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 evaluate the effectiveness of the single-stage anterior eccentric kyphotic distraction reduction technique (EKD-RT) for treating lower cervical dislocation with locked facet joints, assessing its reduction success rate, neurological improvement, and safety. METHODS: A retrospective analysis was conducted on 67 patients with lower cervical dislocation and locked facet joints (21 unilateral, 46 bilateral) treated between January 2015 and January 2024. There were 39 males and 28 females, with an average age of 49.5 years (range, 22-75 years). The injured segments included C _{3, 4} in 4 cases, C _{4, 5} in 13 cases, C _{5, 6} in 22 cases, and C _{6, 7} in 28 cases. The interval between injury and admission ranged from 2 hours to 2 days (mean, 5.6 hours). Preoperative Frankel grading included grade A in 9 cases, grade B in 28 cases, grade C in 17 cases, grade D in 11 cases, and grade E in 2 cases. Japanese Orthopaedic Association (JOA) score was 7.0±1.4. All patients underwent single-stage anterior cervical discectomy and fusion. Following discectomy at the dislocated level, the EKD-RT was applied to unlock and reduce the locked facet joints, followed by internal fixation. Operation time, blood loss, reduction success rate, and complications were recorded. Interbody fusion status was evaluated using Bridwell criteria. Neurological status was assessed pre- and post-operatively using Frankel grading. Spinal cord function was scored using the 17-point JOA score, and the improvement rate was calculated. RESULTS: Successful reduction of the locked facet joints achieved in all cases. The operation time was 41-85 minutes (range, 63.3 minutes), and intraoperative blood loss was 50-360 mL (range, 125.0 mL). Complications included cerebrospinal fluid leakage in 2 cases; no severe complications such as major vascular injury or recurrent laryngeal nerve injury occurred. All patients were followed up 12-24 months (mean, 17.9 months). At last follow-up, radiological examination confirmed interbody fusion in all patients, with no implant failure or migration. The Frankel grading included grade A in 3 cases, grade B in 9 cases, grade C in 13 cases, grade D in 16 cases, and grade E in 26 cases; the JOA score reached 13.7±2.3; all of which significantly improved compared to preoperative levels ( P<0.05). The improvement rate of JOA score was 66.1%±24.7%. CONCLUSION The EKD-RT is an effective surgical approach for lower cervical dislocation with locked facet joints. It enables safe and efficient reduction of the locked facet joints via a single incision, resulting in significant neurological improvement with a low complication rate.
Humans ; Male ; Middle Aged ; Female ; Cervical Vertebrae/diagnostic imaging* ; Retrospective Studies ; Adult ; Aged ; Zygapophyseal Joint/injuries* ; Joint Dislocations/diagnostic imaging* ; Treatment Outcome ; Spinal Fusion/methods* ; Young Adult ; Kyphosis/surgery*

Objective To investigate the expression levels of micro RNA-651(miR-651)and the transcrip-tion factor Forkhead Box N2(FOXN2)in lung cancer tissues and to analyse their relationship with patients' prognosis after lobectomy.Methods A total of 98 patients with lung cancer who underwent lobectomy from January 2020 to December 2021 in Nantong Cancer Hospital were selected as research objects,the lung cancer tissue specimens and corresponding paracancerous tissue specimens of patients were collected,the expression levels of miR-651 and FOXN2 were detected by real-time fluorescence quantitative PCR(qPCR),and their re-lationship with the prognosis of patients after lobectomy was analyzed.Results At 2-year follow-up,19(19.39％)of 98 patients had recurrent metastasis,and the median time to recurrent metastasis was 20 months(95％CI:18.626--21.374).qPCR assay showed that the expression levels of miR-651 and FOXN2 in lung cancer tissues were significantly lower than those in paracancerous tissues(P＜0.05).miR-651 and FOXN2 expression levels were significantly correlated with clinicopathological features such as tumour size,TNM stage and lymph node metastasis(P＜0.05).The results of univariate Cox regression analysis showed that the percentages of maximum tumor diameter ≥3 cm,TNM stage Ⅱ,lymph node metastasis,miR-651 low ex-pression and FOXN2 low expression were higher in the poor prognosis group than those in the good prognosis group(P＜0.05).Multifactorial Cox regression analysis showed that maximum tumor diameter ≥ 3 cm(HR=3.185,95％CI:1.105-9.182),TNM stage Ⅱ(HR=5.167,95％CI:1.939-13.771),lymph node metastasis(HR=2.860,95％CI:1.115-7.338),low miR-651 expression(HR=5.345,95％CI:1.845-15.483)and low FOXN2 expression(HR=5.404,95％CI:1.744-16.745)were independent risk factors for the prognosis of lung cancer patients after lobectomy(P＜0.05).Conclusion The expression levels of miR-651 and FOXN2 were reduced in the tissues of lung cancer patients,and both were associated with tumour size,TNM stage,lymph node metastasis,and patients' prognosis after lobectomy.

Objective To explore the application effect of the dual-track nursing intervention model in the treatment process of children with lobar pneumonia.Methods A total of 186 children with lobar pneumonia were selected and randomly divided into control group and intervention group u-sing a double-blind method,with 93 cases in each group.The control group received conventional nursing intervention,while the intervention group implemented the dual-track nursing intervention model on the basis of conventional nursing.This model included the establishment and training of nurs-ing teams,personalized nursing plans,health education,and psychological support.Outside the hos-pital,it emphasized family support,regular follow-up guidance,and community-based collaborative ed-ucation.Both groups received a 3-week intervention.The improvement times of clinical symptoms,hos-pital stay,pulmonary function indicators before and after nursing,treatment compliance,and family members' satisfaction with nursing were compared and analyzed between the two groups.Results The fever resolution time[(3.89±0.96)d],cough relief time[(6.21±1.34)d],disappearance time of pulmonary rales[(7.89±1.56)d],and hospital stay duration[(9.45±1.89)d]in the intervention group were all shorter than those in the control group[(5.23±1.14),(7.45±1.67),(9.32±2.01),and(11.28±2.35)d,respectively],with statistically significant differences(P＜0.05).After nursing,the forced expiratory volume in one second(FEV1)[(1.51±0.22)L],forced vital capacity(FVC)[(1.75±0.25)L],and FEV1/FVC[(94.12±5.65)％]in the intervention group were all higher than those in the control group[(1.42±0.15)L,(1.66±0.22)L,and(85.73±8.41)％,respectively],with statistically significant differences(P＜0.05).The scores for exami-nation cooperation[(23.91±3.82)points],nursing cooperation[(24.19±4.03)points],standardized medication use[(24.26±3.94)points],and rational diet[(23.77±3.62)points]in the intervention group were higher than those in the control group[(20.16±3.53),(19.64±3.46),(23.05±3.68),and(18.85±3.41)points,respectively],with statistically significant differences(P＜0.05).The satisfaction rate of family members with nursing work in the intervention group was higher than that in the control group,with a statistically significant difference(98.92％versus 89.25％,P＜0.05).Conclusion The dual-track nursing intervention model has a signifi-cant application effect in children with lobar pneumonia.It can accelerate their recovery process,improve treatment compliance,promote pulmonary function improvement,and enhance family mem-bers' satisfaction.

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 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.