Objective To sort out the management system of clinical trial drugs in our hospital,and analyze the construction and practical experience of the information system in the whole process management of clinical trial drugs,and to further improve the efficiency and quality of clinical trials.Methods Based on the original management of clinical trial drugs,an information system in line with the situation of our hospital was applied to manage the whole process of clinical trial drugs.Results Compared with the traditional management,the information system can automatically record the data of inbound and outbound storage,distribution,retrieval and return of trial drugs in real time,pre-review the prescriptions and randomized documents of clinical trial drugs,and realise paperless office.Conclusions The information system can ensure the safety,accuracy and traceability of the data of drugs used in clinical trial.The system can also save resources,improve the efficiency and quality of clinical trial management.

The randomized controlled trials (RCTs) regarding acupuncture direction published from January 1st, 2013, to November 7th, 2023 were searched in China National Knowledge Infrastructure (CNKI), Wanfang Data Knowledge Service Platform, and VIP Chinese Journal Database. As a result, 21 RCTs were included. The problems identified included conceptual misunderstandings regarding acupuncture direction, incomplete selection strategies, confounding research factors, and inaccuracies in reporting. Based on the findings, four strategic approaches for enhancing therapeutic efficacy through acupuncture direction were summarized: aligning needle direction with the meridian pathway, directing the needle toward the lesion site, orienting the needle toward adjacent acupoints, and targeting special anatomical structures. Two additional strategies were proposed for optimizing the procedure: simplifying acupuncture operations and directing the needle toward safe anatomical sites. Recommendations were made to improve the rationality of research factor settings and the completeness of acupuncture operation reporting. Furthermore, three methods for reporting acupuncture direction were discussed: reporting the tip-pointed position, reporting the insertion angle and orientation, and reporting azimuth and polar angles, aiming to promote greater standardization and completeness in acupuncture practice and reporting.
Acupuncture Therapy/standards* ; Humans ; Acupuncture Points ; Randomized Controlled Trials as Topic ; Meridians

OBJECTIVE To explore the changes of microribonucleic acid(miR)-223,miR-155 and miR-125 in the neonates with sepsis and analyze the distribution of pathogens so as to provide bases for clinical diagnosis and treatment of neonates with sepsis.METHODS A total of 39 neonates with sepsis who were treated in Jinan Second Maternal and Child Health Hospital from May 2021 to May 2023 were enrolled in the study and were assigned as the study group,meanwhile,42 healthy neonates who were born in the hospital were chosen as the control group.The distribution and drug resistance of the pathogens isolated from the neonates of the study group were statistically analyzed.The relative expression levels of peripheral blood miR-223,miR-155 and miR-125 were com-pared between the two groups,and the values of the three indexes in diagnosis of neonatal sepsis were analyzed.RESULTS Totally 46 strains of pathogens were isolated from the 39 neonates with sepsis,20 of which were Escherichia coli,and 10 were Staphylococcus aureus.The E.coli strains were resistant to ampicillin,tetra-cycline,ciprofloxacin and cefazolin;the S.aureus strains were resistant to penicillin,erythromycin,cefazolin and clindamycin,with the drug resistance rates higher than 50％.The expression level of miR-223 of the study group was 2.13±0.70,higher than that of the control group,the expression level of miR-125 of the study group was 0.92±0.30,higher than that of the control group;while the expression level of miR-155 of the study group was 2.08±0.68,lower than that of the control group(P＜0.05).The area under the curve(AUC)of the joint detec-tion of miR-223,miR-155 and miR-125 was 0.945 in diagnosis of neonatal sepsis,with the sensitivity 92.31％,the specificity 88.10％.CONCLUSIONS E.coli and S.aureus are dominant among the pathogens isolated from the neonates with sepsis.The neonates with sepsis show abnormal expressions of peripheral blood miR-223,miR-155 and miR-125,and the joint detection of the three indexes has high value in diagnosis of neonatal sepsis.

The new era imposes heightened demands on medical professionals,who must not only possess a solid theoretical foundation but also exhibit strong practical skills and innovative capabilities.The quality of medical func-tional laboratory construction is crucial for cultivating high-caliber medical talents.In light of the current developmental status and trends regarding functional experiment teaching within Chinese higher education institutions,particularly the disparities in development across various regions and institutions,the Functional Experiment Teaching Committee of the Chinese Pathophysiology Society has developed an expert consensus on laboratory construction standards.This consensus was established through comprehensive investigations,research,and extensive discussions to provide a reference for di-verse institutions to continuously enhance their levels of laboratory construction.

