scholarly journals Efficacy and Tolerability of Lacosamide in Lennox–Gastaut Syndrome: A Systematic Review and Meta-analysis

2022 ◽  
Author(s):  
Prateek Kumar Panda ◽  
Indar Kumar Sharawat ◽  
Lesa Dawman ◽  
Pragnya Panda ◽  
Ananthanarayanan Kasinathan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Seizure Frequency ◽  
Retrospective Studies ◽  
Case Reports ◽  
Random Effect ◽  
Random Effect Model ◽  
Case Series ◽  
Eligibility Criteria ◽  
Serious Adverse Events

Abstract Purpose Lennox–Gastaut syndrome (LGS) is one of the most difficult to treat childhood-onset epileptic encephalopathies. There is growing evidence that lacosamide is safe and efficacious in patients and adults with refractory epilepsy. However, the evidence regarding the efficacy of lacosamide in LGS is controversial so far. We aimed to evaluate the efficacy and tolerability of lacosamide in patients with LGS. Methods We conducted a systematic review on MEDLINE, EMBASE, COCHRANE CENTRAL, Google Scholar, and Web of Science, collating all available literature till July 31, 2020. The qualitative review included case reports, case series, and both controlled/uncontrolled trials as well as retrospective studies, but for determining pooled estimates, we only included studies with a sample size of 5 or more. The primary outcome was the efficacy of lacosamide in patients with LGS. Clinical variables related to efficacy and adverse events attributed to lacosamide were extracted from each publication. The pooled estimate of variables related to these parameters was performed using a random-effect model. Results Of the 68 items identified by the search, 14 were reviewed as full-text. Eleven articles including two prospective and six retrospective studies fulfilled eligibility criteria and described outcomes in 81 patients (42 adults, 39 children, 60% male, range—1.4–61 years). On average, 35.2%, 27.9%, 7.3%, and 29.4% patients had > 50% reduction, < 50% reduction, no change, and worsening of seizure frequency, respectively. Although 36% of patients had adverse events like somnolence, behavioral abnormalities including irritability, aggressiveness, nausea, tremor, memory problems, dizziness, gastrointestinal discomfort, vomiting, and weight loss, no serious adverse events were noted. Conclusion The evidence available in the current literature is not sufficient to support or refute the use of lacosamide in patients with LGS. Although it is one of the possible therapeutic options worth exploring in patients with LGS, caution is still necessary, as there are reports of worsening of seizure frequency in some patients.

scholarly journals Lipoprotein(a) as a Risk Factor for Venous Thromboembolism: A Systematic Review and Meta-analysis of the Literature

2017 ◽  
Vol 43 (06) ◽  
pp. 614-620 ◽  
Author(s):  
Vera Gessi ◽  
Rossella Marcucci ◽  
Monica Gianni ◽  
Anna Grandi ◽  
Massimo Franchini ◽  
...  
Keyword(s):  
Systematic Review ◽  
Risk Factor ◽  
Venous Thromboembolism ◽  
Case Reports ◽  
Random Effect ◽  
Random Effect Model ◽  
Case Series ◽  
Lipoprotein A ◽  
Increased Risk ◽  
Venous Thromboembolic Events

AbstractElevated plasma levels of lipoprotein(a) (Lp(a)) are associated with increased cardiovascular risk in several clinical studies. However, there is a lack of data supporting a positive association between elevated Lp(a) levels and venous thromboembolism (VTE). Thus, we conducted a systematic review of the literature to better clarify its role as a risk factor for VTE. Medline and the Embase (up to May 2015) electronic databases were used to identify potentially eligible studies. Studies measuring Lp(a) values in adult patients with deep vein thrombosis and/or pulmonary embolism and in a population of patients without a VTE were selected. Studies on patients with major venous thromboembolic events occurring at other unusual site, case reports, and case series were excluded. The odds ratios (ORs) of the association between high values of Lp(a) and VTE and the weighted mean difference (WMD) in Lp(a) levels in cases and in controls were calculated using a random-effect model. Results were presented with 95% confidence interval (CI). Fourteen studies for a total of more than 14,000 patients were finally included in our analysis. Lp(a) was slightly but significantly associated with an increased risk of VTE (OR: 1.56, 95% CI: 1.36, 1.79; 10 studies, 13,541 patients). VTE patients had significantly higher Lp(a) values compared with controls (WMD: 14.46 mg/L, 95% CI: 12.14, 16.78; 4 studies, 470 patients). Lp(a) appeared to be significantly associated with increased risk of VTE. However, Lp(a) levels were only slightly increased in VTE patients compared with controls.

