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.

A review of studies related to the loneliness of family caregivers of chronically ill patients aims to provide a basis for understanding the current situation of loneliness among family caregivers of chronically ill patients, assessing the degree of loneliness among family caregivers, and formulating individualized interventions with a view to reducing the loneliness of family caregivers and promoting their physical and mental health.

Objective:To investigate the expression of retinoic acid receptor responsive gene 2 (RARRES2), microtubule microfilament cross-linking factor 1 (MACF1), and core protein polysaccharide (DCN) in cerebrospinal fluid (CSF) of patients with neurosyphilis, and their diagnostic value for neurosyphilis.Methods:A total of 64 non neurosyphilis syphilis patients (syphilis group) and 78 neurosyphilis patients (neurosyphilis group) admitted to the Second Hospital of Nanjing between June 2020 and September 2022 were included. Among neurosyphilis patients, there were 48 early neurosyphilis patients (early group) and 30 late neurosyphilis patients (late group). Patients with neurosyphilis are treated with routine symptomatic therapy and antibiotic therapy to expel syphilis. The mRNA levels of RARRES2, MACF1, and DCN in CSF of patients with neurosyphilis before and after treatment were detected by quantitative real-time polymerase chain reaction (qRT-PCR). The National Institutes of Health Stroke Scale (NIHSS) was used to evaluate the neurological function of patients with neurosyphilis before and after treatment. The diagnostic value of various indicators for neurosyphilis was analyzed using receiver operating characteristic (ROC) curves.Results:The mRNA levels of RARRES2, MACF1, and DCN in CSF of patients with neurosyphilis were higher than those in the syphilis group (all P<0.001). The mRNA levels of RARRES2, MACF1, and DCN in the CSF of patients with advanced neurosyphilis were higher than those in the early group (all P<0.001). Compared with before treatment, the NIHSS score and RARRES2, MACF1, and DCN mRNA levels of neurosyphilis patients decreased after treatment (all P<0.001). The area under the curve (AUC), sensitivity, and specificity of the combined diagnosis of RARRES2, MACF1, and DCN mRNA in CSF for neurosyphilis were 0.995%, 100.00%, and 93.75%, respectively. The AUC and sensitivity were higher than those of individual diagnosis. Conclusions:The expression of RARRES2, MACF1, and DCN is elevated in CSF of patients with neurosyphilis, and is associated with disease severity and treatment response. These three genes may be candidate biomarkers for diagnosing neurosyphilis.

Objective To construction of discharge readiness assessment index for patients with percutaneous transhepatic biliary drainage.Methods Based on the framework of the Meleis's transitions theory,the relevant literature was consulted,the semi-structured interview and group discussion were implemented,and the framework of the assessment index system for discharge readiness of patients with percutaneous transhepatic biliary drainage was initially constructed.Then,two rounds of Delphi expert consultations were conducted.The weight of each indicator was set by Analytic Hierarchy Process.Results The effective recovery of 2 rounds of expert consultations were both 100％.The authority coefficients were 0.964 and 0.972,The Kendall harmony coefficients were 0.240 and 0.228(P＜0.001).The final discharge readiness assessment index system for patients with percutaneous transhepatic biliary drainage was established,including 4 first-level indicators and 35 second-level indicators.Conclusion The discharge readiness assessment index system for patients with percutaneous transhepatic biliary drainage was scientific and reliable,which can provide references for the evaluation of discharge readiness for patients with percutaneous transhepatic biliary drainage.

