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A small-dose naloxone infusion alleviates nausea and sedation without impacting analgesia via intravenous tramadol

Chinese Medical Journal 2010年第13期123卷 1695-1698页

作者： JIA Dong-lin NI Cheng XU Ting ZHANG Li-ping GUO Xiang-yang Department of Anesthesiology Peking University Third Hospital Beijing 100191 China

Background Early studies showed that naloxone infusion decreases the incidence of morphine-related side effects from intravenous patient-controlled analgesia. This study aimed to determine whether naloxone preserved analgesia while minimizing side effects caused by intravenous tramadol administration. Methods Eighty patients undergoing general anesthesia for cervical vertebrae surgery were randomly divided into four groups. All patients received 1 mg/kg tramadol 30 minutes before the end of surgery, followed by a continuous infusion with 0.3 mg-kg1.h^-1 tramadol with no naloxone （group I, n=20）, 0.05 μg.kg.^-1.h^-1 naloxone （group Ⅱ, n=20）, 0.1 pg.kg^-1.h^-1 naloxone （group Ⅲ, n=-20） and 0.2 μg.kg^-1.h^-1 naloxone （group Ⅳ, n=20）. Visual analog scales （VAS） for pain during rest and cough, nausea five-point scale （NFPS） for nausea and vomiting, and ramsay sedation score （RSS） for sedation were assessed at 2, 6, 12, 24 and 48 hours postoperatively. Analgesia and side effects were evaluated by blinded observers. Results Seventy-eight patients were included in this study. The intravenous tramadol administration provided the satisfied analgesia. There was no significant difference in either resting or coughing VAS scores among naloxone groups and control group. Compared with control group, sedation was less in groups Ⅱ, Ⅲ, and Ⅳ at 6, 12, and 24 hours （P 〈0.05）; nausea was less in groups Ⅱ, Ⅲ and Ⅳ than group I at 2, 6, 12, 24 and 48 hours postoperatively （P 〈0.05）. The incidence of vomiting in the control group was 35% vs. 10% for the highest dose naloxone group （group Ⅳ）（P 〈0.01）. Conclusion A small-dose naloxone infusion could reduce tramadol induced side effects without reversing its analgesic effects.

关键词： tramadol naloxone analgesia nausea sedation

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Metatranscriptome of human lung microbial communities in a cohort of mechanically ventilated COVID-19 Omicron patients

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Signal Transduction and Targeted Therapy 2023年第12期8卷 5919-5930页

作者： lin Wang jia-Bao Cao Bin-Bin Xia Yue-Juan li xuan zhang guo-Xin Mo Rui-Juan Wang Si-Qi guo Yu-Qing zhang Kun Xiao Guang-Fa Zhu Peng-Fei liu li-cheng Song Xi-Hui Ma ping-Chao xiang jiang Wang Yu-Hong liu Fei Xie xu-dong zhang xiang-Xin li Wan-Lu Sun Yan Cao Kai-Fei Wang Wen-Hui zhang Wei-Chao Zhao Peng Yan Ji-Chao Chen Yu-Wei yang Zhong-Kuo Yu Jing-Si Tang li Xiao Jie-Min Zhou li-Xin Xie Jun Wang College of Pulmonary&Critical Care Medicine 8th Medical Center of Chinese PLA General HospitalBeijing 100091China CAS Key Laboratory of Pathogenic Microbiology and Immunology Institute of MicrobiologyChinese Academy of SciencesBeijing 100101China University of Chinese Academy of Sciences Beijing 100049China Faculty of Biological Science and Technology Baotou Teacher’s CollegeBaotou 014030China Department of Respiratory Medicine PLA Strategic Support Force Medical CenterBeijing 100101China Department of Respiratory and Critical Care Medicine Beijing Anzhen HospitalCapital Medical UniversityBeijing Institute of HeartLung and Blood Vessel DiseasesBeijing 100029China Respiratory Research Institute Department of Pulmonary&Critical Care MedicineBeijing Key Laboratory of OTIRthe 8th Medical Center of Chinese PLA General HospitalBeijing 100091China Shougang hospital of Peking University Beijing 100144China Department of Respiratory Medicine Beijing Changping HospitalBeijing 102200China Department of Respiratory and Critical Care Medicine Beijing Institute of Respiratory Medicine and Beijing Chao-Yang HospitalCapital Medical UniversityBeijing 100020China Pulmonary research institute Senior Department of Respiratory and Critical Care Medicinethe 8th medical center of Chinese PLA general hospitalBeijing 100091China College of Pulmonary&Critical Care Medicine Chinese PLA General HospitalBeijing 100853China China Aerospace Science&Industry Corporation 731 hospital Beijing 100074China Department of Respiratory and Critical Care Medicine Aerospace Center HospitalBeijing 100049China Vision Medicals Center for Infectious Diseases Guangzhou 510700China

