1.Clinical Efficacy of Tangning Tongluo Tablets for Nonproliferative Diabetic Retinopathy
Fuwen ZHANG ; Junguo DUAN ; Wen XIA ; Tiantian SUN ; Yuheng SHI ; Shicui MEI ; Xiangxia LUO ; Xing LI ; Yujie PAN ; Yong DENG ; Chuanlian RAN ; Hao CHEN ; Li PEI ; Shuyu YANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):132-139
ObjectiveTo observe the clinical efficacy and safety of Tangning Tongluo tablets in the treatment of nonproliferative diabetic retinopathy (DR). MethodsFourteen research centers participated in this study, which spanned a time interval from September 2021 to May 2023. A total of 240 patients with nonproliferative DR were included and randomly assigned into an observation group (120 cases) and a control group (120 cases). The observation group was treated with Tangning Tongluo tablets, and the control group with calcium dobesilate capsules. Both groups were treated for 24 consecutive weeks. The vision, DR progression rate, retinal microhemangioma, hemorrhage area, exudation area, glycosylated hemoglobin (HbA1c) level, and TCM syndrome score were assessed before and after treatment, and the safety was observed. ResultsThe vision changed in both groups after treatment (P<0.05), and the observation group showed higher best corrected visual acuity (BCVA) than the control group (P<0.05). The DR progression was slow with similar rates in the two groups. The fundus hemorrhage area and exudation area did not change significantly after treatment in both groups, while the observation group outperformed the control group in reducing the fundus hemorrhage area and exudation area. There was no significant difference in the number of microhemangiomas between the two groups before treatment. After treatment, the number of microhemangiomas decreased in both the observation group (Z=-1.437, P<0.05) and the control group (Z=-2.238, P<0.05), and it showed no significant difference between the two groups. As the treatment time prolonged, the number of microhemangiomas gradually decreased in both groups. There was no significant difference in the HbA1c level between the two groups before treatment. After treatment, the decline in the HbA1c level showed no significant difference between the two groups. The TCM syndrome score did not have a statistically significant difference between the two groups before treatment. After treatment, neither the TCM syndrome score nor the response rate had significant difference between the two groups. With the extension of the treatment time, both groups showed amelioration of TCM syndrome compared with the baseline. ConclusionTangning Tongluo tablets are safe and effective in the treatment of nonproliferative DR, being capable of improving vision and reducing hemorrhage and exudation in the fundus.
2.Exploration of Pulmonary Vascular Remodeling Improvement in Rats at Different Stages of Chronic Obstructive Pulmonary Disease by Qibai Pingfei Capsules Based on TLR4/NF-κB Signaling Pathway
Lu ZHANG ; Li FANG ; Shuyu XU ; Xue LIANG ; Jie ZHU ; Xiangli TONG ; Zegeng LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):48-56
ObjectiveTo investigate the improvement effect of Qibai Pingfei capsules on pulmonary vascular remodeling in rats at different stages of chronic obstructive pulmonary disease (COPD) and to analyze its possible mechanism of action. MethodsMale Sprague-Dawley (SD) rats were randomly divided into a normal group, an early COPD model group, an advanced COPD model group, an early-intervention high-dose group, a late-intervention high-dose group, an early-intervention low-dose group, a late-intervention low-dose group, an early-intervention pyrrolidine dithiocarbamate (PDTC) group, and a late-intervention PDTC group, with 15 rats in each group. A rat model of early COPD was constructed by using cigarette smoke combined with airway infusion using lipopolysaccharide(LPS), and a rat model of advanced COPD was constructed by using airway infusion with LPS, cigarette smoke, and hypoxia. All groups except the normal group were given LPS airway drops on days 1 and 14 of the experiment, smoked for 1 h per day, and administered the drug once a day for 40 weeks from day 15 onward. In the high- and low-dose groups, rats were given 1 g·kg-1 and 250 mg·kg-1 Qibai Pingfei capsules, respectively by gavage, and in PDTC groups, rats were given 100 mg·kg-1 of PDTC by intraperitoneal injection. The advanced COPD model group underwent 6 h of hypoxia per day in weeks 5-6. Lung function and mean pulmonary artery pressure were tested in rats. Morphologic changes in lung tissues were detected by hematoxylin-eosin(HE)staining. Collagen deposition in lung tissues was examined by Masson staining, and the levels of inflammatory factors including interleukin-1β(IL-1β), interleukin-6(IL-6), and tumor necrosis factor-α(TNF-α)in lung tissues were detected by enzyme-linked immunosorbent assay (ELISA). The