美国食品药物管理总局(FOOD AND DRUG ADMINISTRATION,简称 FDA)情况简介

FDA是美联邦政府卫生部(DEPARTMENT OF HEALTH AND HUMAN SERVICE简称DHHS直译应为卫生及人类服务部,实即卫生部及有关福利事宜)下的直属机构。是对食品及药物等方面制定规范及进行管理的权威性机关。FDA除主要对食品、药物外还包括有生物制品,化妆品及医疗设施等的管理,与农业部(负责肉类、疏菜、水果的管理)、环境保护局(E.P.A)(负责空气、饮水、废弃物、农药、毒品等的管理)分工统管环境中的化学物。它们都是以立法为根据的代表政府的执法机关。 FDA的前身为化学部(DEPARTMENT OF CHEMLSTRY)建于1906年。现有工作人员约8。

Evaluation of Mass Drug Administration Impact on Transmission of Lymphatic Filariasis in 13 Sanitary Districts in Burkina Faso

Introduction: Lymphatic filariasis (LF) is one of the neglected tropical diseases targeted for elimination as a public health issue in the world by 2020. To achieve this goal, one of the strategies is interruption of transmission using chemotherapy (mass drug administration). Burkina Faso in west Africa, an endemic country, has endorsed this resolution. In 2000, all Sanitary Districts (SD) in the country were endemic, and then a national elimination program has made it possible to stop mass treatment in 45 out of 70 SD over 12 years. Sixteen years later, 13 other SD were reeligible for Transmission Assessment Surveys (TAS). This study aimed to determine the current level of the Mass drugs Administration (MDA) impact indicators in these 13 targeted SD in order to decide whether we need to continue MDA. Method: It was a descriptive study that took place from June to September 2017 in 13 SD regrouped into 7 Evaluation Units (EU). The population of the study was 6 to 7 years old children. The community-based cluster survey method was used. The diagnostic test used to detect Wuchereria bancrofti’s circulating antigen (W. bancrofti) is the Filariasis Test Strip (FTS). The critical threshold of positivity was set at 18 positive subjects per EU. Results: We sampled a total of 12,060 children, 48.9% were female and 51.1% male. In the 7 EU, 13 children were positive to W. bancrofti test. The average antigenic prevalence was 0.11% (13/12,060). In all EU, the number of positive subjects was below the critical threshold. Conclusion: At the end of this evaluation of the transmission of lymphatic filariasis in 13 SD of Burkina Faso, we can tell the MDA could be stopped in these areas without risk of resurgence of the disease, according to the current recommendations of WHO. This can be possible by setting up post-TMM surveillance, considering migratory flows, and including villages where positive cases were found to search possible residual transmission zones.

Work Hard to Ensure Food,Drugs Safety for the People——An interview with Shao Mingli,director-general of the State Food and Drug Administration(SFDA)

Following is an interview given by Shao Mingli, director-general of China＇s State Food and Drug Administration to our reporter on what is being done to ensure food and drug safety in China. As everybody knows, food and drug safety is vital to people＇s lives.

Prevalence of epilepsy in the onchocerciasis endemic middle belt of Ghana after 27 years of mass drug administration with ivermectin

BackgroundIn onchocerciasis-endemic areas with high ongoing Onchocerca volvulus transmission,a high prevalence of epilepsy has been reported.This study aimed to determine the prevalence and clinical characteristics of epilepsy in the Bono Region of Ghana following 27 years of implementation of ivermectin mass drug administration(MDA).MethodsBetween October 2020 and August 2021,cross-sectional surveys were conducted in nine communities in the Tain District and Wenchi Municipality of the Bono Region of Ghana.In the first stage,a random door-to-door approach was used to screen the population for epilepsy using a pre-tested questionnaire.Persons suspected of having epilepsy were invited for a second-stage neurological examination for case verification.Community O.volvulus microfilarial infection status and Ov16 seropositivity were also determined.Ninety-five confidence intervals(95%CI)for prevalence values were calculated using the Wilson Score Interval.ResultsOf the 971 participants,500(51.5%)were females,and the median age(interquartile range)was 26(15‒43)years.Fourteen participants(1.4%,95%CI:1.0‒2.0)were diagnosed as having epilepsy with generalized seizures being the most frequent seizure type(85.7%,12/14).The overall microfilarial prevalence of O.volvulus was 10.3%(November 2020)and 9.9%(August 2021);the Ov16 seroprevalence was 22.2%(June 2021).Only 63.2%took ivermectin in the last round of MDA distribution in March 2021.ConclusionsThe 1.4%prevalence of epilepsy in the Bono region is similar to the median epilepsy prevalence in sub-Saharan Africa.However,the persistent microfilarial prevalence and low ivermectin study coverage call for the Ghana Onchocerciasis Elimination Programme to step up its efforts to ensure that the gains achieved are consolidated and improved to achieve the elimination of onchocerciasis by 2030.

