Diseases of the central nervous system have become a growing global health concern. At present， there are many adverse reactions in the treatment with Western medicine. In contrast， traditional Chinese medicine has shown unique efficacy and rich clinical practice accumulation in diseases of the central nervous system. As a traditional Chinese medicine， Bupleuri Radix has played an important role in the treatment of neurological diseases through multi-target regulation， multi-pathway intervention， and multi-pathway mechanism of action. In recent years， with the in-depth study of the pharmacological effects of Bupleuri Radix， it has been found that the active ingredients such as saikosaponin， baicalin， quercetin， and kaempferol in Bupleuri Radix can be used as the main material basis for the treatment of neurological diseases. The results of this study showed that in neurodegenerative diseases， active ingredients of Bupleuri Radix can inhibit β-amyloid （Aβ） deposition and abnormal phosphorylation of microtubule-associated protein （Tau protein） in Alzheimer's disease， regulate the nuclear factor-κB/nuclear factor E₂ related factor 2 （NF-κB/Nrf2） pathway to play the anti-inflammatory role， and alleviate α-Synuclein （α-Syn） aggregation and mitochondrial damage in Parkinson's disease. In epilepsy， depression， and cerebral ischemia， they can improve symptoms by regulating neurotransmitters， oxidative stress， and apoptosis pathways， and inhibit brain glioma proliferation. However， the mechanism of action has not been fully elucidated， and the complexity of compound components and poor blood-brain barrier penetration limit their clinical application. In the future， it is necessary to integrate multi-omics， network pharmacology， and nano-delivery technologies， focus on the optimization of active ingredient group compounds and the precise guidance of biomarkers， accelerate the development of innovative therapies for Alzheimer's disease， Parkinson's disease， and other diseases for laying a solid theoretical foundation for further development and application and inspiring new research ideas.

Bone grafting is a primary method for treating bone defects. Among various graft materials, xenogeneic bone substitutes are widely used in clinical practice due to their abundant sources, convenient processing and storage, and avoidance of secondary surgeries. With the advancement of domestic production and the limitations of imported products, an increasing number of bone filling or grafting substitute materials isentering clinical trials. Relevant experts have drafted this consensus to enhance the management of medical device clinical trials, protect the rights of participants, and ensure the scientific and effective execution of trials. It summarizes clinical experience in aspects, such as design principles, participant inclusion/exclusion criteria, observation periods, efficacy evaluation metrics, safety assessment indicators, and quality control, to provide guidance for professionals in the field.
Humans ; Bone Substitutes/therapeutic use* ; Randomized Controlled Trials as Topic/methods* ; Consensus ; Bone Transplantation ; Research Design

Objective To analyze pathogen distribution and drug resistance in a tertiary hospital in Shenyang in 2022 and provide evi-dence-based guidance for this and other hospitals to formulate antibacterial drug application strategies.Methods In 2022,bacterial iso-lates collected from patients in a tertiary hospital in Shenyang were identified and subjected to drug sensitivity tests based on the require-ments of the national clinical laboratory operation procedures.The data were analyzed using Whonet 5.6 software.Results In total,4968 pathogenic strains were isolated from this hospital in 2022.The top five isolates were Escherichia coli,Klebsiella pneumoniae,Acineto-bacter baumannii,Enterococcus faecalis,and Pseudomonas aeruginosa.The resistance rates of Escherichia coliand Klebsiella pneumo-niaeto carbapenems were 1.9%and 17.7%,respectively.The resistance rates of Enterobacter cloacaeto imipenem and meropenem were 26.7%and 25.0%,respectively.The isolation rate of methicillin-resistant Staphylococcus aureus(MRSA)was 15.6%.The resistance rates of vancomycin-resistant Enterococcusand linezolid-resistant Enterococcus faecaliswere 7.1%and 11.6%,respectively.The resist-ance rates of tropical yeasts to fluconazole was>20%.Conclusion The distribution and drug resistance of pathogens in this hospital differed from those in other regions of China.The drug resistance of strains in this hospital should be closely monitored to understand the distribution and drug resistance of pathogens in a timely manner and to provide guidance for the diagnosis and treatment of infections.

