The Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines （hereinafter referred to as the Guidelines） is first specialized in the field of drug safety for oral Chinese patent medicines （OCPMs） in China. Rooted in China's healthcare context， the Guidelines address the unique usage patterns and risk characteristics of OCPMs， filling a regulatory gap in the pharmacovigilance framework specific to this category. To facilitate accurate understanding and effective implementation of the Guidelines， and to promote the standardized development of pharmacovigilance practices for OCPMs， this study offered a systematic interpretation based on its three core components. In the domain of risk monitoring and reporting， the paper analyzed the rationale for multi-source information integration and clarified the criteria for identifying key products and target populations for intensive monitoring. Regarding risk assessment， the Guidelines were examined from three dimensions of formulation components， medication behaviors， and population to address complex safety issues arising from medicinal constituents， irrational use， and individual susceptibility. In the area of risk control， the analysis focused on context-based interventions and dynamic closed-loop management strategies， exploring practical pathways to shift from passive response to proactive risk mitigation. Furthermore， this paper evaluated the applied value of the Guidelines and identified implementation challenges， such as insufficient capacity at the primary-care level and limited digital infrastructure. In response， the study proposed optimization strategies including establishing a dynamic updating mechanism， strengthening training at the grassroots level， and incorporating artificial intelligence to enhance pharmacovigilance capacity. This interpretation aims to provide actionable insights for marketing authorization holders （including manufacturers）， pharmaceutical distributors， healthcare institutions， and research organizations， ultimately supporting the establishment and refinement of a full lifecycle pharmacovigilance system for OCPMs.

The field of post-marketing benefit-risk assessment for traditional Chinese medicine（TCM） is still in its nascent stage， lacking a universally accepted and cohesive evaluation framework and standards. This study presented a strategy developed for the benefit-risk assessment of post-marketing of TCM， and explored the critical techniques and specific implementation steps involved in the assessment process. Initially， appropriate qualitative assessment frameworks and quantitative analysis models were selected for the integrated qualitative and quantitative benefit-risk assessment. Subsequently， key technologies were outlined， including the establishment of a benefit-risk indicator system， the assignment of indicator weights， and the definition of criteria attributes. Furthermore， the implementation steps were elaborated， which involved defining decision-making issues， data collection， evaluation methodologies， variability factors， and sensitivity analysis. Finally， a case study of the benefit-risk assessment of a TCM injection for hepatitis B treatment was conducted to validate the feasibility of the proposed strategy. The objective of this research was to provide theoretical support and practical references for the development of a comprehensive post-marketing benefit-risk assessment system for TCM.

OBJECTIVE To explore the APOA5 gene polymorphisms,serum lipase(LPS),soluble programmed death ligand 1(sPD-L1)and procalcitonin(PCT)in the severe acute pancreatitis(SAP)patients with secondary infectious pancreatic necrosis(IPN).METHODS A total of 122 patients with SAP who were treated in the First Affiliated Hospital of Hebei North University from Jan.2020 to Nov.2023 were recruited as the research subjects and were divided into the secondary group with 31 cases and the non-secondary group with 91 cases according to the status of secondary IPN.The APOA5 gene polymorphisms were detected for the two groups of patients by means of polymerase chain reaction-restriction fragment length polymorphism(PCR-RFLP).The levels of LPS,sPD-L1 and PCT as well as Ranson score were compared between he two groups.The association of the serum LPS,sPD-L1 and PCT with Ranson score was observed by Spearman analysis.The value of the joint detection of LPS,sPD-L1 and PCT in diagnosis of secondary IPN in the SAP patients was analyzed by means of receiver oper-ating characteristic(ROC)curves.RESULTS The frequencies of AA genotype and A allele at rs619054 locus of APOA5 gene were higher in the secondary group than in the non-secondary group(P＜0.05),and the frequency of G allele of the secondary group was lower than that of the non-secondary group(P＜0.05).There were significant differences in the levels of serum LPS,sPD-L1 and PCT as well as Ranson score between the secondary group and the non-secondary group(P＜0.05).Spearman analysis showed that the Ranson score was positively correlated with the levels of serum LPS,sPD-L1 and PCT(r=0.738,0.701,0.721,P＜0.05).ROC curve analysis indicated that the area under the curve(AUC)of the joint detection of the three indexes was higher than that of the single detection in diagnosis of secondary IPN in the SAP patients(P＜0.05),with the sensitivity 90.30％,the specifici-ty 84.60％.CONCLUSIONS The SAP patients with secondary IPN show the high expressions of LPS,sPD-L1 and PCT.The joint detection of the indexes may facilitate the diagnosis of the secondary IPN in the SAP patients.There is association between the levels of LPS,sPD-L1 and PCT and the Ranson score.The rs619054 locus of APOA5 gene may be involved in pathogenesis of secondary IPN in the SAP patients.

