1.Correlation between serum cystatin C and bone turnover markers in elderly patients with type 2 diabetes mellitus and osteoporosis
Mengqian WANG ; Shaohong ZHANG ; Mengyue SUN ; Min CHEN ; Weimin WANG
Journal of Public Health and Preventive Medicine 2025;36(4):89-92
Objective To analyze the correlation between serum cystatin C (Cys-C) and bone turnover markers in elderly patients with type 2 diabetes mellitus (T2DM) and osteoporosis. Methods A retrospective analysis was conducted on the data of 320 elderly patients with T2DM admitted to Huai'an First People's Hospital from August 2021 to June 2024. Patients were divided into the osteoporosis group and the non-osteoporosis group according to whether they had osteoporosis. General information, bone turnover markers, and serum Cys-C levels were collected from all patients. The data were compared between the two groups to analyze the influencing factors of osteoporosis in elderly patients with T2DM and the correlation between serum Cys-C and bone turnover markers. Results The levels of total cholesterol and LDL-C in the osteoporosis group were higher than those in the non-osteoporosis group, and the bone mineral density was lower than that in the non-osteoporosis group (P<0.05). The levels of TPINP, β-CTX, and Cys-C in the osteoporosis group were higher than those in the non-osteoporosis group, and 25-OH-D3 level was lower than that in the non-osteoporosis group (P<0.05). Serum Cys-C was positively correlated with TPINP and β-CTX, and negatively correlated with 25-OH-D3 (P<0.05). Multivariate logistic regression analysis found that total cholesterol, LDL-C, TPINP, β-CTX, 25-OH-D3, and Cys-C were factors influencing osteoporosis in elderly patients with T2DM (P<0.05). Conclusion Serum Cys-C levels in elderly patients with T2DM and osteoporosis are elevated. There is a significant correlation between Cys-C level and bone turnover markers.
2.Clinical Utilization Analysis of Rituximab Biosimilar: A Single-Center Retrospective Study
Yuzhen ZOU ; Ran XIAO ; Shaohong WANG ; Rui DAI ; Xiaoli DU
Medical Journal of Peking Union Medical College Hospital 2025;16(6):1484-1492
To investigate the clinical utilization of Rituximab biosimilar (Rituximab injection) in order to provide references for evaluating its rationality and economic value in clinical application. A retrospective analysis was conducted on medical records of inpatients who received Rituximab injection at Peking Union Medical College Hospital between January 1, 2020, and December 31, 2023. The clinical usage patterns, off-label use, economic benefits compared to the originator drug, and adverse drug reactions (ADRs) were analyzed. A total of 725 patients treated with Rituximab injection were included. The majority of patients were from the Department of Nephrology (80.69%), followed by Rheumatology and Immunology (9.24%), Hematology (8.41%), and Dermatology (0.97%). The drug was used for 27 different diseases, with the top five being membranous nephropathy (62.90%), minimal change disease (7.31%), systemic lupus erythematosus (4.41%), anti-neutrophil cytoplasmic antibody-associated vasculitis (3.72%), and granulomatosis with polyangiitis or microscopic polyangiitis (3.59%). The off-label use rate was as high as 96.28% (698/725). The overall incidence of ADRs was 21.24%. The total consumption of Rituximab injection was 1183.2 g, resulting in calculated cost savings of about ¥7.35 million compared to the originator drug. Rituximab injection is widely used in hematologic malignancies and immune-mediated diseases, with a low overall incidence of ADRs and greater cost-effectiveness compared to the originator drug. The extremely high rate of off-label use is supported by corresponding guidelines or clinical studies.
