1.Expert Consensus on Clinical Application of Qidong Yixin Oral Liquid
Changkuan FU ; Xiaochang MA ; Mingjun ZHU ; Yue DENG ; Hongxu LIU ; Mingxue ZHANG ; Ying CHEN ; Yan ZHOU ; Ling ZHANG ; Jianhua FU ; Wei YANG ; Yu'er HU ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):147-158
The prescription of Qidong Yixin oral liquid is derived from the experience of national medical master Ren Jixue in treating viral myocarditis (VMC). It has the functions of tonifying Qi, nourishing the heart,calming the mind, and relieving palpitations. It is used to treat VMC and angina pectoris of coronary heart disease caused by deficiency of both Qi and Yin. However,the understanding of its efficacy evidence, advantageous aspects, dosage and administration, and medication safety remains insufficient in clinical practice. Therefore,the development of the Expert Consensus on the Clinical Application of Qidong Yixin Oral Liquid (hereinafter referred to as consensus) was initiated. Consensus strictly followed the process and methods of the expert consensus on the clinical application of Chinese patent medicines of the China Association of Chinese Medicine,successively completing multiple tasks such as the consensus project initiation,determination of clinical problems,evidence search and evaluation,formation of recommendation opinions and consensus suggestions,solicitation of opinions,peer review, submission for review and release, and so on. Consensus formed a total of 10 recommendation opinions and 12 consensus suggestions,clarifying the clinical positioning,efficacy advantages,syndrome differentiation,dosage and administration,combination therapy,timing of medication,adverse reactions,contraindications, and precautions of Qidong Yixin oral liquid,indicating that it has good clinical advantages and safety in the treatment of VMC and angina pectoris of coronary heart disease,providing norms and references for physicians to safely and rationally apply Qidong Yixin oral liquid. Consensus was reviewed and approved for release by the Standardization Office of the China Association of Chinese Medicine on December 23, 2024. Standard number:GSCACM-376-2024.
2.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
To interpret the evidence-to-decision (EtD) framework and to illustrate its application in traditional Chinese medicine (TCM) guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine, thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework (formulating the question, making an assessment of the evidence, and drawing conclusions), critical decision points and evaluation evidence within the evidence-translation process were systematically addressed, aligning with the purpose, scope, and key questions of the guideline. Qualitative research methods, such as the nominal group technique, were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation, the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified, focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment, multi-source evidence was integrated, including policy documents, literature research, and expert consensus, completing the evidence evaluation. Finally, in recommendation-forming, dispersed research evidence and expert experience were synthesized into consensus, culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development, effectively enhancing the transparency and scientific rigor of the process. Therefore, it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
3.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
To interpret the evidence-to-decision (EtD) framework and to illustrate its application in traditional Chinese medicine (TCM) guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine, thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework (formulating the question, making an assessment of the evidence, and drawing conclusions), critical decision points and evaluation evidence within the evidence-translation process were systematically addressed, aligning with the purpose, scope, and key questions of the guideline. Qualitative research methods, such as the nominal group technique, were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation, the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified, focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment, multi-source evidence was integrated, including policy documents, literature research, and expert consensus, completing the evidence evaluation. Finally, in recommendation-forming, dispersed research evidence and expert experience were synthesized into consensus, culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development, effectively enhancing the transparency and scientific rigor of the process. Therefore, it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
4.Effect of Wenshen Tongluo Zhitong formula on mouse H-type bone microvascular endothelial cell/bone marrow mesenchymal stem cell co-culture system
Shijie ZHOU ; Muzhe LI ; Li YUN ; Tianchi ZHANG ; Yuanyuan NIU ; Yihua ZHU ; Qinfeng ZHOU ; Yang GUO ; Yong MA ; Lining WANG
Chinese Journal of Tissue Engineering Research 2025;29(1):8-15
