1.Effect of transcranial direct current stimulation combined with seated Taijiquan Yunshou in different sequences on cerebral cortical activation in stroke patients with hemiplegia:a functional near-infrared spectroscopy study
Qi XU ; Dingzhao ZHENG ; Zhenyuan NIU ; Yaling YANG ; Weiyou WEN ; Jingsheng XU ; Longqiang WU ; Fan WU ; Tiebin YAN
Chinese Journal of Rehabilitation Theory and Practice 2025;31(10):1121-1127
Objective To investigate the immediate effect of transcranial direct current stimulation(tDCS)combined with seated Tai-jiquan Yunshou training under different sequences on cerebral cortical activation in stroke patients with hemiple-gia.Methods From September to December,2024,14 stroke inpatients with hemiplegia were enrolled from the Fifth Hospi-tal of Xiamen.Based on the routine medication and rehabilitation,the patients were randomly assigned to a spe-cific intervention sequence,receiving three interventions in a fixed order:tDCS followed by Yunshou(S-Y group),Yunshou followed by tDCS(Y-S group),and simultaneous tDCS and Yunshou(Sim group).Functional near-infrared spectroscopy was used to detect oxyhemoglobin(HbO?)concentration in bilateral sensorimotor cor-tex,premotor and supplementary motor cortex,and prefrontal cortex before and after each intervention.Results Three patients dropped out.In all the regions of interest,inter-group effects were significant in HbO? concentra-tions(F>3.697,P<0.05),and interaction effects were significant in some brain regions(F>3.276,P<0.05).Post-hoc test showed a general trend of Sim Group≥S-Y Group>Y-S Group(P<0.05),although some varia-tions existed across different brain regions.Conclusion Both simultaneous intervention(tDCS and Yunshou)and tDCS followed by Yunshou are more effective on immediate activation of key motor-related cortices in stroke patients with hemiplegia than Yunshou followed by tDCS intervention.
2.Effect of transcranial direct current stimulation combined with seated Taijiquan Yunshou in different sequences on cerebral cortical activation in stroke patients with hemiplegia:a functional near-infrared spectroscopy study
Qi XU ; Dingzhao ZHENG ; Zhenyuan NIU ; Yaling YANG ; Weiyou WEN ; Jingsheng XU ; Longqiang WU ; Fan WU ; Tiebin YAN
Chinese Journal of Rehabilitation Theory and Practice 2025;31(10):1121-1127
Objective To investigate the immediate effect of transcranial direct current stimulation(tDCS)combined with seated Tai-jiquan Yunshou training under different sequences on cerebral cortical activation in stroke patients with hemiple-gia.Methods From September to December,2024,14 stroke inpatients with hemiplegia were enrolled from the Fifth Hospi-tal of Xiamen.Based on the routine medication and rehabilitation,the patients were randomly assigned to a spe-cific intervention sequence,receiving three interventions in a fixed order:tDCS followed by Yunshou(S-Y group),Yunshou followed by tDCS(Y-S group),and simultaneous tDCS and Yunshou(Sim group).Functional near-infrared spectroscopy was used to detect oxyhemoglobin(HbO?)concentration in bilateral sensorimotor cor-tex,premotor and supplementary motor cortex,and prefrontal cortex before and after each intervention.Results Three patients dropped out.In all the regions of interest,inter-group effects were significant in HbO? concentra-tions(F>3.697,P<0.05),and interaction effects were significant in some brain regions(F>3.276,P<0.05).Post-hoc test showed a general trend of Sim Group≥S-Y Group>Y-S Group(P<0.05),although some varia-tions existed across different brain regions.Conclusion Both simultaneous intervention(tDCS and Yunshou)and tDCS followed by Yunshou are more effective on immediate activation of key motor-related cortices in stroke patients with hemiplegia than Yunshou followed by tDCS intervention.