scholarly journals The Safety and Toxicity of Phage Therapy: A Review of Pre-Clinical and Clinical Studies

2021 ◽  
Author(s):  
Dan Liu ◽  
Jonas D Van Belleghem ◽  
Christiaan Robert de Vries ◽  
Elizabeth Burgener ◽  
Qingquan Chen ◽  
...  
Keyword(s):  
Systematic Review ◽  
English Language ◽  
Phage Therapy ◽  
Case Reports ◽  
Case Series ◽  
Resistant Bacteria ◽  
Toxicity Data ◽  
Eligibility Criteria ◽  
Serious Adverse Events ◽  
Safety And Toxicity

Increasing rates of infection by antibiotic resistant bacteria have led to a resurgence of interest in bacteriophage (phage) therapy. Several phage therapy studies in animals and humans have been completed over the last two decades. We conducted a systematic review of safety and toxicity data associated with phage therapy in both animals and humans reported in English-language publications from 2008 &ndash; 2021. Overall, 69 publications met our eligibility criteria including 20 animal studies, 35 clinical case reports or case series, and 14 clinical trials. After summarizing safety and toxicity data from these publications, we discuss potential approaches to optimizing safety and toxicity monitoring with the therapeutic use of phage moving forward. In our systematic review of the literature, we found few, but no serious, adverse events associated with phage therapy. Comprehensive and standardized reporting of potential toxicities associated with phage therapy has generally been lacking in the published literature. Structured safety and tolerability endpoints are necessary when phages are administered as anti-infective therapeutics.

scholarly journals Neurological Complications of SARS-CoV-2 Infection in Children: A Systematic Review and Meta-Analysis

2020 ◽  
Author(s):  
Prateek Kumar Panda ◽  
Indar Kumar Sharawat ◽  
Pragnya Panda ◽  
Vivekanand Natarajan ◽  
Rahul Bhakat ◽  
...  
Keyword(s):  
Systematic Review ◽  
Case Reports ◽  
Meta Analysis ◽  
Random Effect ◽  
Case Series ◽  
Neurological Complications ◽  
Severe Illness ◽  
Neurological Manifestations ◽  
Eligibility Criteria ◽  
Symptomatic Seizures

Abstract Background Knowledge about neurological complications of COVID-19 in children is limited due to the paucity of data in the existing literature. Some systematic reviews are available describing overall clinical features of COVID-19 in children and neurological complications of COVID-19 in adults. But to the best of our knowledge, no systematic review has been performed to determine neurological manifestations of COVID-19. Methods Six different electronic databases (MEDLINE, EMBASE, Web of Science, CENTRAL, medRxiv and bioRxiv) were searched for articles related to COVID-19 and neurological complications in children. Studies/case series reporting neurological manifestations of COVID-19 in patients aged ≤18 years, as well as case reports, as neurological complications appear to be rare. The pooled estimate of various non-specific and specific neurological manifestations was performed using a random effect meta-analysis. Results Twenty-one studies/case series and five case reports (3707 patients) fulfilled the eligibility criteria and were included in this systematic review, from a total of 460 records. Headache, myalgia and fatigue were predominant non-specific neurological manifestations, presenting altogether in 16.7% cases. Total of 42 children (1%) were found to have been reported with definite neurological complications, more in those suffering from a severe illness (encephalopathy—25, seizure—12, meningeal signs—17). Rare neurological complications were intracranial hemorrhage, cranial nerve palsy, Guillain–Barré syndrome and vision problems. All children with acute symptomatic seizures survived suggesting a favorable short-term prognosis. Conclusion Neurological complications are rare in children suffering from COVID-19. Still, these children are at risk of developing seizures and encephalopathy, more in those suffering from severe illness.

