1.Rapid health technology assessment Meta-analysis of drug-eluting coronary stent system for the treatment of coronary heart disease
Dandan ZHU ; Huilin XIA ; Yali JIANG ; Bin ZHOU ; Jianchao JIA ; Xiaoyan ZHANG ; Yuefei LI
China Medical Equipment 2024;21(7):116-121,127
Objective:To evaluate the effectiveness,safety and economics of absorbable drug-eluting coronary stent systems using rapid health technology assessment tools,and to provide evidence-based basis for rational use for clinicians use and expert evaluation.Methods:A computer search was performed on PubMed,CNKI,Wanfang,VIP and other databases from 1 January 2014 to 1 January 2023 for relevant literature on patients with coronary artery disease who were treated with coronary artery stent interventional surgery.The 210 collected literatures were screened and extracted according to the inclusion and exclusion criteria,and the literature quality evaluation was carried out.The extracted data related to the intravascular thrombosis rate,myocardial infarction rate,cardiac mortality rate,all-cause mortality rate,target lesion revascularization rate and intravascular adverse event incidence of absorbable drug-eluting coronary stents and drug-eluting coronary stents were meta-analyzed by Revman5.4 software.Results:7 studies were ultimately included in the comparative study of absorbable drug-eluting coronary stents and drug-eluting coronary stents.The thrombosis rate,all-cause mortality rate and intravascular adverse event rate of absorbable drug-eluting coronary stents were lower than those of drug-eluting coronary stents,and the difference was statistically significant(Z=2.16,1.89,2.22,P<0.05).There were no statistically significant difference in the myocardial infarction rate,cardiac mortality rate and target lesion revascularization rate between absorbable drug-eluting coronary stents and drug-eluting coronary stents(P>0.05).Conclusion:There was no significant difference in safety and efficacy between absorbable drug-eluting coronary stents and drug-eluting coronary stents.In terms of economy,the cost of absorbable drug-eluting coronary stents is significantly higher than that of drug-eluting coronary stents,and patients can choose stents according to their own economic conditions and other actual conditions.
2.Closed femoro-femoral partial bypass management strategies for thoracoabdominal aortic replacement
Yang ZHOU ; Jiaxin HUANG ; Jianchao LI
The Journal of Practical Medicine 2024;40(19):2760-2765
Objective Discuss the application methods and effects of closed femoro-femoral partial bypass(C-FPB)in thoracoabdominal aortic replacement(TAAAR)surgery.Methods A retrospective analysis of the clinical data of 70 cases of TAAAR assisted by C-FPB from April 2021 to May 2023,some of which combined with abdominal organ perfusion.The main evaluation indicators were in-hospital mortality,postoperative stroke,postop-erative spinal cord injury,and the incidence of hemodialysis.Based on an open-type conventional Cardiopulmonary bypass(CPB)circuit,the venous tubing was split with a 10×10×10 mm"Y"connector directly connected to the inlet of the centrifugal pump,and the tubing after the roller pump was connected to the outlet of the centrifugal pump,while the front of the membrane oxygenator with another 10×10×10 mm"Y"connector to establish a closed femoro-femoral bypass.During bypass,the lower body is perfused by the centrifugal pump,while the upper body is perfused by the roller pump.Results No system failures happen in all cases.The average bypass time was(101.0±22.2)minutes,the average time for intercostal artery reconstruction was(18.6±5.4)minutes,with an average of(4.7±1.8)pairs.The average length of stay in the ICU was(5.1±1.5)days,and the average length of hospital stay was(34.4±12.5)days.2 cases(2.9%)experienced postoperative stroke,1 case(1.4%)resulted in in-hospital mortality,2 cases(2.9%)experienced postoperative paraplegia,7 cases(10.0%)underwent postop-erative hemodialysis,and 3 cases(4.3%)experienced prolonged mechanical ventilation.Conclusion The Closed-type femoro-femoral partial bypass takes the whole surgical process into account,reduces the management difficulty for perfusionist,and provides a unique advantage for distal perfusion during thoracoabdominal aortic replacement surgery.