The Omicron variant of the severe acute respiratory syndrome coronavirus 2(SARS‑CoV‑2)infected a substantial proportion of Chinese population,and understanding the factors underlying the severity of the disease and fatality is valuable for future prevention and clinical treatment.We recruited 64 patients with invasive ventilation for COVID-19 and performed metatranscriptomic sequencing to profile host transcriptomic profiles,plus viral,bacterial,and fungal content,as well as virulence factors and examined their relationships to 28-day mortality were examined.In addition,the bronchoalveolar lavage fluid(BALF)samples from invasive ventilated hospital/community-acquired pneumonia patients(HAP/CAP)sampled in 2019 were included for comparison.Genomic analysis revealed that all Omicron strains belong to BA.5 and BF.7 sub-lineages,with no difference in 28-day mortality between them.Compared to HAP/CAP cohort,invasive ventilated COVID-19 patients have distinct host transcriptomic and microbial signatures in the lower respiratory tract;and in the COVID-19 non-survivors,we found significantly lower gene expressions in pathways related viral processes and positive regulation of protein localization to plasma membrane,higher abundance of opportunistic pathogens including bacterial Alloprevotella,Caulobacter,Escherichia-Shigella,Ralstonia and fungal Aspergillus sydowii and Penicillium rubens.Correlational analysis further revealed significant associations between host immune responses and microbial compositions,besides synergy within viral,bacterial,and fungal pathogens.Our study presents the relationships of lower respiratory tract microbiome and transcriptome in invasive ventilated COVID-19 patients,providing the basis for future clinical treatment and reduction of fatality.

关键词： patients mortality prevention

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Protective effect of Pai-Nong-San against AOM/DSS-induced CAC in mice through inhibiting the Wnt signaling pathway

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Chinese Journal of Natural Medicines 2021年第12期19卷 912-920页

作者： zhang Meng-Meng YIN Deng-Ke RUI xue-lin SHAO Fu-ping li jia-cheng xu li yang Ye School of Pharmacy Anhui University of Chinese MedicineHefei 230031China Anhui Provincial Key Laboratory for Chinese Medicinal Formula Hefei 230031China Institute of Pharmaceutics Anhui Academy of Chinese MedicineHefei 230021China Anhui Provincial Key Laboratory of Research&Development of Chinese Medicine Hefei 230021China

Pai-Nong-San(PNS), a prescription of traditional Chinese medicine, has been used for years to treat abscessation-induced diseases including colitis and colorectal cancer. This study was aimed to investigate the preventive effects and possible protective mechanism of PNS on a colitis-associated colorectal cancer(CAC) mouse model induced by azoxymethane(AOM)/dextran sodium sulfate(DSS). The macroscopic and histopathologic examinations of colon injury and DAI score were observed. The inflammatory indicators of intestinal immunity were determined by immunohistochemistry and immunofluorescence. The high throughput 16S rRNA sequence of gut microbiota in the feces of mice was performed. Western blot was used to investigate the protein expression of the Wnt signaling pathway in colon tissues. PNS improved colon injury, as manifested by the alleviation of hematochezia, decreased DAI score, increased colon length, and reversal of pathological changes. PNS treatment protected against AOM/DSS-induced colon inflammation by regulating the expression of CD4;and CD8;T cells, inhibiting the production of HIF-α, IL-6, and TNF-α, and promoting the expression of IL-4 and IFN-γ in colon tissues. Meanwhile, PNS improved the components of gut microbiota, as measured by the adjusted levels of Firmicutes, Bacteroidetes, Proteobacteria, and Lactobacillus. PNS down-regulated the protein expression of pGSK-3β, β-catenin, and c-Myc, while up-regulating the GSK-3β and p-β-catenin in colon tissues of CAC mice. In conclusion, our results suggested that PNS exhibits protective effect on AOM/DSS-induced colon injury and alleviates the development of CAC through suppressing inflammation, improving gut microbiota, and inhibiting the Wnt signaling pathway.