scholarly journals Adverse events associated with human papillomavirus vaccines: a protocol for systematic review with network meta-analysis incorporating all randomised controlled trials comparing with placebo, adjuvants and other vaccines

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e026924 ◽  
Author(s):  
Jiro Takeuchi ◽  
Hisashi Noma ◽  
Yuta Sakanishi ◽  
Takashi Kawamura
Keyword(s):  
Systematic Review ◽  
Human Papillomavirus ◽  
Adverse Events ◽  
Systematic Reviews ◽  
Meta Analysis ◽  
Random Effect ◽  
Random Effect Model ◽  
Splitting Method ◽  
Health Concern ◽  
Human Papillomavirus Vaccine

IntroductionAdverse events following the injection (AEFIs) of human papillomavirus vaccine (HPVv) among female adolescents are still a major public health concern.MethodsAccording to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension statement for systematic reviews incorporating network meta-analyses, all prospective randomised trials will be included. The primary outcome for adverse events is topical pain during the observation period.We will mainly search 17 electronic databases from January 2000 through September 2019 with suitable Medical Subject Headings and text words for PubMed. Two reviewers will independently check the reports at the title/abstract level and identify potentially applicable studies. Then we will obtain their full texts and decide whether to include them based on the same eligible criteria.We will compare HPVv with placebo, HPVv with adjuvant and HPVv with other vaccines. Interstudy heterogeneity, publication biases or small study effects will be evaluated using conventional meta-analysis methods. The consistency of the network will be checked using tests for local and global inconsistency and the side-splitting method. To address the heterogeneity of treatment effects among the studies, we will use the multivariable random effect model.Ethics and disseminationThis pairwise or network meta-analysis does not require ethics approval. The data used here are not individual nor private. We will be able to determine which component of the vaccine induces adverse events, especially topical pain. This systematic review with network meta-analysis will provide valid answers regarding AEFIs for HPVv.PROSPERO registration numberCRD42018109265

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.

scholarly journals Effectiveness and Safety of Remdesivir in Patients with COVID-19: A Systematic Review and Meta-Analysis

2021 ◽  
Author(s):  
Hai-Bo Yao ◽  
Jie-Ru Peng ◽  
Xue-Mei Zheng ◽  
Zhuo Yang ◽  
Huang Yan ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Improvement ◽  
Observational Studies ◽  
Meta Analysis ◽  
Random Effect ◽  
Random Effect Model ◽  
Antiviral Drug ◽  
Serious Adverse Events ◽  
Effect Model ◽  
Grade 3

