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1.
Zhonghua Xin Xue Guan Bing Za Zhi ; 52(7): 798-805, 2024 Jul 24.
Artículo en Zh | MEDLINE | ID: mdl-39019829

RESUMEN

Objective: To investigate the incidence of coronary artery tortuosity and its correlation with poor prognosis in patients with septal hypertrophic cardiomyopathy (HCM). Methods: This was a retrospective cohort study. Patients with septal HCM who were hospitalized in Fuwai Central China Cardiovascular Hospital and Zhengzhou University People's Hospital between December 1, 2017 and June 10, 2021 were selected. Non-HCM patients were matched by gender, age, and hypertension as control group. Septal HCM was divided into two groups based on the presence or absence of coronary artery tortuosity. Clinical baseline data and coronary angiography findings were compared using a multifactorial logistic analysis of the risk factors for coronary artery tortuosity. Patients were followed up until July 1, 2022, with the primary outcome being the composite endpoint of malignant arrhythmia, ischemic stroke and all-cause death. Incidence densities were compared between the coronary artery tortuosity and non-coronary artery tortuosity groups of septal HCM patients. The Cox risk-ratio model was used to analyze risk factors for primary outcomes in septal HCM patients. Results: There were 156 patients in the septal HCM group and 156 patients in the control group, both aged (57.0±11.4) years, and 75 (48.1%) were female. The incidence of coronary artery tortuosity was significantly higher in the septal HCM group than in the control group (63.5% vs. 36.5%, P<0.01), and the coronary artery tortuosity score was also higher in the septal HCM group than in the control group (P<0.01). Multiple logistic regression analysis showed that septal HCM was a risk factor for coronary artery tortuosity (OR=3.27, 95%CI: 2.02-5.29, P<0.01). In the septal HCM patients, after (2.5±1.2) years of follow-up, the incidence density of primary outcome was significantly higher in the coronary artery tortuosity group than in the non-coronary artery tortuosity group (P=0.02), while each on-point in coronary artery tortuosity score increased the risk of primary outcome by 53% for septal HCM patients (HR=1.53, 95%CI: 1.26-1.86, P<0.01). Conclusions: Patients with septal HCM are more prone to suffer coronary artery tortuosity and suffer from it to a greater extent. Coronary artery tortuosity is an important risk factor for adverse events in patients with septal HCM.


Asunto(s)
Cardiomiopatía Hipertrófica , Vasos Coronarios , Humanos , Cardiomiopatía Hipertrófica/complicaciones , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/patología , Factores de Riesgo , Masculino , Femenino , Angiografía Coronaria , Anomalías de los Vasos Coronarios/epidemiología , China/epidemiología , Incidencia
2.
Zhonghua Fu Chan Ke Za Zhi ; 58(1): 37-43, 2023 Jan 25.
Artículo en Zh | MEDLINE | ID: mdl-36720613

RESUMEN

Objective: To observe the clinical outcomes of continued pregnancy in pregnant women with cesarean scar pregnancy (CSP). Methods: A retrospective analysis was performed on the pregnancy outcomes of 55 pregnant women who were diagnosed with CSP at the Second Affiliated Hospital of Army Medical University during the first trimester of pregnancy from August 1st, 2018 to October 31st, 2021 and strongly requested to continue the pregnancy. Results: Of the 55 pregnant women, 15 terminated the pregnancy in the first trimester, 1 underwent hysterotomy at 23 weeks of gestation due to cervical dilation, and 39 (71%, 39/55) continued pregnancy to the third trimester achieving live births via cesarean section. The gestational age of the 39 pregnant women delivered by cesarean section was 35+6 weeks (range: 28+5-39+2 weeks), of whom 7 cases at 28+5-33+6 weeks, 20 cases at 34-36+6 weeks, and 12 cases at 37-39+2 weeks. The results of pathological examination were normal placenta in 3 cases (8%, 3/39), placenta creta in 4 cases (10%, 4/39), placenta increta in 9 cases (23%, 9/39) and placenta percreta in 23 cases (59%, 23/39). Among the 36 pregnant women who were pathologically confirmed as placenta accreta spectrum disorders (PAS) after surgery, the last prenatal ultrasonography showed placenta previa in 27 cases (75%, 27/36) and not observed placenta previa in 9 cases. The median intraoperative blood loss, autologous blood transfusion, and allogeneic suspended red blood cell infusion of 39 pregnant women during cesarean section were 1 000 ml (300-3 500 ml), 300 ml (0-2 000 ml) and 400 ml (0-2 400 ml), respectively. The uterine preservation rate was 100% (39/39), and only 1 case received cystostomy due to intracystic hemorrhage. The birth weight of the newborn was 2 580 g (1 350-3 800 g), and 1 case of mild asphyxia. Conclusions: Pregnant women with CSP who continue pregnancy under close monitoring after adequate ultrasound evaluation and doctor-patient communication could achieve better maternal and infant outcomes, but pregnant women with CSP are highly likely to continue pregnancy and develop into PAS. Effective hemostasis means and multidisciplinary team cooperation are needed in perinatal period for ensuring maternal and fetal safety.


Asunto(s)
Cesárea , Placenta Previa , Embarazo , Lactante , Recién Nacido , Humanos , Femenino , Cesárea/efectos adversos , Cicatriz , Placenta Previa/cirugía , Estudios Retrospectivos , Peso al Nacer
3.
Zhonghua Xin Xue Guan Bing Za Zhi ; 50(7): 690-697, 2022 Jul 24.
Artículo en Zh | MEDLINE | ID: mdl-35856226