3.Mechanism of Tibetan Medicine Sanwei Doukoutang to Improve Cognitive Dysfunction in 5×FAD Mice Based on Wnt/β-catenin Signaling Pathway
Shuran LI ; Yaxin WANG ; Jing SUN ; Lei BAO ; Zihan GENG ; Dan XIE ; Ronghua ZHAO ; Yanyan BAO ; Qiyue SUN ; Jingsheng ZHANG ; Xinwei WANG ; Xinying LI ; Xihe CUI ; Xiaowei YANG ; LIUXIAN ; Mengyao CUI ; Qingshan LIU ; Shanshan GUO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):54-60
ObjectiveTo explore the effects of the Tibetan medicine Sanwei Doukoutang (SWDK) on cognitive dysfunction in mice suffering from Alzheimer's disease (AD) and its related mechanism. MethodsFifty SPF 5 × FAD mice were randomly divided into model group, total ginsenoside group(0.04 g·kg-1), high-, medium-, and low-dose groups of SWDK (32.60, 16.30, 8.15 g·kg-1), with 10 mice in each group, and ten wild-type mice of the same age were used as the normal group, male and female in 1∶1. Gavage administration was performed once daily for 8 weeks. The Morris water maze test and contextual fear memory experiment were used to observe learning and memory function. Hematoxylin-eosin (HE) staining was utilized to observe the changes in the pathomorphology of brain tissue in mice. The levels of synaptophysin (SYP) and postsynaptic dense substance 95 (PSD95) in mice serum were detected by enzyme-linked immunosorbent assay (ELISA). The positive expression of brain-derived neurotrophic factor(BDNF) in the dentate gyrus (DG) region of mouse brain tissue was observed by immunohistochemistry (IHC). The protein levels of BDNF, Wnt family member 3A(Wnt3a), and β-catenin were detected in the hippocampus of mice by Western blot. ResultsCompared with the normal group of mice, the model group of mice had significantly more complex swimming routes and lower swimming speed (P<0.01), significantly lower percentage of time spent in the target quadrant (P<0.01), and a significantly lower percentage of freezing time (P<0.05). The number of neurons in the hippocampal region of mice was obviously reduced and unevenly arranged. The levels of SYP and PSD95(P<0.01) in the serum of mice were reduced, and the positive expression of BDNF in the DG region of the brain tissue of mice was reduced. The levels of hippocampal BDNF, Wnt3a, and β-catenin proteins in the hippocampus of mice were obviously reduced (P<0.05, P<0.01). Compared with the model group, the mice in the SWDK group and the total ginsenoside group had significantly shorter swimming routes, the high- and medium- dose SWDK groups significantly higher swimming speeds (P<0.01), significantly higher percentage of time spent in the target quadrant (P<0.01), obviously higher percentage of Freezing time (P<0.05), and obviously more neurons in the hippocampal region of the mice with tighter arrangement. The mice had elevated levels of serum SYP (P<0.05, P<0.01), PSD95 (P<0.01), increased BDNF-positive cells in the DG region of brain tissue, and obviously elevated levels of BDNF, Wnt3a, and β-catenin proteins in the hippocampus of mice (P<0.05, P<0.01). ConclusionSWDK can significantly improve the cognitive dysfunction of AD mice, and its mechanism may be related to regulating the Wnt/β-catenin signaling pathway, which promotes BDNF expression and thereby enhances synaptic plasticity, allowing neuronal signaling to be restored.
