Objective:To investigate the safety and efficacy of Fuzheng Kangfu (FK) formula combined with chemotherapy in the treatment of pancreatic cancer.Methods:A retrospective analysis was conducted on 95 pancreatic cancer patients who received conventional chemotherapy between June 2021 and June 2024. The patients were divided into the integrated traditional Chinese medicine treatment group (treatment group) and the chemotherapy-only group (control group) according to whether receiving FK formula during chemotherapy. Baseline characteristics, clinical indicators before and after treatment, incidence of adverse reactions, and overall survival were compared between the two groups.Results:After propensity score matching, 39 patients were included in each group. Compared with the control group, the treatment group presented significantly higher globulin levels [28.60 (24.70, 32.15) g/L vs 24.90 (22.40, 29.95) g/L], alongside lower levels of D-dimer [1 200 (720, 1 690) μg/L vs 2 230 (1 040, 3 330) μg/L], creatinine (64.29±15.97 μmol/L vs 77.71±12.26 μmol/L), urea nitrogen [3.43(2.58, 4.67) mmol/L vs 4.87 (3.80, 6.24) mmol/L], and fasting blood glucose [4.68(3.95, 5.73) mmol/L vs 6.91 (5.27, 7.70) mmol/L]. Furthermore, the treatment group exhibited significantly greater decreases in C-reactive protein (CRP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), indirect bilirubin, D-dimer, fibrinogen, and urea nitrogen levels compared to the control group. Conversely, the decreases of hemoglobin level and body mass index in the control group were more pronounced than that of the treatment group. The incidence of chemotherapy-related adverse reactions such as leukopenia (7.7% vs 33.3%), anemia (15.4% vs 35.9%), liver dysfunction (28.2% vs 53.8%), gastrointestinal reactions (5.1% vs 20.5%), and neurotoxicity (0.0% vs 15.4%) in the treatment group was notably lower than that in the control group. The treatment group showed prolonged median survival (14 month vs 9 month). The 1, 1.5 and 2-year survival rates of the treatment group were higher than the control group (56.76% vs 42.95%, 35.77% vs 32.72% and 23.85% vs 19.63%). All aforementioned differences were statistically significant (all P value <0.05). Conclusions:The integration of the FK formula with chemotherapy in the management of pancreatic cancer could effectively mitigate clinical manifestations, enhance quality of life, extend survival duration, and diminish chemotherapy-induced adverse effects.

Objective:To investigate the safety and efficacy of Fuzheng Kangfu (FK) formula combined with chemotherapy in the treatment of pancreatic cancer.Methods:A retrospective analysis was conducted on 95 pancreatic cancer patients who received conventional chemotherapy between June 2021 and June 2024. The patients were divided into the integrated traditional Chinese medicine treatment group (treatment group) and the chemotherapy-only group (control group) according to whether receiving FK formula during chemotherapy. Baseline characteristics, clinical indicators before and after treatment, incidence of adverse reactions, and overall survival were compared between the two groups.Results:After propensity score matching, 39 patients were included in each group. Compared with the control group, the treatment group presented significantly higher globulin levels [28.60 (24.70, 32.15) g/L vs 24.90 (22.40, 29.95) g/L], alongside lower levels of D-dimer [1 200 (720, 1 690) μg/L vs 2 230 (1 040, 3 330) μg/L], creatinine (64.29±15.97 μmol/L vs 77.71±12.26 μmol/L), urea nitrogen [3.43(2.58, 4.67) mmol/L vs 4.87 (3.80, 6.24) mmol/L], and fasting blood glucose [4.68(3.95, 5.73) mmol/L vs 6.91 (5.27, 7.70) mmol/L]. Furthermore, the treatment group exhibited significantly greater decreases in C-reactive protein (CRP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), indirect bilirubin, D-dimer, fibrinogen, and urea nitrogen levels compared to the control group. Conversely, the decreases of hemoglobin level and body mass index in the control group were more pronounced than that of the treatment group. The incidence of chemotherapy-related adverse reactions such as leukopenia (7.7% vs 33.3%), anemia (15.4% vs 35.9%), liver dysfunction (28.2% vs 53.8%), gastrointestinal reactions (5.1% vs 20.5%), and neurotoxicity (0.0% vs 15.4%) in the treatment group was notably lower than that in the control group. The treatment group showed prolonged median survival (14 month vs 9 month). The 1, 1.5 and 2-year survival rates of the treatment group were higher than the control group (56.76% vs 42.95%, 35.77% vs 32.72% and 23.85% vs 19.63%). All aforementioned differences were statistically significant (all P value <0.05). Conclusions:The integration of the FK formula with chemotherapy in the management of pancreatic cancer could effectively mitigate clinical manifestations, enhance quality of life, extend survival duration, and diminish chemotherapy-induced adverse effects.