RESUMEN

Objective: To investigate the effect and mechanism of sacubitril/valsartan on left ventricular remodeling and cardiac function in rats with heart failure. Methods: A total of 46 SPF-grade male Wistar rats weighed 300-350 g were acclimatized to the laboratory for 7 days. Rats were then divided into 4 groups: the heart failure group (n=12, intraperitoneal injection of adriamycin hydrochloride 2.5 mg/kg once a week for 6 consecutive weeks, establishing a model of heart failure); heart failure+sacubitril/valsartan group (treatment group, n=12, intragastric administration with sacubitril/valsartan 1 week before the first injection of adriamycin, at a dose of 60 mg·kg-1·d-1 for 7 weeks); heart failure+sacubitril/valsartan+APJ antagonist F13A group (F13A group, n=12, adriamycin and sacubitril/valsartan, intraperitoneal injection of 100 µg·kg-1·d-1 APJ antagonist F13A for 7 weeks) and control group (n=10, intraperitoneal injection of equal volume of normal saline). One week after the last injection of adriamycin or saline, transthoracic echocardiography was performed to detect the cardiac structure and function, and then the rats were executed, blood and left ventricular specimens were obtained for further analysis. Hematoxylin-eosin staining and Masson trichrome staining were performed to analyze the left ventricular pathological change and myocardial fibrosis. TUNEL staining was performed to detect cardiomyocyte apoptosis. mRNA expression of left ventricular myocardial apelin and APJ was detected by RT-qRCR. ELISA was performed to detect plasma apelin-12 concentration. The protein expression of left ventricular myocardial apelin and APJ was detected by Western blot. Results: Seven rats survived in the heart failure group, 10 in the treatment group, and 8 in the F13A group. Echocardiography showed that the left ventricular end-diastolic diameter (LVEDD) and the left ventricular end-systolic diameter (LVESD) were higher (both P<0.05), while the left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) were lower in the heart failure group than in the control group (both P<0.05). Compared with the heart failure group, rats in the treatment group were featured with lower LVEDD and LVESD (both P<0.05), higher LVEF and LVFS (both P<0.05), these beneficial effects were reversed in rats assigned to F13A group (all P<0.05 vs. treatment group). The results of HE staining showed that the cardiomyocytes of rats in the control group were arranged neatly and densely structured, the cardiomyocytes in the heart failure group were arranged in disorder, distorted and the gap between cells was increased, the cardiomyocytes in the treatment group were slightly neat and dense, and cardiomyocytes in the F13A group were featured similarly as the heart failure group. Masson staining showed that there were small amount of collagen fibers in the left ventricular myocardial interstitium of the control group, while left ventricular myocardial fibrosis was significantly increased, and collagen volume fraction (CVF) was significantly higher in the heart failure group than that of the control group (P<0.05). Compared with the heart failure group, the left ventricular myocardial fibrosis and the CVF were reduced in the treatment group (both P<0.05), these effects were reversed in the F13A group (all P<0.05 vs. treatment group). TUNEL staining showed that the apoptosis index (AI) of cardiomyocytes in rats was higher in the heart failure group compared with the control group (P<0.05), which was reduced in the treatment group (P<0.05 vs. heart failure group), this effect again was reversed in the F13A group (P<0.05 vs. treatment group). The results of RT-qPCR and Western blot showed that the mRNA and protein levels of apelin and APJ in left ventricular myocardial tissue of rats were downregulated in heart failure group (all P<0.05) compared with the control group. Compared with the heart failure group, the mRNA and protein levels of apelin and APJ were upregulated in the treatment group (all P<0.05), these effects were reversed in the F13A group (all P<0.05 vs. treatment group). ELISA test showed that the plasma apelin concentration of rats was lower in the heart failure group compared with the control group (P<0.05); compared with the heart failure group, the plasma apelin concentration of rats was higher in the treatment group (P<0.05), this effect was reversed in the F13A group (P<0.05 vs. treatment group). Conclusion: Sacubitril/valsartan can partially reverse left ventricular remodeling and improve cardiac function in rats with heart failure through modulating Apelin/APJ pathways.


Asunto(s)
Aminobutiratos , Apelina , Insuficiencia Cardíaca , Valsartán , Remodelación Ventricular , Aminobutiratos/farmacología , Animales , Apelina/metabolismo , Compuestos de Bifenilo , Colágeno/metabolismo , Doxorrubicina/farmacología , Fibrosis , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/patología , Masculino , Miocitos Cardíacos/efectos de los fármacos , Miocitos Cardíacos/patología , ARN Mensajero/genética , ARN Mensajero/metabolismo , Ratas , Ratas Wistar , Valsartán/farmacología , Función Ventricular Izquierda/efectos de los fármacos
4.
Zhonghua Yi Xue Za Zhi ; 101(40): 3323-3328, 2021 Nov 02.
Artículo en Zh | MEDLINE | ID: mdl-34758533

RESUMEN

Objective: To retrospectively analyze the occurrence and treatment of perioperative complete atrioventricular block (CAVB) by transcatheter aortic valve implantation (TAVI). Methods: A total of 65 patients who underwent TAVI via femoral artery in the Heart Center of Henan People's Hospital from October 2017 to May 2021 were enrolled. Perioperative data of patients were recorded. The patients were divided into two groups according to whether complete atrioventricular block was occurred during TAVI: complete atrioventricular block group (Group CAVB) and non-complete atrioventricular block group (Group NCAVB). Multivariate logistic regression model was used to analyze the risk factors of complete atrioventricular block during transcatheter aortic valve implantation. The incidence of perioperative complications were recorded. Results: The patients age was (69.1±7.3) years old. and there were 35 males and 30 femals. There were 15 patients in group CAVB with complete atrioventricular block and 50 patients in group NCAVB. Multivariate analysis showed that preoperative right bundle branch block [OR (95%CI) vs 3.325 (2.132-13.061), P=0.005] and severe aortic valve calcification [OR (95%CI) vs 1.271 (1.052-3.326), P=0.030] were independent correlative factors for CAVB during TAVI perioperative period. The implantation rate of permanent pacemaker in group CAVB was 73.3% (11 cases), which was higher than 6.0% (3 cases) in group NCAVB (P<0.001). Conclusions: It indicated that preoperative right bundle branch block and severe aortic valve calcification are correlative factors for complete atrioventricular block for TAVI. The implantation rate of permanent pacemaker in complete atrioventricular block group increased significantly.