4.Mechanism of Tibetan Medicine Sanwei Doukoutang to Improve Cognitive Dysfunction in 5×FAD Mice Based on Wnt/β-catenin Signaling Pathway
Shuran LI ; Yaxin WANG ; Jing SUN ; Lei BAO ; Zihan GENG ; Dan XIE ; Ronghua ZHAO ; Yanyan BAO ; Qiyue SUN ; Jingsheng ZHANG ; Xinwei WANG ; Xinying LI ; Xihe CUI ; Xiaowei YANG ; LIUXIAN ; Mengyao CUI ; Qingshan LIU ; Shanshan GUO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):54-60
ObjectiveTo explore the effects of the Tibetan medicine Sanwei Doukoutang (SWDK) on cognitive dysfunction in mice suffering from Alzheimer's disease (AD) and its related mechanism. MethodsFifty SPF 5 × FAD mice were randomly divided into model group, total ginsenoside group(0.04 g·kg-1), high-, medium-, and low-dose groups of SWDK (32.60, 16.30, 8.15 g·kg-1), with 10 mice in each group, and ten wild-type mice of the same age were used as the normal group, male and female in 1∶1. Gavage administration was performed once daily for 8 weeks. The Morris water maze test and contextual fear memory experiment were used to observe learning and memory function. Hematoxylin-eosin (HE) staining was utilized to observe the changes in the pathomorphology of brain tissue in mice. The levels of synaptophysin (SYP) and postsynaptic dense substance 95 (PSD95) in mice serum were detected by enzyme-linked immunosorbent assay (ELISA). The positive expression of brain-derived neurotrophic factor(BDNF) in the dentate gyrus (DG) region of mouse brain tissue was observed by immunohistochemistry (IHC). The protein levels of BDNF, Wnt family member 3A(Wnt3a), and β-catenin were detected in the hippocampus of mice by Western blot. ResultsCompared with the normal group of mice, the model group of mice had significantly more complex swimming routes and lower swimming speed (P<0.01), significantly lower percentage of time spent in the target quadrant (P<0.01), and a significantly lower percentage of freezing time (P<0.05). The number of neurons in the hippocampal region of mice was obviously reduced and unevenly arranged. The levels of SYP and PSD95(P<0.01) in the serum of mice were reduced, and the positive expression of BDNF in the DG region of the brain tissue of mice was reduced. The levels of hippocampal BDNF, Wnt3a, and β-catenin proteins in the hippocampus of mice were obviously reduced (P<0.05, P<0.01). Compared with the model group, the mice in the SWDK group and the total ginsenoside group had significantly shorter swimming routes, the high- and medium- dose SWDK groups significantly higher swimming speeds (P<0.01), significantly higher percentage of time spent in the target quadrant (P<0.01), obviously higher percentage of Freezing time (P<0.05), and obviously more neurons in the hippocampal region of the mice with tighter arrangement. The mice had elevated levels of serum SYP (P<0.05, P<0.01), PSD95 (P<0.01), increased BDNF-positive cells in the DG region of brain tissue, and obviously elevated levels of BDNF, Wnt3a, and β-catenin proteins in the hippocampus of mice (P<0.05, P<0.01). ConclusionSWDK can significantly improve the cognitive dysfunction of AD mice, and its mechanism may be related to regulating the Wnt/β-catenin signaling pathway, which promotes BDNF expression and thereby enhances synaptic plasticity, allowing neuronal signaling to be restored.
5.Study on the movement patterns and influencing factors of lung tumors tracked by M6 cyberknife stereoscopic radiotherapy system
Niu ZEQIAN ; Song YONGCHUN ; Yuan ZHIYONG ; Wang JINGSHENG ; Dong YANG ; Yu XUYAO ; Chen HUAMING ; Tian XIAOLIN
Chinese Journal of Clinical Oncology 2025;52(2):71-74
Objective:To explore the movement patterns and factors influencing lung tumors tracked using the M6 cyberknife stereotactic radiotherapy(SRT)system and to provide a reference for the implementation of precise stereotactic radiotherapy for lung tumors.Method:A retrospective analysis was conducted on 29 patients with lung tumors who were treated using x-sight lung tracking technology and the M6 cyberknife SRT system at Tianjin Medical University Cancer Institute&Hospital,from January 2022 to August 2024.The tumor location and volume,irradiation dose,isodose line,and number of divisions were recorded.Lung tumor location and SPSS 26.0 software were used to analyze