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Randomized trials of the efficacy of multicancer early detection, by means of measurement of cell-free DNA and/or protein biomarkers in peripheral blood specimens, will attempt to document a difference in cancer mortality between persons assigned to intervention and control arms. Their ability to do so is limited by the relatively low rate of death from individual forms of cancer, the relatively low sensitivity of the tests currently being used, and the use of other cancer screening modalities among trial participants. However, if those same blood specimens also could be obtained from control arm participants in a given trial and then tested for the same markers, with results not known (or not made available) until the conclusion of follow-up for cancer mortality, it would be possible to compare mortality from given forms of cancer between test-positive individuals whose results were known and not known during the course of the trial. Such an analysis addresses the impact of a stimulus to offer targeted diagnostic testing, potentially leading to early treatment, against cancer mortality. Among persons who screen as positive, it should provide a relatively more sensitive means of gauging a possible mortality benefit resulting from multicancer screening.
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Biomarcadores Tumorais , Detecção Precoce de Câncer , Neoplasias , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Detecção Precoce de Câncer/métodos , Neoplasias/mortalidade , Neoplasias/diagnóstico , Neoplasias/sangue , Biomarcadores Tumorais/sangue , Programas de Rastreamento/métodos , Feminino , MasculinoRESUMO
Background: Surgical correction of aphakia without capsular support continues to be a challenge. Improvements in the technology of cataract surgery have provided advancements in techniques in surgical management of aphakia. Locally, we have limited data on the outcomes of the different intraocular lenses used in aphakia. Objective: This study aimed to determine visual outcomes and complications associated with different techniques of intraocular lens implantation in the absence of capsular support. Methods: We reviewed the medical charts of 207 patients who underwent intraocular lens implantation without capsular support. Excluded were patients with incomplete follow up, pediatric patients, and lost records. Best corrected visual acuity at day 1, 1st month, 3rd month and 6th month postoperatively, and the complications were noted. Results: Mean age was 60 and 51% (n=105) were females. The mean follow-up time was 9.33 ± 0.71 months. Loss of capsular support was most frequently caused by intraoperative complication (n=146, 70%) and trauma. Retropupillary fixation iris claw intraocular lens was frequently used (n=93, 44.9%). Across all patients, visual acuities showed excellent outcomes with 20/50 or better. Across IOL types, the most frequent postoperative complication was increase in IOP. Statistically significant results were set at P <0.05. Conclusion: There is a notable preference towards iris claw retropupillary lenses through time. Iris claw lenses showed the shortest operative time. All intraocular lenses used in aphakia showed comparably good postoperative visual acuities, except for the superior visual acuity trend seen among retropupillary iris claw and anterior chamber IOL groups. Complications included elevated intraocular pressures, corneal edema, and pigment dispersion.
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As mass coral bleaching events become more frequent, it is increasingly important to elucidate the factors underlying coral susceptibility and survival. We measured photosynthesis, respiration, and O2 concentration at the coral tissue surface, Symbiodiniaceae genotypes, and energy metabolic enzyme activities in Agaricia agaricites and Orbicella franksi throughout experimentally-induced thermal bleaching (+3 °C). A. agaricites colonies started to bleach two days into the thermal treatment and were fully bleached between Days 19-31. In contrast, O. franksi colonies only started to bleach on Day 12 and five colonies fully bleached between Days 24-38 while the remining three colonies took up 55 days. Both species experienced decreased photosynthesis and respiration rates as bleaching progressed. As a result, daytime O2 concentration at the coral surface shifted from hyperoxia in unbleached corals to normoxia in partially bleached corals, and to near hypoxia in fully bleached corals. Additionally, nighttime tissue surface O2 concentration shifted from hypoxia to normoxia, likely resulting from decreased symbiotic algae density, respiration, and photosynthates that fuel coral aerobic respiration. Genetic profiling of internal transcribed spacer 2 (ITS2) revealed differences in Symbiodiniaceae clade proportions between control and bleached colonies. Activity levels of energy metabolic enzymes did not significantly vary between control and bleached A. agaricites, but malate dehydrogenase and strombine dehydrogenase activities were significantly higher in bleached O. franksi colonies compared to controls. These differences were driven by the three O. franksi colonies that took the longest to bleach and contained >98 % Durusdinium sp. D1. The shifts in O2 dynamics within the microhabitat of bleached corals may have important implications for the metabolism of the coral holobiont while the changes in Symbiodiniaceae ITS2 profile and the upregulation of energy metabolic enzymes identify a potential factor contributing to bleaching dynamics.
