1.The introduction and inspiration from US FDA guidance: bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion
Ningjie ZHANG ; Yuanqing YANG ; Yuanpei ZHU ; Yongjun WANG ; Yongjian GUO
Chinese Journal of Blood Transfusion 2025;38(1):142-148
Room temperature stored platelets are associated with a higher risk of sepsis and related fatality. The risk of bacterial contamination of platelets is a leading risk of infection from blood transfusion. U.S. Food and Drug Administration recently issued a guidance on bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion. The prevention and control strategies in the guidance would be informative and instructive for further development of risk control strategies of platelet bacterial contamination in China.
2.Antibiotic-loaded bone cement in treatment of calf compartment syndrome caused by diabetic foot necrotizing fasciitis
Peng XU ; Mingyu XUE ; Yongjun RUI ; Fanyu BU ; Xiaofeng GUO ; Yikai XIE
Chinese Journal of Tissue Engineering Research 2024;28(17):2637-2641
BACKGROUND:At present,the treatment methods for necrotizing fasciitis mostly use negative pressure sealing suction after thorough debridement.This method requires repeated debridement to completely remove necrotic infected tissue,causing serious physical and economic burdens to patients. OBJECTIVE:To introduce a rare clinical case of calf compartment syndrome caused by diabetic foot necrotizing fasciitis,and summarize the clinical experience of using antibiotic-loaded bone cement for treatment and comprehensive management. METHODS:A total of 6 patients with calf compartment syndrome caused by diabetic necrotizing fasciitis admitted to Wuxi 9th Affiliated Hospital of Soochow University from August 2017 to August 2020 were selected,including 5 males and 1 female with an average age of 54 years.During the perioperative period,the patients'general condition was evaluated and systemic nutritional support treatment was given.In the first stage,all patients received complete debridement to control infection,antibiotic-loaded bone cement packing,and negative pressure sealed drainage.In the second stage,bone cement was removed and wound repair was performed.The wound healing,as well as the occurrence of redness,swelling,and exudation was observed during the follow-up. RESULTS AND CONCLUSION:(1)The wounds of four patients were fresh after twice antibiotic-loaded bone cement packing,and the membrane formation was good,and one patient was good after three times of antibiotic-loaded bone cement packing,and the wounds of all five patients healed well after the second stage of skin grafting.Due to the difficulty in maintaining intraoperative blood pressure and infection in all four compartments of the lower leg,a patient underwent emergency knee amputation.Meanwhile,the stump wound was placed with antibiotic-loaded bone cement.The wound was closed directly after the secondary bone cement was removed,and the wound healed in the first stage.(2)The six patients were followed up for 6-24 months after discharge.At the last follow-up,all six patients had good wound healing and no symptoms such as redness,swelling,and exudation.The quality of life of the patients was significantly improved,and all of them were satisfied with the curative effect.(3)The occurrence of calf compartment syndrome should be vigilant when diabetic foot necrotizing fasciitis is highly suspected.Early diagnosis and timely incision decompression are of great importance.Besides,the application of antibiotic-loaded bone cement in the treatment of calf compartment syndrome caused by diabetic necrotizing fasciitis has a good short-term effect.
3.Clinical study of Kanglaite injection combined with anlotinib and DC chemotherapy in the treatment of non small cell lung cancer
Yongjun ZHAO ; Feng GUO ; Zhen WANG
Chinese Journal of Postgraduates of Medicine 2024;47(8):722-726
