Addressing the enduring challenge of evaluating traditional Chinese medicines (TCMs), the integrated evidence chain-based effectiveness evaluation of TCMs (Eff-iEC) has emerged. This paper explored its capacity through a demonstration study that evaluated the effectiveness evidence of six commonly used anti-hepatic fibrosis Chinese patent medicines (CPMs), including Biejiajian Pill (BP), Dahuang Zhechong Pill (DZP), Biejia Ruangan Compound (BRC), Fuzheng Huayu Capsule (FHC), Anluo Huaxian Pill (AHP), and Heluo Shugan Capsule (HSC), using both Eff-iEC and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system. The recognition of these CPMs within the TCM academic community was also assessed through their inclusion in relevant medical documents. Results showed that the evidence of BRC and FHC received higher assessments in both Eff-iEC and GRADE system, while the assessments for others varied. Analysis of community recognition revealed that Eff-iEC more accurately reflects the clinical value of these CPMs, exhibiting superior evaluative capabilities. By breaking through the conventional pattern of TCMs effectiveness evaluation, Eff-iEC offers a novel epistemology that better aligns with the clinical realities and reasoning of TCMs, providing a coherent methodology for clinical decision-making, new drug evaluations, and health policy formulation.

Reninoma is a rare renal secretory tumor，prevalent in the young population. This disease is mostly surgically resected，and the use of microwave ablation to treat reninoma in children is scarce. A case of reninoma in a child was reported in this paper. The patient presented with refractory hypertension，hypokalemia，hyperreninemia and hyperaldosteronemia. Enhanced CT and contrast-enhanced ultrasound showed mass in the lower pole of the right kidney，which was considered as reninoma and microwave ablation was performed. The renin concentration decreased to 68.42 pg/ml at 4 hours after surgery. After 1 year of postoperative follow-up，there was no recurrence of hypertension and hypokalemia，and no signs of tumor recurrence were seen on repeated ultrasound examinations.

Reninoma is a rare renal secretory tumor，prevalent in the young population. This disease is mostly surgically resected，and the use of microwave ablation to treat reninoma in children is scarce. A case of reninoma in a child was reported in this paper. The patient presented with refractory hypertension，hypokalemia，hyperreninemia and hyperaldosteronemia. Enhanced CT and contrast-enhanced ultrasound showed mass in the lower pole of the right kidney，which was considered as reninoma and microwave ablation was performed. The renin concentration decreased to 68.42 pg/ml at 4 hours after surgery. After 1 year of postoperative follow-up，there was no recurrence of hypertension and hypokalemia，and no signs of tumor recurrence were seen on repeated ultrasound examinations.

Objective To analyze adverse drug event(ADE)signals associated with exenatide based on data from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS),and to provide insights for rational medication use in clinical settings.Methods ADE reports of exenatide as the primary suspected drug were obtained by collecting the data of FAERS database from the first quarter 2014 to the second quarter 2024.ADE signals were analyzed by joint reporting odds ratio(ROR)method,proportional reporting odds ratio(PRR)method,Bayesian confidence interval progressive neural network(BCPNN)method and multi-item gamma Poisson shrinker(MGPS)method.Results After data cleaning,118 745 reports of exenatide-related ADEs were collected.These ADEs spanned 14 system-organ classes and involved 185 preferred terms.Commonly reported ADEs included reactions at the injection site,hypoglycemia,reduced appetite,and cholelithiasis.Severe ADEs were primarily cases of acute pancreatitis,in consistent with the drug's labeling.Moreover,the instructions did not record ADE signals of pancreatic cancer,thyroiditis,and reduced frustration tolerance.Conclusion Prescription of the exenatide should be vigilant about the signals not listed on the product labeling,such as pancreatic cancer,thyroid cancer,and decreased frustration tolerance,to improve the safety of medication use in patients.

Objective To mine adverse drug event(ADE)signals of pioglitazone,and to provide references for the safe clinical use of the medication.Methods The reporting odds ratio(ROR)method and the Bayesian confidence propagation neural network(BCPNN)method were utilized to analyze pioglitazone ADE reports from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,spanning from the first quarter of 2013 to the second quarter of 2024.Results After data cleaning,a total of 16 904 pioglitazone ADE reports were retrieved.The ADE reports primarily involved individuals over the age of 45,with a male predominance,and were mainly reported from the United States.After screening,180 ADE signals were identified,affecting 27 system-organ classes(SOC).Out of these,34 ADE signals were classified as medium to high risk,with 9 ADE signals not mentioned in the product labeling,including ureteral cancer,urethral cancer,gallbladder tumors,malignant tumors of the renal pelvis,pericardial tamponade,left ventricular dysfunction,pulmonary edema,cystitis,and somniloquy.Conclusion In addition to closely monitoring weight gain,systemic edema,and heart failure,clinical attention should be given to left ventricular dysfunction,pulmonary edema,cystitis,and pericardial tamponade ADEs that are not mentioned in the instructions,to ensure the safety of pioglitazone use in clinical practice.