关键词： Pai-Nong-San CAC AOM-DSS Gut microbiota Wnt signaling pathway

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Phylogenomic relationships and molecular convergences to subterranean life in rodent family Spalacidae

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Zoological Research 2021年第5期42卷 671-674页

作者： Yuan-ting guo jia zhang dong-Ming xu li-Zhou Tang Zhen liu State Key Laboratory of Genetic Resources and Evolution Kunming Institute of ZoologyChinese Academy of SciencesKunmingYunnan 650223China Kunming College of life Science University of Chinese Academy of SciencesKunmingYunnan 650204China Center for Yunnan Plateau Biological Resources Protection and Utilization College of Biological Resource and Food EngineeringQujing Normal UniversityQujingYunnan 655011China

All extant species in the rodent family Spalacidae are subterranean and have evolved various traits for underground life.However,the phylogenomic relationships among its three subfamilies(Myospalacinae,Spalacinae,and Rhizomyinae)and the molecular basis underlying their adaptations to underground life remain poorly understood.Here,we inferred the phylogenomic relationships among these subfamilies based on de novo sequencing the genome of the hoary bamboo rat(Rhizomys pruinosus).Analyses showed that 50%of the identified 11028 one-to-one orthologous protein-coding genes and the concatenated sequences of these orthologous genes strongly supported a sister relationship between Myospalacinae and Rhizomyinae.

关键词： underground life rodent

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Establishment of a Rat Model of Capillary Leakage Syndrome Induced by Cardiopulmonary Resuscitation After Cardiac Arrest

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当代医学科学(英文) 2023年第4期43卷 708-715页

作者： Xiao-lei zhang Ye cheng Chun-lin XING jia-yun YING xue yang Xiao-di CAI guo-ping LU Department of Pediatric Emergency Medicine and Critical Care Medicine Children's Hospital of Fudan UniversityShanghai 201102China Department of Pediatric Critical Care Medicine Children's Hospital of Chongqing Medical UniversityChongqing 400014China

Objective:Cardiopulmonary resuscitation(CPR)after cardiac arrest(CA)is one of the main causes of capillary leakage syndrome(CLS).This study aimed to establish a stable CLS model following the CA and cardiopulmonary resuscitation(CA-CPR)model in Sprague-Dawley(SD)rats.Methods:We conducted a prospective,randomized,animal model study.All adult male SD rats were randomly divided into a normal group(group N),a sham operation group(group S),and a cardiopulmonary resuscitation group(group T).The SD rats of the three groups were all inserted with 24-G needles through their left femoral arteries and right femoral veins.In group S and group T,the endotracheal tube was intubated.In group T,CA induced by asphyxia(AACA)was caused by vecuronium bromide with the endotracheal tube obstructed for 8 min,and the rats were resuscitated with manual chest compression and mechanical ventilation.Preresuscitation and postresuscitation measurements,including basic vital signs(BVS),blood gas analysis(BG),routine complete blood count(CBC),wet-to-dry ratio of tissues(W/D),and the HE staining results after 6 h were evaluated.Results:In group T,the success rate of the CA-CPR model was 60%(18/30),and CLS occurred in 26.6%(8/30)of the rats.There were no significant differences in the baseline characteristics,including BVS,BG,and CBC,among the three groups(P>0.05).Compared with pre-asphyxia,there were significant differences in BVS,CBC,and BG,including temperature,oxygen saturation(SpO_(2)),mean arterial pressure(MAP),central venous pressure(CVP),white blood cell count(WBC),hemoglobin,hematocrit,pH,pCO_(2),pO_(2),SO_(2),lactate(Lac),base excess(BE),and Na+(Pnificant differences in temperature,heart rate(HR),respiratory rate(RR),SpO_(2),MAP,CVP,WBC,pH,pCO_(2),Na+,and K+among the three groups(Pnificantly increased W/D weight r

关键词： cardiac arrest cardiopulmonary resuscitation capillary leakage model

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Identification of fangchinoline as a broad-spectrum enterovirus inhibitor through reporter virus based high-content screening

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Virologica Sinica 2024年第2期39卷 301-308页

作者： Qiu-Yan zhang jia-Qi li Qi li yang zhang Zhe-Rui zhang Xiao-Dan li Hong-Qing zhang cheng-lin Deng Feng-Xia yang Yi xu Bo zhang The Joint Center of Translational Precision Medicine Department of Infections and DiseasesGuangzhou Institute of PediatricsGuangzhou Women and Children's Medical CenterGuangzhou510623China Key Laboratory of Special Pathogens and Biosafety Wuhan Institute of VirologyCenter for Biosafety Mega-ScienceChinese Academy of SciencesWuhan430071China University of Science and Technology of China Department of Life Sciences and MedicineHefei230026China Hunan Normal University School of MedicineChangsha410081China

