Objective:To analyze the current management status of real-world studies (RWS) in the medical institutions in China and suggest improvement focus for the management optimization.Methods:Surveys were conducted in 81 medical institutions nationwide. Convenience sampling was used to recruit survey subjects, and data were collected through self-administered questionnaires, followed by statistical analysis using descriptive methods.Results:The survey results indicated that 92.6% (75/81) of the medical institutions surveyed had undertaken RWS projects, with electronic medical records being the primary data source (89.3%, 67/75). Retrospective and prospective observational studies were the main types of study designs. Additionally, 96.3% (78/81) of the research subjects indicated that their medical institution expressed willingness to participate in or undertake RWS projects in the future. In terms of management, all types of RWS projects were managed by clinical trial center (24.0, 18/75), but differences existed in the management practices among medical institutions. Moreover, the challenges in data quality and standardization, study design and staff training, data and privacy protection and information technology support appeared in the management of RWS projects.Conclusions:It suggests to optimize the management processes of RWS projects in medical institutions and improve relevant laws and regulations to promote the development of RWS in China.

The incidence of vascular diseases is extremely high and mechanical stress plays an important role in vascular remodeling.Reactive oxygen species(ROS)at physiological levels modulate cell signaling while excessive ROS trigger oxidative stress and induce injury.The types of mechanical stresses in the vascular system and the sources of ROS are summarized.Besides,the roles and mechanisms of mechanical stress-induced oxidative stress in vascular diseases are discussed.This review will facilitate a deeper understanding of vascular activity and disease development at the molecular level,provide potential targets for treating vascular diseases.In addition,there are still research gaps on the mechanism of oxidative stress induced by mechanical stress in vascular diseases.Therefore,the potential research direction of mechanical stress-induced oxidative stress in the vascular system is also predicted,with the aim to promote the development of mechanobiology to a certain extent.

Objective To explore the distribution pattern of Chinese medicine symptoms in childhood non-Hodgkin's lymphoma cancer-related fatigue(CRF)and provide a basis for clinical treatment.Methods Information on the four TCM diagnoses of 103 children diagnosed with childhood non-Hodgkin's lymphoma CRF from July 2023 to July 2024 was collected from a single centre,and a database was established.Lantern 5.0software was used to analyse the characteristics of common TCM signs and symptoms of children with non-Hodgkin's lymphoma CRF by hidden structure model.Results Seventy-five high-frequency symptoms and signs,including yellow u-rine,general weakness,mental fatigue,thick and greasy moss,and irritability.Hidden structure model was constructed to obtain 5syndromes,according to which the identification rules were formulated for the secondary identification of children with CRF,and their syn-dromes types were,in descending order,heart-spleen stagnant heat,dampness-heat accumulation syndromes,qi deficiency and stasis,liver-qi stagnation syndromes,and heart-liver-blood deficiency syndromes.Conclusion The symptom types of CRF in children with non-Hodgkin's lymphoma were mainly deficiency and mixed reality syndromes,with pathological factors such as heat,stasis,dampness and accumulation on the basis of deficiency of qi,blood and yin.The study finally obtained five types of CRF in children with non-Hodgkin's lymphoma,and the distribution of the types is different from that of adults due to the influence of paediatric characteristics and pathophysiological characteristics.The treatment should be based on supporting the positive qi,and at the same time focusing on the method of eliminating food and resolving accumulation,regulating qi and diarrhoea,especially taking care of the lung,the spleen and the kidney of children.

