The Pharmacopeia of the People’s Republic of China 2025 Edition (referred to as the Chinese Pharmacopoeia 2025 Edition, ChP 2025) will be promulgated and implemented. This article introduces the process of development of ChP 2025 Edition (Volume Ⅱ), including the selection, the revision of general notices,the addition and revision of drug monographs, etc., and provides some analysis and examples to illustrate,which can facilitate the readers to understand and implement the ChP 2025 Edition (Volume Ⅱ).

Objective To understand the application effect of early screening scale and behavioral intervention effect in children with autism spectrum disorder (ASD). Methods A total of 348 children with suspected ASD were selected and evaluated using the Modified Checklist for Autism in Toddlers (M-CHAT) and Autism Behavior Checklist (ABC). The evaluation results were compared with those from the Diagnostic and Statistical Manual of Mental Disorders (DSM-V). Children enrolled were given Early start Denver model (ESDM) intervention. The evaluation results of Gesell Developmental Scale and Autism Treatment Evaluation Checklist (ATEC) scores were compared before and after intervention. Results The sensitivity, specificity, accuracy and Kappa value of M-CHAT for evaluating ASD in children aged 1-3 years were 89.53%, 90.70%, 89.92% and 0.78. The corresponding values of ABC were 78.49%, 81.40%, 79.46% and 0.56. The sensitivity, specificity, accuracy and Kappa value of M-CHAT for evaluating children aged >3-6 years were 87.30%, 77.78%, 84.44% and 0.64. The corresponding values of ABC were 85.71%, 77.78%, 83.33% and 0.62. The sensitivity and accuracy of M-CHAT were higher than ABC for evaluating ASD in children aged 1-3 years (P<0.05). There were no significant differences in sensitivity, specificity and accuracy between M-CHAT and ABC for evaluating ASD in children aged 3-6 years (P>0.05). After intervention, development quotients (DQ) of personal-social aspects, adaptability, language, gross motor, and fine motor of children with ASD were higher than those before intervention (P<0.05). ATEC scores for language, behavior, sensation, and social contact of children with ASD were lower than those before intervention (P<0.05). Conclusion M-CHAT and ABC both can be used for early screening of ASD in children, especially M-CHAT. Early behavioral intervention can effectively improve the condition and developmental level of children with ASD.

Humans ; Urinary Bladder Neoplasms/pathology* ; Carcinoma, Transitional Cell/pathology* ; Genetic Markers ; Biomarkers, Tumor/genetics* ; Urothelium/pathology*

ObjectiveTo construct traditional Chinese medicine （TCM） diagnostic scale of turbid toxin syndrome in order to provide corresponding reference for the standardization of TCM syndromes and studies. MethodsWe systematically searched the Chinese Medical Dictionary （CMD）， China Knowledge Network （CNKI）， Wanfang Data Knowledge Service Platform （WF） and VIP database for TCM classics and modern literature on turbid toxin syndrome， and initially screened the four diagnosis information of turbid toxin syndrome， established a pool of information entries， and conducted a cross-sectional clinical survey. Discrete trend method， correlation coefficient method， Cronbach's coefficient method， and factor analysis method were applied to objectively screen the entries. The diagnostic scale of turbid toxin syndrome were constructed through three rounds of Delphi method expert survey to determine the scale entries， using hierarchical analysis to get the judgement matrix scores and relative weight of each entry， after passing consistency test and then isometric expansion of the relative weight of the entries to get the weight of each entry and assign the value. ResultsA total of 35 articles were included， 45 entries were obtained after the initial screening. After the clinical investigation， 12 entries were not suitable by the discrete trend method， 23 entries not suitable by correlation coefficient method， 13 entries by the internal consistency screening were removed with the Cronbach's alpha coefficient rising， and 10 entries not suitable by the factor analysis method. Twenty-two entries were retained after objective screening by the combined use of the four statistical methods. The positive coefficients of experts in the three rounds of Delphi method of expert consultation were 96.67%， the coefficients of expert authority were 0.834， 0.856， and 0.867， and the coefficients of co-ordination were 0.126， 0.326， and 0.312， respectively. After consulting with clinical experts， and three rounds of Delphi method survey and hierarchical analysis method weight assignment， the diagnostic scale entries of turbid toxin syndrome were finally established. Primary symptoms： dark red or purple and dusky tongue， yellowish greasy or dry coating （10 points）； sticky and unpleasant stools （8 points）； disharmony of tastes including halitosis， sticky and greasy taste in the mouth， dry mouth and bitter taste in the mouth （6 points）； unfavourable or yellowish or red urination （5 points）； and dark complexion （4 points）. Secondary symptoms： heavy body （3 points）； dizziness （3 points）； profuse， sticky， foul-smelling secretions （2 points）； wiry and slippery， or slippery， or slippery and rapid pulse （2 points）； feeling of hardness in the abdomen （1 point）. ConclusionUsing Delphi method combined with the hierarchical analysis method， combining qualitative and quantitative study， a diagnostic scale of turbid toxin syndrome was initially developed.

