1.Study on the current status and pathway optimization of traditional Chinese medicine preparations record-filing management in medical institutions across different provinces
Chao LIN ; Chenjie SHU ; Chuchu WAN ; Yang DONG ; Mengting DI ; Huiying SHEN ; Bo ZHANG
China Pharmacy 2026;37(13):1673-1678
OBJECTIVE To provide scientific reference for perfecting the record-filing management policy of traditional Chinese medicine preparations formulated via traditional processes for medical applications (hereinafter referred to as “TCM preparations”) in medical institutions, and further promote the sound development of the research and record-filing work of such preparations. METHODS A literature review combined with cross-sectional research was carried out. We collected policy documents and preparation information related to the record-filing of TCM preparations issued by national and provincial drug administration authorities on official websites during 2018-2025. A comparative analysis was conducted on the implementation and revision of core policy documents for the registration management of TCM preparations across provinces, the scope of record-filing dosage forms, conditions for rejection of record-filing, and exemptions for registration materials. Statistical analysis on the quantity and dosage forms of record-filing preparations in each province was conducted by means of data induction and trend chart plotting, and targeted suggestions were put forward to optimize the management pathway of record-filing. RESULTS CONCLUSIONS There was obvious heterogeneity in record-filing policies among provinces. Twelve provinces refined the applicable dosage forms for record-filing, fifteen provinces supplemented conditions for rejection of record-filing (16 items in total), and nine provinces expanded the scope of material exemptions. The number of recorded preparations presented a striking regional imbalance:Qinghai had the largest quantity of 4 269 varieties, while Hainan only had 14 varieties, with a gap of more than 300 times. The recorded preparations were mainly traditional dosage forms including pills (6 928 varieties) and powders (4 360 varieties). Only 12 provinces formulated the provincial catalog for TCM preparations allocation. In most regions, preparation circulation was only permitted within medical consortia, leading to a low transformation rate of scientific and technological achievements of preparations. It is recommended to optimize the record-filing management pathway from three aspects: strengthening policy standardization while maintaining flexibility, streamlining record-filing procedures and documentary requirements, and reinforcing technical support and achievement transformation. These measures can reduce regional policy differences, improve work efficiency of record-filing, and advance the standardized development and clinical value transformation of hospital-made TCM preparations.
2.Study on the current status and pathway optimization of traditional Chinese medicine preparations record-filing management in medical institutions across different provinces
Chao LIN ; Chenjie SHU ; Chuchu WAN ; Yang DONG ; Mengting DI ; Huiying SHEN ; Bo ZHANG
China Pharmacy 2026;37(13):1673-1678
OBJECTIVE To provide scientific reference for perfecting the record-filing management policy of traditional Chinese medicine preparations formulated via traditional processes for medical applications (hereinafter referred to as “TCM preparations”) in medical institutions, and further promote the sound development of the research and record-filing work of such preparations. METHODS A literature review combined with cross-sectional research was carried out. We collected policy documents and preparation information related to the record-filing of TCM preparations issued by national and provincial drug administration authorities on official websites during 2018-2025. A comparative analysis was conducted on the implementation and revision of core policy documents for the registration management of TCM preparations across provinces, the scope of record-filing dosage forms, conditions for rejection of record-filing, and exemptions for registration materials. Statistical analysis on the quantity and dosage forms of record-filing preparations in each province was conducted by means of data induction and trend chart plotting, and targeted suggestions were put forward to optimize the management pathway of record-filing. RESULTS CONCLUSIONS There was obvious heterogeneity in record-filing policies among provinces. Twelve provinces refined the applicable dosage forms for record-filing, fifteen provinces supplemented conditions for rejection of record-filing (16 items in total), and nine provinces expanded the scope of material exemptions. The number of recorded preparations presented a striking regional imbalance:Qinghai had the largest quantity of 4 269 varieties, while Hainan only had 14 varieties, with a gap of more than 300 times. The recorded preparations were mainly traditional dosage forms including pills (6 928 varieties) and powders (4 360 varieties). Only 12 provinces formulated the provincial catalog for TCM preparations allocation. In most regions, preparation circulation was only permitted within medical consortia, leading to a low transformation rate of scientific and technological achievements of preparations. It is recommended to optimize the record-filing management pathway from three aspects: strengthening policy standardization while maintaining flexibility, streamlining record-filing procedures and documentary requirements, and reinforcing technical support and achievement transformation. These measures can reduce regional policy differences, improve work efficiency of record-filing, and advance the standardized development and clinical value transformation of hospital-made TCM preparations.
