Objective To investigate the safety and efficacy of novel bioabsorbable vascular scaffold(BVS)in the treatment of patients with complex coronary artery disease.Methods This was a retrospective,matched,single-center observational study.45 patients with coronary atherosclerotic cardiopathy received BVS treatment in the cardiovascular medicine department Department of the Affiliated Hospital of Guangdong Medical University from June 2020 to June 2021(BVS),and 45 patients treated with drug-eluting stents(DES)group were selected according to matching study requirements during the same period.Baseline,surgical,and follow-up data were compared between the two groups to evaluate safety and efficacy.The main measures of safety were:surgical time,intraoperative adverse events,etc.,and the end point of efficacy was target lesion failure(TLF),including cardiac death,target vessel myocardial infarction,and ischa-driven target lesion revascularization.Results A total of 90 patients were enrolled in this study,all of whom were followed up for at least 3 years.There were 20 cases of bifurcation lesions and 25 cases of diffuse long lesions in the two groups,and 50 cases of imaging were reviewed among the 90 patients.The proportion of stable coronary heart disease,history of diabetes,history of hypertension,history of smoking,pre-dilated balloon pressure and postoperative diastolic blood pressure in BVS group was higher than that in DES group,and the proportion of family history was lower than that in DES group(all P＜0.05).There were no statistically significant differences in the rates of cardiac death,target vessel myocardial infarction,and ischemia-driven revascularization of target lesions between the two groups(all P＞0.05).Binary Logistic regression model analysis showed that the diameter stenosis ratio of target lesions was an independent risk factor for intrastent restenosis(OR 2.786,95％CI 1.096-7.081,P=0.031).Conclusions Compared with traditional DES,BVS implantation has consistent safety and efficacy in the treatment of complex coronary artery disease within 3 years.The diameter stenosis ratio of target lesions was an independent risk factor for intrastent restenosis.

OBJECTIVE: To explore the carrier rate, genotype and phenotype of α-thalassemia fusion gene in Huadu district of Guangzhou, Guangdong province of China, and provide data reference for the prevention and control of thalassemia. METHODS: A total of 10 769 samples who were screened for thalassemia in Maternal and Child Health Hospital of Huadu District from July 2019 to November 2020 were analyzed retrospectively. Blood cell analysis and hemoglobin (Hb) electrophoresis were performed. Thalassemia genes were analyzed by gap-PCR and PCR-reverse dot blot hybridization (PCR-RDB). RESULTS: A total of 9 cases with α-thalassemia fusion gene were detected in 10 769 samples (0.08%). There were 7 cases with fusion gene heterozygote, 1 case with compound of α-thalassemia fusion gene and Hb G-Honolulu, 1 case with compound of α-thalassemia fusion gene and Hb QS. The MCV results of 4 samples of blood cell analysis were within the reference range, the Hb A2 value of 1 case was decreased, and there were no other abnormalities found. CONCLUSION The α-thalassemia fusion gene is common in Huadu district of Guangzhou, and heterozygotes are more common, and current screening methods easily lead to misdiagnosis.
Humans ; alpha-Thalassemia/genetics* ; Retrospective Studies ; beta-Thalassemia/genetics* ; Genotype ; Phenotype ; Heterozygote ; China ; Mutation