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Antozoários , Dinoflagellida , Animais , Antozoários/fisiologia , Oxigênio/metabolismo , Região do Caribe , Metabolismo Energético , Hipóxia , Recifes de CoraisRESUMO
This study compared the functional efficacy of therapeutic transforaminal versus interlaminar epidural steroid injection. Adult patients were selected and randomized using an online research randomizer website and assigned into two groups and were given epidural injection either via transforaminal route or interlaminar route. The outcome was measured based on the Modified Japanese Orthopedic Association back index score (mJOA), Oswestry disability index (ODI), and visual analog scale (VAS) over a follow-up on 1st, 3rd, and 6th month postinjection period. It was found that there was no significant difference seen in m JOA, ODI, and VAS score at 1 month, 3 months, and 6 months between transforaminal and interlaminar epidural steroid injection. Pain management in the epidural route was comparable to the interlaminar route. Even though the transforaminal epidural route has the advantage of being a selective nerve route block, it has similar results as the interlaminar route at 6 months follow-up.
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OBJECTIVE: Identification of characteristics associated with active disease in juvenile idiopathic arthritis (JIA) could inform early disease treatment strategies. This study evaluated characteristics associated with active disease at 12 and 24 months after JIA diagnosis in the era in which biologic disease-modifying antirheumatic drugs (DMARDs) became available for JIA. METHODS: This single-center retrospective study from 2004 through 2018 assessed characteristics associated with active nonsystemic categories of JIA at 12 and 24 months after diagnosis. Relative prevalence (RP) of disease activity was evaluated in relation to prespecified characteristics. Using RP, the effect of increasing biologic DMARD availability on these predictors was assessed at 12 months. RESULTS: A total of 1,151 patients with JIA were included. At 12 months, a 40% to 45% higher point prevalence of active disease was noted in older children (>5 years). Patients with active disease at 3 months had a greater prevalence of active disease at 12 months (RP 1.5, 95% confidence interval [CI] 1.2-1.8) and 24 months (RP 1.3, 95% CI 1-1.6). Compared to oligoarticular JIA, polyarticular RF-negative, psoriatic, and enthesitis-related JIA had a greater prevalence of active disease at 12 and 24 months. At 24 months, a greater prevalence of active disease was observed in children ≥10 years. RP of active disease was 25% lower in the late cohort (2013-2018) than in the earliest cohort (2004-2008; RP 0.75, 95% CI 0.62-0.92) when more biologic medications were available, but disease activity predictors were broadly similar over time. CONCLUSION: Patients with JIA with active disease at 12 and 24 months were older at diagnosis, categorized as polyarticular RF-negative, psoriatic, or enthesitis-related JIA. Active disease at 3 months after diagnosis was associated with worse outcomes at 12 and 24 months.
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Rationale: Understanding contributors to costly and potentially burdensome care for patients with dementia is of interest to healthcare systems and may facilitate efforts to promote goal-concordant care. Objective: To identify risk factors, in particular whether an early goals-of-care discussion (GOCD) took place, for high-cost hospitalization among patients with dementia and acute respiratory failure. Methods: We conducted an electronic health record-based retrospective cohort study of 298 adults with dementia hospitalized with respiratory failure (receiving ⩾48 h of mechanical ventilation) within an academic healthcare system. We collected demographic and clinical characteristics, including clinical markers of advanced dementia (weight loss, pressure ulcers, hypernatremia, mobility limitations) and intensive care unit (ICU) service (medical, surgical, neurologic). We ascertained whether a GOCD was documented within 48 hours of ICU admission. We used logistic regression to identify patient characteristics associated with high-cost hospitalization measured using the hospital system accounting database and defined as total cost in the top third of the sample (⩾$145,000). We examined a path model that included hospital length of stay as a final mediator between exposure variables and high-cost hospitalization. Results: Patients in the sample had a median age of 71 (IQR, 62-79) years. Approximately half (49%) were admitted to a medical ICU, 29% to a surgical ICU, and 22% to a neurologic ICU. More than half (59%) had a clinical indicator of advanced dementia. A minority (31%) had a GOCD documented within 48 hours of ICU admission; those who did had a 50% lower risk of a high-cost hospitalization (risk ratio, 0.50; 95% confidence interval, 0.2-0.8). Older age, limited English proficiency, and nursing home residence were associated with a lower likelihood of high-cost hospitalization, whereas greater comorbidity burden and admission to a surgical or neurologic ICU compared with a medical ICU were associated with a higher likelihood of high-cost hospitalization. Conclusions: Early GOCDs for patients with dementia and respiratory failure may promote high-value care by ensuring aggressive and costly life support interventions are aligned with patients' goals. Future work should focus on increasing early palliative care delivery for patients with dementia and respiratory failure, in particular in surgical and neurologic ICU settings.
