Objective To explore the impact of gender factors in participant selection during bioequivalence studies,and to provide insights for improving the screening success rate in subsequent trials.Methods A retrospective study was con-ducted to summarize the screening information of healthy subjects in the bioequivalence study conducted in the Phase Ⅰ Clinical Trial Laboratory of the Affiliated Hospital of Xiangnan University from July 2021 to July 2023.The number of failed screening ca-ses in different stages of screening for each project was counted,and the influence of gender factors on subject screening was ana-lyzed.Results A total of 32 bioequivalence studies involving 2 794 subjects,including 1 816 males and 978 females,were in-cluded in the study.The proportion of males was higher in vital signs and BMI abnormalities,and the proportion of females was higher in ECG abnormalities and active withdrawal,and the pass rate was lower in males than in females(40.0％ vs.45.8％),and the existence of the two was statistically significant(P＜0.05).The results of PC A showed that the distribution of data in males was more dispersed,and the distribution of data in females was centralized,and the two could be clearly differentiated.Binary lo-gistic regression analysis showed significant differences between males and females in laboratory test screening failures and BMI(P＜0.05).Further analysis showed that the screening failure rates of blood biochemistry,urine routine,coagulation function and blood transfusion were higher in males than in females,but the screening failure rates of blood routine were lower than those of fe-males.Conclusions Gender is an important influencing factor in the screening process of bioequivalence studies.Including subjects with appropriate gender ratios can help improve enrollment speed and reduce clinical trial costs.

Objective To explore the impact of gender factors in participant selection during bioequivalence studies,and to provide insights for improving the screening success rate in subsequent trials.Methods A retrospective study was con-ducted to summarize the screening information of healthy subjects in the bioequivalence study conducted in the Phase Ⅰ Clinical Trial Laboratory of the Affiliated Hospital of Xiangnan University from July 2021 to July 2023.The number of failed screening ca-ses in different stages of screening for each project was counted,and the influence of gender factors on subject screening was ana-lyzed.Results A total of 32 bioequivalence studies involving 2 794 subjects,including 1 816 males and 978 females,were in-cluded in the study.The proportion of males was higher in vital signs and BMI abnormalities,and the proportion of females was higher in ECG abnormalities and active withdrawal,and the pass rate was lower in males than in females(40.0％ vs.45.8％),and the existence of the two was statistically significant(P＜0.05).The results of PC A showed that the distribution of data in males was more dispersed,and the distribution of data in females was centralized,and the two could be clearly differentiated.Binary lo-gistic regression analysis showed significant differences between males and females in laboratory test screening failures and BMI(P＜0.05).Further analysis showed that the screening failure rates of blood biochemistry,urine routine,coagulation function and blood transfusion were higher in males than in females,but the screening failure rates of blood routine were lower than those of fe-males.Conclusions Gender is an important influencing factor in the screening process of bioequivalence studies.Including subjects with appropriate gender ratios can help improve enrollment speed and reduce clinical trial costs.

Objective To explore the sample type and drug resistance characteristics of Streptococcus pneu-monia(Spn)isolated from pediatric patients in Guangzhou district,and their age distribution to offer instruc-tions for prevention and clinical treatment.Methods Spn isolates were cultured and identified according to the national standard procedure for clinical laboratory operation,followed by analysis of sample type and age dis-tribution of pediatric patients with positive isolates of Spn in Guangzhou Women and Children′s Medical Cen-ter from 2013 Jan 1st to 2015 Dec 31st,drug resistance status was determined by MIC test.Results Totally, 1 243 strains of Spn were isolated,which were mainly from pediatric patients under 1 year old(42.80%).Spn isolates were mainly isolated from respiratory tract(72.81%),ear secretions(15.37%),blood(5.63%),cere-brospinal fluid(3.06%)and hydrothorax(2.01%).For all Spn isolates,the resistance rate to erythromycin, tetracycline and sulfamethoxazole was especially high as 94.93%,85.76%,73.53% respectively,with relative high resistance to penicillin G(24.70%),amoxicillin(39.59%),ceftriaxone(24.05%),meropenem(22.85%) and cefotaxime(19.89%),low resistance to quinolone antibiotics(<10.00%),and no resistance to vancomycin and linezolid.Conclusion The major age group of children with Spn infection is infants under one year old in Guangzhou,clinicians should be serious about the high resistant rate of Spn to erythromycin,tetracycline and sulfamethoxazole,the significantly increased resistant rate to penicillin,amoxicillin and ceftriaxone.Clinicians should choose antibiotics rationally according to the characteristics of drug sensitivity for better treatment.

Objective To observe the efficacy of multifactor intensive nursing intervention on chronic heart failure patients with outside hospital treatment,including self-management ability and related clinical indicators.Methods By application of prospective study,a total of 215 patients with chronic heart failure discharged from hospital were randomized into the usual care group (105 cases) and the intensive nursing intervention group (1 10 cases).Patients were followed up for 12 months,and 205 patients completed the follow-up.The usual care group only received conventional outpatient follow-up,the intensive intervention group patients received telephone counseling,more detailed clinical follow-up and regular health education.The intervention effect was compared between two groups.Results Compared with the usual care group,the passing rate of sodium/water limit and daily monitoring of weight was higher in the intensive intervention group.Left ventricular ejection fraction and six-minute walking test were better in the intensive intervention group,while the level of NT-pro-BNP was lower in the intensive intervention group.Compared with the usual care group,re-hospitalization rate and incidence of cardiovascular events were lower in the intensive intervention group.Conclusions Multifactor intensive nursing intervention is helpful on improving self-management ability,alleviate cardiac function,reduce re-hospitalization rate and incidence of cardiovascular events for chronic heart failure patients.

Objective To observe the expression of the polysialic acid neural cell adhesion molecule ( PSA-NCAM) in the hippocampus of rats after exposure to low intensity ( 16 Hz,90 dB) infrasound for different periods.Methods One hundred and twenty male Sprague-Dawley rats were randomly divided into infrasound exposure and normal groups.The exposure group was tjem further divided into 1 day,7 days,14 days and 21 days exposure groups.After exposure,the rats' brains were removed and an immunohistochemical technique was used to observe the expression of PSA-NCAM in the hippocampus after 1,7,14 or 21 days of exposure. Methods The expression of PSA-NCAM had increased significantly after exposure for 7 days. It peaked at 14 days,then had decreased by 21 days,but always remaining higher than in the normal group.After the infrasound exposure had ended,the expression of PSA-NCAM demonstrated a tendency of decrease over time,and the least was on the 21st day.The largest decrease was observed in the 14 days exposure groups. Conclusion 16 Hz,90 dB infrasound can increase the expression of PSA-NCAM in the hippocampus,at least in rats.This suggests that low intensity infrasound might initiate recovery of an injured central nervous system.Migration of neural stem cells may aid in the repair of neural injuries resulted from infrasound exposure.