OBJECTIVES: To investigate the clinical treatment outcomes and the changes of the outcomes over time in extremely preterm twins in Guangdong Province, China. METHODS: A retrospective analysis was performed for 269 pairs of extremely preterm twins with a gestational age of <28 weeks who were admitted to the department of neonatology in 26 grade A tertiary hospitals in Guangdong Province from January 2008 to December 2017. According to the admission time, they were divided into two groups: 2008-2012 and 2013-2017. Besides, each pair of twins was divided into the heavier infant and the lighter infant subgroups according to birth weight. The perinatal data of mothers and hospitalization data of neonates were collected. The survival rate of twins and the incidence rate of complications were compared between the 2008-2012 and 2013-2017 groups. RESULTS: Compared with the 2008-2012 group, the 2013-2017 group (both the heavier infant and lighter infant subgroups) had lower incidence rates of severe asphyxia and smaller head circumference at birth (P<0.05). The mortality rates of both of the twins, the heavier infant of the twins, and the lighter infant of the twins were lower in the 2013-2017 group compared with the 2008-2012 group (P<0.05). Compared with the 2008-2012 group, the 2013-2017 group (both the heavier infant and lighter infant subgroups) had lower incidence rates of pulmonary hemorrhage, patent ductus arteriosus (PDA), periventricular-intraventricular hemorrhage (P-IVH), and neonatal respiratory distress syndrome (NRDS) and a higher incidence rate of bronchopulmonary dysplasia (P<0.05). CONCLUSIONS There is a significant increase in the survival rate over time in extremely preterm twins with a gestational age of <28 weeks in the 26 grade A tertiary hospitals in Guangdong Province. The incidences of severe asphyxia, pulmonary hemorrhage, PDA, P-IVH, and NRDS decrease in both the heavier and lighter infants of the twins, but the incidence of bronchopulmonary dysplasia increases. With the improvement of diagnosis and treatment, the multidisciplinary collaboration between different fields of fetal medicine including prenatal diagnosis, obstetrics, and neonatology is needed in the future to jointly develop management strategies for twin pregnancy.
Bronchopulmonary Dysplasia/epidemiology* ; Female ; Gestational Age ; Humans ; Infant ; Infant, Extremely Premature ; Infant, Newborn ; Pregnancy ; Respiratory Distress Syndrome, Newborn/epidemiology* ; Retrospective Studies ; Treatment Outcome

ObjectiveTo explore the mechanism of Xueniao capsule in the treatment of acute pyelonephritis （APN） by network pharmacology and experimental verification. MethodThe effect of Xueniao capsule on APN was investigated based on the APN model in rats. The Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform （TCMSP）， Chemistryl Database， and SymMap were searched for the chemical components of Smilacis Chinae Rhizoma，Coicis Semen， and Trachycarpi Petiolus. The target information of the components was collected from PharmMapper and SwissTargetPrediction， and disease target information from Therapeutic Target Database （TTD）， DrugBank， DisGeNET， GeneCards， and Online Mendelian Inheritance in Man（OMIM）. The key genes of Xueniao capsule for APN underwent Gene Ontology（GO） and Kyoto Encyclopedia of Genes and Genomes（KEGG） pathway enrichment analyses by Metascap. Real-time quantitative polymerase chain reaction （PCR） and Western blot were employed to verify the prediction results. ResultCompared with the blank group and the sham operation group， the model group showed an increased ratio of the left kidney to the right kidney and organ index（P<0.05， P<0.01），up-regulated white blood cells （WBC），neutrophils （NEUT），monocytes （MONO）， and lymphocytes （LY）（P<0.05， P<0.01）， and elevated levels of nuclear factor-κB（NF-κB）， interleukin-6 （IL-6）， and tumor necrosis factor-α （TNF-α）（P<0.05， P<0.01）. Compared with the model group， the norfloxacin group， the low- and high-dose Xueniao capsule groups showed a decreased ratio of the left kidney to the right kidney and organ index（P<0.05， P<0.01）， dwindled levels of WBC， NEUT， MONO， and LY（P<0.05， P<0.01）， and reduced levels of NF-κB， IL-6， and TNF-α（P<0.05， P<0.01）. The medium-dose Xueniao capsule group showed a decreased ratio of the left kidney to the right kidney and organ index（P<0.05， P<0.01）， reduced levels of WBC， NEUT， MONO， and LY（P<0.05， P<0.01）， and dwindled levels of IL-6 and TNF-α（P<0.05， P<0.01）. Network pharmacological analysis revealed 17 active compounds from Smilacis Chinae Rhizoma， 18 active compounds from Coicis Semen， six active compounds from Trachycarpi Petiolus， and 39 key genes for the treatment of APN in Xueniao capsule. GO enrichment analysis demonstrated 704 biological processes， 22 cellular components， and 59 molecular functions. Sixty-two pathways were enriched in KEGG enrichment analysis. The experimental verification results showed that compared with the blank group， the model group showed increased mRNA expression of prostaglandin-endoperoxide synthase 2 （PTGS2）， mitogen-activated protein kinase 1 （MAPK1）/extracellular signal-regulated protein kinase 2 （ERK2），phosphoinositide 3 kinase （PI3K），protein kinase B2（Akt2），Janus kinase 2 （JAK2），and signal transducer and activator of transcription 3 （STAT3）and protein expression of PI3K， Akt2， JAK2， and STAT3 （P<0.05， P<0.01）. Compared with the model group， the low-dose Xueniao capsule group showed decreased mRNA expression of MAPK1， PI3K， JAK2， and STAT3 and protein expression of PI3K， JAK2， and STAT3 （P<0.05， P<0.01）. The medium-dose Xueniao capsule group showed decreased mRNA expression of MAPK1， PTGS2， PI3K， JAK2， and STAT3， and protein expression of PI3K， JAK2， and STAT3 （P<0.05， P<0.01）. The high-dose Xueniao capsule group showed reduced mRNA expression of PTGS2， MAPK1， PI3K， Akt2， JAK2， and STAT3 and protein expression of PI3K， Akt2， JAK2， and STAT3 （P<0.05， P<0.01）. ConclusionXueniao capsule has a certain curative effect on APN via multiple targets and multiple pathways. The mechanism may be related to the inhibition of the PI3K/Akt signaling pathway and the JAK2/STAT3 signaling pathway.

