1.Pathogenesis of Chronic Obstructive Pulmonary Disease and Modulating Effect of Traditional Chinese Medicine: A Review
Jiyu ZOU ; Tianjiao WANG ; Ningzi ZANG ; Yongming LIU ; Lijian PANG ; Linlin WANG ; Xiaodong LYU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):287-298
Chronic obstructive pulmonary disease (COPD), as a chronic respiratory disease that can be prevented and intervened but cannot be completely cured, has increasing incidence and mortality rates year by year, often complicated by one or more comorbidities. However, there is currently no specific treatment available. Therefore, the healthcare issues related to COPD are urgent and prominent. Traditional Chinese medicine (TCM) delays the progression of COPD through multiple mechanisms, pathways, and targets. As a result, exploring the pathogenesis of COPD and identifying TCM treatment approaches and effective prescriptions are key issues that urgently need to be addressed in clinical practice. In TCM, COPD is categorized into syndromes such as "cough", "asthma", and "lung distension". It is believed that the deficiency in the origin runs through the entire disease. When external pathogens invade, Qi becomes disordered, and phlegm and blood stasis begin to accumulate, leading to an excess condition in the manifestation. Modern medicine research on the pathogenesis of COPD mainly involves aspects such as inflammatory response, oxidative stress, autophagy imbalance, and aging. Studies have found that Chinese medicine monomers, single herbs, and compound prescriptions can improve COPD by inhibiting inflammation, reducing oxidative damage, correcting autophagy, and delaying aging. However, there is no study that intuitively organizes the various pathogenesis mechanisms of COPD and their interrelationships. At the same time, research on the therapeutic effects of TCM on COPD primarily focuses on exploring a single mechanism or pathway, without integrating multiple mechanisms, pathways, and targets. Additionally, there are very few studies that summarize the corresponding relationships between the various pathogenesis mechanisms of COPD and the regulatory effects and signaling pathways of Chinese medicine. This study, for the first time, combines the latest literature in China and abroad to explain the various pathogenesis mechanisms of COPD and their interrelationships using a combination of graphs, text, and tables. It also outlines the signaling pathways, targets, and mechanisms of Chinese medicine monomers, single herbs, and compound prescriptions in regulating COPD, in order to provide new ideas and strategies for the in-depth research and systematic treatment of COPD with TCM.
2.Clinical Observation of Modified Zhigancao Tang in Treating Patients with Liver and Kidney Deficiency of Parkinson's Disease and Its Effect on Neuronal Signal-related Proteins
Yifo WEI ; Furong LYU ; Jia YAO ; Guonian LI ; Xianyi LUO ; Meng LUO ; Zhengzheng WEN ; Qiuqi LI ; Yihan LIU ; Linlin YANG ; Rui ZUO ; Wenxin DANG ; Fang MI ; Xiaoyan WANG ; Zhigang CHEN ; Fan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):166-173
ObjectiveMicrotube associated protein-2 (MAP-2), alpha-tubulin (α-tubulin), and synaptophysin (SYP) are important proteins in neuronal signal communication. This paper observed the effects of modified Zhigancao Tang on the expression of serum α-Synuclein (α-Syn) and its oligomers, MAP-2, α-tubulin, and SYP of patients with liver and kidney deficiency of Parkinson's disease (PD), analyzed their correlation, and evaluated the therapeutic effect of modified Zhigancao Tang in patients with liver and kidney deficiency of PD based on α-Syn transmission pathway mediated by neuronal communication in vivo. MethodsA total of 60 patients with PD who met the inclusion criteria were randomly divided into a treatment group (30 cases) and a control group (30 cases). Both groups were treated on the basis of PD medicine, and the treatment group was treated with modified Zhigancao Tang. Both groups were treated for 12 weeks. The changes in UPDRS score, TCM syndrome score, and expression of serum α-Syn and its oligomers, MAP-2, α-tubulin, and SYP were observed