Asunto(s)
Estenosis de la Válvula Aórtica , Bloqueo Atrioventricular , Prótesis Valvulares Cardíacas , Marcapaso Artificial , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Bloqueo Atrioventricular/etiología , Bloqueo Atrioventricular/terapia , Electrocardiografía , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento
5.
Entropy (Basel) ; 23(2)2021 Feb 17.
Artículo en Inglés | MEDLINE | ID: mdl-33671461

RESUMEN

We prove that, within the class of pair potential Hamiltonians, the excess entropy is a universal, temperature-independent functional of the density and pair correlation function. This result extends Henderson's theorem, which states that the free energy is a temperature dependent functional of the density and pair correlation. The stationarity and concavity of the excess entropy functional are discussed and related to the Gibbs-Bugoliubov inequality and to the free energy. We apply the Kirkwood approximation, which is commonly used for fluids, to both fluids and solids. Approximate excess entropy functionals are developed and compared to results from thermodynamic integration. The pair functional approach gives the absolute entropy and free energy based on simulation output at a single temperature without thermodynamic integration. We argue that a functional of the type, which is strictly applicable to pair potentials, is also suitable for first principles calculation of free energies from Born-Oppenheimer molecular dynamics performed at a single temperature. This advancement has the potential to reduce the evaluation the free energy to a simple modification to any procedure that evaluates the energy and the pair correlation function.

6.
Zhonghua Xin Xue Guan Bing Za Zhi ; 49(1): 54-59, 2021 Jan 11.
Artículo en Zh | MEDLINE | ID: mdl-33429487

RESUMEN

Objective: To explore the association between healthy lifestyle and risk of rehospitalization in male or female patients with chronic heart failure (CHF). Methods: Discharged patients with CHF of Henan Provincial People's Hospital Collaboration Hospital were recruited in our study from January 1,2017 to December 31, 2018. The basic information of patients were collected through the electronic medical record system,the questionnaires were used to collect the related influencing factors. Healthy lifestyle includes 4 items, namely non-smoking, moderate exercise, healthy body mass index (BMI) and reasonable diet.Multivariate logistic regression was used to analyze the association between healthy lifestyle and the risk of rehospitalization of CHF patients of different genders. Results: A total of 2 697 patients with CHF were enrolled in this study, including 1 308 male patients(621 rehospitalizations,687 controls)and 1 389 female patients(684 rehospitalizations,705 controls).Among male patients, there was no significant difference in age, residence, marital status, education level, average monthly income, and medical insurance between the rehospitalization group and the control group (all P>0.05). Among female patients, there was no significant difference in age, residence, marital status, education level, average monthly income, and medical insurance between the rehospitalization group and the control group (all P>0.05). Whether in male or female patients with CHF, we found that patients with 4 healthy lifestyles were associated with reduced risk of rehospitalization: male patients OR=0.34, 95%CI 0.11-0.99, P=0.002,female patients OR=0.27, 95%CI 0.13-0.79, P=0.012. A combination of non-smoking and any other 2 healthy lifestyles was associated with reduced risk of rehospitalization: male patients with no smoking, moderate exercise, healthy BMI, OR=0.32, 95%CI 0.11-0.99, P=0.043; female patients OR=0.28, 95%CI 0.12-0.93, P=0.032;male patients with no smoking, moderate exercise, reasonable diet OR=0.42, 95%CI 0.24-0.98, P=0.044,female patients OR=0.40, 95%CI 0.12-0.94, P=0.031;male patients with no smoking, healthy BMI, reasonable diet OR=0.31, 95%CI 0.21-0.92, P=0.039,female patients OR=0.27,95%CI 0.11-0.87, P=0.014. In female patients with CHF, the combination of non-smoking and moderate sports was associated with reduced risk of hospitalization (OR=0.23, 95%CI 0.19-0.97, P=0.038), while no similar results were seen in male patients (OR=0.65, 95%CI 0.33-1.84, P=0.315). Conclusion: Healthy lifestyle is associated with reduced risk of rehospitalization in patients with CHF, and the related healthy lifestyle and its combination may differ between male and female patients.

7.
Zhonghua Xin Xue Guan Bing Za Zhi ; 49(11): 1094-1101, 2021 Nov 24.
Artículo en Zh | MEDLINE | ID: mdl-34775719

RESUMEN

Objective: To investigate the efficacy and safety of percutaneous closure of ventricular septal rupture (VSR) after acute myocardial infarction (AMI) and the risk factors of all-cause mortality at 30 days after operation. Methods: This is a retrospective case series study. A total of 69 patients with post-AMI VSR, underwent percutaneous closure of VSR from October 2013 to May 2020 in Department of Cardiology of Henan Provincial People's Hospital and Department of Cardiology of Central China Fuwai Hospital, were included. Patients were divided into survival group (53 cases) and non-survival group (16 cases) according to the status at 30 days after operation. Clinical data were collected and analyzed during hospitalization. Telephone follow-up was performed 30 days after operation. The primary safety endpoint was occlusion failure and all-cause mortality at 30 days post operation. The secondary safety endpoint was the operation related or non-operation related complications. Efficacy endpoint included NYHA classification of cardiac function, index measured by right heart catheterization and echocardiography. Multivariate logistic regression was performed to analyze the risk factors of all-cause mortality at 30 days after operation. Results: A total of 69 patients, aged 67 (64, 71) years, including 42 women (60.9%), were enrolled in this study. All-cause death occurred in 16 patients (23.2%), including 13 in-hospital death and 3 death during follow-up. There were 4 cases of closure failure (5.8%). Among the 65 patients with successful closure, 12 (18.5%) experienced operation-related complications, among which 8 (12.3%) experienced valve injury. The mortality was significantly higher in patients with operation-related complications than that in patients without operation-related complications (41.7% (5/12) vs. 13.2% (7/53), P = 0.022). One case received percutaneous closure of VSR and PCI, this patient experienced new-onset AMI immediately post procedure and died thereafter (1.5%). One case (1.5%) developed multiple organ failure and 2 cases (3.1%) developed gastrointestinal bleeding post operation. All of the 65 patients with successful occlusion completed postoperative echocardiography, 56 patients completed cardiac function assessment at discharge, and 53 patients who survived up to 30 days post discharge completed clinical follow up by telephone. The NYHA cardiac function at discharge and 30 days after operation were significantly improved as compared to that before operation (P<0.001), the ratio of NYHA Ⅰ and Ⅱ patients was significantly higher post operation at these two time points as compared to baseline level (76.8% (43/56) vs. 23.1% (15/65), P<0.001, 77.4% (41/53) vs. 23.1% (15/65), P<0.001). The pulmonary circulation/systemic circulation blood flow ratio (Qp/Qs), pulmonary artery systolic pressure (PASP) and left ventricular end-diastolic diameter (LVDd) were decreased, aortic systolic pressure (ASP) and left ventricular ejection fraction (LVEF) were increased post operation (P<0.05). Multivariate logistic regression analysis showed that WBC>9.8×109/L (OR=20.94, 95%CI 1.21-362.93, P=0.037) and NT-ProBNP>6 000 ng/L (OR=869.11, 95%CI 2.93-258 058.34, P=0.020) were the independent risk factors of mortality at 30 days. Conclusions: Percutaneous closure in VSR after AMI is safe and effective. The increase of WBC and NT-ProBNP are the independent risk factors of all-cause mortality at 30 days after operation.