3.Discussion on Difficulties of Ethical Review of DCD Organ Donation and Transplant based on Cases
Guishu CHEN ; Lan LI ; Shaohong YU ; Lei ZHANG ; Longrui DUAN ; Hongying LI ; Hui JIANG ; Junling WANG ; Rui CHEN
Chinese Medical Ethics 2024;35(5):518-521
The ethics committee of organ transplantation technology and clinical application in a hospital has encountered some difficulties and typical cases in its review work and practice for many years. Sometimes, it is difficult to make a decision in these dilemmas. Based on the previous experience of the hospital in the ethical review of organ donation and transplantation, combined with two typical cases, this paper discussed and analyzed two review points of whether the voluntary unpaid donation and the principle of informed consent were met, and whether the risk-benefit ratio was reasonable, and put forward relevant ethical and legal countermeasure for further research by institutional ethics committees and other parties, in order to provide reference for discussing the practical problems and ethical confusion of ethical review of organ donation and transplantation.
4.Risk factors for central venous catheter-associated bloodstream infection in patients with emergency hemorrhagic shock
Jianping ZHU ; Yanxin XU ; Shaohong WU ; Feiyao WANG ; Weixing ZHANG ; Ruilan WANG
Chinese Journal of Emergency Medicine 2024;33(5):683-689
Objective:To analyze the risk factors for central venous catheter-associated bloodstream infection in patients with emergency hemorrhagic shock.Methods:Patients with hemorrhagic shock and central venous catheterization admitted to the emergency department of Shanghai First People's Hospital from June 2016 to June 2022 were retrospectively analyzed. The patients were divided into infected group and non-infected group according to whether catheter-related bloodstream infection occurred. The puncture site samples and catheter tip samples of infected patients were collected for etiological detection and drug sensitivity test. The difference of baseline data between the two groups was analyzed, and the relationship between central venous catheter-associated infection and influencing factors was analyzed by multivariate logistic regression.Results:A total of 249 patients were included in this study, including 54 patients in the infected group and 195 patients in the non-infected group. There were significant differences in age, catheterization position, ultrasound-guided puncture, acute physiology and chronic health evaluationⅡ(APACHEⅡ) score, catheter retention time and application of broad-spectrum antibiotics between the infected group and the non-infected group (all P<0.05). Multivariate logistic regression analysis showed that advanced age, femoral vein catheterization, no ultrasound-guided puncture, high APACHEⅡ score, long catheter indent time and application of broad-spectrum antibiotics were risk factors for central venous catheter-associated bloodstream infection. Among the 54 infected patients, Staphylococcus epidermidis accounted for 44.4%, followed by Escherichia coli accounted for 24.1% and fungus accounted for 11.1%. The resistance rate of gram-positive cocci to vancomycin was the lowest (3.4%) followed by tetracycline (34.5%), and the highest resistance rate was amoxicillin (100.0%). The resistance rates of gram-negative bacilli to amikacin and ceftriaxone were relatively high, both of which were 94.7%. Conclusions:The risk factors for central venous catheter-related blood stream infection in patients with emergency hemorrhagic shock included advanced age, femoral vein catheterization, no ultrasound-guided puncture, high APACHEⅡ score, long catheter retention time and use of broad-spectrum antibiotics. The common pathogenic bacteria were Staphylococcus epidermidis and Escherichia coli.