Objective To analyze the influencing factors and principal components of care needs outside hospital for acute leukemia patients with chemotherapy.Methods A total of 240 acute leu-kemia patients with chemotherapy in authors'hospital from January 2021 to December 2022 were se-lected as research objects,and the patients were divided into no demand group and unsatisfied group according to score of the Supportive Care Needs Questionnaire.The survey questionnaire was used to collect the related materials of patients;the influencing factors were analyzed by Logistic regression coefficient;the principal component analysis(PCA)was used to extract the principal components of influencing factors.Results A total of 240 patients completed the Supportive Care Needs Questionnaire assessment,of which 132 cases(55.00％)had a need for health information,121 cases(50.42％)had a need for care and support,101 cases(42.08％)had a need for psychology,86 cases(35.83％)had a need for physiology and daily life,and 31 cases(12.92％)had a need for sexual support.There were significant differences in gender,age,educational level,average household income and payment method between the two groups(P＜0.05);there were significant differences in the course of dis-ease,patterns of activity and comorbidity of symptoms between the two groups(P＜0.05).Univari-ate Logistic regression analysis showed that gender,age,education level,payment method,average household income,course of disease,patterns of activity and comorbidity of symptoms were the influencing factors of care needs(P＜0.05).Principal component analysis extracted three principal components:payment method,syndrome merging status,anddisease course,with a cumulative con-tribution rate of 63.556％.Conclusion Acute leukemia patients have the highest proportion of health information needs and the lowest proportion of sexual support needs.Payment methods,comor-bidity of symptoms and the course of disease show significant impacts on the care needs of patients.

Objective To analyze the influencing factors and principal components of care needs outside hospital for acute leukemia patients with chemotherapy.Methods A total of 240 acute leu-kemia patients with chemotherapy in authors'hospital from January 2021 to December 2022 were se-lected as research objects,and the patients were divided into no demand group and unsatisfied group according to score of the Supportive Care Needs Questionnaire.The survey questionnaire was used to collect the related materials of patients;the influencing factors were analyzed by Logistic regression coefficient;the principal component analysis(PCA)was used to extract the principal components of influencing factors.Results A total of 240 patients completed the Supportive Care Needs Questionnaire assessment,of which 132 cases(55.00％)had a need for health information,121 cases(50.42％)had a need for care and support,101 cases(42.08％)had a need for psychology,86 cases(35.83％)had a need for physiology and daily life,and 31 cases(12.92％)had a need for sexual support.There were significant differences in gender,age,educational level,average household income and payment method between the two groups(P＜0.05);there were significant differences in the course of dis-ease,patterns of activity and comorbidity of symptoms between the two groups(P＜0.05).Univari-ate Logistic regression analysis showed that gender,age,education level,payment method,average household income,course of disease,patterns of activity and comorbidity of symptoms were the influencing factors of care needs(P＜0.05).Principal component analysis extracted three principal components:payment method,syndrome merging status,anddisease course,with a cumulative con-tribution rate of 63.556％.Conclusion Acute leukemia patients have the highest proportion of health information needs and the lowest proportion of sexual support needs.Payment methods,comor-bidity of symptoms and the course of disease show significant impacts on the care needs of patients.

Objective: To investigate the efficacy and safety of the new investigational drug pegylated interferon α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 µg/week) combined with ribavirin in the treatment of patients with genotype 1/6 chronic hepatitis C (CHC), with standard-dose Peg-IFN-α-2a combined with ribavirin as a positive control. Methods: A multicenter, randomized, open-label, and positive-controlled phase III clinical trial was performed. Eligible patients with genotype 1/6 CHC were screened out and randomly divided into Peg-IFN-α-2b(Y shape, 40kD) group and Peg-IFN-α-2a group at a ratio of 2:1. The patients in both groups were given oral ribavirin for 48 weeks in addition and then followed up for 24 weeks after drug withdrawal. Abbott Real Time HCV Genotype II was used to determine HCV genotype, and Cobas TaqMan quantitative real-time PCR was used to measure HCV RNA level at 0, 4, 12, 24, 48, and 72 weeks. Adverse events were recorded in detail. The primary efficacy endpoint was sustained virological response (SVR), and a non-inferiority test was also performed. Results: A total of 561 patients with genotype 1/6 CHC were enrolled, among whom 529 received treatment; 90.9% of these patients had genotype 1 CHC. The data of the full analysis set showed that SVR rate was 69.80% (95% CI 65.00%-74.60%) in the trial group and 74.16% (95% CI 67.73%-80.59%) in the control group (P = 0.297 0). The data of the per protocol set (PPS) showed that SVR rate was 80.63% (95% CI 76.04%-85.23%) in the trial group and 81.33% (95% CI 75.10%-87.57%) in the control group (P = 0.849 8), and the 95% CI of rate difference conformed to the non-inferiority standard. The analysis of the PPS population showed that of all subjects, 47.9% achieved rapid virologic response, with a positive predictive value of 93.8%. The incidence rate of adverse events was 96.30% in the trial group and 94.94% in the control group, and the incidence rate of serious adverse events was 5.13% in the trail group and 5.06% in the control group. Conclusion In the regimen of Peg-IFN-α combined with ribavirin for the treatment of genotype 1/6 CHC, the new investigational drug Peg-IFN-α-2b(Y shape, 40 kD) has comparable clinical effect and safety to the control drug Peg-IFN-α-2a.