before and after 12 weeks of treatment in each group. The correlation between the above-mentioned serum biological indexes and the levels of serum α-Syn and its oligomers was analyzed. ResultsAfter treatment, the TCM syndrome score, UPDRS score, UPDRS-Ⅱ score, and UPDRS-Ⅲ score of the treatment group were significantly decreased (P<0.05, P<0.01). The UPDRS score, UPDRS-Ⅱ score, and UPDRS-Ⅲ scores in the treatment group were significantly decreased compared with those in the control group after treatment (P<0.05). After treatment, the total effective rate of the control group was 63.3% (19/30), and that of the treatment group was 86.7% (26/30). The clinical effect of the observation group was better than the control group (Z=-2.03, P<0.05). The total effective rate of the observation group was better than that of the control group, and the difference was statistically significant (χ2=5.136, P<0.05). After treatment, the oligomer level of serum α-Syn and MAP-2 level in the treatment group were significantly decreased (P<0.05, P<0.01). The levels of serum α-Syn and its oligomers, as well as α-tubulin in the treatment group, were significantly decreased compared with those in the control group after treatment (P<0.05, P<0.01). Serum α-Syn was correlated with serum MAP-2 and α-Syn oligomer in patients with PD (P<0.05, P<0.01) but not correlated with serum SYP . Serum α-Syn oligomers of patients with PD were correlated with serum MAP-2 and α-tubulin (P<0.05, P<0.01) but not correlated with serum SYP level. Serum SYP of patients with PD was correlated with serum MAP-2 (P<0.05). ConclusionModified Zhigancao Tang has a therapeutic effect on patients with liver and kidney deficiency of PD by inhibiting the production of α-Syn oligomers and intervening α-Syn microtubule transport pathway in vivo.
3.Study on the synergistic antifungal effects of caspofungin acetate loaded glyceryl monostearate nanoparticle on Candida albicans
Lingyi GUO ; Yanchao LIU ; Lu GAO ; Ruiyao LIU ; Quanzhen LYU ; Yuan YU
Journal of Pharmaceutical Practice and Service 2025;43(3):136-142
Objective To prepare and characterize caspofungin acetate-loaded solid lipid nanoparticles using glycerol monostearate (CAS-SLNs), and investigate the antifungal effect of potentiation on Candida albicans in vitro and in vivo. Methods A high performance liquid chromatography method was established for the determination of caspofungin acetate (CAS). CAS-SLNs were prepared by the melt-emulsification method and characterized. The minimum inhibitory concentration (MIC) and the inhibitory effect on Candida albicans biofilm were determined. A systemic infection model of Candida albicans was established in mice, and the growth curve models for body weight and fungal load of kidneys of the animals were investigated after intravenous infection. Results The retention time of CAS was 6.8 min. The calibration curve showed good linearity, and the precision and stability met the requirements of the assay. Transmission electron microscopy revealed that CAS-SLNs were spherical, with a particle size of (135.97±1.73) nm. The Zeta potential was (19.33±0.37) mV, drug loading was (7.55±0.68)%, and encapsulation efficiency was (67.71±1.74)%. CAS-SLNs showed significant in vitro antifungal inhibition with a MIC of 9.78×10−4 g/ml, which was significantly better than CAS group and the physical mixture group of CAS and GMS, as well as the same biofilm inhibition was observed (P<0.001). Pharmacodynamic studies demonstrated that CAS-SLNs maintained stable body weight gain compared to the control (P<0.01) and CAS groups in Candida albicans invasive infection model, and that CAS-SLNs significantly reduced renal fungal burden load relative to the CAS group (P<0.05). In vivo study revealed that a stable body weight was maintained in CAS-SLNs group compared to the control group (P<0.01) in Candida albicans invasive infection model. CAS-SLNs also significantly reduced renal fungal load compared to the CAS group (P<0.05). Conclusion CAS-SLNs significantly enhanced the antifungal effects of CAS in vitro and in vivo, which provided a valuable insight for the research of new formulation of CAS.
