1.Ethylene oxide residue detection method based on multi-component medical devices
Ruo-Jin LIU ; Zi-Meng WANG ; Hui LI ; Wen-Liang SHAO ; Bao-Yu LIU ; Yi FENG
Chinese Medical Equipment Journal 2024;45(1):56-61
Objective To establish a stable and reliable method for the determination of ethylene oxide residue,and to analyze ethylene oxide residue in multi components made of different materials involved in some medical devices,so as to provide references for sample selection and ethylene oxide residue detection of multi-component medical device kits.Methods A method for the determination of ethylene oxide residue of multi-component medical devices was developed using headspace-gas chromatography and DB-WAX column under the conditions of headspace extraction with equilibration at 80℃ for 20 min,and the weighing mass,linearity,limit of detection,limit of quantification,precision and recovery of the method were determined.Trials of the method were carried out on the items undergoing ethylene oxide sterilization,including disposable perineal care kit,disposable gynecological examination kit,disposable suture dressing kit,disposable debridement kit and the components contacting human body in the disposable dialysis kit,and the abilities of different materials of the components were analyzed in absorbing,retaining and releasing ethylene oxide.Results The method showed high linearity(r=0.999 8)in the range of ethylene oxide mass concentration from 0.4 to 16.0 μg/mL with a weighing mass of 1.00 g,which had the limit of detection being 0.11 μg/mL,the limit of quantification being 0.37 μg/mL and the relative standard deviations(RSDs)for the precision from 0.35%to 1.52%.The average recoveries of different spiked amounts of ethylene oxide in the three blank matrices ranged from 92.68%to 101.42%with the relative standard deviations(RSDs)from 2.46%to 7.59%,which all satisfied the detection requirements.The components made of rubber and acrylonitrile-butadiene-styrene copolymer(ABS)in multi-component medical device kits had the highest ethylene oxide residues,followed by the components made of wood,degreased cotton,polypropylene and polystyrene.Conclusion The method proposed gains advantages in easy operation and high specificity,quantification and reproducibility,which can be used for the determination of ethylene oxide residue in the multi-component medical device kit undergoing ethylene oxide sterilization.References are provided for sample selection of multi-component medical devices.[Chinese Medical Equipment Journal,2024,45(1):56-61]
2.Investigation and analysis of the current status of transjugular intrahepatic portosystemic shunt treatment for portal hypertension in China
Haozhuo GUO ; Meng NIU ; Haibo SHAO ; Xinwei HAN ; Jianbo ZHAO ; Junhui SUN ; Zhuting FANG ; Bin XIONG ; Xiaoli ZHU ; Weixin REN ; Min YUAN ; Shiping YU ; Weifu LYU ; Xueqiang ZHANG ; Chunqing ZHANG ; Lei LI ; Xuefeng LUO ; Yusheng SONG ; Yilong MA ; Tong DANG ; Hua XIANG ; Yun JIN ; Hui XUE ; Guiyun JIN ; Xiao LI ; Jiarui LI ; Shi ZHOU ; Changlu YU ; Song HE ; Lei YU ; Hongmei ZU ; Jun MA ; Yanming LEI ; Ke XU ; Xiaolong QI
Chinese Journal of Radiology 2024;58(4):437-443
Objective:To investigate the current situation of the use of transjugular intrahepatic portosystemic shunt (TIPS) for portal hypertension, which should aid the development of TIPS in China.Methods:The China Portal Hypertension Alliance (CHESS) initiated this study that comprehensively investigated the basic situation of TIPS for portal hypertension in China through network research. The survey included the following: the number of surgical cases, main indications, the development of Early-TIPS, TIPS for portal vein cavernous transformation, collateral circulation embolization, intraoperative portal pressure gradient measurement, commonly used stent types, conventional anticoagulation and time, postoperative follow-up, obstacles, and the application of domestic instruments.Results:According to the survey, a total of 13 527 TIPS operations were carried out in 545 hospitals participating in the survey in 2021, and 94.1% of the hospital had the habit of routine follow-up after TIPS. Most hospitals believed that the main indications of TIPS were the control of acute bleeding (42.6%) and the prevention of rebleeding (40.7%). 48.1% of the teams carried out early or priority TIPS, 53.0% of the teams carried out TIPS for the cavernous transformation of the portal vein, and 81.0% chose routine embolization of collateral circulation during operation. Most of them used coils and biological glue as embolic materials, and 78.5% of the team routinely performed intraoperative portal pressure gradient measurements. In selecting TIPS stents, 57.1% of the hospitals woulel choose Viator-specific stents, 57.2% woulel choose conventional anticoagulation after TIPS, and the duration of anticoagulation was between 3-6 months (55.4%). The limitation of TIPS surgery was mainly due to cost (72.3%) and insufficient understanding of doctors in related departments (77.4%). Most teams accepted the domestic instruments used in TIPS (92.7%).Conclusions:This survey shows that TIPS treatment is an essential part of treating portal hypertension in China. The total number of TIPS cases is far from that of patients with portal hypertension. In the future, it is still necessary to popularize TIPS technology and further standardize surgical indications, routine operations, and instrument application.
