ObjectiveTo observe the clinical efficacy of modified Xiangsha Liujunzi Decoction （香砂六君子汤， XLD） in the treatment of abemaciclib-related diarrhea of spleen-stomach deficiency type， and its regulatory effect on immune function in patients with advanced hormone receptor-positive/human epidermal growth factor receptor 2-negative （HR+/HER2-） breast cancer. MethodsA prospective， randomized， open-label， blinded-endpoint （PROBE） study was conducted. A total of 70 patients with advanced HR+/HER2- breast cancer and abemaciclib-related diarrhea were randomly divided into two groups， with 35 cases in each group. In addition to abemaciclib， the control group was treated with oral loperamide， while the trial group was treated with oral modified XLD. Both groups received treatment for 7 days as one course. The efficacy for diarrhea after treatment was compared between groups. Traditional Chinese medicine （TCM） syndrome score， Karnofsky performance status （KPS） score， inflammatory markers including interleukin-6 （IL-6） and C-reactive protein （CRP）， and immune function indicators including CD4⁺， CD8⁺， and CD4⁺/CD8⁺ ratio were compared between groups before and after treatment. Adverse events during the study were recorded， and safety was assessed. ResultsDuring the study， 1 case in the trial group and 2 cases in the control group， were lost to follow-up leaving 34 cases in the trial group and 33 cases in the control group for final analysis. The total effective rate of diarrhea in the trial group was 94.12% （32/34）， higher than 72.73% （24/33） in the control group （P＜0.05）. After treatment， both groups showed decreased TCM syndrome scores， increased KPS scores， increased CD4⁺， CD8⁺， and CD4⁺/CD8⁺ ratio， and decreased IL-6 and CRP levels （all P＜0.05）. Compared to the control group， the trial group had higher KPS scores， CD4⁺ levels， and CD4⁺/CD8⁺ ratios， and lower TCM syndrome scores and IL-6， CRP， and CD8⁺ levels （P＜0.05）. The incidence of adverse events in the trial group was 20.59% （7/34）， with an incidence of adverse drug reactions of 14.71% （5/34） after causality assessment； in the control group， the corresponding rates were 45.45% （15/33） and 39.39% （13/33）， respectively. The incidence of adverse events in the trial group was significantly lower than that in the control group （P＜0.05）. ConclusionModified XLD can effectively alleviate abemaciclib-related diarrhea in patients with advanced HR+/HER2- breast cancer of the spleen-stomach deficiency type， reduce levels of inflammatory cytokines， and regulate immune function， with a favorable safety profile.

Objective:To construct analytical dimensions for policy texts related to the pilot work of Health Impact Assessment (HIA) system in Zhejiang Province and conduct quantitative analysis, thereby providing references for improving the pilot work.Methods:Policy texts issued by Zhejiang Province between February 11, 2018, and February 29, 2024, which involved HIA content, were selected. The policy instruments theory was employed to construct an analytical framework around the dimensions of policy instruments, policy objectives, policy actors, and the interactions between policy instruments and policy objectives, and between policy instruments and policy actors. Based on this framework, a combination of literature analysis and content analysis was used to conduct a multi-dimensional quantitative analysis of the policy texts related to the pilot work of HIA system in Zhejiang Province.Results:Fifty core policy texts were included and 1 588 codes were obtained. In terms of policy instruments, environmental-type instruments were the most widely used (852 items), with internal responsibilities and methodological measures being the most frequently used; supply-type instruments were the second most used (459 items), with mechanism improvement being the most frequently used; demand-type instruments were the least used (277 items), with multi-stakeholder participation being the most frequently used. In terms of policy objectives, the objective of system construction dominated (701 articles, accounting for 56.45%), while the proportion of policy coverage, evaluation technology, and effectiveness evaluation was relatively low. In terms of policy subjects, the Party committee and government were the main policy subjects (434 articles, accounting for 39.20%), followed by health departments and public policy-making departments, while the proportion of public health institutions and social forces was extremely low. In the interaction between policy instruments and policy objectives, policy coverage, system construction, and effectiveness evaluation objectives all responded most frequently to environmental-type instruments, while the evaluation technology objectives responded more frequently to supply-type instruments. In the interaction between policy instruments and policy subjects, the Party committee and government played a dominant role in the use of policy instruments, with the health department and public policy-making department in the middle.Conclusions:The pilot work of the HIA system in Zhejiang Province presented a " environment-driven, system-construction-priority, Party-committee-and-government-led" policy characteristic. The main challenges were the imbalanced structure of policy instruments, insufficient synergy among policy objectives, and the need for greater participation of multiple stakeholders.

