ABSTRACT
BACKGROUND: Lower limb coronal alignment was thought to be a predictive factor for Unicompartmental Knee Arthroplasty (UKA) result. The tibial bony resection and implant position lead to joint line change postoperatively. Analysis was done to find out the correlation between these factors. METHODS: From 2019 to 2021, 90 medial Oxford UKA were implanted by a single surgeon. Hip Knee Ankle Angle (HKAA), Lateral Distal Femoral Angle (LDFA), Medial Proximal Tibial Angle (MPTA), and intraoperative bony resection thickness were measured. The medial joint line change was calculated. The correlation between joint line change and alignment change was evaluated. RESULTS: The mean tibial resection thickness was 4.3 mm. The mean tibial joint line was elevated by 2.3 mm, while the mean femoral joint line proximalized by 0.8 mm. HKAA changed from 8.4° varus preoperatively to 3.6° varus postoperatively. LDFA changed from 89.0° to 86.7°. MPTA changed from 85.6° to 86.6°. Preoperative HKAA showed a strong correlation with postoperative HKAA (p < 0.001), and preoperative MPTA showed a positive correlation with postoperative HKAA (p < 0.001). While preoperative LDFA had a negative correlation with postoperative HKAA (p < 0.001). The femoral joint line change and LDFA change had a significant correlation with HKAA change (p < 0.05). CONCLUSION: The change of joint line had no correlation with postoperative HKAA in Oxford UKA. Preoperative HKAA strongly correlated with postoperative HKAA; while preoperative smaller LDFA and larger MPTA had a moderate correlation with postoperative HKAA. The femoral joint line change and LDFA change had a weak to moderate correlation with HKAA change.
Subject(s)
Arthroplasty, Replacement, Knee , Knee Joint , Humans , Arthroplasty, Replacement, Knee/methods , Male , Female , Aged , Middle Aged , Knee Joint/surgery , Tibia/surgery , Retrospective Studies , Femur/surgery , Knee Prosthesis , Postoperative Period , Treatment Outcome , Aged, 80 and over , Osteoarthritis, Knee/surgeryABSTRACT
OBJECTIVE: In this population-based cohort study, we compared the risks of incident hyperopia, myopia, astigmatism, and strabismus between children with autism spectrum disorder (ASD) and children without ASD. METHODS: This study included children who were born in Taiwan at any time between 2004 and 2017. Data were collected from the Taiwan Maternal and Child Health Database. We included 20,688 children with ASD and 2,062,120 matched controls to estimate the risks of incident hyperopia, myopia, astigmatism, and strabismus. Cox proportional hazards regression models were constructed for risk assessment. The models were adjusted for sex, calendar year of birth, and gestational age at birth. Statistical significance was determined by calculating adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs). RESULTS: Children with ASD had higher risks of incident hyperopia (aHR: 1.78; 95% CI: 1.70-1.86), myopia (aHR: 1.27; 95% CI: 1.24-1.30), astigmatism (aHR: 1.51; 95% CI: 1.46-1.56), and strabismus (aHR: 2.18; 95% CI: 2.05-2.32) than did those without it. CONCLUSION: Clinicians should screen children with ASD for potential ophthalmic conditions. Further studies are required to elucidate the mechanisms underlying the associations between ASD and ophthalmic diseases. The roles of types and severities of ASD symptoms in detecting ophthalmic disease also requires further study.
ABSTRACT
Hepatocellular carcinoma (HCC) is one of the deadliest cancers. For patients with advanced HCC, liver function decompensation often occurs, which leads to poor tolerance to chemotherapies and other aggressive treatments. Therefore, it remains critical to develop effective therapeutic strategies for HCC. Etiological factors for HCC are complex and multifaceted, including hepatitis virus infection, alcohol, drug abuse, chronic metabolic abnormalities, and others. Thus, HCC has been categorized as a "genomically unstable" cancer due to the typical manifestation of chromosome breakage and aneuploidy, and oxidative DNA damage. In recent years, immunotherapy has provided a new option for cancer treatments, and the degree of genomic instability positively correlates with immunotherapy efficacies. This article reviews the endogenous and exogenous causes that affect the genomic stability of liver cells; it also updates the current biomarkers and their detection methods for genomic instabilities and relevant applications in cancer immunotherapies. Including genomic instability biomarkers in consideration of cancer treatment options shall increase the patients' well-being.