3.Speech and language rehabilitation services for children with hearing impairment based on ICF:theoretical framework and service system
Jing ZHOU ; Ling YI ; Jianchao CHEN ; Xuefen CHEN ; Xingxing WEI ; Jingjing CHEN
Chinese Journal of Rehabilitation Theory and Practice 2024;30(7):745-751
Objective Based on the bio-psycho-social model of functioning and health of International Classification of Function-ing,Disability and Health(ICF)framework,this paper systematically analyzes rehabilitation-related policy docu-ments of the World Health Organization(WHO)to explore the theoretical and policy principles,service systems,priority development areas,and main policy and technical measures for speech and language rehabilitation for children with hearing impairment. Methods Under literature research and policy analysis methods,this paper systematically reviewed the functioning and health framework of ICF,relevant WHO policy reports and American Speech and Hearing Association technical documents,analyzed the current status and needs of rehabilitation services in China,and proposed a theoretical framework,priority areas,and main policy and technical measures for constructing an ICF-based speech and lan-guage rehabilitation service system for children with hearing impairment. Results There were eight major principles for the development of speech and language rehabilitation for children with hearing impairment:child-centered and respect for individual differences,life-cycle support and promoting con-tinuous development,evidence-based practice,multidisciplinary collaboration,building family participation sup-port networks,promoting integrated education and social participation,focusing on cultural sensitivity,and tech-nology-empowered rehabilitation innovation.Five service systems were elaborated,including comprehensive ear-ly screening,diagnosis,and intervention system;family and social support system;multidisciplinary team servic-es system;comprehensive,multi-level speech and language rehabilitation service system;and digitally empow-ered services to build new rehabilitation service models.The priority development areas,and main policy and technical measures for speech and language rehabilitation for children with hearing impairment were also dis-cussed. Conclusion Based on the bio-psycho-social model of functioning and health of ICF,comprehensive,personalized,con-tinuous,high-quality and universally accessible speech and language rehabilitation services can be developed by implementing measures,such as strengthening policy support,improving service systems,cultivating multidisci-plinary professionals,promoting digital empowerment technologies and enhancing support system,to promote the overall development,social participation and quality of life for children with hearing impairment.
4.Effect of speech and language rehabilitation on children with intellectual and developmental disabilities:a system-atic review
Jing ZHOU ; Xiaoxiao ZHANG ; Zhongbing DING ; Jianchao CHEN ; Xingxing WEI ; Shuqi LIN
Chinese Journal of Rehabilitation Theory and Practice 2024;30(8):894-902
Objective To systematically evaluate the effect of speech and language therapies and educational interventions on chil-dren with intellectual and developmental disabilities(IDD). Methods A systematic review was conducted by searching relevant literature in PubMed,PsycINFO,ERIC,Cochrane Library and Web of Science databases,ranging from January,2018 to May,2024. Results A total of eight English articles were included,from six countries including the United States,France,Italy,Nor-way,Poland and New Zealand,involving 610 children with IDD,from journals about speech language pathology,Down syndrome research and speech language hearing research.The publication time was mainly from 2018 to 2023.The age of the subjects was two to twelve years,and the main health conditions included intellectual dis-ability,autism and Down syndrome.The intervention methods included routine speech therapy(individualized therapy and group therapy),augmentative and alternative communication(device-assisted and sign language and picture cards),family-involved language training programs(parent training and family interaction),computer-as-sisted language learning(language learning software and telehealth),and play-based interventions(interactive games and structured games);15 to 150 minutes a time,one to ten times a week,for ten to 144 weeks.The out-comes were reflected in five aspects:increasing the vocabulary in speaking;improving the language comprehen-sion,symbol recognition and vocabulary comprehension;improving both expressive and receptive language skills;improving participation in game diversity and game participation levels,communication,social interaction and interaction skills;and improving overall language and non-verbal communication skills. Conclusion Combining a variety of methods,such as individualized therapy,family participation,technologic assistance and interactive games,speech and language therapies and education are effective on spoken language production,language comprehension,speech production,social interaction and communication skills for children with IDD.