3.Interpretation of a clinical practice guideline on the management of chronic pain associated with temporomandibular joint disorders
Chenxi LI ; Zhiqiang SONG ; Xing JIN ; Zhongcheng GONG ; Hui LIU ; Xu LIU ; Mingchao DING ; Jialin SUN ; Xing LONG ; Bo SHAO
Chinese Journal of Stomatology 2024;59(10):988-997
Temporomandibular disorders (TMD) are a heterogeneous group of diseases that affect the temporomandibular joint, chewing muscle system, dental occlusion, and even various structures throughout the body, with significant characteristics of biological-psychological-social pattern. TMD related chronic pain, as the most important clinical symptom, can result in negative emotions seriously affecting patients′ quality of life and physical and mental health. Although a variety of therapies have been previously reported to treat TMD related chronic pain, there is a lack of widely recognized therapies. Professor Jason W Busse (from Michael G DeGroote National Pain Centre, McMaster University, Hamilton ON, Canada) took the lead and collaborated with multiple internationally renowned schools/hospitals of stomatology to develop an international consensus on the management of chronic pain associated with TMD, a clinical practice guideline, which took two years and was published in December 15th, 2023 in a global top journal of clinical research The British Medical Journal. This clinical practice guideline explored the comparative effectiveness of available therapies for chronic pain associated with TMD, conditionally recommended the specific intervention for different treatment or pain relief, proposed a comprehensive, agreed, and standardized clinical practice guideline. This present article describes the methodology and key elements of the clinical practice guideline to help clinicians fully understand and appropriately apply this guidance, which could provide the references for clinical practice of TMD associated chronic pain in China.
4.Progress of biomacromolecule drug nanodelivery systems in the treatment of rare diseases
Shu-jie WEI ; Han-xing HE ; Jin-tao HAO ; Qian-qian LV ; Ding-yang LIU ; Shao-kun YANG ; Hui-feng ZHANG ; Chao-xing HE ; Bai XIANG
Acta Pharmaceutica Sinica 2024;59(7):1952-1961
Rare diseases still lack effective treatments, and the development of drugs for rare diseases (known as orphan drugs) is an urgent medical problem. As natural active ingredients in living organisms, some biomacromolecule drugs have good biocompatibility, low immunogenicity, and high targeting. They have become one of the most promising fields in drug research and development in the 21st century. However, there are still many obstacles in terms of
5.Correlations of Mas-related G protein-coupled receptor X2 and interleukin in patients with chronic spontaneous urticaria
Yiqi ZHU ; Yixin SHAO ; Duoqin WANG ; Yanyun SHEN ; Taiyu JIN ; Lisi PENG ; Hui TANG ; Zijing XIAO
Chinese Journal of Clinical Medicine 2024;31(6):875-882
Objective To explore the correlations between serum Mas-related G protein-coupled receptor X2 (MRGPRX2), interleukin (IL)-4, IL-5, IL-6, IL-13, IL-23 and IL-33 levels and chronic spontaneous urticaria (CSU). Methods The clinical characteristics and laboratory data from 55 patients with CSU and 21 healthy controls at Huashan Hospital, Fudan University from February 2021 to September 2023 were collected. The disease activity and severity of CSU patients were assessed. Serum level of MRGPRX2 was tested using enzyme-linked immunosorbent assay (ELISA), and levels of IL-4, IL-5, IL-6, IL-13, IL-23, and IL-33 were measured using Luminex multiplex assay in all subjects. Spearman correlation analysis was used to evaluate the correlations between biomarkers and other parameters in CSU patients, and logistic regression analysis was performed to identify factors influencing CSU. Results CSU patients exhibited significantly higher serum levels of MRGPRX2 (2.41[0, 11.51] ng/mL vs 0[0, 2.86] ng/mL, P=0.015) and IL-23 (0.09[0.04, 0.56] pg/mL vs 0.05[0.03, 0.08] pg/mL, P=0.033) than healthy controls. There was no difference in levels of other cytokines between the two groups. There was no difference in levels of MRGPRX2 and cytokines between severe and non-severe CSU patients. Correlation analysis showed that serum MRGPRX2 levels in CSU patients were positively correlated with IL-4 (r=0.345, P=0.010) and IL-6 (r=0.395, P=0.003) levels. Logistic regression analysis indicated that MRGPRX2≥0.055 ng/mL and IL-23≥0.135 pg/mL were independent risk factors for CSU (P<0.05). Conclusions Serum levels of MRGPRX2 and IL-23 in CSU patients are elevated, which may be involved in the pathogenesis of CSU.