ABSTRACT
Despite good hepatitis B virus (HBV) inhibition by nucleoside analogs (NAs), cases of hepatocellular carcinoma (HCC) still occur. This study proposed a non-invasive predictive model to assess HCC risk in patients with chronic hepatitis B (CHB) receiving NAs treatment. Data were obtained from a hospital-based retrospective cohort registered on the Platform of Medical Data Science Academy of Chongqing Medical University, from 2013 to 2019. A total of 501 patients under NAs treatment had their FIB-4 index updated semiannually by recalculation based on laboratory values. Patients were divided into three groups based on FIB-4 index values: < 1.45, 1.45-3.25, and ≥ 3.25. Subsequently, HCC incidence was reassessed every six months using Kaplan-Meier curves based on the updated FIB-4 index. The median follow-up time of CHB patients after receiving NAs treatment was 2.5 years. HCC incidences with FIB-4 index < 1.45, 1.45-3.25, and ≥ 3.25 were 1.18%, 1.32%, and 9.09%, respectively. Dynamic assessment showed that the percentage of patients with FIB-4 index < 1.45 significantly increased semiannually (P < 0.001), and of patients with FIB-4 index ≥ 3.25 significantly decreased (P < 0.001). HCC incidence was the highest among patients with FIB-4 index ≥ 3.25. The FIB-4 index effectively predicted HCC incidence, and its dynamic assessment could be used for regular surveillance to implement early intervention and reduce HCC risk.
Subject(s)
Antiviral Agents , Carcinoma, Hepatocellular , Hepatitis B, Chronic , Liver Cirrhosis , Liver Neoplasms , Humans , Hepatitis B, Chronic/complications , Hepatitis B, Chronic/drug therapy , Male , Female , Retrospective Studies , Antiviral Agents/therapeutic use , Middle Aged , Adult , Risk Factors , Nucleosides/therapeutic use , Incidence , Risk AssessmentABSTRACT
Lupus remains a disease with a low prioritisation in the national agendas of many countries in Latin America, the Middle East, and Asia-Pacific, where there is a dearth of rheumatologists and limited access to new or even standard lupus treatments. There is thus an important need for education, advocacy, and outreach to prioritise lupus in these regions to ensure that patients receive the care they need. This article reviews some of the specific challenges facing the care and management of people with lupus in these regions and suggests strategies for improving patient outcomes. Specifically, we review and discuss (with a focus on the aforementioned regions) the epidemiology of lupus; economic costs, disease burden, and effects on quality of life; barriers to care related to disease assessment; barriers to effective treatment, including limitations of standard treatments, high glucocorticoid use, inadequate access to new treatments, and low adherence to medications; and strategies to improve lupus management and patient outcomes. We hope that this represents a call to action to come together and act now for the lupus community, policymakers, health authorities, and healthcare professionals to improve lupus management and patient outcomes in Latin America, the Middle East, and Asia-Pacific.
Subject(s)
Lupus Erythematosus, Systemic , Humans , Latin America/epidemiology , Lupus Erythematosus, Systemic/therapy , Lupus Erythematosus, Systemic/drug therapy , Lupus Erythematosus, Systemic/epidemiology , Middle East/epidemiology , Asia/epidemiology , Health Services Accessibility , Quality of Life , Cost of Illness , Disease ManagementABSTRACT
OBJECTIVES: To explore prevalence, characteristics and risk factors of COVID-19 breakthrough infections (BIs) in idiopathic inflammatory myopathies (IIM) using data from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. METHODS: A validated patient self-reporting e-survey was circulated by the COVAD study group to collect data on COVID-19 infection and vaccination in 2022. BIs were defined as COVID-19 occurring ≥14 days after 2 vaccine doses. We compared BIs characteristics and severity among IIMs, other autoimmune rheumatic and non-rheumatic diseases (AIRD, nrAID), and healthy controls (HC). Multivariable Cox regression models assessed the risk factors for BI, severe BI and hospitalisations among IIMs. RESULTS: Among 9449 included response, BIs occurred in 1447 (15.3%) respondents, median age 44 years (IQR 21), 77.4% female, and 182 BIs (12.9%) occurred among 1406 IIMs. Multivariable Cox regression among IIMs showed age as a protective factor for BIs [Hazard Ratio (HR)=0.98, 95%CI = 0.97-0.99], hydroxychloroquine and sulfasalazine use were risk factors (HR = 1.81, 95%CI = 1.24-2.64, and HR = 3.79, 95%CI = 1.69-8.42, respectively). Glucocorticoid use was a risk factor for severe BI (HR = 3.61, 95%CI = 1.09-11.8). Non-White ethnicity (HR = 2.61, 95%CI = 1.03-6.59) was a risk factor for hospitalisation. Compared with other groups, patients with IIMs required more supplemental oxygen therapy (IIM = 6.0% vs AIRD = 1.8%, nrAID = 2.2%, and HC = 0.9%), intensive care unit admission (IIM = 2.2% vs AIRD = 0.6%, nrAID, and HC = 0%), advanced treatment with antiviral or monoclonal antibodies (IIM = 34.1% vs AIRD = 25.8%, nrAID = 14.6%, and HC = 12.8%), and had more hospitalisation (IIM = 7.7% vs AIRD = 4.6%, nrAID = 1.1%, and HC = 1.5%). CONCLUSION: Patients with IIMs are susceptible to severe COVID-19 BI. Age and immunosuppressive treatments were related to the risk of BIs.
