BACKGROUND:The anatomical morphology of the distal end of humerus is an important factor for restricting the treatment of fracture at the site, also for designing and improving of internal fixator and prosthesis. It is very significant to determine the anatomical parameters of the distal end of humerus for correcting the deformation, fixation of internal fixator and replacement of prosthesis.OBJECTIVE: To measure 17 anatomical parameters of the angles and structural width or depth related to the distal end of the humerus, verify their fitness with bone after implantations of internal fixator and prosthesis, and identify the association between the characteristics and the mechanical properties of the internal fixator and prosthesis.DESIGN: A repetitive measurement and comparative observation.SETTING: Affiliated Hospital of Nantong University.MATERIALS: The experiments were carried out in the Trauma Research Room, Affiliated Hospital of Nantong University from October 2005 to February 2006. Fifty-four pairs of humerus samples from adult antisepsis corpses were randomly selected (provided by the Department of Human Anatomy, Medical College of Nantong University), including 30 pairs from males and 24 pairs from females, while those with deformation and degeneration of elbow joint were excluded. METHODS: The soft tissues adhered to the humerus samples were all rejected, and the anatomical parameters of the distal end of humerus were measured with slide gaud (0.01 mm in precision, produced by Shanghai Measuring and Cutting Tool Works), calipers and goniometer. ① Measurement of angles related to the distal end of humerus: The measured parameters included the anteverted angle of the distal humerus, the lateral rotation angle of humerus trochlea,the anteverted angulation of humerus capitulum, the anteverted angulation of humerus trochlea, the condyle-shaft angle of humerus, and the internal rotation angle of the line of lateral-medial humerus epicondyle. ② Measurement of structural width and depth related to the distal end of humerus: The measured parameters included the horizontal diameter of the anterior end of humerus trochlea, the horizontal diameter of the inferior end of humerus trochlea, the sagittal diameter of humerus trochlea, the width between medial epicondyle and external epicondyle, the width between medial trochlea and lateral capitulum, the width of olecranon fossa, the depth of olecranon fossa, the width of medial epicondyle, the depth of sulcus for ulnar nerve, the width of humerus capitulum, and the sagittal diameter of humerus capitulum..MAIN OUTCOME MEASURES: Results of the angles and structural width or depth related to the distal end of the humerus.males and females in the anteverted angle of the distal humerus [(35.62±5.21)°, (96.22±5.29)°], the lateral rotation angle of humerus trochlea [(5.22±1.15)°, (5.46±1.33)°], the anteverted angulation of humerus capitulum [(48.35±8.78)°,(49.65±9.12)°], the anteverted angulation of humerus trochlea [(33.08±7.15)°, (34.45±7.52)°], the condyle-shaft angle of humerus [(80.12±5.22)°, (80.17±5.45)°], and the internal rotation angle of the line of lateral-medial humerus humerus: There were no significant differences between males and females in the horizontal diameter of the anterior end of humerus trochlea [(21.40±4.21), (21.12±4.34) mm], the horizontal diameter of the inferior end of humerus trochlea [(23.54±4.52), (23.31±4.43) mm], the sagittal diameter of humerus trochlea [(23.91 ±4.85), (23.55±4.63) mm], the width between medial epicondyle and external epicondyle [(58.23±6.44), (55.32±6.55) mm], the width between medial trochlea and lateral capitulum [(45.36±5.21), (42.15±5.03) mm], the width of olecranon fossa [(24.56±4.25), (25.34±4.42) mm],the depth of olecranon fossa [(13.43±2.52), (12.95±2.13) mm], the width of medial epicondyle [(14.35±3.32), (13.02±2.96) mm], the depth of sulcus for ulnar nerve [(8.53±2.96), (7.90±2.54) mm], the width of humerus capitulum [(18.05±2.87), (16.51±2.75) mm], and the sagittal diameter of humerus capitulum [(19.59±3.84), (19.12±3.55) mm] (P＞0.05).CONCLUSION: The anatomical parameters of the distal end of humerus should be considered in performing correction of elbow joint, internal fixation and prosthesis replacement in order to get better recovery of elbow joint function.