5.Efficacy of rehabilitation exoskeleton robots on post-stroke lower limb motor dysfunction:a Meta-analysis
Wanpeng CHANG ; Zhongwen ZHANG ; Yulin YANG ; Yang ZI ; Mengqi YANG ; Bingyu DU ; Nan WANG ; Shaohong YU
Chinese Journal of Tissue Engineering Research 2024;28(2):321-328
OBJECTIVE:To systematically evaluate the efficacy of rehabilitation exoskeleton robots on the lower limb motor function of stroke patients using Meta-analysis and to compare the efficacy of different lower limb exoskeleton robots,so as to provide a theoretical basis for the scientific selection of suitable exoskeleton robots for patients with post-stroke lower limb motor dysfunction. METHODS:Computer searches of the Cochrane Library,PubMed,Web of Science,Embase,CNKI,VIP,and WanFang Data were conducted to collect randomized controlled clinical studies on exploring lower extremity rehabilitation exoskeleton robots to improve lower limb motor function in stroke patients published from database inception to November 2022.Two researchers conducted the literature search and screening.The quality of the included literature was evaluated using the Cochrane 5.1.0 risk of bias assessment tool and the Jadad scale.Meta-analysis was performed using RevMan 5.4 and Stata 17.0 software. RESULTS:(1)Finally 22 publications were included,involving 865 patients(n=436 in the test group and n=429 in the control group),and the Jadad score showed that all the included articles were of high quality.(2)Meta-analysis results showed that the exoskeleton robot significantly improved the Fugl-Meyer Assessment of Lower Extremity score(mean difference[MD]=2.63,95%confidence interval[CI]:1.87-3.38,P<0.05),Berg Balance Scale score(MD=3.62,95%CI:1.21-6.03,P<0.05),Timed Up and Go score(MD=-2.77,95%CI:-4.48 to-1.05,P<0.05)and step frequency score(MD=3.15,95%CI:1.57-4.72,P<0.05)in stroke patients compared with the control group.However,there was no significant improvement in the Functional Ambulation Category Scale score(MD=0.30,95%CI:-0.01 to 0.61,P>0.05)and 6-minute walk test score(MD=3.77,95%CI:-6.60 to 14.14,P>0.05).(3)Network Meta-analysis results showed that compared with the conventional rehabilitation therapy,both the level-walking exoskeleton(MD=10.23,95%CI:3.81-27.49,P<0.05)and the body-weight support exoskeleton(MD=33.66,95%CI:11.49-98.54,P<0.05)improved the Fugl-Meyer Assessment of Lower Extremity score.Compared with the conventional rehabilitation therapy,body-weight support exoskeleton significantly improved the Berg Balance Scale scores(MD=79.86,95%CI:2.34-2 725.99,P<0.05).In terms of Fugl-Meyer Assessment of Lower Extremity and Berg Balance Scale scores,the ranking results were body-weight support exoskeleton>level-walking exoskeleton>conventional rehabilitation therapy.Compared with the conventional rehabilitation therapy,level-walking exoskeleton significantly improved the Functional Ambulation Category Scale score(MD=1.38,95%CI:1.00-1.90,P<0.05)and body-weight support exoskeleton significantly improved the Timed Up and Go score(MD=0.07,95%CI:0.01-0.51,P<0.05).In terms of Functional Ambulation Category Scale and Timed Up and Go scores,the ranking results were level-walking exoskeleton>body-weight support exoskeleton>conventional rehabilitation therapy. CONCLUSION:Rehabilitation exoskeleton robots can improve balance,walking and activities of daily living in stroke patients,with body-weight support exoskeleton being more effective in improving lower limb motor function and balance and level walking exoskeleton being more effective in improving functional walking and transfer.
6.Study on Drug List and Accessibility of Rare Diseases Based on the China's Second List of Rare Diseases
Qingyang LIU ; Xin LIU ; Wei ZUO ; Shaohong WANG ; Bo ZHANG ; Shuyang ZHANG
JOURNAL OF RARE DISEASES 2024;3(2):195-201
Objective This study aims to sort out the rare disease drugs in the China's Second List of Rare Diseases,to provide reference for the management of rare disease drug treatment.Methods Up to December 31,2023,based on the China's Second List of Rare Diseases,we sorted out the drugs approved in China with the drug label,or approved by the U.S.Food and Drug Administration(FDA)and the European Medicines Agency(EMA)for the treatment of the above diseases,and developed the second batch of rare dis-ease drug catalog in China.The accessibility,localization and coverage of the national medical insurance were also analyzed.Results From the point of view of diseases,a total of 37 diseases in the China's Second List of Rare Diseases have drug indications approved in China,and 10 diseases have drugs listed by the U.S.FDA/EMA and approved in China,but for off-label use.From the point of view of drugs,there are 55 drug indications ap-proved for the treatment of the China's Second List of Rare Diseases,and 22 drugs listed in the U.S.FDA/EMA and approved in the China,but for off-label use.Among the above-mentioned drugs with domestic approved rare disease indications or approved numbers,39 drugs have at least one domestic approval number for a dosage form,covering 30 rare diseases;37 drugs used for at least one rare disease are included in the national medical insur-ance catalog and are covered by reimbursement,covering 29 rare diseases.Conclusions The list of rare disease drugs in the China's Second List of Rare Diseases was established.The number of rare disease drugs and covered diseases approved by China and the U.S.FDA/EMA has increased,and the number of rare disease drugs and covered diseases that are localized and included in the medical insurance catalog has also continued to increase.