ABSTRACT
ABSTRACT Despite good hepatitis B virus (HBV) inhibition by nucleoside analogs (NAs), cases of hepatocellular carcinoma (HCC) still occur. This study proposed a non-invasive predictive model to assess HCC risk in patients with chronic hepatitis B (CHB) receiving NAs treatment. Data were obtained from a hospital-based retrospective cohort registered on the Platform of Medical Data Science Academy of Chongqing Medical University, from 2013 to 2019. A total of 501 patients under NAs treatment had their FIB-4 index updated semiannually by recalculation based on laboratory values. Patients were divided into three groups based on FIB-4 index values: < 1.45, 1.45-3.25, and ≥ 3.25. Subsequently, HCC incidence was reassessed every six months using Kaplan-Meier curves based on the updated FIB-4 index. The median follow-up time of CHB patients after receiving NAs treatment was 2.5 years. HCC incidences with FIB-4 index < 1.45, 1.45-3.25, and ≥ 3.25 were 1.18%, 1.32%, and 9.09%, respectively. Dynamic assessment showed that the percentage of patients with FIB-4 index < 1.45 significantly increased semiannually (P < 0.001), and of patients with FIB-4 index ≥ 3.25 significantly decreased (P < 0.001). HCC incidence was the highest among patients with FIB-4 index ≥ 3.25. The FIB-4 index effectively predicted HCC incidence, and its dynamic assessment could be used for regular surveillance to implement early intervention and reduce HCC risk.
ABSTRACT
Abstract Background: Lower limb coronal alignment was thought to be a predictive factor for Unicompartmental Knee Arthroplasty (UKA) result. The tibial bony resection and implant position lead to joint line change postoperatively. Analysis was done to find out the correlation between these factors. Methods: From 2019 to 2021, 90 medial Oxford UKA were implanted by a single surgeon. Hip Knee Ankle Angle (HKAA), Lateral Distal Femoral Angle (LDFA), Medial Proximal Tibial Angle (MPTA), and intraoperative bony resection thickness were measured. The medial joint line change was calculated. The correlation between joint line change and alignment change was evaluated. Results: The mean tibial resection thickness was 4.3 mm. The mean tibial joint line was elevated by 2.3 mm, while the mean femoral joint line proximalized by 0.8 mm. HKAA changed from 8.4° varus preoperatively to 3.6° varus postoperatively. LDFA changed from 89.0° to 86.7°. MPTA changed from 85.6° to 86.6°. Preoperative HKAA showed a strong correlation with postoperative HKAA (p < 0.001), and preoperative MPTA showed a positive correlation with postoperative HKAA (p < 0.001). While preoperative LDFA had a negative correlation with postoperative HKAA (p < 0.001). The femoral joint line change and LDFA change had a significant correlation with HKAA change (p < 0.05). Conclusion: The change of joint line had no correlation with postoperative HKAA in Oxford UKA. Preoperative HKAA strongly correlated with postoperative HKAA; while preoperative smaller LDFA and larger MPTA had a moderate correlation with postoperative HKAA. The femoral joint line change and LDFA change had a weak to moderate correlation with HKAA change.
ABSTRACT
Objectives: The present study analyzed the reciprocal relationships between four common pediatric ophthalmic diseases (i.e., hyperopia, myopia, astigmatism, and strabismus) and attention‐deficit/hyperactivity disorder (ADHD) in children. Methods: This study enrolled 86,028 children with ADHD and 1,798,673 children without ADHD in the Taiwan Maternal and Child Health Database who were born at any time from 2004 to 2017. Cox proportional hazards regression models were used to estimate the bidirectional relationships of the four ophthalmic diseases with ADHD in children after adjusting for age, sex, and gestational age at birth. Survival curves for time-to-event variables were estimated using the Kaplan-Meier method, and the log-rank test was used to compare the curves. Results: The results indicated that ADHD significantly predicted the occurrence of hyperopia, myopia, astigmatism, and strabismus. Furthermore, hyperopia, myopia, astigmatism, and strabismus significantly predicted the occurrence of ADHD. The time between enrollment and ADHD diagnosis was shorter for patients with ophthalmic diseases than for the control group, and the time between enrollment and ophthalmic disease diagnosis was also shorter for ADHD patients than for the control group. Sex differences were found in the associations between ADHD and ophthalmic diseases. Conclusion: Clinicians should monitor children with ADHD for hyperopia, myopia, astigmatism, and strabismus to ensure appropriate treatment, and vice versa.
