To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

Objective:To explore the application effect of nurse-led navigation service in the economic toxicity management of prostate cancer patients, and to provide reference for the economic toxicity management of prostate cancer patients.Methods:By using the method of historical control study, 60 patients with prostate cancer admitted to Beijing Friendship Hospital, Capital Medical University were selected as the research subjects by convenience sampling from March to August 2023. According to the time sequence of admission, 30 patients admitted from March to May 2023 were included in the control group, and 30 patients admitted from June to August 2023 were included in the intervention group. The control group was given routine nursing, and the intervention group was given nurse-led navigation service. The patients were evaluated at admission, discharge and 3 months after discharge using the Comprehensive Scores for Financial Toxicity Based on the Patient-Reported Outcome Measures and the Compliance Behavior Questionnaire.Results:The age of the control group patients was ( 70.07 ± 5.76 ) years, and the age of the intervention group was ( 68.80 ± 7.22 ) years. The economic toxicity scores of the intervention group at discharge and 3 months after discharge were ( 35.13 ± 4.84 ) and ( 37.90 ± 4.89 ), respectively, which were higher than those of the control group ( 21.70 ± 2.52 ) and ( 21.33 ± 2.94 ), the differences were statistically significant ( t=-13.48, -15.89, both P<0.05 ). The complete compliance rate of the control group was 46.67 % (14/30), which was lower than 73.33% (22/30) of the intervention group, and the difference between the two groups was statistically significant ( χ2=4.44, P<0.05). Conclusions:Nurse-led navigation services can effectively monitor and evaluate the level of economic toxicity in patients with prostate cancer, reduce the degree of economic toxicity in patients with prostate cancer, help improve patients′ compliance behavior, and help patients cope with economic toxicity in a positive way.

To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

Objective Based on the"preventive treatment of disease"theory and real-world data,this study aimed to evaluate the clinical efficacy of Yangyin Shugan Formula in patients with ovarian dysfunction characterized by the syndrome of kidney deficiency and liver depression at different stages and to provide evidence for optimizing the timing of traditional Chinese medicine(TCM)in premature ovarian insufficiency(POI)management.Methods Ovarian dysfunction patients under 40 years old characterized by syndrome of kidney deficiency and liver depression,registered in the outpatient electronic medical records of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine from January 2020 to December 2023,were stratified into three groups:subclinical POI,POI,and premature ovarian failure(POF)groups.The therapeutic outcomes of the three groups of patients were compared,including TCM syndrome total response rates,menstrual total response rates/normalization(cured)rates,base follicle-stimulating hormone(FSH)total response rate/normalization rates and anti-Müllerian hormone(AMH)levels.Results A total of 307 patients meeting the research criteria were included(97 cases in subclinical POI group,112 cases in POI group,and 98 cases in POF group).The TCM syndrome total response rates ranked as subclinical POI group(98.97%,96/97)>POI group(95.54%,107/112)>POF group(83.67%,82/98),with the POF group was lower than that of the subclinical POI and POI groups(P<0.017);while the difference of the subclinical POI group with the POI group was not significant.Menstrual total response rates ranked as subclinical POI group(97.22%,70/72)>POI group(72.32%,81/112)>POF group(51.02%,50/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017);normalization rates ranked as subclinical POI group(90.28%,65/72)>POI group(54.46%,61/112)>POF group(26.53%,26/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017).FSH total response rates ranked as subclinical POI group(89.69%,87/97)>POI group(81.25%,91/112)>POF group(60.20%,59/98),while POF group was lower than that of the other two groups(P<0.017),and the difference of the subclinical POI group with the POI group was not significant.Normalization FSH rates ranked as subclinical POI group(71.13%,69/97)>POI group(53.57%,60/112)>POF group(16.33%,16/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017).Compared with before treatment,the FSH levels in all three groups decreased after treatment(P<0.01).The reduction of FSH in the POF and POI groups were better than that in the subclinical P OI group(P<0.017).No significant difference was observed in the reduction of FSH between the POI and POF groups.Post-treatment AMH elevation observed in the subclinical POI and POI groups(P<0.01).Conclusion Yangyin Shugan Formula improves the menstrual conditions and TCM syndromes across all the stages.It also improves elevated FSH levels across all the stages and has a specific effect on normalizing FSH and menstruation.Yangyin Shugan Formula increases the AMH levels of patients with subclinical POI and POI,highlighting the applicability of TCM in staged preventive management.

