Effectiveness of second-line anti-HER2 treatment in HER2-positive metastatic breast cancer patients previously treated with trastuzumab:A real-world study

Objective:Several studies have demonstrated different benefits for patients whose disease progressed despite previous trastuzumab treatment.Due to limited real-world data,we evaluate the effectiveness of anti-human epidermal growth factor receptor 2(HER2)therapy(lapatinib or trastuzumab)plus chemotherapy or chemotherapy alone in patients who were previously treated with trastuzumab-containing regimens and investigate factors associated with effectiveness.And we further show the effectiveness of the two anti-HER2 therapy groups.Methods:A total of 342 HER2-positive metastatic breast cancer(MBC)patients whose disease progressed during prior anti-HER2(trastuzumab)and standard chemotherapy therapy from Department of Breast Oncology,the Fifth Medical Center of Chinese PLA General Hospital,from August 2010 to December 2016 were included.Seventy-eight patients received standard chemotherapy only,148 patients continued to receive trastuzumab and switched to other chemotherapy drugs,and 116 patients received tyrosine-kinase inhibitors(TKIs;lapatinib)and chemotherapy.The main outcome measures were progression-free survival(PFS),overall response rate(ORR),and clinical benefit rate(CBR).Subgroup analyses were conducted to identify patient characteristics associated with the greatest clinical benefit.Results:After a median follow-up of 26.2(range,2.0-56.0)months,PFS significantly improved with anti-HER2 therapy compared with chemotherapy alone:median 6.0 months with lapatinib[95%confidence interval(95%CI),4.53-7.47],4.5 months with trastuzumab(95%CI,3.99-5.01)vs.3.0 months with chemotherapy alone(95%CI,2.42-3.58);stratified hazard ratio(HR)=0.70,95%CI,0.60-0.81;P<0.0001.The ORR values were 33.6%,25.0%and 12.8%,respectively,the CBR values were 60.3%,48.6%and 26.9%,respectively.The effectiveness of lapatinib group and trastuzumab group were further analyzed.In multivariate analysis,lapatinib group was associated with a longer PFS,after controlling other potential confounders(HR=0.68,95%CI,0.52-0.90;P=0.006).Conclusions:The combination of TKIs and chemotherapy was effective in this cohort previously treated with trastuzumab treatment.Therefore,TKIs combined with chemotherapy is an option for Chinese HER2-positive MBC patients previously treated with trastuzumab treatment.

Clinical manifestation,lifestyle,and treatment patterns of chronic erosive gastritis:A multicenter real-world study in China

BACKGROUND Although chronic erosive gastritis(CEG)is common,its clinical characteristics have not been fully elucidated.The lack of consensus regarding its treatment has resulted in varied treatment regimens.AIM To explore the clinical characteristics,treatment patterns,and short-term outcomes in CEG patients in China.METHODS We recruited patients with chronic non-atrophic or mild-to-moderate atrophic gastritis with erosion based on endoscopy and pathology.Patients and treating physicians completed a questionnaire regarding history,endoscopic findings,and treatment plans as well as a follow-up questionnaire to investigate changes in symptoms after 4 wk of treatment.RESULTS Three thousand five hundred sixty-three patients from 42 centers across 24 cities in China were included.Epigastric pain(68.0%),abdominal distension(62.6%),and postprandial fullness(47.5%)were the most common presenting symptoms.Gastritis was classified as chronic non-atrophic in 69.9%of patients.Among those with erosive lesions,72.1%of patients had lesions in the antrum,51.0%had multiple lesions,and 67.3%had superficial flat lesions.In patients with epigastric pain,the combination of a mucosal protective agent(MPA)and proton pump inhibitor was more effective.For those with postprandial fullness,acid regurgitation,early satiety,or nausea,a MPA appeared more promising.CONCLUSION CEG is a multifactorial disease which is common in Asian patients and has non-specific symptoms.Gastroscopy may play a major role in its detection and diagnosis.Treatment should be individualized based on symptom profile.

