The Pharmacopoeia of the People’s Republic of China 2025 edition is to be issued in March 2025. Chinese Pharmacopoeia is the basic requirements on the drug manufacture, drug testing, drug use and drug administration. The new edition Chinese Pharmacopoeia will be dramatically improved on the pharmacopoeia monographs included, establishing the standards system, standards conversion and application of drug quality control for the new technology, new method & new tool, drug control on the safety and effectiveness as well as the drug standard international harmonization. It will take important role on improving the drug quality, ensuring the safety of drugs for public use, strengthen technical support for drug administration, promoting the high-quality development of China’s medical and pharmaceutical industry. This paper introduces the development and revision of the Chinese Pharmacopoeia 2025 Edition,aim at helping the industries well understanding and implantation the new edition Chinese Pharmacopoeia.

The Pharmacopoeia of the People's Republic of China 2025 edition is to be issued in March 2025.Chinese Pharmacopoeia is the basic requirements on the drug manufacture,drug testing,drug use and drug admin-istration.The new edition Chinese Pharmacopoeia will be dramatically improved on the pharmacopoeia monographs included,establishing the standards system,standards conversion and application of drug quality control for the new technology,new method&new tool,drug control on the safety and effectiveness as well as the drug standard international harmonization.It will take important role on improving the drug quality,ensuring the safety of drugs for public use,strengthen technical support for drug administration,promoting the high-quality development of Chi-na's medical and pharmaceutical industry.This paper introduces the development and revision of the Chinese Phar-macopoeia 2025 Edition,aim at helping the industries well understanding and implantation the new edition Chinese Pharmacopoeia.

Objective:To explore the influencing factors for pneumonia occurrence within three months in patients undergoing partial laryngectomy combined with radiotherapy, and to construct a nomogram prediction model for the risk of pneumonia occurrence.Methods:A total of 165 patients with laryngeal squamous cell carcinoma who underwent partial laryngectomy combined with postoperative radiotherapy in the Affiliated Cancer Hospital of Zhengzhou University from 2017 to 2023 were divided into three groups: a group without pneumonia, a low risk pneumonia group, and a medium to high risk pneumonia group according to the occurrence of pneumonia. The receiver operating characteristic (ROC) curve was used to determine the optimal cutoff values of the mean dose to the larynx (Larynx-Dmean) and the mean dose to the pharyngeal constrictor muscles (PCM-Dmean) for predicting the occurrence of pneumonia. Logistic regression analysis was used to screen out the influencing factors of pneumonia within three months after partial laryngectomy combined with radiotherapy, and a nomogram prediction model was constructed.Results:Among the 165 patients, 59 were in the group without pneumonia, 60 were in the group with a low risk of pneumonia, and 46 were in the group with a medium to high risk of pneumonia. The overall incidence of pneumonia was 64.2% (106/165). ROC curve analysis showed that the area under the curve (AUC) of the Larynx-Dmean for predicting the occurrence of pneumonia was 0.876, and the optimal cutoff value was 60.8 Gy. When the Larynx-Dmean was >60.8 Gy, the incidence of pneumonia was 96.7%. The AUC of the PCM-Dmean for predicting the occurrence of pneumonia was 0.747, and the optimal cutoff value was 54.6 Gy. When the PCM-Dmean was >54.6 Gy, the incidence of pneumonia was 74.7%. The AUC of the Larynx-Dmean for predicting the occurrence of medium to high risk pneumonia was 0.987, and the optimal cutoff value was 68.2 Gy. When the Larynx-Dmean was >68.2 Gy, the incidence of medium to high risk pneumonia was 100.0%. The AUC of the PCM-Dmean for predicting the occurrence of medium to high risk pneumonia was 0.850, and the optimal cutoff value was 58.7 Gy. When the PCM-Dmean was >58.7 Gy, the incidence of medium to high risk pneumonia was 85.2%. Multivariate logistic regression analysis showed that the incidence of pneumonia was higher in patients with a history of smoking ( OR=1.54, 95% CI: 1.02-1.74), a higher smoking index ( OR=2.43, 95% CI: 1.16-7.59), a higher Larynx-Dmean ( OR=3.79, 95% CI: 1.25-6.49), and a higher PCM-Dmean ( OR=2.44, 95% CI: 1.53-3.16). A nomogram prediction model for the risk of pneumonia and medium to high risk pneumonia within three months after partial laryngectomy combined with radiotherapy was successfully constructed, with C indices of 0.78 and 0.98, respectively, which had good predictive performance and clinical efficacy. Conclusions:When the Larynx-Dmean was >60.8 Gy and the PCM-Dmean was >54.6 Gy for postoperative radiotherapy after partial laryngectomy, the possibility of pneumonia occurrence in patients within three months increased significantly. Smoking history, smoking index, Larynx-Dmean, and PCM-Dmean were independent influencing factors for the occurrence of pneumonia. The nomogram prediction model constructed based on this can guide clinicians to take intervention measures to prevent the occurrence of pneumonia in patients with laryngeal cancer.