Objective:To investigate the chemotherapy pass rate and interleukin(IL)-17/IL-23 axis of Kanglaite injection combined with anlotinib and DC chemotherapy in the treatment of non small cell lung cancer (NSCLC).Methods:The clinical data of 103 NSCLC patients admitted to Suzhou Hospital Affiliated to Anhui Medical University (Suzhou Municipal Hospital) from January 2021 to December 2022 were selected retrospectively, and they were divided into observation group (52 cases) and control group (51 cases) based on the treatment plan. The patients in the two groups were given DC chemotherapy, and on this basis, the control group was given arotinib, while the observation group was given arotinib combined with Kanglaite injection. Three weeks′treatment was one cycle, and the two groups were treated for 3 consecutive cycles. The total clinical response rate, chemotherapy delay rate and chemotherapy pass rate after treatment were compared between the two groups, and the levels of neuron-specific enolase (NSE), cytokeratin 19 fragment antigen 21-1 (CYFRA21-1), carcinoembryonic antigen (CEA), IL-17 and IL-23 were compared between the two groups before chemotherapy and at the end of each chemotherapy cycle. The incidence of adverse reactions after treatment was compared between the two groups, and the improvement rate of Karnofsky Performance Status Score (KPS score) after chemotherapy was compared.Results:The total clinical response rate in the observation group was higher than that in the control group: 61.54%(32/52) vs. 41.18%(21/51), there was statistical difference ( χ2 = 4.27, P<0.05). At the third cycle of chemotherapy, the delay rate of chemotherapy in the observation group was lower than that in the control group : 1.92% (1/52) vs. 15.69% (8/51), and the chemotherapy pass rate was higher than that in the control group: 92.31% (48/52) vs. 76.47% (39/51), there were statistical differences ( χ2 = 4.51, 4.92, P<0.05). The serum levels of NSE, CYFRA21-1, CEA, IL-17 and IL-23 in the observation group were lower than those in the control group at the first, second and third cycles of chemotherapy ( P<0.05). The incidence of myelosuppression and gastrointestinal adverse reactions in the observation group were lower than those in the control group: 19.23% (10/52) vs. 45.10% (23/51), 59.62% (31/52) vs. 86.27% (44/51), there were statistical differences ( χ2 = 7.91, 9.24, P<0.05). The improvement rate of KPS score in the observation group was higher than that in the control group after chemotherapy: 51.92% (27/52) vs. 29.41% (15/51), there was statistical difference ( χ2 = 5.40, P<0.05). Conclusions:Anlotinib and DC chemotherapy combined with Kanglaite injection can effectively regulate tumor related cytokine levels, reduce adverse reactions, improve chemotherapy pass rate and treatment effect. It may be related to downregulating the IL-17/IL-23 axis.
4.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
5.Brain network mechanism of Xingnao Kaiqiao acupuncture treatment for stroke
Xintong CHEN ; Meng SUN ; Chuan QIAN ; Yongjun TAO ; Wenli XU ; Yu XIE ; Xiaoli GUO ; Zheng JIN
International Journal of Traditional Chinese Medicine 2023;45(8):945-952
Objective:To explore the effect of Xingnao Kaiqiao acupuncture treatment on brain network reorganization for the patients with stroke recovery, and therefore understand the neural mechanism underlying Xingnao Kaiqiao acupuncture treatment.Methods:Prospective case series study. Thirteen acute ischemia stroke patients were recruited from the Department of Neurology, Shanghai Minhang Hospital of Integrated Traditional Chinese and Western Medicine from Aug 2018 to Oct 2019. They were treated with Xingnao Kaiqiao acupuncture once a day for 10 consecutive days in addition to routine treatments, and received clinical assessments before treatment and 14 days after treatment onset. EEG signals were recorded during the first acupuncture treatment, from before inserting the needles (the baseline), during needle retention, to after removal of the needles. The brain network was constructed using phase locking index, and its clustering coefficient (CC), characteristic path length (PL) and small-worldness (S) were analyzed using one-way repeated ANOVA.Results:Compared with the baseline, the CC of delta-band network (sparsity=0.10: t=3.306, P=0.006; 0.12: t=2.909, P=0.013; 0.14: t=2.331, P=0.038) and the PL of delta-band (sparsity=0.12: t=3.236, P=0.007; 0.14: t=2.754, P=0.017, 0.18: t=2.878, P=0.014) and alpha-band (sparsity=0.10: t=2.432, P=0.032) networks were significantly decreased during the needle retention stage. Clinical assessments demonstrated a significant treatment efficacy of Xingnao Kaiqiao acupuncture, and its efficacy which was indicated by improved NIHSS score, was significantly correlated with the CC changes in the delta band network from baseline to needle retention. The correlation was strongest when the network sparsity was 0.12 ( r=0.78, P=0.002). Conclusion:Xingnao Kaiqiao acupuncture can regulate the brain network of stroke patients in real time, and this immediate regulation maybe associated with its treatment effect.
