Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards* ; Humans ; Consensus ; Drugs, Chinese Herbal/therapeutic use* ; Surveys and Questionnaires

Objective:To develop a maternal assessment scale integrating both positive (affirmation, optimism, self-confidence) and negative psychological states (fear, anxiety, depression) throughout the entire pregnancy cycle and evaluate its reliability and validity.Methods:In December 2020, the scale items were preliminarily identified through a literature review, forming a 55-item questionnaire for pilot survey and expert interviews. A pilot survey was conducted among registered pregnant women at the Obstetrics and Gynecology Hospital of Fudan University from April to May 2021. The feasibility and reliability of the questionnaire was validated through reliability and validity analysis, and revisions were made based on the feedback. The finalized version comprised 43 items, categorized into four key event dimensions (pregnancy, childbirth, transition to motherhood, and complications) and six psychological state dimensions (affirmation, fear, anxiety, depression, optimism, and self-confidence). Among these psychological states, affirmation, self-confidence, and optimism represent positive states, while fear, anxiety, and depression reflect negative states. A formal survey was conducted from December 2021 to November 2022. The normality, multicollinearity, reliability, construct validity, convergent validity, and discriminant validity of each item were analyzed.Results:(1) General information: A total of 625 participants were involved in the pilot survey. For the formal survey, 8 045 questionnaires were distributed, with 6 273 valid responses (78.0%). Among the valid questionnaires, 5 694 (90.8%) reported positive psychological states and 579 (9.2%) negative states. All of the psychological state dimensions were correlated (all P<0.01), with no multicollinearity detected [variance inflation factor (VIF)<10]. The four key event dimensions were also correlated (all P<0.01), with no multicollinearity (VIF<10). (2) Reliability: The overall Cronbach's α coefficient of the questionnaire was 0.830, and removing any single item resulted in the value remaining>0.6. Cronbach's α coefficient values for affirmation, fear, anxiety, depression, optimism, and self-confidence were 0.772, 0.724, 0.648, 0.551, 0.257, and 0.740, respectively. The values for the key event dimensions were as follows: 0.722 for pregnancy, 0.554 for childbirth, 0.621 for transition to motherhood, and 0.568 for complications. (3) Model fit: For the psychological states, the Chi-square to degrees of freedom ratio ( χ2/df) was 19.979 (>3), and the root mean square error of approximation (RMSEA) was 0.055 (<0.08). The model of key event dimensions had a χ2/df of 48.557, RMSEA of 0.087, comparative fit index of 0.400 (<0.9), and incremental fit index of 0.400 (<0.9). (4) Convergent and discriminant validity: The average variance extraction (AVE) values for affirmation, fear, anxiety, depression, optimism, and self-confidence were 0.407, 0.099, 0.188, 0.223, 0.419, and 0.362, with composite reliability (CR) values of 0.822, 0.730, 0.655, 0.584, 0.627, and 0.786, respectively. In the model of key event dimensions, the AVE values for pregnancy, childbirth, transition to motherhood, and complications were 0.167, 0.287, 0.328, and 0.166, with CR values of 0.555, 0.832, 0.746, and 0.633, respectively. Significant correlations were observed between all psychological dimensions except optimism-depression and self-confidence-anxiety pairs (all P<0.05). All four key event dimensions were significantly correlated (all P<0.05). Conclusions:This study preliminarily develops a maternal psychological status assessment scale with satisfactory reliability and validity. This scale can be used to evaluate the comprehensive psychological states of pregnant women during critical pregnancy-related events.

Objective To study the need for blood compatibility evaluation of medical devices that come into indirect contact with blood in order to accurately evaluate the risk of their interaction with blood.Methods Seven medical devices with indirect contact with blood were selected as samples including extension tubes of central venous catheters,port bodies of implantable drug delivery devices,infusion sets,receiving lines of dialysis equipment,auxiliary lines of left ventricular assist devices,blood monitors and catheter holders,with high-density polyethylene as the negative control,glass beads as the positive control and blank whole blood or plasma for the blank control.Partial thromboplastin time(PTT)test,platelet count test and hematology test(white blood cell and red blood cell count)were performed by direct contact method and indirect contact method,respectively.In the direct contact method,whole blood or plasma was in direct contact with the sample;while in the indirect contact method,whole blood or plasma was not in direct contact with the extraction solution,with no direct contact with the sample.Results With the indirect contact method the ratios(expressed as a percentage)of the PTT,platelate,WBC and RBC counts of the samples,positive and negative controls to those of the blank control were all higher than those with the direct contact method,and the indirect contact method had the sensitivity lower than that of the direct contact method.Conclusion Medical devices indirectly contacting blood have low risks for causing coagulation and platelet and hematologic adverse reactions,which are suggested to be evaluated for hemolysis testing only in case of the history of safe clinical use.[Chinese Medical Equipment Journal,2025,46(8):44-49]