Objective:To identify the optimal machine learning model for predicting cholecystocardiac syndrome (CCS) in elderly patients and determine key predictive factors.Methods:A total of 150 elderly patients diagnosed as having CCS who presented with chest discomfort as the initial symptom were retrospectively included at Hangzhou First People's Hospital from July 2021 to December 2023, with 150 propensity score-matched controls (1∶1 matching for age, gender, smoking, and drinking history) with chest discomfort but without CCS during the same period. Demographic characteristics, vital signs at admission, laboratory test results, and electrocardiogram (ECG) findings of all patients were collected. The predictive performance of six machine learning models—gradient boosting, logistic regression, random forest (RF), k-nearest neighbor (KNN), multilayer perceptron (MLP), and support vector machine (SVM) for early CCS recognition was compared. The model with the best overall performance was selected according to area under the curve (AUC), and its key predictive factors were identified based on feature importance ranking.Results:Among the six machine learning models, the RF model demonstrated the highest AUC (0.84) and lowest Brier score (0.165) and was therefore identified as the optimal model. In the independent test set, the RF model achieved an AUC of 0.87 (95% CI: 0.735-0.908), with a sensitivity of 86.7% (39/45), specificity of 80.0% (36/45), positive predictive value of 81.3% (39/48) and negative predictive value of 85.7% (36/42). The six most important predictive variables were procalcitonin (PCT), serum amyloid A (SAA), heart rate variability low-frequency to high-frequency ratio (LF/HF), percentage of successive normal RR intervals differing by >50 ms (PMN50), γ-glutamyltransferase/aspartate aminotransferase ratio (GGT/AST), and direct bilirubin (DBIL). Conclusion:The RF model can predict early risk of CCS in elderly patients, with the key predictive factors including PCT, SAA, LF/HF, PMN50, GGT/AST, and DBIL.

Objective:To identify the optimal machine learning model for predicting cholecystocardiac syndrome (CCS) in elderly patients and determine key predictive factors.Methods:A total of 150 elderly patients diagnosed as having CCS who presented with chest discomfort as the initial symptom were retrospectively included at Hangzhou First People's Hospital from July 2021 to December 2023, with 150 propensity score-matched controls (1∶1 matching for age, gender, smoking, and drinking history) with chest discomfort but without CCS during the same period. Demographic characteristics, vital signs at admission, laboratory test results, and electrocardiogram (ECG) findings of all patients were collected. The predictive performance of six machine learning models—gradient boosting, logistic regression, random forest (RF), k-nearest neighbor (KNN), multilayer perceptron (MLP), and support vector machine (SVM) for early CCS recognition was compared. The model with the best overall performance was selected according to area under the curve (AUC), and its key predictive factors were identified based on feature importance ranking.Results:Among the six machine learning models, the RF model demonstrated the highest AUC (0.84) and lowest Brier score (0.165) and was therefore identified as the optimal model. In the independent test set, the RF model achieved an AUC of 0.87 (95% CI: 0.735-0.908), with a sensitivity of 86.7% (39/45), specificity of 80.0% (36/45), positive predictive value of 81.3% (39/48) and negative predictive value of 85.7% (36/42). The six most important predictive variables were procalcitonin (PCT), serum amyloid A (SAA), heart rate variability low-frequency to high-frequency ratio (LF/HF), percentage of successive normal RR intervals differing by >50 ms (PMN50), γ-glutamyltransferase/aspartate aminotransferase ratio (GGT/AST), and direct bilirubin (DBIL). Conclusion:The RF model can predict early risk of CCS in elderly patients, with the key predictive factors including PCT, SAA, LF/HF, PMN50, GGT/AST, and DBIL.

Targeted delivery of antibody bound to antigen is a precise drug delivery mode. It is regarded as one of the ideal targeted drug delivery modes due to its high specificity and affinity, which opens up a new way to successfully solve the problem of poor selectivity of chemotherapy drugs in antitumor therapy. Currently, the research on antibody drug conjugates(ADCs) that bind monoclonal antibodies to target antigens has become a research hotspot of molecular targeted therapy. This paper reviews the mechanism of action, targeting strategies and progress in the targeted delivery of ADCs, in order to provide reference for the clinical development of new ADCs.