A Comparative Study of Metaheuristic Optimization Algorithms for Solving Real-World Engineering Design Problems

Real-world engineering design problems with complex objective functions under some constraints are relatively difficult problems to solve.Such design problems are widely experienced in many engineering fields,such as industry,automotive,construction,machinery,and interdisciplinary research.However,there are established optimization techniques that have shown effectiveness in addressing these types of issues.This research paper gives a comparative study of the implementation of seventeen new metaheuristic methods in order to optimize twelve distinct engineering design issues.The algorithms used in the study are listed as:transient search optimization(TSO),equilibrium optimizer(EO),grey wolf optimizer(GWO),moth-flame optimization(MFO),whale optimization algorithm(WOA),slimemould algorithm(SMA),harris hawks optimization(HHO),chimp optimization algorithm(COA),coot optimization algorithm(COOT),multi-verse optimization(MVO),arithmetic optimization algorithm(AOA),aquila optimizer(AO),sine cosine algorithm(SCA),smell agent optimization(SAO),and seagull optimization algorithm(SOA),pelican optimization algorithm(POA),and coati optimization algorithm(CA).As far as we know,there is no comparative analysis of recent and popular methods against the concrete conditions of real-world engineering problems.Hence,a remarkable research guideline is presented in the study for researchersworking in the fields of engineering and artificial intelligence,especiallywhen applying the optimization methods that have emerged recently.Future research can rely on this work for a literature search on comparisons of metaheuristic optimization methods in real-world problems under similar conditions.

Exploring the Path of Shantytown Renewal Based on the Theory of Environment-behavior Studies: A Case Study of the Northwest Area of Saihantala in Baotou City

The application of environment-behavior studies plays an important role in studying the renewal of shantytowns.One of the most humane ways of renewal is designing and constructing the necessary urban spatial environment from the perspective of human daily behavior.Most of the shantytown renovation projects currently carried out in China are mainly focused on demolition and reconstruction,which not only incurs high costs but also damages the original social structure and economic model.During the process of shantytown renewal,it should improve the urban landscape,living environment,and life quality of residents,and ensure the daily life of shantytown residents without increasing their economic burden,and preserve the traces of urban development.In order to achieve this goal,it should explore the renewal strategies of shantytowns from the perspective of environment-behavior studies through behavior maps,on-site research,and literature review.Updating and design from a human perspective often achieve faster and better development;the renewal of shantytowns should be a bottom-up approach and start from a grassroots perspective,completing the renovation design through the composition of the population and behavioral patterns.

Quantifying the natural growth rate of hepatocellular carcinoma:A real-world retrospective study in southwestern China

BACKGROUND In recent years,approximately half of the newly diagnosed cases and mortalities attributed to hepatocellular carcinoma(HCC)have been reported in China.Despite the high incidence of HCC,there remains a paucity of data regarding the natural growth pattern and the determination of optimal surveillance intervals specific to the Chinese population.AIM To quantify the natural tumor growth pattern of HCC in regional China.METHODS A retrospective analysis was performed on patients from a single institution in Southwest China who had undergone two or more serial dynamic computed tomography or magnetic resonance imaging scans between 2014 and 2020,without having received any anti-cancer therapy.Tumor growth was assessed using tumor volume doubling time(TVDT)and tumor growth rate(TGR),with volumes measured manually by experienced radiologists.Simple univariate linear regression and descriptive analysis were applied to explore associations between growth rates and clinical factors.RESULTS This study identifies the median TVDT for HCC as 163.4 d,interquartile range(IQR)72.1 to 302.3 d,with a daily TGR of 0.42%(IQR 0.206%-0.97%).HCC growth patterns reveal that about one-third of tumors grow indolently with TVDT exceeding 270 d,another one-third of tumors exhibit rapid growth with TVDT under 90 d,and the remaining tumors show intermediate growth rates,with TVDT ranging between 3 to 9 months.CONCLUSION The identified TGRs support biannual surveillance and follow-up for HCC patients in certain regions of China.Given the observed heterogeneity in HCC growth,further investigation is warranted.