BACKGROUND:Bone relies on the close connection between blood vessels and bone cells to maintain its integrity.Bones are in a physiologically hypoxic environment.Therefore,the study of angiogenesis and osteogenesis in hypoxic environment is closer to the microenvironment in vivo. OBJECTIVE:To explore the influence of Wenshen Tongluo Zhitong(WSTLZT)formula on H-type bone microvascular endothelial cell/bone marrow mesenchymal stem cell co-culture system in hypoxia environment and its related mechanism. METHODS:Enzyme digestion method and flow sorting technique were used to isolate and identify H-type bone microvascular endothelial cells.Mouse bone marrow mesenchymal stem cells were isolated and obtained by bone marrow adhesion method.H-type bone microvascular endothelial cell/bone marrow mesenchymal stem cell hypoxic co-culture system was established using Transwell chamber and anoxic culture workstation.WSTLZT formula powder was used to intervene in each group at a mass concentration of 50 and 100 μg/mL.The angiogenic function of H-type bone microvascular endothelial cells in the co-culture system was evaluated by scratch migration test and tube formation test.The osteogenic differentiation ability of bone marrow mesenchymal stem cells in the co-cultured system was evaluated by alkaline phosphatase staining and alizarin red staining.The protein and mRNA expression changes of PDGF/PI3K/AKT signal axis related molecules in H-type bone microvascular endothelial cells in the co-cultured system were detected by Western Blotting and q-PCR,respectively. RESULTS AND CONCLUSION:(1)Compared with the normal oxygen group,the scratch mobility and new blood vessel length of H-type bone microvascular endothelial cells were significantly higher(P<0.05);the osteogenic differentiation capacity of bone marrow mesenchymal stem cells was higher(P<0.05);the expression of PDGF/PI3K/AKT axis-related molecular protein and mRNA increased(P<0.05)in the hypoxia group.(2)Compared with the hypoxia group,scratch mobility and new blood vessel length were significantly increased in the H-type bone microvascular endothelial cells(P<0.05);bone marrow mesenchymal stem cells had stronger osteogenic function(P<0.05);the expression of PDGF/PI3K/AKT axis-related molecular proteins and mRNA further increased(P<0.05)after treatment with different dose concentrations of WSTLZT formula.These findings conclude that H-type angiogenesis and osteogenesis under hypoxia may be related to the PDGF/PI3K/AKT signaling axis,and WSTLZT formula may promote H-type vasculo-dependent bone formation by activating the PDGF/PI3K/AKT signaling axis,thereby preventing and treating osteoporosis.
5.Clinical Study on Chaiqin Xiaoyong Decoction (柴芩消痈饮) Combined with Jinhuang Ointment (金黄膏) for the Nodular Stage of Acne Mastitis of Liver Meridian Heat Accumulation Type:A Randomized,Double-Blind,Placebo-Controlled Trial
Tian MENG ; Feifei MA ; Yuanyuan KANG ; Mengfei SHEN ; Shengfang HU ; Meina YE ; Yiqin CHENG ; Hongfeng CHEN
Journal of Traditional Chinese Medicine 2025;66(9):920-926
ObjectiveTo evaluate the clinical efficacy and safety of the traditional Chinese medicine (TCM) compound Chaiqin Xiaoyong Decoction (柴芩消痈饮, CXD) combined with Jinhuang Ointment (金黄膏, JO) in treating the nodular stage of acne mastitis of liver meridian heat accumulation type. MethodsA randomized, double-blind, placebo-controlled clinical trial was conducted. A total of 108 patients with liver meridian heat accumulation type acne mastitis in the nodular stage were randomly assigned to a treatment group and a control group, with 54 patients in each group. Both groups received topical application of JO once daily at a thickness of 3~5 mm for 8 hours, along with standard nursing care. On this basis, the treatment group received oral CXD granules, while the control group received placebo granules, administered twice daily, 3 sachets per dose, for 14 consecutive days. Clinical efficacy, TCM symptom scores, nodule size, visual analogue scale (VAS) pain scores, white blood cell (WBC) count, C-reactive protein (CRP) level, and systemic immune-inflammation index (SII) were compared. At the end of treatment, efficacy and safety indicators were evaluated. A 6-month follow-up was conducted to compare the proportion of patients undergoing surgical treatment. ResultsThe total clinical efficacy rate in the treatment group was 90.38% (47/52), significantly higher than 32.00% (16/50) in the control group (P<0.01). The treatment group also showed significantly lower TCM symptom scores, VAS scores, nodule size, WBC count, CRP level, and SII (P<0.05 or P<0.01). During follow-up, the surgical intervention rate in the treatment group was 5.77% (3/52), lower than 14.00% (7/50) in the control group, with a statistically significant difference (P<0.01). No significant abnormalities were observed in safety indicators before and after treatment in either group. ConclusionCXD effectively reduces nodule size and alleviates symptoms such as redness and pain in patients with acne mastitis of liver meridian heat accumulation type, improves TCM symptom scores, enhances overall clinical efficacy, and demonstrates good safety.
