OBJECTIVE To promote the standardization of the “Indications” section in package inserts for Chinese patent medicines and ensure rational clinical and patient use. METHODS The “Function and Indications” information of package inserts for Chinese patent medicines was retrieved and collected from the 2020 edition of the Chinese Pharmacopoeia （Volume Ⅰ） and various national and regional standards. Identification criteria were established for syndrome， pathogenesis， disease name， and symptom terminology in the “Indications” section. Microsoft Office Access 2021 was utilized to create query tables for manual extraction of terminological elements， followed by the construction of a three-tier classification system for “Indications” descriptions. A standardized template for “Indications” was developed through quantitative analysis. RESULTS & CONCLUSIONS A total of 9 851 valid package inserts for Chinese patent medicines were included. Among these， the majority （7 991） contained symptom terminology， followed by disease names （5 867） and pathogenesis descriptions （5 167）. Within disease name terminology， Western medical disease names predominated （4 446）， followed by traditional Chinese medicine disease names （2 018）. The “Function and Indications” content of 6 962 package inserts complied with existing requirements. Notably， the secondary classifications of “disease name”， as well as the tertiary classification of “disease name+symptoms” and “symptoms”， failed to meet established standards. Two standardized templates for “Indications” were formulated based on pathogenesis and syndrome：“pathogenesis+disease name+symptoms” and “disease name+syndrome+symptoms”. The “Indications”section should provide complete and accurate information， adhere to standardized formatting， and employ appropriate conjunctions and punctuation. For non-prescription patent medicines， package inserts should be categorized into professional and patient versions. These measures will facilitate the standardization of “Indications” descriptions and advance the overall package inserts for Chinese patent medicines documentation.

Humans ; Diabetes Mellitus, Type 1 ; Hypoglycemia/chemically induced* ; Hypoglycemic Agents/adverse effects* ; China ; Blood Glucose ; Insulin

Objective To evaluate the efficacy of hydromorphone combined with ropivacaine for serra-tus anterior plane block(SAPB)in acute pain after breast cancer surgery.Methods A total of 58 patients un-dergoing breast cancer surgery were divided into the hydromorphone combined with ropivacaine block group(group HR)and the Ropivacaine block group(group R)by the random number table method.Before surgery,the patients in the two groups were treated with SAPB.The patients in both groups underwent SAPB before surgery,and the dosage of opioids during surgery,the scores of Numeric Rating Scale(NRS)at 30 min,2 h,4 h,6 h,12 h,24 h and 48 h after surgery,the perioperative indicators related to block and the incidence of chro-nic pain after surgery were recorded.Results Compared with group R,the resting NRS score at 30 min,2 h,12 h,24 h and 48 h after surgery and exercise NRS score at 12 h,24 h and 48 h after surgery in group HR were decreased(P＜0.05),and after 12(0 vs.31.0％,P=0.020),24(27.6％vs.65.5％,P=0.040)and 48 h(6.9％vs.37.9％,P=0.005),the incidence of moderate and severe pain during exercise decreased.The pa-tients in group HR got out of bed earlier than those in group R[20(18,23)h vs.24(20,27)h,P=0.021].Conclusion Hydromorphone combined with ropivacaine SAPB can reduce the NRS score after breast cancer surgery,reduced the incidence of moderate to severe pain,and shorten the time for patients to get out of bed.

Objective:To analyze the risk factors for central lymph node metastasis (CLNM) in patients with papillary thyroid cancer (PTC) aged 55 years and above, and to construct a predictive model with columnar graph.Methods:This retrospective study included 406 PTC patients aged 55 and above, treated at the First Affiliated Hospital of Zhengzhou University from Nov. 2019 to Feb. 2022. Data on demographic characteristics, disease features, and laboratory test results were collected. Univariate and multivariate logistic regression analyses were used to identify risk factors for CLNM and develop a clinical prediction model and nomogram.Results:The study involved 406 patients, divided into a modeling group (285 patients) and a validation group (121 patients). The predictive model identified independent risk factors for CLNM. In the modeling group, the model demonstrated a ROC AUC of 0.769, with 82.6% sensitivity, 63.0% specificity, and 67.7% accuracy. The validation group showed 66.7% sensitivity, 74.5% specificity, and 72.7% accuracy, with an AUC of 0.760. Hosmer-Lemeshow tests indicated good fit in both groups. Decision curve analysis confirmed the model's clinical decision-making value, showing better performance than traditional strategies and good generalizability and reliability.Conclusions:Sex, maximum tumor diameter, bilateral involvement of thyroid lobes, clinically evident cervical lymph nodes, and local invasion are independent predictive factors for CLNM in patients over 55 with papillary thyroid carcinoma (PTC). A clinical risk stratification nomogram model based on these risk factors demonstrates good predictive performance.