Asunto(s)
Infarto del Miocardio , Intervención Coronaria Percutánea , Rotura Septal Ventricular , Cuidados Posteriores , Femenino , Mortalidad Hospitalaria , Humanos , Alta del Paciente , Estudios Retrospectivos , Volumen Sistólico , Función Ventricular Izquierda , Rotura Septal Ventricular/etiología , Rotura Septal Ventricular/cirugía
8.
Zhonghua Xin Xue Guan Bing Za Zhi ; 49(9): 866-872, 2021 Sep 24.
Artículo en Zh | MEDLINE | ID: mdl-34530593

RESUMEN

Objective: To compare the efficacy and safety of pro-urokinase and reteplase in the treatment of patients with acute ST elevation myocardial infarction (STEMI). Methods: STEMI patients, who received intravenous thrombolytic therapy in Henan STEMI registry between September 2016 and August 2018, were eligible for this study. A total of 5479 patients from 66 hospitals were screened and patients were divided into pro-urokinase group (n=638) and reteplase group (n=702) according to thrombolytic drugs. Data including patient demographics, risk factors, medical histories, patient information at admission, in-hospital treatment, time delays, and clinical events were collected. The clinical recanalization rate, in-hospital mortality, in-hospital death or treatment withdrawal, in-hospital main adverse cardiovascular and cerebrovascular events (MACCE, death or treatment withdrawal, congestive heart failure, reinfarction and ischemic stroke) and post-thrombolysis bleeding were compared between the two groups. Bleeding events were evaluated with Bleeding Academic Research Consortium (BARC) criteria. Results: The median age [61.8 (53.2, 69.0) vs. 62.6 (52.1, 69.8), P=0.833] or the proportion of women [23.0% (147/638) vs. 25.1% (176/702), P=0.385] were similar between the pro-urokinase and reteplase groups. Clinical recanalization rates were similar between the pro-urokinase and reteplase groups [82.1% (524/638) vs. 84.9% (596/702), P=0.172], and there was no difference in the median time from onset to thrombolysis [194.5 (135.0,290.0) min vs. 190 (126.0,292.0) min, P=0.431] and the median recanalization time [95 (67.5,120.0) min vs. 95 (71.0,119.0) min, P=0.561] between the two groups. There was no significant difference in in-hospital mortality [5.5% (35/638) vs. 5.1% (36/702), P =0.770], in-hospital all-cause mortality, treatment withdrawal [8.9% (57/638) vs.7.7% (54/702), P=0.410], and in-hospital MACCE [13.0% (83/638) vs. 10.4% (73/702), P=0.137] between pro-urokinase and reteplase groups. However, the incidence of post-thrombolysis bleeding was significantly higher in reteplase group than in pro-urokinase group [7.8% (55/702) vs. 3.8% (24/638), P=0.002]. Further analysis found that the incidence of oral bleeding and the BARC grades 1-2 bleeding were significantly higher in reteplase group than in pro-urokinase group, whereas the incidence of cerebral hemorrhage was similar between the two groups [0.6% (4/638) vs. 0.4% (3/702), P=0.715]. The comparison of efficacy and safety outcomes between the two groups after adjusting for baseline characteristics using general linear mixed models was consistent with those before the adjustment. There was no significant difference in in-hospital mortality, in-hospital death or treatment withdrawal, in-hospital MACCE after adjusting for baseline characteristics and post-thrombolysis bleeding between the two groups. Conclusions: Pro-urokinase and reteplase have similar clinical efficacy in the treatment of STEMI. In terms of safety, the incidence of cerebral hemorrhage is similar, while the incidence of BARC grades 1-2 bleeding and oral bleeding is higher in reteplase group than in pro-urokinase group, which has no impact on in-hospital outcomes.


Asunto(s)
Infarto del Miocardio , Infarto del Miocardio con Elevación del ST , Femenino , Fibrinolíticos/uso terapéutico , Mortalidad Hospitalaria , Humanos , Infarto del Miocardio/tratamiento farmacológico , Proteínas Recombinantes , Infarto del Miocardio con Elevación del ST/tratamiento farmacológico , Terapia Trombolítica , Activador de Tejido Plasminógeno , Resultado del Tratamiento , Activador de Plasminógeno de Tipo Uroquinasa
9.
Zhonghua Yu Fang Yi Xue Za Zhi ; 54(3): 245-249, 2020 Mar 06.
Artículo en Zh | MEDLINE | ID: mdl-32187930

RESUMEN

The safety of prophylactic vaccine is one of the key points both in clinical trials and evaluation. Based on the review practice of vaccine registration clinical trials in recent years, we puts forward a series of thoughts and suggestions on the common problems of safety study on vaccine, including the hypothesis of safety study, the consideration of inclusion/exclusion criteria and suspension/termination criteria for study; the routine requirements of safety study and some special issue such as medical laboratory test index, vaccine virus shedding and safety of adjuvant, and further clarifies the requirements of safety observation on sequential enrollment; also emphasized the scientific judgment of causality and the quality of safety monitoring. It can be used for reference by vaccine researchers and to explore appropriate solutions to promote vaccine research & development and risk control in China.