ObjectiveTo observe the effectiveness and safety of the Chinese herbal medicine Mingshi Granules （明视方颗粒） for low myopia in children with heart yang insufficiency. MethodsA multicentre， prospective， double-blind randomised controlled study was conducted， in which 290 children with low myopia from 8 centres were randomly divided into 145 cases in the treatment group and 145 cases in the control group， and the treatment group was given education， dispensing glasses， and Chinese herbal medicine Mingshi Granules， while the control group was given education， dispensing glasses， and granules placebo. Both Mingshi Granules and placebo granules were taken orally， 1 bag each time， twice daily， 4 weeks of oral intake and 2 weeks of rest as 1 course of treatment， a total of 4 courses of treatment （24 weeks）. Equivalent spherical lenses， best naked-eye distance visual acuity， ocular axis， corneal curvature K1， adjustment amplitude， traditional Chinese medicine （TCM） symptom scores， calculate the amount of progression of equivalent spherical lenses， were observed at the 12th and the 24th week of treatment， at the 36th week and 48th week of follow-up， resectively， the control rate of myopia progression was evaluated at the 24th week， and safety indexes were observed before treatment. ResultsThe amount of progression of equivalent spherical lenses was lower in the treatment group than in the control group at the 48-week follow-up （P＜0.05）. The control rate of myopia progression at 24 weeks after treatment in the treatment group was higher （57.60%， 72/125） than that in the control group （44.63%， 54/121） （P＜0.05）. The best naked-eye distance visual acuity at 36-week follow-up in the treatment group was higher than that in the control group （P＜0.05）. Equivalent spherical lenses were significantly lower in both groups at all observation time points compared with pre-treatment （P＜0.05）， and were higher in the treatment group than in the control group at the 48-week follow-up （P＜0.05）. The ocular axes of both groups were significantly higher at each observation time point after treatment and at follow-up compared with before treatment （P＜0.05）. The amount of eye axis growth in the treatment group was lower than that in the control group at 24 weeks after treatment and at the 48-week follow-up （P＜0.05）. Corneal curvature K1 was significantly lower in the treatment group at the 24th week of treatment compared to pre-treatment （P＜0.05）. The magnitude of adjustment in the treatment group was significantly higher at the 36-week follow-up and at the 48-week follow-up than before treatment （P＜0.05）. The scores of white/dark complexion， white coating thin pulse， fatigue and total TCM symptom scores of children in both groups at the 12th， 24th， 36th and 48th weeks of follow-up were significantly lower than those before treatment （P＜0.05）； the scores of blurred vision at the 24th and 36th weeks of follow-up were significantly lower than those before treatment （P＜0.05）； and the scores of blurred vision in the treatment group at the 48th week of follow-up were signi-ficantly lower than those before treatment （P＜0.05）. In the treatment group， the score of fatigue was higher than that of the control group at the 36-week follow-up， and the score of blurred vision was lower than that of the control group at the 48-week follow-up （P＜0.05）. No adverse reactions or obvious abnormalities of the safety indexes were observed of the two groups during the treatment. ConclusionChinese herbal medicine Mingshi Granules showed the effect of controlling the progression of low myopia， improving the best naked eye distance visual acuity， slowing down the growth of the eye axis， improving some of the TCM symptoms， with good safety.

