The Pharmacovigilance Guideline for Clinical Application of Chinese Patent Medicine for External Use （T/CACM 1563.5—2024）， the first guideline in China specializing for the clinical safety of Chinese patent medicines for external use， was led by the Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，and jointly developed by more than 30 research institutions of medical sciences across the country. Aiming to standardize the pharmacovigilance activities in the clinical application of Chinese patent medicines for external use，the guideline systematically categorizes potential risks and proposes prevention and control measures that cover 11 core sections of risk monitoring and reporting， signal identification，as well as assessment and control， addressing the gap in domestic and international standardization of this field. The compilation of this guideline strictly adhered to international norms and domestic regulations， involving multiple rounds of expert consultations，hybrid interviews， and evidence integration （covering literature，medical insurance，essential medicine，pharmacopoeia data， and regulatory information）. With the scope of application defined to include medical institutions， pharmaceutical manufacturers and distribution enterprises，as well as regulatory authorities， the guideline focuses on key issues such as inherent medicine risks，quality risks，off-label use，risks of combination therapy，and the safety in special populations. During the compilation，core discrepancies such as the definition of application scope and quality risk control were addressed to ensure alignment with regulations such as the Drug Administration Law of the People's Republic of China and the Good Pharmacovigilance Practice. The guideline is registered internationally （PREPARE—2022CN463）. In the future，the implementation of the guideline will be promoted through hierarchical dissemination，dynamic revision，and post-effectiveness evaluation， contributing to rational clinical use and improved patient safety.

The Pharmacovigilance Guideline for Clinical Application of Chinese Patent Medicine for External Use （T/CACM 1563.5—2024）， the first guideline in China specializing for the clinical safety of Chinese patent medicines for external use， was led by the Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，and jointly developed by more than 30 research institutions of medical sciences across the country. Aiming to standardize the pharmacovigilance activities in the clinical application of Chinese patent medicines for external use，the guideline systematically categorizes potential risks and proposes prevention and control measures that cover 11 core sections of risk monitoring and reporting， signal identification，as well as assessment and control， addressing the gap in domestic and international standardization of this field. The compilation of this guideline strictly adhered to international norms and domestic regulations， involving multiple rounds of expert consultations，hybrid interviews， and evidence integration （covering literature，medical insurance，essential medicine，pharmacopoeia data， and regulatory information）. With the scope of application defined to include medical institutions， pharmaceutical manufacturers and distribution enterprises，as well as regulatory authorities， the guideline focuses on key issues such as inherent medicine risks，quality risks，off-label use，risks of combination therapy，and the safety in special populations. During the compilation，core discrepancies such as the definition of application scope and quality risk control were addressed to ensure alignment with regulations such as the Drug Administration Law of the People's Republic of China and the Good Pharmacovigilance Practice. The guideline is registered internationally （PREPARE—2022CN463）. In the future，the implementation of the guideline will be promoted through hierarchical dissemination，dynamic revision，and post-effectiveness evaluation， contributing to rational clinical use and improved patient safety.

Objective To investigate the safety and clinical efficacy of the Laennec membrane left side hepatic parenchymal transection-first approach combined with APR triangle in laparoscopic anatomical central hepatectomy.Methods 24 patients underwent laparoscopic anatomical central hepatectomy via Laennec membrane left side hepatic parenchymal transection-first approach combined with APR triangle from January 2023 to June 2024 were selected.Statistical analysis of patients with operation time,intraoperative blood loss,postoperative complications,and postoperative hospital stay.Results All the 24 patients underwent laparoscopic anatomical central hepatectomy without perioperative death.The operation time was(210.2±75.6)minutes(range:95～295 min),and the intraoperative blood loss was(358.9±118.4)mL(range:150～1 100 mL).There was no intraoperative blood transfusion and no conversion to open surgery.The abdominal drainage tube was removed on the average of(5.5±0.5)d(range:4～10 d)after operation,and the average postoperative hospital stay was(7.5±1.5)d(range:5～16 d).There were 5 cases of Clavien-Dindo grade Ⅰ and Ⅱ complications,including 4 cases of abdominal effusion and 1 case of pleural effusion.Postoperative pathology:all patients were hepatocellular carcinoma.Patients with liver malignant tumor were followed up for 1 month to 1.5 years.All the patients survived during the follow-up period,and 2 patients had tumor recurrence.Conclusion For central hepatic segment tumors,laparoscopic anatomical central hepatectomy can be performed using the left hepatic parenchyma via Laennec membrane priority approach combined with APR triangle method,which is safe and feasible.