Objective To explore the high-risk factors and prevention strategies for rebleeding in patients with upper gastrointestinal hemorrhage(UGIH)treated with endoscopy,and construct a predictive model.Methods 97 patients with UGIH who experienced rebleeding after endoscopic treatment from January 2020 to December 2023 were selected as the observation group,and another 178 patients with UGIH who did not experience rebleeding after endoscopic treatment admitted during the same period were selected as the control group,both groups were followed up for 1 year after endoscopic treatment.Clinical data of the two groups was compared,the high-risk factors for rebleeding after endoscopic treatment in patients with UGIH were analyzed by multivariate Logistic regression analysis,a predictive model was constructed,and the predictive value of the model for rebleeding after endoscopic treatment in patients with UGIH was analyzed by plotting a receiver operator characteristic curve(ROC curve)to analyze.Results The proportions of patients in the observation group with liver cirrhosis,shock,endoscopic active bleeding,Forrest classification of Ia to Ib,level of blood hemoglobin≤90 g/L,and level of blood platelet≤100×109/L were 55.67%,14.43%,37.11%,62.89%,23.71%,and 23.71%,respectively,which were higher than the control group's 41.57%,2.25%,18.54%,44.38%,3.37%,and 7.87%.The level of serum D-dimer(D-D)of the observation group was higher than that of the control group,and the bleeding volume of the observation group was more than that of the control group,the prothrombin time(PT)of the observation group was longer than that of the control group(P<0.05).Multivariate Logistic regression analysis showed that:cirrhosis((O＾R)=2.423,95%CI:1.124～5.224),shock((O＾R)=6.897,95%CI:1.487～31.995),endoscopic active bleeding((O＾R)=2.604,95%CI:1.109～6.118),Forrest grading of Ia to Ib((O＾R)=2.494,95%CI:1.162～5.354),level of blood hemoglobin≤90 g/L((O＾R)=5.270,95%CI:1.797～15.442),level of blood platelet≤100×109/L((O＾R)=5.018,95%CI:1.733～14.531),bleeding volume>189.61 mL((O＾R)=1.025,95%CI:1.016～1.034),PT>15.99 s((O＾R)=1.996,95%CI:1.618～2.460)were both risk factors for rebleeding in UGIH patients after endoscopic treatment(P<0.05).Regression equation model:logit(P)=-18.551+cirrhosis×0.885+shock×1.931+endoscopic active bleeding×0.957+Forrest grading×0.914+level of blood hemoglobin×1.662+level of blood platelet×1.613+bleeding volume×0.025+PT×0.691.The ROC curve for predicting rebleeding in UGIH patients after endoscopic treatment was plotted according to the diagnostic probability logit(P).When logit(P)>0.30,the 95%CI was 0.891～0.955,and the diagnostic sensitivity and specificity were 88.66%and 83.15%,respectively.The area under the curve(AUC)value was 0.923.Conclusion The cirrhosis,shock,endoscopic active bleeding,Forrest grade Ia to Ib,level of blood hemoglobin≤90 g/L,level of blood platelet≤100×109/L,bleeding volume>189.61 mL,and PT>15.99 s are independent risk factors for rebleeding after endoscopic treatment in patients with UGIH.The model constructed based on this has high predictive value,which can be used clinically to provide personalized intervention and treatment for high-risk patients to reduce or avoid the occurrence of rebleeding.

