Intelligent medical devices are flourishing with the deep integration of modern information and artificial intelligence technologies into healthcare.Testing is an important means of performance evaluation and quality control for intelligent medical devices.Compared with traditional medical devices,the testing methods and technologies of intelligent medical devices are still immature,and need active research to promote the progress in this area.Intelligent medical devices are classified according to their characteristics as artificial intelligence medical devices in the form of software and medical robots based on a general discussion of their development.The medical-device Internet of Things(IoT)system has also been included due to its close relation to the construction of smart hospitals.For each type of intelligent medical device,testing indexes and testing plans are discussed.It is suggested that specific test rules should be further developed for various specific devices.Besides,the evaluation method of complex intelligent systems should be introduced and real-world data should be used for evaluation.This paper aims to accelerate the development of intelligent medical device testing,laying the foundation for quality control and performance evaluation of intelligent medical devices.

This study aims to investigate the effects of Japanese encephalitis virus(JEV)on TLRs signaling pathway and its regulation of the secretion of inflammatory factors during the infection of testicular interstitial cells,In this study,the mRNA levels of TLR3,TLR7,TLR8,TRIF and MyD88 genes were detected by qPCR after 1 MOI dose of JEV was inoculated into testicular stro-mal cells at different time periods.Western blot assay was used to detect the expression levels of TLR3,TLR7,TRIF and MyD88 protein at 6 h after JEV infection,and ELISA was used to detect the expression levels of IL-1β,IL-6 and TNF-α at different time periods(6,12 and 24 h).The re-sults showed as follows:After 6 h of JEV infection,the mRNA levels of TLR3,TLR7,TRIF and MyD88 genes were significantly up-regulated(P＜0.05),and the mRNA levels of TLR8 genes were down-regulated(P＜0.05).Western blot results showed that the protein expressions of TLR3,TLR7,TRIF and MyD88 were significantly up-regulated when JEV infected testicular stromal cells for 6 h(P＜0.05),which was consistent with the corresponding mRNA transcription levels.There was no significant change in TLR8 protein expression.ELISA results showed that 6 h after JEV infection of testicular stromal cells,IL-6 was significantly increased(P＜0.01),and the expressions of IL-1β and TNF-α were not changed.TLR3,TLR7,TLR8,TRIF and MyD88 were si-lenced by siRNA,and the silenced cells were inoculated with JEV for 6 h,and IL-6 expression lev-els were detected by ELISA.The results showed that silenced TLR3,TLR7,TLR8,TRIF and MyD88 could significantly reduce the increase of IL-6 secretion induced by JEV infection(P＜0.05).These results indicated that JEV could induce the expression of inflammatory factor IL-6 by activating TLR3,TLR7 and TLR8 signaling pathway after infection of testicular stromal cells.This study provides a reference for further elucidating the mechanism of reproductive disorders caused by JEV infection.

Porcine circovirus type 2(PCV2)is the main pathogen causing porcine circovirus related diseases.PCV2 infection in pigs may lead to porcine dermatitis and nephrotic syndrome(PDNS)and weaned piglets multiple system failure syndrome(PMWS),etc.At present,the pathogenic mechanism is not fully understood.PCV2 is a single strand of negative link DNA,which can cause immune suppression in the body and lead to increased secondary susceptibility,which has a syner-gistic effect with various pig diseases and brings major economic losses to the pig industry.Al-though there are commercial vaccines,the prevention of vaccines has certain limitations and there is no effective drug treatment so far,an outbreak will threaten people's life and health and public safety,resulting in significant economic losses.In order to understand the latest progress of PCV2 escape mechanism and prevention and control,this paper summarizes the inhibition of interferon production,regulation of apoptosis,regulation of autophagy,regulation of pyroptosis and inflam-matory response,evasion of adaptive immune response,and prevention and control of PCV2,in or-der to provide new theoretical ideas for the research and prevention and control of PCV2.

