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.Finite element analysis of titanium rods after vertebral column decancellation osteotomy for ankylosing spondylitis
Bao-Ke SU ; Yong-Qing WANG ; Zhi-Jie KANG ; Hai-Yan WANG ; Feng JIN ; Xiao-He LI ; Zhen-Hua CAO ; Jia-Xuan HUO ; Yong ZHU ; Feng LI
Acta Anatomica Sinica 2024;55(3):339-344
		                        		
		                        			
		                        			Objective To analyze the stress changes of thoracic vertebra(T)11-sacrum(S)titanium rods in patients with ankylosing spondylitis after vertebral column decancellation(VCD)osteotomy,and provide reference for the selection and improvement of titanium rods before surgery.Methods The original data of the continuous scanning tomographic images of patients with ankylosing spondylitis after VCD osteotomy were imported into Mimics 21.0 in DICOM format,and T11-S vertebrae,screws and titanium rods were respectively reconstructed.They were imported into 3-Matic to establish a preliminary geometric modeling,and then processed with noise removal,paving,smoothing,etc.The improved model was imported into Hypermesh 10 software for grid division,and the material was imported into ANSYS 19.2 to display the finite element model after attribute assignment,Set the boundary and load conditions,and measure the stress value at the connection between the screw and the titanium rod.Results Under neutral position,forward bending,lateral bending,and axial rotation conditions,the titanium rod had the highest stress at the upper vertebrae(T11)and the lowest stress at the top vertebrae(L3);Under the backward extension condition,the titanium rod has the highest stress at the lower end vertebra(L5).Conclusion In the upper and lower vertebrae,it is possible to consider increasing the diameter of the titanium rod,enhancing its hardness,or changing it to a double rod.
		                        		
		                        		
		                        		
		                        	
3.Chinese expert consensus on the diagnosis and treatment of traumatic supraorbital fissure syndrome (version 2024)
Junyu WANG ; Hai JIN ; Danfeng ZHANG ; Rutong YU ; Mingkun YU ; Yijie MA ; Yue MA ; Ning WANG ; Chunhong WANG ; Chunhui WANG ; Qing WANG ; Xinyu WANG ; Xinjun WANG ; Hengli TIAN ; Xinhua TIAN ; Yijun BAO ; Hua FENG ; Wa DA ; Liquan LYU ; Haijun REN ; Jinfang LIU ; Guodong LIU ; Chunhui LIU ; Junwen GUAN ; Rongcai JIANG ; Yiming LI ; Lihong LI ; Zhenxing LI ; Jinglian LI ; Jun YANG ; Chaohua YANG ; Xiao BU ; Xuehai WU ; Li BIE ; Binghui QIU ; Yongming ZHANG ; Qingjiu ZHANG ; Bo ZHANG ; Xiangtong ZHANG ; Rongbin CHEN ; Chao LIN ; Hu JIN ; Weiming ZHENG ; Mingliang ZHAO ; Liang ZHAO ; Rong HU ; Jixin DUAN ; Jiemin YAO ; Hechun XIA ; Ye GU ; Tao QIAN ; Suokai QIAN ; Tao XU ; Guoyi GAO ; Xiaoping TANG ; Qibing HUANG ; Rong FU ; Jun KANG ; Guobiao LIANG ; Kaiwei HAN ; Zhenmin HAN ; Shuo HAN ; Jun PU ; Lijun HENG ; Junji WEI ; Lijun HOU
Chinese Journal of Trauma 2024;40(5):385-396
		                        		