Objective To screen the mutations of ABCC8 gene in probands of maturity-onset diabetes of the young pedigrees,and investigate it sgenetic and clinical characteristics.Methods Whole exome sequencing were performed to screen ABCC8 mutations in 56 MODY probands who were admitted to Department of Endocrinology and Metabolism,Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from July 2021 to December 2023.The mutations were verified by Sanger sequencing,and all participants were genotyped.Clinical phenotypes of the mutation carriers were compared with non-DM controls within the families.The identified mutations were evaluated by bioinformatic softwires.Then the pharmacogenomic characteristics of the mutation carriers were analyzed.Results Two heterozygous mutations D655V and R825Q were identified in two MODY probands and their families respectively,and the D655V was a novel mutation.Bioinformatics studies showed that both mutations were deleterious and pathogenic.In comparison with non-DM controls in the two families,mutation carriers with diabetes exhibited significantly lower fasting insulin/fasting plasma glucose,two-hour postprandial insulin/two-hour postprandial insulin plasma glucose,homeostatic model assessment-β(P<0.05).Treatment with oral hypoglycemic agents such as metformin or insulin in these mutation carriers resulted in a moderate reduction in plasma glucose levels.However,switching to targeted Sulfonylurea's(SUs)proved to be more effective.Conclusions In this study,the prevalence of MODY12 is 3.6%in these MODY pedigrees.The remarkable hypoglycemic efficacy of SUs suggests that both D655V and R825Q were activating mutations of ABCC8,and maybe the cause of MODY12 characterized by impaired insulin secretion.

Objective To screen the mutations of ABCC8 gene in probands of maturity-onset diabetes of the young pedigrees,and investigate it sgenetic and clinical characteristics.Methods Whole exome sequencing were performed to screen ABCC8 mutations in 56 MODY probands who were admitted to Department of Endocrinology and Metabolism,Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from July 2021 to December 2023.The mutations were verified by Sanger sequencing,and all participants were genotyped.Clinical phenotypes of the mutation carriers were compared with non-DM controls within the families.The identified mutations were evaluated by bioinformatic softwires.Then the pharmacogenomic characteristics of the mutation carriers were analyzed.Results Two heterozygous mutations D655V and R825Q were identified in two MODY probands and their families respectively,and the D655V was a novel mutation.Bioinformatics studies showed that both mutations were deleterious and pathogenic.In comparison with non-DM controls in the two families,mutation carriers with diabetes exhibited significantly lower fasting insulin/fasting plasma glucose,two-hour postprandial insulin/two-hour postprandial insulin plasma glucose,homeostatic model assessment-β(P<0.05).Treatment with oral hypoglycemic agents such as metformin or insulin in these mutation carriers resulted in a moderate reduction in plasma glucose levels.However,switching to targeted Sulfonylurea's(SUs)proved to be more effective.Conclusions In this study,the prevalence of MODY12 is 3.6%in these MODY pedigrees.The remarkable hypoglycemic efficacy of SUs suggests that both D655V and R825Q were activating mutations of ABCC8,and maybe the cause of MODY12 characterized by impaired insulin secretion.