Objective To explore the application value of multidetector computed tomography(MDCT),computed tomography cholangiography(CTC)and computed tomography angiography(CTA)reconstruction technology in the diagnosis and classification and the evaluation of the efficacy of biliary drainage in advanced hilar cholangiocarcinoma(HCCA).Methods A total of 44 patients of inoperable advanced HCCA were collected.Conventional CT plain scan and enhanced multi-phase scan were performed before treat-ment.Minimum intensity projection(MinIP)combined with curve planar reformation(CPR)was used to perform CTC.CTA of the portal vein,hepatic artery and hepatic vein were performed by maximum intensity projection(MIP),volume rendering(VR)or CPR,respectively.CT was reexamined after biliary drainage treatment.The study included the comparison between reconstruction technology of CTC and CTA and conventional CT scanning technology,CTC in the classification and diagnosis of HCCA,CTA in the evaluation of vascular invasion,and the evaluation of the effect of jaundice drainage by biliary imaging before and after biliary drain-age treatment.Results All HCCA cases obtained clear location diagnosis,including 39 cases of Bismuth-Corlette type Ⅳ and 5 cases of type Ⅲ.There were 40 cases of hepatic vascular involvement,including 15 cases of bilateral portal vein invasion by tumor,12 cases of portal vein constriction,8 cases of portal vein tumor thrombosis,4 cases of bilateral hepatic arteries involvement,and 1 case of hepatic vein involvement.CTC and CTA could better display a full view of the bile duct and blood vessel than conventional CT scanning ima-ges,and provided more accurate analysis of tumor classification and degree of vascular invasion.Before treatment,CT showed severe dila-tion of bile duct in 21 cases and moderate dilation in 20 cases,severe dilation of the intrahepatic bile duct in the left lobe but mild dilation of the intrahepatic bile duct in the right lobe in 3 cases.After drainage treatment,the contraction rate of intrahepatic bile duct dilation was＜25％in 4 cases,25％to 49％in 13 cases,50％to 74％in 18 cases,and ≥75％in 9 cases.The bile duct contraction rate was positively correlated with the decrease in total bilirubin(TBIL).Conclusion MDCT,CTC and CT A reconstruction technology can well complete the diagnosis of advanced HCCA,Bismuth-Corlette typing,and vascular evaluation.Observing the contraction rate of the intrahepatic bile duct after biliary drainage treatment can evaluate the efficacy of jaundice drainage.

Objective:To investigate the prognostic value of the combined preoperative albumin-globulin score (AGS) and skeletal muscle index (SMI), referred to as the CAS classification, in predicting postoperative outcomes in patients with pancreatic cancer.Methods:The clinical data from 265 patients who underwent surgical treatment and were pathologically confirmed to have pancreatic cancer at the Affiliated Hospital of Qingdao University between January 2012 and December 2022 were retrospectively analyzed. Patients were randomly divided into a training group ( n=184) and a validation group ( n=81) in a 7∶3 ratio. Patients' age, gender, body mass index (BMI), smoking history, alcohol consumption history, previous history of metabolic diseases, AGS, SMI, and CAS classifications within 7 days before surgery, preoperative upper abdominal CT imaging features, presence of vascular and neural invasion, and lymph node metastasis were recorded. Patients with AGS grade 0 were classified into the low AGS group ( n=48), while those with AGS grades 1 and 2 were classified into the high AGS group ( n=136). The optimal cutoff value for SMI was determined using X-tile software: male patients with SMI>42.6 cm 2/m 2 or female patients with SMI>37.8 cm 2/m 2 were categorized into the high SMI group ( n=125), while those below these thresholds were categorized into the low SMI group ( n=59). Patients with AGS grade 0 and SMI>42.6 cm 2/m 2 for males or >37.8 cm 2/m 2 for females were classified into the CAS grade 1 group (n=32). Patients with AGS grades 1 or 2 and SMI ≤42.6 cm 2/m 2 for males or ≤37.8 cm 2/m 2 for females were classified into the CAS grade 3 group ( n=43). The remaining patients were classified into the CAS grade 2 group ( n=109). Clinical characteristics were compared across these groups. Cumulative survival rates were estimated using the Kaplan-Meier method, and survival curves were plotted to analyze the relationship between AGS, SMI, and CAS classifications and overall survival after pancreatic cancer surgery. Differences among groups were assessed using the Log-Rank test. Receiver operating characteristic curves (ROC) were plotted, and the area under the curve (AUC) was calculated to evaluate the predictive efficacy of AGS, SMI, and CAS on postoperative survival. Results:Compared to the high AGS group, the low AGS group exhibited higher SMI values [(46.17±9.63) cm 2/m 2vs (44.11±7.43) cm 2/m 2], and a lower incidence of lymph node metastasis (16 vs 66, 33.3% vs 48.5%). The mortality rate in the low AGS group was 50.0%(24/48), significantly lower than the 70.6% (96/136) observed in the high AGS group, with a median overall survival of 22.08 months (95% CI 16.87-29.62) longer than 13.1 months (95% CI 8.84-18.82) in high AGS group. Compared to the low SMI group, the high SMI group had a lower prevalence of metabolic diseases (26.4% vs 44.1%). The mortality rate in the low SMI group was 78.0% (46/59), higher than the 58.4% (73/125) in the high SMI group, with a median overall survival of 12.97 months (95% CI 9.37-18.20) obviously shorter than 16.20 months (95% CI 10.7-24.12) in high SMI group. Lymph node metastasis rate for CAS grade 1, 2, and 3 was 34.4% ( n=11), 44.0% ( n=48), and 62.8% ( n=27), respectively, with corresponding mortality rate of 34.3% (11/32), 67.9% (74/109), and 79.1% (34/43), and median overall survival time of 25.55 months (95% CI 19.49-30.07), 14.10 months (95% CI 10.22-19.14), and 12.5 months (95% CI 8.53-18.00), respectively. All the differences were statistically significant (all P value <0.05). Kaplan-Meier survival analyses demonstrated that patients in the low AGS group had significantly longer overall survival than those in the high AGS group in both the training and validation cohorts. Similarly, patients in the high SMI group had longer overall survival compared to those in the low SMI group. Notably, patients in CAS grade 1 exhibited the longest overall survival, whereas those in CAS grade 3 had the shortest. ROC curve analysis revealed that the AUC for CAS classification was superior in the training cohort (0.649) compared to AGS (0.588) and SMI (0.593), and in the validation cohort (0.644) compared to AGS (0.587) and SMI (0.577). Conclusions:CAS classification could effectively predict postoperative prognosis in pancreatic cancer patients, with higher CAS grades correlating with poorer outcomes.