4.Characteristics of PRR-derived exosomes and the proliferation abilities of HMEC-1 and BJ under different activation conditions: a comparative study
Lilan GAO ; Mengxing LYU ; Jianxiang LIU ; Meikun HU ; Xiaohong JIN ; Kexuan QU
Chinese Journal of Blood Transfusion 2025;38(3):343-351
[Objective] To compare the characteristics of platelet-rich plasma derived exosomes (PRP-Exos) under different activation conditions and their differential effects on the proliferation capacit of human microvascular endothelial cells (HMEC-1) and human skin fibroblasts (BJ). [Methods] Ten healthy volunteers were recruited, and 10 mL of venous blood anticoagulated with EDTA-K
5.Mechanism of Congrong Zonggan Capsules in Improving Neuroinflammation and Cognitive Impairment in 5×FAD Mice Based on NF-κB/NLRP3 Signaling Pathway
Yanru ZHOU ; Xinru GU ; Yuru LIU ; Shun ZHANG ; Yaozhong LYU ; Zhenzhong WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(10):130-138
ObjectiveTo investigate the effects of Congrong Zonggan capsules (CRZG) on cognitive impairment in the Alzheimer's disease (AD) model of mice and its related mechanisms. MethodsSPF grade 4-week-old 5×FAD mice were divided into a model group, low-dose CRZG (0.819 g·kg-1) and high-dose CRZG (1.638 g·kg-1) groups, and Donepezilepezil hydrochloride group (2 mg·kg-1), with eight mice in each group. Eight C57 mice with the same background were set as the normal group. After one week of adaptive feeding, mice were orally administered continuously for six months. On the 5th month of drug administration, Y maze, new object recognition, and Morris water maze tests were conducted separately. After administration, mouse brain tissue was taken, and the levels of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) in brain tissue were detected by enzyme-linked immunosorbent assay (ELISA). Immunofluorescence (IF) was used to detect the expression of small glial cell markers Iba1, astrocyte markers GFAP, and amyloid protein 1-42 (Aβ1-42) in the hippocampus of the brain tissue. The hematoxylin-eosin (HE) staining was used to detect pathological changes in the hippocampus of brain tissue. Western blot was used to detect the expression of nuclear factor-κB (NF-κB) p65, NOD-like receptor protein 3 (NLRP3), cleaved Caspase-1, apoptosis-associated speck-like protein containing a CARD (ASC), and other proteins in the brain tissue. ResultsCompared with those in the normal group, the mice in the model group had obvious cognitive impairment. The spontaneous alternation rate of the Y maze was decreased, and the discrimination index of novel object recognition was decreased significantly (P<0.01). The escape latency in the water maze was shortened significantly (P<0.01). The contents of IL-6 and TNF-α in brain tissue were increased. The fluorescence levels of Iba1 and Aβ1-42 in the hippocampus were significantly increased (P<0.01). There was a significant increase in neuronal lesions, neuronal atrophy, loose arrangement of tissue structure, and abnormal erythrocyte aggregation in the hippocampus. The protein expressions of p-NF-κB p65/NF-κB p65, cleaved Caspase-1, ASC, IL-6, and IL-1β were significantly increased (P<0.05, P<0.01). Compared with the model group, the spontaneous alternation rate and discrimination index of the high-dose CRZG group were increased significantly (P<0.01), and the escape latency was shortened significantly (P<0.05, P<0.01). The content of IL-6 decreased in the brain, and that of TNF-α dropped significantly (P<0.01). The expression of Iba1 protein and Aβ1-42 in the hippocampus decreased significantly (P<0.05, P<0.01). The hippocampal neurons were densely arranged, and the pyramidal nuclei were clear and centered. The abnormal aggregation of red blood cells was alleviated. The value of p-NF-κB/NF-κB proteins and the expression of ASC, cleaved Caspase-1, IL-6, and IL-1β were significantly decreased (P<0.05, P<0.01). ConclusionCRZG can effectively improve cognitive impairment in 5×FAD mice with Alzheimer's disease, and its mechanism may be related to the regulation of the NF-κB/NLRP3 pathway to reduce the abnormal activation of microglia and inhibit neuroinflammation.