Objective:To construct analytical dimensions for policy texts related to the pilot work of Health Impact Assessment (HIA) system in Zhejiang Province and conduct quantitative analysis, thereby providing references for improving the pilot work.Methods:Policy texts issued by Zhejiang Province between February 11, 2018, and February 29, 2024, which involved HIA content, were selected. The policy instruments theory was employed to construct an analytical framework around the dimensions of policy instruments, policy objectives, policy actors, and the interactions between policy instruments and policy objectives, and between policy instruments and policy actors. Based on this framework, a combination of literature analysis and content analysis was used to conduct a multi-dimensional quantitative analysis of the policy texts related to the pilot work of HIA system in Zhejiang Province.Results:Fifty core policy texts were included and 1 588 codes were obtained. In terms of policy instruments, environmental-type instruments were the most widely used (852 items), with internal responsibilities and methodological measures being the most frequently used; supply-type instruments were the second most used (459 items), with mechanism improvement being the most frequently used; demand-type instruments were the least used (277 items), with multi-stakeholder participation being the most frequently used. In terms of policy objectives, the objective of system construction dominated (701 articles, accounting for 56.45%), while the proportion of policy coverage, evaluation technology, and effectiveness evaluation was relatively low. In terms of policy subjects, the Party committee and government were the main policy subjects (434 articles, accounting for 39.20%), followed by health departments and public policy-making departments, while the proportion of public health institutions and social forces was extremely low. In the interaction between policy instruments and policy objectives, policy coverage, system construction, and effectiveness evaluation objectives all responded most frequently to environmental-type instruments, while the evaluation technology objectives responded more frequently to supply-type instruments. In the interaction between policy instruments and policy subjects, the Party committee and government played a dominant role in the use of policy instruments, with the health department and public policy-making department in the middle.Conclusions:The pilot work of the HIA system in Zhejiang Province presented a " environment-driven, system-construction-priority, Party-committee-and-government-led" policy characteristic. The main challenges were the imbalanced structure of policy instruments, insufficient synergy among policy objectives, and the need for greater participation of multiple stakeholders.

According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the Chinese Pharmacopoeia 2025 Edition has been completed. Among them, 52 new pharmaceutical excipients monographs have been added, an increase of 15.5% compared with the 2020 Edition, and the total number has reached 387. This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.

According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition,the Chinese Pharmacopoeia 2025 Edition has been completed.Among them,52 new pharmaceutical excip-ients monographs have been added,an increase of 15.5%compared with the 2020 Edition,and the total number has reached 387.This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition,which can contribute to accurately under-stand and utilize the standards in Chinese Pharmacopoeia.

Objective:To analyze the relationship between 24-hour urinary calcium (24 h UCa) level and the risk of end-stage kidney disease (ESKD), cardiovascular disease (CVD), and all-cause mortality.Methods:In the Chinese Cohort Study of Chronic Kidney Disease, we examined 3 375 patients aged 18-74 years with CKD stages 1-4. Kaplan-Meier survival and Cox proportional hazard regression models were used to test a time-to-event association between levels of 24 h UCa and incidence of ESKD, CVD, and all-cause mortality.Results:During a follow-up of 4.17 (3.37, 5.20) years, 179, 145, 104 and 38 ESKD events occurred in <0.60, 0.60-, 1.20-, ≥2.32 mmol 24 h UCa groups. Higher levels of 24 h UCa (1.20-,≥2.32 mmol) were independently associated with a lower incidence of ESKD events in patients with CKD, with HR (95% CI) of 0.71 (0.54-0.93) and 0.43 (0.29-0.64), respectively. No significant associations with CVD and all-cause mortality endpoints were detected. Conclusion:Among patients with CKD, levels of 24 h UCa displayed an association with the risk of ESKD among patients with CKD stages 1-4.