Objective:To investigate respiratory virus infection in children with septic shock in pediatric care units (PICU) in China and its influence on clinical outcomes.Methods:The clinical data of children with septic shock in children′s PICU from January 2018 to December 2019 in 10 Chinese hospitals were retrospectively collected. They were divided into the pre-COVID-19 and post-COVID-19 groups according to the onset of disease, and the characteristics and composition of respiratory virus in the 2 groups were compared. Matching age, malignant underlying diseases, bacteria, fungi and other viruses, a new database was generated using 1∶1 propensity score matching method. The children were divided into the respiratory virus group and non-respiratory virus group according to the presence or absence of respiratory virus infection; their clinical characteristics, diagnosis, and treatment were compared by t-test, rank sum test and Chi-square test. The correlation between respiratory virus infection and the clinical outcomes was analyzed by logistic regression. Results:A total of 1 247 children with septic shock were included in the study, of them 748 were male; the age was 37 (11, 105) months. In the pre-and post-COVID-19 groups, there were 530 and 717 cases of septic shock, respectively; the positive rate of respiratory virus was 14.9% (79 cases) and 9.8% (70 cases); the seasonal distribution of septic shock was 28.9% (153/530) and 25.9% (185/717) in autumn, and 30.3% (161/530) and 28.3% (203/717) in winter, respectively, and the corresponding positive rates of respiratory viruses were 19.6% (30/153) and 15.7% (29/185) in autumn, and 21.1% (34/161) and 15.3% (31/203) in winter, respectively. The positive rates of influenza virus and adenovirus in the post-COVID-19 group were lower than those in the pre-COVID-19 group (2.1% (15/717) vs. 7.5% (40/530), and 0.7% (5/717) vs. 3.2% (17/530), χ2=21.51 and 11.08, respectively; all P<0.05). Rhinovirus virus were higher than those in the pre-Covid-19 group (1.7% (12/717) vs. 0.2% (1/530), χ2=6.51, P=0.011). After propensity score matching, there were 147 cases in both the respiratory virus group and the non-respiratory virus group. Rate of respiratory failure, acute respiratory distress, rate of disseminated coagulation dysfunction, and immunoglobulin usage of the respiratory virus group were higher than those of non-respiratory virus group (77.6% (114/147) vs. 59.2% (87/147), 17.7% (26/147) vs. 4.1% (6/147), 15.6% (25/147) vs. 4.1% (7/147), and 35.4% (52/147) vs. 21.4% (32/147); χ2=11.07, 14.02, 11.06 and 6.67, all P<0.05); and PICU hospitalization of the former was longer than that of the later (7 (3, 16) vs. 3 (1, 7)d, Z=5.01, P<0.001). Univariate logistic regression analysis showed that the presence of respiratory viral infection was associated with respiratory failure, disseminated coagulation dysfunction, the use of mechanical ventilation, and the use of immunoglobulin and anti-respiratory viral drugs ( OR=2.42, 0.22, 0.25, 0.56 and 1.12, all P<0.05). Conclusions:The composition of respiratory virus infection in children with septic shock is different between pre and post-COVID-19. Respiratory viral infection is associated with organ dysfunction in children with septic shock. Decreasing respiratory viral infection through respiratory protection may improve the clinical outcome of these children.