6.Research on healthy city construction strategies based on Grounded Theory:A case study of Hubei Province
Jin-Hui SUI ; Nan-Xi CHEN ; Chen CHEN ; Shao-Tang WU
Chinese Journal of Health Policy 2024;17(8):36-42
Objective:This study constructs a strategic model for healthy city construction using Hubei Province as a case study,aiming to provide a reference for advancing healthy city initiatives.Methods:Utilizing grounded theory,we analyzed interview data from 9 cities in Hubei.Through open coding,principal axis coding,and selective coding,we identified and refined the strategic components for healthy city construction.Results:The strategies for healthy city construction in Hubei encompasses 30 initial categories,11 main categories,and 3 core categories:government initiative-led,departmental cooperation,and social co-construction and co-governance.This framework culminates in a theoretical model centered on sustainable construction,with the long-term improvement of population health as the ultimate goal.Conclusion:The strategies of government initiative-led,departmental cooperation,and social co-construction and co-governance function synergistically as guiding,implementing,and mobilizing frameworks for healthy city construction.By integrating these strategies,we can promote the sustainability of healthy cities and ultimately achieve long-term improvement of population health level.
7.Sarcopenia index as a predictor of in-hospital adverse events in patients with acute myocardial infarction after emergency PCI
Cheng-Si LI ; Zhang-Yu WANG ; Shao-Qing CAO ; Yu-Qin WANG ; Jiang-Ping YE ; Ye-Hong LIU ; Tian-Hui JIN ; Gang-Jun ZONG
Medical Journal of Chinese People's Liberation Army 2024;49(4):408-415
Objective To investigate the association between the serum creatinine/cystatin C ratio(SCr/Cys C)as a Sarcopenia index(SI)and the incidence of in-hospital adverse events in patients with acute myocardial infarction(AMI)undergoing emergency percutaneous coronary intervention(PCI).Additionally,we evaluate the predictive efficacy of the SI in predicting major adverse cardiovascular events(MACEs)during hospitalization.Methods A total of 306 patients with AMI who underwent emergency PCI in the 904th Hospital of PLA Joint Logistics Support Force from January 2020 to March 2023 were consecutively included in this retrospective analysis.Patients were divided into two groups based on the occurrence of MACEs during hospitalization:MACEs group(n=43)and non-MACEs group(n=263).Clinical characteristics and pre-PCI laboratory test results were collected.Univariate and multivariate logistic regression analyses were performed to identify independent risk factors for MACEs.The predictive performance of SI was assessed using receiver operating characteristic(ROC)curve analysis.Results The incidence of in-hospital MACEs in AMI patients was 14.1%.The results of the independent samples t-test showed that the SI level in MACEs group was significantly lower than that in non-MACEs group,with a statistically significant difference(P<0.001).The results of the multivariate logistic regression analysis suggested that new-onset atrial fibrillation,Killip class 2-4,SI,and TG were independent risk factors for in-hospital adverse events after emergency PCI.The ROC curve results showed that the predictive value of SI(AUC=0.741,95%CI 0.666-0.816)using the SCr/Cys C ratio was superior to that of single Cys C(AUC=0.658,95%CI 0.570-0.746)for predicting post-PCI MACEs,with a statistically significant difference(P<0.05),and the optimal cutoff value for SI was 78.14.After stratifying SI based on the cutoff value,the results of the independent samples t-test showed that compared to the higher SI group,the lower SI group had a higher occurrence of specific adverse events such as heart failure(P<0.001),malignant arrhythmias(P=0.009),and strokes(P=0.003),with statistically significant differences.Conclusions The results highlight SI as an independent risk factor for MACEs during hospitalization after emergency PCI in AMI patients.Furthermore,SI has proven to be an effective prognostic index for patient outcomes.