Effectiveness of an amino acid beverage formulation in diarrheapredominant irritable bowel syndrome:A pragmatic real-world study

BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable bowel syndrome(IBS)is a gastrointestinal disorder that affects up to 9% of people globally,with diarrhea predominant IBS(IBS-D)being the most prevalent subtype.Further trials are needed to explore potential added benefits when integrated into standard care for IBS-D.AIM To assess the effectiveness of an amino acid-based medical food as an adjunct to standard of care for adults with IBS-D.METHODS This is a pragmatic,real world,open label,single arm study comparing a 2-week baseline assessment to a 2-week intervention period.One hundred adults,aged 18 to 65 years,with IBS-D,according to Rome IV criteria,were enrolled after completing a 2-week baseline assessment period and received a 2-week supply of an amino acid based medical food which was consumed at home twice daily on top of their standard of care.The primary outcome was an assessment of tolerability after 2-weeks of consumption,while secondary outcomes included changes in stool consistency(Bristol Stool Form Scale),severity of abdominal pain&discomfort,symptoms of urgency,Global Improvement Survey(GIS),and the IBS severity scoring system(IBS-SSS).RESULTS The test product was well-tolerated as each participant successfully completed the full 14-day trial,and there were no instances of dropouts or discontinuation of the study product reported.Forty percent of participants achieved a 50% or more reduction in the number of days with type 6-7 bowel movements(IBS-D stool consistency responders).Fifty-three percent of participants achieved a clinically meaningful reduction of 30% in mean weekly pain scores,and 55%experienced the same for mean weekly discomfort scores(IBS-D pain and discomfort responders).Participants experienced a mean-109.4(95% confidence interval:-130.1,-88.8)point reduction on the IBS-SSS and 52% experienced a minimally clinically important difference of>95 points.An IBS-SSS category shift from severe to moderate or mild occurred in 69% of participants.For functional symptoms,76% of participants reported symptom relief on the GIS.CONCLUSION The amino acid-based medical food was well-tolerated,when added to the standard of care,and demonstrated improvements in both overall IBS symptom severity and IBS-D symptoms within just 2 wk.

Real-world 10-year retrospective study of the guidelines for diagnosis and treatment of primary liver cancer in China

BACKGROUND Hepatocellular carcinoma(HCC) is a common malignant tumor worldwide. Many regions across the world have issued various HCC diagnosis and treatment protocols to improve the diagnosis and targeted treatment of patients with HCC. However, real-world studies analysing the practice, application value, and existing problems of the China Liver Cancer(CNLC) staging system are scarce.AIM To analyze the current situation and problems associated with the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China.METHODS We collected the medical records of all patients with HCC admitted to the First Affiliated Hospital of Zhengzhou University from January 1, 2011 to December 31, 2019, and recorded the hospitalization information of those patients until December 31, 2020. All information on the diagnosis and treatment of the target patients was recorded, and their demographic and sociological characteristics, CNLC stages, screening situations, and treatment methods and effects were analyzed. The survival status of the patients was obtained from follow-up data.RESULTS This study included the medical records of 3022 patients with HCC. Among these cases, 304 patients were screened before HCC diagnosis;their early-stage diagnosis rate was 69.08%, which was significantly higher than that of patients with HCC who were diagnosed without screening and early detection(33.74%). Herein, patients with no clinical outcome at discharge were followed up, and the survival information of 1128 patients was obtained. A Cox model was used to analyse independent risk factors affecting overall survival, which were revealed as age > 50 years, no screening, alpha-fetoprotein > 400 ng/mL, Child–Pugh grade B, and middle and late CNLC stages. Based on the Cox model survival analysis, in our study, patients with HCC identified via screening had significant advantages in overall and tumorfree survival after hepatectomy.CONCLUSION Early diagnosis and treatment can be achieved by screening groups at high risk for HCC based on the guidelines;however, real-world compliance is poor.

Real-World Study on the Treatment of Macular Edema in Central Retinal Vein Occlusion Using Traditional Chinese Medicine(TCM)and Its Medication Guidelines