number of inflammatory cells in the alveolar lavage fluid of rats in each group was detected by Giemsa staining, and the protein expression of Toll-like receptor 4(TLR4), myeloid differentiation factor 88(MyD88), nuclear factor-κB(NF-κB), TNF-α, vascular endothelial-cadherin(VE-cadherin), α-smooth muscle actin(α-SMA), and platelet endothelial cell adhesion molecule-1(CD31) was detected by Western blot in the lung tissues of rats. ResultsCompared with the normal group, the model group showed significantly decreased forced expiratory volume in 0.3 s (FEV0.3), forced vital capacity (FVC), and FEV0.3/FVC ratio related to lung function (P<0.05), thickening of pulmonary vasculature, increased collagen deposition in the lungs, and enhanced mean pulmonary arterial pressure and expression levels of IL-6, IL-1β, and TNF-α (P<0.05). Additionally, the model group also exhibited increased numbers of macrophages, lymphocytes, and neutrophils (P<0.05), significantly higher protein expression of TLR4, MyD88, NF-κB, TNF-α, and α-SMA (P<0.05), and significantly lower protein expression of VE-cadherin and CD31 (P<0.05). Lung function was significantly improved in the Qibai Pingfei capsules groups compared with the model group (P<0.05), with mean pulmonary arterial pressure reduced and pulmonary vascular thickening and collagen deposition in the lungs ameliorated. The Qibai Pingfei capsules groups also showed reduced expression levels of IL-6, IL-1β, and TNF-α (P<0.05) and decreased numbers of macrophages, lymphocytes, and neutrophils (P<0.05), as well as reduced protein expression of TLR4, MyD88, NF-κB, TNF-α, and α-SMA (P<0.05) and elevated protein expression of VE-cadherin and CD31 (P<0.05) in rat lung tissues. ConclusionQibai Pingfei capsules inhibits inflammatory response and endothelial-to-mesenchymal transition probably by regulating the TLR4/NF-κB signaling pathway, thus improving pulmonary vascular remodeling in COPD model rats and showing therapeutic effects in the early stage of COPD.
3.Quality Evaluation of Clinical Guidelines for Acute Myocardial Infarction Based on AGREE Ⅱ
Shuyu GUAN ; Tianying CHANG ; Jiankang WANG ; Hang SHANG ; Yueying ZHANG ; Jiajuan GUO ; Yingzi CUI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(10):201-209
ObjectiveThis paper used the AGREE Ⅱ guideline evaluation tool to evaluate the quality of 14 clinical guidelines for acute myocardial infarction,aiming to provide reference for the formulation and improvement of the guidelines. MethodsClinical guidelines and expert consensus related to acute myocardial infarction were searched by web search. The search period ranges from January 1,2019 to November 1,2024 in CNKI,VIP,Wanfang Data,SinoMed,Web of Science,OVID, the International Guidelines Collaboration Network (GIN),the UK National Institute for Health and Clinical Excellence (NICE),Yimaitong, and other platforms. Three researchers independently screened the literature and used AGREE Ⅱ to score the screening results. After ensuring that the researchers have a consistent understanding of each guideline,the quality of the guidelines was evaluated. After that,the ratings were analyzed by layer according to the issuing agency,category,method of formulation,and funding situation and compared longitudinally by rating time. The clinical guidelines and expert consensus were compared in terms of content and evidence. ResultsA total of 14 guidelines and consensus were included. The results of AGREE Ⅱ in the six areas in descending order were scope and purpose (62.82%±10.43%),rigor (62.40%±12.77%),editorial independence (62.11%±22.26%),participants (61.42%±11.65%),clarity of expression (59.98%±9.62%),and application (52.94%±16.90%) . Eleven of the guidelines were at level B, and three were at level A. In the stratified analysis,the score of the guideline formulated by the Chinese Medical Doctor Association was lower. There was little difference between the scores of Chinese/Western and Western medicine guidelines. The average score of the guidelines was higher than the consensus. Funded guidelines and consensus scores were higher. In the longitudinal comparison,the highest number of guidelines were developed in 2020 and 2021,while those developed in 2023 scored the highest. In the differential comparison analysis,the content of the guidelines was more comprehensive, and the evidence level was higher,while the content of the consensus was more novel, and the evidence was less. ConclusionThe AGREE Ⅱ score of the clinical guidelines for acute myocardial infarction is generally moderate,and there is room for improvement in terms of applicability. At the same time,the content quality of expert consensus should be improved,and more efforts should be made to develop and apply Chinese medicine guidelines for complications such as heart failure and microcirculatory obstruction after acute myocardial infarction.