Objective To investigate post-marketing adverse drug event(ADE)signals associated with lixisenatide,and to provide guidance for safe clinical use.Methods The ADE reporting data of lixisenatide ADE were mined and the signals were detected from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database from the first quarter 2013 to the second quarter 2024 using the reporting odds ratio(ROR)method and Bayesian confidence propagation neural network(BCPNN)method.Results After data cleaning,a total of 5 162 ADE reports with lixisenatide as the primary suspected drug were collected.The 85 ADE signals identified by the two statistical analysis methods,affected 14 system-organ classes(SOC).They were primarily concentrated in injuries,poisonings,and procedural complications(25.88％),various examinations(14.12％),systemic diseases and reactions at administration sites(14.12％),gastrointestinal diseases(9.41％),and various neurological diseases(5.88％).There were 28 ADE signals such as pancreatitis,visual impairment,and color blindness,that were not included in the drug instructions.Conclusion In addition to monitoring for common ADE associated with GLP-1 receptor agonists such as hypoglycemia,gastrointestinal,and neurological effects,clinicians should also be vigilant for underlying ADE like pancreatic-related diseases,eye toxicity reaction when using lixisenatide to ensure safe and rational medication use.

bjective To mine signals of post-marketing adverse drug events(ADEs)associated with dapagliflozin,and to provide insights for safe medication in clinical settings.Methods Data on ADEs related to dapagliflozin from U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)were collected from the first quarter of 2013 to the third quarter of 2024.The analyses involved data mining and signal monitoring using disproportionality analysis techniques including the reporting odds ratio(ROR)method,Medicines and Healthcare Products Regulatory Agency(MHRA)method,Bayesian confidence propagation neural network(BCPNN)method,and multi-item gamma Poisson shrinker(MGPS)method.Results After data cleaning,a total of 55 832 qualified dapagliflozin case reports were obtained,involving 25 090 patients,with a slightly higher percentage of males(44.99％)than females(41.18％).The predominant age group was 45 to 64 years(20.78％).A total of 379 ADE signals were detected across 22 system-organ classes(SOC).The ADEs of dapagliflozin were mainly concentrated in the SOC such as infections and infestations,general disorders and administration sites conditions,and metabolism and nutrition disorders,aligning with information provided in the drug instructions.Additionally,the ADE signals were not documented in drug inserts such as scrotal gangrene,periperineal cellulitis,scrotal abscess,hyperglycemia,ketonuria,and pancreatitis.Conclusion When clinically using dapagliflozin,it is essential to conduct a thorough medication assessment.In addition to closely monitoring diabetes ketoacidosis,fungal infection,and acute renal injury.The latent ADEs that are not mentioned in the instructions to should be noticed ensure safe medication.

Objective To mine the real-world risk signals associated with saxagliptin-related adverse drug event(ADE),and to provide insights for evidence-based use of the drug in clinical practice.Methods Data on ADE related to saxagliptin from U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)were collected from the first quarter of 2013 to the third quarter of 2024,and analyzed using the reporting odds ratio(ROR)and Bayesian confidence propagation neural network(BCPNN)techniques.Results After data cleaning,the study analyzed 2 036 qualified case reports from patients who were using saxagliptin,uncovering 4 497 adverse events and identifying 131 adverse event signals across 19 system-organ classes(SOCs),including cardiac organ system diseases(20.61％),various types of investigations(10.69％),and gastrointestinal tract diseases(13.74％).Among them,heart failure,pancreatitis,pancreatic cancer,and hypoglycaemic coma were high-intensity signals.Conclusion In clinical practice,the indications for saxagliptin should be strictly managed.It is advisable to avoid using saxagliptin as monotherapy in patients with a history of heart failure or in patients at elevated risk for arteriosclerotic cardiovascular disease.Continuous monitoring of essential organ functions,especially cardiac and pancreatic,is essential throughout the course of treatment to ensure the safety of the medication.

Objective:The pregnancy outcome,related influencing factors and genetic results of pregnant women with intracranial cysts were comparatively analyzed to provide evidence for prenatal consultation and clini-cal treatment of the fetus with intracranial cyst.Methods:A total of 92 pregnant women with fetal intracranial cysts were selected.The data of pregnancy and delivery were collected by electronic medical record system.The prog-nosis of newborn was recorded by telephone follow-up.According to the pregnancy outcome,they were divided into continued pregnancy group(80/92,87%)and induced labor group(12/92,13%).Analyze the factors that might influence the pregnancy outcome of intracranial cysts,as well as genetic outcomes.Results:Compared with the continued pregnancy group and the induced labor group,there were statistical differences between the gesta-tion age at diagnosis≤28 weeks and the presence of other abnormalities(P＜0.05),but there were no statistical differences in the age of pregnant women and the number of intracranial cysts(P＞0.05).The results of genetic examination were compared between normal and abnormal groups of 25 cases,and there were no statistical differences in the age of pregnant women,the gestation age at diagnosis,whether there was adverse pregnancy history,whether there was single cyst,and the presence of other abnormalities(P＞0.05).Conclusions:Diagno-sis of fetal intracranial cyst at≤28 weeks gestation and other systemic abnormalities are risk factors affecting pregnancy outcome.

Objective:The pregnancy outcome,related influencing factors and genetic results of pregnant women with intracranial cysts were comparatively analyzed to provide evidence for prenatal consultation and clini-cal treatment of the fetus with intracranial cyst.Methods:A total of 92 pregnant women with fetal intracranial cysts were selected.The data of pregnancy and delivery were collected by electronic medical record system.The prog-nosis of newborn was recorded by telephone follow-up.According to the pregnancy outcome,they were divided into continued pregnancy group(80/92,87%)and induced labor group(12/92,13%).Analyze the factors that might influence the pregnancy outcome of intracranial cysts,as well as genetic outcomes.Results:Compared with the continued pregnancy group and the induced labor group,there were statistical differences between the gesta-tion age at diagnosis≤28 weeks and the presence of other abnormalities(P＜0.05),but there were no statistical differences in the age of pregnant women and the number of intracranial cysts(P＞0.05).The results of genetic examination were compared between normal and abnormal groups of 25 cases,and there were no statistical differences in the age of pregnant women,the gestation age at diagnosis,whether there was adverse pregnancy history,whether there was single cyst,and the presence of other abnormalities(P＞0.05).Conclusions:Diagno-sis of fetal intracranial cyst at≤28 weeks gestation and other systemic abnormalities are risk factors affecting pregnancy outcome.