Abstract Background: Remdesivir, a nucleoside analogue antiviral drug developed for Ebola, is approved by the US Food and Drug Administration for the treatment of COVID-19. However, the findings of randomised controlled trials (RCTs) and observational studies vary regarding the effectiveness of remdesivir. We aimed to comprehensively review the available evidence identify the effectiveness and safety of remdesivir in patients with COVID-19.Methods: Seven databases (PubMed, Web of Science, Embase, Wanfang database, SinoMed, Chinese National Knowledge Infrastructure and Chinese Science Journal Database) were searched for literatures published until November 2020.Following the PRISMA flow diagram, we included RCTs and prospective observational studies that reported the effectiveness and safety of remdesivir in patients with COVID-19. With extracting study details, as well as patient characteristics and outcomes, data were meta-analyzed by using Review Manager software version 5.4.1. Meta-analyses were conducted with fixed-effect model or random-effect model to calculate risk ratio (RR).Results: Four studies involving 2,279 patients were included in this meta-analysis. Compared with placebo, 10-day remdesivir was associated with significant increased clinical improvement on days 14 and 28 with RR 1.19 (95%CI 1.09-1.30) and RR 1.09 (95%CI 1.03-1.16). The clinical improvement of 5-day remdesivir was better than 10-day remdesivir on days 7 with RR 1.20 (95%CI 1.02-1.41), but the efficacy advantage of 5-day remdesivir disappeared on days 14 (RR 1.08; 95%CI 0.90-1.29). Remdesivir was associated with lower serious adverse events rates and grade 3 or 4 adverse events rates as compared with placebo with RR 0.75(95%CI 0.63-0.89) and RR 0.89(95%CI 0.80-0.99). Compared with 10-day remdesivir, 5-day remdesivir for patients with COVID-19 decreased the risk of serious adverse events rates and grade 3 or 4 adverse events rates with RR 0.65(95%CI 0.47-0.88) and RR 0.74 (95%CI 0.58-0.95). Conclusions: Our meta-analysis suggested that remdesivir would increase clinical improvement conditions and decrease serious adverse events on patients with COVID-19. 5-day remdesivir had the similar clinical effectiveness and mortality with 10-day remdesivir, and had lower serious adverse events rate. Comprehensive considering the cost and benefit, 5-day remdesivir may be a better therapeutic option if available medical resources are limited.

scholarly journals Fronto-orbito-ethmoidal intradiploic meningiomas: A case study with systematic review

2021 ◽  
Vol 12 ◽  
pp. 485
Author(s):  
Antonio Crea ◽  
Gianluca Grimod ◽  
Gianluca Scalia ◽  
Mariarosaria Verlotta ◽  
Lucio Mazzeo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Case Reports ◽  
Meta Analysis ◽  
Case Series ◽  
Complex Case ◽  
Subtotal Resection ◽  
Eligibility Criteria ◽  
Orbital Roof ◽  
Mesh Terms ◽  
Almost All

Background: Primary intradiploic meningiomas, extra-axial tumors arising primarily in the skull, are rare. The authors reported a complex case of intradiploic intraosseous metaplastic meningioma of the left medial wall and orbital roof with the left frontal sinus invasion and left ethmoidal body bone substitution. The authors also conducted a systematic review concerning diagnosis and management of patients affected by purely calvarial intradiploic meningiomas along with a focus on fronto-orbito-ethmoidal ones. Methods: A literature search was conducted using PubMed and Scopus databases according to preferred reporting items for systematic reviews and meta-analysis statement and with the following Mesh terms: Intradiploic, intraosseous, calvarial, and meningioma. Eligibility criteria were limited by the nature of existing literature on intradiploic meningiomas, consisting of only case series, and case reports. Results: A total of 128 published studies were identified through our search. 41 studies were included in this systematic review, 59 patients with a female/male ratio of 1.2/1. The mean age of the patients is of 47.69 years (range 3–84 years). Only seven out of 59 patients (11.9%) presented a complex intradiploic meningioma located in fronto-orbito-ethmoidal region like our case. In almost all patients, a gross-total resection was performed (96.6%) and only in two patients (3.4%) a subtotal resection was achieved. Conclusion: The authors shared this successfully treated case to add to the overall clinical experience in the management of this rare subtype tumor, with the hope that more studies are conducted to further address the mechanism of intradiploic meningiomas development.

scholarly journals Efficacy and harms of remdesivir for the treatment of COVID-19: a systematic review and meta-analysis

2020 ◽  
Author(s):  
Alejandro Piscoya ◽  
Luis Fernando Ng-Sueng ◽  
Angela Parra del Riego ◽  
Renato Cerna-Viacava ◽  
Vinay Pasupuleti ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Clinical Improvement ◽  
Meta Analysis ◽  
Case Series ◽  
Length Of Hospital Stay ◽  
Invasive Ventilation ◽  
Serious Adverse Events ◽  
All Cause Mortality ◽  
Meta Analyses