Robotic surgery, known for its high precision, minimally invasive nature, and rapid recovery benefits, has been widely utilized in clinical practice. In pancreatic surgery, robotic procedures have become the preferred treatment for most benign or low-grade malignant tumors. However, due to the complexity of pancreatic surgery and the steep learning curve associated with it, the development and promotion of robotic pancreatic surgery still face some challenges. Simulation training serves as an effective method for surgical education. In robotic pancreatic surgery training, simulation not only allows for a systematic review and analysis of the fundamental principles, technical operations, and specific steps of the surgical process, but also offers personalized guidance and support. This helps trainees improve their operational skills and proficiency in robotic pancreatic surgery, ultimately reducing surgical risks, ensuring medical safety, and improving treatment outcomes. The promotion and widespread application of simulation training in robotic-assisted pancreatic surgery education provides a valuable training model for pancreatic surgeons and warrants significant attention from medical institutions.

Objective To explore the dilemmas faced by surrogate decision-makers of severe stroke patients in treatment decision-making,and to provide a basis for developing decision support strategies.Methods From April to December 2023,through phenomenological qualitative research with 16 surrogate decision-makers with severe stroke patients from ICU of the department of neurology in a tertiary hospital in Jing'an District,Shanghai.semi-structured in-depth interviews were used to examine the perceptions of decision-making on surrogate.Data were analyzed via Braun's style of thematic analysis.Results 4 themes and 10 sub-themes were identified.Theme 1:negative emotional dilemmas(urgent decision-making leads to anxiety,fear,and unknown stroke trajectory increases the sense of uncertainty).Theme 2:supportive environment dilemmas(lack of information support delays decision-making;lack of family support increases decision-making stress;insufficient economic support increases the burden of decision-making).Theme 3:the dilemma of weighing the pros and cons(difficult trade-offs between risk and reward,tough decisions between reality and ethics,conflicting choices of life and dignity).Theme 4:preference management dilemmas(practical difficulties in adhering to patient preferences,impediments to decision-making due to unknown patient preferences).Conclusion Surrogate decision-makers of severe stroke patients face multiple decision-making dilemmas.Healthcare professionals should provide emotional support in multiple ways and comprehensive support to reduce the decision-making dilemmas experienced by surrogate decision-makers,as well as implement death education for surrogate decision-makers and promote advance care planning to reduce their decision-making stress.

Objective:To explore the journey map of patients with chronic constipation during fecal microbiota transplantation.Methods:This study adopted phenomenological methods. From October to December 2023, purposive sampling was used to select chronic constipation follow-up patients who underwent fecal microbiota transplantation at the Intestinal Microecology Center of Shanghai Tenth People's Hospital as respondents for semi-structured interviews. Colaizzi 7-step analysis method and NVivo 11.0 software were used for data analysis.Results:A total of 15 interviewees were interviewed. During fecal microbiota transplantation, the journey map of constipation patients included stages, mood changes, touchpoints, themes, emotional experiences and opportunities. The patient's experience and needs were summarized into three themes and ten sub-themes, including pre-transplant adaptation disorders to new environments (unfamiliarity and confusion-admission coordination disorders, anxiety and expectations-diverse complex emotions, puzzle and helplessness-asymmetric doctor and patient information), effectiveness-related psychological and social experiences in transplantation (attention and expectations-longing for positive efficacy, perception of benefits and risk avoidance, shame and inferiority-treatment stigmatization experience, questioning and despair-unrealized expectations, treatment resistance-sensitive economic burden), post-transplant transition dilemmas (inaccessible medical services-lack of continuous treatment and nursing, disease recurrence troubles) .Conclusions:This study visualizes the experiences and needs of constipation patients during microbiota transplantation through a patient journey map and identifies multidimensional issues and needs of patients. Clinical medical and nursing staff should pay attention to the needs of patients at different stages of the treatment process when formulating intervention programs to improve the quality of fecal microbiota transplantation nursing.