Hand,foot,and mouth disease(HFMD)is a common pediatric illness mainly caused by enteroviruses,which are important human pathogens.Currently,there are no available antiviral agents for the therapy of enterovirus infection.In this study,an excellent high-content antiviral screening system utilizing the EV-A71-eGFP reporter virus was developed.Using this screening system,we screened a drug library containing 1042 natural compounds to identify potential EV-A71 inhibitors.Fangchinoline(FAN),a bis-benzylisoquinoline alkaloid,exhibits potential inhibitory effects against various enteroviruses that cause HFMD,such as EV-A71,CV-A10,CV-B3 and CV-A16.Further investigations revealed that FAN targets the early stage of the enterovirus life cycle.Through the selection of FAN-resistant EV-A71 viruses,we demonstrated that the VP1 protein could be a potential target of FAN,as two mutations in VP1(E145G and V258I)resulted in viral resistance to FAN.Our research suggests that FAN is an efficient inhibitor of EV-A71 and has the potential to be a broad-spectrum antiviral drug against human enteroviruses.

关键词： Hand,foot,and mouth disease(HFMD) Enterovirus EV-A71 High-content screening Fangchinoline(FAN)

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Exosomes-mediated tumor treatment: One body plays multiple roles

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Asian Journal of Pharmaceutical Sciences 2022年第3期17卷 385-400页

作者： Na xu Ranran guo Xiaotong yang ning li jia Yu Peng zhang Shenyang Pharmaceutical University Shenyang 110016China

Exosomes are vesicles secreted by a variety of living cells,containing proteins,RNA and other components,which are nanoscale capsules commonly existed in the body.Exosomes play important roles in a variety of physiological and pathological processes by participating in material and information exchange between cells,which can playmultiple roles in tumor treatment.On the one hand,exosomes can be used as carriers and biomarkers,participate in the apoptosis signaling pathway and improve chemotherapy resistance,thus playing beneficial roles in tumor treatment.On the other hand,exosomes play unfavorable roles in tumor treatment.Tumor cell exosomes contain PD-L1,which is a nuclear weapon for tumor growth,metastasis,and immunosuppression.In addition,exosomes can not only promote the epithelial-mesenchymal transition process,tumor angiogenesis and chemoresistance,but also participate in the autocrine pathway.In this review,the multiple roles of exosomes and their prospects in the treatment of tumor were reviewed in detail.

关键词： Extracellular vesicles Exosomes Multiple roles Tumor treatment

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Lung-protective Ventilation in Patients with Brain Injury： A Multicenter Cross-sectional Study and Questionnaire Survey in China

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Chinese Medical Journal 2016年第14期129卷 1643-1651页