Objective:To establish a method for determining the sialylation levels of N-glycan profiles based on ion-exchange chromatography in glycoprotein drugs.Methods:The separation was performed in a column picking with anion-exchange resin(4.6 mm × 250 mm,5 μm,or equivalent).Mobile phase A was 20％ acetonitrile solution,while mobile phase B was a 20％acetonitrile solution containing 0.1 mol·L-1 ammonium formate(pH 4.5).The flow rate was 0.60 mL·min-1.Detection was performed using a fluorescence detector with excita-tion and emission wavelengths of 330 and 420 nm,respectively.The injection volume was 5 μL.Results:Within the target loading sample range of 40％ to 160％,the peak area showed a good linear relationship with protein concentration(r＞0.99).The average recovery rates at three concentration levels were 106.25％,100.00％,and 106.67％,respectively.The limit of quantification was 0.03％.Conclusion:This method is suitable for detecting the sialylation levels of N-glycan profiles in various glycoprotein drugs.

Objective:To analyze the relationship between 24-hour urinary calcium (24 h UCa) level and the risk of end-stage kidney disease (ESKD), cardiovascular disease (CVD), and all-cause mortality.Methods:In the Chinese Cohort Study of Chronic Kidney Disease, we examined 3 375 patients aged 18-74 years with CKD stages 1-4. Kaplan-Meier survival and Cox proportional hazard regression models were used to test a time-to-event association between levels of 24 h UCa and incidence of ESKD, CVD, and all-cause mortality.Results:During a follow-up of 4.17 (3.37, 5.20) years, 179, 145, 104 and 38 ESKD events occurred in <0.60, 0.60-, 1.20-, ≥2.32 mmol 24 h UCa groups. Higher levels of 24 h UCa (1.20-,≥2.32 mmol) were independently associated with a lower incidence of ESKD events in patients with CKD, with HR (95% CI) of 0.71 (0.54-0.93) and 0.43 (0.29-0.64), respectively. No significant associations with CVD and all-cause mortality endpoints were detected. Conclusion:Among patients with CKD, levels of 24 h UCa displayed an association with the risk of ESKD among patients with CKD stages 1-4.

Objective:To establish a method for determining the sialylation levels of N-glycan profiles based on ion-exchange chromatography in glycoprotein drugs.Methods:The separation was performed in a column picking with anion-exchange resin(4.6 mm × 250 mm,5 μm,or equivalent).Mobile phase A was 20％ acetonitrile solution,while mobile phase B was a 20％acetonitrile solution containing 0.1 mol·L-1 ammonium formate(pH 4.5).The flow rate was 0.60 mL·min-1.Detection was performed using a fluorescence detector with excita-tion and emission wavelengths of 330 and 420 nm,respectively.The injection volume was 5 μL.Results:Within the target loading sample range of 40％ to 160％,the peak area showed a good linear relationship with protein concentration(r＞0.99).The average recovery rates at three concentration levels were 106.25％,100.00％,and 106.67％,respectively.The limit of quantification was 0.03％.Conclusion:This method is suitable for detecting the sialylation levels of N-glycan profiles in various glycoprotein drugs.

By applying "homeostasis" to the study of the meridian and collateral system， the concept of meridian and collateral homeostasis has been proposed which refers to a balanced and stable state of meridian and collateral system， and plays an important role in maintaining body health and can provide a reference for the diagnosis and treatment of diseases. Phenomics realizes the cross-scale correlation from micro-phenotypic data， such as genome， proteome， and metabolome， to macro-phenotypic data， such as physiological state， behavioral activities， and external manifestations. From the perspective of phenomics， this paper proposes a meridian and collateral homeostasis dynamic mapping model of "macroscopic signs and microscopic expression". This model combines macro signs such as the four examinations of traditional Chinese medicine （TCM）， biophysical indicators of acupoints， and micro expression information such as genes， proteins， and metabolism， and systematically investigates the relationship between meridian and collateral homeostasis and health and disease， thereby providing ideas and references for the identification of pre-disease states as well as precise diagnosis and treatment in TCM.