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 examine the developmental trajectory of fine motor ability in schoolage children with attention deficit hyperactivity disorder (ADHD) for two years, so as to provide scientific evidence to promote motor development in ADHD children. Methods: From April to June 2019, 31 children aged 6-8 years old were selected from a public elementary school. They were diagnosed with ADHD by two psychiatric professionals according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria. Additionally, 31 typical developmental children, matched for age, sex and IQ with the ADHD group, were recruited as the control group. Fine motor ability was assessed with tasks of hand manual dexterity in Movement Assessment Battery for Children-2 (MACB-2), and a followup assessment was conducted from April to June 2021. The development changes of fine motor ability between two groups of children were compared by using t test and repeated measures analysis of variance. Results: Between baseline and followup periods after two years, the total score of hand fine motor in the ADHD group did not show significant improvement (7.4±3.0, 8.0±3.4; t=-1.05, P>0.05), while there was a small effect size improvement in typically developing control group (9.5±2.1, 10.5±2.4; t=-2.12, effect size=0.38, P<0.05). Followup after two years, coin/peg throwing scores with dominant hand improved between ADHD group and control group (7.0±3.3, 9.5±3.2; 8.4±2.8, 11.6±1.6) (t=-3.74, -6.33, P<0.01; effect size=0.67, 1.14), with a smaller improvement in the ADHD group. The score for threading beads/threads decreased in between ADHD group and control group (7.9±2.4, 5.8±3.1; 9.2±1.1, 8.2±1.9) (t=3.89, 2.78, P<0.01; effect size=0.70, 0.50), with a greater decrease in the ADHD group. Conclusions The development speed of fine motor ability in children with ADHD aged 6-8 is slow and continues to lag behind normal developmental children. Fine motor development in children with ADHD should be closely monitored, and targeted interventions should be implemented when necessary.

Objective:To investigate the current status of endoscopic treatment for gastroesophageal varices in portal hypertension in China, and to provide supporting data and reference for the development of endoscopic treatment.Methods:In this study, initiated by the Liver Health Consortium in China (CHESS), a questionnaire was designed and distributed online to investigate the basic condition of endoscopic treatment for gastroesophageal varices in portal hypertension in 2022 in China. Questions included annual number and indication of endoscopic procedures, adherence to guideline for preventing esophagogastric variceal bleeding (EGVB), management and timing of emergent EGVB, management of gastric and isolated varices, and improvement of endoscopic treatment. Proportions of hospitals concerning therapeutic choices to all participant hospitals were calculated. Guideline adherence between secondary and tertiary hospitals were compared by using Chi-square test.Results:A total of 836 hospitals from 31 provinces (anotomous regions and municipalities) participated in the survey. According to the survey, the control of acute EGVB (49.3%, 412/836) and the prevention of recurrent bleeding (38.3%, 320/836) were major indications of endoscopic treatment. For primary [non-selective β-blocker (NSBB) or endoscopic therapies] and secondary prophylaxis (NSBB and endoscopic therapies) of EGVB, adherence to domestic guideline was 72.5% (606/836) and 39.2% (328/836), respectively. There were significant differences in the adherence between secondary and tertiary hospitals in primary prophylaxis of EGVB [71.0% (495/697) VS 79.9% (111/139), χ2=4.11, P=0.033] and secondary prophylaxis of EGVB [41.6% (290/697) VS 27.3% (38/139), χ2=9.31, P=0.002]. A total of 78.2% (654/836) hospitals preferred endoscopic therapies treating acute EGVB, and endoscopic therapy was more likely to be the first choice for treating acute EGVB in tertiary hospitals (82.6%, 576/697) than secondary hospitals [56.1% (78/139), χ2=46.33, P<0.001]. The optimal timing was usually within 12 hours (48.5%, 317/654) and 12-24 hours (36.9%, 241/654) after the bleeding. Regarding the management of gastroesophageal varices type 2 and isolated gastric varices type 1, most hospitals used cyanoacrylate injection in combination with sclerotherapy [48.2% (403/836) and 29.9% (250/836), respectively], but substantial proportions of hospitals preferred clip-assisted therapies [12.4% (104/836) and 26.4% (221/836), respectively]. Improving the skills of endoscopic doctors (84.2%, 704/836), and enhancing the precision of pre-procedure evaluation and quality of multidisciplinary team (78.9%, 660/836) were considered urgent needs in the development of endoscopic treatment. Conclusion:A variety of endoscopic treatments for gastroesophageal varices in portal hypertension are implemented nationwide. Participant hospitals are active to perform emergent endoscopy for acute EGVB, but are inadequate in following recommendations regarding primary and secondary prophylaxis of EGVB. Moreover, the selection of endoscopic procedures for gastric varices differs greatly among hospitals.