Objective:To retrieve, obtain and summarize the best evidence for ulcer prevention in high-risk patients with diabetic foot, so as to provide reference for clinical medical and nursing staff.Methods:According to the "6S" pyramid model of evidence-based resources, the literature on ulcer prevention in high-risk patients with diabetic foot was systematically searched in British Medical Journal (BMJ) Best Practice, UpToDate, Joanna Briggs Institute (JBI) Evidence-Based Health Care Center Database, National Institute for Health and Clinical Excellence, Scottish Intercollegiate Guidelines Network, Registered Nurses' Association of Ontario, Medlive, Guidelines International Network, International Working Group on the Diabetic Foot, International Diabetes Federation, American Diabetes Association, Australian Diabetic Foot Network, Cochrane Library, PubMed, Embase, China Biomedical Database, China National Knowledge Infrastructure and Wanfang Data. The search period is from database establishment to September 30, 2023. Two researchers independently evaluated the included literature and extracted literature that met quality standards.Results:A total of 15 articles were included, including 7 guidelines, two expert consensus, one clinical practice, and five systematic reviews. This paper summarized 21 best pieces of evidence from five aspects of regular screening, self-monitoring, foot care, exercise prevention and health education for high-risk patients with diabetic foot.Conclusions:The best evidence of ulcer prevention in high-risk patients with diabetic foot summarized provides evidence-based basis for clinical nursing practice.