Object:The aim is to evaluate how effective Traditional Chinese Medicine(TCM)is in treating patients who have central retinal vein occlusion with macular edema(CRVO-ME)in a real-world study.Furthermore,the objective of the research was to examine the TCM prescription trends in the management of CRVO-ME.Method:A single-center real-world study(RWS)was carried out over a span of 19 years,following the established design.The study encompassed 113 patients diagnosed with CRVO-ME.Out of these,74 patients received TCM treatment,while the remaining individuals underwent a combined therapy involving TCM and anti-VEGF drugs through intravitreal injection.The patients were matched using propensity score matching(PSM).The result measured in the RWS was BCVA.The oral prescriptions for CRVO-ME that led to observable and effective outcomes were collected.Excel and the TCM Inheritance Auxiliary Platform V2.5 were utilized to optimize mutual information,hierarchical clustering based on entropy,and other techniques to extract medication regulations and features.Result:After applying PSM,each group comprised 29 cases.Both groups exhibited improved BCVA following treatment;however,there was no statistically significant distinction in BCVA or effectiveness between the two groups(all P>0.05).Apart from the analysis of oral prescriptions for CRVO-ME,the investigation pinpointed the most frequently used TCMs,namely Flos Carthami,Semen Persicae,Radix Angelica sinensis,Radix Rehmanniae,and Radix et Rhizoma Notoginseng.Frequently utilized medications tended to possess cold,warm,or mild attributes and exhibited a taste profile that was either bitter or sweet.The primary meridians associated with the medicines employed in treating CRVO-ME were liver,spleen,stomach,heart,and lung.Through the application of association rule analysis,it was discerned that there were 195 commonly employed combinations of medicines.Additionally,a complex system entropy cluster analysis unveiled 13 key combinations of medicines.By employing an unsupervised entropy hierarchical clustering analysis,a novel prescription was formulated.Conclusion:Within a real-world population of CRVO-ME patients,TCM exhibited its effectiveness.The treatment approach for CRVO-ME predominantly involved the regulation of qi(Qi is an exceedingly subtle substance within the human body,brimming with vitality and ceaseless motion.It constitutes the fundamental element that shapes and sustains the various processes of human life.)and blood as well as the resolution of dampness.The oral prescriptions frequently targeted the meridians of liver,spleen,stomach,heart,and lungs.

Acupuncture for stroke cohort construction:a protocol describing a multicenter,prospective,real-world cohort construction study

Background:Acupuncture for stroke has been endorsed by the World Health Organization,and the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018 lists acupuncture for stroke as a Level II recommendation with Level B evidence.The efficacy of acupuncture in the treatment of acute ischaemic stroke needs to be approved by more high-quality studies.However,there are currently no real-world studies of acupuncture for stroke.Methods:Stroke patients who meet the study criteria and are hospitalized from February 2021 to March 2022 in 23 medical institutions across China,including the First Teaching Hospital of Tianjin University of Chinese Medicine.The number of patients planned to be recruited is 3,000.Due to the impact of COVID-19,we have applied to the competent authorities for an extension(recruit patients until December 2022).Basic patient information and treatment information will be registered at admission,at discharge,and on the following dates after the onset of the disease:90±7 days,180±7 days,and 360±7 days after the onset of the disease.Establish a database for statistical analysis.Discussion:This study proposes to conduct a prospective cohort study of acupuncture intervention for stroke in a real-world medical setting.Analysis of the effect pattern of acupuncture intervention on the recovery of neurological function system and swallowing disorder in stroke patients.Evaluate the long-term effects of acupuncture intervention for stroke and recurrence of cardiovascular and cerebrovascular events.

Epidemiological and clinical features,treatment status,and economic burden of traumatic spinal cord injury in China:a hospital-based retrospective study

Traumatic spinal cord injury is potentially catastrophic and can lead to permanent disability or even death.China has the largest population of patients with traumatic spinal cord injury.Previous studies of traumatic spinal cord injury in China have mostly been regional in scope;national-level studies have been rare.To the best of our knowledge,no national-level study of treatment status and economic burden has been performed.This retrospective study aimed to examine the epidemiological and clinical features,treatment status,and economic burden of traumatic spinal cord injury in China at the national level.We included 13,465 traumatic spinal cord injury patients who were injured between January 2013 and December 2018 and treated in 30 hospitals in 11 provinces/municipalities representing all geographical divisions of China.Patient epidemiological and clinical features,treatment status,and total and daily costs were recorded.Trends in the percentage of traumatic spinal cord injuries among all hospitalized patients and among patients hospitalized in the orthopedic department and cost of care were assessed by annual percentage change using the Joinpoint Regression Program.The percentage of traumatic spinal cord injuries among all hospitalized patients and among patients hospitalized in the orthopedic department did not significantly change overall(annual percentage change,-0.5%and 2.1%,respectively).A total of 10,053(74.7%)patients underwent surgery.Only 2.8%of patients who underwent surgery did so within 24 hours of injury.A total of 2005(14.9%)patients were treated with high-dose(≥500 mg)methylprednisolone sodium succinate/methylprednisolone(MPSS/MP);615(4.6%)received it within 8 hours.The total cost for acute traumatic spinal cord injury decreased over the study period(-4.7%),while daily cost did not significantly change(1.0%increase).Our findings indicate that public health initiatives should aim at improving hospitals’ability to complete early surgery within 24 hours,which is associated with improved sensorimotor recovery,increasing the awareness rate of clinical guidelines related to high-dose MPSS/MP to reduce the use of the treatment with insufficient evidence.