Assuntos
Demência , Unidades de Terapia Intensiva , Respiração Artificial , Insuficiência Respiratória , Humanos , Masculino , Feminino , Estudos Retrospectivos , Idoso , Demência/terapia , Demência/economia , Insuficiência Respiratória/terapia , Idoso de 80 Anos ou mais , Unidades de Terapia Intensiva/economia , Unidades de Terapia Intensiva/estatística & dados numéricos , Fatores de Risco , Respiração Artificial/economia , Respiração Artificial/estatística & dados numéricos , Hospitalização/economia , Hospitalização/estatística & dados numéricos , Tempo de Internação/estatística & dados numéricos , Tempo de Internação/economia , Pessoa de Meia-Idade , Modelos Logísticos , Doença Aguda , Custos Hospitalares/estatística & dados numéricosRESUMO
Importance: Organized screening outreach can reduce differences in colorectal cancer (CRC) incidence and mortality between demographic subgroups. Outcomes associated with additional outreach, beyond universal outreach, are not well known. Objective: To compare CRC screening completion by race and ethnicity, age, and sex after universal automated outreach and additional personalized outreach. Design, Setting, and Participants: This observational cohort study included screening-eligible individuals aged 50 to 75 years assessed during 2019 in a community-based organized CRC screening program within the Kaiser Permanente Northern California (KPNC) integrated health care delivery setting. For KPNC members who are not up to date with screening by colonoscopy, each year the program first uses automated outreach (mailed prescreening notification postcards and fecal immunochemical test [FIT] kits, automated telephone calls, and postcard reminders), followed by personalized components for nonresponders (telephone calls, electronic messaging, and screening offers during office visits). Data analyses were performed between November 2021 and February 2023 and completed on February 5, 2023. Exposures: Completed CRC screening via colonoscopy, sigmoidoscopy, or FIT. Main Outcomes and Measures: The primary outcome was the proportion of participants completing an FIT or colonoscopy after each component of the screening process. Differences across subgroups were assessed using the χ2 test. Results: This study included 1â¯046â¯745 KPNC members. Their mean (SD) age was 61.1 (6.9) years, and more than half (53.2%) were women. A total of 0.4% of members were American Indian or Alaska Native, 18.5% were Asian, 7.2% were Black, 16.2% were Hispanic, 0.8% were Native Hawaiian or Other Pacific Islander, and 56.5% were White. Automated outreach significantly increased screening participation by 31.1%, 38.1%, 29.5%, 31.9%, 31.8%, and 34.5% among these groups, respectively; follow-up personalized outreach further significantly increased participation by absolute additional increases of 12.5%, 12.4%, 13.3%, 14.4%, 14.7%, and 11.2%, respectively (all differences P < .05 compared with White members). Overall screening coverage at the end of the yearly program differed significantly among members who were American Indian or Alaska Native (74.1%), Asian (83.5%), Black (77.7%), Hispanic (76.4%), or Native Hawaiian or Other Pacific Islander (74.4%) compared with White members (82.2%) (all differences P < .05 compared with White members). Screening completion was similar by sex; older members were substantially more likely to be up to date with CRC screening both before and at the end of the screening process. Conclusions and Relevance: In this cohort study of a CRC screening program, sequential automated and personalized strategies each contributed to substantial increases in screening completion in all demographic groups. These findings suggest that such programs may potentially reduce differences in CRC screening completion across demographic groups.
Assuntos
Neoplasias Colorretais , Detecção Precoce de Câncer , Feminino , Humanos , Masculino , Estudos de Coortes , Neoplasias Colorretais/diagnóstico , Pessoa de Meia-Idade , Idoso , Grupos Raciais , EtnicidadeRESUMO
Objectives: The Bioavailability/Bioequivalence Unit (BA/BE Unit) of the Department of Pharmacology and Toxicology, College of Medicine, University of the Philippines Manila which has not been operational since 2012, is due for renewal of its accreditation. To date, there are only three Philippine Food and Drug Administration-accredited laboratories that perform bioequivalence studies in the Philippines. One of the prerequisites of registering specific generic medicines is the conduct of Bioequivalence (BE) studies which are performed to ensure that the generic drug is at par with the innovator drug. Thus, this study aimed to determine the feasibility of re-establishing the BA/BE Unit as a bioequivalence testing center. Methods: The feasibility study done is a qualitative descriptive analysis based on expansive literature review and performance of SWOT analysis within the BA/BE unit. Literatures were selected based on its assessed relevance to the study. The databases checked were PubMed and Google Scholar. The terms used were from the Medical Subject Heading (MeSH) including feasibility studies, therapeutic equivalency, and generic drugs. Literature review was performed on the factors affecting the four types of feasibility studies (market, technical, financial, and organizational). A SWOT analysis of the BA/BE Unit was done through the review of records and documents of previous BE studies and focus group discussion among the BA/BE Unit team members. Results: The BA/BE Unit conducted 24 bioequivalence studies from 2006-2009 and still receives inquiries from drug companies. It implements its QMS throughout the pre-analytical, analytical, and post-analytical stages of the workflow. Its organizational structure consists of qualified professionals with updated GCP and GLP certificates. Because of the adequately equipped facility, lower honoraria for government-employed personnel, and lower expenses for laboratories and in-patient admissions, the cost of conducting a bioequivalence study in the BA/BE Unit will be lower than in other BE centers. Conclusion: Based on the SWOT analysis and market, technical, financial, and organizational considerations, re-establishing the BA/BE Unit as a bioequivalence testing center is feasible.
