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Journal of Geriatric Cardiology 2024年第6期21卷 658-668页

作者： Wen-Jie WANG Ke-Xin WANG Jia-Long NIU Yi-Xuan LIU Hai-Long GE Hua SHEN On behalf of CCC-ACS investigators department of Cardiology Beijing Anzhen HospitalCapital Medical UniversityBeijingChina

BACKGROUND Stress hyperglycemia ratio(SHR)could provide accurate information on the acute status of hyperglycemia.The relationship between SHR and acute coronary syndrome(ACS)prognosis remains unclear.This study was conducted to identity the association between SHR and in-hospital outcomes in patients with ACS.METHODS A total of 12,010 patients were eventually enrolled in the study.The relationship between SHR and in-hospital major adverse cardiovascular events(MACEs)was then modeled by restricted cubic spline(RCS)curves,and all patients were divided into three groups according to the results.The multivariate logistic regression analysis was used to determine the associations between the SHR and in-hospital outcomes,described as odds ratios(ORs)and 95%confidence intervals(CIs).Subgroup analyses were also performed on different diseases.RESULTS The median age of this cohort was 63(54,71)years old,and 8942(74.5%)were male.Group 1 was defined as SHR1(n=5763).Compared with Group 2,Group 1(OR=1.891,95%CI:1.028-3.479,P<0.001)and Group 3(OR=1.868,95%CI:1.434-2.434,P<0.001)had higher risks of suffering from in-hospital MACEs.SHR was associated with higher risks of in-hospital MACEs in the subgroups of DM[OR=2.282,95%CI:1.477-3.524).CONCLUSIONS Both low and high SHR levels were independently associated with in-hospital MACEs.Young males with DM,hypertension,and decreased renal function had much higher risks of suffering from SHR-correlated MACEs.

关键词： acute cardiovascular finding

Oral anti-coagulants use in Chinese hospitalized patients with atrial fibrillation

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Chinese medical Journal 2024年第2期137卷 172-180页

作者： Jing Lin Deyong Long Chenxi Jiang Caihua Sang Ribo Tang Songnan Li Wei Wang Xueyuan Guo Man Ning Zhaoqing Sun Na Yang Yongchen Hao Jun Liu Jing Liu Xin Du Louise Morgan Gregg C.Fonarow Sidney C.Smith Jr Gregory Y.H.Lip Dong Zhao Jianzeng Dong Changsheng Ma On behalf of CCC-AF investigators department of Cardiology Beijing Anzhen HospitalCapital Medical UniversityBeijing 100029China National Clinical Research Center for Cardiovascular Diseases Beijing 100029 China department of Epidemiology Beijing Anzhen HospitalCapital Medical UniversityBeijing Institute of HeartLung and Blood Vessel DiseasesBeijing 100029China International Quality Improvement department American Heart AssociationDallasTX 07076USA Division of Cardiology Geffen School of Medicine at University of CaliforniaLos Angeles CA 90024USA Division of Cardiology University of North CarolinaChapel HillNC 27599USA department of Cardiology Liverpool Centre for Cardiovascular ScienceUniversity of Liverpool and Liverpool Heart&Chest HospitalLiverpool L143PEUK department of Clinical Medicine Aalborg UniversityAalborg 9000Denmark 不详

Background:Oral anti-coagulants(OAC)are the intervention for the prevention of stroke,which consistently improve clinical outcomes and survival among patients with atrial fibrillation(AF).The main purpose of this study is to identify problems in OAC utilization among hospitalized patients with AF in China.Methods:Using data from the Improving Care for Cardiovascular Disease in China-Atrial Fibrillation(CCC-AF)registry,guideline-recommended OAC use in eligible patients was assessed.Results:A total of 52,530 patients with non-valvular AF were enrolled from February 2015 to December 2019,of whom 38,203 were at a high risk of stroke,9717 were at a moderate risk,and 4610 were at a low risk.On admission,only 20.0%(6075/30,420)of patients with a diagnosed AF and a high risk of stroke were taking OAC.The use of pre-hospital OAC on admission was associated with a lower risk of new-onset ischemic stroke/transient ischemic attack among the diagnosed AF population(adjusted odds ratio:0.54,95%confidence interval:0.43-0.68;P70%of AF patients were at a high risk of stroke.Although poor performance on guideline-recommended OAC use was found in this study,over time the CCC-AF project has made progress in stroke prevention in the Chinese AF population.Registration:ClinicalTrials.gov,NCT02309398.