Objective:To study the risk factors for duodenal injury caused by malposition of plastic bile duct stent for the treatment of biliary stricture.Methods:Data of 1 408 patients with biliary stricture (2 607 procedures of plastic stent placement) who received plastic stent placement in Hangzhou First People's Hospital from January 2017 to December 2021 were retrospectively analyzed and duodenal injury caused by bile duct stent malposition after placement was recorded. The patients were divided into two groups: the malposition injury group ( n=23 procedures) and the non-malposition injury group ( n=2 584 procedures). The differences in the baseline data and procedure-related condition between the malposition injury group and the non-malposition injury group were compared, and the independent risk factors for duodenal injury caused by bile duct plastic stent malposition were studied by using logistic regression analysis. Results:A total of 2 607 procedures of plastic stent placement were performed in 1 408 patients with biliary stricture, and 23 cases of duodenal injury were caused by stent malposition. Logistic regression analysis revealed that a history of gastrointestinal surgery ( OR=4.278, 95% CI: 1.332-13.737, P=0.015), a history of endoscopic sphincterotomy (EST) ( OR=8.128, 95% CI: 2.382-27.738, P=0.001), and high-level bile duct stenosis ( OR=4.457, 95% CI: 1.722-11.539, P=0.002), plastic stents with a length≥ 7 cm ( OR=4.701, 95% CI: 1.708-12.938, P=0.003) and Christmas tree-shaped stent ( OR=6.890, 95% CI: 1.540-30.830, P=0.012) were independent risk factors for duodenal injury caused by bile duct plastic stent malposition. Conclusion:High-level bile duct stenosis, the use of plastic stents with a length≥ 7 cm and Christmas tree-shaped stent, a history of gastrointestinal surgery, and a history of EST could increase the risk of duodenal injury caused by bile duct plastic stent malposition in patients with bile duct stenosis.

To evaluate the safety and clinical effectiveness of endoscopic retrograde cholangiopancreatography (ERCP) with biliary and pancreatic duct stenting combined with enucleation (En) for cystadenoma in pancreatic head, clinical data of patients with cystadenoma in pancreatic head treated by ERCP+En (ERCP+En group, n=11) or En (En group, n=12) at Hangzhou First People's Hospital from January 2020 to January 2023 were retrospectively analyzed. The general information, intraoperative condition, perioperative complications, hospital stay, and follow-up outcomes were compared between the two groups. No noteworthy difference in general information was observed between the two groups ( P>0.05). In the ERCP+En group, ERCP was successfully implanted into the biliary pancreatic duct stent, and hyperamylasemia occurred in 3 cases after ERCP, which improved after conservative treatment. No conversion to laparotomy or blood transfusion occurred during the En operation, and no serious complication occurred after EN operation in the two groups. There was 0 case and 3 cases of grade B/C postoperative pancreatic fistula in the ERCP+En group and the En group, respectively ( P=0.001). The median hospital stay was 11 days and 15 days, respectively, with statistical significance ( U=2.25, P=0.031). No noteworthy difference in median En time (145 min VS 155 min, U=0.03, P=0.952) or intraoperative blood loss (100 mL VS 120 mL, U=0.05, P=0.784) was observed between the two groups. During a median follow-up of 18 months, no recurrence happened in either group, and the ERCP+En group did not experience biliary pancreatic duct stenosis, while the En group experienced 2 pancreatic duct stenosis and 1 biliary duct stenosis. Endoscopic biliary and pancreatic duct stenting combined with En is an effective way to reduce postoperative pancreatic fistula and avoid long-term complications such as biliary and pancreatic duct stenosis for cystadenoma in pancreatic head.