		                        			
		                        			Traumatic supraorbital fissure syndrome (TSOFS) is a symptom complex caused by nerve entrapment in the supraorbital fissure after skull base trauma. If the compressed cranial nerve in the supraorbital fissure is not decompressed surgically, ptosis, diplopia and eye movement disorder may exist for a long time and seriously affect the patients′ quality of life. Since its overall incidence is not high, it is not familiarized with the majority of neurosurgeons and some TSOFS may be complicated with skull base vascular injury. If the supraorbital fissure surgery is performed without treatment of vascular injury, it may cause massive hemorrhage, and disability and even life-threatening in severe cases. At present, there is no consensus or guideline on the diagnosis and treatment of TSOFS that can be referred to both domestically and internationally. To improve the understanding of TSOFS among clinical physicians and establish standardized diagnosis and treatment plans, the Skull Base Trauma Group of the Neurorepair Professional Committee of the Chinese Medical Doctor Association, Neurotrauma Group of the Neurosurgery Branch of the Chinese Medical Association, Neurotrauma Group of the Traumatology Branch of the Chinese Medical Association, and Editorial Committee of Chinese Journal of Trauma organized relevant experts to formulate Chinese expert consensus on the diagnosis and treatment of traumatic supraorbital fissure syndrome ( version 2024) based on evidence of evidence-based medicine and clinical experience of diagnosis and treatment. This consensus puts forward 12 recommendations on the diagnosis, classification, treatment, efficacy evaluation and follow-up of TSOFS, aiming to provide references for neurosurgeons from hospitals of all levels to standardize the diagnosis and treatment of TSOFS.
		                        		
		                        		
		                        		
		                        	
4.Study on the changes of skeletal muscle index during chemoradiotherapy for patients with cervical cancer and its correlation with prognosis
Fan ZHOU ; Jin-Feng BAO ; Hui LU ; Mei-Qing DING ; Li-Ping DENG ; Zi YIN ; Zi-Qi CHEN ; Li-Jing ZHU
Parenteral & Enteral Nutrition 2024;31(4):211-219
		                        		
		                        			
		                        			Objective:To study the changes in skeletal muscle and serum nutritional indicators during concurrent chemoradiotherapy in cervical cancer patients,and to evaluate their correlation with short-term efficacy and long-term prognosis. Methods:A retrospective analysis was conducted on 114 patients with cervical cancer who underwent radical concurrent chemoradiotherapy in the Department of Oncology,Nanjing Drum Tower Hospital from February 2019 to February 2023. All patients underwent a treatment regimen comprising external beam radiation (EBRT),internal radiation,and concurrent chemotherapy. Serum nutritional data of the patients were collected before radiotherapy,one week,two weeks and five weeks after the onset of radiotherapy. CT images of the patients at the time of simulation and about five weeks after the onset of radiotherapy were imported into the Pinnacle 39.10 planning system,and the skeletal muscle index (SMI) of the third lumbar vertebra (L3) were calculated for each patients. The changes of the serum nutritional indicators of the patients prior to and post EBRT were analyzed statistically. The patients are categorized into two groups according to the baseline SMI:a sarcopenic group consisting of 35 cases and a non-sarcopenic group comprising 79 cases. The therapeutic outcomes between the two groups were compared,and logistic analysis of the relevant factors affecting the occurrence of sarcopenia during radiotherapy was conducted. The survival curves were drawn using Kaplan-Meier method and disease-free survival (DFS) between the two groups was compared using Log Rank test. We used Cox univariate and multivariate regression analysis to identify prognostic factors related to DFS. Results:The serum nutritional indicators of the patient at one week,two weeks,and five weeks after the beginning of EBRT were significantly lower than those before radiotherapy (P<0.05). The SMI from the CT images of simulation at five weeks after the onset of radiotherapy was significantly lower than that before radiotherapy (P<0.001). There was a significant correlation between hemoglobin levels prior to radiotherapy and incidence of sarcopenia during radiotherapy (P=0.046). There was no significant difference in efficacy between the two groups at the end of EBRT (P>0.05). At the end of radiotherapy,the complete response (CR) rate of the non-sarcopenia group was significantly higher than that of the sarcopenia group (P=0.040). However,the objective response rate (ORR) and disease control rate (DCR) of both groups at the end of radiotherapy were 100%. The 2-year DFS of the sarcopenia group and the non-sarcopenia group were 66.7% and 85.5%,respectively,and the difference was statistically significant (P=0.016). Only four patients died during the 2-year follow-up,so OS was not reached. Baseline SMI,serum squamous cell antigen levels prior to radiotherapy,and degree of bone marrow suppression were three independent prognostic factors affecting DFS in the patients. Conclusion:Cervical cancer patients experience significant nutritional loss during chemoradiotherapy,and baseline SMI is significantly correlated with short-term efficacy and long-term prognosis and can serve as a predictive marker for patients with cervical cancer receiving chemoradiotherapy.
		                        		
