1.Laboratory proficiency testing for creepage distance and electrical clearance test of medical electrical equipment based on GB 9706.1-2020
Xiao-Ming GAO ; Song-Yan XU ; Xiao-Peng HAN ; Zhen-Shi LIANG ; Man ZHANG ; Ting-Ru GUAN ; Hui-Ru WANG ; Yuan-Yuan QU ; Xin-Hua XIANG
Chinese Medical Equipment Journal 2024;45(10):54-59
Objective To clarify the understanding of types of laboratories and manufacturers for GB 9706.1-2020 Medical electrical equipment-Part 1:General requirements for basic safety and essential performance by laboratory proficiency testing for creepage distance and electrical clearance test.Methods An operation guide was formed according to the testing program in GB 9706.1-2020,and the homogeneity and stability of the samples were evaluated according to CNAS-GL003:2018 Guidance on Evaluating the Homogenneity and Stability of Samples Used for Proficiency Testing.Robust statistic methods were used to assess the quantitative parameters of the test results of the participating laboratories according to the requirements in GB/T 28043-2019 Statistical methods for use in proficiency testing by interlaboratory comparison;the results reported by the expert laboratories were used as the specified values of the qualitative parameters.SPSS 25.0 statistical software was used for data analysis.Results All the results of the crreepage distance and electrical clearance tests met the requirements for homogeneity and stability.Of the 46 laboratories involved in,37 ones did have comprehensive satisfactory determinations while the remained 9 ones not.Conclusion Some laboratories don't behave well in understanding the standard,which have to be reformed accordingly to enhance their proficiencies.[Chinese Medical Equipment Journal,2024,45(10):54-59]
2.HbA1c comparison and diagnostic efficacy analysis of multi center different glycosylated hemoglobin detection systems.
Ping LI ; Ying WU ; Yan XIE ; Feng CHEN ; Shao qiang CHEN ; Yun Hao LI ; Qing Qing LU ; Jing LI ; Yong Wei LI ; Dong Xu PEI ; Ya Jun CHEN ; Hui CHEN ; Yan LI ; Wei WANG ; Hai WANG ; He Tao YU ; Zhu BA ; De CHENG ; Le Ping NING ; Chang Liang LUO ; Xiao Song QIN ; Jin ZHANG ; Ning WU ; Hui Jun XIE ; Jina Hua PAN ; Jian SHUI ; Jian WANG ; Jun Ping YANG ; Xing Hui LIU ; Feng Xia XU ; Lei YANG ; Li Yi HU ; Qun ZHANG ; Biao LI ; Qing Lin LIU ; Man ZHANG ; Shou Jun SHEN ; Min Min JIANG ; Yong WU ; Jin Wei HU ; Shuang Quan LIU ; Da Yong GU ; Xiao Bing XIE
Chinese Journal of Preventive Medicine 2023;57(7):1047-1058
Objective: Compare and analyze the results of the domestic Lanyi AH600 glycated hemoglobin analyzer and other different detection systems to understand the comparability of the detection results of different detectors, and establish the best cut point of Lanyi AH600 determination of haemoglobin A1c (HbA1c) in the diagnosis of diabetes. Methods: Multi center cohort study was adopted. The clinical laboratory departments of 18 medical institutions independently collected test samples from their respective hospitals from March to April 2022, and independently completed comparative analysis of the evaluated instrument (Lanyi AH600) and the reference instrument HbA1c. The reference instruments include four different brands of glycosylated hemoglobin meters, including Arkray, Bio-Rad, DOSOH, and Huizhong. Scatter plot was used to calculate the correlation between the results of different detection systems, and the regression equation was calculated. The consistency analysis between the results of different detection systems was evaluated by Bland Altman method. Consistency judgment principles: (1) When the 95% limits of agreement (95% LoA) of the measurement difference