ABSTRACT
OBJECTIVES: The present study analyzed the reciprocal relationships between four common pediatric ophthalmic diseases (i.e., hyperopia, myopia, astigmatism, and strabismus) and attention-deficit/hyperactivity disorder (ADHD) in children. METHODS: This study enrolled 86,028 children with ADHD and 1,798,673 children without ADHD in the Taiwan Maternal and Child Health Database who were born at any time from 2004 to 2017. Cox proportional hazards regression models were used to estimate the bidirectional relationships of the four ophthalmic diseases with ADHD in children after adjusting for age, sex, and gestational age at birth. Survival curves for time-to-event variables were estimated using the Kaplan-Meier method, and the log-rank test was used to compare the curves. RESULTS: The results indicated that ADHD significantly predicted the occurrence of hyperopia, myopia, astigmatism, and strabismus. Furthermore, hyperopia, myopia, astigmatism, and strabismus significantly predicted the occurrence of ADHD. The time between enrollment and ADHD diagnosis was shorter for patients with ophthalmic diseases than for the control group, and the time between enrollment and ophthalmic disease diagnosis was also shorter for ADHD patients than for the control group. Sex differences were found in the associations between ADHD and ophthalmic diseases. CONCLUSION: Clinicians should monitor children with ADHD for hyperopia, myopia, astigmatism, and strabismus to ensure appropriate treatment, and vice versa.
Subject(s)
Astigmatism , Attention Deficit Disorder with Hyperactivity , Hyperopia , Myopia , Strabismus , Infant, Newborn , Humans , Child , Female , Male , Astigmatism/complications , Astigmatism/diagnosis , Astigmatism/epidemiology , Hyperopia/epidemiology , Hyperopia/complications , Hyperopia/diagnosis , Attention Deficit Disorder with Hyperactivity/epidemiology , Cohort Studies , Myopia/complications , Myopia/diagnosis , Myopia/epidemiology , Strabismus/epidemiology , Strabismus/complications , Strabismus/diagnosisABSTRACT
BACKGROUND: Multiple dietary patterns have been recommended by the 2015-2020 Dietary Guidelines for Americans for the prevention of cardiovascular disease (CVD). The adherence to these patterns and its relation with risk of CVD remain unclear in the US Hispanic/Latino population. OBJECTIVES: We aimed to evaluate 3 healthy eating patterns measured by 3 dietary pattern scores [the Alternate Mediterranean diet (aMED), the Healthy Eating Index (HEI)-2015, and the healthful Plant-based Diet Index (hPDI)] across different Hispanic/Latino backgrounds and generations. We further examined the associations of these dietary scores with incident CVD in US Hispanics/Latinos. METHODS: We included 10,293 adult participants of US Hispanics/Latinos of 6 backgrounds (Mexican, Puerto Rican, Cuban, Dominican, Central American, and South American), free of CVD or cancer at baseline, in the Hispanic Community Health Study/Study of Latinos. Dietary pattern scores were derived at the baseline visit using two 24-h dietary recalls. The primary outcome was major incident CVD (n = 232), comprised of coronary heart disease and stroke, during an average 6-y follow-up. RESULTS: Mean levels of all 3 dietary scores were significantly different across the 6 Hispanic/Latino background groups (all P < 0.001), with the highest (i.e., healthiest) in those of Mexican background and lowest in those of Puerto Rican background. Compared with non-mainland-US-born Hispanics/Latinos, mainland-US-born Hispanics/Latinos had significantly lower dietary scores (P < 0.001). Differences in dietary scores between mainland-US-born and non-mainland-US-born Hispanics/Latinos were majorly driven by differences in dietary intakes of healthy plant-based foods. After adjusting for multiple covariates, significantly lower risk ratios (95% CI) of CVD were observed for 1-SD increments of the dietary scores, with 0.74 (0.60, 0.91) for aMED, 0.80 (0.63, 1.00) for HEI-2015, and 0.74 (0.60, 0.93) for hPDI. CONCLUSIONS: Although adherence to healthy eating patterns varied by Hispanic/Latino backgrounds and generations, greater adherence to these eating patterns was associated with lower risk of CVD across diverse US Hispanics/Latinos.
