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.

Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.

Objective To explore the causal relationship between family resilience and mental health in military personnel population.Methods A total of 204 military personnel were recruited from an army unit stationed in Western China with cluster convenience sampling.Family Resilience Scale(FRS)and Symptom Checklist 90(SCL-90)were used to survey them twice,in an interval of 4 months.Amos 26.0 was applied to construct a cross-lag model and analyze the data.Results After controlling mental symptoms from the first survey,family resilience in the first measure significantly predicted mental symptoms in the second measure(β=-0.14,P＜0.05).After controlling for family resilience from the first survey,mental symptoms in the first measure significantly predicted family resilience in the second measure(β=-0.13,P＜0.05).Conclusion The relationship between family resilience and mental health is mutually causal in military personnel,and one predicts the other one.Our findings highlight the key dimensions of the relationship between the two.

Objective To explore the experience and causes of self-neglect of elderly diabetic patients in community,so as to provide references for community nursing workers to identify and intervene the self-neglect behavior of elderly diabetic patients.Methods An interpretative phenomenological method was used to collect data from elderly diabetic patients registered in 3 community health service centers in Hangzhou,Zhejiang Province through semi-structured interviews.Van Manen's method was used to analyze qualitative data.Results The experience and reasons of self-neglect of elderly diabetic patients in community were summarized into 4 themes and 10 sub-themes,including neglecting personal health(low sense of self-worth,high level of self-esteem,being afraid of compromising the family),neglecting blood glucose management(weak health awareness,difficulty in blood glucose management),inadequate self-care capacity(poor financial situation,insufficient personal time,diminished mobility)and inadequate perceived support(low social support,insufficient emotional support).Conclusion The experience and reasons of self-neglect of elderly diabetic patients in community are diversified.Community health services and nursing workers should pay attention to the performance of self-neglect behavior of elderly diabetic patients and actively explore effective prevention and intervention measures.

Malocclusion,identified by the World Health Organization(WHO)as one of three major oral diseases,profoundly impacts the dental-maxillofacial functions,facial esthetics,and long-term development of～260 million children in China.Beyond its physical manifestations,malocclusion also significantly influences the psycho-social well-being of these children.Timely intervention in malocclusion can foster an environment conducive to dental-maxillofacial development and substantially decrease the incidence of malocclusion or reduce the severity and complexity of malocclusion in the permanent dentition,by mitigating the negative impact of abnormal environmental influences on the growth.Early orthodontic treatment encompasses accurate identification and treatment of dental and maxillofacial morphological and functional abnormalities during various stages of dental-maxillofacial development,ranging from fetal stages to the early permanent dentition phase.From an economic and societal standpoint,the urgency for effective early orthodontic treatments for malocclusions in childhood cannot be overstated,underlining its profound practical and social importance.This consensus paper discusses the characteristics and the detrimental effects of malocclusion in children,emphasizing critical need for early treatment.It elaborates on corresponding core principles and fundamental approaches in early orthodontics,proposing comprehensive guidance for preventive and interceptive orthodontic treatment,serving as a reference for clinicians engaged in early orthodontic treatment.

Periodontitis is a chronic inflammatory and destructive disease in which plaque acts as an initiator.Recruitment of host im-mune cells and production of multiple inflammatory mediators leads to periodontal tissue damage.Programmed cell death(PCD)is a self-destructive process that is actively initiated by cells under specific conditions and can be mainly categorized into apoptosis,necrop-tosis,autophagy,pyroptosis,ferroptosis,cuproptosis,etc.Different types of programmed cell death have their own distinctive roles in periodontitis.In this review,we summarizes the characteristics of different types of PCD and their role in the progression of periodonti-tis,in order to provide new research ideas on the pathogenic mechanism of periodontitis and more references for the precise treatment of periodontitis.