Objective:To explore the influencing factors for pneumonia occurrence within three months in patients undergoing partial laryngectomy combined with radiotherapy, and to construct a nomogram prediction model for the risk of pneumonia occurrence.Methods:A total of 165 patients with laryngeal squamous cell carcinoma who underwent partial laryngectomy combined with postoperative radiotherapy in the Affiliated Cancer Hospital of Zhengzhou University from 2017 to 2023 were divided into three groups: a group without pneumonia, a low risk pneumonia group, and a medium to high risk pneumonia group according to the occurrence of pneumonia. The receiver operating characteristic (ROC) curve was used to determine the optimal cutoff values of the mean dose to the larynx (Larynx-Dmean) and the mean dose to the pharyngeal constrictor muscles (PCM-Dmean) for predicting the occurrence of pneumonia. Logistic regression analysis was used to screen out the influencing factors of pneumonia within three months after partial laryngectomy combined with radiotherapy, and a nomogram prediction model was constructed.Results:Among the 165 patients, 59 were in the group without pneumonia, 60 were in the group with a low risk of pneumonia, and 46 were in the group with a medium to high risk of pneumonia. The overall incidence of pneumonia was 64.2% (106/165). ROC curve analysis showed that the area under the curve (AUC) of the Larynx-Dmean for predicting the occurrence of pneumonia was 0.876, and the optimal cutoff value was 60.8 Gy. When the Larynx-Dmean was >60.8 Gy, the incidence of pneumonia was 96.7%. The AUC of the PCM-Dmean for predicting the occurrence of pneumonia was 0.747, and the optimal cutoff value was 54.6 Gy. When the PCM-Dmean was >54.6 Gy, the incidence of pneumonia was 74.7%. The AUC of the Larynx-Dmean for predicting the occurrence of medium to high risk pneumonia was 0.987, and the optimal cutoff value was 68.2 Gy. When the Larynx-Dmean was >68.2 Gy, the incidence of medium to high risk pneumonia was 100.0%. The AUC of the PCM-Dmean for predicting the occurrence of medium to high risk pneumonia was 0.850, and the optimal cutoff value was 58.7 Gy. When the PCM-Dmean was >58.7 Gy, the incidence of medium to high risk pneumonia was 85.2%. Multivariate logistic regression analysis showed that the incidence of pneumonia was higher in patients with a history of smoking ( OR=1.54, 95% CI: 1.02-1.74), a higher smoking index ( OR=2.43, 95% CI: 1.16-7.59), a higher Larynx-Dmean ( OR=3.79, 95% CI: 1.25-6.49), and a higher PCM-Dmean ( OR=2.44, 95% CI: 1.53-3.16). A nomogram prediction model for the risk of pneumonia and medium to high risk pneumonia within three months after partial laryngectomy combined with radiotherapy was successfully constructed, with C indices of 0.78 and 0.98, respectively, which had good predictive performance and clinical efficacy. Conclusions:When the Larynx-Dmean was >60.8 Gy and the PCM-Dmean was >54.6 Gy for postoperative radiotherapy after partial laryngectomy, the possibility of pneumonia occurrence in patients within three months increased significantly. Smoking history, smoking index, Larynx-Dmean, and PCM-Dmean were independent influencing factors for the occurrence of pneumonia. The nomogram prediction model constructed based on this can guide clinicians to take intervention measures to prevent the occurrence of pneumonia in patients with laryngeal cancer.

Objective To evaluate the acceptability and effectiveness of different doses of midazolam oral solution in sedating infants during echocardiographic studies.Methods Two hundred and fourty patients aged 1 to 3 years who underwent echocardiographic study in sedation in our hospital were enrolled in this study.After recording the baseline data of all infants,they were randomly divided into four groups:0.3 mg·kg-1 midazolam oral solution group(M1 group),0.5 mg·kg-1 midazolam oral solution group(M2 group),0.7 mg·kg-1 midazolam oral solution group(M3 group)and 0.5 mL·kg-1 10%chloral hydrate administrated rectally group(C group),60 case per group,and the sedation was performed in the corresponding method of each group.The 5-point facial hedonic and Ramsay scales were used to evaluate acceptability and effectiveness in sedation.The onset time and duration time of sedation were recorded.Results Compared with the C group,the 5-point facial hedonic scale scores in M1,M2,and M3 groups increased during sedation(F=17.50,P<0.017).The onset time of sedation in the M1 and M2 groups was longer than that in the C group(P<0.017),and the duration time of sedation in the M1 and M2 groups was shorter than that in the C group(P<0.017).There was no significant difference in the onset time(P=0.85)and duration time(P=0.50)of sedation between the M3 and C groups.The onset time of sedation in the M1and M2groups was longer than that in the M3 group(P<0.017),and the duration time of sedation in the M1 and M2 groups were shorter than that in the M3 group(P<0.017).Conclusions The acceptability of infants with midazolam oral solution sedation under echocardiographic study was better than that of 10%chloral hydrate administrated rectally.There were fewer adverse reactions with the midazolam oral solution.The 0.7 mg·kg-1 midazolam oral solution had a rapid onset of sedation and definite effect.

