Publications by authors named "Abdelrahman I Abushouk"

17 Publications

  • Page 1 of 1

Incidence and Outcomes of Pericardial Effusion/Tamponade Following Percutaneous Left Atrial Appendage Closure.

Am J Cardiol 2021 12;160:126-129

Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

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http://dx.doi.org/10.1016/j.amjcard.2021.08.028DOI Listing
December 2021

Periprocedural and Short-Term Outcomes of Percutaneous Left Atrial Appendage Closure According to Type of Atrial Fibrillation.

J Am Heart Assoc 2021 Nov 3;10(22):e022124. Epub 2021 Nov 3.

Department of Cardiovascular Medicine Heart, Vascular and Thoracic Institute Cleveland Clinic Cleveland OH.

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http://dx.doi.org/10.1161/JAHA.121.022124DOI Listing
November 2021

Predictors of Procedural Success in Patients With Degenerated Surgical Valves Undergoing Transcatheter Aortic Valve-in-Valve Implantation.

Front Cardiovasc Med 2021 24;8:718835. Epub 2021 Sep 24.

Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Cleveland Clinic Foundation, Cleveland, OH, United States.

Valve-in-Valve transcatheter aortic valve implantation (ViV-TAVI) is a growing alternative for redo-surgery in patients with degenerated surgical valves. To our knowledge, data are lacking on the determinants on ViV-TAVI procedural success in patients with degenerated surgical valves. All consecutive patients undergoing ViV-TAVI for degenerated surgical valves at the Cleveland Clinic were analyzed. Data were extracted from our patient registry on baseline patient characteristics, echocardiographic parameters, and procedural details. To identify possible predictors of ViV-TAVI procedural success, we employed a multivariate logistic regression model. A total of 186 patients who underwent ViV-TAVI were analyzed, with procedural success (VARC-2 device success and absence of periprocedural MACCE) reported in 165 (88.7%) patients. Patients with successful ViV-TAVI were significantly younger and had more frequent utilization of the transfemoral access than those with failed procedure. Other baseline and procedural characteristics were comparable between both groups. In terms of echocardiographic parameters, the procedural success group had a significantly lower AV peak pressure gradient (62.1 ± 24.7 vs. 74.1 ± 34.6 mmHg; = 0.04) and lower incidence of moderate-to-severe aortic regurgitation [AR] (30.4 vs. 55%; = 0.04). However, no significant differences between both groups were noted in terms of AV mean pressure gradient and left ventricular measurements. In multivariate analysis, lower AV peak pressure gradient (OR = 0.97, 95% CI: 0.95-0.99) and absence of moderate-to-severe AR (OR = 0.65, 95% CI: 0.44-0.95) at baseline emerged as independent predictors of ViV-TAVI procedural success. Valve-in-Valve TAVI for degenerated surgical valves is a feasible approach with high success rates, especially in those with lower AV peak pressure gradient and absence of moderate-to-severe AR. Studies with larger sample size and longer follow-up are required to further characterize the predictors of ViV-TAVI success and other clinical outcomes.
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http://dx.doi.org/10.3389/fcvm.2021.718835DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8497979PMC
September 2021

Awareness of Rheumatic Heart Disease in Egypt: A National Multicenter Study.

J Cardiovasc Dev Dis 2021 Sep 4;8(9). Epub 2021 Sep 4.

Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH 44195, USA.

Background: While the prevalence of rheumatic heart disease (RHD) in Egypt is relatively high, data on the awareness of Egyptians about the cause of RHD are lacking.

Methods: Using a pre-tested questionnaire, we performed a multicenter survey of outpatients attending 15 university hospitals across Egypt.

Results: A total of 6958 participants were interviewed. Most subjects (81.7%) reported a previous experience of sore throat. Seeking treatment, most patients (69.3%) consulted a medical professional, while the others relied on self/peer medication. Individuals consulting a physician received antibiotics more frequently than those who did not (89.1 vs. 38.7%; OR: 12.4, 95% CI 10.8-14.1). The median RHD knowledge score in our sample was 4 (IQR = 6). While most subjects (56.3%) claimed knowledge of the complications of an untreated sore throat, only a third (34%) were aware of the association between sore throat and RHD. In a multivariate analysis, older age (Mean Difference [MD]: 1.58, 95% CI 1.37-1.79), female gender (MD: 0.89, 95% CI 0.75-1.04), higher education (MD: 1.10, 95% CI 0.90-1.30), and being interviewed outside Cairo (MD: 0.67, 95% CI 0.51-0.82) were significant predictors of knowledge about RHD.