was within 0.4% HbA1c and the measurement score was≥80 points, the comparison consistency was good; (2) When the measurement difference of 95% LoA exceeded 0.4% HbA1c, and the measurement score was≥80 points, the comparison consistency was relatively good; (3) The measurement score was less than 80 points, the comparison consistency was poor. The difference between the results of different detection systems was tested by paired sample T test or Wilcoxon paired sign rank sum test; The best cut-off point of diabetes was analyzed by receiver operating characteristic curve (ROC). Results: The correlation coefficient R2 of results between Lanyi AH600 and the reference instrument in 16 hospitals is≥0.99; The Bland Altman consistency analysis showed that the difference of 95% LoA in Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180) was -0.486%-0.325%, and the measurement score was 94.6 points (473/500); The difference of 95% LoA in the Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant II) was -0.727%-0.612%, and the measurement score was 89.8 points; The difference of 95% LoA in the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT) was -0.231%-0.461%, and the measurement score was 96.6 points; The difference of 95% LoA in the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT) was -0.469%-0.479%, and the measurement score was 91.9 points. The other 14 hospitals, Lanyi AH600, were compared with 4 reference instrument brands, the difference of 95% LoA was less than 0.4% HbA1c, and the scores were all greater than 95 points. The results of paired sample T test or Wilcoxon paired sign rank sum test showed that there was no statistically significant difference between Lanyi AH600 and the reference instrument Arkray HA8180 (Z=1.665,P=0.096), with no statistical difference. The mean difference between the measured values of the two instruments was 0.004%. The comparison data of Lanyi AH600 and the reference instrument of all other institutions had significant differences (all P<0.001), however, it was necessary to consider whether it was within the clinical acceptable range in combination with the results of the Bland-Altman consistency analysis. The ROC curve of HbA1c detected by Lanyi AH600 in 985 patients with diabetes and 3 423 patients with non-diabetes was analyzed, the area under curve (AUC) was 0.877, the standard error was 0.007, and the 95% confidence interval 95%CI was (0.864, 0.891), which was statistically significant (P<0.001). The maximum value of Youden index was 0.634, and the corresponding HbA1c cut point was 6.235%. The sensitivity and specificity of diabetes diagnosis were 76.2% and 87.2%, respectively. Conclusion: Among the hospitals and instruments currently included in this study, among these four hospitals included Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180), Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant Ⅱ), the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT), and the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT), the comparison between Lanyi AH600 and the reference instruments showed relatively good consistency, while the other 14 hospitals involved four different brands of reference instruments: Arkray, Bio-Rad, DOSOH, and Huizhong, Lanyi AH600 had good consistency with its comparison. The best cut point of the domestic Lanyi AH600 for detecting HbA1c in the diagnosis of diabetes is 6.235%.
Pregnancy
;
Child
;
Humans
;
Female
;
Glycated Hemoglobin
;
Cohort Studies
;
Diabetes Mellitus/diagnosis*
;
Sensitivity and Specificity
;
ROC Curve
3.Analysis on survival time and influencing factors among reported HIV/AIDS in Yunnan Province, 1989-2021.