Objective To investigate the feasibility of macrophages as cell carriers to deliver floate modified oxygen loaded ultrasound contrast agent . Methods The phagocytic activity of macrophages was analyzed by ink phagocytose test , and the expression of folate recepters ( FRs ) on macrophages cell membrane surface was tested by immunofluofluorescence assay . Oxygen/paclitaxel loaded lipid microbubbles( OPLMB) and folate‐targeted OPLMB ( TOPLMB) were synthesized by mechanical shock method and incubated with macrophages in vitro . According to different treatment conditions ,the cells were divided into three groups:group A ( OPLMB) ,group B ( free folic acid + TOPLMB) and group C ( TOPLMB) , the fluorescence intensity of the cells were observed under fluorescence microscope ,and the phagocytic percentage and the phagocytic index of macrophages uptake OPLMB and TOPLMB were observed by bright field microscope . Results The phagocytic percentage of macrophages phagocytose ink was (99 .3 ± 1 .0)% ,FRs was highly expressed on macrophages cultured in vitro . After incubation for 30 minutes ,the fluorescence intensity of group C was significantly higher than those of A and B ,the phagocytic percentage in three groups were (19 .5 ± 0 .2)% ,(21 .0 ± 0 .2)% and (81 .2 ± 10 .0)% respetively . The phagocytic percentage of group C were significantly higher than those in group A and group B ( P <0 .05) . Conclusions Macrophages cultured in vitro possess highly phagocytic activity and these cells highly express FRs ,and can be used as cell carriers to deliver floate modified oxygen loaded multimodality ultrasound contrast agent .

OBJECTIVE To learn the common proto col deviation （PD）in the process of drug clinical trials and discuss the methods and precautions for preventing and reducing PD so as to provide reference for the standardization of drug clinical trials. METHODS According to Good Clinical Practice ，Notice on Issuing Guidelines for Planning and Reporting of Data Management and Statistical Analysis of Drug Clinical Trials ，Guidelines for Ethical Review of Drug Clinical Trials ，ICH E 3，ICH E 6（R2）and other regulations ，the PD reported in the relevant projects managed by the author from March 2017 to February 2022，as well as the PD found in the submission materials and project quality control ，were sorted out and statistically analyzed. RESULTS & CONCLUSIONS A total of 39 drug clinical trials were included ，and 212 subjects were selected. In all projects ，258 PDs were reported，including 28 major PD （accounting for 10.85％）and 230 ordinary PD （accounting for 89.15％）. The report of PD mainly included missed inspections/tests （93 reports，accounting for 36.05％），lack of visits （36 reports，accounting for 13.95％）， inspection/testing out-of-window （29 reports，accounting for 11.24％），dosage and usage of test drugs （28 reports，accounting for 10.85％），drug over-temperature/missing temperature （21 reports，accounting for 8.14％），etc. Avoiding and reducing the occurrence of PD requires the efforts of multiple parties ：the sponsor designs a reasonable protocol with appropriate interview rate and window period after listening to the opinions of multiple parties ；the investigators and clinical research coordinator should strengthen their own learning and training ，and be familiar with the protocol ，Good Clinical Practice and corresponding regulations；the compliance education of the subjects should be strengthened ；the institutional offices and ethics committees should conduct multi-angle and whole-process supervision and management when a drug clinical trial is approved ，in progress ，and jsyj- concluded，to ensure the safety rights and interests of the zdcxX0079） subjects and the quality of clinical trials. On this basis ，all parties should communicate effectively and timely ，report PD in time ，and conduct special studies on major PD that have com occurred and key links that are prone to PD.

OBJECTIVE To provide a reference for improving the relevant standard operating procedures （SOP） and biological sample management in drug clinical trials. METHODS According to Good Clinical Practice， Data On-site Verification Points of Drugs Clinical Trials， Human Genetic Resources Management Regulations Implementation Rules， Qualification Examination Rules of Drug Clinical Trials Institution， based on the experience of managing clinical trials programs， the irregularities in biological samples management were analyzed by using statistical quality control tables and protocol deviation （PD） reported by sponsors， in the context of the quality control of drug clinical trials projects managed by the author from July 2016 to May 2023. The precautions in various aspects of sample management were put forward. RESULTS & CONCLUSIONS A total of 101 biospecimen- related irregularities were found in the 60 drug clinical trials projects. Biological sample collection， preservation， and handling were the aspects with the highest incidence of irregular operations in biological sample management， accounting for 37.62%， 25.74%， and 21.78%， respectively. Regulating the management of biospecimens requires multiple efforts. The institutional office and the ethics committee carefully reviewed the consistency of the protocols， informed consent， and genetic office application involving biospecimen collection and handling when the project was initiated. Institutional office quality controllers should pay attention to the attendance and training of authorized personnel at project initiation. The principal investigator， research nurse， collector， handler， transporter， relevant personnel of the central laboratory， and institutional office quality controller have their roles during the project implementation phase. On this basis， all parties involved in the management of biological samples should do a good job of effective communication， find problems and report them in time， and conduct special studies on key aspects.