Conclusion: The current study showed low levels of awareness on the cause of RHD among Egyptians and highlights a pressing need for interventions to address this public knowledge gap.
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http://dx.doi.org/10.3390/jcdd8090108DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8466231PMC
September 2021

Quality Assessment of Published Systematic Reviews in High Impact Cardiology Journals: Revisiting the Evidence Pyramid.

Front Cardiovasc Med 2021 9;8:671569. Epub 2021 Jun 9.

Department of Cardiovascular Medicine, Heart, Vascular & Thoracic Institute, Cleveland Clinic Foundation, Cleveland, OH, United States.

Systematic reviews are increasingly used as sources of evidence in clinical cardiology guidelines. In the present study, we aimed to assess the quality of published systematic reviews in high impact cardiology journals. We searched PubMed for systematic reviews published between 2010 and 2019 in five general cardiology journals with the highest impact factor (according to Clarivate Analytics 2019). We extracted data on eligibility criteria, methodological characteristics, bias assessments, and sources of funding. Further, we assessed the quality of retrieved reviews using the AMSTAR tool. A total of 352 systematic reviews were assessed. The AMSTAR quality score was low or critically low in 71% (95% CI: 65.7-75.4) of the assessed reviews. Sixty-four reviews (18.2%, 95% CI: 14.5-22.6) registered/published their protocol. Only 221 reviews (62.8%, 95% CI: 57.6-67.7) reported adherence to the EQUATOR checklists, 208 reviews (58.4%, 95% CI: 53.9-64.1) assessed the risk of bias in the included studies, and 177 reviews (52.3%, 95% CI: 45.1-55.5) assessed the risk of publication bias in their primary outcome analysis. The primary outcome was statistically significant in 274 (79.6%, 95% CI: 75.1-83.6) and had statistical heterogeneity in 167 (48.5%, 95% CI: 43.3-53.8) reviews. The use and sources of external funding was not disclosed in 87 reviews (24.7%, 95% CI: 20.5-29.5). Data analysis showed that the existence of publication bias was significantly associated with statistical heterogeneity of the primary outcome and that complex design, larger sample size, and higher AMSTAR quality score were associated with higher citation metrics. Our analysis uncovered widespread gaps in conducting and reporting systematic reviews in cardiology. These findings highlight the importance of rigorous editorial and peer review policies in systematic review publishing, as well as education of the investigators and clinicians on the synthesis and interpretation of evidence.
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http://dx.doi.org/10.3389/fcvm.2021.671569DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8220077PMC
June 2021

Association of statin use in older people primary prevention group with risk of cardiovascular events and mortality: a systematic review and meta-analysis of observational studies.

BMC Med 2021 06 22;19(1):139. Epub 2021 Jun 22.

Head Department of Hypertension, WAM University Hospital in Lodz, Medical University of Lodz (MUL), Lodz, Poland.

Background: Current evidence from randomized controlled trials on statins for primary prevention of cardiovascular disease (CVD) in older people, especially those aged > 75 years, is still lacking. We conducted a systematic review and meta-analysis of observational studies to extend the current evidence about the association of statin use in older people primary prevention group with risk of CVD and mortality.

Methods: PubMed, Scopus, and Embase were searched from inception until March 18, 2021. We included observational studies (cohort or nested case-control) that compared statin use vs non-use for primary prevention of CVD in older people aged ≥ 65 years; provided that each of them reported the risk estimate on at least one of the following primary outcomes: all cause-mortality, CVD death, myocardial infarction (MI), and stroke. Risk estimates of each relevant outcome were pooled as a hazard ratio (HR) with a 95% confidence interval (CI) using the random-effects meta-analysis model. The quality of the evidence was rated using the GRADE approach.