Li Ru FU ; Min Yang XIAO ; Man Hong JIA ; Li Jun SONG ; Xue Hua LI ; Jin NIU ; Xiao Wen WANG ; Zu Yang ZHANG ; Yan Ling MA ; Hong Bing LUO
Chinese Journal of Epidemiology 2023;44(6):960-965
Objective: To analyze the survival time of reported HIV/AIDS and influencing factors of Yunnan Province from 1989 to 2021. Methods: The data were extracted from the Chinese HIV/AIDS comprehensive response information management system. The retrospective cohort study was conducted. The life table method was applied to calculate the survival probability. Kaplan-Meier was used to draw survival curves in different situations. Furthermore, the Cox proportion hazard regression model was constructed to identify the factors related to survival time. Results: Of the 174 510 HIV/AIDS, the all-cause mortality density was 4.23 per 100 person-years, the median survival time was 20.00 (95%CI:19.52-20.48) years, and the cumulative survival rates in 1, 10, 20, and 30 years were 90.75%, 67.50%, 47.93% and 30.85%. Multivariate Cox proportional risk regression model results showed that the risk of death among 0-14 and 15-49 years old groups were 0.44 (95%CI: 0.34-0.56) times and 0.51 (95%CI:0.50-0.52) times of ≥50 years old groups. The risk for death among the first CD4+T lymphocytes counts (CD4) counts levels of 200-349 cells/μl, 350-500 cells/μl and ≥501 cells/μl groups were 0.52 (95%CI: 0.50-0.53) times, 0.41 (95%CI: 0.40-0.42) times and 0.35 (95%CI: 0.34-0.36) times of 0-199 cells/μl groups. The risk of death among the cases that have not received antiretroviral therapy (ART) was 11.56 (95%CI: 11.26-11.87) times. The risk for death among the cases losing to ART, stopping to ART, both losing and stopping ART was 1.66 (95%CI:1.61-1.72) times, 2.49 (95%CI:2.39-2.60) times, and 1.65 (95%CI:1.53-1.78) times of the cases on ART. Conclusions: The influencing factors for the survival time of HIV/AIDS cases were age at diagnosis in Yunnan province from 1989 to 2021. The first CD4 counts levels, antiretroviral therapy, and ART compliance. Early diagnosis, early antiretroviral therapy, and increasing ART compliance could extend the survival time of HIV/AIDS cases.
Humans
;
Middle Aged
;
Retrospective Studies
;
China/epidemiology*
;
Acquired Immunodeficiency Syndrome/epidemiology*
;
Anti-Retroviral Agents/therapeutic use*
;
Asian People
4.Effects of long working hours exposure on occupational stress and depression symptoms in couriers in Zhejiang Province.
Yi Xin ZHANG ; Pan Qi XUE ; Shuang LI ; Xiao Man LIU ; Hua ZOU
Chinese Journal of Industrial Hygiene and Occupational Diseases 2023;41(4):255-261
Objective: To understand the current situation of long working hours exposure of couriers in Zhejiang Province, and to analyze the influence of long working hours exposure levels on their occupational stress and depression symptoms, and provide a basis for promoting the physical and mental health of couriers. Methods: From September to December 2021 , 1159 couriers from Zhejiang Express Transport Companies were selected as respondents by cluster sampling, and their basic information were collected. The occupational stress and depression symptoms of the couriers were assessed using the Core Occupational Stress Scale (COSS) and the Patient Health Questionnaire-9 (PHQ-9). The effects of long work hours (>48 h per week) on the occupational stress and depression symptoms of the couriers were analyzed. Results: The average age of 1159 courier in Zhejiang Province was (33.24±8.42) years, the average weekly working hours were (63.21±18.77) h, and 75.15% (871/1159) were long-term workers. The detection rates of occupational stress and depression symptoms in courier were 32.44% (376/1159) and 32.53% (377/1159), respectively. There were significant differences in the detection rates of occupational stress and depression symptoms among couriers with different ages, educational background, marital status, monthly average income, length of service, position or post, shift status, drinking status, and average weekly working hours (P <0.05). The adjusted logistic regression analysis showed that, after adjusting for the influence of confounding factors such as age, educational background, marital status, monthly average income, length of service, position or post, shift status and drinking status, compared with the weekly working hours ≤48 h, weekly working hours of 63-77 h, 78-92 h, ≥93 h were the risk factors for occupational stress (OR=1.547, 95%CI: 1.019-2.350; OR=1.886, 95%CI: 1.184-3.006; OR=2.338, 95%CI: 1.188-4.062) and depression symptoms (OR=1.897, 95%CI: 1.258-2.860; OR=2.041, 95%CI: 1.290-3.230; OR=4.978, 95%CI: 2.551-9.715) of couriers (P<0.05) . Conclusion: Long working hours could increase the risk of occupational stress and depression symptoms among couriers. It is necessary to arrange working hours reasonably to reduce the occurrence of occupational stress and depression symptoms of couriers.