OBJECTIVE To explore the changes of microribonucleic acid(miR)-223,miR-155 and miR-125 in the neonates with sepsis and analyze the distribution of pathogens so as to provide bases for clinical diagnosis and treatment of neonates with sepsis.METHODS A total of 39 neonates with sepsis who were treated in Jinan Second Maternal and Child Health Hospital from May 2021 to May 2023 were enrolled in the study and were assigned as the study group,meanwhile,42 healthy neonates who were born in the hospital were chosen as the control group.The distribution and drug resistance of the pathogens isolated from the neonates of the study group were statistically analyzed.The relative expression levels of peripheral blood miR-223,miR-155 and miR-125 were com-pared between the two groups,and the values of the three indexes in diagnosis of neonatal sepsis were analyzed.RESULTS Totally 46 strains of pathogens were isolated from the 39 neonates with sepsis,20 of which were Escherichia coli,and 10 were Staphylococcus aureus.The E.coli strains were resistant to ampicillin,tetra-cycline,ciprofloxacin and cefazolin;the S.aureus strains were resistant to penicillin,erythromycin,cefazolin and clindamycin,with the drug resistance rates higher than 50％.The expression level of miR-223 of the study group was 2.13±0.70,higher than that of the control group,the expression level of miR-125 of the study group was 0.92±0.30,higher than that of the control group;while the expression level of miR-155 of the study group was 2.08±0.68,lower than that of the control group(P＜0.05).The area under the curve(AUC)of the joint detec-tion of miR-223,miR-155 and miR-125 was 0.945 in diagnosis of neonatal sepsis,with the sensitivity 92.31％,the specificity 88.10％.CONCLUSIONS E.coli and S.aureus are dominant among the pathogens isolated from the neonates with sepsis.The neonates with sepsis show abnormal expressions of peripheral blood miR-223,miR-155 and miR-125,and the joint detection of the three indexes has high value in diagnosis of neonatal sepsis.

The new era imposes heightened demands on medical professionals,who must not only possess a solid theoretical foundation but also exhibit strong practical skills and innovative capabilities.The quality of medical func-tional laboratory construction is crucial for cultivating high-caliber medical talents.In light of the current developmental status and trends regarding functional experiment teaching within Chinese higher education institutions,particularly the disparities in development across various regions and institutions,the Functional Experiment Teaching Committee of the Chinese Pathophysiology Society has developed an expert consensus on laboratory construction standards.This consensus was established through comprehensive investigations,research,and extensive discussions to provide a reference for di-verse institutions to continuously enhance their levels of laboratory construction.

Objective To sort out the management system of clinical trial drugs in our hospital,and analyze the construction and practical experience of the information system in the whole process management of clinical trial drugs,and to further improve the efficiency and quality of clinical trials.Methods Based on the original management of clinical trial drugs,an information system in line with the situation of our hospital was applied to manage the whole process of clinical trial drugs.Results Compared with the traditional management,the information system can automatically record the data of inbound and outbound storage,distribution,retrieval and return of trial drugs in real time,pre-review the prescriptions and randomized documents of clinical trial drugs,and realise paperless office.Conclusions The information system can ensure the safety,accuracy and traceability of the data of drugs used in clinical trial.The system can also save resources,improve the efficiency and quality of clinical trial management.

Objective:To investigate the effects of wza gene deletion in Klebsiella pneumoniae on capsule formation ability and bacteriophage sensitivity. Methods:The wza deletion mutant strain was constructed through a temperature-sensitive plasmid-mediated homologous recombination. The growth curves of W14 and Δ wza were detected by measuring the optical density OD 600. In order to analyze the effect of gene wza on bacterial capsule formation, wild-type strain W14 and Δ wza mutant strain were detected by transmission electron microscope, and their capsule contents were measured by quantifying the uronic acid contents. The plaque assay was used to detect bacterial sensitivity to bacteriophage in wild-type strain W14 and Δ wza mutant strain. The t test was used to compare whether there were differences in the contents of uronic acid in the capsules of wild-type strain W14 and Δ wza mutant strain. Results:The PCR results revealed that the Δ wza mutant strain was successfully constructed. Compared with wild-type strain W14, the growth curves of Δ wza on the solid plates demonstrated a slightly slower growth. However, no difference in growth was observed among wild-type strain W14 and Δ wza mutant strains in LB broth. The transmission electron microscope results showed that wza gene deletion resulted in the loss of capsule in bacteria. The uronic acid content assay suggested that the capsule content was significantly decreased in Δ wza mutant strain (45.963±2.795) μg/ml compared with wild-type strain W14 (138.800±5.201) μg/ml. There was a statistical difference between the two groups ( t=27.233, P<0.001). The plaque assay indicated that bacteria lost its sensitivity to bacteriophage when gene wza was deleted. Conclusion:Deletion of the wza gene impairs bacterial capsule formation ability and can affect bacterial sensitivity to bacteriophage phiW14.