Results: Ten observational studies (9 cohorts and one case-control study; n = 815,667) fulfilled our criteria. The overall combined estimate suggested that statin therapy was associated with a significantly lower risk of all-cause mortality (HR: 0.86 [95% CI 0.79 to 0.93]), CVD death (HR: 0.80 [95% CI 0.78 to 0.81]), and stroke (HR: 0.85 [95% CI 0.76 to 0.94]) and a non-significant association with risk of MI (HR 0.74 [95% CI 0.53 to 1.02]). The beneficial association of statins with the risk of all-cause mortality remained significant even at higher ages (> 75 years old; HR 0.88 [95% CI 0.81 to 0.96]) and in both men (HR: 0.75 [95% CI: 0.74 to 0.76]) and women (HR 0.85 [95% CI 0.72 to 0.99]). However, this association with the risk of all-cause mortality remained significant only in those with diabetes mellitus (DM) (HR 0.82 [95% CI 0.68 to 0.98]) but not in those without DM. The level of evidence of all the primary outcomes was rated as "very low."

Conclusions: Statin therapy in older people (aged ≥ 65 years) without CVD was associated with a 14%, 20%, and 15% lower risk of all-cause mortality, CVD death, and stroke, respectively. The beneficial association with the risk of all-cause mortality remained significant even at higher ages (> 75 years old), in both men and women, and in individuals with DM, but not in those without DM. These observational findings support the need for trials to test the benefits of statins in those above 75 years of age.
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http://dx.doi.org/10.1186/s12916-021-02009-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8218529PMC
June 2021

KAP-COVID: a multinational survey of the levels and determinants of public knowledge, attitudes and practices towards COVID-19.

BMJ Open 2021 02 23;11(2):e043971. Epub 2021 Feb 23.

Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA

Objective: The adherence to public health recommendations to control COVID-19 spread is influenced by public knowledge, attitudes and practices (KAP). We performed this cross-sectional study to assess the levels and determinants of public KAP towards COVID-19 in a large, multinational sample.

Design: Cross-sectional study (survey).

Setting: The questionnaire was distributed to potential respondents via online platforms.

Participants: 71 890 individuals from 22 countries.

Methods: We formulated a four-section questionnaire in English, followed by validation and translation into seven languages. The questionnaire was distributed (May to June 2020) and each participant received a score for each KAP section.

Results: Overall, the participants had fair knowledge (mean score: 19.24±3.59) and attitudes (3.72±2.31) and good practices (12.12±1.83) regarding COVID-19. About 92% reported moderate to high compliance with national lockdown. However, significant gaps were observed: only 68.2% knew that infected individuals may be asymptomatic; 45.4% believed that antibiotics are an effective treatment; and 55.4% stated that a vaccine has been developed (at the time of data collection). 71.9% believed or were uncertain that COVID-19 is a global conspiracy; 36.8% and 51% were afraid of contacting doctors and Chinese people, respectively. Further, 66.4% reported the pandemic had moderate to high negative effects on their mental health. Female gender, higher education and urban residents had significantly (p≤0.001) higher knowledge and practice scores. Further, we observed significant correlations between all KAP scores.

Conclusions: Although the public have fair/good knowledge and practices regarding COVID-19, significant gaps should be addressed. Future awareness efforts should target less advantaged groups and future studies should develop new strategies to tackle COVID-19 negative mental health effects.
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http://dx.doi.org/10.1136/bmjopen-2020-043971DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7907623PMC
February 2021

Long-term outcomes of transcatheter valve-in-valve replacement for failed aortic bioprosthesis: A meta-analysis.

Catheter Cardiovasc Interv 2021 Feb 8. Epub 2021 Feb 8.

Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.

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http://dx.doi.org/10.1002/ccd.29543DOI Listing
February 2021

Transcatheter Aortic Valve Implantation Outcomes in Chronic Kidney Disease Versus End-Stage Kidney Disease.

Am J Cardiol 2021 03 14;143:165-167. Epub 2021 Jan 14.

Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

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http://dx.doi.org/10.1016/j.amjcard.2021.01.002DOI Listing
March 2021

Diagnosis and Management of Hematological Adverse Events Induced by Immune Checkpoint Inhibitors: A Systematic Review.

Front Immunol 2020 21;11:1354. Epub 2020 Oct 21.

National Centre for Cancer Care and Research, Hamad Medical Corporation, Doha, Qatar.