Objective:The classification model of prognosis of elderly cancer patients in rural areas of Shaanxi province was constructed based on machine learning algorithm, and its effectiveness was verified, providing reference for early prognosis recognition and intervention treatment.Methods:Using a multicenter, cross-sectional survey method and convenience sampling method, 597 elderly cancer patients in rural areas hospitalized in 9 different medical institutions (Shaanxi Cancer Hospital and its member units of specialty alliance) in Shaanxi Province from July to August 2022 were selected as the research objects, and a variable database of "basic information", "self-care ability", "symptoms", "comprehensive needs" and "quality of life" of elderly cancer patients in rural areas was established. Machine learning and statistical analysis were carried out to explore the important prognostic characteristics of elderly cancer patients in rural areas, and a prognostic classification model for elderly cancer patients in rural areas was constructed and verified.Results:The 597 valid questionnaires were ultimately collected.Among the 597 elderly cancer patients in rural areas, 207 were males and 390 were females, aged (69.56 ± 8.84) years. The results of cluster exploration showed that the prognosis of elderly cancer patients in rural areas was divided into three categories: good, medium and poor. The areas under the working characteristic curves of the subjects in good, medium and poor were 0.84, 0.79 and 0.69, respectively. The results of characteristic exploration showed that 10 indicators of "whether accompanied by metastasis", "distress", "sadness", "numbness", "eating", "walking", "fatigue", "forgetfulness", "fun of life" and "relationship with others" were important characteristic indicators of prognosis evaluation of elderly cancer patients in rural areas. There were statistically significant differences among the 10 important characteristic indicators in the three categories of prognosis of rural elderly cancer patients ( χ2=21.07, H values were 18.51-144.38, all P<0.01). There were statistically significant differences in the three categories of "comprehensive needs", "quality of life", "self-care ability" and "symptoms" ( H values were 519.40, 40.80, 103.69, all P<0.01). Conclusions:The construction and verification of a prognostic classification model for elderly cancer patients in rural areas based on machine learning algorithm can effectively explore the important characteristic indicators and prognostic classification of elderly cancer patients in rural areas, and provide basis and guidance for clinical medical staff to make individualized plans.

Objective To explore the relationship between hyperkalemia and adverse outcomes in elderly maintenance hemodialysis(MHD)patients.Methods A retrospective cohort trial was conducted on 177 MHD patients aged≥60 years in the hemodialysis center of Beijing Shijitan Hospital,Capital Medical University.Baseline data were collected.The mean age was(77.28±14.25)years,among them 109 cases were males(61.6%).According to the peak serum potassium within 4 months,patients were divided into the K+＜5.0 mmol/L group(38 cases,21.5%),the 5.0-5.5 mmol/L group(42 cases,23.7%)and the K+≥5.5 mmol/L group(97 cases,54.8%).Based on the frequency of hyperkalemia within 4 months,patients were divided into the 0,1-2 and 3-4 frequency groups.All of patients were followed up for 1 year.The end point events were all-cause mortality and cardiovascular disease(CVD)mortality.Kaplan-Meier survival analysis was used to compare the cumulative survival rate between the 3 groups.A multivariate Cox regression model was employed to analyze the relationship between the degree and frequency of hyperkalemia with all-cause and CVD mortality.Results The mean follow-up time of 177 patients was 12(1-12)months,20(11.3%)patients died of all-cause death and 14(7.9%)of CVD death.Kaplan Meier survival curve showed cardiovascular mortality rate and all-cause mortality were significantly increased in the K+5.0-5.5 mmol/L group and the K+≥5.5 mmol/L group(both P＜0.05).Multivariate Cox regression analysis indicated that,as a continuous variable,peak potassium levels were independently associated with an increased risk of all-cause death and CVD death(P＜0.001).As a categorical variable,the all-cause mortality risk and CVD mortality risk were significantly higher in both the K+5.0-5.5 mmol/L group and the K+≥5.5 mmol/L group than those in the K+＜5.0 mmol/L group(P＜0.05),and those were significantly higher in the 1-2 and 3-4 frequency groups than those in the 0 frequency group of hyperkalemia(P＜0.05).Conclusion Serum potassium>5.0 mmol/L in elderly MHD patients is an independent risk factor for all-cause and CVD mortality.It is recommended to adjust the upper limit of the normal range of serum potassium to 5.0 mmol/L.

