The relevant laws and regulations regarding the utilization of the deceased as medical research subjects are not yet fully developed in China nowadays. Taking the deceased as research subjects as a starting point， this paper discussed the definition of the deceased and the scope of their interest protection from multiple perspectives. It posited that the scope of interest protection for the deceased encompassed two components： spiritual personality interests and material personality interests represented by the remains. The spiritual personality interests of the deceased included identification information such as name， portrait， reputation， honor， privacy， and personal information， as well as medical and health information. The personal information of the deceased was not directly affected by the individual’s life and death status and remained relatively independent. In terms of ethical review， the research team approached from two perspectives： the remains and the personal information of the deceased. Based on the standard of whether the research subjects involve a human body， research with the remains of the deceased as the medical research subjects was classified as non-clinical research. According to the standard of whether a human body is clinically operated， research with the personal information of the deceased （including medical and health information） as the medical research subjects was recognized as clinical research without human research operation. This approach provided evidence for the application of existing laws and regulations in ethical review and record management. The ethical review of investigator-initiated clinical research conducted in medical and health institutions， as well as the regulatory conditions for exemption from ethical review， were examined. The forms， content， and acquisition of informed consent were summarized， and the risk-benefit characteristics of the research activity were evaluated， with a view to providing a basis for the smooth and compliant implementation of research activities involving the deceased as medical research subjects.

Objective:To correlate the expression of interleukin-6 (IL-6), CD40 ligand (CD40L), and soluble triggering receptor expressed on myeloid cells 1 (sTREM-1) with regulatory T lymphocyte (Treg)/helper T lymphocyte 17 (Th17) in children with immune thrombocytopenic purpura (ITP) and to assess their combined diagnostic value.Methods:A retrospective study was conducted involving 80 children with ITP (ITP group) and 80 healthy children undergoing routine health screenings (control group) at Jinhua Central Hospital from February 2023 to February 2024. The levels of IL-6, CD40L, and sTREM-1, along with the Treg/Th17 ratio, were compared between the two groups and among children with different degrees of ITP severity. The correlations between IL-6, CD40L, and sTREM-1 and the severity of ITP, as well as the Treg/Th17 ratio were analyzed. Additionally, the diagnostic value of the combined tests was evaluated.Results:The levels of IL-6, CD40L, and sTREM-1 in the ITP group were (46.53 ± 8.69) ng/L, (6.51 ± 1.51), and (18.76 ± 3.72) ng/L, respectively. These values in the ITP group were significantly higher than those in the control group [(11.72 ± 1.58) ng/L, (4.31 ± 1.25), (8.07 ± 1.34) ng/L, t = 35.25, 10.04, 24.18, all P < 0.001]. The Treg/Th17 ratio in the ITP group was (1.34 ± 0.41), which was significantly lower than that in the control group [(13.56 ± 2.87), t = 37.70, P < 0.001]. In children with severe ITP, the levels of IL-6, CD40L, and sTREM-1 were (56.39 ± 11.70) ng/L, (9.62 ± 1.78), and (24.72 ± 4.81) ng/L, respectively. For those with moderate ITP, the levels were (45.41 ± 8.27) ng/L, (6.38 ± 1.40), and (17.69 ± 3.56) ng/L, respectively. In children with mild ITP, the levels were (37.04 ± 6.32) ng/L, (5.11 ± 1.32), and (14.50 ± 3.04) ng/L. The Treg/Th17 ratio in children with mild ITP was (0.95 ± 0.26), which was significantly lower than that in the moderate (1.37 ± 0.40) and severe (2.88 ± 0.56) groups. All differences were statistically significant among the three groups ( F = 23.98, 42.57, 37.15, 122.23, all P < 0.001). The levels of IL-6, CD40L, and sTREM-1 were positively correlated with the severity of ITP ( r = 0.565, 0.542, 0.538) and negatively correlated with the Treg/Th17 ratio ( r = -0.572, -0.536, -0.532), with all correlations being statistically significant (all P < 0.001). The receiver operating characteristic curve analysis indicated that the area under the curve values for the individual diagnoses of IL-6, CD40L, and sTREM-1 were 0.779, 0.750, and 0.763, respectively. In contrast, the area under the curve value for the combined diagnosis was 0.951, which was greater than that for each individual marker ( Z = 1.924, 2.137, 2.015, P = 0.037, 0.026, 0.031). Conclusions:The levels of IL-6, CD40L, and sTREM-1 in children with ITP are substantially correlated with the severity of ITP and the Treg/Th17 ratio, demonstrating notable diagnostic efficacy for ITP. Notably, the combination of IL-6, CD40L, and sTREM-1 greatly enhances diagnostic value.