Objective:To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in the treatment of peripheral T-cell lymphoma (PTCL) in a real-world setting.Methods:This was a real-world ambispective cohort study (MOMENT study) (Chinese clinical trial registry number: ChiCTR2200062067). Clinical data were collected from 198 patients who received mitoxantrone hydrochloride liposome injection as monotherapy or combination therapy at 37 hospitals from January 2022 to January 2023, including 166 patients in the retrospective cohort and 32 patients in the prospective cohort; 10 patients in the treatment-na?ve group and 188 patients in the relapsed/refractory group. Clinical characteristics, efficacy and adverse events were summarized, and the overall survival (OS) and progression-free survival (PFS) were analyzed.Results:All 198 patients were treated with mitoxantrone hydrochloride liposome injection for a median of 3 cycles (range 1-7 cycles); 28 cases were treated with mitoxantrone hydrochloride liposome injection as monotherapy, and 170 cases were treated with the combination regimen. Among 188 relapsed/refractory patients, 45 cases (23.9%) were in complete remission (CR), 82 cases (43.6%) were in partial remission (PR), and 28 cases (14.9%) were in disease stabilization (SD), and 33 cases (17.6%) were in disease progression (PD), with an objective remission rate (ORR) of 67.6% (127/188). Among 10 treatment-na?ve patients, 4 cases (40.0%) were in CR, 5 cases (50.0%) were in PR, and 1 case (10.0%) was in PD, with an ORR of 90.0% (9/10). The median follow-up time was 2.9 months (95% CI 2.4-3.7 months), and the median PFS and OS of patients in relapsed/refractory and treatment-na?ve groups were not reached. In relapsed/refractory patients, the difference in ORR between patients with different number of treatment lines of mitoxantrone hydrochloride liposome injection [ORR of the second-line, the third-line and ≥the forth-line treatment was 74.4% (67/90), 73.9% (34/46) and 50.0% (26/52)] was statistically significant ( P = 0.008). Of the 198 PTCL patients, 182 cases (91.9%) experienced at least 1 time of treatment-related adverse events, and the incidence rate of ≥grade 3 adverse events was 66.7% (132/198), which was mainly characterized by hematologic adverse events. The ≥ grade 3 hematologic adverse events mainly included decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and anemia; non-hematologic adverse events were mostly grade 1-2, mainly including pigmentation disorders and upper respiratory tract infection. Conclusions:The use of mitoxantrone hydrochloride liposome injection-containing regimen in the treatment of PTCL has definite efficacy and is well tolerated, and it is a new therapeutic option for PTCL patients.

Objective:To construct a quality evaluation index system for postoperative rehabilitation in children with developmental dislocation of the hip (DDH) .Methods:From August to November 2021, a quality evaluation index system for postoperative rehabilitation in children with DDH was established through literature review, group discussion, and Delphi expert consultation. The analytic hierarchy process was used to determine the weights of various indicators. The positive coefficient of experts was expressed by the effective response rate of the questionnaire. The authority level of experts was represented by the authority coefficient ( Cr) , which was determined by the expert judgment coefficient ( Ca) and the expert familiarity level ( Cs) . The degree of coordination of expert opinions was represented by the Kendall harmony coefficient (Kendall's W) . The degree of concentration of expert opinions was represented by the average score of importance assignment, coefficient of variation, and full score rate. Results:The effective response rates of the two rounds of expert consultation questionnaires were 90.00% and 100.00%, respectively. The Cr of experts in two rounds were 0.785 and 0.815, and the Kendall harmony coefficients were 0.098-0.193 and 0.147-0.212 ( P<0.05) . In the second round of expert consultation, the average scores of importance assignment for all levels of indicators were≥4.0, with coefficients of variation of 0-0.24 and a full score rate of ≥50%. The final quality evaluation index system for postoperative rehabilitation in children with DDH included 3 first-level indicators, 9 second-level indicators, and 37 third-level indicators. In the consistency test results of each indicator at all levels, all of the CI were <0.001, and all of the CR were<0.001. Conclusions:The construction process of the quality evaluation index system for postoperative rehabilitation in children with DDH is scientific, and the weight distribution of the indicators is reasonable, which can be used as an effective tool for evaluating the postoperative rehabilitation quality of DDH children.