Background and Aims:Centrally located breast cancer(CLBC),due to its proximity to the nipple-areolar complex,has long been treated primarily with mastectomy,while the oncologic safety of breast-conserving surgery(BCS)remains controversial.This study,based on a large-scale database combined with a real-world cohort,compared the survival outcomes of BCS and mastectomy to evaluate the feasibility and oncologic safety of BCS in CLBC patients.Methods:Data of 10 325 female CLBC patients diagnosed between 2010 and 2015 were extracted from the SEER database,including 5 601 patients who underwent BCS and 4 724 who underwent mastectomy.Propensity score matching(PSM)yielded 1 951 matched pairs,and disease-specific survival(DSS)and overall survival(OS)were compared between groups.Cox regression analyses were performed to identify prognostic factors,and subgroup analyses were conducted.Additionally,an independent validation cohort from Xiangya Hospital,Central South University(2015-2016)included 221 BCS and 636 mastectomy patients,with OS and progression-free survival(PFS)assessed.Results:After PSM,baseline characteristics between groups were well balanced.Kaplan-Meier analysis demonstrated no significant differences in DSS or OS between BCS and mastectomy,and 5-,7-,and 10-year OS rates were comparable(all P＞0.05).Subgroup analyses revealed equivalent outcomes for BCS and mastectomy in patients with T1/T2 disease,different HER2 statuses,and those receiving chemotherapy,while in patients receiving radiotherapy,BCS showed significantly better DSS and OS than mastectomy(both P＜0.05).Multivariate Cox regression identified T,N,and M stage,histologic grade,molecular subtype,ER/PR status,and chemotherapy as independent prognostic factors(all P＜0.05),whereas surgical type was not(P＞0.05).The validation cohort confirmed the SEER findings,with no significant differences in OS or PFS between the two groups(both P＞0.05).Conclusions:BCS provides DSS and OS comparable to mastectomy in CLBC patients and may confer additional survival benefits when combined with radiotherapy.These findings suggest that CLBC should not be considered a contraindication to BCS,supporting BCS as a feasible and safe surgical strategy that offers valuable evidence for individualized clinical decision-making and may help improve patients' quality of life.

Background and Aims:Centrally located breast cancer(CLBC),due to its proximity to the nipple-areolar complex,has long been treated primarily with mastectomy,while the oncologic safety of breast-conserving surgery(BCS)remains controversial.This study,based on a large-scale database combined with a real-world cohort,compared the survival outcomes of BCS and mastectomy to evaluate the feasibility and oncologic safety of BCS in CLBC patients.Methods:Data of 10 325 female CLBC patients diagnosed between 2010 and 2015 were extracted from the SEER database,including 5 601 patients who underwent BCS and 4 724 who underwent mastectomy.Propensity score matching(PSM)yielded 1 951 matched pairs,and disease-specific survival(DSS)and overall survival(OS)were compared between groups.Cox regression analyses were performed to identify prognostic factors,and subgroup analyses were conducted.Additionally,an independent validation cohort from Xiangya Hospital,Central South University(2015-2016)included 221 BCS and 636 mastectomy patients,with OS and progression-free survival(PFS)assessed.Results:After PSM,baseline characteristics between groups were well balanced.Kaplan-Meier analysis demonstrated no significant differences in DSS or OS between BCS and mastectomy,and 5-,7-,and 10-year OS rates were comparable(all P＞0.05).Subgroup analyses revealed equivalent outcomes for BCS and mastectomy in patients with T1/T2 disease,different HER2 statuses,and those receiving chemotherapy,while in patients receiving radiotherapy,BCS showed significantly better DSS and OS than mastectomy(both P＜0.05).Multivariate Cox regression identified T,N,and M stage,histologic grade,molecular subtype,ER/PR status,and chemotherapy as independent prognostic factors(all P＜0.05),whereas surgical type was not(P＞0.05).The validation cohort confirmed the SEER findings,with no significant differences in OS or PFS between the two groups(both P＞0.05).Conclusions:BCS provides DSS and OS comparable to mastectomy in CLBC patients and may confer additional survival benefits when combined with radiotherapy.These findings suggest that CLBC should not be considered a contraindication to BCS,supporting BCS as a feasible and safe surgical strategy that offers valuable evidence for individualized clinical decision-making and may help improve patients' quality of life.