5.Exploration of data security management methods in clinical research
Zongmei TIAN ; Jian ZHOU ; Jianchao YANG
Chinese Journal of Medical Science Research Management 2024;37(5):391-395
Objective:This study aimed to explore how to ensure the safety of hospital data and protect patients′ privacy in clinical research work.Methods:A hospital data security management system was established, according to different clinical research data application scenarios, we formulated different data security control procedures, different management strategies, and different technical measures.Results:A full process information management model was achieved for clinical data research application, including application, retrieval, export, and use, which was helpful for clinical research and data security management, effectively protecting patients′ privacy.Conclusions:Good data security management strategy can effectively promote the development of hospital research work.
6.Research on performance optimization method of human-machine physical interaction system considering exoskeleton wearing comfort.
Wenyao QI ; Yuwei YANG ; Zuyi ZHOU ; Jianchao GONG ; Pengyu CHEN
Journal of Biomedical Engineering 2023;40(1):118-124
In order to improve the wearing comfort and bearing effectiveness of the exoskeleton, based on the prototype and working mechanism analysis of a relaxation wearable system for knee exoskeleton robot, the static optimization synthesis and its method are studied. Firstly, based on the construction of the virtual prototype model of the system, a comprehensive wearable comfort evaluation index considering the factors such as stress, deformation and the proportion of stress nodes was constructed. Secondly, based on the static simulation and evaluation index of system virtual prototype, multi-objective genetic optimization and local optimization synthesis of armor layer topology were carried out. Finally, the model reconstruction simulation data confirmed that the system had good wearing comfort. Our study provides a theoretical basis for the bearing performance and prototype construction of the subsequent wearable system.
Humans
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Exoskeleton Device
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Computer Simulation
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Emotions
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Knee Joint
7. Effects of glycaemic control and CYP3A5 polymorphisms on tacrolimus trough concentrations after adult kidney transplantation
Kun LI ; Nannan LI ; Weihong HU ; Jianchao ZHOU ; Lulu LI
Chinese Journal of Clinical Pharmacology and Therapeutics 2023;28(7):767-774
AIM: Diabetes mellitus affects the pharmacokinetics of cytochrome P450 3A4 / 5 (CYP3A4/5) substrates. We evaluated the relationship between haemoglobin A1c (HbA1c) levels and the pharmacokinetics of controlled-release tacrolimus. METHODS: This retrospective observational cohort study included kidney transplant recipients (>18 years) receiving controlled-release tacrolimus orally. CYP3A5 genotypes were categorized as expressers (*1/*1 or *1/*3) and non-expressers (*3/*3). Multiple linear regression analysis determined the predictors for trough concentration / dose-normalized by body weight (C/D) ratio of tacrolimus at 7 days, 6 months and 12 months after administration. Correlations between the C/D ratio and HbA1c levels at baseline, 6 and 12 months after tacrolimus initiation were evaluated with Bonferroni correction. RESULTS: Out of 42 patients (CYP3A5 expressers, n=56, and non-expressers, n= 83), the multiple linear regression analysis showed that the C/D ratio on Day 7 was marginally higher in CYP3A5 non-expressers than in CYP3A5 expressers. Factors affecting the elevation of tacrolimus C/ D ratio after 6 and 12 months of treatment were male sex and CYP3A5 non-expressers and increased HbA1c levels and CYP3A5 non-expressers, respectively. The C/D ratio and HbA1c levels after 12 months was positively correlated in CYP3A5 non-expressers (y=54.6x+194.6, R=0.63, P=0.004, Bonferroni correction). Furthermore, intra-individual changes in the C/D ratio and HbA1c levels from 6 to 12 months were nearly correlated (y=54.5x + 20.2, R=0.41, P=0.036, Bonferroni correction). CONCLUSION: HbA1c and CYP3A5 genotypes might be considered to understand the inter- and intra-individual variability in blood tacrolimus concentrations after 6 months post-kidney transplantation.
