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: o develop an onset risk prediction nomogram for patients with homocysteine-type (H-type) hypertension (HTH) based on pulse diagram parameters to assist early clinical prediction and diagnosis of HTH. Methods: Patients diagnosed with essential hypertension and admitted to Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai Hospital of Traditional Chinese Medicine, and Shanghai Hospital of Integrated Traditional Chinese and Western Medicine from July 6th 2020 to June 16th 2021, and from August 11th 2023 to January 22nd 2024, were enrolled in this retrospective research. The baselines and clinical biochemical indicators of patients were collected. The SMART-I TCM pulse instrument was applied to gather pulse diagram parameters. Multivariate logistic regression was adopted to analyze the risk factors for HTH. RStudio was employed to construct the nomogram model, receiver operating characteristic (ROC) curve, and calibration curve (bootstrap self-sampling 200 times), and clinical decision curve were drawn to evaluate the model’s discrimination and clinical effectiveness. Results: A total of 168 hospitalized patients with essential hypertension were selected and divided into non-HTH group (n = 29) and HTH group (n = 139). Compared with non-HTH group, HTH group had a lower body mass index (BMI), and higher proportions of male patients and drinkers (P < 0.05). The ventricular wall thickening (VWT) could not be determined. The proportions of left common carotid intima-media wall thickness (LCCIMWT) and serum creatinine (SCR) were higher in HTH group (P < 0.05). The pulse diagram parameter As was significantly higher, and H4/H1 and T1/T were lower in HTH group (P < 0.05). Gender, alcohol consumption, serum creatinine, and the pulse diagram parameter H4/H1 were identified as independent risk factors for HTH (P < 0.05). The nomogram’s area under the ROC curve (AUC) was 0.795 [95% confidence interval (CI): (0.706 6, 0.882 8)], with a specificity of 0.724 and sensitivity of 0.799. After 200 times repeated bootstrap self-samplings, the calibration curve showed that the simulated curve fits well with the actual curve (x2 = 9.5002, P = 0.301 9). The clinical decision curve indicated that the nomogram’s applicability was optimal when the threshold for predicting HTH was between 0.38 and 1.00. Conclusion The nomogram model could be valuable for predicting the onset risk of HTH and pulse diagram parameters can facilitate early screening and prevention of HTH.

Objective:To establish a quantitative diagnostic standard for Crohn's disease with dampness syndrome based on clinical data using a disease syndrome combination model and conduct bidirectional validation.Methods:256 patients with Crohn's disease from the Department of Spleen and Stomach Diseases at Guangdong Provincial Hospital of Chinese Medicine, the Department of Gastroenterology at the Sixth Affiliated Hospital of Sun Yat-sen University, and the Outpatient Department of Guangdong Provincial Hospital of Chinese Medicine from October 2021 to January 2022 were selected as the observation objects. They were divided into an operation group of 205 patients and a verification group of 51 patients in an 8:2 ratio using a random number table method. The frequency advantage method, χ2 test, and binary logistic regression analysis were used to screen for relevant standard factors. The conditional probability method was used to assign scores to relevant items, and the maximum likelihood method was used to determine the quantitative diagnostic threshold. A quantitative diagnostic standard for Crohn's disease with dampness syndrome based on disease syndrome combination was established, and it was retrospectively analyzed and prospectively verified. Results:On the basis of the 20 candidate quantitative diagnostic criteria items for Crohn's disease dampness syndrome, binary logistic regression analysis was performed to calculate the OR values between each item. The quantitative diagnostic criteria for Crohn's disease with dampness syndrome included tongue coating greasiness (7 points), body heaviness (13 points), waist and knee soreness (8 points), head weight (9 points), bland mouth (6 points), anal heaviness (8 points), uncomfortable bowel movements (8 points), and sticky stools (7 points), with a quantitative diagnostic threshold of 11. Conclusion:The scoring of relevant items in the quantitative diagnostic criteria for Crohn's disease with dampness syndrome is reasonable and has good diagnostic value, which can provide reference for further quantitative research on Crohn's disease syndromes.