Asunto(s)
Ensayos Clínicos como Asunto , Proyectos de Investigación , Vacunas , China
10.
Zhonghua Yu Fang Yi Xue Za Zhi ; 54(3): 250-255, 2020 Mar 06.
Artículo en Zh | MEDLINE | ID: mdl-32187931

RESUMEN

The safety of prophylactic vaccine is one of the key points both in clinical trials and evaluation. Based on the review practice of vaccine registration clinical trials in recent years, we summarized the common problems in safety analysis and report and accordingly puts forward a series of thoughts and suggestions, including discussing the role of statistics in safety analysis, putting forward the framework of safety analysis and report involved analysis content, analysis index and analysis dimension, in which attention is paid to the severity analysis; emphasizing the initiative analysis on risk signal and encouraging the evidence-based initiative safety evaluation. At the same time, this paper discusses the basic principles of the presentation of safety data in the package inserts, as well as the comprehensive consideration of the safety data of each phase of the trial and different subjects. It can be used for reference by sponsor to promote vaccine clinical research and evaluation in China.


Asunto(s)
Investigación Biomédica , Ensayos Clínicos como Asunto , Vacunas , China , Análisis de Datos
11.
Zhonghua Nei Ke Za Zhi ; 58(4): 278-281, 2019 Apr 01.
Artículo en Zh | MEDLINE | ID: mdl-30917420

RESUMEN

Objective: To analyze the relationship between the level of microRNA-29b in circulation and left ventricular hypertrophy in hypertensive patients. Methods: A total of 240 subjects from Henan Province People's Hospital from June 2015 to June 2018 were included in the present study. Among them, 160 were hospitalized patients, and were divided into two groups. Patients with simple hypertension and had no left ventricular hypertrophy (80 cases) were in the simple hypertension group (HBP-NLVH), and patients with hypertension combined with left ventricular hypertrophy (80 cases) were in the high blood pressure with left ventricular hypertrophy group (HBP-LVH). Normal control subjects (80 cases) were those with no hypertension and randomly selected from the medical center of Henan Province People's Hospital. Serum microRNA-29b expressions were detected by real time fluorescence quantitative PCR. The thickness of interventricular septum (IVSD) and left ventricular posterior wall thickness (LVPWD) were measured by echocardiography. Results: Compared with the normal control group (1.95±0.79), the relative expression of microRNA-29b in the patients both in the HBP-NLVH group (2.67±0.92) and the HBP-LVH group (5.12±1.23) was up-regulated, and the difference between normal control and patients was statistically significant (P<0.05). In patients, the microRNA-29b level in the HBP-LVH group was significantly higher than that in the HBP-NLVH group (P<0.05). The expression level of microRNA-29b was positively correlated with IVSD (r=0.71, P<0.05) and LVPWD (r=0.74, P<0.05), respectively. The sensitivity and specificity of serum microRNA-29b levels in the diagnosis of left ventricular hypertrophy in hypertension patients were 96.8% and 91.3%, respectively. Conclusion: Serum microRNA-29b level is elevated in hypertensive patients with left ventricular hypertrophy, and is positively correlated with left ventricular hypertrophy. The circulation microRNA-29b might be a useful biomarker with prognostic value in left ventricular hypertrophy in hypertension patients.


Asunto(s)
Hipertensión , Hipertrofia Ventricular Izquierda , MicroARNs/genética , MicroARN Circulante , Ecocardiografía , Humanos , Hipertensión/genética , Pronóstico
12.
Zhonghua Yi Xue Za Zhi ; 99(19): 1490-1493, 2019 May 21.
Artículo en Zh | MEDLINE | ID: mdl-31137140

RESUMEN

Objective: To investigate the relationship between Lipoprotein (LP) (a) level and the characteristics of tissue components of left main coronary artery (LMCA) plaque. Methods: A total of 102 patients with stable angina pectoris who underwent percutaneous coronary intervention (PCI) in the People's Hospital of Henan Province from June 2010 to October 2016 were included. We performed intravascular ultrasound-virtual histology (IVUS-VH) to their LMCAs and evaluated the tissue characteristics, and the blood level of total cholesterol (TC), triacylglycerol (TG), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), ApoB, ApoA1, LP(a) were measured. According to the value of their LP(a) level they were divided into 2 groups (high LP(a) group (>300 mg/L) (n=35) and low LP(a) group (≤300 mg/L) (n=67)), then the relationship between the above lipid values and the tissue characteristics of the LMCA plaque in the patients were evaluated. Results: Patients with a high LP(a) had a larger percentage of fibrolipid volume and a smaller percentage fibrous volume compared to patients with a normal LP(a) (25%±5% vs 13%±6%, P<0.01 and 50%±8% vs 61%±9%, P<0.01). Using multivariate linear regression analysis after adjustment for the above-mentioned confounding factors, LP(a) had a significantly positive correlation with fibrolipid volume percentage (r=0.645, ß=0.29, P<0.01), and had a negative correlation with fibrous volume percentage (r=-0.467, ß=-0.32,P<0.01), suggesting that the LP(a) was associated with the vulnerability of the LMCA plaque. Conclusion: For the patients with stable angina pectoris, the LP(a) has a significantly positive correlation with the percentage of fibrolipid volume and a negative correlation with the percentage of fibrous volume, suggesting that the LP(a) could predict the vulnerability of the LMCA plaque.


