As a new clinical trial mode,decentralized & digitalized clinical trial(DCT)is based on digital health equipment and uses internet and artificial intelligence technologies to complete the screening,registration,randomization,intervention,evaluation and follow-up of subjects,which is helpful to improve efficiency and reduce trial costs.The DCT mode has been applied to evaluate the treatment and management effects of cardiovascular diseases such as atrial fibrilla-tion,heart failure,coronary heart disease,and hypertension,showing broad development prospects and application space.This article will provide a brief introduction to representative DCT in the global cardiovascular disease field,and look for-ward to the application prospects of this model,providing reference and guidance for accelerating the development of cardio-vascular DCT in China.

Objective·To measure the parameters of the uterine artery,umbilical artery and middle cerebral artery in a rat model of preeclampsia(PE)by Doppler ultrasound,and compare the pathological changes in placental blood vessels and pregnancy outcomes,in order to provide an effective method and reference for evaluating placental function in PE animal models.Methods·PE(n=8)and normal pregnancy(NP,n=8)groups in Sprague-Dawley(SD)rat models were established by intraperitoneal injections of N'-nitro-L-arginine methylesterhydrochloride(L-NAME)and 0.9%sodium chloride solution.Blood pressure and proteinuria indexes were detected to evaluate whether the model was successfully established.On gestational day 19(GD19),Doppler ultrasound was utilized to measure the parameters of the uterine artery,umbilical artery and the fetal middle cerebral artery in both the PE and NP groups.After termination of the pregnancies,placental function was evaluated through the pathology of placental blood vessels and the quality of the fetuses and placentas.Results·In the PE group,both blood pressure(GD15:P=0.001;GD19:P=0.001)and proteinuria(GD15:P=0.001;GD19:P=0.001)were significantly higher than those in the NP group.The pulsatility index(PI)of the umbilical artery and uterine artery was notably elevated in the PE group compared to the NP group(both P=0.000).Furthermore,the resistance index(RI)of the fetal middle cerebral artery was significantly lower than that in the PE group(P=0.000).While the number of fetal rats did not differ significantly,the quality of placental and fetal rats was notably lower in the PE group(P=0.006 and P=0.000,respectively).Immunohistochemical staining of placental tissue revealed that the number of placental micro vessel densities in the PE group was less than that in the NP group(P=0.001).Correlation analysis revealed that placental micro vessel density,fetal quality and placental quality were inversely related with the RI of the umbilical artery and the PI and RI of the uterine artery,and positively correlated with the S/D,PI and RI of the fetal middle cerebral artery(all P<0.05).Conculsion·Doppler ultrasound assessment of the uterine artery,umbilical artery and middle cerebral artery indices in L-NAME-induced PE rat models effectively reflects pregnancy outcomes and placental vascular pathology.This method is valuable for evaluating placental vascular perfusion in PE rat models,offering practicality and convenience for research involving animal models.