Causal associations between gastroesophageal reflux disease and essential hypertension: A bidirectional Mendelian randomization study

BACKGROUND Clinical studies have reported that patients with gastroesophageal reflux disease(GERD)have a higher prevalence of hypertension.AIM To performed a bidirectional Mendelian randomization(MR)analysis to investi-gate the causal link between GERD and essential hypertension.METHODS Eligible single nucleotide polymorphisms(SNPs)were selected,and weighted median,inverse variance weighted(IVW)as well as MR egger(MR-Egger)re-gression were used to examine the potential causal association between GERD and hypertension.The MR-Pleiotropy RESidual Sum and Outlier analysis was used to detect and attempt to reduce horizontal pleiotropy by removing outliers SNPs.The MR-Egger intercept test,Cochran’s Q test and“leave-one-out”sen-sitivity analysis were performed to evaluate the horizontal pleiotropy,heterogen-eities,and stability of single instrumental variable.RESULTS IVW analysis exhibited an increased risk of hypertension(OR=1.46,95%CI:1.33-1.59,P=2.14E-16)in GERD patients.And the same result was obtained in replication practice(OR=1.002,95%CI:1.0008-1.003,P=0.000498).Meanwhile,the IVW analysis showed an increased risk of systolic blood pressure(β=0.78,95%CI:0.11-1.44,P=0.021)and hypertensive heart disease(OR=1.68,95%CI:1.36-2.08,P=0.0000016)in GERD patients.Moreover,we found an decreased risk of Barrett's esophagus(OR=0.91,95%CI:0.83-0.99,P=0.043)in essential hypertension patients.CONCLUSION We found that GERD would increase the risk of essential hypertension,which provided a novel prevent and therapeutic perspectives of essential hypertension.

Real-world efficacy and safety of tofacitinib treatment in Asian patients with ulcerative colitis

BACKGROUND Real-world data on tofacitinib(TOF)covering a period of more than 1 year for a sufficient number of Asian patients with ulcerative colitis(UC)are scarce.AIM To investigate the long-term efficacy and safety of TOF treatment for UC,including clinical issues.METHODS We performed a retrospective single-center observational analysis of 111 UC patients administered TOF at Hyogo Medical University as a tertiary inflammatory bowel disease center.All consecutive UC patients who received TOF between May 2018 and February 2020 were enrolled.Patients were followed up until August 2020.The primary outcome was the clinical response rate at week 8.Secondary outcomes included clinical remission at week 8,cumulative persistence rate of TOF administration,colectomy-free survival,relapse after tapering of TOF and predictors of clinical response at week 8 and week 48.RESULTS The clinical response and remission rates were 66.3%and 50.5%at week 8,and 47.1%and 43.5%at week 48,respectively.The overall cumulative clinical remission rate was 61.7%at week 48 and history of anti-tumor necrosis factor-alpha(TNF-α)agents use had no influence(P=0.25).The cumulative TOF persistence rate at week 48 was significantly lower in patients without clinical remission than in those with remission at week 8(30.9%vs 88.1%;P<0.001).Baseline partial Mayo Score was significantly lower in responders vs non-responders at week 8(odds ratio:0.61,95%confidence interval:0.45-0.82,P=0.001).Relapse occurred in 45.7%of patients after TOF tapering,and 85.7%of patients responded within 4 wk after re-increase.All 6 patients with herpes zoster(HZ)developed the infection after achieving remission by TOF.CONCLUSION TOF was more effective in UC patients with mild activity at baseline and its efficacy was not affected by previous treatment with anti-TNF-αagents.Most relapsed patients responded again after re-increase of TOF and nearly half relapsed after tapering off TOF.Special attention is needed for tapering and HZ.