Impact of five annual rounds of mass drug administration with ivermectin on onchocerciasis in Sierra Leone

Background:Onchocerciasis is endemic in 12 of the 14 health districts of Sierra Leone.Good treatment coverage of community-directed treatment with ivermectin was achieved between 2005 and 2009 after the 11-year civil conflict.Sentinel site surveys were conducted in 2010 to evaluate the impact of five annual rounds of ivermectin distribution.Methods:In total,39 sentinel villages from hyper-and meso-endemic areas across the 12 endemic districts were surveyed using skin snips in 2010.Results were analyzed and compared with the baseline data from the same 39 villages.Results:The average microfilaridermia(MF)prevalence across 39 sentinel villages was 53.10%at baseline.The MF prevalence was higher in older age groups,with the lowest in the age group of 1-9 years(11.00%)and the highest in the age group of 40-49 years(82.31%).Overall mean MF density among the positives was 28.87 microfilariae(mf)/snip,increasing with age with the lowest in the age group of 1-9 years and the highest in the age group of 40-49 years.Males had higher MF prevalence and density than females.In 2010 after five rounds of mass drug administration,the overall MF prevalence decreased by 60.26%from 53.10%to 21.10%;the overall mean MF density among the positives decreased by 71.29%from 28.87 mf/snip to 8.29 mf/snip;and the overall mean MF density among all persons examined decreased by 88.58%from 15.33 mf/snip to 1.75 mf/snip.Ten of 12 endemic districts had>50%reduction in MF prevalence.Eleven of 12 districts had≥50%reduction in mean MF density among the positives.Conclusions:A significant reduction of onchocerciasis MF prevalence and mean density was recorded in all 12 districts of Sierra Leone after five annual MDAs with effective treatment coverage.The results suggested that the onchocerciasis elimination programme in Sierra Leone was on course to reach the objective of eliminating onchocerciasis in the country by the year 2025.Annual MDA with ivermectin should continue in all 12 districts and further evaluations are needed across the country to assist the NTDP with programme decision making.

Lymphatic filariasis, infection status in Culex quinquefasciatus and Anopheles species after six rounds of mass drug administration in Masasi District, Tanzania

Background:Lymphatic filariasis(LF)elimination program in Tanzania started in 2000 in response to the Global program for the elimination of LF by 2020.Evidence shows a persistent LF transmission despite more than a decade of mass drug administration(MDA).It is advocated that,regular monitoring should be conducted in endemic areas to evaluate the progress towards elimination and detect resurgence of the disease timely.This study was therefore designed to assess the status of Wuchererio bancrofti infection in Culex quinqefasciatus and Anopheles species after six rounds of MDA in Masasi District,South Eastern Tanzania.

Uses of mathematical modeling to estimate the impact of mass drug administration of antibiotics on antimicrobial resistance within and between communities

Background: Antibiotics are a key part of modern healthcare,but their use has downsides,including selecting for antibiotic resistance,both in the individuals treated with antibiotics and in the community at large.When evaluating the benefits and costs of mass administration of azithromycin to reduce childhood mortality,effects of antibiotic use on antibiotic resistance are important but difficult to measure,especially when evaluating resistance that“spills over”from antibiotic-treated individuals to other members of their community.The aim of this scoping review was to identify how the existing literature on antibiotic resistance modeling could be better leveraged to understand the effect of mass drug administration(MDA)on antibiotic resistance.Main text: Mathematical models of antibiotic use and resistance may be useful for estimating the expected effects of different MDA implementations on different populations,as well as aiding interpretation of existing data and guiding future experimental design.Here,strengths and limitations of models of antibiotic resistance are reviewed,and possible applications of those models in the context of mass drug administration with azithromycin are discussed.Conclusions: Statistical models of antibiotic use and resistance may provide robust and relevant estimates of the possible effects of MDA on resistance.Mechanistic models of resistance,while able to more precisely estimate the effects of different implementations of MDA on resistance,may require more data from MDA trials to be accurately parameterized.