3.Latent profile analysis of nutrition literacy among young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity and its relationship with dietary motivation
Xiangjie SHEN ; Wei YIN ; Qiaoyan LIU ; Songmei CAO ; Houjuan ZU ; Huiying SHA ; Jingjing WANG
Chinese Journal of Nursing 2025;60(16):1974-1980
Objective To investigate the potential categories of nutrition literacy in young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity,and analyze the relationship between various latent categories and dietary motivation,so as to provide references for clinical working staff to develop relevant dietary intervention strategies.Methods A convenient sampling method was used to enroll 270 young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity from the endocrine department of a tertiary general hospital in Zhenjiang City,Jiangsu province,using basic information questionnaire,Nutrition Literacy Measurement Scale for Chinese adults,and the Regulation of Eating Behaviors Scale to collect data,using latent profile analysis to extract nutrition literacy potential categories,with general data and potential categories as independent variables,dietary motivation as the dependent variable for univariate analysis and multiple linear regression analysis.Results A total of 262 young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity completed the survey,and their nutrition literacy could be divided into 3 potential categories:low nutrition literacy group(16.41%),transformation dilemma group(54.96%),and middle and high nutrition literacy group(28.63%).The results of multiple linear regression analysis showed that residency style,potential categories of nutrition literacy and presence of diabetic complications were the influencing factors of dietary motivation in young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity(P<0.05).Conclusion There was a group heterogeneity in nutrition literacy in young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity.Clinical working staff should provide targeted interventions based on the patient's potential categories of nutrition literacy to stimulate ongoing motivation to maintain a healthy diet.
4.Prognostic value of plasma sST2 in elderly patients with coronary heart disease and chronic kidney disease
Huiying LI ; Lili CAI ; Bing ZHU ; Shen LIU ; Qiwei ZHU
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(5):611-615
Objective To explore the prognostic value of plasma sST2 in the population of coronary heart disease(CHD)complicated with chronic kidney disease(CKD).Methods A total of 326 elderly patients with CHD or CKD undergoing physical examination in the Second Medical Center of Chinese PLA General Hospital from April 2021 to July 2022 were continuously enrolled,and according to whether having CHD or CKD,they were divided into a CHD-CKD comorbidity group(n=117),a CHD group(n=124),and a CKD group(n=85).Their baseline data were compared,and the plasma concentration of sST2 was detected using chemiluminescence assay.Multiple linear regression analysis was used to identify the relevant factors of sST2.Kaplan-Meier survival curve and Cox proportional hazards regression analyses were applied to determine the impact of plasma sST2 on all-cause mortality and major adverse cardiovascular events(MACE).Results There were significant differences among the three groups in terms of age,sST2 and NT-proBNP levels,Log(NT-proBNP),eGFR,ratios of hyperuricemia,cerebral infarction,tumors,and using anti-platelet drugs and statins,PR interval,LVEF,and TC,TG,HDL-C and Hb levels(P<0.05,P<0.01).Multiple linear regression analysis showed that the sST2 level was positively correlated with logNT-proBNP and negatively with Hb level in the comorbidity group(t=2.266,P=0.025;t=-2.235,P=0.021).Kaplan-Meier survival curve analysis indicated that during a median fol-low-up of 31.5(22.0,32.2)months,the comorbidity group had a lower survival rate than the two single-disease groups(P<0.05,P<0.01),and higher incidence of MACEs than the CKD group(P<0.01).ROC curve analysis suggests that the AUC value of sST2 in predicting all-cause mor-tality in the comorbid group was 0.692.Cox proportional hazards regression model revealed that after adjustment for cofounders,sST2 was still an independent risk factor for all-cause mortality in the comorbid patients(HR=4.461,95%CI:1.640-8.399,P=0.024),although this prognos-tic value may be influenced by NT-proBNP.Conclusion sST2 can independently predict the risk of mortality in elderly patients with CHD-CKD comorbidity.