6.Analysis of medical quality in psychiatric hospitals based on DRG evaluation
Yizhu PAN ; Moning GUO ; Yelong QIU ; Xiaohong LI ; Yongjun SHE ; Hao CHEN ; Cunli XIAO ; Xiuqi SUN ; Zhiwu LI
Chinese Journal of Hospital Administration 2023;39(1):22-26
Objective:To evaluate the medical service quality of psychiatric hospitals in Beijing based on diagnostic related group (DRG), analyze the evaluation effect, for refences to constructe a DRG performance evaluation system suitable for psychiatric hospitals.Methods:This study extracted data such as the number of DRG groups, etc. of hospitalized patients in 14 tertiary and secondary psychiatric hospitals in Beijing from 2018 to 2020 from the Beijing inpatient medical performance evaluation platform, and analyzed data on DRG performance evaluation indicators, as well as the average length of hospital stay and average cost of DRG enrolled cases. All data were analyzed using descriptive research methods, and inter group comparisons were conducted using the Mann Whitney U-test. Results:From 2018 to 2020, the average number of DRG groups in tertiary hospitals (28) was higher than that in secondary hospitals (10) ( P<0.05), and the average CMI values of both were the same(1.79); The average cost consumption index (1.15) of tertiary hospitals was higher than that of secondary hospitals (0.65) ( P<0.05), while the average time consumption index (1.11) was slightly lower than that of secondary hospitals (1.30); The mortality rate of the low-risk group in tertiary hospitals (0.01%) was generally lower than that in secondary hospitals (0.88%), and the average percentage of DRG admitted inpatients (82.8%) was significantly higher than that in secondary hospitals (27.3%) ( P>0.05). The average length of stay and cost per case for DRG enrolled inpatients in tertiary and secondary hospitals were lower than the overall hospital discharge cases ( P<0.05). Conclusions:The number of DRG groups, CMI value, and low-risk mortality rate could be used for evaluating the medical service capacity and safety of psychiatric hospitals, but the cost and time consumption index could not objectively reflect the efficiency of hospital medical services. DRG performance evaluation indicators are more suitable for evaluating short-term hospitalization of psychiatric patients. The proportion of DRG enrolled cases might be a potential indicator for evaluating the service quality of psychiatric hospitals.
7.Simultaneous Determination of Three Impurities in Caspofungin Acetate by LC-MS
Yongjun ZHANG ; Ziqi LIANG ; YONGzheng GUO ; Yonghua ZHU ; Wenwu ZHOU ; Shufang WANG
Chinese Journal of Modern Applied Pharmacy 2023;40(24):3418-3422
Abstract
OBJECTIVE To develop LC-MS method for the simultaneous determination of impurities A, C, and D of caspofungin acetate. METHODS Waters CORTECS® C18+(4.6 mm×150 mm, 2.7 μm) was used as the chromatography column. Mobile phase A and B were 0.1% formic acid-H2O and 0.1% formic acid-CH3CN, respectively. Electrospray ion source-single quadrupole mass spectrometry was used to detect impurities A and C in positive ion mode and impurity D in negative ion mode. RESULTS The correlation coefficient r was ≥ 0.999 in linearity ranges of impurities A, C and D. The average recoveries were 100.5%, 104.1% and 105.2%, respectively, with RSD<4%(n=6). The LOQs (S/N=10) of impurities A, C and D were 31.8, 6.99 and 15.5 ng·mL-1 respectively. The contents of impurities A, C and D in the three samples were all below the limits. CONCLUSION The developed LC-MS method is simple, sensitive, and applicable, which can be used to simultaneously determine impurities A, C and D in caspofungin acetate and can also provide a reference for the detection of other impurities in caspofungin acetate.
8.Qualitative Analysis of Caspofungin and Its Impurities by LC-QTOF-MS
Yongjun ZHANG ; Ziqi LIANG ; Yongzheng GUO ; Yonghua ZHU ; Wenwu ZHOU ; Shufang WANG
Chinese Journal of Modern Applied Pharmacy 2023;40(23):3281-3287
OBJECTIVE To analyze caspofungin acetate and the samples under different strong degradation conditions by LC-QTOF-MS, and to study the characteristics in mass spectra of caspofungin and its related impurities(impurities A, B, C, D and E). METHODS Chromatographic separation was accomplished on Waters CORTECS® C18+(4.6 mm×150 mm, 2.7 μm) column using a gradient elution with monile phase of 0.1% formic acid-H2O(A) and 0.1% formic acid-CH3CN(B) at a flow velocity of 0.6 mL·min-1; The analytes was detected in positive ion scan mode by ESI-QTOF-MS. RESULTS In MS1 spectra, except that impurity D mainly showed single-charge quasi-molecular ion, caspofungin and the other four impurities showed muti-charge quasi-molecular ions with high abundance; In MS2 spectra, caspofungin and its impurities that containing ethylenediamine generated fragment ions at m/z 1 033 by losing the ethylenediamine and the groups attached to it; caspofungin and its impurities produced a series of fragment ions mainly through the cleavage of peptide bonds, as well as through the loss of hydroxyl, acyl, or amino groups from amino acid residues; Impurity A and C showed characteristic fragment ions m/z 137.070 8 and m/z 77.071 1 with high abundance, respectively, which could be used to distinguish them from caspofungin and the other impurities. CONCLUSION Caspofungin and its five impurities have distict characteristics in their mass spectra. The research results can provide reference for identifying the structures of unknown impurities that may occur in the production process of caspofungin, so as to quickly discover the potential problems in the production process and reduce the quality risk of the products.