关键词： Atrial fibrillation Oral anti-coagulants OAC Stroke prevention Contraindication

Targeted drug approvals in 2023:breakthroughs by the FDA and NMPA

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Signal Transduction and Targeted Therapy 2024年第3期9卷 813-821页

作者： Lang Zheng Wenjing Wang Qiu Sun department of Biotherapy Cancer Center and State Key Laboratory of BiotherapyWest China HospitalSichuan UniversityChengdu 610041China West China medical Publishers West China HospitalSichuan UniversityChengdu 610041China

According to the official website of China’s National Medicines and Pharmaceutical Administration(NMPA),a total of 87 novel drugs were approved in China in 2023,with targeted drugs accounting for 67.8%of the total,amounting to 59 drugs(Fig.1a;Table 1)[https://***/yaopin/ypjgdt/index.html].Notably,domestic innovation is flourishing,with five first-in-class drugs,including Glumetinib,a c-Met inhibitor from Haihe Biopharma;Leritrelvir,a 3CL protease inhibitor from Raynovent;Anaprazole,a proton pump inhibitor from Xuanzhu Biopharm;Pegol-Sihematide,an EPO drug from Hansoh Pharma;and Zuberitamab from BioRay Biopharmaceutical Co.,Ltd.Additionally,the world’s first allosteric inhibitor targeting TYK2,Sotyktu(deucravacitinib),has been approved for the treatment of psoriasis and Selumetinib,a MEK inhibitor co-developed by astrazeneca and Merck Sharp&Dohme(MSD),became the first approved drug in China for the treatment of neurofibromatosis type I(NF1).Beyond these drugs,the approval of novel drug types such as CAR-T cell products,siRNA,monoclonal antibodies,dual antibodies,and ADCs in China is a significant development in the country’s pharmaceutical industry(Fig.1a).

关键词： drugs Merck approval

Clinical usefulness of adherence to gastro-esophageal reflux disease guideline by Spanish gastroenterologists

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World Journal of Gastroenterology 2012年第35期18卷 4885-4891页

作者： Fermín Mearin Julio Ponce Marta Ponce Agustín Balboa Miguel A González Javier Zapardiel Service of Gastroenterology Centro Medico Teknon Digestive Disease Unit Hospital Quiron Centro de Investigacion Biomedica en Red:Enfermedades Hepaticasy Digestivas Service of Gastroenterology Hospital Universitario La Fe Biostatistics Innovex-Grupo Quintiles Espana medical department astrazeneca farmaceutica

AIM:To investigate usefulness of adherence to gastroesophageal reflux disease(GERD) guideline established by the Spanish Association of Gastroenterology.METHODS:Prospective,observational and multicentre study of 301 patients with typical symptoms of GERD who should be managed in accordance with guidelines and were attended by gastroenterologists in daily practice.Patients(aged > 18 years) were eligible for inclusion if they had typical symptoms of GERD(heartburn and/or acid regurgitation) as the major complaint in the presence or absence of accompanying atypical symptoms,such as dyspeptic symptoms and/or supraesophageal symptoms.Diagnostic and therapeutic decisions should be made based on specific recommendations of the Spanish clinical practice guideline for GERD which is a widely disseminated and well known instrument among Spanish in digestive disease specialists.RESULTS:Endoscopy was indicated in 123(41%) patients:50 with alarm symptoms,32 with age > 50 years without alarm symptom.Seventy-two patients(58.5%) had esophagitis(grade A,23,grade B,28,grade C,18,grade D,3).In the presence of alarm symptoms,endoscopy was indicated consistently with recommendations in 98% of cases.However,in the absence of alarm symptoms,endoscopy was indicated in 33% of patients > 50 years(not recommended by the guideline).Adherence for proton pump inhibitors(PPIs) therapy was 80%,but doses prescribed were lower(half) in 5% of cases and higher(double) in 15%.Adherence regarding duration of PPI therapy was 69%;duration was shorter than recommended in 1%(4 wk in esophagitis grades C-D) or longer in 30%(8 wk in esophagitis grades A-B or in patients without endoscopy).Treatment response was higher when PPI doses were consistent with guidelines,although differences were not significant(95% vs 85%).CONCLUSION:GERD guideline compliance was quite good although endoscopy was over indicated in patients > 50 years without alarm symptoms;PPIs were prescribed at higher doses and longer duration.