the movement amplitude of tumors in the left and right(LFT/RGT,LR)directions,the anterior-posterior(ANT/POS,AP)direction,and the superior-inferior(SUP/INF,SI)direction.The results are expressed as the mean±standard deviation((x)±s)mm,and a t-test was used for inter-group comparisons.Multiple linear regression was used to analyze the effects of factors such as age,gender,tumor location(upper and lower lungs),and tumor volume on the amplitudes of the lung tumor movements.Result:The average motion amplitudes in the LR direc-tions,AP direction,and SI direction of the tumor target areas were(3.5±1.8)mm,(5.3±1.7)mm,and(7.3±5.4)mm for the upper lung,based on 19 cases,and(3.1±1.6)mm,(4.5±2.2)mm,and(12.2±4.4)mm for the lower lung,based on 10 cases,respectively.There was a statistic-ally significant difference(P=0.015 3)in the amplitude of movements between the lower and upper lung tumors in the SI direction.The lung tumor movement amplitude in the SI direction was influenced by tumor location(P=0.035),and the movement amplitudes in the LR direc-tions and the AP direction were not related to factors such as gender,age,tumor location,and tumor volume.Conclusions:The lung tumor movement amplitudes for the different locations varied depending on the respiratory movement shown by the patient.In the SI direction,the movement amplitude of the lower lung tumors was greater than that of upper lung tumors,and this was due to tumor location effects.The movement amplitudes of the lower and upper lung tumors were similar in the LR directions and AP directions.Furthermore,movement amplitude was not affected by gender,age,tumor location,and tumor volume.
6.Study on the movement patterns and influencing factors of lung tumors tracked by M6 cyberknife stereoscopic radiotherapy system
Niu ZEQIAN ; Song YONGCHUN ; Yuan ZHIYONG ; Wang JINGSHENG ; Dong YANG ; Yu XUYAO ; Chen HUAMING ; Tian XIAOLIN
Chinese Journal of Clinical Oncology 2025;52(2):71-74
Objective:To explore the movement patterns and factors influencing lung tumors tracked using the M6 cyberknife stereotactic radiotherapy(SRT)system and to provide a reference for the implementation of precise stereotactic radiotherapy for lung tumors.Method:A retrospective analysis was conducted on 29 patients with lung tumors who were treated using x-sight lung tracking technology and the M6 cyberknife SRT system at Tianjin Medical University Cancer Institute&Hospital,from January 2022 to August 2024.The tumor location and volume,irradiation dose,isodose line,and number of divisions were recorded.Lung tumor location and SPSS 26.0 software were used to analyze the movement amplitude of tumors in the left and right(LFT/RGT,LR)directions,the anterior-posterior(ANT/POS,AP)direction,and the superior-inferior(SUP/INF,SI)direction.The results are expressed as the mean±standard deviation((x)±s)mm,and a t-test was used for inter-group comparisons.Multiple linear regression was used to analyze the effects of factors such as age,gender,tumor location(upper and lower lungs),and tumor volume on the amplitudes of the lung tumor movements.Result:The average motion amplitudes in the LR direc-tions,AP direction,and SI direction of the tumor target areas were(3.5±1.8)mm,(5.3±1.7)mm,and(7.3±5.4)mm for the upper lung,based on 19 cases,and(3.1±1.6)mm,(4.5±2.2)mm,and(12.2±4.4)mm for the lower lung,based on 10 cases,respectively.There was a statistic-ally significant difference(P=0.015 3)in the amplitude of movements between the lower and upper lung tumors in the SI direction.The lung tumor movement amplitude in the SI direction was influenced by tumor location(P=0.035),and the movement amplitudes in the LR direc-tions and the AP direction were not related to factors such as gender,age,tumor location,and tumor volume.Conclusions:The lung tumor movement amplitudes for the different locations varied depending on the respiratory movement shown by the patient.In the SI direction,the movement amplitude of the lower lung tumors was greater than that of upper lung tumors,and this was due to tumor location effects.The movement amplitudes of the lower and upper lung tumors were similar in the LR directions and AP directions.Furthermore,movement amplitude was not affected by gender,age,tumor location,and tumor volume.