Asunto(s)
Angina Estable , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Placa Aterosclerótica , Humanos , Lipoproteína(a) , Ultrasonografía Intervencional
13.
Zhonghua Xin Xue Guan Bing Za Zhi ; 47(5): 360-366, 2019 May 24.
Artículo en Zh | MEDLINE | ID: mdl-31142079

RESUMEN

Objective: To investigate the blood lipid levels and prevalence of dyslipidemia in people with hypertension and diabetes in Henan province. Methods: From April 2016 to April 2017, multi-stage cluster sampling was adopted to investigate 71 285 local residents aged between 35 and 75 from 6 districts and counties in Henan province including Zhongmu county of Zhengzhou city, Huojia county of Xinxiang city, Hualong district of Puyang city, Qi county of Hebi city, Xigong district of Luoyang city, and Wugang city of Pingdingshan city. Blood samples were collected. According to the diagnostic criteria of hypertension and diabetes, the study population was divided into control group (n=29 427), hypertension group (n=21 965), diabetes group (n=8 009) and hypertension-diabetes group (n=11 884). Comparisons on blood lipid levels and dyslipidemia between 4 groups were performed. Results: The total cholesterol (TC) level of all subjects was 4.37 (3.78, 5.05) mmol/L. The triglyceride (TG) level was 1.27 (0.97, 1.80) mmol/L, the low-density lipoprotein cholesterol (LDL-C) level was 2.34 (1.88, 2.88) mmol/L and the high-density lipoprotein cholesterol (HDL-C) level was 1.31 (1.08, 1.59) mmol/L. Except for the TC level in women aged 65-75 years and LDL-C levels in women aged 55-64 and 65-75 years, there were significant differences in TC, TG, LDL-C and HDL-C levels between subjects of control group, hypertension group, diabetes group, and hypertension-diabetes group in different age ranges (including 35-44, 45-54, 55-64,and 65-75 years) and genders(all P<0.01).Except for the LDL-C and HDL-C in men aged 35-44 years and LDL-C in women aged 65-75 years, there were significant differences in the dyslipidemia rates of TC, TG, LDL-C and HDL-C between subjects of control group, hypertension group, diabetes group and hypertension-diabetes group in different age ranges and genders(P<0.01 or <0.05). After adjusting for age, gender, smoking, drinking, snoring, region, and body mass index, multivariate logistic regression analysis showed that hypertension (OR=1.221, 95%CI 1.113-1.339, P<0.01), diabetes (OR=1.636, 95%CI 1.461-1.833, P<0.01) and hypertension-diabetes (OR=1.832, 95%CI 1.658-2.023, P<0.01) were independent risk factors for TC abnormality. Hypertension (OR=1.566, 95%CI 1.478-1.659, P<0.01), diabetes (OR=2.182, 95%CI 2.031-2.342, P<0.01) and hypertension-diabetes (OR=2.655, 95%CI 2.492-2.829, P<0.01) were also independent risk factors for TG abnormality. Diabetes (OR=1.510, 95%CI 1.309-1.742, P<0.01) and hypertension-diabetes (OR=1.461, 95%CI 1.285-1.661, P<0.01) were independent risk factors for LDL-C abnormality. Diabetes (OR=1.261, 95%CI 1.180-1.346, P<0.01) and hypertension-diabetes (OR=1.195, 95%CI 1.126-1.268, P<0.01) were independent risk factors for HDL-C abnormality. Conclusion: The prevalence of dyslipidemia in patients with hypertension and diabetes is high in Henan province, so adequate blood lipid education and control should be applied to people with risk factors as soon as possible.


Asunto(s)
Diabetes Mellitus , Dislipidemias , Hipertensión , Lípidos , Adulto , Anciano , China/epidemiología , HDL-Colesterol , Diabetes Mellitus/epidemiología , Dislipidemias/epidemiología , Femenino , Humanos , Hipertensión/epidemiología , Lípidos/sangre , Masculino , Persona de Mediana Edad , Factores de Riesgo , Triglicéridos/sangre
14.
Zhonghua Nei Ke Za Zhi ; 57(4): 258-263, 2018 Apr 01.
Artículo en Zh | MEDLINE | ID: mdl-29614583

RESUMEN

Objective: To determine whether thyroid hormone (TH) level could also be an independent and incremental predictor of adverse events in patients with hypertrophic cardiomyopathy (HCM). Methods: A total of 982 consecutive patients with HCM at the National Center for Cardiovascular Diseases (China) from October 2009 to December 2013 were included in the present study, and followed up till the end of December 2016. The patients were divided into three groups according to the levels of free triiodothyronine (FT3): the group 1 (FT3≤4.28 pmol/L, n=335), the group 2 (FT3>4.28-<4.79 pmol/L, n=310), and the group 3 (FT3 4.79-6.30 pmol/L, n=337). Results: After a follow-up period of (53.8±14.1) months, 39 patients (4.0%) either suffered death with all causes or received a cardiac transplantation (7.8%, 2.9% and 1.2% of the patients in the group 1, group 2 and group 3, respectively). A multivariable Cox regression analysis revealed that FT3≤4.28 pmol/L was associated with a significantly higher risk of all-cause mortality or cardiac transplantation (HR 8.83, 95% CI 1.115- 69.905,P=0.039) in HCM patients. Conclusions: Low levels of FT3 is a risk factor of adverse events for patients with HCM, indicting a role of FT3 as a marker for assessing the risk of long-term adverse events in these patients.


Asunto(s)
Cardiomiopatía Hipertrófica/diagnóstico , Triyodotironina/sangre , Biomarcadores/sangre , Cardiomiopatía Hipertrófica/sangre , Cardiomiopatía Hipertrófica/mortalidad , China/epidemiología , Humanos , Pronóstico , Factores de Riesgo , Tasa de Supervivencia
15.
Zhonghua Yi Xue Za Zhi ; 98(8): 617-621, 2018 Feb 27.
Artículo en Zh | MEDLINE | ID: mdl-29534392

RESUMEN

Objective: To explore the effect of miR-19b on the function of P19CL6 cells and its molecular mechanism. Methods: Overexpression of miR-19b was carried out by transfecting miR-19b plasmid into the P19CL6 cells. MTT assay and flow cytometry were used to determine cell growth and apoptosis, respectively. Western blot was used to detect the expression level of Sox6 in P19CL6 cells. ELISA assay was used to detect the expression levels of apoptosis-related genes (Bax, Bcl-2) in P19CL6 cells at late-stage cardiac differentiation. Further online software TargetScan was used to predict the target genes of miR-19b and verified by dual luciferase reporter assay. Results: Our data showed that overexpression of miR-19b in P19CL6 cells significantly increased the cell growth rates and the apoptosis inhibition rates. The ratio of apoptosis-related proteins (Bax/Bcl-2) was significantly reduced. Results from the TargetScan and dual luciferase reporter showed that Sox6 is the direct target of miR-19b. Conclusions: We conclude that miR-19b might promote cell proliferation and inhibits cell apoptosis during the late-stage of cardiac differentiation by targeting Sox6 expression.