Objective:An in vivo mammalian hepatocyte Unscheduled DNA Synthesis(UDS)test was used to evaluate the genotoxicity of Cross-linked Sodium Hyaluronate Gel and Bone Repair Materials,providing experimental evidence for establishing a UDS testing method for medical devices and materials.Methods:0.9％sodium chloride injection and cottonseed oil were used as the solvent for test materials and negative control,respectively.N-dimethylnitrosamine(NDMA)was used as the positive control for the early sampling times,and 2-acetylaminofluorene(2-AAF)was used as the positive control for the late sampling times.SD rats were administered a single dose for toxic exposure,and liver tissues were collected at 4 h and 16 h,respectively.Hepatocytes were isolated using collagenase perfusion.After labeling with 5-ethynyl-2'-deoxyuridine(EdU),and the net average fluorescence intensity(NAFI)of cell nuclei and nucleoplasm was measured by fluorescence microscope.Data from 50 cells were used to analyze the DNA repair level.Results:Compared with the negative control groups,the positive control groups(NDMA and 2-AAF)showed highly statistically significant differences in NAFI(P＜0.01),indicating successful induction of DNA damage.There was no statistically significant differences between the cross-linked sodium hyaluronate gel groups,bone repair material groups and the negative control group(P＞0.05),suggesting that these materials did not significantly induce DNA damage under the experimental conditions.Conclusion:This study first applied EdU labeling technology to the in vivo hepatic UDS assay,achieving non-radioactive labeling through click chemistry reactions.Under the conditions of this study,cross-linked sodium hyaluronate gel and bone repair materials did not exhibit genotoxicity.In the follow-up,the sample range can be expanded and the observation period can be prolonged to further improve the genotoxicity evaluation system of medical devices.

Objective To evaluate the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets using hydroxyethyl starch(HES)130/0.4 sodium chloride injection as an extraction medium.Methods Firstly,40 Sprague Dawley(SD)rats including 20 male and 20 female ones were seleted and randomly enrolled into a sample group and a control group by sex,with 20 ones in each group.Secondly,instead of plasma HES 130/0.4 sodium chloride injection was used to leach disposable plasma virus-inactivated blood transfusion sets to prepare the test solution by simulating clinical application such as lighting,adsorption and filtration and storage.Finally,the test solution and HES 130/0.4 sodium chloride injection were injected into the tail vein of the SD rats at a dose of 20 mL/kg for 28 d in the sample group and in the control group respectively,and the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets and the feasibility of using HES 130/0.4 sodium chloride injection as the extraction medium to assess their subchronic systemic toxicity were evaluated with clinical observation,body mass monitoring,clinical pathology examination,gross necropsy and histopathology examination.Results The sample group and control group had no significant differences in mortality rates,clinical observation results,body mass,gross necropsy results,hematological and coagulation examination results and organ weight(all P>0.05);blood biochemical examinations showed the male rats in the sample group had the cholesterol(CHO)values higher while the creatinine(CR)values lower than those in the control group,with the differences being statistically significant(both P<0.05)and the two indexes within the range of the laboratory's historical reference data,and other blood biochemical indexes were not significantly different(all P>0.05);the sample group had the spleen weight-to-body mass ratios of the female rates lower significantly than those in the control group(P<0.05),and the ratios of other organ weight to body mass had significant differences(all P>0.05);histopathology examination showed slight pathological changes in liver,spleen and kidney of female rats and in spleen and kidney of male rats in the sample group,and the female and male rats in the control group had similar pathological changes found in the sample group,which might be caused by HES metabolites.Conclusion Disposable plasma virus-inactivated blood transfusion sets prove to have no significant subchronic systemic toxicity,and its feasible to use HES 130/0.4 sodium chloride injection as the extraction medium to evaluate the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets.[Chinese Medical Equipment Journal,2025,46(10):29-35]