Internet of Things (IoT) technology plays an important role in smart healthcare. This paper discusses IoT solution for emergency medical devices in hospitals. Based on the cloud-edge-device architecture, different medical devices were connected; Streaming data were parsed, distributed, and computed at the edge nodes; Data were stored, analyzed and visualized in the cloud nodes. The IoT system has been working steadily for nearly 20 months since it run in the emergency department in January 2021. Through preliminary analysis with collected data, IoT performance testing and development of early warning model, the feasibility and reliability of the in-hospital emergency medical devices IoT was verified, which can collect data for a long time on a large scale and support the development and deployment of machine learning models. The paper ends with an outlook on medical device data exchange and wireless transmission in the IoT of emergency medical devices, the connection of emergency equipment inside and outside the hospital, and the next step of analyzing IoT data to develop emergency intelligent IoT applications.
Internet of Things ; Reproducibility of Results ; Internet ; Machine Learning ; Technology

As a low-load physiological monitoring technology, wearable devices can provide new methods for monitoring, evaluating and managing chronic diseases, which is a direction for the future development of monitoring technology. However, as a new type of monitoring technology, its clinical application mode and value are still unclear and need to be further explored. In this study, a central monitoring system based on wearable devices was built in the general ward (non-ICU ward) of PLA General Hospital, the value points of clinical application of wearable physiological monitoring technology were analyzed, and the system was combined with the treatment process and applied to clinical monitoring. The system is able to effectively collect data such as electrocardiogram, respiration, blood oxygen, pulse rate, and body position/movement to achieve real-time monitoring, prediction and early warning, and condition assessment. And since its operation from March 2018, 1 268 people (657 patients) have undergone wearable continuous physiological monitoring until January 2020, with data from a total of 1 198 people (632 cases) screened for signals through signal quality algorithms and manual interpretation were available for analysis, accounting for 94.48 % (96.19%) of the total. Through continuous physiological data analysis and manual correction, sleep apnea event, nocturnal hypoxemia, tachycardia, and ventricular premature beats were detected in 232 (36.65%), 58 (9.16%), 30 (4.74%), and 42 (6.64%) of the total patients, while the number of these abnormal events recorded in the archives was 4 (0.63%), 0 (0.00%), 24 (3.80%), and 15 (2.37%) cases. The statistical analysis of sleep apnea event outcomes revealed that patients with chronic diseases were more likely to have sleep apnea events than healthy individuals, and the incidence was higher in men (62.93%) than in women (37.07%). The results indicate that wearable physiological monitoring technology can provide a new monitoring mode for inpatients, capturing more abnormal events and provide richer information for clinical diagnosis and treatment through continuous physiological parameter analysis, and can be effectively integrated into existing medical processes. We will continue to explore the applicability of this new monitoring mode in different clinical scenarios to further enrich the clinical application of wearable technology and provide richer tools and methods for the monitoring, evaluation and management of chronic diseases.
Heart Rate ; Humans ; Monitoring, Physiologic ; Movement ; Sleep Apnea Syndromes ; Wearable Electronic Devices