5.The relationship between variant angina pectoris syncope and coronary artery spastic targeted location, arrhythmia and coronary artery stenostic lesion
Xiangmei ZHAO ; Yuxiang SHEN ; Chuanyu GAO ; Muwei LI ; Huiying WU ; Wei YANG ; Ling ZHANG ; Ming LIU ; Fei XING ; Tianmin DU ; Lin LIU
Chinese Journal of Cardiology 2025;53(12):1404-1410
Objective:Investigation of the relationship between variant angina pectoris syncope and coronary artery spastic targeted location, arrhythmias, and coronary artery stenostic lesion.Methods:This study combined retrospective and prospective registry approaches. Data were sourced from the case database of Henan province "Multicenter Clinical Observation Study of Variant Angina Pectoris". A total of 507 patients with variant angina pectoris who had complete records from June 1980 to December 2022 were consecutively enrolled. Select patients among them who experienced syncope, and analyze the target vessel sites of coronary artery spasm, arrhythmias during variant angina pectoris attacks, and the degree of stenosis in coronary artery lesions.Results:Among 507 variant angina pectoris patients, 88 experienced syncope. Age was (53.9±9.7) years and 66 patients (75.0%) were male. Forty patients (45.5%, 40/88) were aged 50-59 years. The incidence of syncope in variant angina pectoris caused by left anterior descending artery (LAD) spasm, right coronary artery (RCA) spasm, and multivessel coronary artery spasm was 7.4% (15/202), 22.7% (42/185), and 23.6% (25/106), respectively. The latter two were significantly higher than those in the LAD group ( P all<0.05). Among 77 patients with variant angina pectoris syncope, definitive electrocardiogram recordings were available during syncope episodes. All patients exhibited arrhythmias during syncope: 34 cases involved tachyarrhythmias and 43 cases involved bradyarrhythmias. The incidence of rapid arrhythmias in patients with LAD, RCA, and multi-vessel spasm syncope was 72.7% (8/11), 24.3% (9/37), and 54.2% (13/24), respectively, with P<0.05 for the first two. Bradyarrhythmias occurred in 27.3% (3/11) of LAD, 75.7% (28/37) of RCA, and 45.8% (11/24) of multivessel coronary artery spasm syncope cases, with the first two showing P<0.05. Coronary angiography analysis of 56 syncope patients revealed target vessel locations and stenosis severity: 12 patients had LAD lesions and 41 had RCA lesions, stenosis ≥50% occurred in 66.7% (8/12) and 43.9% (18/41) of these lesions, respectively ( P>0.05). Conclusions:Variant angina pectoris syncope predominantly affects middle-aged males. Bradyarrhythmias triggered by RCA spasm are a common cause, while the incidence of syncope shows no significant correlation with the degree of coronary artery stenostic lesion, whether in the LAD or the RCA.
6.Latent profile analysis of nutrition literacy among young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity and its relationship with dietary motivation
Xiangjie SHEN ; Wei YIN ; Qiaoyan LIU ; Songmei CAO ; Houjuan ZU ; Huiying SHA ; Jingjing WANG
Chinese Journal of Nursing 2025;60(16):1974-1980
Objective To investigate the potential categories of nutrition literacy in young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity,and analyze the relationship between various latent categories and dietary motivation,so as to provide references for clinical working staff to develop relevant dietary intervention strategies.Methods A convenient sampling method was used to enroll 270 young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity from the endocrine department of a tertiary general hospital in Zhenjiang City,Jiangsu province,using basic information questionnaire,Nutrition Literacy Measurement Scale for Chinese adults,and the Regulation of Eating Behaviors Scale to collect data,using latent profile analysis to extract nutrition literacy potential categories,with general data and potential categories as independent variables,dietary motivation as the dependent variable for univariate analysis and multiple linear regression analysis.Results A total of 262 young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity completed the survey,and their nutrition literacy could be divided into 3 potential categories:low nutrition literacy group(16.41%),transformation dilemma group(54.96%),and middle and high nutrition literacy group(28.63%).The results of multiple linear regression analysis showed that residency style,potential categories of nutrition literacy and presence of diabetic complications were the influencing factors of dietary motivation in young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity(P<0.05).Conclusion There was a group heterogeneity in nutrition literacy in young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity.Clinical working staff should provide targeted interventions based on the patient's potential categories of nutrition literacy to stimulate ongoing motivation to maintain a healthy diet.