作者： xu-Ying Luo Ying-Hong Hu xiang-Yuan Cao Yan Kang li-ping liu Shou-Hong Wang Rong-guo Yu xiang-You Yu Xia zhang Bao-Shan li Zeng-xiang Ma Yi-Bing Weng Heng zhang De-Chang Chen Wei Chen Wen-Jin Chen Xiu-Mei Chen Bin Du Mei-li Duan Jin Hu Yun-Feng Hoang Gui-Jun jia li-Hong li Yu-Min liang Bing-Yu Qin Xian-dong Wang jian Xiong li-Mei Yan Zheng-ping yang Chen-Ming dong dong-Xin Wang Qing-Yuan Zhan Shuang-lin FU lin Zhao Qi-Bing Huang Ying-Guang Xie Xiao-Bo Huang guo-Bin zhang Wang-Bin xu Yuan xu Yaling liu He-ling Zhao Rong-Qing Sun Ming Sun Qing-Hong cheng Xin Qu Xiao-Feng yang Ming xu Zhong-Hua Shi Han Chen xuan He Yan-lin yang Guang-Qiang Chen Xiu-Mei Sun jian-Xin Zhou Department of Critical Care Medicine Beijing Tiantan Hospital Capital Medical University Beijing 100050 China Department of Critical Care Medicine Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang 310009 China Department of Critical Care Medicine General Hospital of Ningxia Medical University Yinchuan Ningxia 750004 China Department of Critical Care Medicine West China Hospital Sichuan University Chengdu Sichuan 610041 China Neurological Intensive Care Unit Beijing Tiantan Hospital Capital Medical University Beijing 100050 China Department of Critical Care Medicine Guangdong General Hospital Guangzhou Guangdong 510000 China Surgical Intensive Care Unit Fujian Province Hospital Fuzhou Fujian 350000 China Department of Critical Care Medicine First Affiliated Hospital of Xinjiang Medical University Urumqi Xinjiang 830054 China Department of Critical Care Medicine Bethune International Peace Hospital Shijiazhuang Hebei 050000 China Department of Critical Care Medicine Yuncheng Central Hospital Yuncheng Shanxi 044000 China Department of Emergency and Critical Care Medicine Cangzhou People's Hospital Cangzhou Hebei 061000 China Department of Critical Care Medicine Beijing Luhe Hospital Capital Medical University Beijing 101100 China Department of Critical Care Medicine First Hospital of China Medical University Shenyang Liaoning 110000 China Department of Critical Care Medicine Shanghai Changzheng Hospital Shanghai 200000 China Department of Critical Care Medicine Beijing Shijitan Hospital Capital Medical University Beijing 100038 China Department of Critical Care Medicine Xuanwu Hospital Capital Medical University Beijing 100053 China Department of Critical Care Medicine Miyun County Hospital Beijing 100038 China Medical Intensive Care Unit Peking Union Medical College Hospital Beijing 101500 China Department of Critical Care Medicine Beijing Friendship Hospital Capital Medical University Beijing 100050 Chin

Background： Over the years, the mechanical ventilation （MV） strategy has changed worldwide. The aim of the present study was to describe the ventilation practices, particularly lung-protective ventilation （LPV）, among brain-injured patients in China. Methods： This study was a multicenter, 1-day, cross-sectional study in 47 Intensive Care Units （ICUs） across China. Mechanically ventilated patients （18 years and older） with brain injury in a participating ICU during the time of the study, including traumatic brain injury, stroke, postoperation with intracranial tumor, hypoxic-ischemic encephalopathy, intracranial infection, and idiopathic epilepsy, were enrolled. Demographic data, primary diagnoses, indications for MV, MV modes and settings, and prognoses on the 60th day were collected. Multivariable logistic analysis was used to assess factors that might affect the use of LPV. Results： A total of 104 patients were enrolled in the present study, 87 （83.7%） of whom were identified with severe brain injury based on a Glasgow Coma Scale 〈8 points. Synchronized intermittent mandatory ventilation （SIMV） was the most frequent ventilator mode, accounting for 46.2% of the entire cohort. The median tidal volume was set to 8.0 ml/kg （interquartile range [IQR], 7.0-8.9 ml/kg） of the predicted body weight; 50 （48.1%） patients received LPV. The median positive end-expiratory pressure （PEEP） was set to 5 cmH20 （IQR, 5-5 cmH20）. No PEEP values were higher than 10 cmH20. Compared with partially mandatory ventilation, supportive and spontaneous ventilation practices were associated with LPV. There were no significant differences in mortality and MV duration between patients subjected to LPV and those were not. Conclusions： Among brain-injured patients in China, SIMV was the most frequent ventilation mode. Nearly one-half of the brain-injured patients received LPV. Patients under supportive and spontaneous ventilation were more likely to receive LPV.

关键词： Brain Injury Epidemiology Lung-protective Ventilation Mechanical Ventilation

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Multiscale Failure Mechanism Analysis of SiC Fiber‑Reinforced TC17 Composite Subjected to Transverse Tensile Loading at Elevated Temperature

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Acta Metallurgica Sinica(English Letters) 2023年第6期36卷 1007-1022页

作者： Qiu‑Yue jia Yu‑Min Wang xu zhang guo‑Xing zhang Qing yang li‑Na yang xu Kong Xiao‑Fang li Rui yang Shi‑Changxu Innovation Center for Advanced Materials Institute of Metal ResearchChinese Academy of SciencesShenyang 110016China School of Materials Science and Engineering University of Science and Technology of ChinaShenyang 110016China

This study presents a multiscale method to evaluate the transverse tensile strength and failure mechanism of SiC_(f)/TC17 cruciform specimen machined from a large-size ring.The mechanical properties and failure of the specimen were evaluated through a macroscale model under transverse tensile loading at 200°C.A mesoscale model was developed to analyze the transverse tensile behavior and failure of the composite specimen.Interfacial debonding,plastic deformation of matrix and cladding,and damage to the composite core were incorporated into the mesoscopic and macroscopic models.The stress–strain curves and fracture modes obtained from the numerical simulation showed good agreement with the experimental curves,acoustic emission test results,and fracture morphology.The simulation results suggested that the damage to the central region interface and the plastic deformation of the matrix initiated first and propagated outwards.Subsequently,the interfacial failure,matrix failure,and formation of macro-crack developed,which led to the crack of the titanium matrix composite core.Finally,cladding was plastically deformed and crack developed,which led to the severe failure of the cruciform specimen.