Objective:An in vivo mammalian hepatocyte Unscheduled DNA Synthesis(UDS)test was used to evaluate the genotoxicity of Cross-linked Sodium Hyaluronate Gel and Bone Repair Materials,providing experimental evidence for establishing a UDS testing method for medical devices and materials.Methods:0.9％sodium chloride injection and cottonseed oil were used as the solvent for test materials and negative control,respectively.N-dimethylnitrosamine(NDMA)was used as the positive control for the early sampling times,and 2-acetylaminofluorene(2-AAF)was used as the positive control for the late sampling times.SD rats were administered a single dose for toxic exposure,and liver tissues were collected at 4 h and 16 h,respectively.Hepatocytes were isolated using collagenase perfusion.After labeling with 5-ethynyl-2'-deoxyuridine(EdU),and the net average fluorescence intensity(NAFI)of cell nuclei and nucleoplasm was measured by fluorescence microscope.Data from 50 cells were used to analyze the DNA repair level.Results:Compared with the negative control groups,the positive control groups(NDMA and 2-AAF)showed highly statistically significant differences in NAFI(P＜0.01),indicating successful induction of DNA damage.There was no statistically significant differences between the cross-linked sodium hyaluronate gel groups,bone repair material groups and the negative control group(P＞0.05),suggesting that these materials did not significantly induce DNA damage under the experimental conditions.Conclusion:This study first applied EdU labeling technology to the in vivo hepatic UDS assay,achieving non-radioactive labeling through click chemistry reactions.Under the conditions of this study,cross-linked sodium hyaluronate gel and bone repair materials did not exhibit genotoxicity.In the follow-up,the sample range can be expanded and the observation period can be prolonged to further improve the genotoxicity evaluation system of medical devices.

Objective To evaluate the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets using hydroxyethyl starch(HES)130/0.4 sodium chloride injection as an extraction medium.Methods Firstly,40 Sprague Dawley(SD)rats including 20 male and 20 female ones were seleted and randomly enrolled into a sample group and a control group by sex,with 20 ones in each group.Secondly,instead of plasma HES 130/0.4 sodium chloride injection was used to leach disposable plasma virus-inactivated blood transfusion sets to prepare the test solution by simulating clinical application such as lighting,adsorption and filtration and storage.Finally,the test solution and HES 130/0.4 sodium chloride injection were injected into the tail vein of the SD rats at a dose of 20 mL/kg for 28 d in the sample group and in the control group respectively,and the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets and the feasibility of using HES 130/0.4 sodium chloride injection as the extraction medium to assess their subchronic systemic toxicity were evaluated with clinical observation,body mass monitoring,clinical pathology examination,gross necropsy and histopathology examination.Results The sample group and control group had no significant differences in mortality rates,clinical observation results,body mass,gross necropsy results,hematological and coagulation examination results and organ weight(all P>0.05);blood biochemical examinations showed the male rats in the sample group had the cholesterol(CHO)values higher while the creatinine(CR)values lower than those in the control group,with the differences being statistically significant(both P<0.05)and the two indexes within the range of the laboratory's historical reference data,and other blood biochemical indexes were not significantly different(all P>0.05);the sample group had the spleen weight-to-body mass ratios of the female rates lower significantly than those in the control group(P<0.05),and the ratios of other organ weight to body mass had significant differences(all P>0.05);histopathology examination showed slight pathological changes in liver,spleen and kidney of female rats and in spleen and kidney of male rats in the sample group,and the female and male rats in the control group had similar pathological changes found in the sample group,which might be caused by HES metabolites.Conclusion Disposable plasma virus-inactivated blood transfusion sets prove to have no significant subchronic systemic toxicity,and its feasible to use HES 130/0.4 sodium chloride injection as the extraction medium to evaluate the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets.[Chinese Medical Equipment Journal,2025,46(10):29-35]

Objective To study the need for blood compatibility evaluation of medical devices that come into indirect contact with blood in order to accurately evaluate the risk of their interaction with blood.Methods Seven medical devices with indirect contact with blood were selected as samples including extension tubes of central venous catheters,port bodies of implantable drug delivery devices,infusion sets,receiving lines of dialysis equipment,auxiliary lines of left ventricular assist devices,blood monitors and catheter holders,with high-density polyethylene as the negative control,glass beads as the positive control and blank whole blood or plasma for the blank control.Partial thromboplastin time(PTT)test,platelet count test and hematology test(white blood cell and red blood cell count)were performed by direct contact method and indirect contact method,respectively.In the direct contact method,whole blood or plasma was in direct contact with the sample;while in the indirect contact method,whole blood or plasma was not in direct contact with the extraction solution,with no direct contact with the sample.Results With the indirect contact method the ratios(expressed as a percentage)of the PTT,platelate,WBC and RBC counts of the samples,positive and negative controls to those of the blank control were all higher than those with the direct contact method,and the indirect contact method had the sensitivity lower than that of the direct contact method.Conclusion Medical devices indirectly contacting blood have low risks for causing coagulation and platelet and hematologic adverse reactions,which are suggested to be evaluated for hemolysis testing only in case of the history of safe clinical use.[Chinese Medical Equipment Journal,2025,46(8):44-49]