Humans
;
Depression/psychology*
;
Occupational Stress/psychology*
;
Mental Health
;
Risk Factors
;
Job Satisfaction
;
Surveys and Questionnaires
5.Performance and applicability evaluation of pressure infusion cuff and blood warmer under severe cold environments in the field
Yin-Tu MA ; Li CHEN ; Xiao-Fei CHEN ; Yi-Man ZHAO ; Jin-Bao WANG ; Liang WANG ; Li-Hua LI
Chinese Medical Equipment Journal 2023;44(11):117-120
Objective To test the performances and applicability of the pressure infusion cuff and blood warmer under severe cold environments in the field.Methods Under the severe cold conditions in the field,the simulated hemorrhagic shock patient was placed on a stretcher and transported to a transfer vehicle 2 km away,a pressure infusion cuff and blood warmer was used to perform fluid resuscitation and heating and pressurization blood transfusion during the transport,and the effect of heating and pressurization of the device during the transport was evaluated;two healthy adult male pigs were selected to construct animal models of hemorrhagic shock from war wounds,of which one pig was used as an experimental animal to be treated by blood transfusion with a pressure infusion cuff and blood warmer and the other pig was recognized as a control animal to be treated by blood transfusion using commercially available inflatable pressurized bags and thermostats,and comparison analysis was carried out on the changes in vital signs of animals before and after treatment by the 2 methods of warming and pressurization and the effects of warming and pressurization transfusion.Results The pressure infusion cuff and blood warmer gained advantages in convenience,efficiency and applicability during patient transport;the experimental animal behaved better than the control animal in vital signs such as blood volume,pressure and respiration,transfusion speed and fluid warming.Conclusion The pressure infusion cuff and blood warmer has high efficiency and is applicable under severe cold conditions in the field.[Chinese Medical Equipment Journal,2023,44(11):117-120]
6.Effect of Jiuwei Zhuhuang Powder on Cough Resolution in Children with Upper Respiratory Tract Infections: A Multicenter Randomized Controlled Trial.
Hui LUO ; Gui-Hua SONG ; Xiao-Jian MA ; Meng-Meng SUN ; Man ZHANG ; Jian-Rong XIE ; Shao PENG
Chinese journal of integrative medicine 2022;28(5):387-393
OBJECTIVE:
To assess the effectiveness of Jiuwei Zhuhuang Powder (JWZH), a Tibetan patent medicine in treating upper respiratory tract infection (URTI) associated cough in children.
METHODS:
The study was a multicenter, randomized, open-label, controlled trial. A total of 142 children aged 2 to 14 years old, with URTI-associated cough within 48 h of onset, were randomly assigned to two groups at a 1:1 ratio by computer-generated randomization sequence. Children were treated with JWZH (1 to 1.5 g, twice to thrice daily) in the treatment group or conventional treatment (Pediatric Paracetamol, Artificial Cow-bezoar and Chlorphenamine Maleate Granules, 0.25 to 1 g, thrice daily) in the control group for 5 days. The primary endpoints were the time to cough resolution and 4-day cough resolution rate. The secondary endpoints were the daily improvement in symptom scores and cough resolution rate during the study period.
RESULTS:
A total of 138 children were included in the intention-to-treat analysis, with 71 cases in the treatment group and 67 cases in the control group. Compared with the conventional treatment, the children receiving JWZH had a shorter time to cough resolution [hazard ratio, 2.10; 95% confidence interval (CI), 1.29-3.40; P=0.003]. The median time to cough resolution for children receiving JWZH was shorter than that of the conventional treatment (2 days vs. 3 days; P<0.001). The 4-day cough resolution rate in the JWZH group was higher than that of the control group (94.4% vs. 74.6%; risk difference: 19.8%, 95% CI: 8.1%-31.5%; relative risk: 1.265, 95% CI: 1.088-1.470; P=0.001). There were no statistically significant differences in the improvement of other symptoms caused by URTI (P>0.05). Adverse events was reported in 5.6% (4/71) and 4.5% (3/67) in participants of JWZH and PPACCM groups (P>0.05), respectively, which were all mild and resolved without treatment.