Performance evaluation of seven multi-label classification methods on real-world patent and publication datasets

Purpose:Many science,technology and innovation(STI)resources are attached with several different labels.To assign automatically the resulting labels to an interested instance,many approaches with good performance on the benchmark datasets have been proposed for multi-label classification task in the literature.Furthermore,several open-source tools implementing these approaches have also been developed.However,the characteristics of real-world multi-label patent and publication datasets are not completely in line with those of benchmark ones.Therefore,the main purpose of this paper is to evaluate comprehensively seven multi-label classification methods on real-world datasets.Research limitations:Three real-world datasets differ in the following aspects:statement,data quality,and purposes.Additionally,open-source tools designed for multi-label classification also have intrinsic differences in their approaches for data processing and feature selection,which in turn impacts the performance of a multi-label classification approach.In the near future,we will enhance experimental precision and reinforce the validity of conclusions by employing more rigorous control over variables through introducing expanded parameter settings.Practical implications:The observed Macro F1 and Micro F1 scores on real-world datasets typically fall short of those achieved on benchmark datasets,underscoring the complexity of real-world multi-label classification tasks.Approaches leveraging deep learning techniques offer promising solutions by accommodating the hierarchical relationships and interdependencies among labels.With ongoing enhancements in deep learning algorithms and large-scale models,it is expected that the efficacy of multi-label classification tasks will be significantly improved,reaching a level of practical utility in the foreseeable future.Originality/value:(1)Seven multi-label classification methods are comprehensively compared on three real-world datasets.(2)The TextCNN and TextRCNN models perform better on small-scale datasets with more complex hierarchical structure of labels and more balanced document-label distribution.(3)The MLkNN method works better on the larger-scale dataset with more unbalanced document-label distribution.

Recent progresses in the development of tubular segmented-in-series solid oxide fuel cells:Experimental and numerical study

Solid oxide fuel cells(SOFCs)have attracted a great deal of interest because they have the highest efficiency without using any noble metal as catalysts among all the fuel cell technologies.However,traditional SOFCs suffer from having a higher volume,current leakage,complex connections,and difficulty in gas sealing.To solve these problems,Rolls-Royce has fabricated a simple design by stacking cells in series on an insulating porous support,resulting in the tubular segmented-in-series solid oxide fuel cells(SIS-SOFCs),which achieved higher output voltage.This work systematically reviews recent advances in the structures,preparation methods,perform-ances,and stability of tubular SIS-SOFCs in experimental and numerical studies.Finally,the challenges and future development of tubular SIS-SOFCs are also discussed.The findings of this work can help guide the direction and inspire innovation of future development in this field.

A hierarchical enhanced data-driven battery pack capacity estimation framework for real-world operating conditions with fewer labeled data

Battery pack capacity estimation under real-world operating conditions is important for battery performance optimization and health management,contributing to the reliability and longevity of batterypowered systems.However,complex operating conditions,coupling cell-to-cell inconsistency,and limited labeled data pose great challenges to accurate and robust battery pack capacity estimation.To address these issues,this paper proposes a hierarchical data-driven framework aimed at enhancing the training of machine learning models with fewer labeled data.Unlike traditional data-driven methods that lack interpretability,the hierarchical data-driven framework unveils the“mechanism”of the black box inside the data-driven framework by splitting the final estimation target into cell-level and pack-level intermediate targets.A generalized feature matrix is devised without requiring all cell voltages,significantly reducing the computational cost and memory resources.The generated intermediate target labels and the corresponding features are hierarchically employed to enhance the training of two machine learning models,effectively alleviating the difficulty of learning the relationship from all features due to fewer labeled data and addressing the dilemma of requiring extensive labeled data for accurate estimation.Using only 10%of degradation data,the proposed framework outperforms the state-of-the-art battery pack capacity estimation methods,achieving mean absolute percentage errors of 0.608%,0.601%,and 1.128%for three battery packs whose degradation load profiles represent real-world operating conditions.Its high accuracy,adaptability,and robustness indicate the potential in different application scenarios,which is promising for reducing laborious and expensive aging experiments at the pack level and facilitating the development of battery technology.