7.Relationship between serum sST2 and cardiac diastolic function in elderly patients with coronary heart disease and chronic kidney disease
Huiying LI ; Bing ZHU ; Lili CAI ; Shen LIU ; Hongbin LIU ; Qiwei ZHU
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(3):270-273
Objective To investigate the relationship between serum soluble suppression of tumori-genicity 2(sST2)and cardiac diastolic function in elderly patients with coronary heart disease(CHD)and chronic kidney disease(CKD).Methods A total of 116 elderly CHD patients suffer-ing from CKD taking physical examinations at the Second Medical Center of Chinese PLA General Hospital from April 2021 to July 2022 were recruited,and according to their serum sST2 level,they were divided into high sST2 group(>28.65 μg/L,58 cases)and low sST2 group(≤28.65μg/L,58 cases).The baseline data of all subjected patients were collected,including N-terminal pro-B-type natriuretic peptide(NT-proBNP),as well as peak early diastolic mitral flow velocity(E),peak early diastolic mitral annular velocity(e'),isovolumetric relaxation time(IVRT)and some other indicators in echocardiography.Serum sST2 level was measured using chemilumines-cence assay.Pearson correlation analysis and multiple linear regression analysis were used for analysis.Results The high sST2 group had significantly larger proportion of diabetes and usingβ-blockers,higher levels of sST2,urea and logNT-proBNP,increased left ventricular mass index,thicker left ventricular posterior wall thickness,and elevated E/e'and IVRT,and lower levels of hemoglobin and triacylglycerol,and decreased e'value when compared with the low sST2 group(P<0.05,P<0.01).The correlation analysis showed that sST2 was positively correlated with taking β-blockers,urea and logNT-proBNP levels,and E/e'ratio(r=0.226,P=0.015;r=0.362,P=0.001;r=0.374,P=0.001;r=0.257,P=0.005),and negatively correlated with triglycerides,hemoglobin and e'value(r=-0.227,P=0.014;r=-0.314,P=0.001;r=-0.203,P=0.029).Multiple linear regression analysis displayed that sST2 was linearly correlated with triglycerides,urea and NT-proBNP levels,and E/e'(P<0.05,P<0.01).Conclusion Serum sST2 level is cor-related with cardiac diastolic function in elderly patients with comorbidities of CHD and CKD.
8.Relationship between serum sST2 and cardiac diastolic function in elderly patients with coronary heart disease and chronic kidney disease
Huiying LI ; Bing ZHU ; Lili CAI ; Shen LIU ; Hongbin LIU ; Qiwei ZHU
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(3):270-273
Objective To investigate the relationship between serum soluble suppression of tumori-genicity 2(sST2)and cardiac diastolic function in elderly patients with coronary heart disease(CHD)and chronic kidney disease(CKD).Methods A total of 116 elderly CHD patients suffer-ing from CKD taking physical examinations at the Second Medical Center of Chinese PLA General Hospital from April 2021 to July 2022 were recruited,and according to their serum sST2 level,they were divided into high sST2 group(>28.65 μg/L,58 cases)and low sST2 group(≤28.65μg/L,58 cases).The baseline data of all subjected patients were collected,including N-terminal pro-B-type natriuretic peptide(NT-proBNP),as well as peak early diastolic mitral flow velocity(E),peak early diastolic mitral annular velocity(e'),isovolumetric relaxation time(IVRT)and some other indicators in echocardiography.Serum sST2 level was measured using chemilumines-cence assay.Pearson correlation analysis and multiple linear regression analysis were used for analysis.Results The high sST2 group had significantly larger proportion of diabetes and usingβ-blockers,higher levels of sST2,urea and logNT-proBNP,increased left ventricular mass index,thicker left ventricular posterior wall thickness,and elevated E/e'and IVRT,and lower levels of hemoglobin and triacylglycerol,and decreased e'value when compared with the low sST2 group(P<0.05,P<0.01).The correlation analysis showed that sST2 was positively correlated with taking β-blockers,urea and logNT-proBNP levels,and E/e'ratio(r=0.226,P=0.015;r=0.362,P=0.001;r=0.374,P=0.001;r=0.257,P=0.005),and negatively correlated with triglycerides,hemoglobin and e'value(r=-0.227,P=0.014;r=-0.314,P=0.001;r=-0.203,P=0.029).Multiple linear regression analysis displayed that sST2 was linearly correlated with triglycerides,urea and NT-proBNP levels,and E/e'(P<0.05,P<0.01).Conclusion Serum sST2 level is cor-related with cardiac diastolic function in elderly patients with comorbidities of CHD and CKD.
