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.

Hearing loss is the most prevalent disabling disease. Cochlear implantation（CI） serves as the primary intervention for severe to profound hearing loss. This consensus systematically explores the value of genetic diagnosis in the pre-operative assessment and efficacy prognosis for CI. Drawing upon domestic and international research and clinical experience, it proposes an evidence-based medicine three-tiered prognostic classification system（Favorable, Marginal, Poor）. The consensus focuses on common hereditary non-syndromic hearing loss（such as that caused by mutations in genes like GJB2, SLC26A4, OTOF, LOXHD1） and syndromic hereditary hearing loss（such as Jervell & Lange-Nielsen syndrome and Waardenburg syndrome）, which are closely associated with congenital hearing loss, analyzing the impact of their pathological mechanisms on CI outcomes. The consensus provides recommendations based on multiple round of expert discussion and voting. It emphasizes that genetic diagnosis can optimize patient selection, predict prognosis, guide post-operative rehabilitation, offer stratified management strategies for patients with different genotypes, and advance the application of precision medicine in the field of CI.
Humans ; Cochlear Implantation ; Prognosis ; Hearing Loss/surgery* ; Consensus ; Connexin 26 ; Mutation ; Sulfate Transporters ; Connexins/genetics*

Pituitary adenoma is a common intracranial tumor, and endoscopic endonasal surgery has become one of its primary treatment modalities. Intraoperative magnetic resonance imaging (iMRI) technology can provide surgeons with real-time imaging during surgery, significantly enhancing surgical precision and safety. This case report retrospectively analyzes a case of recurrent pituitary adenoma treated at the Department of Neurosurgery, Huashan Hospital, Fudan University. During endoscopic endonasal surgery, the iMRI revealed residual tumor tissue located above the scar from previous surgery. With the aid of neuronavigation, the surgeon precisely identified and incised the proliferative fibrous tissue that had been misidentified as the diaphragma sellae, successfully removing the concealed tumor and achieving gross total resection. Postoperatively, the patient experienced marked improvement in visual acuity, preserved normal pituitary function, and had no cerebrospinal fluid leakage. Based on this case and relevant literature, this paper discusses the advantages of iMRI in endoscopic endonasal surgery and its potential to improve patient outcomes, aiming to provide reference and guidance for clinical practice.

Clinical trials are an important method for evaluating the safety and efficacy of in vitro diagnostic reagents, and are a key basis for product registration review and approval. In order to strengthen the management of clinical trials of in vitro diagnostic reagents, the National Medical Products Administration and relevant departments have formulated a series of regulations at the regulatory level, and require applicants and clinical trial institutions to establish a quality management system for clinical trials of in vitro diagnostic reagents. Medical laboratory is the main department and implementer of in vitro diagnostic reagent clinical trials in medical institutions. In recent years, with the rapid development of the in vitro diagnostic industry, the clinical trial projects of in vitro diagnostic reagents conducted by medical laboratory have been increasing day by day. However, there are currently few discussions on the clinical trial of in vitro diagnostic reagents from the perspective of researchers. Therefore, this article summarizes the characteristics of clinical trials of in vitro diagnostic reagents, analyzes the problems and difficulties in conducting clinical trials of in vitro diagnostic reagents in current medical laboratories, and introduces the laboratory′s experience in management; to provide reference for medical testing laboratories that have not yet conducted or have already conducted clinical trials of in vitro diagnostic reagents, in order to improve the quality and efficiency of clinical trials.

Clinical trials are an important method for evaluating the safety and efficacy of in vitro diagnostic reagents, and are a key basis for product registration review and approval. In order to strengthen the management of clinical trials of in vitro diagnostic reagents, the National Medical Products Administration and relevant departments have formulated a series of regulations at the regulatory level, and require applicants and clinical trial institutions to establish a quality management system for clinical trials of in vitro diagnostic reagents. Medical laboratory is the main department and implementer of in vitro diagnostic reagent clinical trials in medical institutions. In recent years, with the rapid development of the in vitro diagnostic industry, the clinical trial projects of in vitro diagnostic reagents conducted by medical laboratory have been increasing day by day. However, there are currently few discussions on the clinical trial of in vitro diagnostic reagents from the perspective of researchers. Therefore, this article summarizes the characteristics of clinical trials of in vitro diagnostic reagents, analyzes the problems and difficulties in conducting clinical trials of in vitro diagnostic reagents in current medical laboratories, and introduces the laboratory′s experience in management; to provide reference for medical testing laboratories that have not yet conducted or have already conducted clinical trials of in vitro diagnostic reagents, in order to improve the quality and efficiency of clinical trials.