Objective To evaluate the effect of programmed nursing on dry eye after the phacoemulsification for cataract.Methods A total of 100 cases undergoing the phacoemulsification for cataract in our hospital from January 2022 to January 2024 were divided randomly into the control group and the observation group based on nursing differences with 50 cases in each group.The control group received the routine nursing,while the observation group was given the programmed nursing.The incidence of postoperative dry eye,nursing satisfaction,and dry eye-related complications were compared between the two groups.Results The results showed that the corneal fluorescence staining,tear secretion test,and tear film rupture time in the observation group were(1.46±1.13)points,(17.18±1.45)mm,and(6.86±0.92)s,respectively,which were superior to the control group's(2.96±0.09)points,(11.04±2.79)mm,and(5.98±1.26)s(all P<0.05);The incidence of dry eye complications in the observation group at 45 days and 90 days after the surgery was 8.0%and 6.0%,respectively,lower than that in the control group at 18.0%and 16.0%(both P<0.05);The satisfaction rate of the observation group with nursing care was 98.0%,which was higher than the control group's 84.0%(P<0.05).The differences between the groups were statistically significant.Conclusion Programmed nursing for patients undergoing the phacoemulsification for cataract can reduce the incidence of dry eye,improve the eye condition of patients and increase the patient satisfaction.

Circulating tumor DNA (ctDNA) is cell-free DNA released by tumors or circulating tumor cells, containing abundant tumor-specific information that can serve as biomarkers for cancer early screening, monitoring, prognosis, and prediction of treatment response. This is particularly attractive in the field of gastric cancer, where high-quality screening, monitoring, and prediction methods are currently lacking. Gastric cancer exhibits significant tumor heterogeneity, with large differences in genetic and epigenetic characteristics among different subgroups. Methylated ctDNA has high sensitivity and specificity, which can help clarify tumor genotyping and facilitate the formulation of precise diagnostic and therapeutic strategies. Furthermore, numerous studies have confirmed the unique advantages of methylated DNA in predicting treatment response, adjuvant therapy, and drug resistance assessment, which may be used in the future to enhance the efficacy of chemotherapy regimens and improve patient chemotherapeutic response, and even treat multidrug resistance. However, there are several challenges associated with methylated ctDNA, such as low sensitivity and specificity at single-target sites, limited association between some gastric cancer subtypes and ctDNA, off-target risks, and the lack of large-scale and high-quality clinical research evidence. This review mainly summarizes current research on the methylation status of ctDNA in gastric cancer and connects these findings to early screening, recurrence monitoring, and potential treatment opportunities for gastric cancer. With advances in technology and the deepening of interdisciplinary research, ctDNA detection will reveal more disease information and become an essential foundation for gastric cancer research and precision medicine treatment.

Circulating tumor DNA (ctDNA) is cell-free DNA released by tumors or circulating tumor cells, containing abundant tumor-specific information that can serve as biomarkers for cancer early screening, monitoring, prognosis, and prediction of treatment response. This is particularly attractive in the field of gastric cancer, where high-quality screening, monitoring, and prediction methods are currently lacking. Gastric cancer exhibits significant tumor heterogeneity, with large differences in genetic and epigenetic characteristics among different subgroups. Methylated ctDNA has high sensitivity and specificity, which can help clarify tumor genotyping and facilitate the formulation of precise diagnostic and therapeutic strategies. Furthermore, numerous studies have confirmed the unique advantages of methylated DNA in predicting treatment response, adjuvant therapy, and drug resistance assessment, which may be used in the future to enhance the efficacy of chemotherapy regimens and improve patient chemotherapeutic response, and even treat multidrug resistance. However, there are several challenges associated with methylated ctDNA, such as low sensitivity and specificity at single-target sites, limited association between some gastric cancer subtypes and ctDNA, off-target risks, and the lack of large-scale and high-quality clinical research evidence. This review mainly summarizes current research on the methylation status of ctDNA in gastric cancer and connects these findings to early screening, recurrence monitoring, and potential treatment opportunities for gastric cancer. With advances in technology and the deepening of interdisciplinary research, ctDNA detection will reveal more disease information and become an essential foundation for gastric cancer research and precision medicine treatment.