6.Mechanism of joint injection of Caulophyllum robustum Maxim in the treatment of rheumatoid arthritis
Shaowa LYU ; Yunyu WU ; Quanli LIU ; Yuhan REN ; Yuyan GUO ; Haixue KUANG
China Pharmacy 2025;36(8):926-931
OBJECTIVE To explore the mechanism of joint injection of Caulophyllum robustum Maxim in the treatment of rheumatoid arthritis (RA). METHODS The targets of main saponins in C. robustum Maxim were obtained from Swiss Target Prediction, and the RA treatment targets collected from the GeneCards and OMIM database were intercrossed to establish an interaction network based on network pharmacology. Gene ontology analysis and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway analysis were performed. RA model was established by injecting complete Freund’s adjuvant into the back of rabbits for verification. The arthritis index score, knee diameter and pain threshold of rabbits were compared. Pathological examination of rabbit synovial tissue was carried out. The levels of tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β) and IL-6 in rabbit serum and synovial fluid were detected. The phosphorylation levels of tyrosine protein Janus kinase 2 (JAK2) and signal transducer and activator of transcription 3 (STAT3) proteins in rabbit synovium were detected. RESULTS Network pharmacology identified 143 intersection targets between the drug and RA. After the construction of the “drug-component-target” network, the core components of the network were echinocystic acid, oleanolic acid, hederagenin, cauloside A and cauloside C, etc. Additionally, the top 10 core targets of PPI network were SRC, STAT3, MAPK1, EGFR, PIK3CA, MAPK3, GRB2, JUN, PTPN11 and JAK2. The results of KEGG pathway analysis showed that the JAK/STAT signaling pathway was mainly involved in the treatment of RA by joint injection of C. robustum Maxim. Results of validation test showed that compared with model group, joint injection of C. robustum Maxim could reduce the swelling of rabbit knee joint, relieve the hyperplasia of synovial layer, reduce the hyperplasia of lower connective tissue, and reduce the number of inflammatory cells and capillaries. The arthritis index score (excluding low-dose group of C. robustum Maxim), knee diameter, the levels of TNF-α, IL-1β and IL-6 in serum and synovial fluid, and the protein phosphorylation levels of JAK2 and STAT3 were decreased significantly (P<0.05 of P<0.01), while the pain threshold were reduced significantly (P<0.01). CONCLUSIONS The core components that may alleviate the inflammatory response of RA in joint injection of C. robustum Maxim could include echinocystic acid, oleanolic acid, hederagenin, cauloside A, and cauloside C. Its mechanism may be related to the inhibition of JAK/STAT signaling pathway and the reduction of inflammatory responses.
7.Mechanism of Tangbikang Dry Paste in Prevention and Treatment of Type 2 Diabetic Peripheral Neuropathy Based on GLO-1/AGE/RAGE Pathway
Lijia WU ; Chengfei ZHANG ; Xiaolei JIA ; Lingling QIN ; Haiyan WANG ; Yukun HUANG ; You WANG ; Xincui BAO ; Jing YANG ; Cuiyan LYU ; Tonghua LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):60-69
ObjectiveTo investigate the mechanism of Tangbikang dry paste in the prevention and treatment of type 2 diabetic peripheral neuropathy (DPN) based on the glyoxalase-1 (GLO-1)/advanced glycation end products (AGE)/receptor for advanced glycation end products (RAGE) pathway. MethodsA total of 56 Sprague-Dawley rats were randomly divided, with eight assigned to the normal group. The remaining 48 rats were fed a high-fat diet combined with intraperitoneal injection of streptozotocin (STZ) to induce a type 2 diabetes mellitus (T2DM) model. Based on blood glucose levels, the rats were randomly assigned to the model group, Tanglin group (13.5 mg·kg-1), metformin group (135 mg·kg-1), and Tangbikang dry paste low-, medium-, and high-dose groups (3, 6, 12 g·kg-1). Successful modeling of DPN was confirmed by a decrease in mechanical pain threshold in the model group at week 4. Fasting blood glucose, body weight, and mechanical pain threshold were measured every 4 weeks. After 16 weeks of intervention, the pathological morphology of the sciatic nerve was observed using hematoxylin-eosin (HE) staining. The expression of RAGE, AGE, protein kinase C (PKC), and collagen (COL) in the sciatic nerve was assessed by immunohistochemistry. The mRNA expression of RAGE, PKC, Toll-like receptor (TLR), COL, and