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 observe the impacts of using heated and humidified gas sources for delivery room resuscitation on the short-term outcomes of extremely preterm infants.Methods:A retrospective study was conducted on 231 extremely preterm infants admitted to the neonatal intensive care unit of Shenzhen Maternity & Child Healthcare Hospital, the First School of Clinical Medicine, Southern Medical University, from January 2020 to December 2022. The infants were divided into two groups based on whether heated and humidified gas sources were used during delivery room resuscitation: the heated and humidified group (103 cases) and the non-heated and humidified group (128 cases). Independent sample t-tests, Chi-square tests, and Mann-Whitney U tests were used to compare general conditions and short-term outcomes between the groups. Multivariate logistic regression analysis was used to assess the impact of using heated and humidified gas sources during delivery room resuscitation on the short-term outcomes of extremely preterm infants. Results:Compared to the non-heated and humidified group, the heated and humidified group had a lower incidence of intubation resuscitation [28.2% (29/103) vs. 41.4% (53/128), χ 2=4.38], moderate to severe bronchopulmonary dysplasia (BPD)/death [22.3% (23/103) vs. 39.1% (50/128), χ 2=7.39] and low rectal temperature upon admission (<36.7 ℃) [57.3% (59/103) vs. 79.7% (102/128), χ 2=13.57], while the rectal temperature upon admission was higher [36.3 ℃ (36.0-36.7 ℃) vs. 35.9 ℃ (35.5-36.3 ℃), U=－5.05], with all differences being statistically significant (all P<0.05). After adjusting for gender, gestational age, mode of delivery, amniotic fluid condition, weight on admission, maternal premature rupture of membranes, assisted reproductive technology, and full course of prenatal steroid use, multivariate logistic regression analysis showed that the use of heated and humidified gas sources during delivery room resuscitation could increase the hospital admission rectal temperature ( β=0.46, 95% CI: 0.28-0.64), and decrease the risks of severe BPD/death ( aOR=0.39, 95% CI: 0.20-0.75), and low rectal temperature upon admission ( aOR=0.29, 95% CI: 0.16-0.55)(all P<0.05). Compared to the non-heated and humidified group, the heated and humidified group showed no statistically significant differences in the use of pulmonary surfactant [37.9% (39/103) vs. 43.8% (56/128), χ 2=1.45], incidence of stage Ⅲ or higher necrotizing enterocolitis [2.0% (2/103) vs. 5.5% (7/128), χ 2=2.06], grade Ⅲ or higher intracranial hemorrhage [2.9% (3/103) vs. 3.9% (5/128), χ 2=0.22], and retinopathy of prematurity requiring surgical treatment [3.9% (4/103) vs. 10.2% (13/128), χ 2=3.60] (all P>0.05). Conclusion:The use of heated and humidified gas sources during resuscitation of extremely preterm infants can reduce the risk of moderate to severe BPD/death, help maintain warmth during resuscitation, and do not adversely affect other short-term outcomes.

Objective: To investigate the effects of a ketogenic diet (KD) alone and in combination with resistance training (KD+RT) on body composition and glucolipid metabolism of obese and female college students, and to provide a theoretical basis for the application of KD+RT in obese patients. Methods: Totally 45 obese and female college students in Wuyi University were recruited and randomly divided into KD group ( n =23) and KD+RT group ( n =22) in September 2021. After received training for 4 weeks, the changes of body composition and glucose and lipid metabolism of obese and female college students were compared before and after intervention. Results: Both a 4 week KD and KD+RT led to decreases in weight, BMI, body fat mass, body fat percentage, waist to hip ratio, visceral fat area of obese female college students ( t =16.19, 16.21, 12.42, 7.99, 2.10, 6.37; 18.82, 18.02, 17.80, 10.72, 3.41, 7.59, P <0.01). The change of muscle mass was decreased in KD group( t=4.12, P <0.01), but there was no statistically significant difference in KD+RT group( P >0.05). Both a 4 week KD and KD+RT significantly reduced the levels of the fasting blood glucose, fasting insulin, glycosylated hemoglobin and triglyceride (TG) of obese female college students ( t =10.15, 8.94 , 6.94, 7.63; 9.23, 12.75, 9.85, 9.09, P <0.01), and increased the high density lipoprotein (HDL) level( t =-7.36, -5.22, P <0.01). However, only KD+RT group had a significant decrease in the level of LDL ( t =5.27, P <0.01), and there was no significant change in the level of TC both groups ( P >0.05). After the intervention, there was no statistically significant difference between the KD+RT group compared to the KD group ( P >0.05), except for a significant decrease in triacylglycerol ( t =2.51, P < 0.05 ). Conclusion Both a short term KD and KD+RT show beneficial changes in body composition and glucolipid metabolism in obese female college students. However, the KD+RT is superior to a KD in maintaining muscle mass and reducing the effects of lipid metabolism.

