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.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.
3.The effects of gastrodin on TLR4 expression in microglia induced by ischemia and hypoxia
Shunda LI ; Yongqiang ZHAO ; Xueke YANG ; Shuyu CHEN ; Yan YANG ; Yun YUAN
Chinese Journal of Neuroanatomy 2024;40(1):50-56
Objective:To determine the effect of gastrodin(GAS)on toll-like receptor 4(TLR4)expression in mi-croglia after hypoxic-ischemic brain damage.Methods:Hypoxia-ischemic brain damage(HIBD)model was established in neonatal rat in vivo.Thirty 3 d SD rats of were randomly divided into there groups:Sham group,HIBD model group,HIBD model+gastrodin intervention group(HIBD+G).Oxygen glucose deprivation(OGD)model was established in BV2 cells in vitro,Control group(Control),oxygen glucose deprivation group(OGD),OGD+gastrodin intervention group(OGD+G)were randomly set in vitro.Both Western Blot and immunofluorescence staining techniques were used to detect the expression of TLR4 in cells of each group in vitro and in the left corpus callosum region in vivo.Results:The expression of TLR4 was significantly increased in OGD-induced microglia.After gastrodin intervention,TLR4 expression was decreased significantly(P<0.05).Conclusion:GAS can inhibit the expression of TLR4 in activated microglia and thus play a neuroprotective role in HIBD.
4.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.
5.Methodology for Developing Patient Guideline (2):Process and Methodology
Lijiao YAN ; Ning LIANG ; Nannan SHI ; Sihong YANG ; Ziyu TIAN ; Dan YANG ; Xiaojia NI ; Yufang HAO ; Wei CHEN ; Ruixiang WANG ; Yingfeng ZHOU ; Shibing LIANG ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(21):2194-2198
At present, the process and methodology of patient guidelines (PGs) development varies greatly and lacks systematic and standardised guidance. In addition to the interviews with PG developers, we have sorted out the relevant methodology for the adaptation and development of existing clinical practice guideline recommendations and facilitated expert deliberations to achieve a consensus, so as to finally put forward a proposal for guidance on the process and methodology for the development of PGs. The development of PGs can be divided into the preparation stage, the construction stage, and the completion stage in general, but the specific steps vary according to the different modes of development of PGs. The development process of Model 1 is basically the same as the patient version of the guideline development process provided by the International Guidelines Network, i.e., team formation, screening of recommendations, guideline drafing, user testing and feedback, approval and dissemination. The developer should also first determine the need for and scope of translating the clinical practice guideline into a patient version during the preparation phase. Model 2 adds user experience and feedback to the conventional clinical practice guideline development process (forming a team, determining the scope of the PG, searching, evaluating and integrating evidence, forming recommendations, writing the guideline, and expert review). Based on the different models, we sort out the process and methods of PG development and introduce the specific methods of PG development, including how to identify the clinical problem and how to form recommendations based on the existing clinical practice guidelines, with a view to providing reference for guideline developers and related researchers.