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Importance: The fecal immunochemical test (FIT) is widely used for colorectal cancer (CRC) screening, but evidence of its effectiveness is limited. Objective: To evaluate whether FIT screening is associated with a lower risk of dying from CRC overall, according to cancer location, and within demographic groups. Design, Setting, and Participants: This nested case-control study in a cohort of screening-eligible people was conducted in 2 large, integrated health systems of racially, ethnically, and socioeconomically diverse members with long-term programs of mailed FIT screening outreach. Eligible participants included people aged 52 to 85 years who died from colorectal adenocarcinoma between 2011 and 2017 (cases); cases were matched in a 1:8 ratio based on age, sex, health-plan membership duration, and geographic area to randomly selected persons who were alive and CRC-free on case's diagnosis date (controls). Data analysis was conducted from January 2002 to December 2017. Exposures: Completing 1 or more FIT screenings in the 5-year period prior to the CRC diagnosis date among cases or the corresponding date among controls; in secondary analyses, 2- to 10-year intervals were evaluated. Main Outcomes and Measures: The primary study outcome was CRC death overall and by tumor location. Secondary analyses were performed to assess CRC death by race and ethnicity. Results: From a cohort of 2â¯127â¯128 people, a total of 10â¯711 participants (3529 aged 60-69 years [32.9%]; 5587 male [52.1%] and 5124 female [47.8%]; 1254 non-Hispanic Asian [11.7%]; 973 non-Hispanic Black [9.1%]; 1929 Hispanic or Latino [18.0%]; 6345 non-Hispanic White [59.2%]) was identified, including 1103 cases and 9608 controls. Among controls during the 10-year period prior to the reference date, 6101 (63.5%) completed 1 or more FITs with a cumulative 12.6% positivity rate (768 controls), of whom 610 (79.4%) had a colonoscopy within 1 year. During the 5-year period, 494 cases (44.8%) and 5345 controls (55.6%) completed 1 or more FITs. In regression analysis, completing 1 or more FIT screening was associated with a 33% lower risk of death from CRC (adjusted odds ratio [aOR], 0.67; 95% CI, 0.59-0.76) and 42% lower risk in the left colon and rectum (aOR, 0.58; 95% CI, 0.48-0.71). There was no association with right colon cancers (aOR, 0.83; 95% CI, 0.69-1.01) but the difference in the estimates between the right colon and left colon or rectum was statistically significant (P = .01). FIT screening was associated with lower CRC mortality risk among non-Hispanic Asian (aOR, 0.37; 95% CI, 0.23-0.59), non-Hispanic Black (aOR, 0.58; 95% CI, 0.39-0.85) and non-Hispanic White individuals (aOR, 0.70; 95% CI, 0.57-0.86) (P for homogeneity = .04 for homogeneity). Conclusions and Relevance: In this nested case-control study, completing FIT was associated with a lower risk of overall death from CRC, particularly in the left colon, and the associations were observed across racial and ethnic groups. These findings support the use of FIT in population-based screening strategies.
Assuntos
Neoplasias Colorretais , Detecção Precoce de Câncer , Sangue Oculto , Humanos , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/mortalidade , Masculino , Idoso , Feminino , Pessoa de Meia-Idade , Estudos de Casos e Controles , Detecção Precoce de Câncer/métodos , Idoso de 80 Anos ou mais , Programas de Rastreamento/métodos , Fezes/químicaRESUMO
PURPOSE: To evaluate the effectiveness of endoscopic screening against incidence of and mortality from esophageal squamous cell carcinoma (ESCC). METHODS: From January 2012 to September 2016, we conducted a community-based cluster randomized controlled trial involving permanent residents age 45-69 years in a high-risk region for ESCC in northern China. A total of 668 targeted villages were randomly assigned in a 1:1 ratio to the screening group (offered Lugol's chromoendoscopy) or control group (no screening). Intention-to-treat and per-protocol analyses were performed to compare esophageal cancer (EC) incidence and mortality between the two groups. The per-protocol analysis adjusted for nonadherence to the screening procedure. RESULTS: A total of 33,847 participants were included in the analysis: 17,104 in the screening group, 15,165 (88.7%) of whom underwent screening, and 16,743 in the control group. During a maximum follow-up of 9 years, EC incidence in the screening and control groups were 60.9 and 72.5 per 100,000 person-years, respectively; mortality in the screening and control groups were 29.7 and 32.4 per 100,000 person-years, respectively. Compared with the control group, the incidence and mortality of the screening group reduced by 19% (adjusted hazard ratio [aHR], 0.81 [95% CI, 0.60 to 1.09]) and 18% (aHR, 0.82 [95% CI, 0.53 to 1.26]), respectively, in the intention-to-treat analysis; and by 22% (aHR, 0.78 [95% CI, 0.56 to 1.10]) and 21% (aHR, 0.79 [95% CI, 0.49 to 1.30]), respectively, in the per-protocol analysis. CONCLUSION: With a 9-year follow-up, our trial suggests that chromoendoscopic screening induces modest reductions in EC incidence and mortality. A more efficient strategy for EC screening and subsequent patient management should be established to guarantee the effectiveness of endoscopic screening.