Objective:To explore the effect of action research method in optimizing follow-up of patients undergoing knee arthroplasty, so as to provide reference for improving follow-up efficiency and success rate and promoting patients ' rehabilitation. Methods:From August 2019 to August 2021, 282 patients undergoing knee arthroplasty in Second Ward of Orthopedics of Peking Union Medical College Hospital were selected as the study subjects by convenience sampling method. Set patients who underwent routine follow-up from August to September 2019 as the baseline group. Three stages of follow-up mode optimization were conducted in clinical practice, evaluating the average follow-up duration, success rate of follow-up, and range of motion of patients undergoing knee arthroplasty.Results:The average follow-up duration of first, second and third stage follow-up procedures had no statistically differences ( P>0.05) , while the follow-up success rate gradually increased ( P<0.05) . The range of motion of patients undergoing knee arthroplasty in the second and third stage of the follow-up was better than those in the first stage and baseline, and the differences were statistically significant ( P<0.05) . Conclusions:The application of action research method can optimize the follow-up mode of patients undergoing knee arthroplasty, and improve the follow-up efficiency and quality.

BackgroundElderly cataract patients with depressive symptoms have heavier self-perceived burden， and worse vision-related quality of life compared to patients without depressive symptoms， resulting in the increase of family burden. Most previous studies showed that family relationship and vision were the main factors leading to depression in elderly cataract patients， and ignored the effects of self-feeling and complicated diseases on the psychological state of elderly cataract patients. ObjectiveTo explore the relationship between depressive symptoms， self-perceived burden and postoperative vision-related quality of life in elderly cataract patients， and to analyze the risk factors of depressive symptoms. So as to provide references for targeted psychological intervention in this population. MethodsA total of 104 elderly cataract patients admitted to Jiangsu Province Hospital （The First Affiliated Hospital with Nanjing Medical University） from July 1， 2020 to December 31， 2022 were included. General information， self-perceived burden and postoperative vision-related quality of life were investigated by self-designed questionnaire， Patients' Health Questionnaire depressive Scale-9 item （PHQ-9）， Self-Perceived Burden Scale （SPBS） and National Eye Institute Visual Function Questionnaire-25 （NEI-VFQ-25）. Pearson correlation analysis was performed to analyze the correlation among PHQ-9， SPBS and NEI-VFQ-25 scores. Logistic regression analysis was used to analyze the influencing factors of depressive symptoms in eldery cataract patients. ResultsA total of 100 elderly cataract patients completed an effective questionnaire survey. Among the participants， 31 cases （31.00%） were found to have depressive symptoms. The depressive group exhibited significantly higher SPBS score （t=11.062， P<0.01） and significantly lower NEI-VFQ-25 score （t=-5.235， P<0.01） than those of the non-depressive group. Pearson correlation analysis showed a positive correlation between PHQ-9 and SPBS score （r=0.485， P<0.01）， and a negative correlation between PHQ-9 and NEI-VFQ-25 score （r=-0.440， P<0.01）. Complicated with diabetes （OR=1.441， P<0.01）， osteoarthritis （OR=1.324， P<0.05） and high SPBS score （OR=1.340， P<0.05） were risk factors of depressive sympptoms in elderly cataract patients. ConclusionThe detection rate of depressive symptoms in elderly cataract patients is higher， and postoperative vision-related quality of life in elderly cataract patients complicated with depressive symptoms is poor. Risk factors include diabetes， osteoarthritis and high self-perceived burden. ［Funded by 2022 Jiangsu Province Elderly Health Scientific Research Project （number， LKM2022019）］