7.Overview and Analysis of Rare Disease Drugs Approved for Market in China,the United States,the European Union,and Japan in 2023
Shaohong WANG ; Xin LIU ; Qingyang LIU ; Yan TANG ; Bo ZHANG
JOURNAL OF RARE DISEASES 2024;3(2):202-213
Objective To summarize and analyze what the listing in market of orphan drugs in China,the United States,the European Union,and Japan in 2023,and to provide empirical reference to Chinese phar-maceutical enterprises,pharmaceutical management,and new drug research and development departments.Methods Collect the 2023 drug market data released by official drug regulatory agencies in four countries and international organization-China,the United States,the European Union,and Japan categorize the market of rare disease drugs and and their indications,approval dates,R&D status in China,component therapeutic are-as,and special review and approval pathways were analyzed.Results Findings in 2023,28 orphan drugs were listed in the United States,mostly anti-tumor related,accounting for 32.1%(9 out of 28);17 orphan drugs were listed in the European Union,anti-tumor related accounting for 47.0%(8 of 17);22 listed in Japan;and 45 listed in China.In 2023,over 70%orphan drugs listed in the European Union and Japan entered the phase of clinical trials/marketing and applications/approved clinical applications in China(86.4%from Japan and 70.6%from European Union).Conclusions Currently,there is no qualification accreditation mechanism for orphan drugs in China.However,in 2023,the number of rare disease drugs listed in China was the greatest among the four countries/international organization.It reflects that China's Catalog for Rare Diseases played a guiding role in drug research and development.Meanwhile,the reform of drug approval and review in China and the issue of rare disease catalogs took place in a short period of time,so the review and approval,as well as re-search and development of rare disease drugs are still in the catching up stage.
8.Literature Review of Using Bisphosphonates in the Treatment of Calciphylaxis
Chunsu LIANG ; Shaohong WANG ; Yizhou ZHANG ; Xin LIU ; Ziran NIU ; Yili SHI ; Bo ZHANG
JOURNAL OF RARE DISEASES 2024;3(2):214-220
Objective To analyze the effectiveness and safety of bisphosphonates in the treatment of pa-tients with calcification defense.Methods PubMed,Embase databases,CNKI and Wanfang were searched to collect the case reports and clinical studies of bisphosphonates for calcification defense.Then,the relevant infor-mation of patients was extracted for statistical analysis.Results A total of 18 case reports were selected involving 20 patients.Thirteen patients(65.0%)were treated with pamidronate,four(20.0%)were treated with etidr-onate,two(10.0%)were treated with alendronate,and one(5.0%)was treated with zoledronic acid.Thirteen patients(65.0%)recovered completely,the recovery time of whom ranged from half month to nine months.The tolerance of bisphosphonates in most patients(90.0%)was good,while one patient who did not tolerate pamidr-onate recovered after the frequency of administration was adjusted and one patient with high dosage of etidronate returned to normal after the discontinuation of the usage.Conclusions Bisphosphonates,an inhibitor of bone resorption,is effective and safe in the treatment of patients with calcification defense.