Objective:To explore the mediating effect of empowerment between self-perceived burden and medication adherence in kidney transplant recipients, so as to provide reference for improving medication adherence in kidney transplant recipients.Methods:This study was a cross-sectional survey. From August to December 2022, convenience sampling was used to select 240 kidney transplant recipients who were followed up at the Kidney Transplantation Center of Shanghai General Hospital as the research subject. A survey was conducted on subjects using the General Information Questionnaire, Self-Perceived Burden Scale (SPBS), Client Empowerment Scale (CES), and Basel Assessment of Adherence with Immunosuppressive Medication Scale (BAASIS) to analyze the correlation between patient self-perceived burden, empowerment, and medication compliance, as well as the mediating effect of empowerment between the two.Results:A total of 240 questionnaires were distributed, and 226 valid questionnaires were collected, with a valid response rate of 94.2% (226/240). Among 226 kidney transplant recipients, the total scores of SPBS, CES, and BAASIS were (27.34±8.03), (159.86±13.45), and (5.05±1.75), respectively. The SPBS score of the recipient was negatively correlated with the CES score ( r=-0.366, P<0.05), and positively correlated with the BAASIS score ( r=0.448, P<0.05). The CES score was negatively correlated with the BAASIS score ( r=-0.456, P<0.05). The above differences were statistically significant. Empowerment partially mediated the association between self-perceived burden and medication adherence in kidney transplant recipients, with a mediating effect ratio of 38.7%. Conclusions:Renal transplant recipients have poor medication adherence, and empowerment is a mediating variable between self-perceived burden and medication adherence. Medical and nursing staff should attach importance to and enhance the empowerment of kidney transplant recipients, in order to alleviate the negative impact of self-perceived burden, increase medication compliance of recipients, and improve their health outcomes.

Neonates, especially extremely preterm infants or those who have suffered birth asphyxia, require placental transfusion to stabilize blood pressure and respiratory support to maintain pulmonary expansion after birth. In clinical practices, it is common to first perform delayed cord clamping, followed by respiratory support after the umbilical cord has been cut. Nevertheless, as the prolonged onset of respiratory support carries risks, recent clinical studies have been investigating the possibility of implementing concurrent placental transfusion and respiratory support. This review discusses the physiological principles of placental transfusion combined with respiratory support, different methods of implementation, and their effects on neonates.

Objective:To investigate the effect of quality improvement (QI) project on delayed cord clamping (DCC) implementation in very preterm infants.Methods:This study retrospectively collected the clinical data and assessed the QI indices of very preterm infants born in the Women and Children's Hospital of Chongqing Medical University and transferred to the Neonatology Department from January 2017 to January 2021. The indices for QI assessment included three types: (1) process indices: the implementation rate and timing of DCC; (2) outcome indices: hemoglobin level and hematocrit, etc; (3) balancing indices: the proportion of neonates requiring endotracheal intubation in the delivery room and chest compressions, Apgar score body temperature, and blood pH value on admission, etc. There were four phases for the implementation of QI, the pre-QI period (January to December of 2017), the QI period (January to December of 2018), the post-QI period (January to December of 2019), and the sustained-QI period (January 2020 to January 2021). The QI project was performed since August 2018. Control charts or statistical tests were used for statistical analysis.Results:(1) Process indices: After the implementation of the QI project, the practice of DCC increased from 0 to 82.2%, and the timing of umbilical cord clamping was from 0 s to a delay of 47.1 s. (2) Outcome indices: The levels of hemoglobin in the QI period, the post-QI period, and the sustained-QI period were significantly higher than those in the pre-QI period [(202.22±28.84), (210.10±33.52), (210.52±32.27) g/L vs. (187.94±35.29) g/L; F=8.61, P<0.001]. The hematocrit values in the post-QI period and the sustained-QI period were significantly higher than those in the pre-QI period [(58.99±8.71) %, (60.18±8.06)% vs. (55.41±9.17)%; χ2=5.13, P=0.002]. The other indices showed no statistical differences in different phases. (3) Balancing indices: The proportions of neonates receiving endotracheal intubation in the delivery room in the post-QI period and the sustained-QI period were significantly lower than those in the pre-QI period [16.0% (19/119), 13.2% (25/191) vs. 42.3% (30/71); χ2=29.08, P<0.001]. The body temperature on admission increased gradually through the four periods [pre-QI period: 35.3 ℃ (34.5-36.1 ℃); QI period: 36.0 ℃ (34.0-37.7 ℃); post-QI period: 36.0 ℃ (35.6-37.4 ℃); sustained-QI period: 37.0 ℃ (35.9-38.1 ℃); H=277.88, P<0.001]. The blood pH value on admission in the sustained-QI period [7.32 (6.85-7.50)] was significantly higher than those in the other three periods [7.26 (7.07-7.46), 7.26 (7.04-7.43), and 7.25 (6.91-7.49); H=34.46, P<0.001]. Conclusion:The interventions in this QI project significantly increase the practice of DCC and enable a longer DCC in very preterm infants.