This paper discussed how to set the limit of impurities in the quality standard when the impurities in small-molecular innovative drugs were metabolites.Firstly,through the analysis and interpretation of each relevant guideline,in combination with the review cases of FDA and EMA,found out the conditions for qualification of im-purity,and then establ ish the acceptable limit of impurities based on the test results of multiple batches,the incre-ments of production process and storage process.

Objective:To summarize the current research status, assessment tools, and influencing factors of fatigue in patients receiving maintenance hemodialysis (MHD) and provide a reference for the management of fatigue in this patient population.Methods:A literature search was conducted in databases including PubMed, Web of Science, ProQuest, Cochrane Library, Science Direct, Embase, CINAHL, China National Knowledge Infrastructure, WanFang Data, VIP, and China Biology Medicine disc for studies related to fatigue in patients receiving MHD. The search timeframe was from establishing the databases to January 23, 2024.Results:A total of 46 studies were included. Various assessment tools for fatigue in patients receiving MHD were identified, though specific tools were limited. The Short Form 36 Vitality Subscale (SF-36 VS) was the most commonly used assessment tool. The main factors influencing fatigue in these patients included sociodemographic, dialysis-related, disease-related, physical, nutritional, and psychological factors.Conclusions:Fatigue is a significant symptom in patients receiving MHD. Healthcare professionals must develop specific tools for accurately assessing fatigue in this population and explore standardized management plans.

Objective:To explore the long-term efficacy of laparoscopic fundoplication for proton pump inhibitor dependent gastroesophageal reflux disease (GERD).Method:Clinical data of proton pump inhibitor dependent GERD patients who underwent fundoplication at the Rocket Force Characteristic Medical Center from Jan to Jun 2012 were analyzed, including GERD symptom score, subjective symptom relief rate, PPI discontinuation rate and surgical satisfaction, as well as recurrence and complications.Result:A total of 160 GERD patients were included in this study, with 64% of patients having respiratory symptoms. Nissen and Toupet fundoplication were performed in 43 and 117 cases, respectively, with a follow-up time of (127±3) months. The postoperative GERD symptom scores of the patients were significantly lower than before treatment (all P<0.001); The subjective relief of overall symptoms in the digestive tract and airway problem was 90% (80%, 100%) and 100%, respectively. The PPI discontinuation rate was 86%, and the overall satisfaction rate of the treatment was 92%, and the satisfaction rate of patients with respiratory symptoms was 89%. 7% of patients experienced varying degrees of symptomatic recurrence, 4% of patients re-underwent endoscopic treatment and/or laparoscopic fundoplication due to symptom recurrence. The incidence of long-term postoperative dysphagia, bloating, belching, increased exhaust, abdominal pain, diarrhea, and constipation were 11.3%, 16.9%, 0, 1.3%, 0, 2.5%, and 5.6%, respectively. Conclusions:Laparoscopic fundoplication has good long-term efficacy in the treatment of GERD. A small number of patients may experience postoperative recurrence, as well as complications such as dysphagia and gas-bloat syndrome. Most recurrent patients can achieve good therapeutic effect by redoing endoscopic treatment or redoing surgery.