Objective To explore the effect of high quality nursing on the negative emotions and the complication in patients with acute leukemia, providing the basis for the clinical nursing work in acute leukemia disease. Methods A total of 94 cases with acute leukemia disease who were treated in the hospital from January 2014 to December 2015 were recruited as the study objects. The patients were divided into the observation group and the control group according to the random digit table method, with 46 cases in each group. The control group was given routine nursing, while the observation group was given high quality nursing. The nursing quality was compared between the two groups, mainly on the scores of the nursing quality, the incidence of postoperative complications, negative emotions and satisfaction of children and their families before and after nursing. Results The comprehensive quality score of nursing in nursing skills, nurses' attitude, ward management and health education in the observation group were significantly higher than that in the control group, and the difference were statistically significant (χ2=17.542- 38.002, P<0.01). The incidences of postoperative complications (infection, phlebitis, hemorrhage, fever) in the observation group were 4.25%(2/47), 2.13%(1/47), 4.25%(2/47), 0,which were significantly lower than those in the control group,17.14%(6/47), 10.64%(5/47), 17.14%(6/47), 6.38%(3/47),and the differences were statistically significant (χ2=3.683-4.021, P<0.05 or 0.01). The scores of negative sentiment in the process of treatment and after the treatment in the observation group were 27.82±7.04, 33.25±8.37,significantly lower than those in the control group, 36.02± 6.81, 45.74 ± 9.13,and the differences were statistically significant(t=3.992, 4.006, P<0.05). The satisfaction of patients and their families in the observation group was 95.74%(45/47),significantly higher than that in the control group, 72.34%(34/47), and the difference was statistically significant (χ2=4.336, P=0.001). Conclusions High quality nursing could reduce the negative emotions and complication of children with the acute leukemia disease effectively, improve the quality of nursing work, and enhance the satisfaction of the family, which had the characteristics of efficiency, scientificalness, rationality and convenience, and has important guiding significance for clinical management of acute leukemia diseases and related nursing work.

Objective To investigate the effect ofatorvastatin on angiogenesis of brain tissues in focal cerebral ischemia rats,and explore the corresponding mechanism.Methods Ninety male SD rats were randomly divided into sham-operated group,model group and treatment group (n=30);and then,each group was divided into three subgroups:1 d group,3 d group and 7 d group (n=10).The focal cerebral ischemia models were induced by middle cerebral artery occlusion (MCAO);3 h after MCAO,rats in the treatment group received a gavage of atorvastatin 4 mg/(kg.d),and others were given the same amount of normal saline at corresponding time.The nerve function defects were estimated at 3 h after MCAO and before being killed;the protein expressions of vascular endothelial cell markers CD105 and glucose-regulated protein 78 (GRP78) were analyzed by immunohistochemistry;the vascular endothelial growth factor (VEGF) mRNA expression was analyzed by real time-PCR;the caspase-12 protein expression was analyzed by Western blotting.Results (1) Nerve function defects scores:there was no significantly statistical difference between model group and treatment group at 3 h after MCAO (P＞0.05),but statistical differences at different time points before being killed were noted (P＜0.05).(2) Microvessel density (MVD):at all time points,that of model group was increased as compared with that of sham-operated group,that of treatment group was increased as compared with that of model group,and the differences were all statistically significant (P＜0.05).(3)The VEGF rmRNA expression gradually increased over time;at all time points,the VEGF mRNA expression of model group was significantly higher than that in the sham-operated group,and that of treatment group was significantly higher than that in the model group (P＜0.05).(4)The GRP78 and caspase-12 expressions were gradually decreased over time;at all time points,the GRP78/BiP and caspase-12 expressions in the model group were significantly higher than those in the sham-operated group;those in the treatment group were statistically lower than those in the model group,but obviously higher than those in the sham-operated group (P＜0.05).Conclusion The angiogenesis of brain tissues in MCAO rats is obvious,and atorvastatin can enhance this effect;the mechanism may be that atorvastatin can weaken the endoplasmic reticulum stress,and then,reduce the apoptosis of endothelial cells.

Objective To discuss a optimal culture method of primary hippocampal neurons and a more suitable method of mor-phological observation ,and provide basis to the study of synapse in Alzheimer′s Disease .Methods Postnatal 0 -1 days (P0 -1 ) C57BL/6J mice were decollated and bilateral hippocampus were separated .Low level concentration of trypsin and mechanical disso-ciation were adopted .And culture medium without serum was used to culture neurons .After 17 days culturing ,transfected neurons with Green Fluorescent Protein(GFP) by calcium phosphate precipitation ,and then observed neurons and spines by fluorescence mi-croscope .Results The neurons looked good and healthy by using this method .And the axons ,dendrites and spines which were typ-ical structure of neurons were observed clearly after transfected with GFP .Conclusion The cultured hippocampal neurons look good by this method .And the morphological characteristics of neurons and spines are observed much more clearly after transfected GFP by calcium phosphate precipitation .