Objective:To develop a formula correlating body weight and the insertion length of peripherally inserted central catheters (PICC) in very low birth weight infants (VLBWI) undergoing lower limb PICC placement, aiming to improve the success rate of one-time catheter placement.Methods:A prospective research method was adopted, 205 VLBWI patients who were hospitalized in the NICU of Shenzhen Maternal and Child Health Hospital from May 2023 to February 2024 and had indwelling PICC in the lower extremities were selected as the research subjects using the convenience sampling method. Data including gender, insertion vein, body weight on the day of catheterization, and the vertical distance from the puncture site to the first popliteal crease were collected. Pearson correlation analysis and linear regression analysis were used to construct a predictive formula for estimating the insertion length of PICC based on body weight. The Bland-Altman plot was applied to evaluate the consistency between the predicted insertion depth using the formula and the actual correct insertion length.Results:A total of 182 VLBWI were included in the study, comprising 102 male infants and 80 female infants. The catheterization sites were the right lower extremity in 166 cases and the left lower extremity in 16 cases. The body weight was (1.08 ± 0.26) kg. The vertical distance from the puncture site to the first popliteal crease was (5.58 ± 1.72) cm. The prediction formula for the length of lower extremity PICC catheterization was constructed through linear regression analysis: PICC insertion length = 8.013 + [5.194×body weight (kg)] ± vertical distance from the puncture site to the popliteal crease (cm). Consistency evaluation showed good agreement between the predicted insertion depth and the actual correct insertion length, with 95% of the measurement differences falling within the limits of agreement. The mean difference was 0.07 cm ( P > 0.05). Conclusions:The weight-based formula derived for VLBWI provides a basis for predicting the optimal insertion length of PICC in clinical practice.

BACKGROUND:At present,modern medical treatment has certain limitations on the treatment of knee osteoarthritis.Traditional Chinese medicine alkaloids can effectively prevent and treat knee osteoarthritis through various mechanisms. OBJECTIVE:To review the mechanism of alkaloids in traditional Chinese medicine in the prevention and treatment of knee osteoarthritis,providing a scientific basis for the clinical development of drugs for the treatment of knee osteoarthritis. METHODS:CNKI,WanFang,PubMed,Web of Science and Google Scholar were retrieved for relevant literature published from database inception to May 2024.The key words were"knee osteoarthritis""osteoarthritis""osteoclast""chondrocyte""alkaloids"in Chinese and English.Duplicates and obsolete non-referenced literature were excluded,and a total of 68 eligible papers were included for further review. RESULTS AND CONCLUSION:Although traditional Chinese medicine has a long history of treating knee osteoarthritis,only a small number of natural compounds are in the preclinical stage of research against knee osteoarthritis.Alkaloids have a greater potential for the prevention and treatment of knee osteoarthritis,among which,sophocarpidine,oxymatrine,sinomenine,and betaine have been shown to be effective in the prevention and treatment of knee osteoarthritis by modulating multiple signaling pathways.Alkaloids can delay the progression of knee osteoarthritis by inhibiting inflammatory response,exerting antioxidant response,inhibiting chondrocyte apoptosis,promoting chondrocyte proliferation,and inhibiting osteoclast formation and differentiation.

Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

Objective:To analyze changes of donor corneal endothelial cell density (ECD) and morphology from eye bank before and after keratolasty and the influencing factors.Methods:An observational case series study was performed.A total of 118 donor corneas, retrieved by the Shandong Province Eye Bank between July 2020 and June 2021 for penetrating keratoplasty (PKP) and endothelial keratoplasty (EK) were included.Among them, 99 corneas (83.90%) were used for PKP, and 19(16.10%) for EK.The basic information of donors and the results of corneal quality tests were analyzed and compared with ECD measured by endothelial microscopy one month after keratolasty.Morphological changes in endothelial cells before and after surgery were observed, and factors influencing corneal ECD and morphology were analyzed.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Shandong Eye Hospital (No.SDSYKYY20170319).Written informed consent was obtained from each subject.Results:Among the 99 donor corneas for PKP, there were statistically significant differences in preoperative donor corneal ECD and 1-month postoperative ECD of implant among different age groups ( F=18.136, 5.936; both P<0.01), which were lower in the 31-60-year-old group and the >60-year-old group than in the 0-30-year-old group and higher in the 31-60-year-old group than in the >60-year-old group, with statistically significant differences (all P<0.01).There were statistically significant differences in the preoperative donor corneal ECD among different donor cause of death groups ( F=4.524, P<0.01), which was higher in the traumatic accident group compared to the cardiovascular and cerebrovascular disease group, chronic organ failure group and malignant tumor group (all P<0.01).The preoperative donor ECD in the death-tissue retrieval time ≤6 hours group was (2 577.66±284.63)cells/mm 2, which was higher than (2 372.46±399.75)cells/mm 2 in the death-tissue retrieval time >6 hours group, with a statistically significant difference ( t=2.289, P<0.05).There were statistically significant differences in 1-month postoperative ECD among the preservation-surgery time ≤3 days, 3-6 days, and >6 days groups ( F=6.201, P<0.01), with higher ECD in preservation-surgery time ≤3 days groups than in 3-6 days and >6 days groups (both P<0.01).The preoperative donor corneal ECD applied to EK was significantly higher than that applied to PKP ( t=-2.660, P<0.01).ECD at 1 month after surgery applied to PKP was significantly higher than that applied to EK ( t=4.286, P<0.01).The ECD reduction rate was 7.14% (0.01%, 17.69%) and 31.07% (22.11%, 45.86%) in PKP group and EK group, respectively, with a statistically significant difference ( Z=4.969, P<0.01).The ECD was lower in the group with dark area than in the non-dark area group before PKP, with a statistically significant difference ( t=6.789, P=0.011).There was no significant difference in ECD at 1 month after keratoplasty between the two groups ( t=0.005, P=0.945).Multivariate logistic regression model results showed that preservation-surgery time >6 days and the cause of donor death being malignant tumor were risk factors for the appearance of dark areas in donor corneal endothelium ( OR=9.038, P=0.030; OR=6.577, P=0.018). Conclusions:The older the donor, the lower the ECD.Prolonged preservation-surgery time (>6 days) is the main factor contributing to the decline in ECD after keratolasty.Compared to PKP, there is a higher endothelial cell loss after EK.The tissue preservation-surgery time >6 days and the cause of donor death being malignant tumor are the main risk factors affecting the appearance of dark areas in the donor corneal endothelium.But the presence of physiological dark areas does not significantly influence the ECD after surgery.

Objective:To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia(ChP)2025 Edition,and explore its novel requirements in risk-based pharmaceutical product lifecycle management.Methods:A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview,international harmonization of microbiological standards,risk-based quality man-agement system,and novel tools and methods with Chinese characteristics.Results:The ChP 2025 edition demon-strates three prominent features in microbiological-related standards:enhanced international harmonization,intro-duced emerging molecular biological technologies,and established a risk-based microbiological quality control sys-tem.Conclusion:The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system,which significantly improves the scientificity,standardization and applicability of the standards,providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