Objective:This article analyzed the current situation, similarities and differences and main problems of the registration and management systems of innovative medical devices in China and the United States.Methods:This article summarized the requirements and policies for the registration management of innovative medical devices in China and the United States, as well as the development and differences of the registration of innovative medical devices in China and the United States, and the main problems in the registration management of innovative medical devices in China.Results:At present, the development level of medical device industry in China and the United States was different, facing different development problems, and there were differences in the access standards and management methods of innovative medical devices. The registration management system established for innovative medical devices in China was gradually improving, and to a certain extent, it had promoted the enthusiasm of innovative product research and development and registration applications, but there were also problems such as unclear innovation evaluation scales, insufficient early intervention of review resources, and insufficient utilization of post-marketing data.Conclusions:Drawing on the beneficial experience of breakthrough device registration management in the United States, we will improve the registration management system for innovative products and shorten the review and approval cycle by clarifying the identification criteria for innovative medical devices, promoting the placement of review resources in the R&D stage, and further strengthening the use of post-marketing data and regulatory scientific research.

Objective Based on the framework of"quantitative analysis of supporting policies",this study focuses on the formulation and implementation of supporting policies for pharmaceutical science and technology innovative enterprises in China,so as to provide a certain reference for the implementation and improvement of policies for pharmaceutical science and technology innovative enterprises in China.Methods This study used Roy Rothwell and Walter Zegveld's innovative policy tools as the basis for analysis,and combined with the dimension of policy type,the policy was quantitatively analyzed.Results A total of 47 effective policy documents were selected,including 22 issued by the state and 25 issued by Beijing municipal government.A total of 104 policy instruments were included through the dismantling of policy provisions.Specifically,environment-based policy tools accounted for the highest proportion(60.58%),while demand-based and supply-based policy tools were relatively few.From the perspective of policy types,there were more planning policy documents(25 articles),while there were relatively few specific implementation policies(22 articles).Conclusion It is necessary to focus on optimizing the formulation stage of support policies and improving the use of supply-oriented and demand-oriented policy tools to better meet the needs of pharmaceutical science and technology innovative enterprises.

Purpose: The interval between neoadjuvant chemotherapy (NAC) and surgery for locally advanced breast cancer (LABC) remains controversial. At the same time, the prognostic effect of delayed surgery in patients with poor responses is currently unclear. Methods: Data was collected from patients who had poor responses to NAC and underwent modified radical surgery from January 2013 to December 2018. The interval from completion of NAC to surgery was divided into two groups: a longer (greater than four weeks) or shorter (four weeks or less) interval. The associations of these interval groups with overall survival (OS) and recurrence-free survival (RFS) were evaluated by multivariable Cox models adjusting for the existing prognostic factors. Propensity score matching (PSM) was used to minimize election bias. Results: A total of 1,229 patients (mean age, 47.2 ± 8.9 years; median follow-up duration, 32.67 [6.57–52.63] months) were included. The 5-year OS rates were 73.2% and 60.8% in the shorter (n = 171) and longer interval group (n = 1,058), respectively, while the 3-year RFS rates were 80.8% and 71.7%, respectively. In multivariate Cox analysis, the longer interval was associated with an increased risk of mortality (hazard ratio [HR], 1.43; 95% confidence interval [CI], 1.01–2.02; p = 0.046) and recurrence (HR, 1.50; 95% CI, 1.12–1.99; p = 0.006).There was an interaction between the molecular subtype and the surgery interval for OS (pinteraction = 0.014) and RFS (pinteraction = 0.027). After PSM, no significant difference in OS (p = 0.180) and RFS (p = 0.069) was observed between the two groups. Conclusion Among LABC patients with a poor response, those with a longer interval between NAC and surgery had worse OS and RFS. The results indicate that these patients should receive modified radical surgery timely, which may in turn improve their prognosis.