Objective:To express and purify the phage depolymerase from hypervirulent Klebsiella pneumoniae (hv Kp) serotype K1 and validate its function. Methods:Phage that infected serotype K1-type hv Kp was isolated from hospital sewage. The biology and morphology of the phage were determined by plaque assay and transmission electron microscopy. The whole genome of the phage was sequenced by the Illumina HiSeq 2500 platform. The presence of depolymerase was determined by observing the plaque halo. Bioinformatic analysis and prokaryotic protein expression system were further used to predict and identify phage depolymerase. The depolymerase gene fragment was obtained by PCR and cloned into the pET28a expression vector, and the expression and purification of the depolymerase were completed in strain BL21. The depolymerase activities on the capsular polysaccharide of serotype K1-type hv Kp clinical isolates were detected by plaque assay and low-speed centrifugation assay. Results:A lytic phage (phiA2) that infected serotype K1-type hv Kp clinical isolate was isolated from hospital sewage. It was typical of the Caudovirales order and Autographiviridae family, and its whole genome was 43 526 bp in length and contained 51 coding domain sequences. The phage phiA2-derived depolymerase phiA2-dep was predicted, expressed and purified. The plaque assay and low-speed centrifugation assay indicated that the depolymerase phiA2-dep had good lytic activity on the capsular polysaccharide of serotype K1-type hv Kp clinical isolates. Conclusion:Depolymerase phiA2-dep can specifically degrade the capsular polysaccharide of serotype K1-type hv Kp, which has potential application value in treating bacterial infection.

Objective To evaluate the efficacy of a modified sericin hydrogel scaffold loaded with dexamethasone(SMH-CD/DEX)scaffold for promoting bone defect healing by stimulating anti-inflammatory macrophage polarization.Methods The light-curable SMH-CD/DEX scaffold was prepared using dexamethasone-loaded NH2-β-cyclodextrin(NH2-β-CD)and sericin hydrogel and characterized by scanning electron microscopy(SEM),Fourier transform infrared spectroscopy(FTIR),biocompatibility assessment and drug release test.THP-1 macrophages incubated with the scaffold were examined for protein expressions of iNOS and Arg-1,mRNA expressions of IL-6,Il-10,Arg-1 and iNOS,and surface markers CD86 and CD206 using Western blotting,RT-qPCR,and flow cytometry.In a co-culture system of human periodontal ligament stem cells(HPDLSCs)and THP-1 macrophages,the osteogenic ability of the stem cells incubated with the scaffold was evaluated by detecting protein expressions of COL1A1 and Runx2 and expressions of ALP,Runx2,OCN and BMP2 mRNA,ALP staining,and alizarin red staining.In a rat model of mandibular bone defect,the osteogenic effect of the scaffold was assessed by observing bone regeneration using micro-CT and histopathological staining.Results In THP-1 macrophages,incubation with SMH-CD/DEX scaffold significantly enhanced protein expressions of Arg-1 and mRNA expressions of IL-10 and Arg-1 and lowered iNOS protein expression and IL-6 and iNOS mRNA expressions.In the co-culture system,SMH-CD/DEX effectively increased the protein expressions of COL1A1 and Runx2 and mRNA expressions of ALP and BMP2 in HPDLSCs and promoted their osteogenic differentiation.In the rat models,implantation of SMH-CD/DEX scaffold significantly promoted bone repair and bone regeneration in the bone defect.Conclusion The SMH-CD/DEX scaffold capable of sustained dexamethasone release promotes osteogenic differentiation of stem cells and bone defect repair in rats by regulating M2 polarization.