6.Association of menopausal time and menopausal age with nonalcoholic fatty liver disease: An analysis based on a restricted cubic spline model
Chenlu ZHAO ; Suping MA ; Dongfang SHANG ; Sutong LIU ; Xiaoyan LIU ; Yuanyuan ZHENG ; Wenxia ZHAO
Journal of Clinical Hepatology 2025;41(2):247-253
ObjectiveTo investigate the association of menopausal time and menopausal age with the risk of nonalcoholic fatty liver disease (NAFLD), and to provide a basis for the early prevention and treatment of NAFLD in clinical practice. MethodsRelated data were collected from 373 postmenopausal women who attended the outpatient service of Department of Spleen, Stomach, Liver and Gallbladder Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, from January 2017 to December 2021, including general information, menopausal age, menopausal time, and presence or absence of NAFLD. The chi-square test was used for comparison of categorical data; the independent-samples t test was used for comparison of normally distributed continuous data between groups, and the Wilcoxon rank-sum test was used for comparison of non-normally distributed continuous data between groups. A Logistic regression analysis was used to calculate the association intensity and 95% confidence interval (95%CI) of menopausal time and menopausal age for the risk of NAFLD, and the restricted cubic spline (RCS) method was used to investigate the dose-response relationship between menopausal time/age and the risk of NAFLD. ResultsCompared with the women with normal menopause or late menopause, the women with early menopause had a higher prevalence rate of NAFLD and a higher degree of steatosis and fibrosis (all P<0.05). After adjustment for the confounding factors such as age and age of menarche, the risk of NAFLD in women with a menopausal time of >3 years was 4.80 (95%CI: 1.93 — 11.95, P=0.001) times that in women with a menopausal time of ≤3 years, and the risk of NAFLD in women with early or late menopause was 8.14 times (95%CI: 1.77 — 37.58, P=0.007) and 0.09 times (95%CI: 0.03 — 0.32, P<0.001), respectively, that in those with a normal menopausal age. There is a dose-response relationship between menopausal time/age and the risk of NAFLD. Menopausal time is positively correlated with the association intensity of NAFLD, while menopausal age is negatively correlated with the association intensity of NAFLD. ConclusionThe longer the menopause time and the earlier the menopause age, the ligher the risk of NAFLD.
7.Bacterial contamination of platelets apheresis: a single-center retrospective analysis
Yuanyuan LUO ; Chunya MA ; Lihui FU ; Zeshan WANG ; Yang YU
Chinese Journal of Blood Transfusion 2025;38(2):233-237
[Objective] To evaluate the risk of bacterial contamination of platelets apheresis and improve the clinical diagnosis rate of transfusion-transmitted bacterial infections. [Methods] A retrospective analysis was conducted on 11 cases involving bacterial contamination detected in apheresis platelets during quality inspections at our center from 2021 to 2023, as well as cases of transfusion-transmitted bacterial infection (TTBI) caused by platelet transfusion. The return of positive platelet bacteria test results and clinical transfusion adverse reactions were statistically analyzed. [Results] There were 9 donors with bacteria-contaminated platelets, of which 3 were reported as clinical transfusion reaction, 4 were detected by quality sampling, and 2 were identified by appearance detection before transfusion. The bacterial contamination rate of platelets was about 0.08% (9/10 762). The contaminated platelets were involved in 11 cases of TTBI, with an incidence of TTBI of approximately 0.05% (11/21 916). Only 3 cases of transfusion reactions were clinically reported, while the rest were case tracking with positive results of platelet bacterial test from quality sampling. The clinical return rate of TTBI was 27.27% (3/11), with an average reporting time of 8.12 hours after the occurrence of transfusion reactions. The majority of the contaminated platelets were detected at the end stage of storage, with 55.56% (5/9) of platelets collected on the 4th day after collection. Partial contaminated platelets were identified through quality sampling, with a positive rate of 2.78% (4/144). [Conclusion] The platelet bacterial contamination rate is high, but with low clinical return rate. It is recommended to conduct routine platelet bacterial monitoring and improve clinical diagnostic level.
