1.Quality Evaluation of Zhuye Shigao Granules and Its Therapeutic Effect on Mice with Cold-dampness Pestilence Attacking Lung Syndrome
Haihong LI ; Jiaqi SHEN ; Liwen LIANG ; Ziqi YANG ; Yuting YANG ; Shuyun LIANG ; Zhiliang SUN ; Jiannan LI ; Guangzhi CAI ; Jiyu GONG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(15):182-190
		                        		
		                        			
		                        			ObjectiveTo establish a quality evaluation method for Zhuye Shigao granules(Zhuye Shigaotang) based on fingerprint and determination of index components, and to investigate the therapeutic effect of Zhuye Shigao granules on mice with cold-dampness pestilence attacking lung syndrome. MethodsThe fingerprint of Zhuye Shigao granules was established by high performance liquid chromatography(HPLC), and the methods for determination of total calcium, orientin, isoorientin, ginsenosides Rg1, Re and Rb1 and other 2 index components were established. Fifty ICR mice were randomly divided into the blank group, model group, Zhuye Shigao granules low, medium and high dose groups(9.3, 18.6, 37.2 g·kg-1·d-1), with 10 mice in each group. In addition to the blank group, the model mice with cold-dampness pestilence attacking lung syndrome was prepared by nasal drip of lipopolysaccharide combined with cold-dampness environment. Each administration group was given the corresponding liquid by gavage according to the dose, while the blank group and model group were given the same volume of normal saline by gavage. Then, the body temperature and organ index of mice in each group were measured, hematoxylin-eosin(HE) staining was used to investigate the lung tissue injury of mice in each group, and enzyme-linked immunosorbent assay(ELISA) was used to detect the changes of tumor necrosis factor-α(TNF-α), interleukin(IL)-lβ, IL-6, IL-10 levels in serum and lung tissue, as well as immunoglobulin(Ig)A and IgM levels in serum. ResultsThe fingerprint similarity of 10 batches of Zhuye Shigao granules was>0.950, and 20 common peaks were calibrated. Seven of them were identified, including peak 11(isoorientin), peak 12(orientin), peak 14(apioside liquiritin), peak 15(liquiritin), peak 17(apioside isoliquiritin), peak 19(isoliquiritin) and peak 20(liquiritigenin). The results of quantitative analysis showed that the content range of each index component in 10 batches of Zhuye Shigao granules was as follows:Total calcium of 9.978-11.294 mg·g-1, isoorientin of 0.033-0.041 mg·g-1, orientin of 0.046-0.055 mg·g-1, ginsenoside Rg1+ginsenoside Re of 0.748-0.762 mg·g-1, ginsenoside Rb1 of 0.151-0.197 mg·g-1, liquiritin of 1.106-1.366 mg·g-1, glycyrrhizic acid of 0.904-1.182 mg·g-1. Compared with the blank group, the body temperature of mice in the model group was significantly increased, the organ indexes of liver, lung and spleen were significantly decreased, the organ index of thymus was significantly increased, HE staining of lung tissue showed infiltration of inflammatory cells, a small amount of serous exudation was observed in the alveoli, and lung tissue was damaged. After the intervention of Zhuye Shigao granules, the pathological changes were improved compared with the model group. The expression levels of IL-1β, IL-6 and TNF-α were significantly increased, the expression level of IL-10 was significantly decreased in serum and lung tissue. The levels of IgA and IgM in serum were significantly decreased(P<0.01). Compared with the model group, the body temperature, the organ indexes and immune factor levels in serum and lung tissue of mice in the Zhuye Shigao granules medium and high dose groups were significantly reduced(P<0.05, P<0.01). ConclusionIn this study, the quality evaluation of Zhuye Shigao granules was carried out based on fingerprint combined with determination of index components, and the fingerprint of four herbs(Lophatheri Herba, Ophiopogonis Radix, Pinelliae Rhizoma and Glycyrrhizae Radix et Rhizoma) in this formula and the determination of 8 index components were established. The therapeutic effect of Zhuye Shigao granules on mice with cold-dampness pestilence attacking lung syndrome may be related to inhibiting inflammatory response and mediating immune regulation. 
		                        		