Objective To explore the high-risk factors and prevention strategies for rebleeding in patients with upper gastrointestinal hemorrhage(UGIH)treated with endoscopy,and construct a predictive model.Methods 97 patients with UGIH who experienced rebleeding after endoscopic treatment from January 2020 to December 2023 were selected as the observation group,and another 178 patients with UGIH who did not experience rebleeding after endoscopic treatment admitted during the same period were selected as the control group,both groups were followed up for 1 year after endoscopic treatment.Clinical data of the two groups was compared,the high-risk factors for rebleeding after endoscopic treatment in patients with UGIH were analyzed by multivariate Logistic regression analysis,a predictive model was constructed,and the predictive value of the model for rebleeding after endoscopic treatment in patients with UGIH was analyzed by plotting a receiver operator characteristic curve(ROC curve)to analyze.Results The proportions of patients in the observation group with liver cirrhosis,shock,endoscopic active bleeding,Forrest classification of Ia to Ib,level of blood hemoglobin≤90 g/L,and level of blood platelet≤100×109/L were 55.67%,14.43%,37.11%,62.89%,23.71%,and 23.71%,respectively,which were higher than the control group's 41.57%,2.25%,18.54%,44.38%,3.37%,and 7.87%.The level of serum D-dimer(D-D)of the observation group was higher than that of the control group,and the bleeding volume of the observation group was more than that of the control group,the prothrombin time(PT)of the observation group was longer than that of the control group(P<0.05).Multivariate Logistic regression analysis showed that:cirrhosis((O＾R)=2.423,95%CI:1.124～5.224),shock((O＾R)=6.897,95%CI:1.487～31.995),endoscopic active bleeding((O＾R)=2.604,95%CI:1.109～6.118),Forrest grading of Ia to Ib((O＾R)=2.494,95%CI:1.162～5.354),level of blood hemoglobin≤90 g/L((O＾R)=5.270,95%CI:1.797～15.442),level of blood platelet≤100×109/L((O＾R)=5.018,95%CI:1.733～14.531),bleeding volume>189.61 mL((O＾R)=1.025,95%CI:1.016～1.034),PT>15.99 s((O＾R)=1.996,95%CI:1.618～2.460)were both risk factors for rebleeding in UGIH patients after endoscopic treatment(P<0.05).Regression equation model:logit(P)=-18.551+cirrhosis×0.885+shock×1.931+endoscopic active bleeding×0.957+Forrest grading×0.914+level of blood hemoglobin×1.662+level of blood platelet×1.613+bleeding volume×0.025+PT×0.691.The ROC curve for predicting rebleeding in UGIH patients after endoscopic treatment was plotted according to the diagnostic probability logit(P).When logit(P)>0.30,the 95%CI was 0.891～0.955,and the diagnostic sensitivity and specificity were 88.66%and 83.15%,respectively.The area under the curve(AUC)value was 0.923.Conclusion The cirrhosis,shock,endoscopic active bleeding,Forrest grade Ia to Ib,level of blood hemoglobin≤90 g/L,level of blood platelet≤100×109/L,bleeding volume>189.61 mL,and PT>15.99 s are independent risk factors for rebleeding after endoscopic treatment in patients with UGIH.The model constructed based on this has high predictive value,which can be used clinically to provide personalized intervention and treatment for high-risk patients to reduce or avoid the occurrence of rebleeding.

Objective:To investigate the efficacy and safety of percutaneous trans-hepatic choledochoscopic lithotripsy (PTCSL) in the treatment of recurrent hepatobiliary calculi under enhanced recovery after surgery (ERAS) mode.Methods:Clinical data of 88 patients with recurrent hepatobiliary calculi, who were treated with PTCSL at Zhengzhou Central Hospital Affiliated to Zhengzhou University and the First Affiliated Hospital of Xi'an Jiaotong University between June 2022 and June 2024 were retrospectively analyzed, including 34 males and 54 females, aged (52.0±13.8) years. The scheme includes preoperative education, prophylactic antibiotic application, ensuring the quality of surgery, early postoperative feeding and activity, etc. The operation can be divided into two fashions: percutaneous transhepatic cholangial drainage and PTCSL, which can be completed in one stage (one-stage expansion method) or in two stages (staged expansion method). Clinical data such as gender, age, operative time, intraoperative blood loss, residual stone, and surgical complications were recorded.Results:All 88 patients underwent PTCSL under ERAS mode successfully, including 52 cases using one-stage expansion method and 36 cases using staged expansion method. The operative time was (53±20) min, the intraoperative blood loss was (9.7±3.8) ml, the postoperative hospital stay was (3.6±1.7) d, and the hospitalization cost was (17 500±4 700) yuan. Sixty-nine patients (78.4%, 69/88) had one-time stone removal in the first PTCSL. A total of 19 cases of residual stones were managed again by percutaneous sinus soft choledochoscopy, of which 12 cases were managed by one-time choledochoscopy, five cases by two-time choledochoscopy, and two cases by three-time choledochoscopy. The rate of residual stone was significantly higher in one-stage expansion method compared to staged expansion method [28.8% (15/52) vs. 11.1% (4/36), P=0.040]. No death, conversion to open surgery, or severe complications such as intra-abdominal hemorrhage or bile leakage occurred in the patients. No residual stones or recurrence were found during the follow-ups of (7.5±2.1) months after discharge. Conclusion:PTCSL under ERAS mode is safe and effective in the treatment of recurrent hepatobiliary calculi.