Objective: We evaluated the safety and efficacy of lipoprotein apheresis (LA) in patients with familial hypercholesterolemia (FH) who can't reach low-density lipoprotein cholesterol(LDL-C) target goals with the maximal tolerated dose of lipid-lowering agents. Methods: This was a retrospective cross-sectional study. Between February 2015 and November 2019, patients with FH who were admitted in Fuwai hospital and treated with LA were consecutively enrolled. Based on intensive lipid-lowering agents, these patients received LA by double filtration plasma pheresis (DFPP) method. The changes of lipid levels such as LDL-C and lipoprotein(a)[Lp(a)] were compared before and after LA treatment, and the changes of immunoglobulin (Ig) concentration and LA-related adverse effects were also discussed. Results: A total of 115 patients with FH were enrolled in this study, of which 8 cases were homozygous FH and 107 cases were heterozygous FH. The age was (43.9±12.2) years and there were 75 (65.2%) males, and 108 (93.8%) with coronary artery disease. For pre-and immediately after LA treatment, the LDL-C was (5.20±2.94) mmol/L vs. (1.83±1.08) mmol/L, Lp(a) concentration was 428.70(177.00, 829.50)mg/L vs. 148.90(75.90, 317.00) mg/L (P<0.001), with a decrease of 64.2% and 59.8% respectively. The levels of IgG and IgA measured 1 day after LA treatment were both in the normal range and IgM concentration was below the reference value, the reductions of which were 15.1%, 25.0% and 58.7% respectively (P<0.001). Six patients had mild symptoms of nausea, hypotension dyspnea and palpitation, the symptoms were relieved by symptomatic treatment. Conclusion: For patients with FH who do not achieve LDL-C target goal with the maximal tolerated lipid-lowering agents, especially those with elevated Lp(a) levels, LA, which can significantly further reduce LDL-C and Lp(a) levels, is an effective and safe option.
Adult ; Blood Component Removal/methods* ; Cholesterol, LDL ; Cross-Sectional Studies ; Female ; Humans ; Hyperlipoproteinemia Type II/therapy* ; Lipoprotein(a)/chemistry* ; Lipoproteins/chemistry* ; Male ; Middle Aged ; Retrospective Studies

The pre-market approval and clinical application of innovative medical devices should be based on high-quality evidence, proving their reliability, safety and effectiveness. In 2016, the IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up) collaboration modified the original IDEAL framework and recommendation to the IDEAL-D methodological framework for the entire life cycle evaluation of innovative medical devices. The framework included five stages, namely the preclinical development stage, idea stage, exploration stage, assessment stage and long-term follow-up stage. This paper aims to interpret the study purpose, content and design at each step of the IDEAL-D framework based on IDEAL framework and recommendation (2019) to provide practical methodological guidance for the design and conduct of clinical research on innovative medical devices.