Subject(s)
Cardiovascular Diseases , Adult , Cardiovascular Diseases/prevention & control , Hispanic or Latino , Humans , Prevalence , Public Health , Puerto Rico , Risk Factors , United States/epidemiologyABSTRACT
Listeria monocytogenes is a major foodborne pathogen that can contaminate food products and colonize food-producing facilities. Foodservice operations (FSOp) are frequently responsible for foodborne outbreaks due to food safety practices failures. We investigated the presence of and characterized L. monocytogenes from two FSOp (cafeterias) distributing ready-to-eat meals and verified FSOp's compliance with good manufacturing practices (GMP). Two facilities (FSOp-A and FSOp-B) were visited three times each over 5 months. We sampled foods, ingredients, and surfaces for microbiological analysis, and L. monocytogenes isolates were characterized by phylogenetic analyses and phenotypic characteristics. GMP audits were performed in the first and third visits. A ready-to-eat salad (FSOp-A) and a frozen ingredient (FSOp-B) were contaminated with L. monocytogenes, which was also detected on Zone 3 surfaces (floor, drains, and a boot cover). The phylogenetic analysis demonstrated that FSOp-B had persistent L. monocytogenes strains, but environmental isolates were not closely related to food or ingredient isolates. GMP audits showed that both operations worked under "fair" conditions, and "facilities and equipment" was the section with the least compliances. The presence of L. monocytogenes in the environment and GMP failures could promote food contamination with this pathogen, presenting a risk to consumers.
ABSTRACT
The process from high-risk human papillomavirus (HR-HPV) infection to cervical cancer is a continuous and long-term process, but the pathogenesis of the whole process is not completely clear. Here, 59 Chinese women were engaged in this study, and divided into five groups: normal healthy group, HR-HPV infections group, low-grade intraepithelial neoplasia (LSIL) group, high-SIL(HSIL) group, and cervical cancer group. With the occurrence of HR-HPV infection and the development of cervical lesions, the diversity of vaginal microbiota species was increased, and the relative abundance of Lactobacillus (L.), the dominant bacteria in maintaining vaginal microecological balance, was decreased gradually. In contrast, the abundance of Actinobacteria in the four disease groups was significantly higher than that in normal group. Furthermore L. iners may be related to the serious progression of cervical cancer. After analyzing the whole process, we found that Gardnerella(G.), Atopobium(A.) and Dialister(D.) have important effects on both persistent HR-HPV infection and the pathogenesis of cervical cancer. In addition, PICRUSt2 and KEGG results showed that the KEGG pathways enriched by the predicted genes of vaginal microbiota in cancer group included metabolic diseases, endocrine system and immune systems when compared with that in normal group. These findings may provide insights into the pathogenesis of cervical cancer, and help to improve the early detection and prevention of cervical precancerous lesions.
ABSTRACT
Although vaccination is carried out worldwide, the vaccination rate varies greatly. As of 24 May 2021, in some countries, the proportion of the population fully vaccinated against COVID-19 has exceeded 50%, but in many countries, this proportion is still very low, less than 1%. This article aims to explore the impact of vaccination on the spread of the COVID-19 pandemic. As the herd immunity of almost all countries in the world has not been reached, several countries were selected as sample cases by employing the following criteria: more than 60 vaccine doses per 100 people and a population of more than one million people. In the end, a total of eight countries/regions were selected, including Israel, the UAE, Chile, the United Kingdom, the United States, Hungary, and Qatar. The results find that vaccination has a major impact on reducing infection rates in all countries. However, the infection rate after vaccination showed two trends. One is an inverted U-shaped trend, and the other is an L-shaped trend. For those countries with an inverted U-shaped trend, the infection rate begins to decline when the vaccination rate reaches 1.46-50.91 doses per 100 people.