Objective:To analyze the new value of gastroscopy in the diagnosis of esophageal hiatal hernia(EHH).Methods:From March 7 to September 24 in 2019, 194 patients with gastroesophageal reflux disease who received endoscopy and high resolution esophageal manometry (HREM) at the Department of Gastroesophageal Surgery, the PLA Rocket Force Medical Center were selected. The transverse diameter of esophageal hiatus and the upward length of esophagogastric junction (EGJ) were measured under endoscopy, and the relevant data of reflux esophagitis (RE) and length and pressure of lower esophageal sphincter (LES) were collected. The value of traditional method under endoscopy and esophageal hiatus transverse diameter (EHTD) method under endoscopy in the diagnosis of EHH was compared. Independent sample- t test, rank sum test and chi-square test were used for statistical analysis. Results:The detection rate of EHH by EHTD method under endescopy was higher than that by traditional method under endoscopy and HREM method (60.8%, 118/194 vs. 14.9%, 29/194 and 37.1%, 72/194), and the detection rate of EHH by HREM method was higher than that by traditional method under endoscopy, and the differences were statistically significant ( χ2=86.75, 21.82, and 24.75; all P<0.001). The proportion of RE, the upward length of EGJ and the transverse diameter of esophageal hiatus of EHH patients diagnosed by traditional method under endoscopy and EHTD method under endoscopy were all higher than those of non-EHH patients (79.3%, 23/29 vs. 28.5%, 47/165; 49.2%, 58/118 vs. 15.8%, 12/76; 2.0 (2.0, 3.0) cm vs. 0.4(0, 0.7) cm, 0.7(0, 1.6) cm vs. 0(0, 0.6) cm; (2.60±0.71) cm vs. (1.88±0.44) cm, (2.30±0.45) cm vs. (1.51±0.29) cm); the minimum resting pressure of LES and resting pressure of LES were both lower than those of non-EHH patients(3.7(0.3, 12.1) mmHg (1 mmHg=0.133 kPa) vs. 9.1(3.3, 14.2) mmHg, 6.4(2.2, 12.5) mmHg vs. 10.8 (4.7, 15.5) mmHg; (9.70±7.92) mmHg vs. (14.92±10.30) mmHg, (11.36±7.79) mmHg vs. (18.44±11.78) mmHg); the length of intraperitoneal LES were shorter than that of non-EHH patients (0(0, 1.4) cm vs. 1.1(0, 1.7) cm, 0.3(0, 1.5) cm vs. 1.3(0.4, 1.8) cm); the length of LES of EHH patients diagnosed by EHTD method under endoscopy was shorter than that of non-EHH patients ((2.83±0.63) cm vs. (3.10±0.66) cm), and the differences were statistically significant ( χ2=26.53 and 22.31, Z=-8.26 and-5.04, t=5.26 and 13.67, Z=-2.14 and-2.71, t=-2.59 and-4.63, Z=-2.58 and-3.60, t=-2.96; all P<0.05). There were no significant differences in gender, LES length, intraperitoneal LES length, minimum resting pressure of LES, resting pressure of LES and residual pressure of LES between EHH patients diagnosed by EHTD method and traditional method under endoscopy (all P>0.05). Conclusions:Endoscopy plays a significant role in the diagnosis of EHH. EHTD method under endoscopy is more accurate in the diagnosis of sliding EHH, which is worthy of clinical reference.

The management of hospital volunteers is one of the main tasks of medical social workers.In practical work,they are often in a dilemma due to ethical problems,which restricts the scientific development of hospital volunteer organizations.Based on the experience of frontline medical social workers in the"Guangji Boat"Volunteer Service Alliance of the Second Affiliated Hospital Zhejiang University School of Medicine,while investigating other public hospitals,this paper summarized and organized ethical issues,analyzed their causes,and proposed improvement strategies.The ethical dilemma of hospital volunteer service was mainly in the conflict between the dual relationship of human emotion and norm,the conflict between incentive mechanism and non-reward value,as well as the conflict between participation motivation and organizational goal.The ethical dilemma in the management of hospital volunteers was attributed to the lack of standardized practical operation systems.Based on the above ethical dilemmas,combined with the development experience of volunteer service in public hospitals,this paper proposed reasonable countermeasures to provide a reference for the management of hospital volunteers.