7.Host Targets Interacting with Influenza Virus NP and Mechanism of Gardenia Jasminoides Iridoid Glycoside Against Influenza Virus
Xiaowei YANG ; Lei BAO ; Yu ZHANG ; Xian LIU ; Zihan GENG ; Shuran LI ; Jingsheng ZHANG ; Xiaolan CUI ; Shanshan GUO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(13):60-66
ObjectiveTo explore host factors interacting with influenza virus nucleoprotein (NP) and study their effects on influenza virus replication, as well as the mechanism of gardenia jasminoides iridoid glycoside (IGE) in inhibiting influenza virus. MethodA yeast two-hybrid system was utilized to screen host factors that interacted with influenza virus NP. Heterogeneous nuclear ribonucleoprotein D0 (HNRNPD), glucosamine-6-phosphate deaminase 1 (GNPDA1), poly(rC)-binding protein 1 (PCBP1), and protein inhibitor of activated signal transducer and activator of transcription (STAT) protein 1 (PIAS1) were validated by immunoprecipitation assay. The effects of PIAS1 and HNRNPD on influenza virus replication were compared by a dual luciferase assay, and the effects of IGE on influenza virus replication were examined in the presence of transfected ribonucleoprotein (RNP) and knockdown of PIAS1. ICR mice were randomly divided into a normal group, model group, oseltamivir phosphate group, and high, medium, and low dose IGE groups, with 10 mice in each group. In addition to the normal group, each group was infected with the influenza A virus FM1 strain by nasal drip to establish a viral pneumonia model. The high, medium, and low dose IGE groups were given drugs of 50, 25, and 12.5 mg∙kg-1 by gavage, and the oseltamivir phosphate group was given the drug of 27.5 mg∙kg-1 by gavage. Equal amounts of distilled water were instilled in the normal and model groups for four consecutive days. Later, protein expression of PIAS1, NP, phosphorylated (p)-STAT3, STAT3, p-STAT1, and STAT1 were detected in the lung tissue by Western blot. ResultIn yeast two-hybrid assays, 16 potential host targets interacting with influenza virus NP were identified. Immunoprecipitation experiments revealed that HNRNPD and PIAS1 could interact with influenza virus NP. The dual luciferase reporter assays found that both PIAS1 knockdown and overexpression significantly affected IAV RNP activity (P<0.05, P<0.01), and the effect of HNRNPD on IAV RNP was not significant. Both high and low dose IGE groups reduced influenza virus replication (P<0.05) and reversed the increase in influenza virus replication caused by the knockdown of PIAS1(P<0.05, P<0.01). The expressions of PIAS1, NP, p-STAT3, p-STAT1, and STAT1 in the lung tissue of infected mice were reduced to different degrees in each IGE group (P<0.05, P<0.01). ConclusionPIAS1 interacts with influenza virus NP and is able to inhibit influenza virus replication. IGE may exert antiviral effects by inhibiting the activity of IAV RNP through the PIAS1/STAT1 pathway.
