BACKGROUND: Early control of low-density lipoprotein cholesterol (LDL-C) is crucial for reducing the progress of cardiovascular disease. However, its additional role to the risk of primary osteoporosis in men with coronary heart disease was inconclusive. Our study aims to determine the association of LDL-C and its trajectories for osteoporosis risk in the middle-aged and aged men of China. METHODS: The retrospective cohort study of 1546 men aged 69.74 ± 11.30 years conducted in Beijing, China from 2015 to 2022. And the incidence of primary osteoporosis was annually recorded. LDL-C trajectories were further identified by latent class growth model using repeated measurements of LDL-C. The association of baseline LDL-C for osteoporosis was estimated using hazard ratio (HR) with 95% CI in Cox proportional hazard model, while mean level and trajectories of LDL-C for osteoporosis were evaluated using odds ratio (OR) with 95% CI in logistic regression model. RESULTS: During the median 6.2-year follow-up period, 70 men developed primary osteoporosis. The higher level of baseline LDL-C (HR = 1.539, 95% CI: 1.012-2.342) and mean LDL-C (OR = 2.190, 95% CI: 1.443-3.324) were associated with higher risk of osteoporosis in men with coronary heart disease after adjusted for covariates. Compared with those in the LDL-C trajectory of low-stable decrease, participants with medium-fluctuant trajectory, whose longitudinal LDL-C started with a medium LDL-C level and appeared an increase and then decrease, were negatively associated with osteoporosis risk (OR = 2.451, 95% CI: 1.152-5.216). And participants with initially high LDL-C level and then a rapid decrease demonstrated a tendency towards reduced risk (OR = 0.718, 95% CI: 0.212-2.437). CONCLUSIONS Elevated LDL-C level and its long-term fluctuation may increase the risk of primary osteoporosis in men. Early controlling a stable level of LDL-C is also essential for bone health.

AIM To study the chemical constituents from the leaves of Drynaria fortunei(Kunze)J.Sm.and their antioxidant activity.METHODS ODS-AG-HG,Sephadex LH-20 and semi-preparative HPLC were used for separation and purification,then the structures of obtained compounds were identified by physicochemical properties and spectral data.The antioxidant activity was determined by DPPH mothod.RESULTS Fifteen compounds were isolated and identified as kaempferol-3-O-neohesperidoside(1),dihydrodehydrodiconiferyl alcohol(2),kaempferol-3,7-di-O-α-L-rahmnoside(3),astragalin(4),loliolid(5),trichothecene analogue(6),2,2-[bis-4-(2,3-dihydroxypropoxy)phenyl]propane(7),maculatin(8),trichothecin(9),4-[(Z)-but-2-enoyloxy]-8-chloro-12-hydroxy-7,13-epoxytrichothec-9-ene(10),8-deoxy-trichotecin(11),β-sitosterol(12),daucosterol(13),afzelin(14),samwinol(15).The IC50 values of the leaf and rhizome extracts against DPPH free radicals were(0.072±0.005),(0.287±0.012)mg/mL,respectively.CONCLUSION Compounds 1,2,5-11,15 are isolated from this plant for the first time.The leaves of D.fortunei exhibit strong antioxidant activity.