		                        		
		                        		
		                        	
5.Risk factors and survival of EBV-infected aplastic anemia patients after haploid allogeneic hematopoietic stem cell transplantation
Xin-He ZHANG ; Jia FENG ; Zheng-Wei TAN ; Yue-Chao ZHAO ; Hui-Jin HU ; Jun-Fa CHEN ; Li-Qiang WU ; Qing-Hong YU ; Di-Jiong WU ; Bao-Dong YE ; Wen-Bin LIU
Chinese Journal of Infection Control 2024;23(10):1228-1235
		                        		
		                        			
		                        			Objective To analyze the risk factors and survival status of Epstein-Barr virus(EBV)infection in pa-tients with aplastic anemia(AA)after haploid allogeneic hematopoietic stem cell transplantation(Haplo-HSCT).Methods Clinical data of 78 AA patients who underwent Haplo-HSCT in the hematology department of a hospital from January 1,2019 to October 31,2022 were analyzed retrospectively.The occurrence and onset time of EBV viremia,EBV-related diseases(EBV diseases),and post-transplant lymphoproliferative disorders(PTLD)were ob-served,risk factors and survival status were analyzed.Results Among the 78 patients,38 were males and 40 were females,with a median age of 33(9-56)years old;53 patients experienced EBV reactivation,with a total inci-dence of 67.9%,and the median time for EBV reactivation was 33(13,416)days after transplantation.Among pa-tients with EBV reactivation,49 cases(62.8%)were simple EBV viremia,2 cases(2.6%)were possible EBV di-seases,and 2 cases(2.6%)were already confirmed EBV diseases(PTLD).Univariate analysis showed that age 1<40 years old at the time of transplantation,umbilical cord blood infusion,occurrence of acute graft-versus-host disease(aGVHD)after transplantation,and concurrent cytomegalovirus(CMV)infection were independent risk fac-tors for EBV reactivation in AA patients after Haplo-HSCT.Multivariate analysis showed that concurrent CMV in-fection was an independent risk factor for EBV reactivation in A A patients after Haplo-HSCT(P=0.048).Ritu-ximab intervention before stem cell reinfusion was a factor affecting the duration of EBV reactivation(P<0.05).The mortality of EBV viremia,EBV diseases,and PTLD alone were 8.2%,50.0%,and 100%,respectively.The 2-year overall survival rate of patients with and without EBV reactivation were 85.3%,and 90.7%,respectively,difference was not statistically significant(P=0.897).However,patients treated with rituximab had 2-year lower survival rate than those who did not use it,with a statistically significant difference(P=0.046).Conclusion EBV reactivation is one of the serious complications in AA patients after Haplo-HSCT,which affects the prognosis and survival of patients.
		                        		
		                        		
		                        		
		                        	
6.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]
		                        		
		                        		
		                        		
		                        	
7.Clinical and imaging analysis of COVID-19-related osmotic demyelination syndrome
Yuyue QIU ; Chenhui MAO ; Jialu BAO ; Li SHANG ; Tianyi WANG ; Bo LI ; Yixuan HUANG ; Yuhan JIANG ; Shanshan CHU ; Wei JIN ; Liling DONG ; Feng FENG ; Jing GAO
Chinese Journal of Neurology 2024;57(7):763-769
		                        		