Objective To evaluate the clinical efficacy of stellate ganglion block(SGB)combined with intranasal dexmedetomidine for the treatment of insomnia.Methods A total of 64 patients aged 18 to 75 with insom-nia were randomly assigned to either the experimental group(DS group)or the control group(S group).The S group received SGB treatment for 14 consecutive days,whereas the DS group received an additional intranasal dexmedeto-midine spray at a dose of 100 μg,administered 30 minutes before bedtime on days 1 through 6,in conjunction with SGB.We measured and recorded the Pittsburgh Sleep Quality Index(PSQI),Self-Rating Depression Scale(SDS),Self-Rating Anxiety Scale(SAS)scores,and Psychomotor Vigilance Test(PVT)results for both groups at three time points:baseline(T1),the day after treatment(T2),and one month after treatment(T3).Results Intra-group Com-parison:In both the DS and S groups,PSQI scores and dimensionspecific scores at T2 and T3 were significantly lower compared to T1(P<0.05).SAS and SDS scores in both groups showed a significant reduction at T3 compared to T1 and T2(P<0.05),while PVT results exhibited no significant changes(P>0.05).Inter-group Comparison:The PSQI scores and dimensionspecific scores in the DS group at T2(8.44±2.99)and T3(8.22±2.60)were significantly lower than those in the S group at T2(10.88±2.56)and T3(10.88±2.84)(P<0.05).However,no significant differences were observed in SDS and SAS scores between the DS and S groups at T2 and T3(P>0.05).Conclusion Compared to standalone SGB,the combination of SGB with intranasal dexmedetomidine significantly enhances sleep quality in patients with insomnia,while not impacting their levels of anxiety,depression,or alertness.

Objective To evaluate the clinical efficacy of Shenshi Jiangzhuo Formula(composed of Poria,Atractylodis Rhizoma,Magnoliae Officinalis Cortex,Pinelliae Rhizoma Praeparatum,Aurantii Fructus Immaturus,Arecae Semen,Talcum,Tetrapanacis Medulla,Notoginseng Radix et Rhizoma,Paeoniae Radix Rubra,Rubiae Radix et Rhizoma,Broussonetiae Fructus,etc.)in treating non-alcoholic fatty liver disease(NAFLD)with phlegm blended with stasis syndrome.Methods A total of 76 NAFLD patients with phlegm blended with stasis syndrome from the Seventh School of Clinical Medicine,Guangzhou University of Chinese Medicine(Shenzhen Bao'an Traditional Chinese Medicine Hospital)were enrolled between February 2024 and December 2024.The patients were randomly assigned(via random number table)to either the trial group(n=38,treated with Silibinin Meglumine Tablets plus Shenshi Jiangzhuo Formula)or the control group(n=38,treated with Silibinin Meglumine Tablets alone)for 8 weeks.The changes in liver controlled attenuation parameter(CAP),liver function markers[alanine aminotransferase(ALT),aspartate aminotransferase(AST),gamma-glutamyl transferase(GGT)],lipid profiles[triglycerides(TG),total cholesterol(TC),low-density lipoprotein cholesterol(LDL-C)],and traditional Chinese medicine(TCM)syndrome scores were observed before and after treatment.Clinical efficacy and safety were evaluated.Results(1)One case dropped out from each group during the study and 37 cases in each group were included for final statistics.(2)After 8 weeks of treatment,the overall response rate in the trial group was 94.59％(35/37),compared with 62.16％(23/37)in the control group.Intergroup comparison revealed that the trial group demonstrated significantly superior overall therapeutic efficacy(by rank-sum test)and overall response rate(by chi-square test)compared with the control group(P＜0.01).(3)Both groups showed improved CAP values after treatment,and the trial group demonstrated significantly greater improvement compared to the control group(P＜0.01).(4)Post-treatment improvements in alanine aminotransferase(ALT),aspartate aminotransferase(AST),and gamma-glutamyl transferase(GGT)were improved in both groups(P＜0.01),with the trial group showing significantly superior improvements(P＜0.05 or P＜0.01).(5)Triglycerides(TG),total cholesterol(TC),and low-density lipoprotein cholesterol(LDL-C)were improved in both groups after treatment,and the trial group exhibited significantly better outcomes(P＜0.01).(6)Both groups presented reduced TCM syndrome scores after treatment,and the trial group showed greater reduction(P＜0.01).(7)No significant adverse recations were observed in both groups,showing high safety.Conclusion Integrative therapy with Shenshi Jiangzhuo Formula exerts certain effects in improving CAP values,liver function,lipid metabolism,and TCM symptoms in NAFLD patients with phlegm blended with stasis syndrome,demonstrating robust clinical value.