9.MS4A6D promotes carrageenan-induced mouse foot pad swelling by activating NLRP3 inflammasome
Guoning GUO ; Ying HE ; Hongye LIU ; Yongjun SHANG
Immunological Journal 2023;39(10):886-892
We here investigated the effect of MS4A6D(the membrane spanning 4-domain subfamily A(MS4A)superfamily protein 6D),one of the tetraspanins which specifically expresses on the membrane of macrophages,on carrageenan(CGN)-induced mouse foot pad swelling and its possible mechanism.Male C57BL/6 wild-type(WT)and various gene knockout(including Ms4a6d-/-,Nlrp3-/-,Casp-1-/-and IlR1-/-)mice were recruited and injected with 100 μl 1%CGN(w/v)and 20 μl CaCl2(50 mmol/L)to establish the foot pad swelling model,and then the severity of foot pad swelling in WT and gene knockout mice were compared.H&E staining was performed to investigate the pathological changes,and immunofluorescence was used to detect the infiltration of F4/80+ macrophages in the foot pad tissue.Finally,Western blot was used to determine the protein expression of NLRP3,IL-1 β,TNF-α and IL-6.Data showed that the combined injection of 100 μl 1%CGN(w/v)and 20 μl CaCl2(50 mmol/L)significantly promoted the swelling of foot pads,while the degree of foot pad swelling in Ms4a6d-/-mice was significantly lower than that in WT littermates(P<0.05);Significant tissue damage and inflammatory infiltration as well as necrotic lesions were observed in the WT foot pads,whereas,the degrees from Ms4a6d-/-foot pads showed significantly reduced;The protein levels of Caspase-1 and IL-1β in the foot pad tissue of the WT model were significantly higher than those of the Ms4a6d-/-groups;Compared with WT controls,the degree of foot pad swelling in Nlrp3-/-,Casp-1-/-,and IlR1-/-mice induced by 1%CGN(w/v)and CaCl2(50 mmol/L)were also significantly reduced(P<0.05).Taken together,MS4A6D promotes the activation of NLRP3 inflammasome in macrophages and induces IL-1β secretion,by thus deteriorates CGN-mediated swelling of mouse foot pads.
10.Design of internal quality control program for specific protein testing based on patient risk
Jiali LIU ; Huizhen SUN ; Yongjun GUO ; Xiangyi LIU ; Wei WANG ; Zhiguo WANG
Chinese Journal of Laboratory Medicine 2022;45(9):963-967
Objective:Patient risk-based statistical quality control (SQC) program was designed for 9 specific protein projects using Westgard sigma rules with run length.Methods:The cumulative coefficient of variation of immunoglobulin (Ig)G, IgA, IgM, C3, C4, rheumatoid factor (RF), antistreptolysin O (ASO), transferrin (TRF) and prealbumin (PA) from the laboratory department of Beijing Tongren Hospital between December 2018 to May 2019 were used as the estimated value of imprecision. The mean of the absolute value of the percentage difference of 10 batches in the laboratory, which was derived from the results of participating the external quality assessment (EQA), was used as the estimated value of bias. The National Center for Clinical Laboratories EQA evaluation criteria was used as an allowable total error (TEa), and the sigma value of each project (σ) was calculated. Westgard Sigma rule with run length was used to design appropriate SQC program for each project, including quality control rules, number of control measurements (N) and frequency of quality control.Results:The sigma value was larger than 6 for SQC procedure of IgG, IgA, IgM, C4 and TRF. SQC could be established with the use of 1 3s rule, number of control measurements (N)=2, number of runs (R)=1, and a run length of 1 000 patient samples. Combined with the average daily workload, internal quality control could be conducted once every 10 days for IgG, IgA, IgM and C4, every 50 days for TRF. The σ was 5.86 for C3, SQC program could be established with run length of 450 using 1 3S/2 2S/R 4s rule (N=2, R=1), combined with average daily workload, internal quality control could be conducted every 4.5 days. σ was between 3 and 4 for RF, ASO and PA. With the use of 1 3S/2 2S/R 4s/4 1s/6 X rule (N=6, R=1), SQC program with a run length of 45 and higher frequency internal quality control activities. Conclusion:It is feasible to use Westgard sigma rules with run length for the laboratories design of personalized risk-based SQC procedures, the method is very simple and intuitive. This tool is valued to be recommended to be actively applied by all clinical laboratories.


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