AbstractBackgroundWe evaluated the efficacy and safety of remdesivir for the treatment of COVID-19.MethodsSystematic review in five engines, pre-print webpages and RCT registries until May 22, 2020 for randomized controlled trials (RCTs) and observational studies evaluating remdesivir on confirmed, COVID-19 adults with pneumonia and/or respiratory insufficiency. Primary outcomes were all-cause mortality, clinical improvement or recovery, need for invasive ventilation, and serious adverse events (SAE). Secondary outcomes included length of hospital stay, progression of pneumonia, and adverse events (AE). Inverse variance random effects meta-analyses were performed.ResultsTwo placebo-controlled RCTs (n=1300) and two case series (n=88) were included. All studies used remdesivir 200mg IV the first day and 100mg IV for 9 more days, and followed up until 28 days. Wang et al. RCT was stopped early due to AEs; ACTT-1 was preliminary reported at 15-day follow up. Time to clinical improvement was not decreased in Wang et al. RCT, but median time to recovery was decreased by 4 days in ACTT-1. Remdesivir did not decrease all-cause mortality (RR 0.71, 95%CI 0.39 to 1.28) and need for invasive ventilation at 14 days (RR 0.57, 95%CI 0.23 to 1.42), but had fewer SAEs (RR 0.77, 95%CI 0.63 to 0.94). AEs were similar between remdesivir and placebo arms. Risk of bias ranged from some concerns to high risk in RCTs.InterpretationThere is paucity of adequately powered and fully reported RCTs evaluating effects of remdesivir in adult, hospitalized COVID-19 patients. Remdesivir should not be recommended for the treatment of severe COVID-19.

scholarly journals Repurposing of drugs for Covid-19: a systematic review and meta-analysis

2020 ◽  
Author(s):  
Pinky Kotecha ◽  
Alexander Light ◽  
Enrico Checcucci ◽  
Daniele Amparore ◽  
Cristian Fiori ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Clinical Improvement ◽  
Case Reports ◽  
Meta Analysis ◽  
Case Series ◽  
Cochrane Library ◽  
Control Group ◽  
Significant Difference

AbstractObjectiveThe aim of this systematic review is to evaluate the data currently available regarding the repurposing of different drugs for Covid-19 treatment. Participants with suspected or diagnosed Covid-19 will be included. The interventions being considered are drugs being repurposed, and comparators will include standard of care treatment or placebo.MethodsWe searched Ovid-MEDLINE, EMBASE, Cochrane library, clinical trial registration site in the UK(NIHR), Europe (clinicaltrialsregister.eu), US (ClinicalTrials.gov) and internationally (isrctn.com), and reviewed the reference lists of articles for eligible articles published up to April 22, 2020. All studies in English that evaluated the efficacy of the listed drugs were included. Cochrane RoB 2.0 and ROBINS-I tool were used to assess study quality. This systematic review adheres to the PRISMA guidelines. The protocol is available at PROSPERO (CRD42020180915).ResultsFrom 708 identified studies or clinical trials, 16 studies and 16 case reports met our eligibility criteria. Of these, 6 were randomized controlled trials (763 patients), 7 cohort studies (321 patients) and 3 case series (191 patients). Chloroquine (CQ) had a 100% discharge rate compared to 50% with lopinavir-ritonavir at day 14, however a trial has recommended against a high dosage due to cardiotoxic events. Hydroxychloroquine (HCQ) has shown no significant improvement in negative seroconversion rate which is also seen in our meta-analysis (p=0.68). Adverse events with HCQ have a significant difference compared to the control group (p=0.001). Lopinavir-ritonavir has shown no improvement in time to clinical improvement which is seen in our meta-analyses (p=0.1). Remdesivir has shown no significant improvement in time to clinical improvement but this trial had insufficient power.DiscussionDue to the paucity in evidence, it is difficult to establish the efficacy of these drugs in the treatment of Covid-19 as currently there is no significant clinical effectiveness of the repurposed drugs. Further large clinical trials are required to achieve more reliable findings. A risk-benefit analysis is required on an individual basis to weigh out the potential improvement in clinical outcome and viral load reduction compared to the risks of the adverse events. (1-16)

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