There has been less volume of literature focusing on the Immune-related Hematological Adverse Drug Events (Hem-irAEs) of Immune Checkpoint Inhibitors (ICPis) in cancer patients. Furthermore, there has been no consensus about the management of hematological toxicity from immunotherapy in the recently published practice guidelines by the European Society for Medical Oncology (ESMO). We conducted a systematic review of case reports/series to describe the diagnosis and management of potentially rare and unrecognized Hem-irAEs. We searched Medline, OVID, Web of Science for eligible articles. Data were extracted on patient characteristics, Hem-irAEs, and management strategies. We performed quality assessment using the Pierson-5 evaluation scheme and causality assessment using the Naranjo scale. Our search retrieved 49 articles that described 118 cases. The majority of patients had melanoma (57.6%) and lung cancer (26.3%). The most common Hem-irAEs reported with ICPis (such as nivolumab, ipilimumab, and pembrolizumab) were thrombocytopenia, hemolytic and aplastic anemias. Less reported adverse events included agranulocytosis and neutropenia. Steroids were commonly used to treat these adverse events with frequent success. Other used strategies included intravenous immunoglobulins (IVIG), rituximab, and transfusion of blood components. The findings of this review provide more insights into the diagnosis and management of the rarely reported Hem-irAEs of ICPis.
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http://dx.doi.org/10.3389/fimmu.2020.01354DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7640759PMC
April 2021

Prognostic value of the miRNA-27a and PPAR/RXRα signaling axis in patients with thyroid carcinoma.

Epigenomics 2020 10 24;12(20):1825-1843. Epub 2020 Sep 24.

Department of Medical Biochemistry & Molecular Biology, Faculty of Medicine, Suez Canal University, Ismailia 41522, Egypt.

The authors aimed to evaluate the prognostic value of miRNA-27a (miR-27a), peroxisome proliferator-activated receptor alpha/gamma () and retinoid X receptor alpha ) tissue expression in patients with thyroid carcinoma. The expression levels were quantified in 174 archived thyroid specimens using real-time quantitative PCR. Downregulation of miR-27a was associated with lymph node stage and multifocality. expression was associated with histopathological type, tumor size and lymph node invasion. Moreover, expression was lower in patients who underwent total/subtotal thyroidectomy or received radioactive iodine treatment. Patients with upregulated miR-27a and downregulated RXRα showed a higher frequency of advanced lymph node stage and relapse by cluster analysis. Both miR-27a and PPARα/RXRα showed association with different poor prognostic indices in thyroid cancer patients.
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http://dx.doi.org/10.2217/epi-2020-0167DOI Listing
October 2020

Estimating global injuries morbidity and mortality: methods and data used in the Global Burden of Disease 2017 study.

Inj Prev 2020 10 24;26(Supp 1):i125-i153. Epub 2020 Aug 24.

Department of Pharmacy, Adigrat University, Adigrat, Ethiopia.

Background: While there is a long history of measuring death and disability from injuries, modern research methods must account for the wide spectrum of disability that can occur in an injury, and must provide estimates with sufficient demographic, geographical and temporal detail to be useful for policy makers. The Global Burden of Disease (GBD) 2017 study used methods to provide highly detailed estimates of global injury burden that meet these criteria.

Methods: In this study, we report and discuss the methods used in GBD 2017 for injury morbidity and mortality burden estimation. In summary, these methods included estimating cause-specific mortality for every cause of injury, and then estimating incidence for every cause of injury. Non-fatal disability for each cause is then calculated based on the probabilities of suffering from different types of bodily injury experienced.

Results: GBD 2017 produced morbidity and mortality estimates for 38 causes of injury. Estimates were produced in terms of incidence, prevalence, years lived with disability, cause-specific mortality, years of life lost and disability-adjusted life-years for a 28-year period for 22 age groups, 195 countries and both sexes.

Conclusions: GBD 2017 demonstrated a complex and sophisticated series of analytical steps using the largest known database of morbidity and mortality data on injuries. GBD 2017 results should be used to help inform injury prevention policy making and resource allocation. We also identify important avenues for improving injury burden estimation in the future.
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http://dx.doi.org/10.1136/injuryprev-2019-043531DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7571362PMC
October 2020

Global injury morbidity and mortality from 1990 to 2017: results from the Global Burden of Disease Study 2017.

Inj Prev 2020 10 24;26(Supp 1):i96-i114. Epub 2020 Apr 24.

Faculty of Health Sciences - Health Management and Policy, American University of Beirut, Beirut, Lebanon.

Background: Past research in population health trends has shown that injuries form a substantial burden of population health loss. Regular updates to injury burden assessments are critical. We report Global Burden of Disease (GBD) 2017 Study estimates on morbidity and mortality for all injuries.

