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.

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.

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 investigate the prognosis and influencing factors of different treatment strategies in T 3-T 4 nasal sinus adenocarcinoma. Methods:The data of 93 cases of T 3-T 4 stage nasal sinus adenocarcinoma diagnosed from 2006 to 2018 were retrospectively analyzed. All patients were divided into combined operation group and non-operation group. The survival status and failure mode after corresponding treatment were analyzed. The enumeration data were analyzed by Chi-square test or Fisher's exact test. Survival analysis was performed by Kaplan-Meier method. Univariate analysis was conducted by log-rank test. Multivariate prognostic analysis was performed by Cox model. Results:The average follow-up time in the whole cohort was 81.3 months (18-156 months). By the end of follow-up, a total of 38.7% (36/93) of patients had local recurrence, 14.0% (13/93) had distant metastasis, 17.2% (16/93) had local recurrence complicated with distant metastasis, and 28.0% (26/93) were stable. The overall 2-, 5-, and 10-year overall survival (OS) and progression free survival (PFS) rates were 83.5%, 59.3%, 31.8% and 73.6%, 40.7% and 25.3%, respectively. In univariate analysis, the PFS and OS of patients aged 46-64 years old (all P<0.001), male ( P=0.022, P=0.001), patients with lesions located in the maxillary sinus ( P=0.001, P<0.001), adenoid cystic carcinoma ( P=0.001, P<0.001), non-invasion of orbital / clivus ( P=0.041, P<0.001), GTV P dose>64 Gy ( P=0.003, P=0.006) and N 1 stage ( P=0.014, P=0.014) were statistically different among different treatment modes. Multivariate analysis showed that age ≥65 years old ( P=0.012, P=0.005), orbital / clival invasion ( P<0.001, P=0.005), and GTV p dose ≤64 Gy ( P<0.001, P=0.011) were the independent adverse prognostic factors affecting PFS and OS in T 3-T 4 stage nasal sinus adenocarcinoma. Conclusions:The local failure rate of T 3-T 4 stage nasal sinus adenocarcinoma is high after treatment. Age, orbital / clival invasion, and GTV p dosage are the independent adverse prognostic factors. Surgery based intervention is superior to other treatment strategies.

Objective:To investigate the clinical value of changes in peripheral NKT cells and tumor abnormal proteins (TAPs) in stage Ⅲ-Ⅳ B head and neck squamous cell carcinoma (HNSCC) before and after radiotherapy. Methods:A retrospective analysis was performed using the data of 101 HNSCC patients, who were confirmed from January 2019 to December 2021 and treated with radical and postoperative radiotherapy. Flow cytometry and the agglutination method were used to determine the proportion of NKT cells in peripheral blood and the TAP coagulation area, respectively before and after radiotherapy. The relationships of clinical features and the cellular features such as changes in NKT cells and ATPs with local recurrence and long-term survival were analyzed. The χ2 test or Fisher′s exact test was employed for intergroup comparison. The Kaplan-Meier method and the Cox model were utilized for univariate and multivariate survival prognosis analyses, respectively. The bivariate Pearson linear correlation analysis was conducted to analyze the relationship between NKT and TAP. Results:The median follow-up time of the whole group was 25 months. Regarding the 1-, 2-, and 3-year survival rates, the local-regional recurrence-free survival (LRRFS) rates were 76.2%, 67.3%, and 64.4%, respectively, the distant metastasis-free survival (DMFS) rates 91.1%, 90.1%, and 89.1%, respectively, and the progression-free survival (PFS) rates 69.3%, 59.4%, and 55.4%, respectively. The 3-year overall survival (OS) rate was influenced by age, surgery, N stage, TNM stage, NKT cell ratio, and TAP, while the 3-year PFS rate was affected by TAP, sex, N stage, and TNM stage. Multivariate analysis suggests that independent adverse prognostic factors for HNSCC included sex, age, N stage, NKT cells, and TAP ( HR=3.00, 2.35, 2.27, 2.02, 2.56, P<0.05). The correlation analysis indicates a positive correlation between NKT cells and TAP ( r=0.26, P=0.009). Conclusions:Stage Ⅲ-Ⅳ B HNSCC treated with radical and postoperative radiotherapy is subjected to a high recurrence rate. Further research is required for the expression levels of NKT cells and TAP in peripheral blood, as well as the influence of their changes during radiotherapy on the 3-year OS, PFS, and LRRFS rates of locally advanced HNSCC.