Mass drug administration for lymphatic filariasis elimination in a coastal state of India: a study on barriers to coverage and compliance

Background:Lymphatic filariasis is targeted for elimination in India through mass drug administration(MDA)with diethylcarbamazine(DEC)combined with albendazole(ABZ).For the strategy to be effective,>65%of those living in endemic areas must be covered by and compliant to MDA.Post the MDA 2011 campaign in the endemic district of Odisha,we conducted a survey to assess:(i)the filariasis knowledge in the community,(ii)the coverage and compliance of MDA from the community perspective,and(iii)factors affecting compliance,as well as the operational issues involved in carrying out MDA activities from the drug distributor’s perspective.Methods:A sample of 691 participants-both male and female,aged two years or above-were selected through multistage stratified sampling and interviewed using a semi-structured questionnaire.Additionally,drug distributors and the medical officers in charge of the MDA were also interviewed to understand some of the operational issues encountered during MDA.Results:Ninety-nine percent of the study participants received DEC and ABZ tablets during MDA,of which only just above a quarter actually consumed the drugs.The cause of non-compliance was mostly due to fear of side effects,lack of awareness of the benefits of MDA,and non-attendance of health staff in the villages.Lack of adequate training of drug distributors and poor health communication activities before the MDA campaign commenced and the absence of follow-up by health workers following MDA were a few of the operational difficulties encountered during the MDA campaign.Conclusion:Currently MDA is restricted to the distribution of drugs only and the key issues of implementation in compliance,health education,managing side effects,and logistics are not given enough attention.It is therefore essential to address the issues linked to low compliance to make the program more efficient and achieve the goal of filariasis elimination.

Effectiveness of azithromycin mass drug administration on trachoma:a systematic review

Backgrounds:Azithromycin mass drug administration(MDA)is a key part of the strategy for controlling trachoma.This systematic review aimed to comprehensively summarize the present studies of azithromycin MDA on trachoma;provide an overview of the impact of azithromycin MDA on trachoma in different districts;and explore the possible methods to enhance the effectiveness of azithromycin MDA in hyperendemic districts.Methods:PubMed,Embase,the Cochrane Central Register of Controlled Trials,Web of Science,and ClinicalTrials.gov were searched up to February 2021 with no language restriction.Studies reporting the effect of azithromycin MDA on trachoma were included.Mathematical modeling studies,animal studies,case reports,and reviews were excluded.The trachomatous inflammation-follicular(TF)<5.0%was used to judge the effect of azithromycin MDA on eliminating trachoma as a public health problem.Two researchers independently conducted the selection process and risk of bias assessment.Results:A total of 1543 studies were screened,of which 67 studies including 13 cluster-randomized controlled trials and 54 non-randomized studies were included.The effect of azithromycin MDA on trachoma was closely related to the baseline prevalence in districts.For the districts with baseline prevalence between 5.0%and 9.9%,a single round of MDA achieved a TF<5.0%.For the districts with baseline between 10.0%and 29.9%,annual MDA for 3 to 5 years reduced TF<5.0%.However,for the districts with high level of baseline prevalence(TF>30.0%),especially with baseline TF>50.0%,annual MDA was unable to achieve the TF<5.0%even after 5 to 7 years of treatment.Quarterly MDA is more effective in controlling trachoma in these hyperendemic districts.Conclusions:Azithromycin MDA for controlling trachoma depends on the baseline prevalence.The recommendation by the World Health Organization that annual MDA for 3 to 5 years in the districts with TF baseline>10.0%is not appropriate for all eligible districts.