Objective:To develop a maternal assessment scale integrating both positive (affirmation, optimism, self-confidence) and negative psychological states (fear, anxiety, depression) throughout the entire pregnancy cycle and evaluate its reliability and validity.Methods:In December 2020, the scale items were preliminarily identified through a literature review, forming a 55-item questionnaire for pilot survey and expert interviews. A pilot survey was conducted among registered pregnant women at the Obstetrics and Gynecology Hospital of Fudan University from April to May 2021. The feasibility and reliability of the questionnaire was validated through reliability and validity analysis, and revisions were made based on the feedback. The finalized version comprised 43 items, categorized into four key event dimensions (pregnancy, childbirth, transition to motherhood, and complications) and six psychological state dimensions (affirmation, fear, anxiety, depression, optimism, and self-confidence). Among these psychological states, affirmation, self-confidence, and optimism represent positive states, while fear, anxiety, and depression reflect negative states. A formal survey was conducted from December 2021 to November 2022. The normality, multicollinearity, reliability, construct validity, convergent validity, and discriminant validity of each item were analyzed.Results:(1) General information: A total of 625 participants were involved in the pilot survey. For the formal survey, 8 045 questionnaires were distributed, with 6 273 valid responses (78.0%). Among the valid questionnaires, 5 694 (90.8%) reported positive psychological states and 579 (9.2%) negative states. All of the psychological state dimensions were correlated (all P<0.01), with no multicollinearity detected [variance inflation factor (VIF)<10]. The four key event dimensions were also correlated (all P<0.01), with no multicollinearity (VIF<10). (2) Reliability: The overall Cronbach's α coefficient of the questionnaire was 0.830, and removing any single item resulted in the value remaining>0.6. Cronbach's α coefficient values for affirmation, fear, anxiety, depression, optimism, and self-confidence were 0.772, 0.724, 0.648, 0.551, 0.257, and 0.740, respectively. The values for the key event dimensions were as follows: 0.722 for pregnancy, 0.554 for childbirth, 0.621 for transition to motherhood, and 0.568 for complications. (3) Model fit: For the psychological states, the Chi-square to degrees of freedom ratio ( χ2/df) was 19.979 (>3), and the root mean square error of approximation (RMSEA) was 0.055 (<0.08). The model of key event dimensions had a χ2/df of 48.557, RMSEA of 0.087, comparative fit index of 0.400 (<0.9), and incremental fit index of 0.400 (<0.9). (4) Convergent and discriminant validity: The average variance extraction (AVE) values for affirmation, fear, anxiety, depression, optimism, and self-confidence were 0.407, 0.099, 0.188, 0.223, 0.419, and 0.362, with composite reliability (CR) values of 0.822, 0.730, 0.655, 0.584, 0.627, and 0.786, respectively. In the model of key event dimensions, the AVE values for pregnancy, childbirth, transition to motherhood, and complications were 0.167, 0.287, 0.328, and 0.166, with CR values of 0.555, 0.832, 0.746, and 0.633, respectively. Significant correlations were observed between all psychological dimensions except optimism-depression and self-confidence-anxiety pairs (all P<0.05). All four key event dimensions were significantly correlated (all P<0.05). Conclusions:This study preliminarily develops a maternal psychological status assessment scale with satisfactory reliability and validity. This scale can be used to evaluate the comprehensive psychological states of pregnant women during critical pregnancy-related events.

Soluble programmed cell death 1 ligand 1(PD-L1)in the serum includes exosomal,mi-crovesical and secreted forms of PD-L1.Previous studies have shown that the level of exosomal PD-L1 in the serum significantly correlated with the prognosis of various cancers.However,current analysis detects all forms of PD-L1 in the serum as a whole,without distinguishing exosomal PD-L1 from other forms.In this study,a specific detection method for exosomal PD-L1 was established based on surface plasmon res-onance.This method first captures PD-L1 by antibody recognition and immobilizes it on the surface of the detection chip.Then,α-hemolysin was recruited to form multiple oligomers on the exosomal membrane.This method quantifies the content of exosomal PD-L1 by monitoring the signal change during the binding process of α-hemolysin,effectively reducing background noises and amplifying the signal.The linear range before signal amplification with α-hemolysin was 0.035-2.208 pg/mL,and after signal amplifica-tion,it was 0.004-0.552 pg/mL.Methodological validation showed that this method has good specifici-ty,sensitivity,and repeatability,and has certain clinical application prospects.