8.Risk factors and prognostic analyses of acute kidney injury after heart transplantation
Qiang ZHOU ; Zhiming ZHOU ; Jianchao CHEN ; Hongling CHEN ; Bo GENG ; Bin YANG
Chinese Journal of Organ Transplantation 2023;44(8):479-486
Objective:This study aims to investigate the incidence, risk factors, and prognosis of acute kidney injury after heart transplantation.Methods:Clinical data of 180 recipients of heart transplantation at Zhengzhou Seventh People's Hospital from April 2018 to November 2022 are retrospectively analyzed. According to whether AKI occurred 7 days after surgery, the recipients are divided into a non AKI group(85 cases)and an AKI group(95 cases). The baseline data, general perioperative conditions, and clinical data of the two groups of recipients are compared using chi square test and rank sum test to identify possible influencing factors for AKI after heart transplantation.Determine independent risk factors through binary logistic regression.The Kaplan Meier method is used to draw survival curves to further clarify the impact of AKI on the survival and cumulative hospitalization of heart transplant recipients.Results:The incidence of postoperative AKI in 180 recipients of this study is 52.7%(95/180). Univariate analysis showed that there are statistically significant differences in recipient age, preoperative albumin, platelet count, graft cold ischemia time, and surgical time between the AKI group and the non AKI group(all P<0.05). Further multivariate analysis showes that recipient age( OR=1.021, 95% CI: 1.001~1.043, P=0.043), surgical time( OR=1.005, 95% CI: 1.001~1.008, P=0.005), platelet count( OR=0.995, 95% CI: 0.990~1.000, P=0.034), and donor cold ischemia time ( OR=0.996, 95% CI: 0.993~0.996, P=0.004)are independent risk factors for AKI after heart transplantation. Prognostic analysis showed that 35.7%(25 cases)of the AKI group received continuous renal replacement therapy(CRRT)after surgery, and 31.9%(23 cases) received aortic balloon counterpulsation(IABP)after surgery. Compared with 0 and 8.9%(7 cases)of the AKI group without AKI, the differences are statistically significant(all P<0.01). Compared with the non AKI group, the invasive mechanical ventilation time is 614 (504, 707) hours and 540 (460, 610) hours( P<0.01), the stay time in the intensive care unit is 12(8, 16)days and 10(6, 15)days( P=0.050), and the estimated glomerular filtration rate(eGFR)on the 7th day after surgery is 10(6, 15)ml/(min·1.73 m 2)and 68(57.5, 91.0)ml/(min·1.73 m 2)( P<0.01), with statistical significance. The cumulative survival rate of the AKI group after heart transplantation is lower than that of the non AKI group, and the cumulative hospitalization rate Is higher than the latter. The differences between the groups are statistically significant(all P<0.01). Conclusions:The incidence of AKI after heart transplantation is relatively high, and recipient age, platelet count, graft cold ischemia time, and surgical time are independent risk factors for AKI. Recipients with AKI after heart transplantation have a higher proportion of postoperative use of CRRT and IABP, longer invasive mechanical ventilation time and monitoring room stay time, and lower eGFR on the 7th day after surgery; at the same time, recipients with AKI after heart transplantation have a lower postoperative survival rate and a higher cumulative hospitalization rate.
