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.

With the progress of science and technology and the increase of clinical demand, medical robots have developed rapidly and played a important role in promoting the medical cause. Service robot is a branch of medical robot, which is mainly oriented to medical service and assistance needs, and has been applied in many medical scenarios and achieved demonstration effects. This research first describes the development of medical service robots, and then summarizes the key technologies and clinical applications of robots. Finally, it points out the challenges and directions that medical service robots face at present, and puts forward prospects for their further development in the medical field.
Robotics ; Technology

Objective:To investigate the survival benefit of radiotherapy on the basis of systemic treatment for stage ⅣB esophageal squamous cell carcinoma (ESCC).Methods:Based on inclusion and exclusion criteria, we collected the treatment information of 298 patients with newly diagnosed stage ⅣB ESCC admitted to Affiliated Cancer Hospital of Zhengzhou University from January 2016 to February 2021. All patients were divided into two groups based on treatment: early radiotherapy intervention group (CRT group, n=197) and salvage radiotherapy intervention or no intervention group (CT group, n=101). Propensity score matching (PSM) was used to balance baseline characteristics between two groups. Kaplan-Meier method was used to calculate the survival rate and log-rank was used to test the difference. Cox model was used to analyze the multivariate prognosis. Results:In the CRT and CT groups, the objective response rate (ORR) and disease control rate (DCR) were 52.8% vs. 31.5%( P=0.006) and 98.9% vs. 85.4%( P=0.001) respectively, and the 1-, 2- and 3-year survival rates were 74.2% vs. 52.8%、31.5% vs. 10.1% and 15.7% vs. 2.2%, respectively. Median progression-free survival (PFS) was 8.5 months (95% CI: 6.7-10.3 months) vs. 4.4 months (95% CI: 3.5-5.3 months)( P<0.001). Median overall survival (OS) were 17.1 months (95% CI: 14.9-19.3 months) vs. 12.7 months (95% CI: 8.0-17.4 months)( P<0.001). The difference of adverse reactions was mainly in hematology. Conclusions:For newly diagnosed stage ⅣB patients with ESCC, radiotherapy should be combined with systemic therapy as early as possible. It yields longer PFS and OS, and effectively improves dysphagia. Adverse reactions are tolerated. Further validation is recommended in larger prospective studies.

【Objective】 To determine the reference range of thromboelastogram(TEG) and establish a TEG feature for local population by measuring TEG parameters in healthy adults in Shenzhen comparing the difference between gender and age, and analyzing the reference data provided by reagent manufacturer. 【Methods】 A total of 916 healthy adults, aged between 19 to 59, who did their regular health checks in our hospital from September 2020 to August 2021 were selected. The TEG(from Lepu Medical Technology Co., Ltd.) was performed, and the clot reaction time(R), clot formation time(K), coagulation angle(α-Angle), maximum amplitude(MA), coagulation index(CI), fibrinolysis index LY30 and the estimated percent lysis (EPL) were analyzed. 【Results】 The reference ranges of TEG parameters, including R, K, α-Angle, MA, CI, LY30 and EPL, of 916 healthy adults from Shenzhen were 3.25~8.19 min, 0.66~3.18min, 47.70~76.56deg, 50.05~72.91mm, -4.3~3.4, 0~2.2% and 0~3%, respectively. The value of α-Angle, CI, K, LY30, MA and R didn’t all meet the given range provided by the manufacturer; some were exceeding and some inferior to. A total of 227 out of 916 individuals presented abnormal results, relative to the references, in at least one parameter, and 78 were diagnosed of abnormal coagulation based on the given reference range, with a specificity of 75.2%. 【Conclusion】 The reference range of TEG parameters of Shenzhen locals is significantly different from that provided by manufacturers. And it is imperative for local TEG laboratories to establish their own reference ranges according to age and gender groups based on local population characteristics.