4.Research on ethical issues and coping strategies of voice biomarkers in medical applications
Sikai SHAN ; Shuyu HAN ; Wenxia WANG ; Yufan YANG ; Xiaomeng WANG ; Wenmin ZHANG ; Siye CHEN ; Mo CHEN ; Zhiwen WANG
Chinese Medical Ethics 2025;38(10):1233-1239
Voice biomarkers, as an emerging smart medical technology, are now being used in applications such as assisting in the diagnosis and treatment of diseases, facilitating accurate and personalized medical services for patients. However, it also raises many ethical issues, including informed consent, privacy protection, accuracy and reliability, data security, legal risks, and other issues. This paper systematically sorted out the ethical issues in the applications of voice biomarkers in the medical field, summarized these issues, such as informed consent, privacy protection, accuracy and reliability, data security, and legal risks, as well as explored the corresponding coping strategies. These countermeasures encompassed utilizing new media platforms to raise public awareness of voice biomarkers, strengthening supervision and management to promote the privacy protection of voice biomarkers, reducing algorithm biases to promote the general benefits of voice biomarkers to the public, establishing multidisciplinary teams to protect the data security of voice biomarkers, and encouraging medical professionals and researchers to participate in policy research, with a view to providing references for promoting and regulating the applications of voice biomarkers in the medical field.
5.Correlation between insomnia,gastrointestinal symptoms,and glycated hemoglobin in patients with type 2 diabetes:a cross-sectional study based on the co-management platform of three disciplines of diabetes
Bo LI ; Qi YUAN ; Yongfa WANG ; Youjian FENG ; Guimiao WANG ; Weidong NIAN ; Yi ZHOU ; Tianchi HU ; Sisi MA ; Liyan JIA ; Zhihai ZHANG ; Jin LI ; Bing YAN ; Nengjiang ZHAO ; Shuyu YANG
Journal of Beijing University of Traditional Chinese Medicine 2024;47(7):989-997
Objective To investigate the relationship between insomnia,gastrointestinal symptoms,and glycosylated hemoglobin(HbA1c)levels in individuals diagnosed with type 2 diabetes mellitus(T2DM),as well as the related influencing factors.Methods A total of 910 T2DM patients treated in our multicenter from January 2022 to December 2022 were enrolled in this study.General information(gender,age,smoking and drinking history,exercise,course of disease,treatment and complications),HbA1c,Athens Insomnia Scale(AIS)scores and Gastrointestinal Symptoms Rating Scale(GSRS)scores of patients were collected.The differences of sleep and gastrointestinal symptoms between groups were analyzed,and the correlation between the differences and HbA1c was analyzed.Furthermore,the risk factors for non-standard HbA1c were analyzed.Results The AIS score and GSRS score in the HbA1c control group were less than those in the non-standard group(P<0.01).Insomnia was reported by 37.0%of T2DM patients,and the HbA1c level in the insomnia group was significantly higher than that in the non-insomnia group(10.00%±2.38%vs.8.26%±1.73%,P<0.01).Gastrointestinal symptoms were present in 57.5%of T2DM patients,and the HbA1c levels in the group with gastrointestinal symptoms were significantly higher than those in the group without gastrointestinal symptoms(9.26%±2.23%vs.8.43%±1.98%,P<0.01).Furthermore,26.3%of T2DM patients experienced both insomnia and gastrointestinal symptoms.Remarkably,the HbA1c levels in the group with both insomnia and gastrointestinal symptoms were significantly higher than those in the group without either condition(10.18%±2.44%vs.8.45%±1.86%,P<0.01).Correlation analysis demonstrated a significant association between sleep quality,gastrointestinal function,and HbA1c levels(P<0.01).The logistic regression analysis result revealed that age,GSRS score,AIS score,and the presence of insomnia combined with gastrointestinal symptoms were independent risk factors for predicting HbA1c≥6.5%(P<0.01).Having both insomnia and gastrointestinal symptoms concurrently was the strongest risk factor for substandard HbA1c control,and the risk of blood sugar control may increase about 5 times when both appear together.Conclusion Insomnia and gastrointestinal symptoms are common comorbidities in T2DM patients,showing a cross-interfering relationship,and they appear together with poor blood sugar control,interact causally,and amplify each other.