The Compilation Instructions for Expert Consensus on Clinical Application of Dieda Huoxue capsules systematically expound the development methods and evidence-based basis of this consensus. In view of the weak clinical application evidence and ambiguous indications of Dieda Huoxue capsules， the Institute of Basic Research in Clinical Medicine of the China Academy of Chinese Medical Sciences and Wangjing Hospital took the lead and collaborated with 33 experts from 28 medical institutions nationwide. They strictly followed the World Health Organization （WHO） guideline-making norms and the Grading of Recommendations Assessment， Development and Evaluations （GRADE） evidence-grading system and completed the compilation through multidisciplinary cooperation. The workflow included constructing clinical questions （19 items were screened by the nominal group technique）， retrieving evidence （from Chinese and English databases and grey literature）， assessing safety （integrating drug monitoring data and clinical investigations）， and forming recommendations and consensus suggestions （3 recommendations were reached via the GRADE grid method， and 16 consensus suggestions were reached by the majority vote rule）. The results indicate that the consensus clearly states that this medicine （Dieda Huoxue capsules） is applicable to conditions like traumatic injury， blood stasis-induced pain， and sudden lumbar sprains. The recommended dose is 6 capsules each time， twice a day. Combining oral administration with external application can enhance the efficacy， and elderly patients should take the medicine at intervals. Safety monitoring suggests that it should be used with caution in people with a bleeding tendency and those with an allergic constitution. The compilation process involved three rounds of reviews by internal and external experts. Literature analysis， the Delphi method， and clinical applicability tests were employed to ensure methodological rigor. The compilation instructions comprehensively present key aspects such as project approval and registration， conflict-of-interest statements， and evidence evaluation through 12 appendices， providing methodological support for the clinical translation of the consensus. In the future， it will be continuously improved through a dynamic revision mechanism.

Objective:To investigate relationship between IL-17/IL-23 immunoinflammatory axis and chronic heart failure(CHF)and clinical prognosis.Methods:A total of 112 patients with CHF in Chengde Central Hospital from January 2020 to Septem-ber 2021 were selected as observation group,and another 112 patients admitted to same period for healthy physical examination were selected as control group.Serum IL-17 and IL-23 levels of two groups were compared,relationship between serum IL-17 and IL-23 levels and degree of disease were analyzed;clinical data,serum IL-17 and IL-23 levels of patients with different prognosis were compared,relationship between serum IL-17 and IL-23 levels and clinical prognosis of CHF patients were analyzed.Predictive value of serum IL-17 and IL-23 levels on clinical prognosis of CHF patients was evaluated,and predictive value of each prediction scheme was compared.Results:Serum IL-17 and IL-23 levels were higher in observation group than control group(P<0.05);serum IL-17 and IL-23 levels of CHF patients were positively correlated with NYHA classification(P<0.05).Serum IL-17 and IL-23 levels were higher in patients with poor prognosis than in those with good prognosis(P<0.05).Serum IL-17 and IL-23 were independently associated with clinical prognosis of CHF patients,and the higher the serum IL-17 and IL-23 levels,the greater risk of poor clinical prognosis of CHF patients.AUC of serum IL-17 and IL-23 levels for predicting clinical prognosis of CHF patients were 0.787 and 0.726,respectively,and combined predicted AUC was 0.918(P<0.001);combined predicted AUC of serum IL-17 and IL-23 was significantly higher than single index(P<0.05).Conclusion:IL-17 and IL-23 levels in IL-17/IL-23 immunoinflammatory axis of CHF patients are significantly elevated and involve in disease occurence and development,whose clinical detection can help predict clinical prognosis of CHF.