Methods: We reviewed results for injuries from the GBD 2017 study. GBD 2017 measured injury-specific mortality and years of life lost (YLLs) using the Cause of Death Ensemble model. To measure non-fatal injuries, GBD 2017 modelled injury-specific incidence and converted this to prevalence and years lived with disability (YLDs). YLLs and YLDs were summed to calculate disability-adjusted life years (DALYs).

Findings: In 1990, there were 4 260 493 (4 085 700 to 4 396 138) injury deaths, which increased to 4 484 722 (4 332 010 to 4 585 554) deaths in 2017, while age-standardised mortality decreased from 1079 (1073 to 1086) to 738 (730 to 745) per 100 000. In 1990, there were 354 064 302 (95% uncertainty interval: 338 174 876 to 371 610 802) new cases of injury globally, which increased to 520 710 288 (493 430 247 to 547 988 635) new cases in 2017. During this time, age-standardised incidence decreased non-significantly from 6824 (6534 to 7147) to 6763 (6412 to 7118) per 100 000. Between 1990 and 2017, age-standardised DALYs decreased from 4947 (4655 to 5233) per 100 000 to 3267 (3058 to 3505).

Interpretation: Injuries are an important cause of health loss globally, though mortality has declined between 1990 and 2017. Future research in injury burden should focus on prevention in high-burden populations, improving data collection and ensuring access to medical care.
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http://dx.doi.org/10.1136/injuryprev-2019-043494DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7571366PMC
October 2020

Knowledge, attitudes, and practices of Egypt's future physicians towards antimicrobial resistance (KAP-AMR study): a multicenter cross-sectional study.

Environ Sci Pollut Res Int 2020 Jun 8;27(17):21292-21298. Epub 2020 Apr 8.

Department of Pharmacology, Suez Canal University, Ismailia, Egypt.

Antimicrobial resistance (AMR) is a growing threat that causes over 700,000 deaths per year worldwide. The goal of the current multicenter, cross-sectional study was to identify the knowledge and practice gaps in antimicrobial stewardship among Egypt's undergraduate medical students. Nine-hundred and sixty-three participants (375 male) from 25 medical schools responded to our self-administered questionnaire. Overall, the majority of students (96%) exhibited fair/satisfactory knowledge and attitude scores towards AMR. However, the most common misconceptions were that skipping one or two antimicrobial doses does not contribute to AMR (43%) and that antimicrobials are the drug of choice for the treatment of sore throat (38.8%). About 36% of the students thought that bacteria cause common cold and influenza. In terms of practices, about 62% of the students reported taking antibiotics when they have cough or sore throat and saving the remaining antibiotic for the next time. About 48% of the students reported that when they start feeling better, they stop the antibiotic course, and 41% stated that they often/sometimes discard the remaining leftover or share the leftover antibiotics with their friends. Interestingly, males had more frequently poorer levels of knowledge than females (p = 0.02). Moreover, students in the clinical science years (p < 0.001), living in urban areas (p = 0.02) or Cairo (p < 0.01) reported better practices than their counterparts. Educational programs about antimicrobial stewardship and the role of healthcare professionals in preventing AMR should be introduced early in medical curricula. Further, active educational techniques as clinical scenarios that simulate clinical settings and interactive learning workshops would be more efficient teaching methods.
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http://dx.doi.org/10.1007/s11356-020-08534-5DOI Listing
June 2020

Protective Effects of Evening Primrose Oil against Cyclophosphamide-Induced Biochemical, Histopathological, and Genotoxic Alterations in Mice.

Pathogens 2020 Feb 5;9(2). Epub 2020 Feb 5.

Department of Zoology, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.