Subject(s)
COVID-19 , Immunity, Herd , Chile/epidemiology , Humans , Hungary , Israel/epidemiology , Pandemics , Qatar , SARS-CoV-2 , United Kingdom , VaccinationABSTRACT
BACKGROUND: The coronavirus disease of 2019 (COVID-19) has quickly spread to all corners of the world since its emergence in Wuhan, China in December of 2019. The disease burden has been heterogeneous across regions of the world, with Americas leading in cumulative cases and deaths, followed by Europe, Southeast Asia, Eastern Mediterranean, Africa and Western Pacific. Initial responses to COVID-19 also varied between governments, ranging from proactive containment to delayed intervention. Understanding these variabilities allow high burden countries to learn from low burden countries on ways to create more sustainable response plans in the future. METHODS: This study used a mixed-methods approach to perform cross-country comparisons of pandemic responses in the United States (US), Brazil, Germany, Australia, South Korea, Thailand, New Zealand, Italy and China. These countries were selected based on their income level, relative COVID-19 burden and geographic location. To rationalize the epidemiological variability, a list of 14 indicators was established to assess the countries' preparedness, actual response, and socioeconomic and demographic profile in the context of COVID-19. RESULTS: As of 1 April 2021, the US had the highest cases per million out of the nine countries, followed by Brazil, Italy, Germany, South Korea, Australia, New Zealand, Thailand and China. Meanwhile, Italy ranked first out of the nine countries' total deaths per million, followed by the US, Brazil, Germany, Australia, South Korea, New Zealand, China and Thailand. The epidemiological differences between these countries could be explained by nine indicators, and they were 1) leadership, governance and coordination of response, 2) communication, 3) community engagement, 4) multisectoral actions, 5) public health capacity, 6) universal health coverage, 7) medical services and hospital capacity, 8) demography and 9) burden of non-communicable diseases. CONCLUSION: The COVID-19 pandemic manifests varied outcomes due to differences in countries' vulnerability, preparedness and response. Our study rationalizes why South Korea, New Zealand, Thailand, Australia and China performed better than the US, Italy and Brazil. By identifying the strengths of low burden countries and weaknesses of hotspot countries, we elucidate factors constituting an effective pandemic response that can be adopted by leaders in preparation for re-emerging public health threats.
Subject(s)
COVID-19 , Pandemics , Africa , Americas , Asia, Southeastern , Australia/epidemiology , Brazil , China/epidemiology , Europe , Germany , Humans , Italy , New Zealand/epidemiology , Republic of Korea , SARS-CoV-2 , Thailand , United StatesABSTRACT
INTRODUCTION/OBJECTIVES: To evaluate the incidence rate (IR) of tuberculosis (TB) and viral hepatitis B and C (HBV/HCV) during certolizumab pegol (CZP) treatment, worldwide and in Asia-Pacific countries, across clinical trials and post-marketing reports (non-interventional studies and real-world practice). METHOD: CZP safety data were pooled across 49 clinical trials from 1998 to June 2017. Post-marketing reports were from initial commercialization until March 2015 (TB)/February 2017 (HBV/HCV). All suspected TB and HBV/HCV cases underwent centralized retrospective review by external experts. Incidence rates (IRs) were calculated per 100 patient-years (PY) of CZP exposure. RESULTS: Among 11,317 clinical trial patients (21,695 PY), 62 TB cases were confirmed (IR 0.29/100 PY) including 2 in Japan (0.10/100 PY) and 3 in other Asia-Pacific countries (0.58/100 PY). From > 238,000 PY estimated post-marketing CZP exposure, there were 31 confirmed TB cases (0.01/100 PY): 5 in Japan (0.05/100 PY), 1 in other Asia-Pacific countries (0.03/100 PY). Reported regional TB IRs were highest in eastern Europe (0.17/100 PY), central Europe (0.09/100 PY), and Mexico (0.16/100 PY). Across clinical trials, there was 1 confirmed HBV reactivation and no HCV cases. From > 420,000 PY estimated post-marketing CZP exposure, 5 HBV/HCV cases were confirmed (0.001/100 PY): 2 HCV reactivations; 1 new HCV; plus 2 HBV reactivations in Japan (0.008/100 PY). CONCLUSIONS: CZP TB risk is aligned with nationwide TB rates, being slightly higher in Asia-Pacific countries excluding Japan. Overall, TB and HBV/HCV risk with CZP treatment is currently relatively low, as risk can be minimized with patient/physician education, screening, and vigilant treatment, according to international guidelines. KEY POINTS: ⢠TB rates were highest in eastern/central Europe, Mexico, and Asia-Pacific regions. ⢠With the implementation of stricter TB screening and risk evaluations in 2007, especially in high TB incidence countries, there was a notable reduction TB occurrence. ⢠Safety profile of biologics in real-world settings complements controlled studies. ⢠TB and hepatitis (HBV/HCV) risk with certolizumab pegol (CZP) treatment is low.