GLO-1 was detected using real-time quantitative PCR (Real-time PCR). Serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine (CREA), urea (UREA), interleukin-6 (IL-6), and tumor necrosis factor (TNF)-α were measured by enzyme-linked immunosorbent assay (ELISA). ResultsCompared with the normal group, the model group showed significantly increased fasting blood glucose (P<0.01), decreased body weight and mechanical pain threshold (P<0.01), and elevated serum AST, ALT, CREA, UREA, IL-6, and TNF-α levels (P<0.01). The expression of RAGE, AGE, and PKC in the sciatic nerve was significantly increased (P<0.01), while COL expression was decreased (P<0.01). The mRNA expression of TLR, RAGE, and PKC was upregulated (P<0.01), whereas COL and GLO-1 mRNA levels were downregulated (P<0.01). Histological examination showed irregular nerve morphology, axonal alterations, and myelin degeneration. Compared with the model group, fasting blood glucose levels in the Tangbikang dry paste high-dose group at all time points and in the medium-dose group at weeks 4 and 16 were significantly reduced (P<0.05, P<0.01). No significant changes in body weight were observed across all Tangbikang dose groups. The mechanical pain threshold was elevated at different time points after administration in all Tangbikang groups (P<0.05, P<0.01). Serum IL-6 and TNF-α levels were decreased in all dose groups (P<0.05, P<0.01). The expression of RAGE, AGE, and PKC in the sciatic nerve was reduced (P<0.01), while COL expression was increased (P<0.01). The mRNA expression of TLR, RAGE, and PKC was downregulated (P<0.01), whereas GLO-1 mRNA expression was upregulated (P<0.05, P<0.01). Additionally, COL mRNA expression was significantly increased in the low- and high-dose groups (P<0.01). Pathological changes in the sciatic nerve were milder in all Tangbikang groups compared to the model group. ConclusionTangbikang dry paste significantly improves DPN, and its mechanism may be associated with the regulation of the GLO-1/AGE/RAGE signaling pathway.
8.Traditional Chinese Medicine Intervention in Diabetic Nephropathy Based on PI3K/Akt Signaling Pathway: A Review
Miao XU ; Xiaolei JIA ; Lingling QIN ; Haiyan WANG ; You WANG ; Yuzhuo CHANG ; Cuiyan LYU ; Tonghua LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):90-97
Diabetic nephropathy (DN) is a renal disorder induced by prolonged hyperglycemia, with major pathological features including persistent albuminuria, progressive decline in glomerular filtration rate, and elevated arterial blood pressure. As one of the most common and severe microvascular complications of diabetes, the pathogenesis of DN is complex and multifactorial. Without timely and effective treatment, DN may eventually progress to end-stage renal disease (ESRD). Currently available therapeutic options are often associated with significant adverse effects and high costs, and a large number of patients still progress to ESRD due to delayed treatment. Therefore, there is an urgent need for safer and more effective treatment strategies to improve the living standards and enhance the survival and quality of life of patients with DN. Modern studies have demonstrated that the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt) signaling pathway plays a critical role in oxidative stress, inflammatory responses, autophagy, and glycolysis, and is closely associated with the pathophysiological progression of DN. In recent years, traditional Chinese medicine (TCM) has achieved remarkable progress in the prevention and treatment of DN, supported by rich clinical experience and confirmed therapeutic efficacy. With its characteristics of multi-target, multi-component, and multi-pathway actions, along with minimal side effects, TCM can delay the progression of DN and alleviate patient symptoms. Among these mechanisms, the regulation of the PI3K/Akt signaling pathway has gradually become a research hotspot. This paper systematically reviews the role and mechanisms of the PI3K/Akt signaling pathway in the onset and progression of DN based on extensive literature research, summarizes the latest research advances on the precise modulation of the PI3K/Akt pathway by Chinese medicine monomers, active constituents, Chinese patent medicines, and herbal compound formulas in the treatment of DN, aiming to provide a strong theoretical reference for the development of clinically effective agents for DN prevention and treatment.