Assuntos
Detecção Precoce de Câncer , Neoplasias Esofágicas , Humanos , Neoplasias Esofágicas/mortalidade , Neoplasias Esofágicas/epidemiologia , Neoplasias Esofágicas/diagnóstico , Masculino , China/epidemiologia , Feminino , Incidência , Pessoa de Meia-Idade , Idoso , Detecção Precoce de Câncer/métodos , Carcinoma de Células Escamosas do Esôfago/mortalidade , Carcinoma de Células Escamosas do Esôfago/epidemiologia , Carcinoma de Células Escamosas do Esôfago/diagnóstico , Esofagoscopia , Programas de Rastreamento/métodosRESUMO
Background@#Surgical correction of aphakia without capsular support continues to be a challenge. Improvements in the technology of cataract surgery have provided advancements in techniques in surgical management of aphakia. Locally, we have limited data on the outcomes of the different intraocular lenses used in aphakia.@*Objective@#This study aimed to determine visual outcomes and complications associated with different techniques of intraocular lens implantation in the absence of capsular support.@*Methods@#We reviewed the medical charts of 207 patients who underwent intraocular lens implantation without capsular support. Excluded were patients with incomplete follow up, pediatric patients, and lost records. Best corrected visual acuity at day 1, 1st month, 3rd month and 6th month postoperatively, and the complications were noted.@*Results@#Mean age was 60 and 51% (n=105) were females. The mean follow-up time was 9.33 ± 0.71 months. Loss of capsular support was most frequently caused by intraoperative complication (n=146, 70%) and trauma. Retropupillary fixation iris claw intraocular lens was frequently used (n=93, 44.9%). Across all patients, visual acuities showed excellent outcomes with 20/50 or better. Across IOL types, the most frequent postoperative complication was increase in IOP. Statistically significant results were set at P <0.05. @*Conclusion@#There is a notable preference towards iris claw retropupillary lenses through time. Iris claw lenses showed the shortest operative time. All intraocular lenses used in aphakia showed comparably good postoperative visual acuities, except for the superior visual acuity trend seen among retropupillary iris claw and anterior chamber IOL groups. Complications included elevated intraocular pressures, corneal edema, and pigment dispersion.
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Afacia , FilipinasRESUMO
Introduction@#Spirituality was defined as a way individual seek and express meaning and purpose and the way they experience their connectedness to the moment. Studies showed that spiritual beliefs provided comfort to cancer patients and that different dimensions were related with the different aspects of health.@*Objectives@#The aim of the study is to determine the correlation on effects of spirituality and the quality of life among patients enrolled in the outpatient chemotherapy clinic.@*Methodology@#An analytical cross-sectional study using a non-probability convenience sampling was done of which validated questionnaires on the Spirituality and Quality of Life were the research instruments of the study. The Pearson’s correlation coefficient/Spearman rho computed on the relationship between the dimensions of spirituality and subscales of the quality of life among cancer patients. Chi Square/Fisher’s test was used to determine the correlation among the types and stages of cancer with the quality of life and spirituality of the respondents.@*Results@#A total of 105 cancer patients participated in this study, with ages ranging from 21 to 76 years and a mean age of 51 +/- 11 years, 2/5 were married females and 4/5 were Roman Catholic. Fifty-six percent of the cancer patients have Invasive Ductal Carcinoma (Breast Cancer). Most of the respondents are at stages 2 and 3 with equal percentages of 41%. This study revealed that most of the cancer patients enrolled in the outpatient chemotherapy clinic had a mean score of 3.56 + 0.35 indicating moderate to high level of spirituality. It also showed a mean score of 5.41 +.53 indicating high QOLs. Dimensions of spirituality which were found to have significant association with QOL domains (p < 0.05) were Mindfulness and Feeling of Security which were both found to have positive correlation with Emotional Wellbeing and Social Status.@*Conclusion@#Spiritual care should be included as one of the non-pharmacological modalities in the comprehensive management and palliative care for the Filipino cancer patients in order to improve the over-all well-being, healthcare outcomes and quality of life of patients and their families.