Objective:To evaluate the safety and efficacy of domestically produced magnetic sphincter augmentation (MSA) for gastroesophageal reflux disease.Method:This study is a prospective cohort study. Patients with typical heartburn and reflux symptoms (at least partial response to proton pump inhibitors), abnormal esophageal acid exposure and normal esophageal peristalsis were included, prospectively in the Department of Gastroesophageal Surgery, Rocket Force Characteristic Medical Center from June 2019 to September 2022. Patients with hiatal hernia >2 cm and severe esophagitis were excluded. The MSA was wrapped around the distal esophagus after esophageal hiatus repair by laparoscopy. A postoperative questionnaire survey was conducted to assess the relief of symptom, complications, the discontinuation rate of proton pump inhibitor, and surgical satisfaction. Gastroscopy, high-resolution esophageal pressure measurement, and pH value impedance monitoring were also reviewed. The pre- and postoperative rates were compared using the McNeinar χ2 test. Result:Currently, 23 patients with gastroesophageal reflux disease were enrolled and underwent MSA surgery. There were 20 males and 3 females, aged ( M (IQR)) 48 (14) years (range: 25 to 64 years). All cases were successfully implanted with MSA. Subjective indicators were followed for 17 (18) months (range: 14 to 53 months), while objective indicators were followed for 17 (1) months (range: 12 to 23 months). The postoperative gastrointestinal and extraesophageal symptom scores showed a significant decrease compared to preoperative levels as follows: the degree of subjective relief of overall digestive symptoms was 90 (20)% (range:0~100%), the degree of subjective relief of overall respiratory symptoms was 100(10)% (range: 10%~100%), the overall satisfaction rate was 83% (19/23), the proton pump inhibitor discontinuation rate was 70% (16/23). The proportion of esophagitis has decreased from 44% (10/23) to 9% (2/23) ( κ=0.169, P=0.039), The Hill grade of gastroesophageal valve morphology improved from 1 case of grade Ⅰ, 5 cases of grade Ⅱ, 10 cases of grade Ⅲ, and 7 cases of grade Ⅲ preoperative to 22, 1, 0, and 0 cases postoperative. The proportion of lower esophageal sphincter pressure below normal has decreased from 70% (16/23) to 35% (8/23) ( κ=0.170, P=0.012). There were 21 patients who restored normal esophageal acid exposure. Eleven patients had mild long-term dysphagia, but it didn′t affect their daily life. No postoperative device migration, erosion, or secondary surgical removal occurred. Conclusions:Laparoscopic implantation of the MSA device was safe and well tolerated. It can effectively control the symptoms of gastroesophageal reflux disease, reduce medication, restore normal cardia morphology and function, and esophageal acid exposure. The main postoperative complication was dysphagia, but it was relatively mild.

Objective:To evaluate the safety and efficacy of domestically produced magnetic sphincter augmentation (MSA) for gastroesophageal reflux disease.Method:This study is a prospective cohort study. Patients with typical heartburn and reflux symptoms (at least partial response to proton pump inhibitors), abnormal esophageal acid exposure and normal esophageal peristalsis were included, prospectively in the Department of Gastroesophageal Surgery, Rocket Force Characteristic Medical Center from June 2019 to September 2022. Patients with hiatal hernia >2 cm and severe esophagitis were excluded. The MSA was wrapped around the distal esophagus after esophageal hiatus repair by laparoscopy. A postoperative questionnaire survey was conducted to assess the relief of symptom, complications, the discontinuation rate of proton pump inhibitor, and surgical satisfaction. Gastroscopy, high-resolution esophageal pressure measurement, and pH value impedance monitoring were also reviewed. The pre- and postoperative rates were compared using the McNeinar χ2 test. Result:Currently, 23 patients with gastroesophageal reflux disease were enrolled and underwent MSA surgery. There were 20 males and 3 females, aged ( M (IQR)) 48 (14) years (range: 25 to 64 years). All cases were successfully implanted with MSA. Subjective indicators were followed for 17 (18) months (range: 14 to 53 months), while objective indicators were followed for 17 (1) months (range: 12 to 23 months). The postoperative gastrointestinal and extraesophageal symptom scores showed a significant decrease compared to preoperative levels as follows: the degree of subjective relief of overall digestive symptoms was 90 (20)% (range:0~100%), the degree of subjective relief of overall respiratory symptoms was 100(10)% (range: 10%~100%), the overall satisfaction rate was 83% (19/23), the proton pump inhibitor discontinuation rate was 70% (16/23). The proportion of esophagitis has decreased from 44% (10/23) to 9% (2/23) ( κ=0.169, P=0.039), The Hill grade of gastroesophageal valve morphology improved from 1 case of grade Ⅰ, 5 cases of grade Ⅱ, 10 cases of grade Ⅲ, and 7 cases of grade Ⅲ preoperative to 22, 1, 0, and 0 cases postoperative. The proportion of lower esophageal sphincter pressure below normal has decreased from 70% (16/23) to 35% (8/23) ( κ=0.170, P=0.012). There were 21 patients who restored normal esophageal acid exposure. Eleven patients had mild long-term dysphagia, but it didn′t affect their daily life. No postoperative device migration, erosion, or secondary surgical removal occurred. Conclusions:Laparoscopic implantation of the MSA device was safe and well tolerated. It can effectively control the symptoms of gastroesophageal reflux disease, reduce medication, restore normal cardia morphology and function, and esophageal acid exposure. The main postoperative complication was dysphagia, but it was relatively mild.