Objective To investigate current status in knowledge,attitude and practice(KAP)of transitional care among the nurses in Shaanxi province,identify the influencing factors that hinder the transitional care and carry out training of transitional care for the nurses in different specialties in order to provide a theoretical basis for establishing a transitional care model for discharged patients.Methods A total of 2 288 nurses were selected to participate the survey from 41 hospitals in Shaanxi province by the stratified two-stage random sampling method.A self-designed questionnaire for general information,an obstacle factor scale,and a KAP of transitional care questionnaire were used as the survey instruments.The data acquired from the survey were processed by Cluster analysis to identify potential categories and the influencing factors.Results Totally 2085 nurses finished the study.Total score of KAP of transitional care among the nurses in Shaanxi province was found at(134.96±23.75),which was at a medium level.The scores of knowledge,attitude and practice were 77.24%,80.64%and 76.98%respectively.Cluster analysis showed that all the nurses could be categorised into either a lower scored group(n=1 596,76.5%)or a higher scored group(489,23.5%),with a best potential category number of 2 for the 2 085 nurses who participated the survey.There were statistically significant differences between the groups in terms of care training,telephone follow-up,network platform,outpatient service of nursing experts,family visits,patient club and hospital categories(all P＜0.05).Logistic regression analysis on even factors above showed that care training,telephone follow-up,network platform and patient club could significantly affect the potential categorisation of KAP of the nurses in transitional care(all P＜0.05).The main factors that hindered the transitional care included insufficient human resources(93.81%),insufficient supply of community services(93.57%)and lack of a standardised flowchart for transitional care(93.09%).Conclusions Levels of KAP about the transitional care are at a medium level among the nurses of 41 hospitals in Shaanxi province,which indicates that the nurses are active in attitude,but the knowledge and practice are required to be further improved and standardised.The results of cluster analysis indicate that it is necessary for nursing managers to carry out targeted trainings in transitional care for the nurses in different categories.This study provides a theoretical basis to establish a diversified transitional care mode for discharged patients in Shaanxi province.

Objective:To investigate the endoscopic and histopathological features, diagnosis and differential diagnosis of gastric hamartomatous inverted polyp (GHIP).Methods:Five cases of GHIP were collected at the University Town Hospital of Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China, from May 2021 to May 2023. The endoscopic, pathological and immunohistochemical features of the 5 GHIP cases were analyzed. The relevant literature was reviewed.Results:There were 3 males and 2 females, aged from 49 to 60 years, with a mean age of 56 years. The lesions were located in the fundus and body of the stomach, and presented as polyps or masses under endoscopy. Microscopically, the lesions were mainly in the submucosa and consisted of lobulated or clustered gastric glandular epithelium surrounded by hyperplastic smooth muscle. In some areas, there were differentiated glandular elements mimicking the normal gastric mucosa. The irregularly dilated glandular elements in the center were lined by hyperplastic foveolar epithelium, while the glands in the periphery were fundic or pyloric glands. In addition, in some areas, the glands showed cystic expansion, disordered arrangement and lack of differentiation. The hyperplastic glandular epithelium included foveolar epithelium, fundic gland and pyloric gland. There were scattered neuroendocrine cells and smooth muscle bundles in the stroma. Immunohistochemically, the tumor cells were positive for MUC5AC, MUC6, Pepsinogen Ⅰ and H +/K + ATPase β, but negative for MUC2. The scattered neuroendocrine cells were positive for synaptophysin, and the desmin stain highlighted hyperplastic smooth muscle bundles. One case was classified as type 2 gastric inverted polyp, and 4 cases were classified as type 3. Conclusions:GHIP is a rare gastric polyp with unique histological features. It should be distinguished from inverted hyperplastic polyp, gastritis cystica profunda, adenomyoma, hyperplastic polyps and well-differentiated gastric tubular adenocarcinoma, etc. Improving the understanding of its pathogenesis and diagnostic features can help avoid misdiagnoses.