6.Shenqi Tiaoshen Formula alleviates airway inflammation in rats with chronic obstructive pulmonary disease and kidney qi deficiency syndrome by inhibiting ferroptosis via regulating the Nrf2/SLC7A11/GPX4 signaling pathway
Qinjun YANG ; Hui WANG ; Shuyu XU ; Cheng YANG ; Huanzhang DING ; Di WU ; Jie ZHU ; Jiabing TONG ; Zegeng LI
Journal of Southern Medical University 2024;44(10):1937-1946
Objective To investigate the effects of Shenqi Tiaoshen Formula(SQTSF)for alleviating airway inflammation in rats with both chronic obstructive pulmonary disease(COPD)and lung-kidney qi deficiency syndrome and explore its therapeutic mechanism.Methods Forty-eight SD rats were randomly divided into control group,model group,low-,medium-,and high-dose SQTSF groups,and aminophylline(APL)group.In all but the control group,rat models of COPD with lung-kidney qi deficiency syndrome were established and treated with saline,SQTSF or APL via daily gavage as indicated(starting from day 30).The rats were observed for changes in body weight,grip strength,lung function,lung pathology,inflammatory cytokines in bronchoalveolar lavage fluid(BALF),oxidative stress levels,iron ion metabolism,cellular and mitochondrial ultrastructural changes in the lung tissue,and expressions of Nrf2/SLC7A11/GPX4 signaling pathway and ferroptosis-related proteins.Results The rats in the model group exhibited obvious symptoms of lung-kidney qi deficiency syndrome with significantly decreased body weight,grip strength,and lung function parameters.Examination of the lung tissue revealed showed significant inflammatory cell infiltration and emphysema with obvious bronchial,perivascular,and alveolar inflammation and alveolar destruction,significantly increased IL-1β,TNF-α,IL-6,and IL-13 levels in BALF,and elevated pulmonary oxidative stress levels and Fe2+and total iron ion concentrations.The rat models also showed characteristic ultrastructural changes of ferroptosis in the lung tissue cells under transmission electron microscope and significantly decreased Nrf2,GPX4,and SLC7A11 and increased ACSL4 expressions in the lung tissue.Treatment with SQTSF significantly improved these pathological changes in the rat models with a better effect than APL.Conclusion SQTSF can effectively improve airway inflammation and oxidative stress in COPD rats with lung-kidney qi deficiency possibly by inhibiting ferroptosis via regulating the Nrf2/SLC7A11/GPX4 signaling pathway.
7.Clinical Treatment Ideas and Methods of Diabetes from the Perspective of Improving Symptoms
Yi ZHOU ; Shuyu YANG ; Hongfei KE ; Bo LI ; Sisi MA
Journal of Traditional Chinese Medicine 2024;65(5):464-468
This paper discussed the clinical ideas and methods of treating diabetes by improving symptoms. Diabetes-related symptoms can affect the control of blood glucose and other metabolic indicators to varying degrees, and affect the quality of life of patients. In the clinical diagnosis and treatment of diabetes, “equal emphasis on both indicators” is suggested, meaning that quality of life indicators is as important as metabolic indicators. The patient's symptoms should be paied attention to, and the diagnosis and treatment should start from “symptom differentiation”, and emphasize the “key symptoms”. When there are many symptoms, it is advised to adopt the combined treatment mode of “syndrome cluster”, and take the principle of “treating both the root and accompanying symptoms in mild cases with multiple symptoms, and prescribing multiple formulas daily”. At the same time, the model of co-management of three disciplines of diabetes consisting of diabetes specialists, traditional Chinese medicine doctors, and health managers can help the management of diabetes symptoms.
8.Rehabilitation effect of intelligent ankle stretching on lower extremity spasm in patients with spinal cord injury:a randomized controlled trial
Mingming GAO ; Xiaoping YUN ; Shuyu ZHAO ; Ran XIN ; Guiyun SONG ; Yang ZHAO
Chinese Journal of Rehabilitation Theory and Practice 2024;30(10):1187-1192
Objective To observe the effect of intelligent flexible ankle stretching training on lower extremity spasm in patients with spinal cord injury. Methods From June,2021 to May,2024,28 patients with spinal cord injury were randomly divided into control group(n=14)and experimental group(n=14).Both groups received conventional rehabilitation treatment.On this ba-sis,the control group received manual extension treatment,and the experimental group received intelligent flexi-ble ankle stretching system training,for eight weeks.The modified Ashworth Scale(MAS),ankle dorsiflexion an-gle,Clinical Spasticity Index(CSI),max root mean square(RMSmax)of surface electromyography of gastrocne-mius medial head and vibration perception threshold(VPT)of great toe were compared. Results After treatment,MAS(χ2=10.378,P=0.035),ankle dorsiflexion angle(Z=-3.306,P<0.001),CSI(t=4.101,P=0.001)and RMSmax of gastrocnemius medial head(Z=-3.296,P<0.001)improved in the experimental group,while MAS(χ2=11.418,P=0.022),ankle dorsiflexion angle(Z=-1.986,P=0.047)and RMSmax of gas-trocnemius medial head(Z=-2.297,P=0.021)were better in the experimental group than in the control group.Although VPT was improved after treatment,no significant difference was found within and beteen groups(P>0.05). Conclusion The intelligent flexible ankle stretching training could improve the lower limb muscle spasticity in patients with spinal cord injury,and may be benefit for foot proprioception.
9.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.
10.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.

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