Subject(s)
Antirheumatic Agents , Arthritis, Rheumatoid , Hepatitis, Viral, Human , Tuberculosis , Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/drug therapy , Asia/epidemiology , Certolizumab Pegol/adverse effects , Europe , Europe, Eastern , Hepatitis, Viral, Human/drug therapy , Humans , Japan , Mexico , Retrospective Studies , Treatment Outcome , Tuberculosis/drug therapy , Tuberculosis/epidemiologyABSTRACT
INTRODUCTION: The presence of poor quality antibiotics on the market has contributed to the antibiotics resistance and global threat to public health. Antibiotic resistance is now a global concern. One area to address this issue is by evaluating the quality of antibiotics accessible to the public. The purpose of this study was to test and compare (with corresponding pharmacopeia) the quality of common oral antibiotics available in the country of Belize with a view to providing base-line data on the testing of medications imported to the country for public consumption. The study focused only on level 2 field-based screening quality assurance on three Key Access Antibiotics from the World Health Organization (WHO) Model List of Essential Medicines. METHODS: Five brands of antibiotic tablets/capsules with denoted pharmacopeia imported into the country of Belize were tested for quality at The University of Belize pharmacy laboratory. A sample of 30 tablets/capsules each of the selected antibiotic brand were used for study. Visual inspection and weight variation were done for each sample while Monsanto type tablet hardness tester, Roche@Tablet Friability Test Apparatus (single drum), and Ajanta@ Tablet Disintegration Test Apparatus (double basket) were conducted on selected antibiotics. Results were recorded and compared with corresponding pharmacopoeia references. RESULTS: Most of the samples collected passed performed tests. Only a few samples from both BP and USP antibiotics failed in visual inspection and weight variation tests. All antibiotics tested conformed to their corresponding pharmacopeia reference in terms of friability and disintegration time. CONCLUSION: Most of the selected antibiotics passed performed tests when compared with their pharmacopeia. Only a few samples from both BP and USP antibiotics failed the tests conducted. There is need for regular quality assurance tests on all medications imported to Belize especially antibiotics.
Subject(s)
Anti-Bacterial Agents , Quality Control , Administration, Oral , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/pharmacology , Anti-Bacterial Agents/standards , Belize , Drug Resistance, MicrobialABSTRACT
OBJECTIVE: This study aims to investigate the application value of magnetic resonance (MR) hydrography of the inner ear in cochlear implantation. METHODS: 146 patients were enrolled. MR hydrography and spiral CT examinations for the intracranial auditory canal were performed before surgery, and all imaging results were statistically analyzed in order to explore the application value of MR hydrography of the inner ear in cochlear implantation. RESULTS: 146 patients (292 ears) were examined. Among these patients, 13 were diagnosed with abnormal vestibular aqueducts (20 ears) by MR hydrography, while five were diagnosed with this disease by CT; 15 patients were diagnosed with inner ear malformation (19 ears) by MR hydrography, while 11 were diagnosed by CT (four were misdiagnosed); five patients were diagnosed with internal acoustic canal stenosis (eight ears) by MR hydrography, while two were diagnosed by CT (three were misdiagnosed); and four patients were diagnosed with cochlear fibrosis (five ears) by MR hydrography, while four were diagnosed by CT (four ears). The correct rate of diagnosis was 77.40% (113/146) based on CT, while the rate was 93.84% (137/146) based on MR hydrography. CONCLUSIONS: MR hydrography imaging technique can be applied to the preoperative evaluation of cochlear implantation, providing accurate and reliable anatomic information on the inner membranous labyrinth and nerves in the internal acoustic canal and an accurate basis for the diagnosis of cochlear fibrosis and nerve development. This has a guiding significance for the selection of treatment schemes.
Subject(s)
Cochlear Implantation/methods , Ear, Inner/diagnostic imaging , Magnetic Resonance Imaging/methods , Adolescent , Adult , Child , Child, Preschool , Ear, Inner/surgery , Female , Hearing Loss, Sensorineural/diagnostic imaging , Hearing Loss, Sensorineural/surgery , Humans , Infant , Labyrinth Diseases/diagnostic imaging , Labyrinth Diseases/surgery , Male , Middle Aged , Preoperative Period , Reference Values , Reproducibility of Results , Tomography, Spiral Computed/methods , Young AdultABSTRACT
INTRODUCTION AND OBJECTIVES: HBV covalently closed circular (ccc) DNA is the key player in viral persistence and an important predictive biomarker for hepatitis relapse. Precise quantification of intracellular cccDNA is challenging because cccDNA is present in very low levels in hepatocytes, where it also co-exists with a large excess amount of relaxed circular (rc) DNA. We aimed to develop a highly sensitive cccDNA detection method for cccDNA quantification by digital PCR (dPCR). PATIENTS OR MATERIALS AND METHODS: A standard plasmid containing the whole HBV genome in the closed circular conformation was employed to characterize the performance of dPCR. rcDNA in the growth medium of HBV-producing HepAD38 cells was used as a matrix for cccDNA detection. Intrahepatic cccDNA measurement by dPCR and qPCR was performed to determine the correlation of the analysis results for the two methods. RESULTS: The limit of detection (LOD) of the cccDNA dPCR was 1.05copy/µl, and the linear range of detection was 1.02×104copies/µl, achieving a dynamic detection range of 104-fold. cccDNA measurement using excess rcDNA as the matrix did not reveal false-positive detection, indicating that dPCR was highly specific. In the HepAD38 cells, the cccDNA levels measured by dPCR were highly correlated with those measured by qPCR but had a higher sensitivity. The CDK inhibitor AZD-5438 was found to block intracellular cccDNA synthesis. CONCLUSIONS: Dpcr greatly improved the sensitivity and specificity of cccDNA detection. Host CDK activities are likely required for cccDNA synthesis. dPCR can potentially be applied for drug screening for effective cccDNA inhibitors.