Objective To investigate the impact of seasonal and meteorological factors on the incidence of sudden sensorineural hearing loss(SSNHL)in Shenzhen area and provide a reference for the prevention of the dis-ease.Methods The data of patients with SSNHL who visited our hospital between March 2017～February 2021 were collected.The local temperature and humidity data at the time of onset were analyzed.The incidence of SSNHL under different seasons and meteorological conditions were counted to explore the correlation among sea-sons,meteorological conditions and the incidence of SSNHL.Results A total of 579 cases were included.The dis-tribution trend of cases in the four seasons was summer＞autumn＞spring＞winter,and the time distribution trend was that the number of sick cases increases year by year.Under different onset season,the incidence of SSNHL in summer was positively correlated with temperature(mean temperature,maximum temperature and minimum tem-perature)(r=0.153,r=0.1444,r=0.15,P＜0.05).The mean temperature,maximum temperature,minimum temperature and relative humidity were positively correlated with the frequency distribution of hearing loss in pa-tients with SSNHL(P＜0.05).Conclusion Summer is the peak season for patients with SSNHL in Shenzhen,and the season,temperature,relative humidity have an impact on the incidence of SSNHL and the frequency distribution of hearing loss.

OBJECTIVE:With the popularity of simulated barefoot running,minimalist shoes have become a new way of foot exercise.As an important muscle group of the foot,the maintenance of foot muscle morphology is important for the execution of foot functions.In this paper,by combing the literature about the effect of minimalist shoes on foot muscle morphology in recent years,we systematically evaluate the effect of minimalist shoes on foot muscle morphology compared with traditional running shoes. METHODS:The relevant articles published from 2012 to 2022 were searched in Chinese and English databases(PubMed,Web of Science,ProQuest,CNKI and WanFang databases)with"minimal shoes,minimal footwear,minimalist shoes,minimalist footwear,foot muscle,feet muscle"as Chinese and English keywords,respectively.Meta-analysis,sensitivity tests were performed on the included literature using Review Manager 5.4.1 and Stata 14 software,the Egger method was used to test for publication bias in the literature,and Meta-regression was used to identify the subgroups with heterogeneity. RESULTS:Compared with traditional running shoes,minimalist shoes increased muscle circumference of the abductor hallucis[standardized mean difference=2.034,95%confidence interval(1.192,2.877),Z=4.73,P＜0.001].And the results were not reversed after clipping and patching,with a more robust combined effect size(P＜0.05).For the toe short flexors,the total combined effect size did not show a difference between traditional running shoes and minimalist shoes[standardized mean difference=0.470,95%confidence interval(-0.45,1.39),Z=1.00,P=0.318]. CONCLUSION:Compared with traditional running shoes,minimalist shoes intervention can effectively improve muscle circumference of the abductor hallucis,but the promoting effect on the flexor digitorum brevis muscle is not obvious.Running in minimalist shoes has positive implications for the maintenance of the medial longitudinal arch,but it is necessary to enrich the research content of minimalist shoes on different foot muscles and different populations in order to further explore the mechanisms by which minimalist shoe interventions promote foot function.

ObjectiveTo investigate the developmental characteristics of gross motor skills and executive functions, and the correlation between them in school-age children with attention deficit hyperactivity disorder (ADHD). MethodsFrom November, 2020 to May, 2021, 90 children with ADHD were recruited from Peking University Sixth Hospital and Beijing Haidian Wanquan Primary School, and other 90 children with normal development from this primary school were recruited matched their age and gender. Gross motor skills were assessed with the Test of Gross Motor Development in Children, Third Edition (TGMD-3), and inhibitory control, working memory, and cognitive flexibility were assessed with Stroop Color Words Test (SCWT), Rey-Osterrich Complex Figure Test (ROCFT) and Trail Making Test (TMT), respectively. ResultsThe TGMD-3 score was significantly lower in children with ADHD than in normal children (t = -6.275, P < 0.001), while the test results of SCWT, ROCFT and TMT were worse (|t| ≥ 1.986, P ≤ 0.05). The TGMD-3 score of children with ADHD was negatively correlated with the word sense reaction time (r = -0.261), the number of word sense errors (r = -0.404) and the number of color errors (r = -0.326) (P < 0.05), positively correlated with the delayed structural memory scores (r = 0.228) (P < 0.05), and negatively correlated with the TMT-A reaction time (r = -0.255), the number of TMT-A errors (r = -0.329), TMT-B reaction time (r = -0.214) and the number of TMT-B errors (r = -0.474) (P < 0.05). Stratified linear regression analyses showed that the TGMD-3 score of children with ADHD was significant only in predicting test results for inhibitory control and cognitive flexibility (P < 0.05), with explanations of 8.7% and 22.5%, respectively. ConclusionDevelopments of both gross motor skills and executive function delay in children with ADHD, and there is a relation between them, especially the level of gross motor skills relating to the developments of inhibitory control and cognitive flexibility.