Objective To explore the association between R611H(G/A,rs734312)variation of WFS1 gene and early-onset type 2 diabetes mellitus(T2DM).Methods A total of 181 Chinese patients with early-onset T2DM(T2DM group)and 196 non-diabetic controls(NC group)were enrolled in this study.The rs734312 variation was detected by PCR-direct sequencing.Genotypic and allelic frequencies of rs734312 and clinical variables were compared and analyzed between the two groups.Results Compared with the NC group,the frequencies of AA genotype and A allele in R611H(G→A)variation were significantly elevated in the early-onset T2DM group,AA vs GA+GG(OR 1.720,95%CI 1.100～2.680,P<0.05).A vs G(OR 1.500,95%CI 1.020～2.220,P<0.05).The remarkable differences of frequencies of genotype and allele in rs734312(G/A)were observed between Asians(China,Japan and Korea)and Caucasians(Denmark,Britain,Spain,France and Russia,P<0.01 for each).Compared with AA genotype,fasting and 2 hours postprandial insulin(FIns and 2 hIns)as well as HOMA-β were significantly rise in GG+GA genotype carriers of early-onset T2DM group(P<0.05).Conclusions The a allele of rs734312 in WFS1 may be a risk factor for early-onset T2DM in Chinese population,and the variation might be a potential genetic marker for predicting the islet β-cell dysfunction in early-onset T2DM in Chinese population.

Objective To observe the value of multimodal models established combined 18F-FDG PET/CT radiomics with clinical data for evaluating response of locally advanced head and neck squamous cell carcinoma(LA-HNSCC)to neoadjuvant immuno-chemotherapy.Methods Totally 213 LA-HNSCC patients were retrospectively enrolled and randomized into training set(n=170)and test set(n=43)at the ratio of 8∶2.Radiomics features of tumors on 18F-FDG PET/CT were extracted and selected from training set,and the independent clinical predictors were screened with sequential univariate and multivariate logistic regressions.Radiomics models,clinical models and combined multimodal models were constructed using different algorithms,including adaptive boosting(AdaBoost),decision tree,naive Bayes,random forest(RF),support vector machine(SVM)and extreme gradient boosting(XGBoost),respectively.The receiver operating characteristic(ROC)curves were drawn,and the area under the curves(AUC)were calculated to assess the efficacy of each model for predicting the response of LA-HNSCC to neoadjuvant immuno-chemotherapy,and the decision curve analysis(DCA)was performed to explore the net benefit of each model.Results Totally 110 radiomics features were selected,and CD4/CD8 ratio was the independent clinical predictor of the response of LA-HNSCC to neoadjuvant immuno-chemotherapy.Models based on AdaBoost and XGBoost algorithms had high and stable efficacy for predicting tumor response to neoadjuvant immuno-chemotherapy,among which the multimodal models had better performance(AUC=0.943,0.930)than radiomics models(AUC=0.939,0.925)and clinical models(AUC=0.903,0.910)in test set(all P＜0.05).Conclusion Multimodal models established combined 18F-FDG PET/CT radiomics with CD4/CD8 ratio were more effective for predicting response of LA-HNSCC to neoadjuvant immuno-chemotherapy than any single model.

Objective:To investigate the dosimetric factors associated with acute nausea and vomiting (RINV) during intensity modulated radiotherapy for nasopharyngeal carcinoma.Methods:General clinical data and organs at risk (OAR) doses from 130 newly diagnosed early nasopharyngeal carcinoma patients who received radiation therapy alone in Henan Cancer Hospital from February 2018 to February 2023 were retrospectively analyzed. Dosimetric parameters were recorded, and the correlation between the parameters and the degree of nausea and vomiting was statistically analyzed using univariate and multivariate logistic regression models.Results:All 130 patients had symptoms of ≥ grade 1 nausea and vomiting. In the comparison of dosimetric parameters between patients with < grade 2 and ≥ grade 2 nausea, except the brainstem V 20 Gy, all parameters showed statistically significant differences (all P<0.05). The inner ear D max, and D max, D mean, V 10 Gy, V 20 Gy, V 30 Gy of the throat, oral cavity, pharyngeal constrictor, dorsal vagal complex (DVC) showed statistically significant differences between patients with grade 1 and grade 2 nausea (all P<0.05). The results of multivariate regression analysis showed that DVC V 30 Gy was a significant influencing factor in predicting the severity of nausea ( OR=73.95, 95% CI: 4.66-1172.60, P<0.001), and there was a significant correlation between oral V 30 Gy and the severity of vomiting ( OR=37.69, 95% CI: 1.26-1125.42, P=0.04). Conclusions:Even if OAR are exposed to lower doses of radiation, nausea or vomiting symptoms can still occur. The occurrence of RINV is significantly associated with DVC and oral radiation doses.