Objective:To investigate microbial ecology in restored milk (RM) -donor human milk (DHM) supplemented with mother's own milk (MOM)-under varying MOM ratios, incubation temperatures, and durations. Methods:This in vitro controlled study utilized breast milk samples collected from mothers of preterm infants (<37 weeks) admitted to the Neonatal Intensive Care Unit of Chongqing Health Center for Women and Children between December 2024 and March 2025, including five MOM samples and one DHM sample. Each MOM sample was mixed with DHM at 10% (RM-10 group) or 30% (RM-30 group) volume ratios. Samples were incubated at room temperature (23-26 ℃) and 37 ℃ for 1 h and 4 h, followed by collection. Microbial α-diversity (Chao/Shannon indices), β-diversity (principal co-ordinates analysis), and taxonomic composition (phylum/genus) were analyzed via high-throughput sequencing. Statistical analysis included analysis of variance and the Kruskal-Wallis H test. Results:No statistically significant differences in the Chao index or Shannon index were observed between the RM-10 and RM-30 groups across different incubation times and temperatures ( H or F values=7.61 and 93.20, respectively; both P>0.05). At 37 ℃, the microbial composition of the RM-30 group at both 1 h and 4 h showed no significant difference compared to the initial MOM samples ( R=－0.018, P=0.540), with Firmicutes abundance restored to 65%-90% of the initial MOM level. At room temperature, incubation of the RM-30 group partially restored microbial communities (50%-60%), but induced overgrowth of Proteobacteria (e.g., Pseudomonas, Acinetobacter). Incubation of the RM-10 group at 37 ℃ for 1 h and 4 h also showed no significant difference in microbial composition compared to the initial MOM ( R=－0.004, P=0.442). However, at room temperature, Proteobacteria consistently increased in the RM-10 group samples, and significant differences in microbial composition compared to initial MOM were observed at both 1 h and 4 h ( R=0.179, P=0.027). Conclusion:Under the experimental conditions of this study, preliminary evidence suggests that incubating a blend of DHM and 30% MOM at 37 ℃ for 1 h or 4 h may modulate the microbial composition toward a potentially beneficial profile.

IgA nephropathy（IgAN）is the most common primary glomerular disease，characterized by the deposition of IgA in the glomerular mesangial area. IgAN is a progressive disease with a protracted and relapsing course. Approximately 50%~75% of adult IgAN patients experience renal function deterioration and eventually progress to end-stage kidney disease（ESKD）within 20 years after diagnosis. Among patients with onset in childhood，about 30% ultimately progress to ESKD after 20 years of long-term follow-up. In recent years，numerous studies have continuously explored important signaling pathways and key molecules in its pathogenesis. This review introduces the therapeutic advances in IgAN，aiming to provide better treatment options for clinicians.

Objective To establish a method for simultaneous determination of trace levels of microcystins,cylindrospermopsin,anatoxin,and nodularin in lake water based on liquid chromatography-tandem mass spectrometry(LC-MS/MS).Methods After being adjusted to alkaline conditions and mixed with six internal standards,the water samples were enriched using dual HLB and ENVI-Carb cartridges.The eluates were then evaporated under nitrogen,reconstituted,and subjected to instrumental analysis.Both water and acetonitrile containing 0.1%formic acid were used as mobile phases.An ACQUITY UPLC? BEH C18 column(150 mm×2.1 mm,1.7 μm)was selected to separate the target cyanotoxins.Multiple reaction monitoring was applied for data acquisition,and quantification was accomplished using internal standard methods.Results Within certain concentration ranges,all 14 cyanotoxins examined in the study showed good linearity,with all correlation coefficients greater than 0.998.When the water volume was 100 mL,the limits of detection and quantification for the 14 cyanotoxins were 0.1-0.9 ng/L and 0.3-2.9 ng/L,respectively,and spiked recoveries and relative standard deviations were 81.7%-132.9%and 1.2%-14.9%,respectively.In the 10 lake water samples analyzed,cylindrospermopsin,anatoxin-α,and multiple microcystins were detected.Conclusion The method developed in the study has high-throughput capacity,as well as high sensitivity,accuracy,and reliability.The method can be applied in the simultaneous detection of microcystins,cylindrospermopsin,anatoxin,and nodularin in lake water.