (4 of 5 studies), remaining from 16 weeks to 12 months. Telemedicine costs were similar or slightly lower compared to usual treatments. Telemedicine had a beneficial effect on asthma control (1 of 5 studies), quality of life (3 out of 5 studies) and hospitalizations (1 of 5 studies). Conclusion: Telemedicine slightly reduces costs with asthma management and may have an impact on morbidity indicators

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