		                        		
		                        		
		                        	
2.Research advances in nonconvulsive status epilepticus
Journal of Apoplexy and Nervous Diseases 2025;42(8):711-717
		                        		
		                        			
		                        			Nonconvulsive status epilepticus (NCSE) is a state of persistent epileptic seizure characterized by disturbance of consciousness or major neurological deficits, without obvious limb convulsions. Due to a lack of obvious clinical manifestations and the potential risk of neurological damage, current research focuses on rapid identification, accurate classification, and optimization of treatment strategies. Since there is a lack of obvious motor symptoms in NCSE, it is difficult for clinicians to quickly identify the disease through traditional signs, which poses great challenges to diagnosis, and underdiagnosis may lead to delayed treatment and poor prognosis. This article systematically reviews the epidemiological characteristics, clinical manifestations, and key diagnostic points of NCSE and discusses existing treatment regimens and prognosis, in order to provide a reference for clinical practice.
		                        		
		                        		
		                        		
		                        			Diagnosis
		                        			
		                        		
		                        	
3.Exploring Academic Characteristics of Contemporary Experts and Schools in Traditional Chinese Medicine Gynecology in Treating Endometriosis Diseases Based on SrTO
Zhiran LI ; Xiaojun BU ; Xiaodan WANG ; Le ZHANG ; Ruixue LIU ; Jingyu REN ; Xing LIAO ; Weiwei SUN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):249-259
		                        		
		                        			
		                        			ObjectiveStarting from the etiology, pathogenesis, and treatment strategies of endometriosis and adenomyosis, to integrate and sort out the academic characteristics of contemporary renowned experts and schools in the field of traditional Chinese medicine gynecology. MethodsAccording to the systematic review of text and opinion (SrTO) process developed by the Joanna Briggs Institute (JBI) in Australia, this paper determined literature screening criteria by searching China National Knowledge Infrastructure (CNKI), VIP, Wanfang, and China Biomedical Literature Database. Information was extracted after literature screening, and quality evaluation was conducted using the JBI Narrative, Text, and Opinion Systematic Review Strict Evaluation Checklist. The JBI Narrative, Opinion, Text Evaluation, and Review Tool Summary Table was used for information synthesis, and data analysis and display were conducted in the form of text and charts. ResultsThe 146 articles related to 39 renowned experts and 19 articles related to 10 schools of thought were included. Research has found that contemporary experts and schools in traditional Chinese medicine gynecology consider blood stasis as the core pathogenesis in understanding the etiology and pathogenesis of two diseases and related infertility. Their viewpoints varied from multiple aspects such as clinical symptom characteristics, meridian circulation location, pathological product evolution, disease duration, emotional psychology, lifestyle habits, preference for food and drink, innate endowment, and acquired injury. In terms of treatment, it was advocated to divide the stage, treat according to different types, adapt to the times, integrate nature and humans, and combine multiple methods to treat comprehensively when necessary. It was also recommended to skillfully use insects, make good use of classic formulas and small prescriptions, pay attention to protecting the spleen and stomach and regulating emotions, and make good use of self-formulated empirical formulas for internal or external use. Besides, individualized long-term management of patients was also advocated. ConclusionThis study applies the SrTO process to systematically summarize the academic ideas of contemporary renowned experts and schools in traditional Chinese medicine gynecology regarding the causes, mechanisms, diagnosis, and treatments of endometriosis, providing a scientific and standardized reference for future theoretical exploration. 
		                        		
		                        		
		                        		
		                        	
4.Role of acetylation modification in the occurrence and development of thyroid cancer and its potential clinical application value
Chinese Journal of Cancer Biotherapy 2025;32(1):30-37
		                        		
		                        			
		                        			[摘  要]  甲状腺癌是内分泌系统中最为常见的恶性肿瘤,近年来其发病率呈现出显著的上升趋势。乙酰化修饰作为一种重要的蛋白质翻译后修饰,参与调控各个类型甲状腺癌相关基因的转录表达、细胞周期进程及侵袭能力。组蛋白去乙酰化酶(HDAC)抑制剂在甲状腺癌治疗中显示出潜在的应用前景。本文通过调研近年来相关文献,系统回顾了乙酰化修饰在参与甲状腺癌发生发展过程中的生物学功能及其调控机制,进一步探讨HDAC抑制剂在临床治疗中的应用前景,为甲状腺癌的靶向治疗提供坚实的理论依据和提出可行的治疗策略。
		                        		