8.Mingshi Formula (明视方) for Low Myopia in Children with Heart Yang Insufficiency Syndrome: A Multicentre, Double-Blind, Randomised Placebo-Controlled Study
Jianquan WANG ; Xinyue HOU ; Zefeng KANG ; Yingxin YANG ; Xinquan LIU ; Zhihua SHEN ; Xiaoyi YU ; Jing YAO ; Fengming LIANG ; Fengmei ZHANG ; Jingsheng YU ; Ningli WANG ; Man SONG ; Hongrui SUN ; Xin YAN
Journal of Traditional Chinese Medicine 2024;65(6):587-593
ObjectiveTo observe the effectiveness and safety of the Chinese herbal medicine Mingshi Granules (明视方颗粒) for low myopia in children with heart yang insufficiency. MethodsA multicentre, prospective, double-blind randomised controlled study was conducted, in which 290 children with low myopia from 8 centres were randomly divided into 145 cases in the treatment group and 145 cases in the control group, and the treatment group was given education, dispensing glasses, and Chinese herbal medicine Mingshi Granules, while the control group was given education, dispensing glasses, and granules placebo. Both Mingshi Granules and placebo granules were taken orally, 1 bag each time, twice daily, 4 weeks of oral intake and 2 weeks of rest as 1 course of treatment, a total of 4 courses of treatment (24 weeks). Equivalent spherical lenses, best naked-eye distance visual acuity, ocular axis, corneal curvature K1, adjustment amplitude, traditional Chinese medicine (TCM) symptom scores, calculate the amount of progression of equivalent spherical lenses, were observed at the 12th and the 24th week of treatment, at the 36th week and 48th week of follow-up, resectively, the control rate of myopia progression was evaluated at the 24th week, and safety indexes were observed before treatment. ResultsThe amount of progression of equivalent spherical lenses was lower in the treatment group than in the control group at the 48-week follow-up (P<0.05). The control rate of myopia progression at 24 weeks after treatment in the treatment group was higher (57.60%, 72/125) than that in the control group (44.63%, 54/121) (P<0.05). The best naked-eye distance visual acuity at 36-week follow-up in the treatment group was higher than that in the control group (P<0.05). Equivalent spherical lenses were significantly lower in both groups at all observation time points compared with pre-treatment (P<0.05), and were higher in the treatment group than in the control group at the 48-week follow-up (P<0.05). The ocular axes of both groups were significantly higher at each observation time point after treatment and at follow-up compared with before treatment (P<0.05). The amount of eye axis growth in the treatment group was lower than that in the control group at 24 weeks after treatment and at the 48-week follow-up (P<0.05). Corneal curvature K1 was significantly lower in the treatment group at the 24th week of treatment compared to pre-treatment (P<0.05). The magnitude of adjustment in the treatment group was significantly higher at the 36-week follow-up and at the 48-week follow-up than before treatment (P<0.05). The scores of white/dark complexion, white coating thin pulse, fatigue and total TCM symptom scores of children in both groups at the 12th, 24th, 36th and 48th weeks of follow-up were significantly lower than those before treatment (P<0.05); the scores of blurred vision at the 24th and 36th weeks of follow-up were significantly lower than those before treatment (P<0.05); and the scores of blurred vision in the treatment group at the 48th week of follow-up were signi-ficantly lower than those before treatment (P<0.05). In the treatment group, the score of fatigue was higher than that of the control group at the 36-week follow-up, and the score of blurred vision was lower than that of the control group at the 48-week follow-up (P<0.05). No adverse reactions or obvious abnormalities of the safety indexes were observed of the two groups during the treatment. ConclusionChinese herbal medicine Mingshi Granules showed the effect of controlling the progression of low myopia, improving the best naked eye distance visual acuity, slowing down the growth of the eye axis, improving some of the TCM symptoms, with good safety.
9.DNA metabarcoding analysis of fungal community on surface of four root herbs.
Yujie DAO ; Jingsheng YU ; Meihua YANG ; Jianping HAN ; Chune FAN ; Xiaohui PANG
Chinese Herbal Medicines 2024;16(1):143-150
OBJECTIVE:
Angelicae Sinensis Radix (ASR, Danggui in Chinese), Cistanches Herba (CH, Roucongrong in Chinese), Ginseng Radix et Rhizoma (PG, Renshen in Chinese), and Panacis Quinquefolii Radix (PQ, Xiyangshen in Chinese), widely used as medicine and dietary supplement around the world, are susceptible to fungal and mycotoxin contamination. In this study, we aim to analyze their fungal community by DNA metabarcoding.
METHODS:
A total of 12 root samples were collected from three main production areas in China. The samples were divided into four groups based on herb species, including ASR, CH, PG, and PQ groups. The fungal community on the surface of four root groups was investigated through DNA metabarcoding via targeting the internal transcribed spacer 2 region (ITS2).