Objective:The purpose of this study is to explore the influencing factors of poor prognosis in henoch-schonlein purpura(HSP)children,and to construct a nomogram model and verify its validity through the analysis results of Logistic regression model.Methods:Collected the clinical data of 170 HSP children who were treated in Fuzhou Luoyuan County Hospital from January 2015 to May 2023 were retrospectively analyzed.They were divided into good prognosis group and poor prognosis group according to the prognosis after treatment.The clinical data and related biochemical indexes of different prognostic groups were compared.The factors of poor prognosis in HSP children were analyzed by Logistic regression model.A predictive model(nomogram)for poor prognosis in HSP children were constructed and evaluated its predictive performance.Prediction accuracy were evaluateed by receiver operating characteristic(ROC)curve.Results:170 HSP children,69 cases(40.59％)had poor prognosis and 101 cases(59.41％)had good prognosis.C-reactive protein(CRP),kidney injury at initial onset,platelet count(PLT),respiratory infection,recurrent rash,and immunoglobulin A(IgA)levels in poor prognosis group were higher than those in good prognosis group(P＜0.05).Multivariate logistic analysis showed that,recurrent rash,respiratory infection,elevated PLT,CRP and IgA levels were independent influencing factors of poor prognosis in HSP children(P＜0.05).The consistency index(C-index)of the column chart model established based on the results of multiple factor analysis was 0.798.The internal verification was carried out by Bootstrap self-sampling method,and the average absolute error of calibration curve was 0.017.ROC curve was drawn according to independent influencing factors and nomogram prediction probability,the area under the curve was 0.674(recurrent rash),0.649(respiratory infection),0.777(PLT),0.733(CRP),0.749(IgA)and 0.910(nomogram prediction probability)respectively.Conclusion:Recurrent rash,respiratory infection,PLT,CRP and IgA are independent factors affecting the prognosis of HSP children.The column chart prediction model constructed based on the above factors has certain predictive value for the poor prognosis in HSP children.

Objective To explore the changes of durability properties of reusable surgical gowns when used in dry and wet conditions.Methods Reusable surgical gowns made of single-layer polyester fiber or 3-layer composite material were selected as test samples,and a Martindale abrasion and pilling tester was used as the basic test platform and modified to form fixtures suitable for the wet state environment.The reusable surgical gowns underwent abrasion experiments in wet and dry conditions to observe the changes in their fiber structure,and were subjected to water penetration resistance and swelling strength tests.Results Visually the reusable surgical gowns had few changes of the microscopic textile fiber structure in dry and wet conditions,and the gowns made of single-layer polyster fiber gained advantages over the outer layers of those of 3-layer composite material in abrasion resistance with the same friction cycles.In dry and wet conditions,the hydrostatic pressure values of the gowns of single-layer polyster fiber gradually decreased with the increase of the degree of abrasion,which were always lower than those of the gowns of 3-layer composite material;the swelling strength of the gowns of single-layer polyster fiber was always greater than that of the gowns of 3-layer composite material,which decreased with the deterioration of the wear more significantly than that of the gowns of 3-layer composite material.Conclusion The reusable surgical gowns made of single-layer polyester fiber or 3-layer composite material have few differences in durability and protective properties at the early stages of ablation in dry and wet conditions.The durability of the gowns decreases as the degree of wear increases,while the trend of the decrease is slowing down until the fabric breaks down and completely loses its barrier effect.[Chinese Medical Equipment Journal,2025,46(6):28-33]

Objective To explore the feasibility and corresponding implementation methods of constructing a sample resource bank based on individual-level data of completed clinical trials and using it to construct external controls for drug/device clinical trials.Methods Taking the pre-marketing clinical trial of transcatheter active valve replacement(TAVR)for the treatment of aortic valve stenosis as an example,the individual-level databases of multiple trials were standardized to form a sample bank.The original data of any trial in the sample bank were selected as the experimental group,and the remaining samples were selected as the control group.The potential confounding was handled by using the propensity score matching and stratification methods to clarify the process of constructing external controls based on the sample bank of individual-level data of clinical trials.Results This study included individual-level data of single-group trials of 4 TAVR devices,with a total of 569 subjects(59.2%male).The number of subjects in Trials 1 to 4 was 120,120,163,and 166,respectively.Propensity score matching enabled the matching of 113,117,125,and 147 subjects with comparable or similar characteristics from individual-level data from other trials,respectively,demonstrating a high matching success rate.The PS score distribution plot after stratification showed that the proportions of subjects in the experimental and control groups in strata 1 to 5 in scheme 1 were 4/103,11/103,22/92,32/87,and 51/64,respectively.For all constructed external controlled trials,a certain number of control samples with similar baseline characteristics to the experimental groups were distributed within each propensity score stratum.The results of the simulation test also reflected the potential differences between different devices in the 12-month all-cause mortality rate.Conclusions The sample bank constructed with individual-level data from clinical trials,as a high-quality data source,can serve as a source of external control for single-arm trials in the same field,and as a useful supplement to the external control scenario of real-world evidence to support drug and device development.At the same time,targeted research on research methods and bias control measures in related fields is also needed.

