According the Good Clinical Practice(GCP)and programmatic requirements,we analyze the management characteristics and the costs of drugs for clinical trials in different specialties from the drug management;The characteristics of the management of drugs for different specialties was summarize and the differential factors that may affect the management cost was explored,so as to provide theoretical support for the research institutions to utilize the resources in a rational and efficient way.This article provides a guarantee for the drug management with the aim of enhancing the quality and efficiency of clinical trials.

Objective This study aims to discuss and summarize the management system for drugs used in clinical trials,with the objective of elevating the management standards.Methods Considering the situation of diverse departmental needs and the multi-campus structure,the study analyzed and explored the management of drugs for clinical trials to build a corresponding management system,including pharmacy construction,equipment,personnel qualifications,data management,drug reception,storage,distribution,and recycling protocols.The effecttivness of the system was evaluated through comparative analysis of data from 2022 to 2023 at our hospital.Result Improvements in the management of drugs for clinical trials were observed in 2023 across varous aspects.Conclusion Refining the management system of drugs for clinical trials can enhance Good Clinical Practice(GCP)supervision and service,providing an important reference for the management system.

Objective This study aims to develop a guideline for assessing and maintaining intrinsic capacity in older adults,offer recommendations to professionals regarding these assessments,and encourage the implementation of evidence-based clinical practices across various settings,including communities,hospitals,nursing homes,and other geriatric care environments.Methods An evidence-based approach guided the collection of questions through a lit-erature review.Preliminary recommendations were developed through a systematic search of domestic and interna-tional guideline networks,professional association websites,and comprehensive databases.Subsequently,the recom-mendations were revised,and the consensus was achieved through a round of expert consensus meetings and 3 rounds of expert correspondence,culminating in the formation of the guidelines.Results The developed guideline encompasses 2 aspects and 5 dimensions of assessment and maintenance,comprising a total of 28 questions and 39 recommendations.Specifically,6 questions and 9 recommendations were formulated for the cognitive dimension,5 questions and 7 recommendations for the locomotion dimension,6 questions and 7 recommendations for the vitality dimension,6 questions and 9 recommendations for the psychological dimension,and 5 questions and 7 recommenda-tions for the sensory dimension.Among these,34 are classified as strong recommendations,while 5 are categorized as weak recommendations.Conclusion The guideline offers scientifically robust,acceptable,and comprehensible rec-ommendations that equip the professionals with a foundation for decision-making aiming at preserving the intrinsic capacity of older adults.

According the Good Clinical Practice(GCP)and programmatic requirements,we analyze the management characteristics and the costs of drugs for clinical trials in different specialties from the drug management;The characteristics of the management of drugs for different specialties was summarize and the differential factors that may affect the management cost was explored,so as to provide theoretical support for the research institutions to utilize the resources in a rational and efficient way.This article provides a guarantee for the drug management with the aim of enhancing the quality and efficiency of clinical trials.

Objective This study aims to develop a guideline for assessing and maintaining intrinsic capacity in older adults,offer recommendations to professionals regarding these assessments,and encourage the implementation of evidence-based clinical practices across various settings,including communities,hospitals,nursing homes,and other geriatric care environments.Methods An evidence-based approach guided the collection of questions through a lit-erature review.Preliminary recommendations were developed through a systematic search of domestic and interna-tional guideline networks,professional association websites,and comprehensive databases.Subsequently,the recom-mendations were revised,and the consensus was achieved through a round of expert consensus meetings and 3 rounds of expert correspondence,culminating in the formation of the guidelines.Results The developed guideline encompasses 2 aspects and 5 dimensions of assessment and maintenance,comprising a total of 28 questions and 39 recommendations.Specifically,6 questions and 9 recommendations were formulated for the cognitive dimension,5 questions and 7 recommendations for the locomotion dimension,6 questions and 7 recommendations for the vitality dimension,6 questions and 9 recommendations for the psychological dimension,and 5 questions and 7 recommenda-tions for the sensory dimension.Among these,34 are classified as strong recommendations,while 5 are categorized as weak recommendations.Conclusion The guideline offers scientifically robust,acceptable,and comprehensible rec-ommendations that equip the professionals with a foundation for decision-making aiming at preserving the intrinsic capacity of older adults.

Objective This study aims to discuss and summarize the management system for drugs used in clinical trials,with the objective of elevating the management standards.Methods Considering the situation of diverse departmental needs and the multi-campus structure,the study analyzed and explored the management of drugs for clinical trials to build a corresponding management system,including pharmacy construction,equipment,personnel qualifications,data management,drug reception,storage,distribution,and recycling protocols.The effecttivness of the system was evaluated through comparative analysis of data from 2022 to 2023 at our hospital.Result Improvements in the management of drugs for clinical trials were observed in 2023 across varous aspects.Conclusion Refining the management system of drugs for clinical trials can enhance Good Clinical Practice(GCP)supervision and service,providing an important reference for the management system.

Objective To explore the correlation between exponential apparent diffusion coefficient(eADC)value before radical hysterectomy and postoperative clinical results in patients with International Federation of Gynecology and Obstetrics(FIGO)stageⅠ/Ⅱ cervical cancer,and to find MR quantitative indicators for predicting the prognosis of patients with early stage cervical cancer.Methods Patients with FIGO stage Ⅰ/Ⅱ cervical cancer who underwent surgical treatment were retrospectively collected.All patients underwent MRI plain scan and diffusion weighted imaging(DWI)scan before surgery.Baseline parameters included age,menopause,stage,tumor size,pathological differentiation and type,lymph node involvement,and postoperative adjuvant therapy.MR parameters included mean apparent diffusion coefficient(ADCmean),normalized apparent diffusion coefficient(nADC),eADC,SIDWI,and SIT2.Baseline and MRI parameters associated with recurrence were determined by Cox regression analysis.Results The progression-free survival(PFS)in the low eADC group was longer than that in the high eADC group(P=0.010).Univariate analysis showed that ADC,nADC and eADC were associated with recurrence(P<0.05).In multivariate analysis,only eADC[hazard ratio(HR)3.610;95%confidence interval(CI)1.467-8.886;P=0.005]was associated with recurrence.Conclusion Preoperative eADC is associated with PFS in patients with surgically treated FIGO stage Ⅰ/Ⅱ cervical cancer and is helpful in evaluating the prognosis of patients with cervical cancer.