9.The correlation between cognitive impairment and DNA methylation in the GRIN2B gene promoter region in bipolar depression patients with anxiety symptom
Hao YU ; Chengji WANG ; Yao WU ; Shaohong ZOU
Chinese Journal of Nervous and Mental Diseases 2024;50(5):274-280
Objective To explore the correlation between cognitive function and methylation levels of various CpG sites in the promoter region of the glutamate ionotropic receptor NMDA type subunit 2B(GRIN2B)gene in patients with bipolar depression accompanied by anxiety symptoms.Methods According to the 14-item Hamilton anxiety rating scale(HAMA)score,31 bipolar depression patients were divided into a group of 15 with anxiety symptoms and a group of 16 without anxiety symptoms.Sixteen healthy individuals were selected as controls during the same period.The Montreal cognitive assessment(MoCA),digital span test(DST),trail making test A(TMT-A),and Stroop color and word test(SCWT)were used to measure cognitive areas such as global cognitive function,attention and executive control,information processing speed,executive function in three groups.The DNA methylation levels of the CpG site in the GRIN2B gene promoter region in the peripheral blood of all participants were measured using Massarray spectrometry.Results The CpG sites showing differences in DNA methylation levels among the three groups were CpG3,CpG5,CpG7,CpG10,and CpG12(P<0.05),and the level of CpG12 methylation was lower in the group with anxiety than in the group without anxiety(36.23%±16.41%vs.50.20%±19.79%,P<0.05).Partial correlation analysis showed that,in the group with anxiety,poor naming ability was correlated with the lower methylation level of GRIN2B gene's CpG4(r=0.670,P=0.034),poor executive function was correlated with the lower CpG6 methylation level(r=0.926,P<0.001),poor attention was correlated with the higher CpG8 methylation level(r=-0.810,P=0.025),poor verbal memory was correlated with the higher CpG9 methylation level(r=-0.810,P<0.001),and poor abstract ability was correlated with the higher CpG10 methylation level(r=-0.756,P=0.011).Conclusion The DNA methylation level in the promoter region of the GRIN2B gene may be associated with cognitive impairment and anxiety symptoms in patients with bipolar depression.
10.Efficacy of electrical stimulation on shoulder-hand syndrome after stroke: a systematic review and meta-analysis
He WANG ; Liang HAN ; Mengfan KAN ; Shaohong YU
Chinese Journal of Rehabilitation Theory and Practice 2023;29(9):1048-1056
ObjectiveTo systematically evaluate the efficacy of electrical stimulation on shoulder-hand syndrome after stroke, and compare the curative effect of different electrical stimulation therapies. MethodsThe randomized controlled trials (RCT) about the effect of electrical stimulation on shoulder-hand syndrome after stroke were retrieved from eight databases, including PubMed, Web of Science, Embase, Cochrane Library, CNKI, CBM, VIP and Wanfang data, from the establishment to February 14th, 2023. Two researchers selected and screened the literature, and evaluated the quality of methodology independently. RevMan 5.4 software and Stata 14.0 software were used for meta-analysis and network meta-analysis, respectively. ResultsA total of 18 RCT were selected, including 1 310 cases. Compared to conventional rehabilitation therapy alone, electrical stimulation combined with conventional rehabilitation therapy could improve the scores of Fugl-Meyer Assessment-Upper Extremities (MD = 8.17, 95%CI 6.90 to 9.45, P < 0.001) and modified Barthel Index (MD = 11.80, 95%CI 10.18 to 13.42, P < 0.001), and reduce the Visual Analogue Score (MD = -1.68, 95%CI -2.03 to -1.32, P < 0.001) and edema score (MD = -0.98, 95%CI -1.18 to -0.79, P < 0.001). The best effect of improving upper limb function followed as intermediate frequency electrotherapy, electroacupuncture, low frequency electrotherapy and routine rehabilitation therapy. The best effect of improving pain followed as electroacupuncture, intermediate frequency electrotherapy, low frequency electrotherapy and routine rehabilitation therapy. ConclusionElectrical stimulation therapy can relieve pain and edema of patients with shoulder-hand syndrome after stroke, and improve upper limb activity and activities of daily living. Intermediate frequency electrotherapy is the best in improving upper limb function, and electroacupuncture is the best in relieving pain.


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