Objective:To explore the effect of core stability training on rehabilitation of patients after lumbar fusion.Methods:From June 2018 to December 2019, 90 patients with lumbar fusion admitted to Wuxi Second Hospital Affiliated to Nanjing Medical University were selected by convenience sampling. The patients were divided into control group and training group according to the method of random number table, with 45 cases in each group. The control group received routine postoperative rehabilitation nursing, while the training group carried out postoperative core stability training nursing. The rehabilitation effects of the two groups were observed.Results:The scores of Numerical Rating Scale (NRS) in the training group were lower than those in the control group at 2, 4, 12 and 24 weeks postoperatively, and the difference were statistical ( P<0.05) . The scores of Oswestry Disability Index (ODI) in the training group 12 and 24 weeks after operation were lower than those in the control group, with statistically significant differences ( P<0.05) . Conclusions:The core stability training nursing is helpful to improve the functional recovery after lumbar fusion, reduce the degree of postoperative pain, and then increase the rehabilitation effect of patients.

Objective:To explore the clinical value of Ki-67 and human epidermal growth factor receptor 2 (HER-2) in salivary duct carcinoma in stage Ⅲ-Ⅳ A. Methods:The data of 52 cases of locally advanced salivary duct carcinoma(SDC) diagnosed from January 2012 to December 2020 were retrospectively analyzed. All patients underwent radical surgery and postoperative radiotherapy. Among them, 15.4% of patients had local recurrence, 28.8% had distant metastasis, 17.3% had regional recurrence with distant metastasis. The relationship between clinical features, pathological features such as Ki-67 and HER-2 and prognosis such as local recurrence and distant metastasis was analyzed.Results:The average follow-up time was 37.6 months. The 1- and 2-year local recurrence free survival, distant metastasis free survival, progression free survival were 86.5%, 73.1%, 65.4% and 67.3%, 55.8%, 46.2% respectively. The 3-year progression free survival rate was 33.3%. Comparison between groups showed that age ≥ 65 years old, T stage, TNM stage, vascular tumor thrombus, radiotherapy dose <60 Gy, Ki-67 positive index and HER-2 positive were related to the prognosis of different stages. In multivariate analysis, only age, Ki-67 positive index ≥ 60% and HER-2 protein (3+ ) were independent poor prognostic factors for locally advanced SDC ( t =5.16, 9.84, 8.23, P<0.05). Conclusions:In stage Ⅲ-Ⅳ A SDC, only radical surgery and postoperative radiotherapy have a high rate of distant metastasis. Ki-67 positive index and HER-2 positive are independent adverse prognostic factors.

Objective:To evaluate the effect of reducing clinical target volume (CTV) on local control and overall survival in postoperative intensity-modulated radiotherapy (IMRT), and analyze the patterns of failure, aiming to provide clinical basis for postoperative IMRT delineation of CTV for parotid gland cancer in the era of precision radiotherapy.Methods:Clinical data of 126 patients who were pathologically diagnosed with parotid gland cancer and treated with parotidectomy as well as postoperative radiotherapy were retrospectively analyzed. All patients were divided into two groups according to the prozone of CTV. It was delineated to the anterior border of parotid gland in group A, and delineated to the anterior border of masseter in group B. Actuarial estimates of local recurrence-free survival, regional recurrence-free survival, distant metastasis-free survival and overall survival were obtained with the Kaplan-Meier method. Univariate prognostic analysis was performed by log-rank test. Multivariate prognostic analysis was conducted by Cox regression model.Results:The 5-year local recurrence-free survival (LRFS), regional recurrence-free survival (RRFS), distant metastasis-free survival (DMFS) and overall survival (OS) in groups A and B were 96.7% vs. 91.3%, 96.7% vs. 90.2%, 86.9% v s. 81.3% and 86.0% vs. 81.4%, respectively. There were no significant differences in these parameters between two groups. Of 126 patients with parotid carcinoma, 7 had local recurrence. There were 2 cases in group A which 1 recurred in-field and 1 recurred out- field. And there were 5 cases in group B which 4 recurred in-field and 1 recurred marginally. Univariate analysis showed that age was associated with LRFS. Age, N stage and pathological grading were associated with OS. Cox multivariate analysis revealed that age, N stage and pathological grading were the independent influencing factors of OS. Conclusions:Reducing the CTV would not increase the risk of local recurrence in patients with parotid gland carcinoma without tumor extravasation and negative surgical margins. There is no significant difference in survival benefit compared to those delineated to the anterior border of the masseter muscle. The delineation of CTV should be treated differently according to the risk factors.