Objective To explore and analyze the characteristics and transmission routes of carbapenem-resistant Klebsiella pneumoniae(CRKP)strains in intensive care unit(ICU).Methods From January to October 2023,17 clinical infection isolates(clinical infection group),5 active screening isolates(active screening group),and 7 envi-ronmental isolates(environmental group)of CRKP in the liver surgery ICU of a hospital were selected and analyzed by whole-genome sequencing.The differences in resistance genes,virulence genes,and sequence typing(ST)were compared,and transmission routes were analyzed based on the phylogenetic tree.Results 29 strains of CRKP car-ried 4-18 resistance genes and 52-98 virulence genes,respectively.There were no statistically significant diffe-rences in genotype distribution of resistance genes,the number of virulence genes,and gene types among three groups of CRKP(all P＞0.05).ST showed that 29 CRKP strains mainly consisted of two categories:ST11 and ST15.Based on the phylogenetic tree constructed from the core genome,there were 7 highly homologous groups of CRKP,among which 4 groups had clear epidemiological associations.Conclusion CRKP in ICU carries more re-sistance and virulence genes,and some strains are highly homologous in ST and phylogenetic tree,which may lead to cross transmission.In the future,prevention and control measures should be strengthened to reduce the trans-mission of CRKP.

Objective To investigate the safety and clinical efficacy of the Laennec membrane left side hepatic parenchymal transection-first approach combined with APR triangle in laparoscopic anatomical central hepatectomy.Methods 24 patients underwent laparoscopic anatomical central hepatectomy via Laennec membrane left side hepatic parenchymal transection-first approach combined with APR triangle from January 2023 to June 2024 were selected.Statistical analysis of patients with operation time,intraoperative blood loss,postoperative complications,and postoperative hospital stay.Results All the 24 patients underwent laparoscopic anatomical central hepatectomy without perioperative death.The operation time was(210.2±75.6)minutes(range:95～295 min),and the intraoperative blood loss was(358.9±118.4)mL(range:150～1 100 mL).There was no intraoperative blood transfusion and no conversion to open surgery.The abdominal drainage tube was removed on the average of(5.5±0.5)d(range:4～10 d)after operation,and the average postoperative hospital stay was(7.5±1.5)d(range:5～16 d).There were 5 cases of Clavien-Dindo grade Ⅰ and Ⅱ complications,including 4 cases of abdominal effusion and 1 case of pleural effusion.Postoperative pathology:all patients were hepatocellular carcinoma.Patients with liver malignant tumor were followed up for 1 month to 1.5 years.All the patients survived during the follow-up period,and 2 patients had tumor recurrence.Conclusion For central hepatic segment tumors,laparoscopic anatomical central hepatectomy can be performed using the left hepatic parenchyma via Laennec membrane priority approach combined with APR triangle method,which is safe and feasible.

Objective:To investigate relationship between IL-17/IL-23 immunoinflammatory axis and chronic heart failure(CHF)and clinical prognosis.Methods:A total of 112 patients with CHF in Chengde Central Hospital from January 2020 to Septem-ber 2021 were selected as observation group,and another 112 patients admitted to same period for healthy physical examination were selected as control group.Serum IL-17 and IL-23 levels of two groups were compared,relationship between serum IL-17 and IL-23 levels and degree of disease were analyzed;clinical data,serum IL-17 and IL-23 levels of patients with different prognosis were compared,relationship between serum IL-17 and IL-23 levels and clinical prognosis of CHF patients were analyzed.Predictive value of serum IL-17 and IL-23 levels on clinical prognosis of CHF patients was evaluated,and predictive value of each prediction scheme was compared.Results:Serum IL-17 and IL-23 levels were higher in observation group than control group(P<0.05);serum IL-17 and IL-23 levels of CHF patients were positively correlated with NYHA classification(P<0.05).Serum IL-17 and IL-23 levels were higher in patients with poor prognosis than in those with good prognosis(P<0.05).Serum IL-17 and IL-23 were independently associated with clinical prognosis of CHF patients,and the higher the serum IL-17 and IL-23 levels,the greater risk of poor clinical prognosis of CHF patients.AUC of serum IL-17 and IL-23 levels for predicting clinical prognosis of CHF patients were 0.787 and 0.726,respectively,and combined predicted AUC was 0.918(P<0.001);combined predicted AUC of serum IL-17 and IL-23 was significantly higher than single index(P<0.05).Conclusion:IL-17 and IL-23 levels in IL-17/IL-23 immunoinflammatory axis of CHF patients are significantly elevated and involve in disease occurence and development,whose clinical detection can help predict clinical prognosis of CHF.