Objective To compare the effectiveness of controlling blood loss in the treatment of complex acetabular fracture between temporary occlusion of abdominal aorta by interventional balloon (TOAAIB),temporary occlusion of common iliac artery by interventional balloon (TOCAIIB) and internal iliac artery ligation (IIAL).Methods Included for this study were 113 complex acetabular fractures which had been treated at Department of Orthopaedic Trauma,Shaoguang Hospital Affiliated to Southern Medical University from January 2000 through January 2017.There were 68 males and 45 females,aged from 23 to 61 years (average,42.3 years).According to the Letournel classification,all of them belonged to complex fractures,including 10 T-type,24 double-column,16 posterior column & posterior wall,46 transverse & posterior wall and 15 anterior & posterior half-transverse ones.They were all treated by open reduction and internal fixation but differed in surgical hemostasis techniques:TOAAIB was used in 37cases,TOCAIIB in 31 and IIAL in 45.Fracture reduction was evaluated by Matta criteria.Intraoperative bleeding and postoperative wound drainage,fracture union and complications related to interventions were recorded.Hip function was evaluated by Modified d'Aubigne & Postal clinical grading system after fracture healing.Results The 3 groups (TOAAIB,TOCAIIB and IIAL) were comparable because there were no significant differences in gender,age,time from injury to surgery,Letournel classification or surgical approaches between the patients in the 3 groups (P ＞ 0.05).Anatomical reduction was achieved in 91.15％ of the patients (103/113) and satisfactory reduction in 8.85％ (10/113).Intraoperative hemorrhage was 1,631.5 ±675.5 mL in the HAL group,892.6 ±217.7 mL in the TOCAIIB group and 648.0 ± 170.2 mL in the TOAAIB group,showing significant differences between the 3 groups (P ＜ 0.05).One case of femoral artery thrombosis occurred in the TOAAIB group at the end of operation but was cured by symptomatic treatment of anticoagulation.There were no interventional complications in the other 2 groups.There were no significant differences between the 3 groups in postoperative wound drainage,fracture union time,hip function score or complications (P ＞ 0.05).Conclusions In controlling intraoperative bleeding in the surgery for complex acetabular fracture,TOAAIB may be the best,followed by TOCAIIB,and IIAL may be the worst.However,choice of a proper surgical hemostasis technique should also depend on the specific intraoperative condition of a specific patient.

To achieve continuously physiological monitoring on hospital inpatients, a ubiquitous and wearable physiological monitoring system SensEcho was developed. The whole system consists of three parts: a wearable physiological monitoring unit, a wireless network and communication unit and a central monitoring system. The wearable physiological monitoring unit is an elastic shirt with respiratory inductive plethysmography sensor and textile electrocardiogram (ECG) electrodes embedded in, to collect physiological signals of ECG, respiration and posture/activity continuously and ubiquitously. The wireless network and communication unit is based on WiFi networking technology to transmit data from each physiological monitoring unit to the central monitoring system. A protocol of multiple data re-transmission and data integrity verification was implemented to reduce packet dropouts during the wireless communication. The central monitoring system displays data collected by the wearable system from each inpatient and monitors the status of each patient. An architecture of data server and algorithm server was established, supporting further data mining and analysis for big medical data. The performance of the whole system was validated. Three kinds of tests were conducted: validation of physiological monitoring algorithms, reliability of the monitoring system on volunteers, and reliability of data transmission. The results show that the whole system can achieve good performance in both physiological monitoring and wireless data transmission. The application of this system in clinical settings has the potential to establish a new model for individualized hospital inpatients monitoring, and provide more precision medicine to the patients with information derived from the continuously collected physiological parameters.

BACKGROUNDThe preclinical experiments and several clinical studies showed icotinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in Chinese patients with advanced non-small cell lung cancer (NSCLC) who failed previous chemotherapy. We performed a retrospective study of the efficacy and safety of icotinib monotherapy in a different and more recent sample of Chinese patients.

METHODSThe clinical data of 149 patients with advanced NSCLC who were admitted to Zhejiang Cancer Hospital from August 1, 2011 to July 31, 2012 were retrospectively analyzed. All patients were given icotinib treatment after the failure of previous chemotherapy. Univariate and multivariate analyses were conducted based on the Kaplan Meier method and Cox proportional hazards model.

RESULTSThe objective response rate was 33/149 and disease control rate was 105/149. No complete response occurred. Median progression free survival (PFS) with icotinib treatment was 5.03 months (95% CI: 3.51 to 6.55). Median overall survival was 12.3 months (95% CI: 10.68 to 13.92). Multivariate analysis showed that the mutation of EGFR and one regimen of prior chemotherapy were significantly associated with longer PFS. At least one drug related adverse event was observed in 65.8% (98/149) of patients, but mostly grade 1 or 2 and reversible and none grade 4 toxicity.

CONCLUSIONSIcotinib monotherapy is an effective and well tolerated regimen for Chinese patients with NSCLC after the failure of chemotherapy. It is a promising agent and further study with icotinib in properly conducted trials with larger patient samples and other ethnic groups is warranted.

Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; Crown Ethers ; adverse effects ; therapeutic use ; Female ; Humans ; Lung Neoplasms ; drug therapy ; Male ; Middle Aged ; Multivariate Analysis ; Proportional Hazards Models ; Quinazolines ; adverse effects ; therapeutic use ; Retrospective Studies

Background and objective Molecular targeting therapy is the direction of individualized treatment of lung cancer, scholars has been established targeted therapy prediction models which provide more guidance for clinical individual therapy. hTis study investigated the relationship among pulmonary surfactant-associated protein D (SP-D), trans-forming growth factorα(TGF-α), matrix metalloproteinase 9 (MMP-9), tissue polypeptide speciifc antigen (TPS), and Krebs von den Lungen-6 (KL-6) and response as well as survival in the patients with recurrent non-small cell lung cancer, which Erlotinib was as second line treatment atfer failure to chemotherapy. hTis study also established a predictive prognostic model.Methods Serum levels of SP-D, TGF-α, MMP-9, TPS, and KL-6 in 114 patients before erlotinib treatment were detected by ELISA method. Combined with clinical factors, these levels were used to investigate the relationship with effcacy in erlotinib treatment and construct a predicted prognostic model by Kaplan-Meier curve and Cox proportional hazard model multivariate analysis. Results hTe objective response rate (ORR) and disease control rate (DCR) in the 114 patients, were 22.8%(26/114) and 72.8%(83/114), to Erlotinib treatment respectively. hTe median progression-free survival (PFS) and one year survival rate with Erlotinib treatment were 5.13 months and 69.3%, respectively. Patients in the SP-D>110 ng/mL group exhibited more ORR (33.3%vs 13.3%, P=0.011) and DCR (83.3%vs 63.3%, P=0.017) than those in the≤110 ng/mL group. Patients in the MMP-9≤535 ng/mL group showed more DCR (83.9%) than those in the>535 ng/mL group (62.1%) (P=0.009). Patients in the TPS<80 U/L group showed more DCR (82.4%) than those in the≥80 U/L group (55.0%) (P=0.002). hTe SP-D>110 ng/mL (5.95 months vs 3.25 months, P=0.009), MMP-9≤535 ng/mL (5.83 months vs 3.47 months, P=0.046), KL-6<500 U/mL (6.03 months vs 3.40 months, P=0.040), and TPS<80 U/L (6.15 months vs 2.42 months, P=0.014) groups showed better PFS. Multivariate analysis showed that current or ever-smoker, wild style of EGFR status, progression atfer prior chemotherapy, absence of skin rash, elevated serum LDH level, and TPS≥80 U/L were independent adverse prognostic factors for PFS. hTese six factors were used in the prognostic model. Patients were categorized into four prognosis risk groups based on the prog-nostic index from the model, namely, low risk, intermediate low risk, intermediate risk, and high risk groups. hTe median PFS of good, intermediate, poor, and very poor prognosis groups were 9.12, 6.88, 3.52, and 0.93 months (P<0.001), respectively. Conclusion hTe prognostic model based on clinical parameters with TPS will be useful in identifying patients who might be most likely to beneift from Erlotinib therapy in the patients with recurrent non-small cell lung cancer.

Anemia is commonly observed in lung cancer patients,and it is mainly caused by chemotherapy.Anemia can cause several debilitating symptoms such as fatigue and tachycardia which will not only influence the patients' quality of life and therapy effect,but also short the survival time.So anemia has been regarded as a poor independent prognostic indicator of the disease.Transfusion the erythrocytes and using the erythropoiesis stimulating agents is the main treatments of the disease.Using the erythropoiesis stimulating agents is the main treatment before the hemoglobin decreasing significantly in order to reduce the times of transfusion.Keeping the hemoglobin between 10.0-12.0 g/dl can improve the patients' quality of life and avoid the adverse events such as thrombus formation at the same time.