Pharmacodynamic Study of Parallel Groups Comparing the Effect of Rivaroxaban 20 Mg (Laboratorios Leti, S.A.V.) vs Rivaroxaban 20 Mg (Bayer Laboratories) on Prothrombin Time

Background: The prevalence of both atrial fibrillation (FA) and diabetes mellitus (DM) is increasing and they often occur together and constitute a high risk of thrombosis. Rivaroxaban is a Factor Xa inhibitor with a rapid onset and disappearance of action after oral administration;it acts by inhibiting the active form of the coagulation factor. In order to reflect the effect of the action of Rivaroxaban, we used the prothrombin time (PT);however, it′s not the most accurate, but it is the one available in our community. Methods: This was a prospective, randomized, analyst-blinded, parallel group clinical study to verify the efficacy of Rivaroxaban Leti 20 mg (RL) (12 volunteers vs Rivaroxaban Bayer 20 mg (RB) (13 volunteers). The variables were determination of PT and Partial Thromboplastin Time (aPTT) at baseline and at 24, 48 and 72 hours after administering a daily dose of 20 mg for three days. The determination was carried out with the IDG method (Integrated Diagnostics Group Sanzay Corporation) with an International Sensitivity Index (ISI) of 1.17 PT and aPTT were taken before the first dose, and then, every day during the next 3 days, three hours after the ingestion of their daily dose at 7 am. Results: The 25 healthy volunteers were similar in age, BMI, and SBP/DBP level with a greater number of men in the Bayer group. The efficacy of rivaroxaban was similar in both groups with prolongation of PTT to the 2nd day of treatment with PT, and percentage changes from baseline (14.46 ± 0.97 for RB vs 14.17 ± 0.94 RL p: 0.45), PTT results and percentage changes from the base (RB: 34 ± 4.53 RL: 33.46 ± 2.82). The safety of rivaroxaban was good in both groups with no serious adverse events. The equivalence in the logarithmically transformed PT result (ln) on day two, Mean and CI (90%) 99.2 (94.4-104) and 100 (99.5-100.8);neither the means nor the 90% confidence intervals of the PT variable transformed logarithmically to ensure its normality, were far from the 80%-125% allowed for declaration of similarity. Conclusion: The test formulation Rivaroxaban Asarap? 20 mg, manufactured by Leti Laboratories, is interchangeable or bioequivalent in clinical and laboratory response to the reference formulation Xarelto? manufactured by Bayer Laboratories.

Dyslipidemia in Adults with Type 2 Diabetes in a Rural Community in Ganadougou, Mali: A Cross-Sectional Study

Dyslipidemia is a disorder where abnormally lipid concentrations circulate in the bloodstream. The disorder is common in type 2 diabetics (T2D) and is linked with T2D comorbidities, particularly cardiovascular disease. Dyslipidemia in T2D is typically characterized by elevated plasma triglyceride and low high-density lipoprotein cholesterol (HDL-C) levels. There is a significant gap in the literature regarding dyslipidemia in rural parts of Africa, where lipid profiles may not be captured through routine surveillance. This study aimed to characterize the prevalence and demo-graphic profile of dyslipidemia in T2D in the rural community of Ganadougou, Mali. We performed a cross-sectional study of 104 subjects with T2D in Ganadougou between November 2021 and March 2022. Demographic and lipid profiles were collected through cross-sectional surveys and serological analyses. The overall prevalence of dyslipidemia in T2D patients was 87.5% (91/104), which did not differ by sex (P = .368). High low-density lipoprotein cholesterol (LDL-C) was the most common lipid abnormality (78.9%, [82/104]). Dyslipidemia was associated with age and hypertension status (P = .013 and.036, respectively). High total and high LDL-C parameters were significantly associated with hypertension (P = .029 and .006, respectively). In low-resource settings such as rural Mali, there is a critical need to improve infrastructure for routine dyslipidemia screening to guide its prevention and intervention approaches. The high rates of dyslipidemia observed in Gandadougou, consistent with concomitant increases in cardiovascular diseases in Africa suggest that lipid profile assessments should be incorporated into routine medical care for T2D patients in African rural settings.

Ganoderma lucidum:a comprehensive review of phytochemistry,efficacy,safety and clinical study

Ganoderma lucidum,one of the most well-known edible fungi,is believed to be very beneficial for longevity and vitality.A long usage history suggests that G.lucidum has various clinical therapeutic effects.And experimental studies have confirmed that G.lucidum has multiple pharmacological effects,including antitumor,anti-microbial,anti-HIV protease,and antidiabetic activity and so on.With the deepening of research,more than 300 compounds have been isolated from G.lucidum.There is an increasing population of G.lucidum-based products,and its international development is expanding.Currently,G.lucidum has drawn much attention to its chemical composition,therapeutic effect,clinical value,and safety.This paper provides a comprehensive review of these aspects to enhance the global promotion of G.lucidum.