Cyclophosphamide (CP) is a well-known antineoplastic agent; however, its clinical use can be associated with various organ toxicities. Evening primrose oil (EPO) contains several phytoconstituents with potent anti-oxidant and anti-inflammatory activities. This experimental study was performed to investigate the chemoprotective effects of EPO in the liver and pancreas of CP-intoxicated mice. Thirty-two albino mice were randomly divided into 4 equal groups: group I received saline (control mice), group II were treated with CP at 100 mg/kg/day for two subsequent days, and groups III and VI were treated with 5 and 10 mg/kg/day bw EPO, respectively for 14 days, followed by two doses of CP at the 15th and 16th days of the experiment. Then, mice were sacrificed and histopathological examinations, biochemical studies, and DNA laddering tests were conducted for hepatic and pancreatic tissues. Cyclophosphamide-intoxicated mice showed significant increases ( < 0.05) in the serum levels of liver enzymes, pancreatic amylase and tissue levels of malondialdehyde, and TNF-α, as well as a significant decrease ( < 0.05) in the serum insulin level. In addition, both hepatic and pancreatic tissues showed disturbed tissue architecture, hydropic degeneration, congested vessels, and inflammatory infiltrates, as well as increased DNA fragmentation. In a dose-dependent manner, pretreatment with EPO was associated with significant improvements ( < 0.05) in all biochemical parameters and significant amelioration of histopathological alterations and DNA fragmentation in CP-intoxicated mice. Pretreatment with EPO showed significant antioxidant, anti-inflammatory, and genoprotective effects against the toxic effects of CP in mice hepatic and pancreatic tissues.
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http://dx.doi.org/10.3390/pathogens9020098DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7168665PMC
February 2020

Nanomedicine as a putative approach for active targeting of hepatocellular carcinoma.

Semin Cancer Biol 2021 Feb 14;69:91-99. Epub 2019 Aug 14.

Department of Tropical Medicine, Faculty of Medicine, Al-Azhar University, Cairo, Egypt. Electronic address:

The effectiveness of chemotherapy in hepatocellular carcinoma (HCC) is restricted by chemo-resistance and systemic side effects. To improve the efficacy and safety of chemotherapeutics in HCC management, scientists have attempted to deliver these drugs to malignant tissues using targeted carriers as nanoparticles (NPs). Among the three types of NPs targeting (active, passive, and stimuli-responsive), active targeting is the most commonly investigated in HCC treatment. Despite the observed promising results so far, clinical research on nanomedicine targeting for HCC treatment still faces many challenges.These include batch-to-batch physicochemical properties' variations, limiting large scale production and insufficient data on human and environmental toxicities. This review summarized the characteristics of different nanocarriers, ligands, targeted receptors on HCC cells and provided recommendations to overcome the challenges, facing this novel line of treatment for HCC.
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http://dx.doi.org/10.1016/j.semcancer.2019.08.016DOI Listing
February 2021

Safety and efficacy of sofosbuvir plus velpatasvir with or without ribavirin for chronic hepatitis C virus infection: A systematic review and meta-analysis.

J Infect Public Health 2018 Mar - Apr;11(2):156-164. Epub 2017 Sep 29.

Pharmacology Department, Faculty of Veterinary Medicine, Suez Canal University, Ismailia 41522, Egypt; Department of Ophthalmology and Micro-Technology, Yokohama City University, Yokohama, Japan. Electronic address:

Velpatasvir is a newly FDA-approved inhibitor of hepatitis C virus (HCV) NS5A protein. We performed this systematic review and meta-analysis to investigate the safety and efficacy of velpatasvir plus sofosbuvir in the treatment of chronic HCV infection. A computerized literature search of PubMed, SCOPUS, EMBASE, EBSCO, Web of science, and Cochrane CENTRAL was conducted using relevant keywords. Data from eligible studies were pooled in a fixed effect meta-analysis model, using OpenMeta[Analyst] software. Pooled data from six randomized trials (n=1427 patients) showed that velpatasvir plus sofosbuvir achieved sustained virological response (SVR12) rates of 98.2% in genotype-1, 99.4% in genotype-2, 94.7% in genotype-3, 99.6% in genotype-4, 97.1% in genotype-5, and 98.8% in genotype-6 patients. The addition of ribavirin did not significantly increase the SVR12 (RR=0.95, 95%CI [0.88, 1.02]) or decrease relapse rates (RR=2.52, 95% CI [0.49, 12.87]) in HCV genotype-1 patients. However, adding ribavirin significantly increased SVR12 (RR=89.5, 95% CI [80.4, 99.5]) in genotype-3 patients. In conclusion, the 12-week regimen of sofosbuvir plus velpatasvir was highly effective in HCV patients, including those with cirrhosis and former treatment experience. Except for genotype-3, adding ribavirin was not associated with significant improvements in SVR12 rates. Further studies should investigate the effect of adding ribavirin to this regimen, especially in HCV genotype-3 patients.
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http://dx.doi.org/10.1016/j.jiph.2017.09.004DOI Listing
November 2018
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