9.Analysis of Mechanism of Xingpi Capsules in Treatment of Functional Dyspepsia Based on Transcriptomics
Rongxin ZHU ; Mingyue HUANG ; Keyan WANG ; Xiangning LIU ; Yinglan LYU ; Gang WANG ; Fangfang RUI ; Qiong DENG ; Jianteng DONG ; Yong WANG ; Chun LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):164-172
ObjectiveTo investigate the ameliorative effect of Xingpi capsules on functional dyspepsia(FD) and the potential mechanism. MethodsSixty SPF-grade male SD neonatal rats(7 days old) were randomly divided into the normal group(n=12) and the modeling group(n=48), and the FD model was prepared by iodoacetamide gavage in the modeling group. After the model was successfully prepared, the rats in the modeling group were randomly divided into the model group, the low-dose and high-dose groups of Xingpi capsules(0.135, 0.54 g·kg-1) and the domperidone group(3 mg·kg-1), with 12 rats in each group. Rats in the normal and model groups were gavaged with distilled water, and rats in the rest of the groups were gavaged with the corresponding medicinal solution, once a day for 7 d. The general survival condition of the rats was observed, and the water intake and food intake of the rats were measured, the gastric emptying rate and the small intestinal propulsion rate were measured at the end of the treatment, the pathological damage of the rat duodenum was examined by hematoxylin-eosin(HE) staining, and the expressions of colonic tight junction protein(Occludin) and zonula occludens protein-1(ZO-1) were detected by immunofluorescence. The differentially expressed genes in the duodenal tissues of the model group and the normal group, and the high-dose group of Xingpi capsules and the model group were detected by transcriptome sequencing after the final administration, and Gene Ontology(GO) and Kyoto Encyclopedia of Genes and Genomes(KEGG) enrichment analyses were carried out. The transcriptomic results were validated by Western blot, immunofluorescence, and real-time fluorescence quantitative polymerase chain reaction(Real-time PCR), and the active ingredients of Xingpi capsules were screened for molecular docking with the key targets. ResultsCompared with the normal group, the general survival condition of rats in the model group was poorer, and the water intake, food intake, gastric emptying rate and small intestinal propulsion rate were all significantly reduced(P<0.05), inflammatory infiltration was seen in duodenal pathology, and the fluorescence intensities of Occludin and ZO-1 in the colon were significantly reduced(P<0.01). Compared with the model group, the general survival condition of rats in the high-dose group of Xingpi capsules improved significantly, and the water intake, food intake, gastric emptying rate and small intestinal propulsion rate were all significantly increased(P<0.05), the duodenal pathology showed a decrease in inflammatory infiltration, and the fluorescence intensities of colonic Occludin and ZO-1 were significantly increased(P<0.01). Transcriptomic results showed that Xingpi capsules might exert therapeutic effects by regulating the phosphatidylinositol 3-kinase(PI3K)/protein kinase B(Akt) through the key genes such as Slc5a1, Abhd6. The validation results showed that compared with the normal group, the phosphorylation levels of PI3K and Akt proteins, the protein expression level of interleukin(IL)-1β, and the fluorescence intensities of IL-6 and IL-1β were significantly increased in the model group(P<0.05, P<0.01), and the mRNA levels of Slc5a1, Abhd6, Mgam, Atp1a1, Slc7a8, Cdr2, Chrm3, Slc5a9 and other key genes were significantly increased(P<0.01). Compared with the model group, the phosphorylation levels of PI3K and Akt, the protein expression level of IL-1β and the fluorescence intensities of IL-6 and IL-1β in the high-dose group of Xingpi capsules were significantly reduced(P<0.05, P<0.01), and the mRNA levels of Slc5a1, Abhd6, Mgam, Atp1a1, Slc7a8, Cdr2, Chrm3 and Slc5a9 were significantly reduced(P<0.05). Weighted gene co-expression network analysis and molecular docking results showed that E-nerolidol and Z-nerolidol in Xingpi capsules were well bound to ABDH6 protein, and linarionoside A, valerosidatum and senkirkine were well bound to Slc5a1 protein. ConclusionXingpi capsules can effectively improve the general survival and gastrointestinal motility of FD rats, its specific mechanism may be related to the inhibition of PI3K/Akt signaling pathway to alleviate the low-grade inflammation of duodenum, and E-nerolidol, Z-nerolidol, linarionoside A, valerosidatum and senkirkine may be its key active ingredients.