Objective To establish an analytical method of LC-MS/MS based on micro-segmentation analysis of multiple hairs,verify the detection of 20 benzodiazepines in 1mm hair,and finally use it for case detection analysis.Methods 5 hairs were cut into 1mm long segments each,and the corresponding segments were immersed and sonicated in an extract containing dithiothreitol,methanol,etc.Mobile phase A was 0.1%formic acid in water,and mobile phase B was acetonitrile.Data were collected using electrospray ion source positive ion mode in multiple reaction monitoring mode.Results The 20 benzodiazepines in multiple hairs had a good linear relationship(r>0.99),detection limit of 0.2～5 pg/mm,minimum quantification limit of 0.5 to 20 pg/mm,the intro-day and inter-day precisions of 2.03%to 13.81%,the intro-day and inter-day accuracies of 87.98%～111.29%,matrix effect of 71.15%～110.43%,and extraction recovery of 69.34%to 99.94%.Using this method,hair samples were analyzed in volunteers taking a single dose of clonazepam for 20 days,and the detected location of clonazepam in 15 hairs was located in segment 6～11 from the hair root,with the concentration range of 1.06～3.45 pg/mm.By this method,the hair of the victims suspected of having taken sleeping pills in the case was analyzed.In 15 hairs,clonazepam was detected in segments 9～13 of the hair root.The quantitative results were 1.07～19.06 pg/mm.The experimental results were basically consistent with the medication time of the victim.Conclusion The micro-segmentation analysis technique of multiple hairs can be applied to the investigation of drug-assisted crime cases,and can roughly estimate the medication time.

Objective To establish an analytical method of LC-MS/MS based on micro-segmentation analysis of multiple hairs,verify the detection of 20 benzodiazepines in 1mm hair,and finally use it for case detection analysis.Methods 5 hairs were cut into 1mm long segments each,and the corresponding segments were immersed and sonicated in an extract containing dithiothreitol,methanol,etc.Mobile phase A was 0.1%formic acid in water,and mobile phase B was acetonitrile.Data were collected using electrospray ion source positive ion mode in multiple reaction monitoring mode.Results The 20 benzodiazepines in multiple hairs had a good linear relationship(r>0.99),detection limit of 0.2～5 pg/mm,minimum quantification limit of 0.5 to 20 pg/mm,the intro-day and inter-day precisions of 2.03%to 13.81%,the intro-day and inter-day accuracies of 87.98%～111.29%,matrix effect of 71.15%～110.43%,and extraction recovery of 69.34%to 99.94%.Using this method,hair samples were analyzed in volunteers taking a single dose of clonazepam for 20 days,and the detected location of clonazepam in 15 hairs was located in segment 6～11 from the hair root,with the concentration range of 1.06～3.45 pg/mm.By this method,the hair of the victims suspected of having taken sleeping pills in the case was analyzed.In 15 hairs,clonazepam was detected in segments 9～13 of the hair root.The quantitative results were 1.07～19.06 pg/mm.The experimental results were basically consistent with the medication time of the victim.Conclusion The micro-segmentation analysis technique of multiple hairs can be applied to the investigation of drug-assisted crime cases,and can roughly estimate the medication time.

Objective:To investigate the relationship between caspase recruitment domain protein 9 (CARD9) gene polymorphism and acute pancreatitis (AP) and the clinical efficacy of somatostatin.Methods:A total of 86 patients with AP treated in Shanghai Songjiang District Central Hospital from June 2019 to may 2020 were selected as the research object, and 81 healthy volunteers were selected as the control group for a prospective cohort study. The nucleotide database of National Center for Biotechnology Information (NCBI) was consulted to screen 10 common single nucleotide polymorphisms of CARD9.The single nucleotide polymorphism of CARD9 was detected by SNapShot micro sequencing. All patients with AP were treated with somatostatin. The relationship between CARD9 single nucleotide polymorphism and clinical symptoms and auxiliary examination indexes was observed.The measurement data of normal distribution were compared by independent sample t-test. The measurement data of non normal distribution are represented by M (Q1, Q3), and the rank sum test is used for comparison between groups. The comparison of counting data between groups was adopted χ 2 inspection. Results:The frequency of CARD9 rs10870077 C>G SNP in patients of AP group was significantly higher than that in healthy controls ( OR=1.934, 95% CI=1.011-3.700, P=0.046). Compared with CC genotype, the disappearance time of abdominal pain and abdominal distension in the somatostatin treatment group of CARD9 rs10870077 C>G moderate and severe AP patients was significantly longer ((5.64±2.06) d and (3.76±1.23) d, t=2.98, P=0.006), and the average hospital stay in the somatostatin treatment group of CARD9 rs10870077 C>G severe AP patients was increased by ((13.25±5.31) d and (9.00±3.68) d, t=1.51, P=0.170). Conclusion:CARD9 rs10870077 C>G is a predisposing factor for AP, which is related to the individual differences in the clinical efficacy of somatostatin in severe AP.