CONCLUSION
JWZH seemed to be a safe and effective therapy for URTI-associated cough in children. (Trial registration No. ChiCTR2000039421).
Child
;
Cough/drug therapy*
;
Drugs, Chinese Herbal
;
Humans
;
Nonprescription Drugs
;
Powders
;
Respiratory Tract Infections/drug therapy*
7.Expression of ROBO3 and Its Effect on Cell Proliferation and Apoptosis in Pediatric Patients with Acute Myeloid Leukemia.
Man-Si CAI ; Ai-Ling LUO ; Xiao-Ping LIU ; Hua JIANG ; Xiao-Dan LIU
Journal of Experimental Hematology 2022;30(5):1324-1330
OBJECTIVE:
To investigate the expression of ROBO3 in pediatric AML patients and explore its function on cell proliferation and apoptosis.
METHODS:
The expression of ROBO3 in pediatric AML patients at different treatment stage was detected by real-time quantitative polymerase chain reaction (RT-qPCR). The relationship between the expression of ROBO3 and clinic pathological characteristics in newly diagnosed pediatric AML patients was analyzed. Moreover, the effects of ROBO3 on the proliferation and apoptosis of AML cell lines HL-60 and THP-1 were estimated by using CCK-8 and flow cytometry after transfection with ROBO3 siRNA.
RESULTS:
It was found that ROBO3 expression was significantly increased in most of newly diagnosed pediatric AML patients, especially in non-M3 subtype, younger patients (<10 years old), and high risk group, compared to corresponding controls. Furthermore, the expression level of ROBO3 was sharply decreased in patients who achieved complete remission. Targeting ROBO3 significantly inhibited AML cell proliferation, as well as increased apoptosis by ROBO3 siRNA transfection in vitro.
CONCLUSION
ROBO3 is differentially expressed within distinct subtypes of the pediatric AML patients, which suggested that ROBO3 may be a potential biomarker and a new therapeutic target for pediatric AML.
Apoptosis
;
Cell Line, Tumor
;
Cell Proliferation
;
Child
;
Humans
;
Leukemia, Myeloid, Acute/genetics*
;
MicroRNAs/genetics*
;
RNA, Small Interfering
;
Receptors, Cell Surface
;
Sincalide
8.Outcomes of partial pubectomy assisted anastomotic urethroplasty for male patients with pelvic fracture urethral distraction defect.
Jian Wei WANG ; Xiao XU ; Zheng Qing BAO ; Zhen Hua LIU ; Feng HE ; Guang Lin HUANG ; Li Bo MAN
Journal of Peking University(Health Sciences) 2021;53(4):798-802
OBJECTIVE:
To summarize the clinical outcomes of partial pubectomy assisted anastomotic urethroplasty for male patients with pelvic fracture urethral distraction defect (PFUDD) and discuss the skills of partial pubectomy.
METHODS:
The clinical data of 63 male patients with PFUDD were retrospective reviewed. The procedure of the anastomotic urethroplasty was as follows: (1) circumferentially mobilizing the bulbar urethra; (2) separating the corporal bodies; (3) performing the urethral anastomosis after partial pubectomy and exposure of the healthy two ends of the urethra.
RESULTS:
The mean age of the patients was (39.2±15.6) years (range: 15-72 years). The median time between incidents and operation was 15 months (range: 3-240 months) and the mean length of stricture was (3.85±0.91) cm (range: 1.5-5.5 cm). All the patients had undergone suprapubic cystostomy in acute setting. Thirteen patients (20.6%) were re-do cases and the patients who had undergone dilation, direct vision internal urethrotomy (DVIU), and open primary realignment were 22 (34.9%), 8 (12.7%), and 8 (12.7%), respectively. Assisted with partial pubectomy, the anastomotic urethroplasty had been successfully performed in all the patients. The mean time of operation was (160.2±28.1) min (110-210 min), and the mean evaluated blood loss was (261.1±130.3) mL (100-800 mL). There were 3 cases (4.8%) with perioperative blood transfusions. The postoperative complications were bleeding and urinary tract infection, which were controlled conservatively. The mean maximum urine flow rate was (23.7±7.4) mL/s (15.0-48.2 mL/s) after removing the catheters 4 weeks after urethroplasty. The median follow-up was 23 months (12-37 months). The urethroscopy showed 2 cases of stricture recurrences and 1 case of iatrogenic penile urethral stricture due the symptoms of urinary tract infection and decreased urine flow and all of them were successfully managed with dilation.