		                        			
		                        			Objective:To analyze the clinical and imaging features of patients with COVID-19-related osmotic demyelination syndrome (ODS).Methods:COVID-19-related ODS cases diagnosed in the Department of Neurology, Peking Union Medical College Hospital from January 2020 to September 2023 were retrospectively reviewed. And their past medical history, possible triggers, clinical manifestations, imaging manifestations, treatment and prognosis were summarized.Results:A total of 5 patients with COVID-19-related ODS were included. Electrolyte disturbances acted as an inducement of ODS in all patients (5/5),4 of whom with hyponatremia. Four of 5 patients first presented with disturbance of consciousness, followed by predominant dystonia. Imaging of all patients (5/5) showed isolated extrapontine myelinolysis (EPM). With the prolongation of the course of disease, such signal intensity could return to normal, and lesions showed atrophic changes in some patients. The patients′ clinical symptoms were partly relieved within a few days to a few months after treatment.Conclusions:COVID-19-related ODS is mostly associated with hyponatremia, and EPM is more common. COVID-19 should be considered as a risk factor for ODS.
		                        		
		                        		
		                        		
		                        	
8.Clinicopathological Features and Prognosis of Patients Newly Diagnosed With Lung Adenocarcinoma With Both EGFR Mutation and C-MET Amplification.
Wan-Ling WANG ; Cun-Bao XU ; Jin-Ling YANG ; Hong-Tu ZHANG ; Yi-Feng CHEN
Acta Academiae Medicinae Sinicae 2023;45(4):627-633
		                        		
		                        			
		                        			Objective To explore the clinicopathological features and prognosis of the patients newly diagnosed with lung adenocarcinoma with both EGFR mutation and C-MET amplification.Methods The pathological sections were reviewed.EGFR mutation was detected by amplification refractory mutation system-quantitative real-time polymerase chain reaction,and C-MET amplification by fluorescence in situ hybridization.The clinicopathological features and survival data of the patients newly diagnosed with lung adenocarcinoma with both EGFR mutation and C-MET amplification were analyzed retrospectively.Results In 11 cases of EGFR mutation combined with C-MET amplification,complex glands and solid high-grade components were observed under a microscope in 10 cases except for one case with a cell block,the tissue structure of which was difficult to be evaluated.The incidence of lung adenocarcinoma in the patients with EGFR mutation combined with C-MET amplification at clinical stage Ⅳ was higher than that in the EGFR mutation or C-MET amplification group (all P<0.001),whereas the difference was not statistically significant between the EGFR mutation group and C-MET amplification group at each clinical stage (all P>0.05).There was no significant difference in the trend of survival rate between EGFR gene group and C-MET amplification group (χ2=0.042,P=0.838),while the survival of the patients with EGFR mutation combined with C-MET amplification was worse than that of the patients with EGFR mutation (χ2=246.72,P<0.001) or C-MET amplification (χ2=236.41,P<0.001).Conclusions The patients newly diagnosed with lung adenocarcinoma with EGFR mutation plus C-MET amplification demonstrate poor histological differentiation,rapid progress,and poor prognosis.The patients are often in the advanced stage when being diagnosed with cancer.Attention should be paid to this concurrent adverse driving molecular event in clinical work.With increasing availability,the inhibitors targeting C-MET may serve as an option to benefit these patients in the near future.
		                        		
		                        		
		                        		
		                        			Humans
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		                        			In Situ Hybridization, Fluorescence
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		                        			Retrospective Studies
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		                        			Prognosis
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		                        			Adenocarcinoma of Lung/genetics*
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		                        			Mutation
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		                        			Lung Neoplasms/genetics*
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		                        			ErbB Receptors/genetics*
		                        			
		                        		
		                        	