Asunto(s)
Apoptosis , Proliferación Celular , Animales , Ciclo Celular , Diferenciación Celular , Línea Celular Tumoral , Ratones , MicroARNs
16.
Zhonghua Xin Xue Guan Bing Za Zhi ; 46(3): 192-197, 2018 Mar 24.
Artículo en Zh | MEDLINE | ID: mdl-29562423

RESUMEN

Objective: To determine the value of N-terminal pro-B-type natriuretic peptide (NT-proBNP) on predicting the long-term outcome of patients with hypertrophic cardiomyopathy (HCM) . Methods: NT-proBNP was measured in 831 consecutive patients with HCM at Fuwai Hospital from October 2009 to December 2013 and patients were followed up clinically for (53.3±15.4) months. Patients were divided into 3 groups according to NT-proBNP values: NT-proBNP<860 pmol/L (n=276) , 860 pmol/L≤NT-proBNP≤1 905 pmol/L (n=278) , NT-proBNP>1 905 pmol/L (n=277) . The related baseline data, laboratory examination and echocardiographic results were compared among groups. The primary endpoints of this study were all-cause mortality and cardiac transplantation. Cox proportional hazards model was used to estimate hazard ratio (HR) . Kaplan-Meier analysis was used to evaluate the survival status of patients among the 3 groups. Results: During a median follow-up of (53.3±15.4) months, all-cause mortality or cardiac transplantation occurred in 37 patients (4.5%) , event rate was 1.4% (4/276) , 4.0% (11/278) and 7.9% (22/277) in patients with NT-proBNP<860 pmol/L, 860 pmol/L≤NT-proBNP≤1 905 pmol/L and NT-proBNP>1 905 pmol/L, respectively. Multivariable Cox regression analysis identified that age (HR 1.066, 95%CI 1.027-1.107) and NT-proBNP (HR 1.026, 95% CI 1.010-1.042) were independent predictors of all-cause mortality or cardiac transplantation. Among the 3 groups, the survival rate of the NT-proBNP<860 pmol/L group was the highest,and that of the NT-proBNP>1 905 pmol/L group was the lowest (P<0.01) . Conclusions: The level of NT-proBNP provides clinically relevant information for long-term adverse events risk stratification in patients with HCM.


Asunto(s)
Cardiomiopatía Hipertrófica , Péptido Natriurético Encefálico , Fragmentos de Péptidos , Biomarcadores , Cardiomiopatía Hipertrófica/sangre , Ecocardiografía , Humanos , Péptido Natriurético Encefálico/sangre , Fragmentos de Péptidos/sangre , Pronóstico
17.
Zhonghua Xin Xue Guan Bing Za Zhi ; 46(5): 364-369, 2018 May 24.
Artículo en Zh | MEDLINE | ID: mdl-29804438

RESUMEN

Objective: This cross-sectional study aimed to address the relationship between the volume of epicardial adipose tissue (EAT) with cardiovascular risk factors and coronary artery calcification(CAC) in the community residents. Methods: Individuals were recruited from the Jidong Community (Tangshan City, Northern China) which mainly comprised employees of the Jidong Co. Ltd. and their family members. From July 2013 to August 2014, 2 647 participants aged ≥40 years were included in this study. The volume of EAT and coronary artery calcification score (CAC score) were determined by a 64-slice CT. Carotid intima-media thickness (CIMT) was measured by a trained sonographer using a high-resolution B-mode topographic ultrasound system. Venous blood samples were analyzed by automated analyzers in the central laboratory. A validated questionnaire specifically designed for this study was used to collect demographic data from all participants by trained doctors. Characteristics of study cohort were compared according to quartiles of EAT volume (n=660, 663, 662, 662, repectively). Results: (1) The mean age of participants was (55.31±7.76) years and 49.94% (n=1 322) were men. The median EAT volume (interquartile) was 129.42 (95.66, 176.51)cm(3). (2) Age, BMI, waist circumference and hip circumference, systolic blood pressure, LDL-C, triglycerides, and fasting blood glucose were significantly higher, while HDL-C level was significantly lower in participants with higher EAT volume than participants with lower EAT volume (all P<0.05). Carotid intima-media thicken (CIMT) and higher CAC score were also significantly higher in participants with higher volume of EAT. Furthermore, percentage of diabetes mellitus, hypertension, hyperlipidemia increased in proportion with increasing EAT volume (P<0.05). (3) In the linear regression, significant positive relations were found for age (ß=0.019 3, 95%CI 0.017-0.021, P<0.001), waist circumference (ß=0.012 7, 95%CI 0.009-0.016, P<0.001), BMI (ß=0.022 4, 95%CI 0.013-0.032, P<0.001), LDL-C (ß=0.048 4, 95%CI 0.021-0.076, P<0.001), and HDL-C (ß=-0.098 1, 95%CI-0.164--0.032, P<0.001) was inversely related to the EAT volume. (4) Logistic regression analysis indicated that EAT volume was an independent risk factor for CAC score>0 (OR=1.233, 95%CI 1.205-1.262, P<0.001) . Conclusions: Our findings indicate that EAT volume is strongly correlated to cardiovascular risk factors and coronary calcification and is an independent risk factor of increased coronary calcification in community residents.