Objective:To evaluate the safety and efficacy of combined inflatable mediastinoscopy with laparoscopy guided by the concept of “reduced field and port” during esophagectomy for esophageal cancer.Methods:This is a retrospective cohort study. The clinical data of 497 patients with esophageal squamous cell carcinoma who underwent minimally invasive esophagectomy at the Center of Minimally Invasive Thoracic Surgery, the Second Affiliated Hospital of Naval Medical University, between January 2017 and December 2024 were retrospectively analyzed. There were 416 male and 81 female patients, with an age of (68.3±8.0) years (range: 44 to 89 years). Patients were divided into the traditional video-assisted thoracoscopic surgery group (Group A, n=354) and the combined inflatable mediastinoscopy with laparoscopic surgery group(Group B, n=143) based on the surgical approach. Furthermore, Group B was subdivided into the multiport laparoscopic group (Group B1, n=81) and the single-incision laparoscopic surgery plus one port group (Group B2, n=62). Perioperative indicators and postoperative survival differences were compared between the groups. Inter-group comparisons were performed using the independent sample t-test, χ2 test, or Fisher′s exact probability test. Survival curves were plotted using the Kaplan-Meier method, and the Log-rank test was used to analyze the survival differences between groups. Results:Compared with Group A, Group B demonstrated a significantly shorter operative time ((181.8±11.4) minutes vs. (196.7±8.1)minutes, t=16.09, P<0.01), a lower incidence of postoperative pulmonary complications (8.4% (12/143) vs. 17.8% (63/354), χ2=6.27, P=0.012), lower perioperative mortality (0 vs. 3.1%(11/354), P=0.039), and a shorter postoperative hospital stay ((16.2±2.2)days vs. (18.9±4.1)days, t=8.56, P<0.01). There was no significant difference in the anastomotic leak rate, number of lymph nodes dissected, or intraoperative blood loss between the two groups (all P>0.05). Overall survival time and recurrence-free survival time showed no significant difference between the two groups (all P>0.05). Subgroup analysis revealed no significant differences in perioperative indicators or postoperative complication rates between Group B1 and Group B2. Conclusions:Compared with traditional thoracoscopic combined with laparoscopic surgery, inflatable mediastinoscopy offered advantages in terms of lower postoperative pulmonary complication rates, shorter operative time, reduced postoperative hospital stay, and lower perioperative mortality. The “reduced field and port” concept could further minimize surgical trauma during the transmediastinal approach for esophagectomy while ensuring surgical safety and efficacy.

OBJECTIVE To explore the APOA5 gene polymorphisms,serum lipase(LPS),soluble programmed death ligand 1(sPD-L1)and procalcitonin(PCT)in the severe acute pancreatitis(SAP)patients with secondary infectious pancreatic necrosis(IPN).METHODS A total of 122 patients with SAP who were treated in the First Affiliated Hospital of Hebei North University from Jan.2020 to Nov.2023 were recruited as the research subjects and were divided into the secondary group with 31 cases and the non-secondary group with 91 cases according to the status of secondary IPN.The APOA5 gene polymorphisms were detected for the two groups of patients by means of polymerase chain reaction-restriction fragment length polymorphism(PCR-RFLP).The levels of LPS,sPD-L1 and PCT as well as Ranson score were compared between he two groups.The association of the serum LPS,sPD-L1 and PCT with Ranson score was observed by Spearman analysis.The value of the joint detection of LPS,sPD-L1 and PCT in diagnosis of secondary IPN in the SAP patients was analyzed by means of receiver oper-ating characteristic(ROC)curves.RESULTS The frequencies of AA genotype and A allele at rs619054 locus of APOA5 gene were higher in the secondary group than in the non-secondary group(P＜0.05),and the frequency of G allele of the secondary group was lower than that of the non-secondary group(P＜0.05).There were significant differences in the levels of serum LPS,sPD-L1 and PCT as well as Ranson score between the secondary group and the non-secondary group(P＜0.05).Spearman analysis showed that the Ranson score was positively correlated with the levels of serum LPS,sPD-L1 and PCT(r=0.738,0.701,0.721,P＜0.05).ROC curve analysis indicated that the area under the curve(AUC)of the joint detection of the three indexes was higher than that of the single detection in diagnosis of secondary IPN in the SAP patients(P＜0.05),with the sensitivity 90.30％,the specifici-ty 84.60％.CONCLUSIONS The SAP patients with secondary IPN show the high expressions of LPS,sPD-L1 and PCT.The joint detection of the indexes may facilitate the diagnosis of the secondary IPN in the SAP patients.There is association between the levels of LPS,sPD-L1 and PCT and the Ranson score.The rs619054 locus of APOA5 gene may be involved in pathogenesis of secondary IPN in the SAP patients.