Objective:To investigate the influence of first pass effect (FPE) in prognoses of patients with acute intracranial large vessel occlusion in anterior circulation accepted mechanical thrombectomy with domestic stent retriever, and the influencing factors for FPE.Methods:A total of 223 patients with acute intracranial large vessel occlusion in anterior circulation accepted mechanical thrombectomy with domestic stent retriever were selected from 3 prospective, multicenter, open, randomized controlled clinical trials (REDIRECT trial, Tonbridge trial, CAPTURE trial). According to modified Rankin Scale (mRS) scores 90 d after thrombectomy, these patients were divided into good prognosis group (mRS scores≤2, n=131) and poor prognosis group (mRS scores>2, n=92); these patients were also divided into FPE group ( n=69) and non-FPE group ( n=154) according to whether FPE was achieved (complete recanalization with single stent retriever, modified Thrombolysis in Cerebral Infarction [mTICI] 3); differences in baseline data and surgical parameters between the 2 groups were compared; multivariate Logistic regression was used to analyze the independent influencing factors. Results:(1) Patients in the good prognosis group had significantly younger age, significantly lower National Institute of Health stroke scale (NIHSS) scores at admission, transient ischemic attack ratio, atrial fibrillation ratio and ratio of internal carotid artery as responsible occlusive vessel, statistically shorter time from onset to admission, time from onset to femoral artery puncture and time from femoral artery puncture to vascular recanalization compared with those in the poor prognosis group ( P<0.05); FPE proportion in the good prognosis group was significantly higher than that in the poor prognosis group ( P<0.05). Multivariate Logistic regression analysis showed that middle cerebral artery occlusion ( OR=0.459, 95% CI: 0.247-0.854, P=0.014), and FPE ( OR=2.485, 95% CI: 1.282-4.816, P=0.007), NIHSS score at admission ( OR=0.894, 95% CI: 0.837-0.955, P=0.001), time from femoral artery puncture to vascular recanalization ( OR=0.993, 95% CI: 0.987-0.999, P<0.001) were independent influencing factors for good prognosis. (2) The FPE group had significantly shorter time from femoral artery puncture to stent thrombectomy and higher proportion of balloon guided catheter (BGC) than the non-FPE group ( P<0.05). Multivariate Logistic regression analysis showed that BGC application was an independent influencing factor for FPE ( OR=3.185, 95% CI: 1.494-6.791, P=0.003). Conclusion:FPE can improve prognosis of patients with acute intracranial large vessel occlusion in anterior circulation accepted mechanical thrombectomy with domestic stent retriever, and BGC application helps FPE.

Objective:To explore the relationship between the imaging features of enhanced MRI in patients with central chronic pulmonary artery thromboembolism (CPTE) and pulmonary vascular resistance (PVR).Methods:Thirty-nine patients with CPTE who had contrast-enhanced MRI examination were retrospectively enrolled this study from January 2018 to December 2020. And 33 patients who received right heart catheterization were divided into two groups based on PVR=1 000 dyn·s·cm -5. The differences of imaging features of CPTE in enhanced MRI between the two groups were compared. The relationship between gender, duration of disease, age, pleural thickening, bilateral bronchial artery dilation, number of the involved vascular segments, number of thrombosis, number of the thrombus-related delayed enhancement of artery wall and PVR was analyzed by binary logistic regression. Results:In 39 patients with central CPTE, the dilated lumen (168, 43.30%) and delayed enhancement of wall (122, 31.52%) were found in most of pulmonary arteries. The rate of the lumen dilatation associated with thrombus was the highest among that of the lumen abnormality (66, 52.80%). There were more thrombi in PVR<1 000 dyn·s·cm -5 group than those in PVR≥1 000 dyn·s·cm -5 group (χ 2=9.55, P=0.002). There was no significant difference in the incidence of wall delayed enhancement associated the thrombus between the two groups (χ 2=0.90, P=0.344). The incidence of bilateral bronchial arterial dilatation in PVR<1 000 dyn·s·cm -5 group was higher than that in PVR≥1 000 dyn·s·cm -5 group ( P=0.019). Logistic regression analysis showed that female, the less number of involved vascular segments and bilateral bronchial artery dilation were correlated with the lower PVR. Conclusions:Enhanced MRI is helpful to accurately evaluate the lumen abnormality of pulmonary artery and wall remodeling in central CPTE, which is of great value for the assessment of patients′ conditions and treatment effect.