		                        		
		                        		
		                        	
5.Effects and mechanism of paeoniflorin on oxidative stress of ulcerative colitis mice
Xin DAI ; Ying WANG ; Xinyue REN ; Dingxing FAN ; Xianzhe LI ; Jiaxuan FENG ; Shilei LOU ; Hui YAN ; Cong SUN
China Pharmacy 2025;36(4):427-433
		                        		
		                        			
		                        			OBJECTIVE To investigate the effects and potential mechanism of paeoniflorin on oxidative stress of ulcerative colitis (UC) mice based on adenosine monophosphate-activated protein kinase (AMPK)/nuclear factor-erythroid 2-related factor 2 (Nrf2) pathway. METHODS Male BALB/c mice were randomly divided into control group, model group, inhibitor group (AMPK inhibitor Compound C 20 mg/kg), paeoniflorin low-, medium- and high-dose groups (paeoniflorin 12.5, 25, 50 mg/kg), high- dose of paeoniflorin+inhibitor group (paeoniflorin 50 mg/kg+Compound C 20 mg/kg), with 8 mice in each group. Except for the control group, mice in all other groups were given 4% dextran sulfate sodium solution for 5 days to establish the UC model. Subsequently, mice in each drug group were given the corresponding drug solution intragastrically or intraperitoneally, once a day, for 7 consecutive days. The changes in body weight of mice were recorded during the experiment. Twenty-four hours after the last administration, colon length, malondialdehyde (MDA) content, and activities of superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) in colon tissues were measured; histopathological morphology of colon tissues, tight junctions between intestinal epithelial cells, and histopathological scoring were all observed and evaluated; the mRNA expressions of AMPK and Nrf2, as well as the protein expressions of heme oxygenase-1(HO-1), occludin and claudin-1, were all determined in colon tissue. RESULTS Compared with model group, paeoniflorin groups exhibited recovery from pathological changes such as inflammatory cell infiltration and crypt damage in the colon tissue, as well as improved tight junction damage between intestinal epithelial cells. Additionally, significant increases or upregulations were observed in body weight, colon length, activities of SOD and GSH-Px, phosphorylation level of AMPK, and protein expression of Nrf2, HO-1, occludin, claudin-1, and mRNA expressions of AMPK and Nrf2; concurrently, MDA content and histopathological scores were significantly reduced (P< 0.05 or P<0.01). In contrast, the inhibitor group showed comparable (P>0.05) or worse (P<0.05 or P<0.01) indicators compared to the model group. Conversely, the addition of AMPK inhibitor could significantly reverse the improvement of high- dose paconiflorin (P<0.01). CONCLUSIONS Paeoniflorin can repair intestinal epithelial cell damage in mice, improve tight junctions between epithelial cells, upregulate the expression of related proteins, and promote the expression and secretion of antioxidant-promoting molecules, thereby ameliorating UC; its mechanism may be associated with activating AMPK/Nrf2 antioxidant pathway.
		                        		
		                        		
		                        		
		                        	
6.Construction of Tax-PC/SDC/PVP-K30 micelles and their protective effect on alcoholic liver injury
Shi-yu ZHANG ; Jing-meng SUN ; Dong-dong LI ; Xin ZHANG ; Jia-hui ZHANG ; Wei-yu ZHANG
Acta Pharmaceutica Sinica 2025;60(2):488-497
		                        		
		                        			
		                        			 Taxifolin (Tax) has been proved to be a medicinal edible substance with protective effects against alcoholic liver injury, however, its poor hydrophilicity and permeability have hindered the clinical application of Tax. In this study, we prepared taxifolin-phosphatidylcholine/sodium deoxycholate/PVP-K30 micells (Tax-MLs). Box-Behnken test was used to obtain the optimal preparation process, and Tax-MLs were characterised by transmission electron microscopy and fourier transform infrared spectroscopy. Physicochemical parameters such as proximate micelle concentration, equilibrium solubility and oil-water partition coefficient were determined, and the release pattern of Tax-MLs was investigated by 
		                        		