Asunto(s)
Tejido Adiposo , Enfermedades Cardiovasculares , Grosor Intima-Media Carotídeo , Calcificación Vascular , Tejido Adiposo/fisiopatología , Adulto , Enfermedades Cardiovasculares/epidemiología , China , Enfermedad de la Arteria Coronaria , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pericardio , Factores de Riesgo
18.
Zhonghua Yi Xue Za Zhi ; 97(27): 2101-2106, 2017 Jul 18.
Artículo en Zh | MEDLINE | ID: mdl-28763883

RESUMEN

Objective: To investigate the relationship between ApoB/A1 ratio and the characteristics of tissue components of their left main coronary artery(LMCA)plaque. Methods: A total of 98 patients with stable angina pectoris who received chronic statin treatment underwentpercutaneous coronary intervention in the People's Hospital of Henan Province from June 2010 to June 2016 were included.We prospectively performed intravascular ultrasound virtualhistology (IVUS-VH) to their LMCA and evaluated the tissue characteristics, and the blood level of total cholesterol (TC) and low-density lipoprotein cholesterol(LDL-C), high-density lipoprotein cholesterol(HDL-C), triglyceride(TG), LDL-C/HDL-C ratio, ApoB, ApoA1, ApoB/A1 ratio were measured, then the association of the tissue characteristics with the aboved lipids values were analyzed. Results: According to the median value of their ApoB/A1ratios (0.80), they were divided into 2 groups [high ApoB/A1 ratio (>0.80) (n=49) and low ApoB/A1 ratio (≤0.80) (n=49)]. The patients with a high ApoB/A1 ratio had alarger fibrolipid volume and a smaller fibrous volume compared to patients with a low ApoB/A1 ratio ( 17.5%±1.2% vs 9.0%±1.0%, P=0.03 and 55.1%±2.1% vs 63.9%±1.8%, P<0.01). Using multivariate linear regression analysis after adjustment for the above-mentioned confounding factors, the ApoB/A1 ratio had a significantly positive correlation with fibrolipid volume (r=0.445, ß=0.29, P=0.010)and had a negative correlation with fibrous volume (r=-0.567, ß=-0.32, P=0.011), suggesting that the ApoB/A1 ratio was associated with the vulnerability of the LMCA plaque. Conclusion: For the patients with stable angina pectoris and chronic treatment of statins, a high ApoB/A1 ratio is associated with a high percentage of fibrolipid volume and a low percentage of fibrous volume in LMCA lesions, suggesting that the ApoB/A1 ratios could predict the vulnerability of the LMCA plaque.


Asunto(s)
Angina Estable , Apolipoproteína A-I , Apolipoproteínas B , Biomarcadores , LDL-Colesterol , Vasos Coronarios , Humanos , Placa Aterosclerótica
19.
Genet Mol Res ; 15(1)2016 Mar 31.
Artículo en Inglés | MEDLINE | ID: mdl-27051029

RESUMEN

We investigated the possible association between two single nucleotide polymorphisms of IL10 (-1082A/G and -592C/A) and susceptibility to ischemic stroke. In total, 335 patients with proven ischemic stroke and 335 control subjects were recruited from Xinxiang Central Hospital between March 2013 and May 2015. The IL10 -1082A/G and -529C/A polymorphisms were investigated by polymerase chain reaction-restriction fragment length polymorphism. When compared with the control subjects, patients with ischemic stroke were more likely to be male, have a habit of tobacco smoking, have higher BMI, have hypertension or diabetes mellitus, and have higher levels of TC, LDL-C, HDL-C, and TG. The multivariate logistic regression analyses revealed that the AA genotype of IL10 -1082A/G was significantly associated with development of ischemic stroke in a Chinese population compared with the GG genotype (OR = 1.93, 95%CI = 1.15-3.25). In the dominant model, the association between GA+AA genotype of IL10 -1082A/G and risk of ischemic stroke was also significant compared with the GG genotype, and the adjusted OR (95%CI) for the GA+AA genotype was 1.41 (1.02-1.94). Thus, our study suggests that IL10 gene polymorphisms contribute to the development of ischemic stroke.


Asunto(s)
Isquemia Encefálica/genética , Interleucina-10/genética , Polimorfismo de Nucleótido Simple , Accidente Cerebrovascular/genética , Isquemia Encefálica/epidemiología , Estudios de Casos y Controles , China , Diabetes Mellitus/epidemiología , Femenino , Humanos , Hipertensión/epidemiología , Masculino , Persona de Mediana Edad , Factores Sexuales , Fumar/epidemiología , Accidente Cerebrovascular/epidemiología
20.
Zhonghua Yi Xue Za Zhi ; 96(14): 1131-3, 2016 Apr 12.
Artículo en Zh | MEDLINE | ID: mdl-27095784

RESUMEN

OBJECTIVE: To evaluate the feasibility of retrograde transcatheter closure of ventricular septal defects (VSD) under trans-esophageal echocardiography (TEE). METHODS: Twelve patients with VSD, with 4 residual shunt, treated by transcatheter VSD closure under solely guidance of TEE were summarized. Mean age, body weight and average diameter of VSD in 12 cases were (11.58±6.57) years, (31.85±13.28) kg, (5.50±2.20) mm, respectively. All patients were treated by retrograde transcatheter closure under solely guidance of TEE. The post-operative efficiency was estimated by TEE immediately. Patients were followed up by echocardiography, X-ray examination and electrocardiogram at 24 hours, 1, 3 and 6 months after the procedures. RESULTS: All 12 patients were treated successfully under solely guidance of TEE. The diameter of devices were 5-14 mm. There were 1 case with trivial residual shunt after the procedures immediately. No patients suffered from residual shunt, occluder malposition, peripheral vascular injury and pericardial effusion during the follow-up. CONCLUSION: Percutaneous transcatheter closure of VSD completely guided by TEE is safe and effective. This method could avoid the radiation and contrast media reaction, and also could simplify the procedure.


Asunto(s)
Cateterismo/métodos , Ecocardiografía Transesofágica/métodos , Defectos del Tabique Interventricular/diagnóstico por imagen , Defectos del Tabique Interventricular/cirugía , Implantación de Prótesis/métodos , Adolescente , Adulto , Niño , Preescolar , Ecocardiografía/métodos , Electrocardiografía , Estudios de Factibilidad , Estudios de Seguimiento , Ventrículos Cardíacos/diagnóstico por imagen , Humanos , Periodo Posoperatorio , Prótesis e Implantes , Resultado del Tratamiento , Ultrasonografía Intervencional , Adulto Joven
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