Objective:To compare the fully covered self-expanding metal stents (FCSEMS) and multiple plastic stents (MPS) in the effectiveness, safety and cost-effectiveness for benign bile duct strictures.Methods:A single-center retrospective study was conducted to analyze the clinical data of 107 patients with benign biliary strictures who underwent FCSEMS or MPS implantation through endoscopic retrograde cholangiopancreatography (ERCP) in Hangzhou First People's Hospital from January 2013 to June 2019.There were 54 cases in group FCSEMS and 53 cases in group MPS. Benign biliary stricture was confirmed by computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP) and endoscopic ultrasonography. The primary index was the rate of stricture remission, and the secondary indices were the incidence of stricture recurrence, ERCP-related complications, the rate of stent migration, hospital stay and charges.Results:The median follow-up times were 10.0 (6.5, 18.0) months and 12.0 (9.0, 20.0) months in group FCSEMS and in group MPS respectively ( P>0.05). The rates of stricture remission in the two groups were 87.0% (47/54) and 83.0% (44/53), the incidences of stricture recurrence were 14.6% (6/41) and 23.5% (8/34), and the incidences of ERCP-related complications were 14.8% (8/54) and 11.9% (13/109), respectively. And the differences were not statistically significant (all P>0.05). But the stent migration rates of the two groups were 22.9% (11/54) and 2.8% (3/109) with significant difference ( P<0.001). Cost-effectiveness analysis showed that the median numbers of ERCP intervention in the two groups were 2 (2,2) times and 3 (2,4) times ( P<0.001), and the median hospital stays were 6.0 (4.0,11.0) days and 9.0 (6.5,16.0) days respectively ( P=0.009). The median hospitalization expenses of the two groups were 44 646 yuan and 51 355 yuan without significant difference ( P>0.05). Conclusion:The effectiveness, safety and cost of FCSEMS for benign bile duct stenosis are similar to those of MPS, but it reduces ERCP intervention and treatment cycles. Even with a certain migration rate, it can still be a first-line treatment approach.

Objective:To evaluate the safety, efficacy and performance of disposable cholangiopancreatoscope in the diagnosis and treatment of bile duct diseases.Methods:A total of 20 subjects were selected and 16 subjects were enrolled in the prospective and exploratory clinical study which were performed in the Digestive Endoscope Center of Hangzhou First People's Hospital Affiliated to Zhejiang University School of Medicine from July 2021 to August 2021. The disposable cholangiopancreatoscope was used to diagnose bile duct diseases in routine endoscopic retrograde cholangiopancreatography. Biopsies were performed in cases where malignancy was considered. The use related indexes and performance indexes of the instruments were analyzed.Results:Among the 16 patients, there were 6 cases of biliary space-occupying lesions, 6 cases of biliary calculi, and 4 cases of benign biliary stricture before operation. The success rate of the disposable insertion was 100.00% (16/16), and the success rate of observation was 100.00% (16/16). Three biliary space-occupying lesions diagnosed as malignant tumor under cholangiopancreatoscope were confirmed by pathology after operation. Diagnosis of other patients was consistent with preoperative diagnose, so no biopsy was conducted. The rate of positive feedback from operators in directional control was 81.25% (13/16), the image failure rate was 18.75% (3/16), and the rate of positive feedback for image clarity was 93.75% (15/16). In terms of clinical performance, the imaging quality of excellence was 93.75% (15/16), the flexible degree of excellence was 81.25% (13/16), and other indexes were all 100.00% excellence. During the period, there were no instrument defects, pancreatitis, perforation, bleeding or other instrument-related adverse events.Conclusion:The effectiveness, safety and performance indexes of domestic disposable cholangiopancreatoscope have reached the standards of clinical application with high pixel, integration, and portability. It's worthy of clinical recommendation.

To evaluate the clinical efficacy and safety of Hot AXIOS, a novel luminal metal stent with a cautery system guided by endoscopic ultrasound, for the treatment of infected pancreatic necrosis (IPN), 5 cases of IPN treated with endoscopic ultrasound-guided Hot AXIOS placement in Hangzhou First People's Hospital from December 2021 to January 2022 were retrospectively analyzed. The results showed that all 5 cases successfully completed the treatment, with 8-21 minutes of the operation time. The symptoms of abdominal pain and bloating on the first day after operation were significantly relieved, and the abdominal CT showed that the walled-off necrosis was significantly reduced. After 2-9 times of direct endoscopic necrosectomy, supplemented by antibiotics, patient's temperature and blood inflammatory indexes returned to normal, the cavity was reduced and necrosis was removed. The Hot AXIOS stent was indwelled for 12-40 days and then removed. After 25-113 days of the follow-up, all patients survived without recurrence. Preliminary results suggest that endoscopic ultrasound-guided Hot AXIOS placement is safe and effective for the treatment of IPN.