Objective To observe the effect of the supine-posture ripple wood training in preventing motion sickness caused by linear acceleration.Methods Totally 61 motion sickness sensitive males were screened by a vertical oscillation simulator and divided into mildly sensitive group(Graybiel score 1-15,n=28)and severely sensitive group(Graybiel score 16,n=33).The participants in the 2 groups received 5-d ripple wood training,30 min/d.The movement frequency of the ripper wood was maintained at 0.25-0.35 Hz,with an acceleration of 0.15-0.25 g.Graybiel score during the training period was recorded.The static balance function test was conducted before and after training on the 1st and 5th day.Results During the training period,the Graybiel scores and motion sickness incidence in the severely sensitive group were decreased with the increase of training days,and all participants achieved complete acclimatization on the 4th day.The Graybiel scores of the mildly sensitive group were low during the whole period,and the complete acclimatization period was 2 d.There was no significant difference in the sway area of the severely sensitive group in static balance function test before and after training(P＞0.05).The mean velocity of the severely sensitive group in static balance function test was significantly increased after training versus before training on the 1st day(P＜0.01),and there was no significant difference before and after training on the 5th day(P＞0.05).There were no significant differences in the sway area or mean velocity of the mildly sensitive group during the whole training period(all P＞0.05).The validation experiment showed that the motion sickness incidence and the symptom severity were significantly decreased in both groups;the motion sickness incidence of the mildly sensitive group decreased from 100.00％(28/28)to 35.71％(10/28);the incidence of severe symptoms in the severely sensitive group decreased from 100.00％(33/33)to 6.06％(2/33)and the vomiting incidence decreased from 96.97％(32/33)to 6.06％(2/33).Conclusion The supine-posture ripple wood training has great effect in preventing motion sickness,with widespread use and simple operation.

Objective To explore the impact of exercise intervention on the reading abilities of chil-dren with Chinese developmental dyslexia(CDD).Methods Twenty-seven CDD children were recruited from patients of Peking University Sixth Hospital,and randomly divided into a CDD exercise interven-tion group of 14 and a CDD control group of 13.Another 14 age-matched normal children were select-ed into a normal control group.All groups kept daily physical activities in school,while the CDD ex-ercise intervention group additionally underwent 8-week individualized gross and fine motor interven-tion.The literacy,reading fluency and reading comprehension of all groups were evaluated by using"Elementary School Students'Literacy Test and Evaluation Scale",one-minute word reading and ele-mentary school students'reading ability assessment.Results Before the intervention,there were no sig-nificant differences between the exercise intervention and control groups in the literacy level,reading fluency,and reading comprehension(P>0.05),which were all significantly lower than the normal con-trol group(P<0.05).However,after the intervention,significant improvement was observed in the aver-age literacy level,reading fluency,and reading comprehension of the CDD exercise intervention group,and the literacy and reading fluency of the CDD control group,as well as the average literacy level and reading comprehension of the normal control group.Moreover,there were no significant differ-ences between the CDD exercise intervention and control groups in the average literacy level and read-ing fluency score(P>0.05),both significantly lower than the normal control group(P<0.05).Mean-while,the reading comprehension score of the CDD exercise intervention group was significantly higher than the CDD control group(P<0.05),but significantly lower than the normal control group(P<0.05).Conclusion Eight-week targeted gross and fine motor intervention can effectively improve reading abili-ty of DD children,especially their reading comprehension.