RESULTS:
All the 12 samples were detected with fungal contamination. Rhizopus (13.04%-74.03%), Aspergillus (1.76%-23.92%), and Fusarium (0.26%-15.27%) were the predominant genera. Ten important fungi were identified at the species level, including two potential toxigenic fungi (Penicillium citrinum and P. oxalicum) and eight human pathogenic fungi (Alternaria infectoria, Candida sake, Hyphopichia burtonii, Malassezia globosa, M. restricta, Rhizopus arrhizus, Rhodotorula mucilaginosa, and Ochroconis tshawytschae). Fungal community in ASR and CH groups was significantly different from other groups, while fungal community in PG and PQ groups was relatively similar.
CONCLUSION
DNA metabarcoding revealed the fungal community in four important root herbs. This study provided an important reference for preventing root herbs against fungal and mycotoxin contamination.
10.Treatment of Diabetic Retinopathy with Blood Stasis, Collateral Obstruction, and Qi and Yin Deficiency Syndrome with Tongluo Mingmu Capsules: A Randomized, Double-blind, and Multi-center Phase Ⅲ Clinical Trial
Junxia REN ; Yongzheng WANG ; Xiaofei LIU ; Li SUN ; Libo YANG ; Lie WU ; Fengmei LIAN ; Qiping WEI ; Lijuan WEI ; Jingsheng YU ; Jianke HAN
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(7):170-178
ObjectiveTo evaluate the clinical efficacy and safety of Tongluo Mingmu capsules in the treatment of diabetic retinopathy with blood stasis, collateral obstruction, and Qi and Yin deficiency syndrome. MethodA randomized, double-blind, positive-control, and multi-center clinical trial design method was used. 416 patients with diabetic retinopathy with blood stasis, collateral obstruction, and Qi and Yin deficiency syndrome in four test centers were included (the ratio of the treatment group to the control group was 3∶1). On the basis of standardized hypoglycemic treatment, the treatment group was given both four Tongluo Mingmu capsules and two Calcium Dobesilate capsule agents three times a day, while the control group were given both two Calcium Dobesilate capsules and four Tongluo Mingmu capsule agents three times a day. The course of treatment was 12 weeks. The curative effect of Tongluo Mingmu capsules was evaluated by comparing the comprehensive curative effect of diabetic retinopathy, traditional Chinese medicine(TCM) syndrome score, corrected visual acuity, fundus changes, fundus fluorescence angiography, and other curative effect indexes before and after treatment in the two groups. At the same time, general examination, laboratory examination, and adverse events were performed to evaluate the safety of the drug. ResultThe baseline demographic data and disease characteristics of the treatment group and the control group were balanced and comparable, with the difference not statistically significant. After 12 weeks of treatment, the total effective rate of the comprehensive curative effect of diabetic retinopathy in the treatment group (61.0%, 189/310) was better than that in the control group (44.1%, 45/102), and the difference was statistically significant (χ2=8.880, P<0.01). The total effective rate of TCM syndromes in the treatment group (88.4%, 259/293) was better than that in the control group (69.9%, 65/93), and the difference was statistically significant (χ2=17.927, P<0.01). The disappearance rate of dry eyes (χ2=8.305), dull complexion (χ2=4.053), lassitude (χ2=10.267), shortness of breath (χ2=8.494), and dry stool (χ2=8.657) in the treatment group was higher than that in the control group, and the difference between the groups was statistically significant (P<0.05, P<0.01). In terms of improving corrected visual acuity (χ2=8.382), fundus changes (χ2=6.026) , the treatment group was significantly better than the control group (P<0.05). During the trial, the incidence of adverse events in the treatment group and the control group was 1.3% and 2.9%, respectively. There was no significant difference between the two groups. In addition, there were no serious adverse events and adverse events leading to withdrawal in both groups. ConclusionTongluo Mingmu capsules can improve the comprehensive curative effect of diabetic retinopathy and enhance the efficacy of TCM syndromes, visual acuity, fundus changes, and fundus fluorescein angiography, with great safety. Therefore, it can provide a new alternative therapeutic drug for patients with diabetic retinopathy.

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