Lymphatic filariasis elimination endgame in an urban Indian setting: the roles of surveillanee and residual microfilaremia after mass drug administration

Background:To secure the gains of lymphatic filariasis(LF)elimination programs,attention is needed to the Yesidual microfilaremia phase;in which high-risk populations may be crucial.The present study documents the impact of mass drug administration(MDA)in the urban Indian setting of Surat City,with high rates of in-migration.

Ethical challenges in mass drug administration for reducing childhood mortality:a qualitative study

Background:Mass drug administration(MDA)of medications to entire at-risk communities or populations has shown promise in the control and elimination of global infectious diseases.MDA of the broad-spectrum antibiotic azithromycin has demonstrated the potential to reduce childhood mortality in children at risk of premature death in some global settings.However,MDA of antibiotics raises complex ethical challenges,including weighing near-term benefts against longer-term risks—particularly the development of antimicrobial resistance that could diminish antibiotic efectiveness for current or future generations.The aim of this study was to understand how key actors involved in MDA perceive the ethical challenges of MDA.Methods:We conducted 35 semi-structured interviews from December 2020–February 2022 with investigators,funders,bioethicists,research ethics committee members,industry representatives,and others from both highincome countries(HICs)and low-and middle-income countries(LMICs).Interview participants were identifed via one of seven MDA studies purposively chosen to represent diversity in terms of use of the antibiotic azithromycin;use of a primary mortality endpoint;and whether the study occurred in a high child mortality country.Data were analyzed using constructivist grounded theory methodology.Results:The most frequently discussed ethical challenges related to meaningful community engagement,how to weigh risks and benefts,and the need to target MDA We developed a concept map of how participants considered ethical issues in MDA for child mortality;it emphasizes MDA’s place alongside other public health interventions,empowerment,and equity.Concerns over an ethical double standard in weighing risks and benefts emerged as a unifying theme,albeit one that participants interpreted in radically diferent ways.Some thought MDA for reducing child mortality was ethically obligatory;others suggested it was impermissible.Conclusions:Ethical challenges raised by MDA of antibiotics for childhood mortality-which span socio-cultural issues,the environment,and efects on future generations-require consideration beyond traditional clinical trial review.The appropriate role of MDA also requires attention to concerns over ethical double standards and power dynamics in global health that afect how we view antibiotic use in HICs versus LMICs.Our fndings suggest the need to develop additional,comprehensive guidance on managing ethical challenges in MDA.

Mass drug administration of antibacterials: weighing the evidence regarding benefits and risks

Background: Mass drug administration(MDA)is a strategy to improve health at the population level through widespread delivery of medicine in a community.We surveyed the literature to summarize the benefits and potential risks associated with MDA of antibacterials,focusing predominantly on azithromycin as it has the greatest evidence base.Main body: High-quality evidence from randomized controlled trials(RCTs)indicate that MDA-azithromycin is effective in reducing the prevalence of infection due to yaws and trachoma.In addition,RCTs suggest that MDA-azithromycin reduces under-five mortality in certain low-resource settings that have high childhood mortality rates at baseline.This reduction in mortality appears to be sustained over time with twice-yearly MDA-azithromycin,with the greatest effect observed in children<1 year of age.In addition,observational data suggest that infections such as skin and soft tissue infections,rheumatic heart disease,acute respiratory illness,diarrheal illness,and malaria may all be treated by azithromycin and thus incidentally impacted by MDA-azithromycin.However,the mechanism by which MDA-azithromycin reduces childhood mortality remains unclear.Verbal autopsies performed in MDA-azithromycin childhood mortality studies have produced conflicting data and are underpowered to answer this question.In addition to benefits,there are several important risks associated with MDA-azithromycin.Direct adverse effects potentially resulting from MDA-azithromycin include gastrointestinal side effects,idiopathic hypertrophic pyloric stenosis,cardiovascular side effects,and increase in chronic diseases such as asthma and obesity.Antibacterial resistance is also a risk associated with MDA-azithromycin and has been reported for both gram-positive and enteric organisms.Further,there is the risk for cross-resistance with other antibacterial agents,especially clindamycin.Conclusions: Evidence shows that MDA-azithromycin programs may be beneficial for reducing trachoma,yaws,and mortality in children<5 years of age in certain under-resourced settings.However,there are significant potential risks that need to be considered when deciding how,when,and where to implement these programs.Robust systems to monitor benefits as well as adverse effects and antibacterial resistance are warranted in communities where MDA-azithromycin programs are implemented.