Assuntos
Neoplasias , Pacientes , Qualidade de VidaRESUMO
Objectives@#The Bioavailability/Bioequivalence Unit (BA/BE Unit) of the Department of Pharmacology and Toxicology, College of Medicine, University of the Philippines Manila which has not been operational since 2012, is due for renewal of its accreditation. To date, there are only three Philippine Food and Drug Administration-accredited laboratories that perform bioequivalence studies in the Philippines. One of the prerequisites of registering specific generic medicines is the conduct of Bioequivalence (BE) studies which are performed to ensure that the generic drug is at par with the innovator drug. Thus, this study aimed to determine the feasibility of re-establishing the BA/BE Unit as a bioequivalence testing center. @*Methods@#The feasibility study done is a qualitative descriptive analysis based on expansive literature review and performance of SWOT analysis within the BA/BE unit. Literatures were selected based on its assessed relevance to the study. The databases checked were PubMed and Google Scholar. The terms used were from the Medical Subject Heading (MeSH) including feasibility studies, therapeutic equivalency, and generic drugs. Literature review was performed on the factors affecting the four types of feasibility studies (market, technical, financial, and organizational). A SWOT analysis of the BA/BE Unit was done through the review of records and documents of previous BE studies and focus group discussion among the BA/BE Unit team members. @*Results@#The BA/BE Unit conducted 24 bioequivalence studies from 2006-2009 and still receives inquiries from drug companies. It implements its QMS throughout the pre-analytical, analytical, and post-analytical stages of the workflow. Its organizational structure consists of qualified professionals with updated GCP and GLP certificates. Because of the adequately equipped facility, lower honoraria for government-employed personnel, and lower expenses for laboratories and in-patient admissions, the cost of conducting a bioequivalence study in the BA/BE Unit will be lower than in other BE centers. @*Conclusion@#Based on the SWOT analysis and market, technical, financial, and organizational considerations, reestablishing the BA/BE Unit as a bioequivalence testing center is feasible.
Assuntos
Estudos de Viabilidade , Equivalência Terapêutica , Medicamentos GenéricosRESUMO
@#Children with weak or absent capsular support requiring lens removal and intraocular lens implantation present as one of the more challenging cases in pediatric ophthalmology practice. The authors present a case series with postoperative follow-up of at least five years after retropupillary fixation of iris-clipped lenses. All cases had improved visual acuity with only minor focal iris atrophy as complication in one case. Retropupillary fixation of iris-clipped IOL should be included in an ophthalmologist's armamentarium when operating on cases with weak or absent capsular support.
Assuntos
Subluxação do CristalinoRESUMO
Background@#The rising public health threat brought about by antibiotic resistance, such as of Staphylococcus aureus, opened doors of opportunities for natural products research to explore novel antimicrobial agents. @*Objective@#This study aimed to determine the antimicrobial activity of cell-free supernatants from Lactobacillus plantarum BS25 and Pediococcus acidilactici S3 against Staphylococcus aureus (ATCC# 25923) and methicillin-resistant S. aureus (ATCC# 33591). @*Methodology@#Cell-free supernatants (CFS) of Lactobacillus plantarum BS25 and Pediococcus acidilactici S3, isolated from fermented rice-fish mixture balao-balao and fermented spicy sausage longganisa, respectively, were tested against methicillin-susceptible (MSSA, ATCC 25923) and methicillin-resistant (MRSA, ATCC 33591) Staphylococcus aureus strains for antibacterial activity using the resazurin assay. @*Results@#Both BS25 and S3 CFS showed high activities against MSSA and partial inhibition against MRSA. Proteinaceous components of the CFS were extracted using ammonium sulfate precipitation with BS25 and S3 exhibited low activities against MSSA but partial inhibition was observed against MRSA. Other small molecules were extracted from the CFS through liquid-liquid extraction using ethyl acetate and tested in 100, 250, 500, 750, and 1000 ppm concentrations. The 1000-ppm concentrations of the BS25 and S3 ethyl acetate extracts achieved the highest antibacterial activity against MSSA and MRSA. @*Conclusion@#This study showed that the crude cell-free supernatants, ammonium sulfate precipitates, and ethyl acetate extracts of BS25 and S3 CFS exhibited potential in inhibiting Gram-positive MSSA and MRSA. However, the partially-purified samples require relatively high concentrations in order to produce significant inhibition activities and therefore require further purification.
Assuntos
Lactobacillus plantarum , Pediococcus acidilactici , Staphylococcus aureus Resistente à MeticilinaRESUMO
Background@#One of the causes of inflammatory arthritis is excessive production of uric acid or hyperuricemia. It is a painful disease that is treated with a commercial xanthine oxidase inhibitor to decrease uric acid synthesis. However, the treatment is associated with adverse side effects and thus, there is interest in medicinal plants that could have similar therapeutic effects with minimal side effects. There are many reported indigenous plants and trees in the Philippines that are reported to have therapeutic and bioactive compounds. One such plant is Canarium ovatum or locally called pili. This study aimed to determine the antihyperuricemic activity of the ethanolic extract of the leaves of C. ovatum. @*Objective@#Determine the antihyperuricemic activity of the crude ethanolic extract of C. ovatum leaves and its partially purified fractions through inhibition of xanthine oxidase and its effect on the blood uric acid level of oxonate-induced hyperuricemic mice. @*Methodology@#The crude ethanol extract from C. ovatum leaves and its partially purified fractions obtained through column chromatography were tested for their in vitro xanthine oxidase (XO) inhibitory activity by measuring spectrophotometrically the uric acid formation from xanthine as the substrate. The crude ethanol extract and the fraction with the most XO inhibitory activity were then tested for their in vivo XO inhibitory activity in oxonate-induced hyperuricemic mice by measuring their blood uric acid levels using uric acid test strips. @*Results@#The crude ethanolic extract of C. ovatum leaves at 100ppm showed 83.62±2.05% in vitro inhibition of XO while the most active fraction showed 80.30±4.00% inhibition. Both were comparable (p>0.05) to the positive control, allopurinol, which showed 91.47±5.64% inhibition. In vivo, the crude extract and the fraction that showed the highest XO inhibitory activity at 200 mg/kg significantly (p<0.01 and p<0.05) respectively reduced the serum uric acid levels of the hyperuricemic mice one hour after induction as compared to the negative control. Moreover, their antihyperuricemic activity were not statistically significant as compared to that of allopurinol (p<0.0001). @*Conclusion@#The crude ethanolic extract of C. ovatum leaves and its most active fraction showed statistically significant in vitro xanthine oxidase inhibition and in vivo antihyperuricemic activity. The activities shown by both crude and active fraction were not statistically different from that determined for allopurinol. Therefore, further studies can be conducted to isolate the most active compound and study its pharmacokinetic properties.