关键词：胃肠病学西班牙语临床实践食管反流典型症状检查结果持续时间

A preliminary study on rectal dose reduction associated with hyaluronic acid implantation in brachytherapy for prostate cancer

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Asian Journal of Urology 2024年第2期11卷 286-293页

作者： Tairo Kashihara Yuka Urago Hiroyuki Okamoto Mihiro Takemori Hiroki Nakayama Shohei Mikasa Tetsu Nakaichi Kotaro Iijima Takahito Chiba Junichi Kuwahara Satoshi Nakamura Weishan Chang Yoshiyuki Matsui Hiroshi Igaki department of Radiation Oncology National Cancer Center Hospital5-1-1 TsukijiChuo-kuTokyoJapan Radiation Safety and Quality Assurance Division National Cancer Center Hospital5-1-1 TsukijiChuo-kuTokyoJapan department of Radiological Sciences Graduate School of Human Health SciencesTokyo Metropolitan University7-2-10 Higashi-OguArakawa-kuTokyoJapan department of Radiological Technology National Cancer Center Hospital5-1-1 TsukijiChuo-kuTokyoJapan department of Urological Oncology National Cancer Center Hospital5-1-1 TsukijiChuo-kuTokyoJapan

Objectives: Hydrogel spacer (HS) was developed to reduce rectal toxicities caused by radiotherapy, but has been reported to cause major adverse events. Our institute has attempted to introduce a hyaluronic acid (HA) as an alternative spacer. This study aimed to compare rectal doses and geometric distributions between the HS and HA implantation in prostate cancer.Methods: HS and HA were inserted in 20 and 18 patients undergoing high-dose brachytherapy, respectively. The rectum spacer volumes injected were 10 mL and 22 mL, respectively. In the treatment planning system, 13.5 Gy was administered with common catheter positions. The rectal dose indices were assessed between the spacer groups for dosimetry evaluation. Distances between the prostate and rectum and configurations of the spacers were compared.Results: The mean doses irradiated to 0.1 and 2 mL of the rectum were 10.45 Gy and 6.71 Gy for HS, and 6.73 Gy and 4.90 Gy for HA (p<0.001). The mean minimum distances between the prostate and rectum were 1.23 cm and 1.79 cm for HS and HA, respectively (p<0.05). Geometrical configuration comparisons revealed that HA has a higher ability to expand the space than HS.Conclusion: The rectal dose reduction ability of HA is significantly greater than that of HS, suggesting its potential as a new spacer.

关键词： Brachytherapy Hyaluronicacid Hydrogel Prostaticneoplasm Radiotherapy

Prodromal Parkinson’s disease: hype or hope for disease-modification trials?

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Translational Neurodegeneration 2022年第1期11卷 777-789页

作者： Philipp Mahlknecht Kathrin Marini Mario Werkmann Werner Poewe Klaus Seppi department of Neurology Innsbruck Medical University6020 InnsbruckAustria

The ultimate goal in Parkinson’s disease (PD) research remains the identification of treatments that are capable of slowing or even halting the progression of the disease. The failure of numerous past disease-modification trials in PD has been attributed to a variety of factors related not only to choosing wrong interventions, but also to using inadequate trial designs and target populations. In patients with clinically established PD, neuronal pathology may already have advanced too far to be modified by any intervention. Based on such reasoning, individuals in yet prediagnostic or prodromal disease stages, may provide a window of opportunity to test disease-modifying strategies. There is now sufficient evidence from prospective studies to define diagnostic criteria for prodromal PD and several approaches have been studied in observational cohorts. These include the use of PD-risk algorithms derived from multiple established risk factors for disease as well as follow-up of cohorts with single defined prodromal markers like hyposmia, rapid eye movement sleep behavior disorders, or PD gene carriers. In this review, we discuss recruitment strategies for disease-modification trials in various prodromal PD cohorts, as well as potential trial designs, required trial durations, and estimated sample sizes. We offer a concluding outlook on how the goal of implementing disease-modification trials in prodromal cohorts might be achieved in the future.