6.Classification and influencing factors of family resilience and post-traumatic growth in spinal tumor patients based on potential profile analysis
Li CHEN ; Lifeng YAO ; Xiaoju ZHANG ; Shoumei JIA ; Li ZHANG ; Lijuan XU ; Shuyu HAN
Chinese Journal of General Practitioners 2024;23(2):153-160
Objective:To explore the classification and influencing factors of family resilience and post-traumatic growth in patients with spinal tumor.Methods:A cross-sectional investigation was conducted among 219 inpatients with spinal tumor admitted from July 2021 to July 2022. The General Demographic Information questionnaire, Chinese-Family Resilience Assessment Scale, Posttraumatic Growth Inventory, Family Crisis-Oriented Personal Evaluation Scales (F-COPES), and Social Support Rating Scale (SSRS) were used in the study. The ordinal and multivariate logistic regression analyses was applied to identify the factors associated with the classification of family resilience and post-traumatic growth.Results:Of the 219 patients, there were 62 cases of primary spinal tumors (28.3%). According to the results of latent profile analysis, the respondents were classified into three categories by family resilience and post-traumatic growth, namely family difficulty-resistant type ( n=38, 17.4%), general resilience-struggle type ( n=99, 45.2%) and family adaptation-growth type ( n=82, 37.4%). There were significant differences in occupational status, commitment to housework, family atmosphere( χ2=10.75, P=0.025; χ2=6.95, P=0.031; χ2=11.37, P=0.017), and total score of F-COPES and SSRS ( F=25.95, P<0.001; F=19.06, P<0.001)among three groups. Ordinal and multivariate logisitc regression analyses showed that retirement ( OR=2.928, 95% CI:1.098-7.808, P<0.05), family coping ( OR=1.113, 95% CI:1.063-1.165, P<0.05), and social support ( OR=1.226, 95% CI:1.103-1.362, P<0.05) were independently associated with family resilience and post-traumatic growth in patients with spinal tumor. Conclusion:Patients with spinal tumor have significant differences in characteristics by family resilience and post-traumatic growth. As a result, more targeted interventions should be provided for different categories of spinal tumor patients in the future.
7.Expert Consensus on Clinical Diseases Responding Specifically to Traditional Chinese Medicine: Threatened Abortion
Xinchun YANG ; Shuyu WANG ; Huilan DU ; Songping LUO ; Zhe JIN ; Rong LI ; Xiangyan RUAN ; Qin ZHANG ; Xiaoling FENG ; Shicai CHEN ; Fengjie HE ; Shaobin WEI ; Qun LU ; Yanqin WANG ; Yang LIU ; Qingwei MENG ; Zengping HAO ; Ying LI ; Mei MO ; Xiaoxiao ZHANG ; Ruihua ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(7):241-246
Threatened abortion is a common disease of obstetrics and gynecology and one of the diseases responding specifically to traditional Chinese medicine (TCM). The China Association of Chinese Medicine organized experts in TCM obstetrics and gynecology, Western medicine obstetrics and gynecology, and pharmacology to deeply discuss the advantages of TCM and integrated Chinese and Western medicine treatment as well as the medication plans for threatened abortion. After discussion, the experts concluded that chromosome, endocrine, and immune abnormalities were the key factors for the occurrence of threatened abortion, and the Qi and blood disorders in thoroughfare and conception vessels were the core pathogenesis. In the treatment of threatened abortion, TCM has advantages in preventing miscarriages, alleviating clinical symptoms and TCM syndromes, relieving anxiety, regulating reproductive endocrine and immune abnormalities, personalized and diversified treatment, enhancing efficiency and reducing toxicity, and preventing the disease before occurrence. The difficulty in diagnosis and treatment of threatened abortion with traditional Chinese and Western medicine lies in identifying the predictors of abortion caused by maternal factors and the treatment of thrombophilia. Recurrent abortion is the breakthrough point of treatment with integrated traditional Chinese and Western medicine. It is urgent to carry out high-quality evidence-based medicine research in the future to improve the modern diagnosis and treatment of threatened abortion with TCM.