To analyze the factors associated with infection and death of carbapenem-resistant Klebsiella pneumoniae (CRKP) in patients. Using a case-control study method, patients with CRKP infection from January 2019 to December 2021 in the 3201 Hospital were selected as the case group, and patients with carbapenem-susceptible Klebsiella pneumoniae (CSKP) infection in the same period were selected as the control group in a ratio of 1∶1. The study subjects were followed up for 30 days. The two groups of patients were categorized into survival and death groups based on whether they died or not, respectively, and the 30-day morbidity and mortality rates of the CRKP case group and the CSKP control group were compared. The logistic regression model was used to analyze the factors associated with CRKP infection and death after CRKP infection. This study included 59 cases in the CRKP case group and 59 in the CSKP control group. The 30-day mortality rate of CRKP-infected patients and CSKP-infected patients were 30.5% (18/59) and 5.1% (3/59), with statistically significant differences ( P<0.001). Surgery within three months prior to KP infection ( OR=17.285, P=0.001), use of carbapenems within three months prior to KP infection ( OR=11.235, P=0.002), use of more than three types of antibiotics ( OR=7.993, P=0.016), albumin<30 g/L in patients prior to KP infection ( OR=10.463, P=0.002), sex ( OR=0.078, P<0.001), and diabetes ( OR=0.076, P=0.011) were associated factors of CRKP infection. Higher age-corrected Charlson Comorbidity Index scores of patients ( OR=1.522, P=0.024) and use of carbapenems by the patients with in the first three months prior to the KP infection ( OR=4.902, P=0.029) were associated factors for the deaths of patients with CRKP. In conclusion, medical personnel should be cautious in performing invasive procedures, strictly control the use of antibiotics, and provide targeted protection and treatment for high-risk patients as soon as possible.

To analyze the factors associated with infection and death of carbapenem-resistant Klebsiella pneumoniae (CRKP) in patients. Using a case-control study method, patients with CRKP infection from January 2019 to December 2021 in the 3201 Hospital were selected as the case group, and patients with carbapenem-susceptible Klebsiella pneumoniae (CSKP) infection in the same period were selected as the control group in a ratio of 1∶1. The study subjects were followed up for 30 days. The two groups of patients were categorized into survival and death groups based on whether they died or not, respectively, and the 30-day morbidity and mortality rates of the CRKP case group and the CSKP control group were compared. The logistic regression model was used to analyze the factors associated with CRKP infection and death after CRKP infection. This study included 59 cases in the CRKP case group and 59 in the CSKP control group. The 30-day mortality rate of CRKP-infected patients and CSKP-infected patients were 30.5% (18/59) and 5.1% (3/59), with statistically significant differences ( P<0.001). Surgery within three months prior to KP infection ( OR=17.285, P=0.001), use of carbapenems within three months prior to KP infection ( OR=11.235, P=0.002), use of more than three types of antibiotics ( OR=7.993, P=0.016), albumin<30 g/L in patients prior to KP infection ( OR=10.463, P=0.002), sex ( OR=0.078, P<0.001), and diabetes ( OR=0.076, P=0.011) were associated factors of CRKP infection. Higher age-corrected Charlson Comorbidity Index scores of patients ( OR=1.522, P=0.024) and use of carbapenems by the patients with in the first three months prior to the KP infection ( OR=4.902, P=0.029) were associated factors for the deaths of patients with CRKP. In conclusion, medical personnel should be cautious in performing invasive procedures, strictly control the use of antibiotics, and provide targeted protection and treatment for high-risk patients as soon as possible.