Evaluation of morbidity in Schistosoma mansoni-positive primary and secondary school children after four years of mass drug administration of praziquantel in western Kenya

Background:World Health Organization guidelines recommend preventive chemotherapy with praziquantel to control morbidity due to schistosomiasis.The primary aim of this cross-sectional study was to determine if 4 years of annual mass drug administration(MDA)in primary and secondary schools lowered potential markers of morbidity in infected children 1 year after the final MDA compared to infected children prior to initial MDA intervention.Methods:Between 2012 and 2016 all students in two primary and three secondary schools within three kilometers of Lake Victoria in western Kenya received annual mass praziquantel administration.To evaluate potential changes in morbidity we measured height,weight,mid-upper arm circumference,hemoglobin levels,abdominal ultrasound,and quality of life in children in these schools.This study compared two cross-sectional samples of Schistosoma mansoni egg-positive children:one at baseline and one at year five,1 year after the fourth annual MDA.Data were analyzed for all ages(6–18 years old)and stratified by primary(6–12 years old)and secondary(12–18 years old)school groups.Results:The prevalence of multiple potential morbidity markers did not differ significantly between the egg-positive participants at baseline and those at 5 years by Mann Whitney nonparametric analysis and Fisher’s exact test for continuous and categorical data,respectively.There was a small but significantly higher score in school-related quality of life assessment by year five compared to baseline by Mann Whitney analysis(P=0.048)in 13–18 year olds where malaria-negative.However,anemia was not positively impacted by four annual rounds of MDA,but registered a significant negative outcome.Conclusions:We did not detect differences in morbidity markers measured in a population of those infected or re-infected after multiple MDA.This could have been due to their relative insensitivity or a failure of MDA to prevent morbidity among those who remain infected.High malaria transmission in this area and/or a lack of suitable methods to measure the more subtle functional morbidities caused by schistosomiasis could be a factor.Further research is needed to identify and develop well-defined,easily quantifiable S.mansoni morbidity markers for this age group.

The fight against lymphatic filariasis:perceptions of community drug distributors during mass drug administration in coastal Kenya

Background:Lymphatic filariasis(LF)#a neglected tropical disease(NTD)and leading cause of global disability,is endemic in 32 countries in Africa with almost 350 million people requiring regular drug administration,and only 16 countries achieving target coverage.Community Drug Distributors(CDDs)are critical for the success of NTD programs,and the distribution of medicines during mass drug administration(MDA)in Africa;however they could also be a weak link.The primary aim of this study is to explore and describe perceptions of CDDs during MDA for LF in Mvita sub-county in Mombasa county and Kaloleni sub-county in Kilifi county,Kenya;and provide recommendations for the effective engagement of communities and CDDs in low-resource settings.Methods:In September 2018,we conducted six focus group discussions with community members in each sub-county,three with men aged 18-30,31-50,and 51 years and above and three with women stratified into the same age groups.In each sub-county,we also conducted semi-struaured interviews with nine community health extension workers(CHEWs),the national LF focal point,the county NTD focal points,and seven community leaders.Content analysis of the data was conducted,involving a process of reading,coding,and displaying data in order to develop a codebook.Results:We found that several barriers and facilitators impact the engagement between CDDs and community members during MDA.These barriers include poor communication and trust between CDDs and communities;community distrust of the federal government;low community knowledge and perceived risk of LF,poor timing of MDA,fragmented supervision of CDDs during MDA;and CDD bias when distributing medicines.We also found that CDD motivation was a critical factor in their ability to successfully meet MDA targets.It was acknowledged that directly observed treatment and adequate health education were often not executed by CDDs.The involvement of community leaders as informal supervisors of CDDs and community members improves MDA.Conclusions:In order to achieve global targets around the elimination of LF,CDDs and communities must be effectively engaged by improving planning and implementation of MDA.