Gastroesophageal reflux disease （GERD） is a frequently and commonly occurring disease in clinic. In recent decades， with the development in pathophysiology and drug researches， modern medicine has achieved remarkable progress and results in diagnosis and treatment. However， the treatments for non-erosive reflux disease， refractory gastroesophageal reflux disease， proton pump inhibitor resistance， overlap of disease symptoms， and extraesophageal symptoms are limited and ineffective. Traditional Chinese medicine （TCM） was widely used in clinical practice， which has been proved effective in relieving symptoms and improving the quality of life. Sponsored by China Association of Chinese Medicine （CACM） and undertaken by the Spleen and Stomach Disease Branch of CACM， "the 12^th Youth Salon of Clinical Predominance Disease Series （GERD）" invited 18 authoritative digestive experts of TCM and western medicine to discuss "the difficulties of clinical diagnosis and treatment of GERD and TCM advantages". The focus issues such as modern medical diagnosis and treatment achievements and contributions， improvement and maintenance of symptoms， response to overlapping disease symptoms， reduction and withdrawal of acid suppressors， and treatment of extra-esophageal symptoms were discussed in depth. TCM and western medicine exchanged and complemented each other's strengths， combing the difficulties of modern medical diagnosis and treatment， which clarified the positioning and advantages of TCM and provided guidance for clinical and scientific research.

Objective:To observe the diagnostic value of six classification intelligent auxiliary diagnosis lightweight model for common fundus diseases based on fundus color photography.Methods:A applied research. A dataset of 2 400 color fundus images from Nanjing Medical University Eye Hospital and Zhejiang Mathematical Medical Society Smart Eye Database was collected, which was desensitized and labeled by a fundus specialist. Of these, 400 each were for diabetic retinopathy, glaucoma, retinal vein occlusion, high myopia, age-related macular degeneration, and normal fundus. The parameters obtained from the classical classification models VGGNet16, ResNet50, DenseNet121 and lightweight classification models MobileNet3, ShuffleNet2, GhostNet trained on the ImageNet dataset were migrated to the six-classified common fundus disease intelligent aid diagnostic model using a migration learning approach during training as initialization parameters for training to obtain the latest model. 1 315 color fundus images of clinical patients were used as the test set. Evaluation metrics included sensitivity, specificity, accuracy, F1-Score and agreement of diagnostic tests (Kappa value); comparison of subject working characteristic curves as well as area under the curve values for different models.Result:Compared with the classical classification model, the storage size and number of parameters of the three lightweight classification models were significantly reduced, with ShuffleNetV2 having an average recognition time per sheet 438.08 ms faster than the classical classification model VGGNet16. All 3 lightweight classification models had Accuracy > 80.0%; Kappa values > 70.0% with significant agreement; sensitivity, specificity, and F1-Score for the diagnosis of normal fundus images were ≥ 98.0%; Macro-F1 was 78.2%, 79.4%, and 81.5%, respectively.Conclusion:The intelligent assisted diagnosis of common fundus diseases based on fundus color photography is a lightweight model with high recognition accuracy and speed; the storage size and number of parameters are significantly reduced compared with the classical classification model.

Objective:To construct a preliminary test items pool of Negative Emotion Screening Scale for Inpatients, so as to lay the foundation for subsequent scale construction and reliability and validity test.Methods:From September 2020 to January 2021, using the psychological stress theory as a reference model, a pool of items for negative emotion assessment of non-psychiatric inpatients was established based on literature research, expert interviews and patient consultation. The Delphi method was used to select 25 experts from related fields in China for 2 rounds of consultation and the consultation results were statistically analyzed.Results:After 2 rounds of expert letter inquiries, a preliminary test item database with 35 items covering 4 dimensions of anxiety, depression, fear of illness and anger was obtained. The effective recovery rates of the two rounds of expert letter questionnaires were 92.59% (25/27) and 100.00% (25/25) , the expert authority coefficient was 0.912 and the Kendall's coordination of the secondary indicators coefficient was 0.191 and 0.126 ( P<0.01) . Conclusions:The application of the Delphi method can obtain relatively reliable results by gathering expert opinions and provide a basis for the construction of Negative Emotion Screening Scale for Inpatients.