Objective:To observe the effect of Guilu Taohong Formula on semen quality in varicocele(VC)models of rats,and to explore its possible mechanism.Methods:Forty-eight male SD rats were randomly divided into four groups(sham group,model group,Guilu Taohong Formula group and L-carnitine group).After the establishment of models,the rats were treated with intra-gastric administration for eight consecutive weeks.The general condition of the rats was observed.After the gavage,the testicular and epididymal indices were calculated.Semen quality was assessed using an automatic semen analyzer.Apoptosis of testicular cells was assessed by TUNEL staining.And the expression levels of B-cell lymphocytoma-2(Bcl-2),Bcl-2-associated X protein(Bax)and cys-teine aspartate protease-3(caspase-3)in testicular tissue were detected by Western blot.Results:Compared with the sham group,testicular index,epididymal index,sperm concentration,the percentage of progressive motility of sperm(PR％)and the expression level of Bcl-2 decreased in model group(P＜0.01).An increased apoptosis rate of spermatogenic cells and the expression levels of Bax and caspase-3 proteins were observed in model group as well(P＜0.01).Compared with the model group,the testicular index,epidid-ymal index,sperm concentration,PR％and the expression level of Bcl-2 in Guilu Taohong Formula group increased significantly(P＜0.05,P＜0.01).A decreased apoptosis rate of spermatogenic cells and the expression levels of Bax and caspase-3 proteins were de-tected in Guilu Taohong Formula group as well(P＜0.01).Similarly,the L-carnitine group showed increased testicular index,epidid-ymal index,sperm concentration,PR％and the expression level of Bcl-2 protein(P＜0.05,P＜0.01),where showed decreased ap-optosis rate of spermatogenic cells and the expression levels of Bax and caspase-3 proteins compared with model group(P＜0.01,P＜0.05).Conclusion:Guilu Taohong Formula improves semen quality in VC model rats and reduces the apoptosis rate of spermato-genic cells in testicular tissue,which may be related to the promotion of Bcl-2 protein expression and the inhibition of Bax and caspase-3 protein expression levels.

Objective To explore the changes of durability properties of reusable surgical gowns when used in dry and wet conditions.Methods Reusable surgical gowns made of single-layer polyester fiber or 3-layer composite material were selected as test samples,and a Martindale abrasion and pilling tester was used as the basic test platform and modified to form fixtures suitable for the wet state environment.The reusable surgical gowns underwent abrasion experiments in wet and dry conditions to observe the changes in their fiber structure,and were subjected to water penetration resistance and swelling strength tests.Results Visually the reusable surgical gowns had few changes of the microscopic textile fiber structure in dry and wet conditions,and the gowns made of single-layer polyster fiber gained advantages over the outer layers of those of 3-layer composite material in abrasion resistance with the same friction cycles.In dry and wet conditions,the hydrostatic pressure values of the gowns of single-layer polyster fiber gradually decreased with the increase of the degree of abrasion,which were always lower than those of the gowns of 3-layer composite material;the swelling strength of the gowns of single-layer polyster fiber was always greater than that of the gowns of 3-layer composite material,which decreased with the deterioration of the wear more significantly than that of the gowns of 3-layer composite material.Conclusion The reusable surgical gowns made of single-layer polyester fiber or 3-layer composite material have few differences in durability and protective properties at the early stages of ablation in dry and wet conditions.The durability of the gowns decreases as the degree of wear increases,while the trend of the decrease is slowing down until the fabric breaks down and completely loses its barrier effect.[Chinese Medical Equipment Journal,2025,46(6):28-33]