Hypothalamic circuits and aging:keeping the circadian clock updated

Over the past century,age-related diseases,such as cancer,type-2 diabetes,obesity,and mental illness,have shown a significant increase,negatively impacting overall quality of life.Studies on aged animal models have unveiled a progressive discoordination at multiple regulatory levels,including transcriptional,translational,and post-translational processes,resulting from cellular stress and circadian derangements.The circadian clock emerges as a key regulator,sustaining physiological homeostasis and promoting healthy aging through timely molecular coordination of pivotal cellular processes,such as stem-cell function,cellular stress responses,and inter-tissue communication,which become disrupted during aging.Given the crucial role of hypothalamic circuits in regulating organismal physiology,metabolic control,sleep homeostasis,and circadian rhythms,and their dependence on these processes,strategies aimed at enhancing hypothalamic and circadian function,including pharmacological and non-pharmacological approaches,offer systemic benefits for healthy aging.Intranasal brain-directed drug administration represents a promising avenue for effectively targeting specific brain regions,like the hypothalamus,while reducing side effects associated with systemic drug delivery,thereby presenting new therapeutic possibilities for diverse age-related conditions.

Ancylostoma ceylanicum and other zoonotic canine hookworms:neglected public and animal health risks in the Asia-Pacific region

Zoonotic hookworm infections remain a significant public health problem,causing nearly 500 milion cases globally and approximately four million disability-adjusted life years lost annually.More than one-fth of these cases are attrib-uted to Ancylostoma ceylanicum,an emerging zoonotic health issue in the Asia-Pacific region.This review presents key research gaps regarding the epidemiology,diagnosis,control,prevention and elimination of A.ceylanicum and other canine zoonotic hookworms as neglected health threats.A.ceylanicum is the second most prevalent human hook-worm in the region;it is the most common hookworm among dogs and cats-reservoirs of zoonotic infections.Previous population genetic and phylogenetic analyses revealed that A.ceylanicum has three possible transmis-sion dynamics:zoonotic,animal-only,and human-only pathways.The actual burden of zoonotic ancylostomiasis in most endemic countries remains unknown due to the use of parasitological techniques(e.g.,Kato-Katz thick smear and floatation techniques)that have reduced diagnostic performance and do not allow accurate species identifica-tion in helminth surveys.The emergence of benzimidazole resistance in soil-transmitted helminths(STHs),includ-ing hookworms,is a concern due to the protracted implementation of mass drug administration(MDA).Resistance is conferred by single nucleotide polymorphisms(SNPs)that occur in theβ-tubulin isotype 1 gene.These mutations have been reported in drug-resistant A.caninum but have not been found in A.ceylanicum in the field.A.ceylanicum remains understudied in the Asia-Pacific region.The zoonotic nature of the parasite warrants investigation of its occur-rence in human and animal reservoir hosts to understand the dynamics of zoonotic transmission in different endemic foci.The detection of benzimidazole resistance-associated SNPs in zoonotic hookworms from Asia-Pacific countries has yet to be thoroughly explored.Considering the high level of hookworm endemicity in the region,the circulation of resistant isolates between humans and animals potentially presents a significant One Health threat that can under-mine current MDA and proposed animal deworming-based control efforts.

Anti-obesity drugs currently used and new compounds in clinical development

Obesity is a chronic disease which requires treatment.As lifestyle interventions alone hardly ever result in long-term weight loss,pharmacotherapy is an important adjunct to lifestyle measures to improve the induction and maintenance of weight loss.Owing to the limited options currently available for the pharmacological treatment of obesity,it is imperative to develop new safe compounds.This study aims to review the current medications approved by European Medicines Agency and United States Food and Drug Administration(FDA)for the treatment of obesity,focusing essentially on their benefits and risks,as well as on the new drugs which are presently under clinical trials.Moreover,it lists the anti-obesity agents that have been recently withdrawn from the market.A revision of the scientific literature was carried out,through a search on Pubmed for papers published from January 2010 to January2013.Orlistat(Xenical) is currently the only long-term pharmacotherapy for obesity available in the European market,as rimonabant and sibutramine were with-drawn in 2008 and 2010,respectively,due to serious psychiatric and cardiovascular adverse effects.Lorcaserin(BelviqTM) and the association of phentermine and topiramate(Qsymia TM) were recently approved by FDA.Orlistat suppresses appetite inhibiting gastrointestinal lipase,being its adverse effects mostly gastrointestinal.Lorcaserin activates 5-HT2 C receptors,phentermine is a norepinephrine releasing drug,and topiramate is an anticonvulsivant drug with weight loss properties.