8.Influence of different intraocular lens implantation methods on visual quality in patients with cataract
Ting SHEN ; Junjie MA ; Fengying HE ; Xiaoyan LYU ; Yuanyuan WANG
International Eye Science 2025;25(3):378-383
AIM: To observe the influence of different intraocular lens implantation methods on visual quality in patients with cataract.METHODS: Retrospective study. Totally 85 patients(113 eyes)with cataract who received phacoemulsification combined with intraocular lens implantation in the hospital June 2020 to December 2023 were selected. According to the different implanted lenses, they were divided into monofocal group(42 cases, 55 eyes)and bifocal group(43 cases, 58 eyes). The uncorrected near visual acuity(UNVA), uncorrected intermediate visual acuity(UIVA), uncorrected distance visual acuity(UDVA), best corrected near visual acuity(BCNVA), best corrected intermediate visual acuity(BCIVA), best corrected distance visual acuity(BCDVA), contrast sensitivity(CS), objective visual quality, National Eye Institute 25-item Visual Function Questionnaire(NEI-VFQ-25)scores and complications were compared between both groups of patients at 3 mo after surgery.RESULTS:At 3 mo after surgery, the UNVA(LogMAR)of the bifocal group was significantly better than that of the monofocal group(0.24±0.06 vs 0.53±0.13, P<0.001), but there were no statistical differences in UIVA, UDVA, BCNVA, BCIVA and BCDVA between the two groups(all P>0.05). The 18 c/d spatial frequency scotopic CS in the bifocal group at 3 mo after surgery was significantly lower than that in the monofocal group(0.84±0.17 vs 0.92±0.22, P<0.05), while the CS in other frequency was not statistically significant(all P>0.05); the objective scatter index(OSI)was higher in the bifocal group than that in the monofocal group(P<0.05), while OV 20% and OV 9% were lower than those in monofocal group(all P<0.05), but there were no statistically significant differences in modulation transfer function cut off(MTFcut off), Strehl ratio(SR)and OV 100% between the two groups(all P>0.05). The scores of overall visual acuity and near visual activity in the bifocal group at 3 mo after surgery were higher than those in the monofocal group(all P<0.001), but there were no statistical differences in the scores of dimensions of overall health, distance visual activity, peripheral visual acuity, color vision, dependence degree, social function, social role and mental health between the two groups(all P>0.05). Furthermore, there were no statistical significance in the incidence of complications in the two groups(P>0.05).CONCLUSION: Phacoemulsification combined with bifocal intraocular lens implantation can provide more ideal near visual acuity and visual-related quality of life for patients with cataract, but its objective visual quality is worse, The two types of intraocular lenses have their own advantages and disadvantages, and it is still necessary to choose the appropriate intraocular lens according to the actual needs of patients.