CONCLUSION
Partial pubectomy can effectively reduce the gap between the ends of the urethra and promote tension-free anastomosis during the anastomotic urethroplsty for patients with PFUDD. The skills of the procedure include good exposure of the anterior surface of pubic symphysis between the separated corporal bodies, carefully mobilizing and securing the deep dorsal vein of the penis, removing the partial pubic bone and the harden scar beneath the pubic bone for good exposure of the proximal urethral end.
Adolescent
;
Adult
;
Aged
;
Anastomosis, Surgical
;
Humans
;
Male
;
Middle Aged
;
Pelvic Bones/surgery*
;
Retrospective Studies
;
Treatment Outcome
;
Urethra/surgery*
;
Urethral Stricture/surgery*
;
Urologic Surgical Procedures, Male
;
Young Adult
9. Effect of Li-Zhong-Tang on gastric ulcer in rats based on Raf/MEK/ERK signaling pathway and its mechanism
Hou-Pan SONG ; Xiao-Juan CHEN ; Xin-Yi CHEN ; Jing-Yue QIU ; Man-Ting WU ; Hou-Pan SONG ; Xiao-Juan CHEN ; Xin-Yi CHEN ; Jing-Yue QIU ; Man-Ting WU ; Hou-Pan SONG ; Qing-Hua PENG ; Mei-Yan ZENG
Chinese Pharmacological Bulletin 2021;37(9):1291-1298
Aim To investigate the effect of Li-Zhong-Tang (LZT) in the treatment of gastric ulcer (GU) with pattern of spleen-stomach vacuity cold in rats based on Raf/MEK/ERK signaling pathway and the underlying molecular mechanism. Methods SD rats were randomly divided into normal group, GU model group, esomeprazole (ESO) group, LZT low dose and high dose groups. The morphological changes of gastric mucosa were observed by naked eyes and HE staining. The activities of gastric acid and pepsin were measured. The contents of prostaglandin E
10.Current Research Status of Aptamer-mediated Liposome Targeted Delivery of Antitumor Drugs
Kun ZHU ; Zhong-lan YANG ; Xiao-qing ZHANG ; Shuang-cheng NING ; Li-li ZHOU ; Man-shu ZOU ; Xin-hua XIA
Chinese Journal of Experimental Traditional Medical Formulae 2020;26(20):206-212
Tumor has become the second most serious disease that threatens human health and life. Treating with chemical drugs (referred to as chemotherapy) is the most basic treatment, but most chemotherapeutic drugs cause damage to normal tissues. It is a difficult problem in the field of biomedical research that how to deliver anti-tumor drugs more efficiently, increase the concentration of drugs in tumor tissues, enhance the anti-tumor effect, and decrease the drug distribution in normal tissues to weaken the damage to normal tissues. In order to achieve the goals of accurate delivery of anti-tumor drugs and synergism and attenuation, the researchers used systematic evolution of ligands by exponential enrichment technology (SELEX technology) to screen aptamers that can specifically target tumor markers or tumor cells, and designed the novel liposome targeting drug delivery system with aptamers as targeting molecules (ligands). This paper briefly introduced nucleic acid aptamer technology and common tumor markers, and reviewed the research advances on the antitumor effect of aptamer-liposome drug delivery system. It will provide references for the selection of appropriate tumor markers as targets and the application of aptamer technology in the research and development of high-efficiency and low-toxicity liposome targeting agents of anti-tumor traditional Chinese medicine. Meanwhile, it is of great significance for promoting the application of aptamer technology in targeted drug delivery systems.

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