Objective:To evaluate the safety and efficacy of combined inflatable mediastinoscopy with laparoscopy guided by the concept of “reduced field and port” during esophagectomy for esophageal cancer.Methods:This is a retrospective cohort study. The clinical data of 497 patients with esophageal squamous cell carcinoma who underwent minimally invasive esophagectomy at the Center of Minimally Invasive Thoracic Surgery, the Second Affiliated Hospital of Naval Medical University, between January 2017 and December 2024 were retrospectively analyzed. There were 416 male and 81 female patients, with an age of (68.3±8.0) years (range: 44 to 89 years). Patients were divided into the traditional video-assisted thoracoscopic surgery group (Group A, n=354) and the combined inflatable mediastinoscopy with laparoscopic surgery group(Group B, n=143) based on the surgical approach. Furthermore, Group B was subdivided into the multiport laparoscopic group (Group B1, n=81) and the single-incision laparoscopic surgery plus one port group (Group B2, n=62). Perioperative indicators and postoperative survival differences were compared between the groups. Inter-group comparisons were performed using the independent sample t-test, χ2 test, or Fisher′s exact probability test. Survival curves were plotted using the Kaplan-Meier method, and the Log-rank test was used to analyze the survival differences between groups. Results:Compared with Group A, Group B demonstrated a significantly shorter operative time ((181.8±11.4) minutes vs. (196.7±8.1)minutes, t=16.09, P<0.01), a lower incidence of postoperative pulmonary complications (8.4% (12/143) vs. 17.8% (63/354), χ2=6.27, P=0.012), lower perioperative mortality (0 vs. 3.1%(11/354), P=0.039), and a shorter postoperative hospital stay ((16.2±2.2)days vs. (18.9±4.1)days, t=8.56, P<0.01). There was no significant difference in the anastomotic leak rate, number of lymph nodes dissected, or intraoperative blood loss between the two groups (all P>0.05). Overall survival time and recurrence-free survival time showed no significant difference between the two groups (all P>0.05). Subgroup analysis revealed no significant differences in perioperative indicators or postoperative complication rates between Group B1 and Group B2. Conclusions:Compared with traditional thoracoscopic combined with laparoscopic surgery, inflatable mediastinoscopy offered advantages in terms of lower postoperative pulmonary complication rates, shorter operative time, reduced postoperative hospital stay, and lower perioperative mortality. The “reduced field and port” concept could further minimize surgical trauma during the transmediastinal approach for esophagectomy while ensuring surgical safety and efficacy.

ObjectiveTo construct the evidence body for revision of safety information on package inserts of Chinese patent medicines in post-marketing by taking Xiaoke'an capsules as an example， so as to provide reference for the revision of instructions of Chinese patent medicines in post-marketing. MethodThe construction of the evidence body was guided by the theory of traditional Chinese medicine（TCM） and the Technical Guiding Principles for Revision of Safety Information Items in Instructions for TCMs After Marketing， and 8 categories and 25 specific items were taken as the main body of the evidence body， and information inclusion， integration， screening and improvement were carried out， then expert demonstrations were conducted， and finally modifications were made based on the opinions of the Center for Drug Evaluation to complete the revision of the safety information in the instructions of Xiaoke'an capsules. Result［Adverse reactions］ of Xiaoke'an capsules was revised to "monitoring data show that the following adverse reactions can be seen with this product：individual hypoglycemic reaction reports". ［Contraindications］ was revised to "contraindicated for those allergic to this product and its ingredients". ［Precautions］ was revised to "（1）pregnant women should use with caution， （2）elderly people should consult a physician， （3）people with spleen deficiency and dampness， spleen and stomach deficiency and cold， or those who eat less and have diarrhea should use with caution， （4）this product contains ginseng， should not be taken at the same time with TCM prescriptions or patent medicines containing veratrum and Wulingzhi， （5）pay attention to monitoring blood sugar during medication， （6）if any other discomfort occurs during medication， you should seek medical attention in time". The warning was revised to "use with caution by pregnant women， and pay attention to regular monitoring of blood sugar". ConclusionIn accordance with the content and process of the evidence body for the revision of safety information in the instructions， the revision of the safety information in the instructions of Xiaoke'an capsules has been completed， providing a strong basis for the rational and safe use of medication in the clinic.