9.Influence of different intraocular lens implantation methods on visual quality in patients with cataract
Ting SHEN ; Junjie MA ; Fengying HE ; Xiaoyan LYU ; Yuanyuan WANG
International Eye Science 2025;25(3):378-383
AIM: To observe the influence of different intraocular lens implantation methods on visual quality in patients with cataract.METHODS: Retrospective study. Totally 85 patients(113 eyes)with cataract who received phacoemulsification combined with intraocular lens implantation in the hospital June 2020 to December 2023 were selected. According to the different implanted lenses, they were divided into monofocal group(42 cases, 55 eyes)and bifocal group(43 cases, 58 eyes). The uncorrected near visual acuity(UNVA), uncorrected intermediate visual acuity(UIVA), uncorrected distance visual acuity(UDVA), best corrected near visual acuity(BCNVA), best corrected intermediate visual acuity(BCIVA), best corrected distance visual acuity(BCDVA), contrast sensitivity(CS), objective visual quality, National Eye Institute 25-item Visual Function Questionnaire(NEI-VFQ-25)scores and complications were compared between both groups of patients at 3 mo after surgery.RESULTS:At 3 mo after surgery, the UNVA(LogMAR)of the bifocal group was significantly better than that of the monofocal group(0.24±0.06 vs 0.53±0.13, P<0.001), but there were no statistical differences in UIVA, UDVA, BCNVA, BCIVA and BCDVA between the two groups(all P>0.05). The 18 c/d spatial frequency scotopic CS in the bifocal group at 3 mo after surgery was significantly lower than that in the monofocal group(0.84±0.17 vs 0.92±0.22, P<0.05), while the CS in other frequency was not statistically significant(all P>0.05); the objective scatter index(OSI)was higher in the bifocal group than that in the monofocal group(P<0.05), while OV 20% and OV 9% were lower than those in monofocal group(all P<0.05), but there were no statistically significant differences in modulation transfer function cut off(MTFcut off), Strehl ratio(SR)and OV 100% between the two groups(all P>0.05). The scores of overall visual acuity and near visual activity in the bifocal group at 3 mo after surgery were higher than those in the monofocal group(all P<0.001), but there were no statistical differences in the scores of dimensions of overall health, distance visual activity, peripheral visual acuity, color vision, dependence degree, social function, social role and mental health between the two groups(all P>0.05). Furthermore, there were no statistical significance in the incidence of complications in the two groups(P>0.05).CONCLUSION: Phacoemulsification combined with bifocal intraocular lens implantation can provide more ideal near visual acuity and visual-related quality of life for patients with cataract, but its objective visual quality is worse, The two types of intraocular lenses have their own advantages and disadvantages, and it is still necessary to choose the appropriate intraocular lens according to the actual needs of patients.
10.Cryopreservation of small-volume red blood cells: evaluation of blood group antigen reactivity and its application value
Yaling ZHAO ; Yanxia WANG ; Ziye WANG ; Siyu MA ; Wei SHAO ; Yuanyuan ZHANG ; Xin JIANG ; Jia GAN
Chinese Journal of Blood Transfusion 2025;38(3):352-357
[Objective] To establish a cryopreservation protocol for small-volume (≤1 mL) red blood cells (RBCs) and to evaluate the reactivity and stability of blood group antigens after cryopreservation, so as to explore its potential application in immunohematology reference laboratories. [Methods] Small-volume RBCs were cryopreserved for 120 days, followed by thawing and deglycerolization to restore the RBC components. The quality of the RBCs was assessed. Serum antibodies were serially diluted and reacted with RBCs before and after cryopreservation, and agglutination scores were recorded to quantitatively evaluate the reactivity and stability of blood group antigens such as Rh, Duffy, Lewis, Kidd, M, and H. Flow cytometry was used to analyze the percentage and mean fluorescence intensity of ABO antigen expression on RBCs before and after cryopreservation to assess the usability of cryopreserved RBCs in flow immunophenotyping and blood group subtype studies. [Results] The hemolysis rate of thawed and deglycerolized RBCs was (0.27±0.10)%, with a supernatant free hemoglobin level of (0.52±0.14) g/L, and the RBC recovery rate was (69.12±7.91)%. The direct antiglobulin test (DAT) was negative for all thawed RBCs. There was no difference in the reactivity of blood group antigens before and after cryopreservation, and no difference in the percentage and mean fluorescence intensity of A and B antigen expression on RBCs before and after cryopreservation. [Conclusion] The small-volume RBC cryopreservation protocol can be applied to immunohematology analysis in reference laboratories and is expected to be widely used in blood group identification, antibody screening, identification, and blood group-related research.

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