AIM: To investigate the effect of different degrees of traction power on the survival rate of retinal ganglion cells(RGCs)and nerve conduction in rats, and to discuss the effect of autophagy level of RGCs on the above parameters.METHODS: A total of 30 healthy male Sprague-Dawley(SD)rats were randomly divided into empty group, sham-operation group, 0.15N, 0.3N and 0.6N group, with 6 rats in each group.Modeling group was performed the transverse quantitative traction to make a rat model of optic nerve injury. In addition, rats in empty group were not operated and rats in sham-operation group only got optic nerve exposed. Flash visual evoked potentials(f-VEP)were performed respectively on 1 and 3d after modeling.The survival of retinal ganglion cells was observed by Brn-3a staining at 3d after modeling, autophagy bodies were observed by transmission electron microscope, and the expression level of LC3B II/I protein was detected by Western blotting.RESULTS: Compared with sham-operation group, the f-VEP P2 peak was significantly delayed and the amplitude reduced at 3d after modeling. In addition, the survival rate of RGCs was decreased, and the expression level of LC3B II/I protein were decreased. Autophagy bodies were observed in the retinal tissue of rats in all groups.CONCLUSION: Optic nerve traction reduced early retinal autophagy level, death of RGCs and corresponding nerve conduction dysfunction in rats,and different traction caused different degrees of injury. In addition,there was a correlation between the autophagy level and the survival of RGCs.

Objective: To determine the situation of myopia among primary and junior high school students from 2019 to 2021 in Yinzhou District, Ningbo City, Zhejiang Province. Methods: Cross-sectional study. Department of Ophthalmology, The Affiliated People's Hospital of Ningbo University, carried out a cross-sectional study by reviewing the results of five times visual acuity screens among primary and junior high school students from 2019 to 2021 in Yinzhou District, Ningbo City, Zhejiang Province. The myopia rate, High myopia rate and spherical equivalent refraction were calculated according to the uncorrected distance visual acuity and non-cycloplegic subjective refraction. Chi-square test and analysis of variance were used to analysis the difference of myopia among term, sex and eye. Results: The visual acuity screen had been completed five times from 2019 to 2021 in Yinzhou District, with a total of 458 654 people, of which 454 812 people met the inclusion criteria. The myopia rate of each screen is 56.6%(50 443/89 122),52.5%(48 463/92 311),63.7%(57 968/91 002),53.2%(48 351/90 886),64.4%(58 920/91 491). The rate of Myopia increased gradually with promoting to high grade, and it was obviously in low grade,up to 17.6%. Conclusion: The myopia rate of primary and junior high school students was raising volatility from 2019 to 2021 in Yinzhou District, Ningbo City, Zhejiang Province.
Humans ; Cross-Sectional Studies ; Myopia ; Refraction, Ocular ; Visual Acuity ; Students ; Prevalence