Mental health and insomnia problems in healthcare workers after the COVID-19 pandemic:A multicenter cross-sectional study

BACKGROUND Healthcare workers(HCWs)are at increased risk of contracting coronavirus disease 2019(COVID-19)as well as worsening mental health problems and insomnia.These problems can persist for a long period,even after the pandemic.However,less is known about this topic.AIM To analyze mental health,insomnia problems,and their influencing factors in HCWs after the COVID-19 pandemic.METHODS This multicenter cross-sectional,hospital-based study was conducted from June 1,2023 to June 30,2023,which was a half-year after the end of the COVID-19 emergency.Region-stratified population-based cluster sampling was applied at the provincial level for Chinese HCWs.Symptoms such as anxiety,depression,and insomnia were evaluated by the Generalized Anxiety Disorder-7,Patient Health Questionnaire-9,and Insomnia Severity Index.Factors influencing the symptoms were identified by multivariable logistic regression.RESULTS A total of 2000 participants were invited,for a response rate of 70.6%.A total of 1412 HCWs[618(43.8%)doctors,583(41.3%)nurses and 211(14.9%)nonfrontline],254(18.0%),231(16.4%),and 289(20.5%)had symptoms of anxiety,depression,and insomnia,respectively;severe symptoms were found in 58(4.1%),49(3.5%),and 111(7.9%)of the participants.Nurses,female sex,and hospitalization for COVID-19 were risk factors for anxiety,depression,and insomnia symptoms;moreover,death from family or friends was a risk factor for insomnia symptoms.During the COVID-19 outbreak,most[1086(76.9%)]of the participating HCWs received psychological interventions,while nearly all[994(70.4%)]of them had received public psychological education.Only 102(7.2%)of the HCWs received individual counseling from COVID-19.CONCLUSION Although the mental health and sleep problems of HCWs were relieved after the COVID-19 pandemic,they still faced challenges and greater risks than did the general population.Identifying risk factors would help in providing targeted interventions.In addition,although a major proportion of HCWs have received public psychological education,individual interventions are still insufficient.

Real-World Evidence in Localized Pancreatic: Coping with Uncertainty in Unselected Populations

Background: Localized pancreatic cancer, including resectable (R), borderline resectable (BR) and locally advanced unresectable disease (LAU), is considered in clinical guidelines for diverse treatment options based on clinical trials in selected populations. Hence, exploring with real world evidence (RWE) clinicians’ preferences for treatment options and their results seems pertinent. Methods: In a set of consecutive patients with localized pancreatic cancer assisted in a third level hospital from January 2013 to December 2022, medical records, symptoms, diagnostic process, distribution between subtypes, and treatment plans, with safety and efficacy results, were assessed. Results: A total of 152 patients with localized disease were included (43.4% R, 21.0% BR, 33.6% LAU). The population characteristics exemplified differences between daily practice and clinical trials. Tumor location and symptoms were as expected. Treatment plan was conditioned by PS or comorbidities in 23.0% of patients. In patients with R disease, surgery followed by different adjuvant chemotherapy (CT) regimes was the antineoplastic treatment of choice (64.8%) with efficacy results (OS 37.5 months;95% CI 18.4 - 56.7), in the range of contemporary standards. The common use of neoadjuvant CT for BR disease (94.4%), with surgery in 50% of them, and its results (OS 30.8 months;95% CI 10.5 - 51.2) reflected current controversies of treatment recommendations and evolution in this scenario. Paliative CT with or without radiotherapy was the standard specific treatment in LAU disease (95.1%) with survival results (PFS: 10.8 months;95% CI 8.8 - 12.7. OS: 20.3 months;95% CI 13.5 - 27.2) that justify the distinct character and the specific study of this entity. Conclusion: RWE for localized pancreatic cancer aroused from the analysis of this population confirms the distinct nature of patients assisted in daily practice, as well as mirrors the complexity of decision making in clinical assumptions in which achieving stronger evidence should be paramount.