8.Identification of vaccine safety signals based on Apriori and GPS in Gansu Province in 2021 -2022
Xuefeng LIANG ; Jing AN ; Shuyu LIU ; Yongzhuo JIAO ; Na JIN ; Xiaoshu ZHANG
Journal of Public Health and Preventive Medicine 2024;35(5):15-19
Objective To identify signals of adverse events associated with vaccines in electronic medical record data. Methods Data cleaning was performed on electronic medical records and vaccination data in Gansu Province from 2020 to 2022. Signal identification was performed using Apriori algorithm and Empirical Bayes Gamma-Poisson Shrinker (GPS) with stratification by gender and age group. Results A total of 33 statistical signals were identified, with 7 signals identified by the Apriori method and 26 signals identified by the GPS method. No overlapping signals were found between the two methods at two different signal thresholds. Conclusion The vaccine safety signals identified by GPS and Apriori in electronic medical records are reliable and accurate, but further research is needed to determine the correlation between the vaccine safety signals recognized by GPS algorithms.
9.Methodology for Developing Patient Guideline (3):Reporting Frameworks and Presentation
Lijiao YAN ; Ning LIANG ; Haili ZHANG ; Nannan SHI ; Ziyu TIAN ; Ruixiang WANG ; Xiaojia NI ; Yufang HAO ; Wei CHEN ; Yingfeng ZHOU ; Dan YANG ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(22):2304-2309
Standardized reporting is a crucial factor affecting the use of patient guidelines (PGs), particularly in the reporting and presentation of recommendations. This paper introduced the current status of PG reporting, including the research on PG content and presentation formats, and provided comprehensive recommendations for PG reporting from aspects such as overall framework, recommendations, presentation format, and readability. First, the presentation of PG recommendations should include clearly defined clinical questions, recommendations and their rationale, and guidance on how patients should implement the interventions; for specific content in the PG, such as level of evidence, level of recommendation, it is recommended to explain in text the reasons for giving different levels of recommendation, i.e., to present the logic behind giving the level of recommendation to the patient; additional information needed in the recommendation framework should be supplemented by tracing references or authoritative textbooks and literature that support the recommendations. Subsequently, the PG text should be written based on the Reporting Checklist for Public Versions of Guidelines (RIGHT-PVG) reporting framework. Finally, to enhance readability and comprehension, it is recommended to refer to the Patient Education Materials Assessment Tool (PEMAT) for translating PG content. To enhance the readability of PGs, it is suggested to present the PG content in a persona-lized and layered manner.
10.Methodology for Developing Patient Guideline(1):The Concept of Patient Guideline
Lijiao YAN ; Ning LIANG ; Ziyu TIAN ; Nannan SHI ; Sihong YANG ; Yufang HAO ; Wei CHEN ; Xiaojia NI ; Yingfeng ZHOU ; Ruixiang WANG ; Zeyu YU ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(20):2086-2091
Since the concept of patient versions of guidelines (PVGs) was introduced into China, several PVGs have been published in China, but we found that there is a big difference between the concept of PVG at home and abroad, and the reason for this difference has not been reasonably explained, which has led to ambiguity and even misapplication of the PVG concept by guideline developers. By analyzing the background and purpose of PVGs, and the understanding of the PVG concept by domestic scholars, we proposed the term patient guidelines (PGs). This refers to guidelines developed under the principles of evidence-based medicine, centered on health issues that concern patients, and based on the best available evidence, intended for patient use. Except for the general attribute of providing information or education, which is typical of common health education materials, PGs also provide recommendations and assist in decision-making, so PGs include both the patient versions of guidelines (PVG) as defined by the Guidelines International Network (GIN) and "patient-directed guidelines", i.e. clinical practice guidelines resulting from the adaptation or reformulation of recommendations through clinical practice guidelines.


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