9.Prognostic value of plasma sST2 in elderly patients with coronary heart disease and chronic kidney disease
Huiying LI ; Lili CAI ; Bing ZHU ; Shen LIU ; Qiwei ZHU
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(5):611-615
Objective To explore the prognostic value of plasma sST2 in the population of coronary heart disease(CHD)complicated with chronic kidney disease(CKD).Methods A total of 326 elderly patients with CHD or CKD undergoing physical examination in the Second Medical Center of Chinese PLA General Hospital from April 2021 to July 2022 were continuously enrolled,and according to whether having CHD or CKD,they were divided into a CHD-CKD comorbidity group(n=117),a CHD group(n=124),and a CKD group(n=85).Their baseline data were compared,and the plasma concentration of sST2 was detected using chemiluminescence assay.Multiple linear regression analysis was used to identify the relevant factors of sST2.Kaplan-Meier survival curve and Cox proportional hazards regression analyses were applied to determine the impact of plasma sST2 on all-cause mortality and major adverse cardiovascular events(MACE).Results There were significant differences among the three groups in terms of age,sST2 and NT-proBNP levels,Log(NT-proBNP),eGFR,ratios of hyperuricemia,cerebral infarction,tumors,and using anti-platelet drugs and statins,PR interval,LVEF,and TC,TG,HDL-C and Hb levels(P<0.05,P<0.01).Multiple linear regression analysis showed that the sST2 level was positively correlated with logNT-proBNP and negatively with Hb level in the comorbidity group(t=2.266,P=0.025;t=-2.235,P=0.021).Kaplan-Meier survival curve analysis indicated that during a median fol-low-up of 31.5(22.0,32.2)months,the comorbidity group had a lower survival rate than the two single-disease groups(P<0.05,P<0.01),and higher incidence of MACEs than the CKD group(P<0.01).ROC curve analysis suggests that the AUC value of sST2 in predicting all-cause mor-tality in the comorbid group was 0.692.Cox proportional hazards regression model revealed that after adjustment for cofounders,sST2 was still an independent risk factor for all-cause mortality in the comorbid patients(HR=4.461,95%CI:1.640-8.399,P=0.024),although this prognos-tic value may be influenced by NT-proBNP.Conclusion sST2 can independently predict the risk of mortality in elderly patients with CHD-CKD comorbidity.
10.The relationship between variant angina pectoris syncope and coronary artery spastic targeted location, arrhythmia and coronary artery stenostic lesion
Xiangmei ZHAO ; Yuxiang SHEN ; Chuanyu GAO ; Muwei LI ; Huiying WU ; Wei YANG ; Ling ZHANG ; Ming LIU ; Fei XING ; Tianmin DU ; Lin LIU
Chinese Journal of Cardiology 2025;53(12):1404-1410
Objective:Investigation of the relationship between variant angina pectoris syncope and coronary artery spastic targeted location, arrhythmias, and coronary artery stenostic lesion.Methods:This study combined retrospective and prospective registry approaches. Data were sourced from the case database of Henan province "Multicenter Clinical Observation Study of Variant Angina Pectoris". A total of 507 patients with variant angina pectoris who had complete records from June 1980 to December 2022 were consecutively enrolled. Select patients among them who experienced syncope, and analyze the target vessel sites of coronary artery spasm, arrhythmias during variant angina pectoris attacks, and the degree of stenosis in coronary artery lesions.Results:Among 507 variant angina pectoris patients, 88 experienced syncope. Age was (53.9±9.7) years and 66 patients (75.0%) were male. Forty patients (45.5%, 40/88) were aged 50-59 years. The incidence of syncope in variant angina pectoris caused by left anterior descending artery (LAD) spasm, right coronary artery (RCA) spasm, and multivessel coronary artery spasm was 7.4% (15/202), 22.7% (42/185), and 23.6% (25/106), respectively. The latter two were significantly higher than those in the LAD group ( P all<0.05). Among 77 patients with variant angina pectoris syncope, definitive electrocardiogram recordings were available during syncope episodes. All patients exhibited arrhythmias during syncope: 34 cases involved tachyarrhythmias and 43 cases involved bradyarrhythmias. The incidence of rapid arrhythmias in patients with LAD, RCA, and multi-vessel spasm syncope was 72.7% (8/11), 24.3% (9/37), and 54.2% (13/24), respectively, with P<0.05 for the first two. Bradyarrhythmias occurred in 27.3% (3/11) of LAD, 75.7% (28/37) of RCA, and 45.8% (11/24) of multivessel coronary artery spasm syncope cases, with the first two showing P<0.05. Coronary angiography analysis of 56 syncope patients revealed target vessel locations and stenosis severity: 12 patients had LAD lesions and 41 had RCA lesions, stenosis ≥50% occurred in 66.7% (8/12) and 43.9% (18/41) of these lesions, respectively ( P>0.05). Conclusions:Variant angina pectoris syncope predominantly affects middle-aged males. Bradyarrhythmias triggered by RCA spasm are a common cause, while the incidence of syncope shows no significant correlation with the degree of coronary artery stenostic lesion, whether in the LAD or the RCA.

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