Objective: To evaluate the efficacy and safety of fecal microbiota transplantation (FMT) in the treatment of autism spectrum disorder (ASD). Methods: A longitudinal study was conducted. Clinical data from ASD patients with gastrointestinal symptoms and who underwent FMT in the Tenth People's Hospital affiliated to Tongji University or Jinling Hospital between May 2012 to May 2021 were retrospectively collected. Scores derived from the autism behavior checklist (ABC), the childhood autism rating scale (CARS), the Bristol stool form scale (BSFS), and the gastrointestinal symptom rating scale (GSRS) were analyzed at baseline and at the 1st, 3rd, 6th, 12th, 24th, 36th, 48th and 60th month after FMT. Records of any adverse reactions were collected. Generalized estimating equations were used for analysis of data on time points before and after FMT. Results: A total of 328 patients met the inclusion criteria for this study. Their mean age was 6.1±3.4 years old. The cohort included 271 boys and 57 girls. The percentage of patients remaining in the study for post-treatment follow-up at the 1st, 3rd, 12th, 24th, 36th, 48th and 60th month were as follows: 303 (92.4%), 284 (86.7%), 213 (64.9%), 190 (57.9%), 143 (43.6%), 79 (24.1%), 46 (14.0%), 31 (9.5%). After FMT, the average ABC score was significantly improved in the first 36 months and remained improved at the 48th month. However, the average score was not significantly different from baseline by the 60th month (1st-36th month, P<0.001; 48th month, P=0.008; 60th month, P=0.108). The average CARS score improved significantly during the first 48 months and remained improved at the 60th month (1st-48th month, P<0.001; 60th month, P=0.010). The average BSFS score was also significantly improved in the first 36 months (with an accompanying stool morphology that resembled type 4). This improvement was maintained at the 48th month. However, the average score was similar to baseline at the 60th month (1st-36th month, P<0.001; 48th month, P=0.008; 60th month, P=0.109). The average GSRS score was significantly improved during the first 24 months, but not afterwards (1st-24th month, P<0.001; 36th month, P=0.209; 48th month, P=0.996; 60th month, P=0.668). The adverse events recorded during treatment included abdominal distension in 21 cases (6.4%), nausea in 14 cases (4.3%), vomiting in 9 cases (2.7%), abdominal pain in 15 cases (4.6%), diarrhea in 18 cases (5.5%), fever in 13 cases (4.0%), and excitement in 24 cases (7.3%). All adverse reactions were mild to moderate and improved immediately after suspension of FMT or on treatment of symptoms. No serious adverse reactions occurred. Conclusion: FMT has satisfactory long-term efficacy and safety for the treatment of ASD with gastrointestinal symptoms.
Autism Spectrum Disorder/therapy* ; Child ; Child, Preschool ; Fecal Microbiota Transplantation/adverse effects* ; Feces ; Female ; Gastrointestinal Diseases ; Humans ; Longitudinal Studies ; Male ; Retrospective Studies

Objective     To systematically evaluate the safety, efficacy, and economics of intracardiac echocardiography (ICE) versus transesophageal echocardiography (TEE) in left atrial appendage occlusion (LAAO). Methods     PubMed, EMbase, The Cochrane Library, CBM, CNKI, VIP and WanFang Database were systematically  searched to collect relevant studies on comparing ICE and TEE-guided LAAO from inception to June 15th, 2022. Two reviewers independently screened the literatures, extracted the data, and assessed the risk of bias of the included studies. Meta-analyses were performed using RevMan 5.3 and R 4.0.3. Retrospective cohort studies were excluded for sensitivity analysis. Subgroup analyses were performed based on the types of occluder and ICE catheter. Results     A total of 14 studies with 6 599 patients were included. Meta-analyses showed no statistical differences in technical success rate, overall complications, device embolization, peri-device leakage, device-related thrombus, stroke, vascular complications, bleeding, operation time, fluoroscopy time, or contrast agent volume between the ICE and TEE-guided LAAO. The total in-room time (MD=–33.47 min, 95%CI –41.20 to –25.73, P<0.000 01) and radiation dosage (MD=–170.20 mGy, 95%CI –309.79 to –30.62, P=0.02) were lower in the ICE group than those in the TEE group, whereas the incidence of pericardial effusion/tamponade was higher than the TEE group (RR=1.57, 95%CI 1.01 to 2.45, P=0.048). Except for pericardial effusion/tamponade, subgroup analyses and sensitivity analysis showed similar results. The analysis based on the cost data from the United States showed comparable or even lower total costs for ICE versus TEE, but comparative domestic cost studies were lacking. Conclusion     Current evidence suggests that ICE-guided LAAO can reduce radiation dosage and total in-room time, and there is no statistical difference in the overall complication rate between the two groups. Owing to the limitations of sample size and quality of the included studies, the conclusion still needs to be verified by large sample size and high-quality randomized controlled trials.