8.Research Progress on the Application of Human Body Surface Microbiome to Fo-rensic Individual Identification
Ming-Hui JIN ; Ya LI ; Shao-Hua YI
Journal of Forensic Medicine 2024;40(4):379-386
Skin and hair are the outermost interfaces between the human body and the external envi-ronment with many microorganisms distributed.These body surface microorganisms have individual speci-ficity and spatial temporal stability and can be transferred to the surface of other objects through con-tact,and can be easily found at the crime scene,which helps to construct the connection between the suspect and the crime scene.When the sample is degraded or the DNA quantity is too low to obtain sufficient human DNA evidence,the highly amplified copies of body surface microbiome analysis can be used as an adjunct to human DNA typing without affecting DNA extraction and typing,and provide useful information for narrowing the range of suspects.This paper reviews the forensic characteristics and analytical methods of body surface microbiome,the research progress on the application of body surface microbiome to forensic individual identification,and puts forward the challenges of applying body surface microbiome to forensic practice.
9.Determination of 2-chloroethanol and ethylene glycol residues in disposable infusion sets
Ruo-Jin LIU ; Bao-Yu LIU ; Hui LI ; Yi FENG ; Wen-Liang SHAO
Chinese Medical Equipment Journal 2024;45(10):31-36
Objective To propose an effective method for the determination of 2-chloroethanol(ethylene chlorohydrin,ECH)and ethylene glycol(EG)residues in disposable infusion sets sterilized by ethylene oxide(EO).Methods Extraction with the ratio of the mass of the disposable infusion set to the volume of the medium being 0.4 g/mL was carried out with the 8890B gas chromatograph with liquid injection,DB-WAX column and ethanol extraction medium,and quantitative determination of ECH and EG in disposable infusion sets were implemented after extraction at 37℃for 10 h.Results The method proposely was highly specific,and showed high linearity in the range of 1.25-100.00 μg/mL for both ECH and EG.The limits of detection were 0.31 and 0.11 μg/mL for ECH and EG,respectively,and the relative standard deviations(RSD)of the precision of ECH was in the range of 0.24%-2.03%and those of EG was in the range of 0.16%-0.87%.The average recoveries were 95.02%-100.58%for ECH and 99.15%-99.98%for EG.Conclusion The method proposed for the determination of ECH and EG residues gains advantages in easy operation,specificity,detection accuracy and reproducibility,and meets the requirements for the determination of ECH and EG residues in EO-sterilized disposable infusion sets.[Chinese Medical Equipment Journal,2024,45(10):31-36]
10.Current status and perspectives of small molecule inhibitors of heat shock protein 70
Jin-yan ZHU ; Ming-hui HE ; Fan WU ; Ying-lan YU ; Lei LUO ; Hao SHAO
Acta Pharmaceutica Sinica 2024;59(11):2962-2974
Heat shock protein 70 (Hsp70) is a class of molecular chaperones essential for maintaining protein homeostasis in cells. Hsp70s also play important roles in the pathogenesis of a variety of diseases, including cancer, neurodegenerative diseases and infectious diseases, which makes them potential targets for the treatment of these diseases. It is necessary to develop small molecule inhibitors to validate this class of important therapeutic targets. In recent years, the discovery of small molecule inhibitors for Hsp70s has made remarkable progress, and Hsp70 inhibitors with different modalities have been reported. In this paper, Hsp70 and relevant diseases are briefly introduced, and the discovery of Hsp70 small molecule inhibitors with distinct modalities are summarized, providing reference for the further discovery and development of Hsp70 small molecule inhibitors.

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