Objective To explore and analyze the characteristics and transmission routes of carbapenem-resistant Klebsiella pneumoniae(CRKP)strains in intensive care unit(ICU).Methods From January to October 2023,17 clinical infection isolates(clinical infection group),5 active screening isolates(active screening group),and 7 envi-ronmental isolates(environmental group)of CRKP in the liver surgery ICU of a hospital were selected and analyzed by whole-genome sequencing.The differences in resistance genes,virulence genes,and sequence typing(ST)were compared,and transmission routes were analyzed based on the phylogenetic tree.Results 29 strains of CRKP car-ried 4-18 resistance genes and 52-98 virulence genes,respectively.There were no statistically significant diffe-rences in genotype distribution of resistance genes,the number of virulence genes,and gene types among three groups of CRKP(all P＞0.05).ST showed that 29 CRKP strains mainly consisted of two categories:ST11 and ST15.Based on the phylogenetic tree constructed from the core genome,there were 7 highly homologous groups of CRKP,among which 4 groups had clear epidemiological associations.Conclusion CRKP in ICU carries more re-sistance and virulence genes,and some strains are highly homologous in ST and phylogenetic tree,which may lead to cross transmission.In the future,prevention and control measures should be strengthened to reduce the trans-mission of CRKP.

Objective This research assessed the impact of incorporating choledochoscopy with laparoscopic left hepatectomy on stress response and bile duct stone removal in patients presenting with complex intrahepatic biliary stones.Methods Clinical data of 194 patients with complex intrahepatic biliary stones from June 2020 to June 2024 were retrospectively analyzed.The patients were divided into control group (n=97) and observation group (n=97) according to different operation methods.The control group received laparoscopic left hepatectomy,while the observation group received choledochoscopic lithotomy combined with laparoscopic left hepatectomy.The changes of stress indexes[cortisol (Cor),adrenaline (AD)],inflammatory factors[C-reactive protein (CRP),interleukin-6 (IL-6),tumor necrosis factor-α (TNF-α)]in the two groups before and 3 days after operation were compared.The liver function indexes[alanine transaminase (ALT),total bilirubin (TBiL),glutamyl transferase (GGT)]of the two groups before and 7 days after operation were compared.The treatment effect levels of the two groups were evaluated 3 months after operation.The incidence of postoperative complications (bile leakage,infection,residual stones and pleural effusion) was recorded and compared between the two groups.Results Three days before and after operation,the levels of Cor,AD,CRP,IL-6 and TNF-α in the two groups had no significant difference (P>0.05),but the postoperative level in two groups were significantly higher than those before surgery,and the differences were statistically significant (P<0.05).Before operation,there was no significant difference in ALT,TBiL and GGT between the two groups (P>0.05).On the 7th day after operation,ALT,TBiL and GGT of the two groups decreased,and the observation group was lower than those of the control group (P<0.05).There was no significant difference in visual analogue scale (VAS),postoperative anal exhaust time and postoperative ambulation time between the two groups (P>0.05).The hospitalization time of the observation group was shorter than that of the control group,the difference was statistically significant (P<0.05).The therapeutic effect of the observation group at 3 months after operation was significantly better than that of the control group,the difference was statistically significant (P<0.05).The total incidence of postoperative complications in the observation group was significantly lower than that in the control group,the difference was statistically significant (P<0.05).Conclusion The combination of laparoscopic left hepatectomy and choledochoscopy effectively addresses complex intrahepatic biliary stones,minimally impacting patient stress responses,enhancing liver function,and reducing complication risks,thereby holding promising clinical applicability.