ObjectiveTo analyze the adverse reactions associated with the clinical use of Banxia （Rhizoma Pinelliae）- Wutou （Aconitum） in the same formula， with the aim of providing a reference for the safety of their clinical application. MethodsLiterature on the clinical application of antagonistic herbs "Banxia-Wutou" used in the same formula， published from January 1st， 2014， to June 30th， 2023， was retrieved from databases including CNKI， VIP， Wanfang， SinoMed， PubMed， Cochrane Library， and Embase. A database was established， and information related to adverse reactions was extracted， including descriptions， classifications， specific manifestations， management and outcomes， patients' primary diseases （western medicine diseases and traditional Chinese medicine diagnoses and syndromes）， and medication information （dosage， ratio， administration routes， and dosage forms）. ResultsA total of 79 researches simultaneously used antagonistic herbs Banxia-Wutou in the same formula and reported associated advers reactions. Gastrointestinal adverse reactions were the most common， with 8 studies reporting management of adverse reactions and 3 studies reporting improvement with no intervention. Among the 11 researches， the adverse reaction relieved to extant， while other 69 researches didn't report the managment of adverse reaction and its prognosis. For the primary disease in western medicine system， chronic bronchitis and chronic obstructive pulmonary disease （COPD） were most common， while gastric pain was the most common symptom in traditional Chinese medicine with spleen and kidney deficiency and spleen stomach cold deficiency being the most frequent syndromes. The most common Banxia dosage was 10 g， while for the Wutou， Fuzi （Radix Aconiti Lateralis Praeparata） was predominant with the highest dose at 15 g. The most frequent herbal combination was Banxia-fuzi， with a 1∶1 ratio. The main administration route was oral， and the primary dosage form was decoction. ConclusionGastrointestinal adverse reactions are the most common in the clinical use of Banxia-Wutou antagonistic herb combinations. Research on the safety of "Banxia-Wutou" combinations should focus on respiratory system diseases and spleen-stomach related conditions.

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.

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.

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.

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.

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.

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.

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.

Animals ; SARS-CoV-2 ; Antibodies, Neutralizing ; Macaca mulatta ; COVID-19/prevention & control* ; Antibodies, Viral ; Vaccines

Objective To analyze the predictive value of serum soluble intercellular adhesion molecule-1(sICAM-1),soluble vascular intercellular adhesion molecule-1(sVCAM-1)and soluble microfiber associated protein 4(sMFAP4)for major adverse cardiovascular events(MACE)after per-cutaneous coronary intervention(PCI)in acute myocardial infarction.Methods A total of 166 pa-tients with acute myocardial infarction after PCI were included in case group,and 166 healthy volun-teers were included in control group during the same period.Enzyme-linked immunosorbent assay was used to detect serum levels of sICAM-1,sVCAM-1 and sMFAP4,and the differences between groups were compared.After being followed-up for 1 year,the case group was divided into MACE group(n=42)and non-MACE(n=113)group after removing 10 cases.General information was compared be-tween the MACE group and the non-MACE group.Logistic regression analysis was used to identify the influencing factors for MACE;receiver operating characteristic(ROC)curve was plotted,and the area under the curve(AUC)was used to evaluate the efficacy of relevant indicators in predicting MACE.Results The incidence of MACE was 27.10％.The serum levels of sICAM-1,sVCAM-1 and sMFAP4 in the case group were significantly higher than those in the control group,and those in the MACE group were significantly higher than those in the non-MACE group(P＜0.05).Smoking history(OR=3.688,95％CI,1.107 to 12.286),drinking history(OR=3.364,95％CI,1.238 to 9.139),combined hypertension(OR=4.255,95％CI,1.250 to 14.483),combined type 2 di-abetes(OR=4.208,95％CI,1.051 to 16.856),combined hyperlipidemia(OR=5.238,95％CI,1.440 to 19.061),Gensini score(OR=5.579,95％CI,1.355 to 22.968),blood platelet count(PLT)(OR=0.519,95％CI,0.281 to 0.961),serum sICAM-1(OR=5.013,95％CI,1.859 to 13.514),sVCAM-1(OR=4.826,95％CI,1.769 to 13.164)as well as sMFAP4(OR=4.745,95％CI,1.372 to 16.407)and no reflow during surgery(OR=2.962,95％CI,1.107 to 7.924),no collateral circulation formation(OR=3.225,95％CI,1.173 to 8.867)were all influen-cing factors for the occurrence of MACE.Serum sICAM-1,sVCAM-1 and sMFAP4 levels predicted the cut-off value of MACE in the case group were 331.53 ng/mL,473.20 ng/mL and 30.63 U/L,respectively,the sensitivity was 80.95％,76.19％and 78.57％,respectively,the specificity was 94.69％,97.35％,88.50％,respectively,and the AUC was 0.835(95％CI,0.767 to 0.890),0.794(95％CI,0.722 to 0.855),0.824(95％CI,0.754 to 0.880),respectively.The sensitivi-ty,specificity and AUC of serum sICAM-1,sVCAM-1 and sMFAP4 to predict MACE were larger or higher than those of Gensini score(P＜0.05);the sensitivity,specificity and AUC of the above ser-um indexes combined to predict the occurrence of MACE in the case group were 100.00％,94.69％and 0.956(95％CI,0.910 to 0.982),respectively,and the sensitivity and AUC of the combined prediction were higher or larger than those of the single prediction(P＜0.05).Conclusion Serum sICAM-1,sVCAM-1 and sMFAP4 levels are increased in patients with acute myocardial infarction,all of which are related to MACE after PCI.The MACE prediction value of the three is better than Gensini score,and the combined prediction value of the three is higher.