		                        	
7.Mechanism of Modified Shengjiangsan in Improving Diabetic Kidney Disease by Activating Mitochondrial Autophagy Based on PINK1/Parkin Signaling Pathway
Jiaxin LI ; Liya ZHOU ; Yishuo ZHANG ; Ziqiang CHEN ; Yijun HOU ; Jian SUN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):121-128
		                        		
		                        			
		                        			ObjectiveTo investigate the mechanism by which modified Shengjiangsan (MSJS) improves diabetic kidney disease (DKD) by activating mitochondrial autophagy. MethodsSixty SPF-grade male Sprague-Dawley rats aged 7-8 weeks were selected. A DKD model was established using a high-sugar, high-fat diet combined with intraperitoneal injection of streptozotocin (STZ). After successful modeling, the rats were randomly divided into six groups: a normal control group, a model group, low-, medium-, and high-dose MSJS groups (7.7, 15.4, 30.8 g·kg-1, respectively), and an irbesartan group (0.384 g·kg-1). Each group received either normal saline or the corresponding drug by gavage once daily for 28 consecutive days. Blood glucose, body weight, and kidney weight were recorded. Serum creatinine (SCr) and blood urea nitrogen (BUN) levels were detected using an automatic blood analyzer. Enzyme-linked immunosorbent assay (ELISA) was used to determine urinary microalbumin (mALB), and serum levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6). Histopathological changes in renal tissues were observed using hematoxylin-eosin (HE) staining, periodic acid-Schiff (PAS) staining, and transmission electron microscopy (TEM). The expression levels of mitochondrial autophagy-related proteins in renal tissues were analyzed by Western blot. Immunofluorescence co-localization was employed to detect the co-expression of microtubule-associated protein 1 light chain 3 beta (LC3B) and cytochrome c oxidase subunit Ⅳ (COX Ⅳ). ResultsCompared with the normal control group, the model group exhibited significant increases in renal index, blood glucose, and 24-hour urinary microalbumin (24 h mALB) (P<0.05, P<0.01). The levels of serum SCr and BUN were significantly elevated (P<0.01), and the serum levels of TNF-α, IL-1β, and IL-6 were markedly upregulated (P<0.01). Histopathological examination revealed glomerular hypertrophy, mesangial expansion and increased deposition, podocyte foot process flattening and fusion, a decreased number of autophagosomes accompanied by mitochondrial swelling, vacuolar degeneration of renal tubular epithelial cells, and inflammatory cell infiltration in the renal interstitium. The expression levels of autophagy-related proteins LC3B, PTEN-induced putative kinase 1 (PINK1), and E3 ubiquitin-protein ligase (Parkin) were significantly decreased (P<0.05, P<0.01), while expression of the selective autophagy adaptor protein p62 was significantly increased (P<0.01). Immunofluorescence signal intensity and LC3B-COX Ⅳ co-expression were both diminished. Compared with the model group, the MSJS treatment groups and the irbesartan group showed significant reductions in renal index, blood glucose, and 24 h mALB (P<0.05, P<0.01). The serum SCr and BUN levels decreased significantly (P<0.05) and TNF-α, IL-1β, and IL-6 levels were significantly downregulated (P<0.05, P<0.01). Histopathological damage was alleviated, including reduced glomerular hypertrophy, decreased mesangial deposition, and attenuated podocyte foot process fusion. The number of autophagosomes increased, and mitochondrial swelling was improved. The expression levels of LC3B, PINK1, and Parkin in renal tissues were significantly upregulated, whereas p62 expression was significantly downregulated (P<0.05, P<0.01) in MSJS groups. Immunofluorescence signal intensity was enhanced, and LC3B-COX Ⅳ co-expression was increased. ConclusionMSJS alleviates the inflammatory response in DKD rats and exerts renal protective effects by regulating the PINK1/Parkin signaling pathway and activating mitochondrial autophagy. 
		                        		