Assuntos
Xantina Oxidase , Ácido Úrico , AlopurinolRESUMO
Given the high morbidity for mother and fetus associated with malaria in pregnancy, safe and efficacious drugs are needed for treatment. Artemisinin derivatives are the most effective antimalarials, but are associated with teratogenic and embryotoxic effects in animal models when used in early pregnancy. However, several organ systems are still under development later in pregnancy. We conducted a systematic review and meta-analysis of the occurrence of adverse pregnancy outcomes among women treated with artemisinins monotherapy or as artemisinin-based combination therapy during the 2nd or 3rd trimesters relative to pregnant women who received non-artemisinin antimalarials or none at all. Pooled odds ratio (POR) were calculated using Mantel-Haenszel fixed effects model with a 0.5 continuity correction for zero events. Eligible studies were identified through Medline, Embase, and the Malaria in Pregnancy Consortium Library. Twenty studies (11 cohort studies and 9 randomized controlled trials) contributed to the analysis, with 3,707 women receiving an artemisinin, 1,951 a non-artemisinin antimalarial, and 13,714 no antimalarial. The PORs (95% confidence interval (CI)) for stillbirth, fetal loss, and congenital anomalies when comparing artemisinin versus quinine were 0.49 (95% CI 0.24-0.97, I2 = 0%, 3 studies); 0.58 (95% CI 0.31-1.16, I2 = 0%, 6 studies); and 1.00 (95% CI 0.27-3.75, I2 = 0%, 3 studies), respectively. The PORs comparing artemisinin users to pregnant women who received no antimalarial were 1.13 (95% CI 0.77-1.66, I2 = 86.7%, 3 studies); 1.10 (95% CI 0.79-1.54, I2 = 0%, 4 studies); and 0.79 (95% CI 0.37-1.67, I2 = 0%, 3 studies) for miscarriage, stillbirth and congenital anomalies respectively. Treatment with artemisinin in 2nd and 3rd trimester was not associated with increased risks of congenital malformations or miscarriage and may be was associated with a reduced risk of stillbirths compared to quinine. This study updates the reviews conducted by the WHO in 2002 and 2006 and supports the current WHO malaria treatment guidelines malaria in pregnancy.
Assuntos
Humanos , Feminino , Gravidez , Artemisininas/efeitos adversos , Artemisininas/uso terapêutico , Malária , Malária/tratamento farmacológico , Aborto Espontâneo , Estudos de Coortes , Complicações Parasitárias na Gravidez/tratamento farmacológico , Antimaláricos/efeitos adversos , Antimaláricos/uso terapêuticoRESUMO
INTRODUCTION: Cytotoxic chemotherapy places all cancer patients at risk of developing myelosuppression. Different chemotherapy regimens could lead to development of neutropenia, anemia and thrombocytopenia which may lead to delays in facilitating chemotherapy and also may place cancer patients at risk of developing severe complications which may be life threatening. This study determined the incidence of neutropenia, anemia, and thrombocytopenia per cycle of chemotherapy starting after the 1st cycle among non-metastatic breast cancer patients. It also evaluated if age, size of primary tumor, number of positive lymph nodes, IHC result, BMI, co-morbidities and chemotherapy used were associated with the development of neutropenia, anemia and thrombocytopenia during the 10 cycle of chemotherapy; this may help in ascertaining which patients may need more intensive monitoring during subsequent chemotherapy sessions.METHODS: This is a time series study wherein the CBC results starting prior 1° chemotherapy cycle were gathered from medical charts of non-metastatic breast cancer patients receiving cyclophosphamide/ doxorubicin/ docetaxel/ fluororuracil chemotherapy at UP-PGH and JRRMMC Medical Oncology Clinics enrolled under the DOH-NCPAM BCMAP program, from 1 January 2009 to 31 June 2014. Incidence rates of neutropenia, anemia and thrombocytopenia were recorded per cycle of chemotherapy. Severity of myelosuppression was graded based on the Common Toxicity Criteria of the National Cancer Institute Version 2.0. Possible predictors of myelosuppression were assessed focusing on the 1st cycle of chemotherapy where interventions were not yet done. Standard statistical methods were used for the descriptive analysis. Variables were analyzed using the Chi square test and logistic regression; level of significance was at pAfter the 1st chemotherapy cycle, the incidence of neutropenia was 4.67% (35 patients), anemia 2.27% (17 patients), and thrombocytopenia 0.8% (6 patients). Of these patients, only 1.17% (9 patients) experienced severe neutropenia and 0.27% (2 patients) experienced grade 3-4 anemia. No patient experienced grade 3-4 thrombocytopenia.Age, size of primary tumor, number of positive lymph nodes, IHC result, BMI, co-morbidities and chemotherapy used were not associated with risk for myelosuppression during the 1st cycle of chemotherappy.CONCLUSION: Incidence rates of neutropenia, anemia and thrombocytopenia were minimal in non-metastatic breast cancer patients undergoing cytotoxic chemotherapy, with low rates of severe myelosupression. Myelosupression from standard doxorubicin/ cyclophosphamide/ docetaxel/ fluoracil containing chemotherapy regimens can be given to non-metastatic breast cancer patients, completing required number of chemotherapy cycles with nil interruption or delay.