Objective:To optimize the Manchester needs tool for injured children (MANTIC) scale , and evaluate its reliability and validity among injured children. Methods:The MANTIC scale was optimized through Delphi expert consultation and pre-tests. From March 2023 to June 2023 , a total of 317 injured children admitted in 7 level A tertiary hospitals in Zhejiang and Shandong provinces and their families were surveyed with general data, optimized MANTIC scale, and EuroQol 5-dimension health questionnaire for youth (EQ-5D-Y). Item analysis was conducted on the data of the 317 patients collected with optimized MANTIC scale through the test for homogeneity and value-based decision-making method and the content validity test of the scale was evaluated with item-level content validity index (I-CVI) and scale-level content validity index (S-CVI). It was evaluated with KMO test values and Bartlett′s test of sphericity to determine whether the scale was suitable for exploratory factors. The number of common factors was determined based on the K1 criterion and scree plot to further obtain the structural validity of the scale of the item load value. The correlation validity of the scale was evaluated with the correlation coefficient of the optimized MANTIC scale and EQ-5D-Y. The reliability of the scale was tested with Cronbach alpha coefficient and Guttman split-half reliability coefficient. Results:A total of 332 questionnaires were distributed, among which 317 valid ones were collected, with a response rate of 95.6%. The test of homogeneity in the item analysis showed that the correlation coefficient between each item and the total score of the scale was 0.40-0.80. The results of the value-based decision-making method showed that the critical ratio of high-and low-scored groups was 6.08-28.01. The quality of all the items met the retention requirements so that the reliability and validity tests could be continued. Validity test found that I-CVI was 0.83-1.00, consistent S-CVI was 0.83, and mean S-CVI was 0.95. In structural validity analysis, the KMO value was 0.96, and the Chi-square value of Bartlett′s test of sphericity was 10755.76 ( P<0.01). A total of 9 common factors were extracted with the K1 criterion (eigen value>1), and the scree plot indicated 9 common factors with a cumulative variance contribution rate of 73.46%. Factor extraction and rotation showed that the load value of each item of the scale ranged from 0.589 to 0.874. The correlation coefficient of the optimized MANTIC scale and EQ-5D-Y was r= 0.55 ( P<0.01).Reliability test showed that the Cronbach alpha coefficient of the total scale and all dimensions was 0.96 and 0.77-0.98, and the Guttman split-half reliability coefficient was 0.76 and 0.73-0.98. Conclusion:The optimized MANTIC scale can attain good reliability, validity, consistency and stability, and can reflect the concept to be expressed and the content to be evaluated, indicating that it can be used to evaluate the injury rehabilitation needs of injured children and their families throughout the entire treatment process.

Objective To explore the expression pattern of Micall2a gene during the early development of zebrafish embryos and the effect of this gene on zebrafish vascular development.MethodsWhole embryo in situ hybridization was used to detect Micall2a expression levels at different stages of early embryo development of Tg (fli:GFP) transgenic (labeled with green fluorescent protein) and wild type zebrafish (AB). Micall2a gene expression was downregulated by microinjection of a morpholine antisense oligonucleotide, and real-time fluorescent quantitative PCR was used to detect mRNA expression of the gene at different developmental stages of zebrafish embryos. Laser confocal microscopy was used to observe and analyze vascular phenotypic changes in zebrafish after the downregulation of Micall2a. ResultsMicall2a was expressed in the brain, heart, and vascular system of zebrafish embryos at the 24th, 36th, and 48th hours post fertilization. The mRNA level of Micall2a increased after microinjection of morpholine antisense oligonucleotides, inhibiting vascular development in zebrafish embryos, resulting in internode angiogenesis defects in zebrafish. ConclusionDownregulation of Micall2a expression inhibits the development of blood vessels in zebrafish.