Diagnosis of breast cancer by tissue analysis

In this paper, we propose a technique to locate abnormal growth of cells in breast tissue and suggest further pathological test, when require. We compare normal breast tissue with malignant invasive breast tissue by a series of image processing steps. Normal ductal epithelial cells and ductal/lobular invasive carcinogenic cells also consider for comparison here in this paper. In fact, features of cancerous breast tissue （invasive） are extracted and analyses with normal breast tissue. We also suggest the breast cancer recognition technique through image processing and prevention by controlling p53 gene mutation to some extent.

Modes of failure with fractional flow reserve guidewires:Insights from the manufacturer and user facility device experience database

BACKGROUND Fractional flow reserve(FFR)measurement is commonly used in the cardiac catheterization laboratory to assess the functional significance of coronary arterial plaques.Robust real-world data on complications and modes of failure of FFR guidewires are limited.AIM To characterize these outcomes by analyzing the post-marketing surveillance data from the United States Food and Drug Administration Manufacturer and User Facility Device Experience(MAUDE)database for commonly used FFR guidewires.METHODS The MAUDE database was queried from January 2010 through April 2020 for 3 FFR guidewires[PressureWireTM X(Abbott),CometTM(Boston Scientific),and VerrataTM(Philips)]by searching for the following events:“Injury”,“malfunction”,“death”,and“other”.This yielded 544 reports.After excluding incomplete reports,486 reports were analyzed.RESULTS Guidewire tip fracture was the most commonly reported mode of failure,in 174(35.8%)cases followed by guidewire kinking(n=152,31.3%),communication failure(n=141,29.0%),and shaft fracture(n=67,13.8%).In total,133(27.4%)device failures resulted in patient adverse events.The most common adverse event was retained guidewire tip,in 71(53.4%)cases,followed by freshly deployed stent dislodgment(n=26,19.6%)and coronary artery dissection(n=23,17.3%).Seven deaths were reported.CONCLUSION FFR guidewire failures can occur because of various mechanisms and cause patient adverse events.The MAUDE database serves as an important platform for improved collaboration among clinicians,device manufacturers,and regulators to improve device performance and optimize patient outcomes.Our analysis provides mechanistic insights of FFR guidewire failure and associated adverse events but cannot verify causality or provide a comparison among different guidewires.

Analysis of the adverse reactions of atezolizumab: A real-world study based on FAERS database

Objective In this study,we aimed to determine the incidence of adverse drug reactions(ADRs)of atezolizumab,identify ADR signals that are significantly related to atezolizumab,and provide a reference for the rational use of atezolizumab in the clinic through the statistical analysis of its adverse drug events(ADEs)reported in the American Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database.Methods In total,4796 cases of atezolizumab ADEs reported in the American FAERS database from 2017 to 2019 were retrospectively analyzed.Results The top three ADEs were febrile neutropenia(3.7%),anemia(2.9%),and acute renal failure(2.3%).In addition,the incidence rates of some ADEs were significantly different according to sex and age.The systematic organ classification of atezolizumab ADEs involved 32 systems,among which the top three were blood and lymphatic system disorders(585 cases,12.2%),gastrointestinal disorders(433 cases,9.0%),and infections and infestations(401 cases,8.4%).The reporting odds ratio(ROR)method was used to detect the ADR signals of atezolizumab.The ROR(95%confidence interval)of the top ADE,febrile neutropenia,was 39.236(33.757–45.604).In addition,we found 121 cases of complications associated with immune-related ADEs.Conclusion The ADRs of atezolizumab reported in the FAERS database were consistent with those mentioned in the instructions for atezolizumab use,suggesting that atezolizumab has an acceptable and controllable drug effect.