Objective To explore the effect of stratified out-of-hospital health management led by case health manager on the health behaviour ability of the patients with chronic diseases.Methods A convenience sampling method was employed to select 481 patients with chronic diseases who underwent physical examinations at outpatient department of a Tier-IIIA hospital from April 2022 to April 2023.A health management team led by case health managers conducted questionnaire survey to investigate the individual characteristics of the patients,established personal record based on the physical examination,and implemented stratified out-of-hospital health management for the patients.The intervention lasted for 12 months.The health behaviour ability and chronic disease self-management efficacy of the patients before and after the intervention were compared with.Results After the case manager-led stratified out-of-hospital health management,the health behaviour ability of patients with chronic diseases was stronger than that before the implementation,the self-management efficacy of chronic diseases was better than that before the implementation,and the patients'satisfaction was higher than that before the implementation(all P<0.001).Conclusion Stratified out-of-hospital health management led by a case health manager can improve the health behaviour ability and self-management efficacy of the patient with chronic diseases,thereby improve the patients'satisfaction.

Objective To explore the effect of stratified out-of-hospital health management led by case health manager on the health behaviour ability of the patients with chronic diseases.Methods A convenience sampling method was employed to select 481 patients with chronic diseases who underwent physical examinations at outpatient department of a Tier-IIIA hospital from April 2022 to April 2023.A health management team led by case health managers conducted questionnaire survey to investigate the individual characteristics of the patients,established personal record based on the physical examination,and implemented stratified out-of-hospital health management for the patients.The intervention lasted for 12 months.The health behaviour ability and chronic disease self-management efficacy of the patients before and after the intervention were compared with.Results After the case manager-led stratified out-of-hospital health management,the health behaviour ability of patients with chronic diseases was stronger than that before the implementation,the self-management efficacy of chronic diseases was better than that before the implementation,and the patients'satisfaction was higher than that before the implementation(all P<0.001).Conclusion Stratified out-of-hospital health management led by a case health manager can improve the health behaviour ability and self-management efficacy of the patient with chronic diseases,thereby improve the patients'satisfaction.

Objective:To investigate the efficacy and safety of percutaneous trans-hepatic choledochoscopic lithotripsy (PTCSL) in the treatment of recurrent hepatobiliary calculi under enhanced recovery after surgery (ERAS) mode.Methods:Clinical data of 88 patients with recurrent hepatobiliary calculi, who were treated with PTCSL at Zhengzhou Central Hospital Affiliated to Zhengzhou University and the First Affiliated Hospital of Xi'an Jiaotong University between June 2022 and June 2024 were retrospectively analyzed, including 34 males and 54 females, aged (52.0±13.8) years. The scheme includes preoperative education, prophylactic antibiotic application, ensuring the quality of surgery, early postoperative feeding and activity, etc. The operation can be divided into two fashions: percutaneous transhepatic cholangial drainage and PTCSL, which can be completed in one stage (one-stage expansion method) or in two stages (staged expansion method). Clinical data such as gender, age, operative time, intraoperative blood loss, residual stone, and surgical complications were recorded.Results:All 88 patients underwent PTCSL under ERAS mode successfully, including 52 cases using one-stage expansion method and 36 cases using staged expansion method. The operative time was (53±20) min, the intraoperative blood loss was (9.7±3.8) ml, the postoperative hospital stay was (3.6±1.7) d, and the hospitalization cost was (17 500±4 700) yuan. Sixty-nine patients (78.4%, 69/88) had one-time stone removal in the first PTCSL. A total of 19 cases of residual stones were managed again by percutaneous sinus soft choledochoscopy, of which 12 cases were managed by one-time choledochoscopy, five cases by two-time choledochoscopy, and two cases by three-time choledochoscopy. The rate of residual stone was significantly higher in one-stage expansion method compared to staged expansion method [28.8% (15/52) vs. 11.1% (4/36), P=0.040]. No death, conversion to open surgery, or severe complications such as intra-abdominal hemorrhage or bile leakage occurred in the patients. No residual stones or recurrence were found during the follow-ups of (7.5±2.1) months after discharge. Conclusion:PTCSL under ERAS mode is safe and effective in the treatment of recurrent hepatobiliary calculi.