Objective:To evaluate the time-zero biopsy of donor kidney with acute kidney injury(AKI)in organ donation donors and examine the clinical effect after transplantation.Methods:From May 2019 to May 2020, clinical data were retrospectively reviewed for 104 donors assessed by time-zero biopsy at First Affiliated Hospital, Zhengzhou University.According to the definition of AKI and Banff2016 criteria, the kidneys of 104 donors were grouped and evaluated for transplantation.And the post-transplantation effects of donor kidneys with different degrees of pathological changes were analyzed.Results:AKI occurred in 32/104 donors.Compared with non-AKI donors, statistically significant differences existed in degrees of renal interstitial fibrosis and acute renal tubular injury ( P<0.05). However, there were no significant differences in other pathological manifestations ( P>0.05). In AKI group, kidneys of 2 donors with Banff score>3 were abandoned; in non-AKI group, among 12 donors with Banff score>3, 1 donor kidney was abandoned due to a high degree of chronic diseases.No significant inter-group difference existed in creatinine value or estimated glomerular filtration rate(eGFR)( P>0.05). AKI group had a higher incidence of postoperative delayed graft function(DGF)and longer duration.There was no statistical significance in other complications ( P>0.05). Conclusions:AKI donor kidneys with pathological manifestations below moderate renal tubular injury and Banff score<3 are feasible for transplantation.Although renal function recovery is slow after transplantation, safe outcomes may be obtained.

Objective:To summarize the preliminary experience of percutaneous radiofrequency ablation(RFA) in the treatment of early breast cancer(the length of the lesion<15 mm) with negative sentinel lymph node(SLN), and to evaluate its feasibility and efficacy.Methods:From October 2016 to November 2019, 18 patients with early breast cancer(the length of the lesion<15 mm) treated in the First Affiliated Hospital of Zhengzhou University underwent FNAC of axillary SLN under the guidance of CEUS were enrolled. Patients with pathologically negative axillary SLN were treated with percutaneous RFA of breast cancer. The complete ablation rate and the relapse rate were evaluated. Intraoperative pain, postoperative complications and postoperative patient satisfaction were analyzed.Results:Eighteen patients underwent CEUS-guided FNAC of SLN, of which 1 case was positive and 17 cases were negative. Seventeen breast cancer lesions of the 17 negative patients underwent percutaneous RFA. The length of the lesions was 3.3-14.0 (8.2±3.9)mm, the complete ablation rate was 100%, the ablation time was 9-18 (12.8±2.7)min. During the follow-up of 9-46 months, no patient developed tumor progression. There were no serious complications related to RFA after operation. The patients′ satisfactory rate for postoperative appearance was 100%.Conclusions:RFA of early breast cancer(the length of the lesion<15 mm) with negative SLN is feasible and has the advantages of safety, minimal invasion and beauty.

OBJECTIVES: To investigate the effect of adriamycin (ADM), idelalisib or ADM and their combination on cell proliferation and intracellular concentration of ADM, and to explore the reversal effect of idelalisib on drug resistance to ADM. METHODS: The K562 and K562/ADM cells were respectively treated with ADM and idelalisib at different concentrations. The 50% inhibitory concentration (IC RESULTS: The cell survival rates were significantly decreased in a dose-dependent manner when the cells were treated with different doses of ADM (0.001-10.000 mg/L ). The IC CONCLUSIONS Idelalisib exerts effect on inhibition of the proliferation in myeloid leukemia K562 and K562/ADM cells, which may partially reverse the drug resistance of K562/ADM cells to ADM. The mechanisms for the effect of idelalisib may be related to increasing the accumulation of ADM and inducing the cell apoptosis in the K562 and K562/ADM cells.
ATP Binding Cassette Transporter, Subfamily B, Member 1 ; Cell Proliferation ; Doxorubicin/pharmacology* ; Drug Resistance, Multiple ; Drug Resistance, Neoplasm ; Humans ; K562 Cells ; Leukemia, Myeloid ; Purines ; Quinazolinones

Currently, the value of adjuvant therapy after radical resection of esophageal squamous cell carcinoma remains elusive. Some studies have reported that radiotherapy can improve the locoregional control rate and overall survival of patients. However, the design of radiotherapy target area, intervention time and dose of radiotherapy are controversial. In this article, literature review was conducted and the current status and controversy of adjuvant radiotherapy after radical resection of esophageal squamous cell carcinoma were reviewed.