Objective To evaluate the clinical efficacy of stellate ganglion block(SGB)combined with intranasal dexmedetomidine for the treatment of insomnia.Methods A total of 64 patients aged 18 to 75 with insom-nia were randomly assigned to either the experimental group(DS group)or the control group(S group).The S group received SGB treatment for 14 consecutive days,whereas the DS group received an additional intranasal dexmedeto-midine spray at a dose of 100 μg,administered 30 minutes before bedtime on days 1 through 6,in conjunction with SGB.We measured and recorded the Pittsburgh Sleep Quality Index(PSQI),Self-Rating Depression Scale(SDS),Self-Rating Anxiety Scale(SAS)scores,and Psychomotor Vigilance Test(PVT)results for both groups at three time points:baseline(T1),the day after treatment(T2),and one month after treatment(T3).Results Intra-group Com-parison:In both the DS and S groups,PSQI scores and dimensionspecific scores at T2 and T3 were significantly lower compared to T1(P<0.05).SAS and SDS scores in both groups showed a significant reduction at T3 compared to T1 and T2(P<0.05),while PVT results exhibited no significant changes(P>0.05).Inter-group Comparison:The PSQI scores and dimensionspecific scores in the DS group at T2(8.44±2.99)and T3(8.22±2.60)were significantly lower than those in the S group at T2(10.88±2.56)and T3(10.88±2.84)(P<0.05).However,no significant differences were observed in SDS and SAS scores between the DS and S groups at T2 and T3(P>0.05).Conclusion Compared to standalone SGB,the combination of SGB with intranasal dexmedetomidine significantly enhances sleep quality in patients with insomnia,while not impacting their levels of anxiety,depression,or alertness.

The incidence of vascular diseases is extremely high and mechanical stress plays an important role in vascular remodeling.Reactive oxygen species(ROS)at physiological levels modulate cell signaling while excessive ROS trigger oxidative stress and induce injury.The types of mechanical stresses in the vascular system and the sources of ROS are summarized.Besides,the roles and mechanisms of mechanical stress-induced oxidative stress in vascular diseases are discussed.This review will facilitate a deeper understanding of vascular activity and disease development at the molecular level,provide potential targets for treating vascular diseases.In addition,there are still research gaps on the mechanism of oxidative stress induced by mechanical stress in vascular diseases.Therefore,the potential research direction of mechanical stress-induced oxidative stress in the vascular system is also predicted,with the aim to promote the development of mechanobiology to a certain extent.

Objective To explore the distribution pattern of Chinese medicine symptoms in childhood non-Hodgkin's lymphoma cancer-related fatigue(CRF)and provide a basis for clinical treatment.Methods Information on the four TCM diagnoses of 103 children diagnosed with childhood non-Hodgkin's lymphoma CRF from July 2023 to July 2024 was collected from a single centre,and a database was established.Lantern 5.0software was used to analyse the characteristics of common TCM signs and symptoms of children with non-Hodgkin's lymphoma CRF by hidden structure model.Results Seventy-five high-frequency symptoms and signs,including yellow u-rine,general weakness,mental fatigue,thick and greasy moss,and irritability.Hidden structure model was constructed to obtain 5syndromes,according to which the identification rules were formulated for the secondary identification of children with CRF,and their syn-dromes types were,in descending order,heart-spleen stagnant heat,dampness-heat accumulation syndromes,qi deficiency and stasis,liver-qi stagnation syndromes,and heart-liver-blood deficiency syndromes.Conclusion The symptom types of CRF in children with non-Hodgkin's lymphoma were mainly deficiency and mixed reality syndromes,with pathological factors such as heat,stasis,dampness and accumulation on the basis of deficiency of qi,blood and yin.The study finally obtained five types of CRF in children with non-Hodgkin's lymphoma,and the distribution of the types is different from that of adults due to the influence of paediatric characteristics and pathophysiological characteristics.The treatment should be based on supporting the positive qi,and at the same time focusing on the method of eliminating food and resolving accumulation,regulating qi and diarrhoea,especially taking care of the lung,the spleen and the kidney of children.