关键词： Continuous fiber-reinforced titanium matrix composite Transverse tensile behavior Multiscale analysis Failure mechanism

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Evaluation of Safety and Efficacy of Qinming8631 DR Implantable Cardiac Pacemaker in Chinese Patients： A Prospective, Multicenter, Randomized Controlled Trial of the First Domestically Developed Pacemaker of China

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Chinese Medical Journal 2016年第22期129卷 2659-2665页

作者： Mei-xiang xiang dong-Qi Wang Jing xu Zheng zhang jian-Xin Hu dong-Mei Wang xiang Gu He-ping liu Tao guo xiang-Jun yang Feng ling jia-Feng lin Shang-Lang Cai guo-Bin Zhu jian-An Wang Department of Cardiology Cardiovascular Key Laboratory of Zhejiang Province The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang 310009 China Department of Cardiology The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi 710061 China Department of Cardiology Tianjin Chest Hospital Tianjin 300051 China Department of Cardiology The First Hospital of Lanzhou University Lanzhou Gansu 730000 China Department of Cardiology The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi 330008 China Department of Cardiology Bethune International Peace Hospital of the Chinese PLA Shijiazhuang Hebei 050082 China Department of Cardiology Northern Jiangsu People's Hospital Yangzhou Jiangsu 225001 China Department of Cardiology Jilin Province People's Hospital Changchun Jilin 130021. China Department of Cardiology The First Affiliated Hospital of Kunming Medical University Kunming Yunnan 650032 China Department of Cardiology The First Affiliated Hospital of Suzhou University Suzhou Jiangsu 215006 China Department of Cardiology The First People's Hospital of Hangzhou Hangzhou Zhejiang 310006 China Department of Cardiology The Second Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang 325027 China Department of Cardiology The Affiliated Hospital of Qingdao University Medical College Qingdao Shandong 266003 China Department of Cardiology The Second Hospital of Shanxi Medical University Taiyuan Shanxi 030001 China

Background：High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia,and a domestically developed pacemaker will help lower the burden.This study aimed to evaluate the safety and efficacy ofQinming8631 DR （Qinming Medical,Baoji,China）,the first domestically developed dual-chamber pacemaker of China,compared with a commercially available pacemaker Talos DR （Biotronik,Berlin,Germany） in Chinese patients.Methods：A prospective randomized trial was conducted at 14 centers in China.Participants were randomized into trial （Qinming8631 DR） and control （Talos DR） groups.Parameters of the pacing systems were collected immediately after device implantation and during follow-ups.The effective pacing rate at 6-month follow-up was recorded as the primary end point.Electrical properties,magnet response,single-and double-pole polarity conversion,rate response function,and adverse events of the pacing system were analyzed.The Cochran-Mantel-Haenszel Chi-square test,paired t-test,and Wilcoxon signed-rank test were used for measuring primary qualitative outcomes and comparing normally and abnormally distributed measurement data.Results：A total of 225 patients with a diagnosis ofbradyarrhythmia and eligible for this study were randomly enrolled into the trial （n =113） and control （n =112） groups.They underwent successful pacemaker implantation with acceptable postoperative pacing threshold and sensitivity.Effective pacing rates of trial and control groups were comparable both in the full analysis set and the per protocol set （81.4% vs.79.5%,P =0.712 and 95.4% vs.89.5%,P =0.143,respectively）.In both data sets,noninferiority of the trial group was above the predefined noninferiority limit（-9.5%）.Conclusions：This study established the noninferiority ofQinming8631 DR to Talos DR.The safety and efficacy ofQinming8631 DR pacemaker were comparable to those of Talos DR in treating patients with cardiac bradyarrhythmia.

关键词： Bradyarrhythmia Cardiac Pacemaker Qinming8631 Safety and Efficacy

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