10.Clinical Randomized Controlled Trial of Traditional Chinese Medicine Compound Shenlong Decoction Granules in Treatment of Idiopathic Pulmonary Fibrosis
Qi SI ; Ningzi ZANG ; Mei WANG ; Weidong ZHENG ; Chuang LIU ; Yongming LIU ; Haoyang ZHANG ; Zhongxue ZHAO ; Jiyu ZOU ; Jingze LI ; Lijian PANG ; Xiaodong LYU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):237-245
ObjectiveTo assess the therapeutic effectiveness and safety of the traditional Chinese medicine compound Shenlong decoction in addressing the symptoms of pulmonary deficiency and stasis in patients with idiopathic pulmonary fibrosis (IPF). MethodsSixty eligible patients with lung deficiency and collateral stasis syndrome of IPF were randomly assigned to the observation (30 patients) and control groups (30 patients). All patients underwent standard Western medical therapy. Additionally,the observation group received Shenlong decoction granules,while the control group received a placebo. Both treatments were packaged in four doses of 10.5 g each,taken twice daily for three months. The indexes of the patients during the treatment cycle were observed,and the main indexes include traditional Chinese medicine (TCM) syndrome scores and 6 min walk test (6MWT). The secondary indexes include pulmonary function test [actual value/expected value of total lung volume (TLC%),actual value/expected value of vital capacity(FVC%),actual/predicted diffusing capacity of the lung for carbon monoxide(DLCO%),actual/predicted forced expiratory volume in one second (FEV1%),and FEV1/ forced vital capacity (FVC)],blood gas analysis [arterial blood diathesis partial pressure of oxygen (PaO2),partial pressure of carbon dioxide (PaCO2),and arterial oxygen saturation (SaO2)],serum inflammatory factors [transforming growth factor-β1 (TGF-β1),interleukin-4 (IL-4),interleukin-13 (IL-13),interleukin-12 (IL-12),and gamma-interferon (IFN-γ)],and quality of survival evaluation [St George's Respiratory Questionnaire (SGRQ) score]. The patients' clinical manifestations were determined at the end of the treatment, and the occurrence of adverse events was recorded. ResultsA total of 53 patients completed the study,comprising 27 in the control group and 26 in the observation group. Upon completion of the treatment period,the control group achieved a total effective rate of 33.33% (9/27),whereas the observation group demonstrated a total effective rate of 53.85% (14/26),which was statistically superior to the control group (χ2=4.034,P<0.05). After the treatment,the TCM syndrome scores,6MWT,DLCO%,FEV1%,PaO2,PaCO2,TGF-β1,IL-4,IL-13,IL-12,and IFN-γ in the two groups were all significantly improved (P<0.01). Compared with those in the control group after treatment at the same period,the TCM syndrome scores,6MWT,PaO2,and PaCO2 were significantly improved in the observation group after 60 days and 90 days of medication (P<0.01). Three months after the end of medication,the SGRQ score in the observation group showed significant improvement when compared to that in the control group (P<0.05),and no severe adverse events were reported during the follow-up period. ConclusionCompound Shenlong decoction can alleviate clinical symptoms such as shortness of breath and wheezing in patients with lung deficiency and collateral stasis syndrome of IPF,enhance exercise tolerance,improve the quality of life,and have certain potential advantages in improving pulmonary function.

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