关键词： Neuroprotection Preclinical Prevention Epidemiology Probability Randomized controlled trial Preventive Neuroprotective

Successful management of vaccine-induced immune thrombotic thrombocytopenia-related cerebral sinus venous thrombosis after ChAdOx1 nCov-19 vaccination

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Stroke & Vascular Neurology 2022年第1期7卷 86-88页

作者： Thomas Gattringer Paul Gressenberger Thomas Gary Albert Wöfler Markus Kneihsl Reinhard Bernd Raggam Neurology Medical University of GrazGrazAustria Divison of Angiology Department of Internal MedicineMedical University of GrazGrazAustria Divison of Haematology Department of Internal MedicineMedical University of GrazGrazAustria

Very recently,unusual thrombotic events in combination with severe thrombocytopenia have been reported 1–2 weeks following SARS-CoV-2 vaccination with ChAdOx1 nCov-19(astrazeneca).This condition,termed VITT(vaccine-induced immune thrombotic thrombocytopenia),has been related to high risk of fatal outcome with both ischaemic and haemorrhagic complications.12 Optimal treatment strategies still need to be elucidated—especially in case of cerebral sinus venous thrombosis(CSVT)with associated brain haemorrhage as the underlying thrombotic event.We here report our clinical experience with two young women diagnosed with VITT-associated CSVT,treated with high-dose intravenous immunoglobulins(IVIGs),corticosteroids and argatroban in the hyperacute phase,followed by dabigatran resulting in excellent outcome.

关键词： vaccination thrombotic cerebral

The critical role of apoptosis in mesenchymal stromal cell therapeutics and implications in homeostasis and normal tissue repair

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Cellular & Molecular Immunology 2023年第6期20卷 570-582页

作者： Chiara Giacomini Ceilia Graneli Ryan Hicks Francesco Dazzi School of Cardiovascular and Metabolic Medicine&Sciences King's College LondonLondonUK BioPharmaceuticals R&D Cell Therapy department Research and Early DevelopmentCardiovascularRenaland Metabolism(CVRM)BioPharmaceuticals R&DAstraZenecaGothenburgSweden

Mesenchymal stromal cells(MsCs)have been extensively tested for the treatment of numerous clinical conditions and have demonstrated good safety but mixed efficacy.Although this outcome can be attributed in part to the heterogeneity of cell preparations,the lack of mechanistic understanding and tools to establish cell pharmacokinetics and pharmacodynamics,as well as the poorly defined criteria for patient stratification,have hampered the design of informative clinical trials.We and others have demonstrated that MsCs can rapidly undergo apoptosis after their infusion.Apoptotic MSCs are phagocytosed by monocytes/macrophages that are then reprogrammed to become anti-inflammatory cells.MsC apoptosis occurs when the cells are injected into patients who harbor activated cytotoxic T or NK cells.Therefore,the activation state of cytotoxic T or NK cells can be used as a biomarker to predict clinical responses to MsC treatment.Building on a large body of preexisting data,an alternative view on the mechanism of MSCs is that an inflammation-dependent MSC secretome is largely responsible for their immunomodulatory activity.We will discuss how these different mechanisms can coexist and are instructed by two different types of Msc"licensing":one that is cell-contact dependent and the second that is mediated by inflammatory cytokines.The varied and complex mechanisms by which MsCs can orchestrate inflammatory responses and how this function is specifically driven by inflammation support a physiological role for tissue stroma in tissue homeostasis,and it acts as a sensor of damage and initiator of tissue repair by reprogramming the inflammatory environment.

关键词： Mesenchymal stromal cells Cell death immunosuppression

Impaired glymphatic system as evidenced by low diffusivity along perivascular spaces is associated with cerebral small vessel disease:a population-based study

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Stroke & Vascular Neurology 2023年第5期8卷 413-423,I0031-I0050页

作者： Yu Tian Xueli Cai Yijun Zhou Aoming Jin Suying Wang Yingying Yang Lerong Mei Jing Jing Shan Li Xia Meng Tiemin Wei Tao Liu Yongjun Wang Yuesong Pan Yilong Wang department of Neurology Beijing Tiantan HospitalCapital Medical UniversityBeijingChina China National Clinical Research Center for Neurological Diseases BeijingChina department of Neurology The Fifth Affiliated Hospital of Wenzhou Medical UniversityLishuiZhejiangChina Beijing Advanced Innovation Center for Biomedical Engineering School of Biological Science and Medical EngineeringBeihang UniversityBeijingChina Cerebrovascular Research Lab The Fifth Affiliated Hospital of Wenzhou Medical UniversityLishuiZhejiangChina department of Cardiology The Fifth Affiliated Hospital of Wenzhou Medical UniversityLishuiZhejiangChina