Abstract OBJECTIVE To develop a vancomycin individualized dosing-assisted decision platform suitable for practical clinical application scenarios and provide individualized dosing recommendations for the rational use of vancomycin. METHODS Based on the vancomycin population pharmacokinetic model that had been constructed and verified to be feasible, the vancomycin individualized assisted decision-making platform was developed by using Idea2019, JDK1.8, ETL and other software tools. The platform development had gone through three main stages, included ①requirement analysis; ②design stage; ③software testing and optimization. RESULTS The vancomycin individualized assisted decision-making platform, which was successfully developed and applied, had the advantages of simple page, perfect function and convenient operation, and was divided into four main modules according to functions, namely retrieval module, information module, concentration prediction module and reporting module. The platform could connect to the hospital intranet platform to automatically obtain patient information, medication information and blood concentration test results, and calculate individual pharmacokinetic parameters for subsequent concentration prediction based on the embedded population pharmacokinetic model, combined with individual parameters. The concentration prediction module incorporated the Bayesian feedback method with patient medication information, drug concentration measurement results and relevant covariate parameter values, took the guideline-recommended trough concentration and AUC range as the target value, calculated the individualized drug administration scheme that met the target concentration range, and set up custom simulation functions considering the actual clinical application scenarios, which was of more popularization and application value. CONCLUSION Based on the vancomycin population pharmacokinetic model that has been successfully constructed in the previous stage, with the assistance of Idea2019, JDK1.8, ETL and other software tools, a vancomycin individualized dosing-assisted decision platform has successfully constructed, which can more efficiently and conveniently assist monitoring pharmacists to provide individualized dosing advice for clinical use of vancomycin.

Objective:To construct a cluster care of oral nutrition supplements (ONS) , and to explore its effect in home care of postoperative patients with gastric cancer.Methods:Literature search was conducted to review the status quo of ONS compliance at home in patients with gastric cancer after surgery, and analyze the existing problems. We summarized and formulated the cluster care plan according to the evidence, and established the home ONS management team and process. From November 2020 to October 2021, 107 patients with gastric cancer who needed to implement ONS at home in Gastrointestinal Surgery of Ningbo First Hospital were selected as research objects by convenience sampling. Postoperative patients with gastric cancer from November 2020 to April 2021 were set as the control group ( n=40) , and those from May to October 2021 were set as the observation group ( n=67) . The control group was treated with conventional ONS, and the observation group was treated with home ONS cluster care plan on the basis of the control group. The compliance of nutritional support, weight gain, body mass index increase and follow-up experience between the two groups were evaluated. Results:After six months of intervention, the scores of ONS compliance, weight gain, body mass index increase and follow-up experience in the observation group were significantly higher than those in the control group, and the differences were statistically significant ( P<0.05) . Conclusions:The cluster care plan improves the ONS compliance at home, nutritional status and satisfaction with the follow-up by medical and nursing staff in patients with gastric cancer after surgery, which is worthy of clinical promotion.

Objective:To summarize the best evidence for early enteral nutrition support in postoperative patients with gastric cancer and evaluate its effectiveness.Methods:From March to August 2021, 108 postoperative patients with gastric cancer admitted to the Gastrointestinal Surgery of the First Affiliated Hospital of Ningbo University were selected. We applied evidence-based nursing methods to summarize the best evidence for early enteral nutrition support in postoperative gastric cancer patients, and constructed and implemented the best evidence application strategy through baseline review, evaluation of evidence application clinical scenarios and barriers. We compared the various indicators of two groups of patients before the application of evidence (March to May 2021, n=55) and after the application of evidence (June to August 2021, n=53) . Results:No adverse events occurred during the application of evidence. After applying evidence, the correct nutritional assessment rate increased from 41.82% (23/55) at baseline review to 90.57% (48/53), the implementation rate of early postoperative enteral nutrition increased from 0 to 45.28% (24/53), the start time of postoperative enteral nutrition shortened from (3.75±2.33) days to (2.06±1.38) days, and the implementation rate of postoperative priority oral nutrition increased from 63.64% (35/55) to 86.79% (46/53), nutritional related complications decreased from 40.00% (22/55) to 20.75% (11/53), and the differences were all statistically significant ( P<0.05) . Conclusions:The application of the best evidence for early enteral nutrition support in postoperative gastric cancer patients can shorten the start time of postoperative enteral nutrition, reduce postoperative nutrition related complications, and promote early recovery of patients.