		                        		
		                        		
		                        	
8.Mechanism of Modified Shengjiangsan in Improving Diabetic Kidney Disease by Activating Mitochondrial Autophagy Based on PINK1/Parkin Signaling Pathway
Jiaxin LI ; Liya ZHOU ; Yishuo ZHANG ; Ziqiang CHEN ; Yijun HOU ; Jian SUN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):121-128
		                        		
		                        			
		                        			ObjectiveTo investigate the mechanism by which modified Shengjiangsan (MSJS) improves diabetic kidney disease (DKD) by activating mitochondrial autophagy. MethodsSixty SPF-grade male Sprague-Dawley rats aged 7-8 weeks were selected. A DKD model was established using a high-sugar, high-fat diet combined with intraperitoneal injection of streptozotocin (STZ). After successful modeling, the rats were randomly divided into six groups: a normal control group, a model group, low-, medium-, and high-dose MSJS groups (7.7, 15.4, 30.8 g·kg-1, respectively), and an irbesartan group (0.384 g·kg-1). Each group received either normal saline or the corresponding drug by gavage once daily for 28 consecutive days. Blood glucose, body weight, and kidney weight were recorded. Serum creatinine (SCr) and blood urea nitrogen (BUN) levels were detected using an automatic blood analyzer. Enzyme-linked immunosorbent assay (ELISA) was used to determine urinary microalbumin (mALB), and serum levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6). Histopathological changes in renal tissues were observed using hematoxylin-eosin (HE) staining, periodic acid-Schiff (PAS) staining, and transmission electron microscopy (TEM). The expression levels of mitochondrial autophagy-related proteins in renal tissues were analyzed by Western blot. Immunofluorescence co-localization was employed to detect the co-expression of microtubule-associated protein 1 light chain 3 beta (LC3B) and cytochrome c oxidase subunit Ⅳ (COX Ⅳ). ResultsCompared with the normal control group, the model group exhibited significant increases in renal index, blood glucose, and 24-hour urinary microalbumin (24 h mALB) (P<0.05, P<0.01). The levels of serum SCr and BUN were significantly elevated (P<0.01), and the serum levels of TNF-α, IL-1β, and IL-6 were markedly upregulated (P<0.01). Histopathological examination revealed glomerular hypertrophy, mesangial expansion and increased deposition, podocyte foot process flattening and fusion, a decreased number of autophagosomes accompanied by mitochondrial swelling, vacuolar degeneration of renal tubular epithelial cells, and inflammatory cell infiltration in the renal interstitium. The expression levels of autophagy-related proteins LC3B, PTEN-induced putative kinase 1 (PINK1), and E3 ubiquitin-protein ligase (Parkin) were significantly decreased (P<0.05, P<0.01), while expression of the selective autophagy adaptor protein p62 was significantly increased (P<0.01). Immunofluorescence signal intensity and LC3B-COX Ⅳ co-expression were both diminished. Compared with the model group, the MSJS treatment groups and the irbesartan group showed significant reductions in renal index, blood glucose, and 24 h mALB (P<0.05, P<0.01). The serum SCr and BUN levels decreased significantly (P<0.05) and TNF-α, IL-1β, and IL-6 levels were significantly downregulated (P<0.05, P<0.01). Histopathological damage was alleviated, including reduced glomerular hypertrophy, decreased mesangial deposition, and attenuated podocyte foot process fusion. The number of autophagosomes increased, and mitochondrial swelling was improved. The expression levels of LC3B, PINK1, and Parkin in renal tissues were significantly upregulated, whereas p62 expression was significantly downregulated (P<0.05, P<0.01) in MSJS groups. Immunofluorescence signal intensity was enhanced, and LC3B-COX Ⅳ co-expression was increased. ConclusionMSJS alleviates the inflammatory response in DKD rats and exerts renal protective effects by regulating the PINK1/Parkin signaling pathway and activating mitochondrial autophagy. 
		                        		
		                        		
		                        		
		                        	
9.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
		                        		
		                        			
		                        			Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
		                        		
		                        		
		                        		
		                        	
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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