Objective This study aims to investigate the associations of glymphatic system with the presence,severity and neuroimaging phenotypes of cerebral small vessel disease(CSVD)in a community-based population.Method This report included 2219 community-dwelling people aged 50-75 years who participated in the PolyvasculaR Evaluation for Cognitive Impairment and vaScular Events cohort.The diffusivity along perivascular spaces based on diffusion tensor imaging(DTI-ALPS index)was measured to assess glymphatic pathway.The presence and severity of CSVD were estimated using a CSVD score(points from 0 to 6)and a modified CSVD score(points from 0 to 4),which were driven by 4 neuroimaging features of CSVD,including white matter hyperintensity(WMH),enlarged perivascular spaces(EPVS),lacunes,cerebral microbleeds.Brain atrophy(BA)was also evaluated.Binary or ordinal logistic regression analyses were carried out to investigate the relationships of DTI-ALPS index with CSVD.Result The mean age was 61.3(SD 6.6)years,and 1019(45.9%)participants were men.The average DTI-ALPS index was 1.67±0.14.Individuals in the first quartile(Q1)of the DTI-ALPS index had higher risks of the presence of CSVD(OR 1.77,95%CI 1.33 to 2.35,p<0.001),modified presence of CSVD(odds ratio(OR)1.80,95%CI 1.38 to 2.34,p<0.001),total burden of CSVD(common OR(cOR)1.89,95%CI 1.43 to 2.49,p<0.001)and modified total burden of CSVD(cOR 1.95,95%CI 1.51 to 2.50,p<0.001)compared with those in the fourth quartile(Q4).Additionally,individuals in Q1 of the DTI-ALPS index had increased risks of WMH burden,modified WMH burden,lacunes,basal ganglia-EPVS and BA(all p<0.05).Conclusion A lower DTI-ALPS index underlay the presence,severity and typical neuroimaging markers of CSVD,implying that glymphatic impairment may interact with CSVD-related pathology in the general ageing population.

关键词： cerebral lymphatic severity

Pharmacokinetics and Bioequivalence Evaluation of Two Rosuvastatin Calcium 20 mg Tablets: A Single Oral Dose, Randomized-Sequence, Open-Label, Two-Period Crossover Study in Healthy Volunteers under Fasting Conditions

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Journal of Biosciences and Medicines 2024年第6期12卷 230-243页

作者： Evelyn Pena Alfredo Inatti José Gregorio Chacón department of Clinical Research Industrias Biocontrolled C.A. Caracas Venezuela

Objectives: To compare the rate and extent of absorption of Racor® 20 mg (Rosuvastatin calcium 20 mg) tablet of Laboratorios Leti, S.A.V., with Crestor® 20 mg (Rosuvastatin calcium 20 mg) tablet of astrazeneca, UK Limited in healthy adult human subjects under fasting conditions. Method: This was an open label, analyst blind, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study in healthy, adult, human subjects under fasting condition. Twenty-four (24) subjects were planned as per the protocol and all subjects completed both periods of the study. The concentrations of Rosuvastatin in plasma were quantitated using a validated LC-MS/MS method of analysis and plasma levels were submitted for statistical analysis. Cmax, AUC0-t, AUC0-∞, Tmax, t1/2, Kel (hrs-1), percent AUC extrapolated [100 * (AUC0-∞ - AUC0-t)/AUC0-∞] (AUC_%Extrapobs) were calculated for rosuvastatin in plasma using SAS® version 9.1.3, SAS Institute. Inc. USA.CARY. ANOVA, 90% confidence interval using Schuirmann’s two one-sided test for bioequivalence, power and ratio analysis, for lntransformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ were computed and reported for Rosuvastatin in plasma for BE. Results: Data showed that 90% confidence intervals for the test/reference geometric mean ratios (GMR) of Cmax (95.01 - 112.66), AUC0-t (93.38 - 111.67) and AUC0-∞ (93.65 - 111.29) were within the BE (80% - 125%) acceptance range. Conclusions: Two products formulation, reference (R) Crestor® (rosuvastatin calcium) of astrazeneca and test (T), Racor® (rosuvastatin calcium) of Laboratorios Leti S.A.V., with a single dose of 20 mg, under fasting conditions were bioequivalent. No severe, serious or unexpected adverse events (AEs) were reported in this study.

关键词： Bioequivalence Rosuvastatin Pharmacokinetics