Objective To explore the feasibility and corresponding implementation methods of constructing a sample resource bank based on individual-level data of completed clinical trials and using it to construct external controls for drug/device clinical trials.Methods Taking the pre-marketing clinical trial of transcatheter active valve replacement(TAVR)for the treatment of aortic valve stenosis as an example,the individual-level databases of multiple trials were standardized to form a sample bank.The original data of any trial in the sample bank were selected as the experimental group,and the remaining samples were selected as the control group.The potential confounding was handled by using the propensity score matching and stratification methods to clarify the process of constructing external controls based on the sample bank of individual-level data of clinical trials.Results This study included individual-level data of single-group trials of 4 TAVR devices,with a total of 569 subjects(59.2%male).The number of subjects in Trials 1 to 4 was 120,120,163,and 166,respectively.Propensity score matching enabled the matching of 113,117,125,and 147 subjects with comparable or similar characteristics from individual-level data from other trials,respectively,demonstrating a high matching success rate.The PS score distribution plot after stratification showed that the proportions of subjects in the experimental and control groups in strata 1 to 5 in scheme 1 were 4/103,11/103,22/92,32/87,and 51/64,respectively.For all constructed external controlled trials,a certain number of control samples with similar baseline characteristics to the experimental groups were distributed within each propensity score stratum.The results of the simulation test also reflected the potential differences between different devices in the 12-month all-cause mortality rate.Conclusions The sample bank constructed with individual-level data from clinical trials,as a high-quality data source,can serve as a source of external control for single-arm trials in the same field,and as a useful supplement to the external control scenario of real-world evidence to support drug and device development.At the same time,targeted research on research methods and bias control measures in related fields is also needed.

Objective:The purpose of this study is to explore the influencing factors of poor prognosis in henoch-schonlein purpura(HSP)children,and to construct a nomogram model and verify its validity through the analysis results of Logistic regression model.Methods:Collected the clinical data of 170 HSP children who were treated in Fuzhou Luoyuan County Hospital from January 2015 to May 2023 were retrospectively analyzed.They were divided into good prognosis group and poor prognosis group according to the prognosis after treatment.The clinical data and related biochemical indexes of different prognostic groups were compared.The factors of poor prognosis in HSP children were analyzed by Logistic regression model.A predictive model(nomogram)for poor prognosis in HSP children were constructed and evaluated its predictive performance.Prediction accuracy were evaluateed by receiver operating characteristic(ROC)curve.Results:170 HSP children,69 cases(40.59％)had poor prognosis and 101 cases(59.41％)had good prognosis.C-reactive protein(CRP),kidney injury at initial onset,platelet count(PLT),respiratory infection,recurrent rash,and immunoglobulin A(IgA)levels in poor prognosis group were higher than those in good prognosis group(P＜0.05).Multivariate logistic analysis showed that,recurrent rash,respiratory infection,elevated PLT,CRP and IgA levels were independent influencing factors of poor prognosis in HSP children(P＜0.05).The consistency index(C-index)of the column chart model established based on the results of multiple factor analysis was 0.798.The internal verification was carried out by Bootstrap self-sampling method,and the average absolute error of calibration curve was 0.017.ROC curve was drawn according to independent influencing factors and nomogram prediction probability,the area under the curve was 0.674(recurrent rash),0.649(respiratory infection),0.777(PLT),0.733(CRP),0.749(IgA)and 0.910(nomogram prediction probability)respectively.Conclusion:Recurrent rash,respiratory infection,PLT,CRP and IgA are independent factors affecting the prognosis of HSP children.The column chart prediction model constructed based on the above factors has certain predictive value for the poor prognosis in HSP children.