Objective:To evaluate the value of bedside ultrasound in evaluating volume responsiveness of patients with septic shock.Methods:A total of 102 patients with septic shock admitted to ICU of the First Affiliated Hospital of Hebei North University from April 2018 to February 2021 were selected. Patients were divided into response group and non-response group according to the value of stroke volume increase (ΔSV) after volume loading test (VE), and the hemodynamic parameters before and after VE were compared between the two groups. Pearson correlation was used to analyze the relationship between ΔSV and hemodynamic indexes. Receiver operating characteristic (ROC) curve was drawn to analyze the sensitivity and specificity of each hemodynamic index in evaluating volumetric reactivity in patients with septic shock.Results:Of the 102 patients, 54 responded and 48 did not. Before VE, the distensibility index of inferior vena cava (ΔIVC 1), espiratory variability index of inferior vena cava (ΔIVC 2), respiratory variability of aortic peak velocity (ΔVpeak AO), brachial artery maximum velocity variability (ΔVpeak BA) and respiratory rate of peak flow velocity of femoral artery (ΔVpeak CFA) in response group were higher than those in non-response group (all P<0.05), but there was no statistical significance in heart rate (HR), mean arterial pressure (MAP) and central venous pressure (CVP) between 2 groups (all P>0.05). After VE, the HR, ΔIVC 1, ΔIVC 2, ΔVpeak AO, ΔVpeak BA and ΔVpeak CFA in response group were significantly decreased, while MAP and CVP were significantly increased (all P<0.05). The CVP was significantly decreased in the non-response group ( P<0.05), while other indexes were not significantly changed. Before VE, the ΔIVC 1, ΔIVC 2, ΔVpeak AO, ΔVpeak BA and ΔVpeak CFA were positively correlated with ΔSV ( r=0.589, 0.647, 0.697, 0.621, 0.766; all P<0.05). There was no correlation between CVP and ΔSV ( r=-0.345, P>0.05). Before VE, the area under the curve of ΔIVC 1, ΔIVC 2, ΔVpeak AO, ΔVpeak BA and ΔVpeak CFA were all >0.7, indicating high sensitivity and specificity. Conclusions:Bedside ultrasound monitoring ΔIVC, ΔVpeak AO, ΔVpeak BA and ΔVpeak CFA can better evaluate the volume response of patients with septic shock, and can provide a reference basis for clinical fluid resuscitation treatment.

Objective To ummarized the clinical characteristics of lactic acidosis combined with hypoglycemic coma,diabetic ketoacidosis and hyperkalemia,so to improve the physician's treatment ability by summary the clinical feature of lactic acidosis combined with hypoglycemic coma,diabetic ketosis and hyperkalemia.Methods Analyzed the clinical characteristics and disease development of one case with lactic acidosis combined with hypoglycemic coma,diabetic ketoacidosis and hyperkalemia,and reviewed literature.Results The patient had hypoglycemia and acidosis at the same time due to taking phenformin and glibenclamide.After 2 days,the patient was better through correcting acidosis,intravenous fluid therapy,lowering blood potassium and controlling blood glucose.Conclusion Because acidosis caused the potassium transfer from intracellular to extracellular,the latter leads to hyperpotassemia,lactic acidosis caused by phenformin should be treated with intravenous fluid therapy,correcting acidosis.

Objective To investigate the mechanism of liposome PGE1 on the survival of the expanded flap.Methods The minipigs were set up as an animal model.They were divided into 2 groups.The expanded flaps (8 cm ×2 cm) were designed and elevated on the back of an minipig.An image analysis technology was used to evaluate the survival rate of the expanded flap,while realtimePCR technique was used to investigate the molecular mechanism.Results The survival area of the expanded flap in the Lipo PGE1 group was significantly enlarged (P＜0.01) compared with the control group.The VEGF,iNOS and Ang-1 gene expression decreased,but TGF-β1 gene expression increased.But there was no significant difference between two groups (P＞0.05).Conclusions The Lipo PGE1 could promote survival rate of the expanded flap,but the mechanism does not involve the regulation of VEGF,iNOS,Ang-1 and TGF-β1 gene expression.