Objective:To explore the prognostic factors of patients with gallbladder cancer in different anatomical locations.Methods:A retrospective analysis of the clinical data of 140 patients with gallbladder cancer who were surgically treated in the 904 Hospital of the Joint Logistics Support Force from January 2015 to December 2015. Among them, 49 were males and 91 were females, with a median age of 64.0 years. According to the location of gallbladder cancer, they were divided into the neck of the gallbladder and the bottom of the gallbladder. The clinical data of the two groups were compared. The Kaplan-Meier method was used for univariate analysis, and Cox multivariate regression analysis was used to analyze the significant factors of univariate survival to determine the independent risk factors that affect the prognosis of patients with gallbladder cancer. Use Pearson correlation to analyze the correlation between clinicopathological characteristics.Results:Patients in the neck of the gallbladder group had higher levels of preoperative total bilirubin, preoperative albumin, carcinoembryonic antigen, carbohydrate antigen 19-9, extrahepatic bile duct resection (biliary-enteric anastomosis), radical resection, breakthrough of the liver/serous membrane invasion, lymph node metastasis, TNM staging, local recurrence in the operation area in the surgical area were statistically significant ( P<0.05). Univariate analysis suggested that preoperative jaundice, Glasgow prognostic score (GPS), C-reactive protein, carcinoembryonic antigen, carbohydrate antigen 19-9, accidental gallbladder cancer, surgical method, tumor pathological type, tumor differentiation degree, tumor growth location (neck than the bottom of the body) are related to the prognosis (all P<0.05). Cox regression analysis indicated that GPS ( RR=3.272, 95 CI: 1.987-5.388), surgical method ( RR=4.149, 95 CI: 2.561-6.723), tumor location ( RR=0.316, 95 CI: 0.209-0.478), distant metastasis ( RR=1.695, 95 CI: 1.036-2.775) and TNM staging ( RR=3.686, 95 CI: 2.222-6.115) are independent risk factors affecting the prognosis of gallbladder cancer. Correlation analysis suggests that neck tumors are related to later staging, liver bile duct invasion, lymph node metastasis, high inflammation levels, and low radical cure rates. Conclusions:Gallbladder cancer that occurs in the neck of the gallbladder is an independent factor influencing the poor prognosis of patients with surgical treatment. In addition, TNM staging, distant metastasis and Glasgow score are important predictors of survival in patients with gallbladder cancer.

Objective:To investigate the expression and clinical significance of Golgi phosphoprotein 3 (GOLPH3) and NOD-like receptor protein 3 (NLRP3) in gallbladder carcinoma (GBC).Methods:Surgical specimens and clinical data were collected from 63 patients with GBC who underwent radical cholecystectomy in the 904th Hospital of Joint Logistic Support Force of PLA from January 2014 to January 2019. In the GBC group, there were 21 males and 42 females, with an average age of 62.5 years. For 30 patients with mild to moderate atypical hyperplasia of gallbladder during the same period were included in the precancerous lesion group, including 9 males and 21 females, with an average age of 62.4 years. Normal gallbladder specimens from 20 patients who underwent surgical resection due to liver trauma or giant hepatic hemangioma were collected and included in the normal group, including 7 males and 13 females, with an average age of 61.9 years. The expressions of GOLPH3, NLRP3, Ki-67 were detected by immunohistochemistry. Log-rank test and Cox regression were adopted to analyze the GOLPH3 and NLRP3 expression and survival prognosis of gallbladder cancer patients.Results:Expression of GOLPH3 and NLRP3 in the tumor group, precancerous lesion group and normal group was decreased separately. In GBC tissues, the level of GOLPH3 and NLRP3 was positively correlated with the Ki-67 expression ( r=0.972 and r=0.969, both P<0.05). Multivariate analysis showed that high level of GOLPH3 ( HR=4.891, 95% CI: 1.776-13.470) and NLRP3 ( HR=3.006, 95% CI: 1.273-7.099) was an independent risk factor for predicting the postoperative survival of patients with GBC (both P<0.05). Conclusion:GOLPH3 and NLRP3 are highly expressed in GBC tissues, and high expression of GOLPH3 and NLRP3 is an independent risk factor for postoperative survival in patients with GBC.