9.Chinese expert consensus on clinical treatment of adult patients with severe traumatic brain injury complicated by corona virus disease 2019 (version 2023)
Zeli ZHANG ; Shoujia SUN ; Yijun BAO ; Li BIE ; Yunxing CAO ; Yangong CHAO ; Juxiang CHEN ; Wenhua FANG ; Guang FENG ; Lei FENG ; Junfeng FENG ; Liang GAO ; Bingsha HAN ; Ping HAN ; Chenggong HU ; Jin HU ; Rong HU ; Wei HE ; Lijun HOU ; Xianjian HUANG ; Jiyao JIANG ; Rongcai JIANG ; Lihong LI ; Xiaopeng LI ; Jinfang LIU ; Jie LIU ; Shengqing LYU ; Binghui QIU ; Xizhou SUN ; Xiaochuan SUN ; Hengli TIAN ; Ye TIAN ; Ke WANG ; Ning WANG ; Xinjun WANG ; Donghai WANG ; Yuhai WANG ; Jianjun WANG ; Xingong WANG ; Junji WEI ; Feng XU ; Min XU ; Can YAN ; Wei YAN ; Xiaofeng YANG ; Chaohua YANG ; Rui ZHANG ; Yongming ZHANG ; Di ZHAO ; Jianxin ZHU ; Guoyi GAO ; Qibing HUANG
Chinese Journal of Trauma 2023;39(3):193-203
		                        		
		                        			
		                        			The condition of patients with severe traumatic brain injury (sTBI) complicated by corona virus 2019 disease (COVID-19) is complex. sTBI can significantly increase the probability of COVID-19 developing into severe or critical stage, while COVID-19 can also increase the surgical risk of sTBI and the severity of postoperative lung lesions. There are many contradictions in the treatment process, which brings difficulties to the clinical treatment of such patients. Up to now, there are few clinical studies and therapeutic norms relevant to sTBI complicated by COVID-19. In order to standardize the clinical treatment of such patients, Critical Care Medicine Branch of China International Exchange and Promotive Association for Medical and Healthcare and Editorial Board of Chinese Journal of Trauma organized relevant experts to formulate the Chinese expert consensus on clinical treatment of adult patients with severe traumatic brain injury complicated by corona virus infection 2019 ( version 2023) based on the joint prevention and control mechanism scheme of the State Council and domestic and foreign literatures on sTBI and COVID-19 in the past 3 years of the international epidemic. Fifteen recommendations focused on emergency treatment, emergency surgery and comprehensive management were put forward to provide a guidance for the diagnosis and treatment of sTBI complicated by COVID-19.
		                        		
		                        		
		                        		
		                        	
10.Clinical diagnosis and treatment of multiple pulmonary nodules.
Hua ZHONG ; Feng YAO ; Qun Hui CHEN ; Jin Dong GUO ; Lin Cheng ZHANG ; Yao ZHANG ; Bao Hui HAN
Chinese Journal of Oncology 2023;45(6):455-463
		                        		
		                        			
		                        			CT screening has markedly reduced the lung cancer mortality in high-risk population and increased the detection of early-stage pulmonary neoplasms, including multiple pulmonary nodules, especially those with a ground-glass appearance on CT. Multiple primary lung cancer (MPLC) constitutes a specific subtype of lung cancer with indolent biological behaviors, which is predominantly early-stage adenocarcinoma. Although MPLC progresses slowly with rare lymphatic metastasis, existence of synchronous lesions and distributed location of these nodules still pose difficulty for the management of such patients. One single operation is usually insufficient to eradicate all neoplastic lesions, whereas repeated surgical procedures bring about another dilemma: whether clinical benefits of surgical treatment outweigh loss of pulmonary function following multiple operations. Therefore, despite the anxiety for treatment among MPLC patients, whether and how to treat the patient should be assessed meticulously. Currently there is a heated discussion upon the timing of clinical intervention, operation mode and the application of local therapy in MPLC. Based on clinical experience of our multiple disciplinary team, we have summarized and commented on the evaluation, surgical treatment, non-surgical local treatment, targeted therapy and immunotherapy of MPLC in this article to provide further insight into this field.
		                        		
		                        		
		                        		
		                        			Humans
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		                        			Multiple Pulmonary Nodules/surgery*
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		                        			Lung Neoplasms/surgery*
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		                        			Adenocarcinoma/surgery*
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		                        			Lung/pathology*
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		                        			Tomography, X-Ray Computed
		                        			
		                        		
		                        	
            
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