Detailed characterizations of genomic alterations have not identified subtype-specific vulnerabilities in adult gliomas. Mapping gliomas into developmental programs may uncover new vulnerabilities that are not strictly related to genomic alterations. After identifying conserved gene modules co-expressed with EGFR or PDGFRA (EM or PM), we recently proposed an EM/PM classification scheme for adult gliomas in a histological subtype- and grade-independent manner. By using cohorts of bulk samples, paired primary and recurrent samples, multi-region samples from the same glioma, single-cell RNA-seq samples, and clinical samples, we here demonstrate the temporal and spatial stability of the EM and PM subtypes. The EM and PM subtypes, which progress in a subtype-specific mode, are robustly maintained in paired longitudinal samples. Elevated activities of cell proliferation, genomic instability and microenvironment, rather than subtype switching, mark recurrent gliomas. Within individual gliomas, the EM/PM subtype was preserved across regions and single cells. Malignant cells in the EM and PM gliomas were correlated to neural stem cell and oligodendrocyte progenitor cell compartment, respectively. Thus, while genetic makeup may change during progression and/or within different tumor areas, adult gliomas evolve within a neurodevelopmental framework of the EM and PM molecular subtypes. The dysregulated developmental pathways embedded in these molecular subtypes may contain subtype-specific vulnerabilities.
Humans ; Brain Neoplasms/pathology* ; Neoplasm Recurrence, Local/metabolism* ; Glioma/pathology* ; Neural Stem Cells/pathology* ; Oligodendrocyte Precursor Cells/pathology* ; Tumor Microenvironment

Objective:To investigate the effect of sarcopenia on physical performance and nutritional status in elderly patients with gastrointestinal tumors.Methods:a total of 120 eligible in-patients were enrolled from gastrointestinal surgery department of a Grade A tertiary hospital in Ningbo city from September 2021 to January 2022. General clinical data were collected, nutritional risk was screened using Nutritional Risk Screening 2002 (NRS 2002), physical performance was assessed by Short Physical Performance Battery (SPPB), skeletal muscle index at the third lumbar vertebra level (L3 SMI) was calculated using abdominal CT scan, and grip strength/muscle strength, gait speed by 6 Meter Timed Walk Test and calf circumference were measured. Subjects were divided into sarcopenia and non-sarcopenia group according to the diagnostic criteria of the Asian Working Group for Sarcopenia (AWGS). Impacting factors of sarcopenia and the correlation between muscle mass and physical performance in elderly patients with gastrointestinal tumors were analyzed.Results:The overall prevalence rate of sarcopenia in elderly patients with gastrointestinal tumors was 28.3% (34/120) and it was 28.9% (22/76) and 27.3% (12/44) in males and females respectively. There were statistically significant differences in age, tumor stage, nutritional risk, body mass index, calf circumference, L3 SMI, grip strength/muscle strength, gait speed and SPPB score between patients with and without sarcopenia (P<0.05). Muscle strength/grip strength, L3 SMI and gait speed were closely correlated with the occurrence of sarcopenia in elderly patients with gastrointestinal tumors (P<0.05). The L3 SMI was positively correlated with physical performance as assessed with SPPB in both groups.Conclusions:Sarcopenia is a common complication in elderly patients with gastrointestinal tumors with multiple influencing factors. Timely nutritional intervention and exercise intervention should be incorporated into the treatment of elderly gastrointestinal tumor patients with sarcopenia in order to improve nutrition status.

Objective:To analyze and monitor the genetic stability of Omicron strain inactivated vaccine.Methods:The virus seeds of Omicron strain for inactivated vaccine through different routes, that was with plaque purification or not, were continuously passaged on cells, and then the supernatant of cell culture was harvested to extract virus nucleic acid. The next generation sequencing was used to analyze virus transcriptome, and the differences of mutation sites, mutation frequencies and insertions/deletions in the whole genome of Omicron virus under different conditions were compared.Results:After continuous passage, more than 5% mutation sites in ORF1ab and S gene sequences were significantly less in the plaque-purified seed than those of the virus without plaque purification, and no insertion/deletion mutations were detected in the whole genome of the purified virus.Conclusions:The nucleic acid sequences of virus with different routes were analyzed by next generation sequencing. The result showed that the genetic stability of virus after plaque purification was better than that of unpurified virus strains, which provides a scientific basis for virus seed selection in the development of inactivated vaccine.