Assuntos
Humanos , Masculino , Feminino , Mama , Neoplasias da Mama , Neutropenia , Anemia , Trombocitopenia , Incidência , Ciclofosfamida , Tratamento FarmacológicoRESUMO
Objectives: To compare HIV care quality provided by non-physician clinicians (NPC) and physicians. Design: Retrospective cohort study assessing the relationship between provider cadre and HIV care quality among non-pregnant adult patients initiating antiretroviral therapy (ART) in the national HIV care programme. Methods: Computerized medical records from patients initiating ART between July 2004 and October 2007 at two HIV public HIV clinics in central Mozambique were used to develop multivariate analyses evaluating differences in process and care continuity measures for patients whose initial provider was a NPC or physician. Results: A total of 5892 patients was included in the study, including 4093 (69.5%) with NPC and 1799 (30.5%) with physicians as initial providers. Those whose initial provider was a NPC were more likely to have a CD4 cell count 90-210 days [risk ratio (RR) 1.13, 1.04Assuntos
Humanos
, Masculino
, Feminino
, Criança
, Adolescente
, Adulto
, Pessoa de Meia-Idade
, Médicos/classificação
, Assistentes Médicos/classificação
, Infecções por HIV/terapia
, Infecções por HIV/epidemiologia
, Contagem de Linfócito CD4
, Terapia Antirretroviral de Alta Atividade/instrumentação
, Moçambique
RESUMO
La escuela, la familia y la comunidad constituyen un instrumento esencial en la atención preventiva de los adolescentes. Con el objetivo de determinar los factores de riesgo psicosociales que inciden en el cumplimiento de los deberes escolares en los adolescentes del municipio Pinar del Río, se realizó una investigación observacional analítica de casos y controles de enero a diciembre de 2009. De las nueve escuelas secundarias básicas urbanas que existen, se seleccionó por muestreo aleatorio simple una, resultando la Escuela Secundaria Básica Urbana Combate de Bacunagua. De los 30 alumnos de octavo y noveno grado que incumplen con los deberes escolares participaron 22 y por cada uno de ellos se seleccionó dos controles del mismo sexo y aula de estudio. Los datos se recogieron en visita al hogar, se realizó una entrevista semi-estructurada, una guía de observación participativa y un cuestionario de preguntas a ambos grupos. Los datos obtenidos se procesaron, tabularon y representaron en tablas. El análisis estadístico se realizó a través del programa Epidat 3,0, por medio del test Ji cuadrado, la razón de productos cruzados de manera puntual y por intervalos de confianza. Como resultado se observó posible asociación causal entre adolescentes que incumplen los deberes escolares y presentan una familia con necesidades básicas insatisfechas, socialmente complejas, cuyos padres presentan actitudes inadecuadas ante el mal desempeño de los hijos y las relaciones afectivas inadecuadas en el hogar...(AU)
School, family and community constitute an essential instrument in the preventive care of adolescences. With the purpose of determining the psychosocial risk factors that influence on the fulfilment of school duties for adolescences in Pinar del Rio municipality, an observational-analytical research of case-control during January-December 2009 was conducted. Out of the nine (9) urban secondary schools (ESBU) one of them was chosen at simple random: Combate de Bacunagua. Out of the 30 pupils in eight and nine grades who did not fulfil the school duties, 22 participated in the research and for each of them two controls were performed with the same sex and classroom. Data were collected through home visits, semi-structured interview, observation-participative guide and a questionnaire were applied to both groups. Data collected were processed, tabulated and showed in tables. The statistical analysis was conducted by means of Epidat 3,0 program, using chi square test, crossed-punctual-product ratio and by intervals of confidence. Results: a possible causal association was found among adolescences without fulfilling school duties and having families with unsatisfied basic needs, where social complexity was observed; and whose parents presented inadequate attitudes towards the performance of their children in school with poor affective relationships in their homes...(AU)