Objective To propose a frequency-domain pulse wave prediction model based on fusion attention mechanism,improving the low classification accuracy and poor generalization performance of hypertension time-domain pulse wave classification based on artificial intelligence technology.Methods Firstly,the time-domain pulse wave was transformed into frequency-domain Mel-scale frequency cepstral coefficient features to enhance its discriminability.Then,temporal convolutional network and Transformer structures were employed to extract the deep features of pulse waves,and self-attention mechanism and selective kernel attention were combined for decision fusion to extract relevant features.Floodings regularization method was used to indirectly control the training loss and prevent overfitting.A 5-fold cross-verification experiment was conducted based on 527 clinical pulse diagnosis data provided by Longhua Hospital,Shanghai University of Traditional Chinese Medicine and Shanghai Traditional Chinese Medicine-Integrated Hospital.Additionally,the extreme gradient boosting algorithm was employed to calculate the contribution rate ranking of frequency-domain pulse wave features,and the key factors affecting the classification accuracy of the model were analyzed to provide reference for the clinical auxiliary diagnosis of traditional Chinese medicine.Results The evaluation metrics accuracy,F1 score,precision,recall rate and area under curve value of the model proposed in this study were 0.939 6,0.924 9,0.940 9,0.929 5,and 0.993 4,respectively.The static characteristics of the pulse wave,the contribution rate of the first-order difference and the second-order difference coefficients were relatively balanced,indicating that the degree of hypertension risk was not only related to the static characteristics of the pulse wave,but also to the dynamic characteristics of the pulse wave.Conclusion The proposed model has higher classification accuracy and generalization performance compared to typical pulse wave classification models.

Objective To analyze the clinical distribution characteristics,drug resistance,and homology of carbapenem resistant Escherichia coli(CRE)isolated from a tertiary hospital from 2019 to 2023,in order to provide a basis for rational drug use and hospital infection prevention and control.Methods A retrospective a-nalysis was conducted on non repetitive CRE strains clinically isolated from 2019 to 2023 in the hospital.WHONET 5.6 software was used to analyze the isolation rate,clinical distribution characteristics,and patho-gen resistance of CRE strains.CRE strains clinically isolated in 2022 in the hospital were collected as research objects,and the resistance gene expression and homology with hospital acquired infection clones were detected through polymerase chain reaction amplification and sequence analysis.Results From 2019 to 2023,a total of 455 non duplicated CRE strains were detected in clinical specimens of the hospital,with a detection rate of 6.00％.The annual detection rates were 72 strains(6.59％)in 2019,91 strains(8.31％)in 2020,117 strains(7.99％)in 2021,78 strains(4.76％)in 2022,and 97 strains(4.24％)in 2023.The CRE detection rates showed a downward trend from 2020 to 2023(P＜0.05).The top two strains in terms of proportion among CRE strains were 324 strains(71.21％)of carbapenem resistant Klebsiella pneumoniae(CRKP)and 57 strains(12.53％)of carbapenem resistant Escherichia coli(CREC).In addition,the detection rate of CRKP showed a decreasing trend from 2021 to 2023,while the detection rate of CREC showed an increasing trend from 2021 to 2023(P＜0.05).The strains mainly came from intensive care medicine,geriatrics,and neurology departments.Most of the CRE strains were isolated from sputum samples,with a detection rate of 67.96％,followed by urine samples with a detection rate of 21.97％.CRE had a very high resistance to common clinical antibiotics,with resistance rates of 94.32％and 96.37％to ertapenem and imipenem,respectively.Out of 78 strains of CRE,55 strains(70.51％)were found to have blaKPC-2 genotype and 14 strains(17.95％)were found to have blaNDM genotype.The detection rate of CRKP MLST typing ST11 was 68.89％(31/45).Con-clusion The detection rate of CRE in the hospital is showing a downward trend,but the resistance of the strains is still high.CRKP is the main strain of CRE strains,mainly carrying blaKPC-2 gene,and ST11 type is the main one.Clinical departments(especially critical care departments)should choose antibiotics reasonably based on the results of drug sensitivity tests for treatment and strengthen hospital management to further curb the growth of CRE.