Subject(s)
Cyclin-Dependent Kinases/metabolism , DNA, Circular/analysis , DNA, Viral/analysis , Hepatitis B virus/genetics , Hepatocytes/metabolism , Polymerase Chain Reaction/methods , Cell Line , Cyclin-Dependent Kinases/antagonists & inhibitors , DNA, Circular/biosynthesis , DNA, Viral/biosynthesis , Hepatitis B virus/drug effects , Hepatocytes/drug effects , Humans , Imidazoles/pharmacology , Pyrimidines/pharmacologyABSTRACT
SUMMARY OBJECTIVE This study aims to investigate the application value of magnetic resonance (MR) hydrography of the inner ear in cochlear implantation. METHODS 146 patients were enrolled. MR hydrography and spiral CT examinations for the intracranial auditory canal were performed before surgery, and all imaging results were statistically analyzed in order to explore the application value of MR hydrography of the inner ear in cochlear implantation. RESULTS 146 patients (292 ears) were examined. Among these patients, 13 were diagnosed with abnormal vestibular aqueducts (20 ears) by MR hydrography, while five were diagnosed with this disease by CT; 15 patients were diagnosed with inner ear malformation (19 ears) by MR hydrography, while 11 were diagnosed by CT (four were misdiagnosed); five patients were diagnosed with internal acoustic canal stenosis (eight ears) by MR hydrography, while two were diagnosed by CT (three were misdiagnosed); and four patients were diagnosed with cochlear fibrosis (five ears) by MR hydrography, while four were diagnosed by CT (four ears). The correct rate of diagnosis was 77.40% (113/146) based on CT, while the rate was 93.84% (137/146) based on MR hydrography. CONCLUSIONS MR hydrography imaging technique can be applied to the preoperative evaluation of cochlear implantation, providing accurate and reliable anatomic information on the inner membranous labyrinth and nerves in the internal acoustic canal and an accurate basis for the diagnosis of cochlear fibrosis and nerve development. This has a guiding significance for the selection of treatment schemes.
RESUMO OBJETIVO Este estudo visa investigar o valor da aplicação da hidrografia por ressonância magnética (RM) do ouvido interno no implante coclear. MÉTODOS Cento e quarenta e seis pacientes foram inscritos. Os exames da hidrografia por RM e do CT espiral para o canal auditivo intracraniano foram executados antes da cirurgia, e todos os resultados da imagem foram analisados estatisticamente, a fim de explorar o valor da aplicação da hidrografia por RM do ouvido interno no implante coclear. RESULTADOS Centro e quarenta e seis pacientes (292 ouvidos) foram examinados. Dentre esses pacientes, 13 foram diagnosticados com aquedutos vestibulares anormais (20 ouvidos) pela hidrografia por RM, enquanto cinco pacientes foram diagnosticados com esta doença pelo CT; 15 pacientes foram diagnosticados com malformação do ouvido interno (19 ouvidos) pela hidrografia por RM, enquanto 11 pacientes foram diagnosticados por CT (quatro foram diagnosticados erroneamente); cinco pacientes foram diagnosticados com estenose de canal acústico interno (oito ouvidos) pela hidrografia por RM, enquanto dois pacientes foram diagnosticados por CT (três foram diagnosticados erroneamente); e quatro pacientes foram diagnosticados com fibrose coclear (cinco ouvidos) pela hidrografia por RM, enquanto quatro foram diagnosticados por CT (quatro ouvidos). A taxa correta de diagnóstico foi de 77,40% (113/146) com base no CT, enquanto a taxa foi de 93,84% (137/146) com base na hidrografia por RM. CONCLUSÕES A técnica de imagem da hidrografia por RM pode ser aplicada à avaliação pré-operatória do implante coclear, que pode fornecer informações anatômicas precisas e confiáveis sobre o labirinto membranoso interno e os nervos no canal acústico interno, além de uma base exata para o diagnóstico da fibrose coclear e do desenvolvimento do nervo. Isso tem um significado orientador para a seleção de esquemas de tratamento.