9.Rapid health technology assessment of bovine pulmonary surfactant versus porcine ones in the treatment of preterm neonates with respiratory distress syndrome
Hua GUO ; Yun SHAO ; Lanlan LIU ; Pengfei REN ; Qiang FU ; Nan SUN ; Jianchao ZHOU ; Jian KANG ; Yanli REN
China Pharmacy 2022;33(22):2786-2790
OBJECTIVE To compare the effectiveness,safety and economy of bovine pulmonary surfactant (PS) and porcine PS in the treatment of preterm neonates with respiratory distress syndrome (RDS). METHODS Retrieved from PubMed,Embase, Cochrane Library,CNKI,SinoMed,Wanfang and health technology assessment (HTA) organization websites and relevant database, HTA report,systematic review/meta-analysis and pharmacoeconomic study about bovine PS versus porcine PS in the treatment of preterm neonates with RDS were included from the inception to Feb 2022. Data extraction and quality evaluation were carried out for the included literature,and then research results were summarized and analyzed descriptively. RESULTS A total of 1 HTA report,6 systematic reviews/meta-analyses,and 6 pharmacoeconomic studies were included. There appeared to be no significant differences between bovine PS and porcine PS in terms of time staying in neonatal intensive care unit and extra-pulmonary outcomes. In terms of PS re-treatment,blood gas index,total effective rate and the incidence of patent ductus arteriosus,porcine PS was superior to bovine PS. Results from other indicators,such as mortality, the incidence of bronchopulmonary dysplasia,air leakage syndrome,pulmonary hemorrhage,were still controversial. In terms of economy,there was no statistical difference in average hospital charges and administration cost per dose between two groups (P>0.05); compared with porcine PS,mean wastage cost per dose of bovine PS was higher (P<0.001),and 24 h treatment cost of bovine PS was lower (P<0.05); the results of average medication cost were controversial. CONCLUSIONS The effectiveness, safety and economy of bovine PS are found to be similar or inferior to porcine PS. It is not certain whether the inferiority has clinical significance.
10.Influencing factors of early mortality after heart transplantation and constructing a prediction model
Ruixue SUN ; Qiang ZHOU ; Zhiming ZHOU ; Bo GENG ; Hongling CHEN ; Jianchao CHEN ; Bin YANG
Chinese Journal of Organ Transplantation 2022;43(12):723-729
Objective:To explore the risk factors for early mortality in heart transplant(HT)recipients and construct a nomogram prediction model.Methods:From 2018 to 2022, preoperative clinical data were retrospectively reviewed for 163 consecutive HT recipients.Risk factor variables were shortlisted by univariate correlation analysis based upon early(90-day)postoperative patient survival.Lasso regression was then employed for screening all variables and common variables were combined.A nomogram was constructed for predicting the probability of early mortality after considering actual circumstance.Receiver operating characteristic(ROC)curve, area under the ROC curve(AUC), Harrell's C-index and calibration curves were employed for evaluating and internally validate the performance of the model.Decision curve analysis was performed for assessing clinical utility of the model.Results:In survival and mortality groups, mechanical ventilation, nervous system lesions, use of extracorporeal membrane oxygenation, red blood cell count ≤3.52×10 12/L, mean pulmonary arterial pressure>27 mmHg, pulmonary vascular resistance>4.01 Wood Unit, albumin≤33 g/L, aspartate aminotransferase >50 U/L, hemoglobin ≤108 g/L, platelet count ≤109×10 9/L and total bilirubin>57 μmol/L demonstrated statistically significant differences( P<0.05). At the same time, according to actual situations and different variables, hemoglobin ≤108 g/L, albumin ≤33 g/L, platelet count ≤109×10 9/L, total bilirubin>57μmol/L, aspartate aminotransferase>50 U/L, nervous system lesions and average pulmonary arterial pressure >27 mmHg were seven variables.And a nomogram with relatively high reliability was constructed for predicting the probability of early mortality post-HT(nomogram model evaluation, AUC 0.917, C index 0.910 and good calibration curve). Decision curve analysis indicated that the nomogram could benefit HT recipients. Conclusions:Risk factors have been identified for early mortality in HT recipients.And the nomogram prediction model offers a simple and reliable tool for predicting early mortality post-HT.It has important implications for individualized treatment of HT candidates.

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