Objective:To investigate the differences between convolutional neural network (CNN) measurements and manual measurements of prosthetic angles and leg length discrepancies after total hip arthroplasty (THA).Methods:Data were collected from 100 patients who underwent unilateral THA at the Department of Orthopaedics, Fourth Medical Center of PLA General Hospital, between January and March 2024. Fifty patients received a ceramic-lined hip prosthesis, and 50 received a polyethylene-lined hip prosthesis. The cohort included 58 males and 42 females, with an average age of 51.6±12.71 years. The left hip was affected in 45 cases, and the right hip in 55 cases. The Attention UNet network was used to segment the prostheses and identify key points, from which the acetabular prosthesis abduction angle, anteversion angle, and leg length discrepancy were calculated. The CNN measurements of anteversion angle, abduction angle, and leg length discrepancy were compared with manual measurements. The consistency between the two methods was evaluated using the Bland-Altman method.Results:CNN measurements of the abduction angle, anteversion angle, and leg length discrepancy for the 100 prostheses were 40.55°±4.76°, 21.5°(19.0°, 27.0°), and 3.6(1.7, 6.8) mm, respectively, while manual measurements were 40.58°±4.93°, 21.0° (17.6°, 23.2°), and 3.0 (2.0, 7.0) mm, respectively. There was a statistically significant difference in anteversion angle between the two methods ( Z=-2.189, P=0.029), but no significant differences in abduction angle or leg length discrepancy ( P>0.05). For the 50 cases with polyethylene-lined prostheses, CNN-measured abduction and anteversion angles were 40.31°±4.70° and 20.0°(18.0°, 22.0°), respectively, while manual measurements were 40.49°±4.92° and 20.0°(17.0°, 21.5°); there were no statistically significant differences ( P>0.05). For the 50 ceramic-lined prostheses, CNN-measured abduction and anteversion angles were 40.79°±4.86° and 26.5°(20.8°, 33.0°), respectively, while manual measurements were 40.68°±4.98° and 20.0°(18.0°, 22.0°), with a significant difference in anteversion angle ( Z=-3.426, P=0.001) but not in abduction angle ( t=0.994, P=0.325). Bland-Altman analysis showed a difference of 0.031°±1.091° for the abduction angle of the 100 prostheses between the two methods, 0.178°±1.296° for the polyethylene-lined prostheses, and -0.116°±0.825° for the ceramic-lined prostheses. For the anteversion angle, the difference was -3.280°±6.920° for the 100 prostheses, -0.002°±1.471° for the polyethylene-lined prostheses, and -6.560°±8.523° for the ceramic-lined prostheses. The difference in leg length discrepancy was -0.101±0.947 mm. Conclusion:CNN measurements of acetabular prosthesis abduction angle, polyethylene-lined prosthesis anteversion angle, and leg length discrepancy after THA showed no significant differences from manual measurements. However, CNN and manual measurements of ceramic-lined prosthesis anteversion angle differed. Bland-Altman analysis indicates that the two methods have good consistency when measuring the abduction angle, the lower limb discrepancy, and the anteversion angle of the polyethylene liner prosthesis.

Objective:To investigate the diagnostic accuracy of serological indicators and evaluate the diagnostic value of a new established combined serological model on identifying the minimal hepatic encephalopathy (MHE) in patients with compensated cirrhosis.Methods:This prospective multicenter study enrolled 263 compensated cirrhotic patients from 23 hospitals in 15 provinces, autonomous regions and municipalities of China between October 2021 and August 2022. Clinical data and laboratory test results were collected, and the model for end-stage liver disease (MELD) score was calculated. Ammonia level was corrected to the upper limit of normal (AMM-ULN) by the baseline blood ammonia measurements/upper limit of the normal reference value. MHE was diagnosed by combined abnormal number connection test-A and abnormal digit symbol test as suggested by Guidelines on the management of hepatic encephalopathy in cirrhosis. The patients were randomly divided (7∶3) into training set ( n=185) and validation set ( n=78) based on caret package of R language. Logistic regression was used to establish a combined model of MHE diagnosis. The diagnostic performance was evaluated by the area under the curve (AUC) of receiver operating characteristic curve, Hosmer-Lemeshow test and calibration curve. The internal verification was carried out by the Bootstrap method ( n=200). AUC comparisons were achieved using the Delong test. Results:In the training set, prevalence of MHE was 37.8% (70/185). There were statistically significant differences in AMM-ULN, albumin, platelet, alkaline phosphatase, international normalized ratio, MELD score and education between non-MHE group and MHE group (all P<0.05). Multivariate Logistic regression analysis showed that AMM-ULN [odds ratio ( OR)=1.78, 95% confidence interval ( CI) 1.05-3.14, P=0.038] and MELD score ( OR=1.11, 95% CI 1.04-1.20, P=0.002) were independent risk factors for MHE, and the AUC for predicting MHE were 0.663, 0.625, respectively. Compared with the use of blood AMM-ULN and MELD score alone, the AUC of the combined model of AMM-ULN, MELD score and education exhibited better predictive performance in determining the presence of MHE was 0.755, the specificity and sensitivity was 85.2% and 55.7%, respectively. Hosmer-Lemeshow test and calibration curve showed that the model had good calibration ( P=0.733). The AUC for internal validation of the combined model for diagnosing MHE was 0.752. In the validation set, the AUC of the combined model for diagnosing MHE was 0.794, and Hosmer-Lemeshow test showed good calibration ( P=0.841). Conclusion:Use of the combined model including AMM-ULN, MELD score and education could improve the predictive efficiency of MHE among patients with compensated cirrhosis.