1.Flos Buddlejae self-heating steam eye mask combined with sodium hyaluronate eye drops in the treatment of dry eye disease
Zhaodan TAN ; Qian LI ; Yan SHI ; Kangyuan HU ; Jin HUANG
Journal of Pharmaceutical Practice and Service 2026;44(2):96-102
Objective To assess the clinical efficacy of sodium hyaluronate (0.3%) eye drops combined with herbal self-heating steam eye mask in the treatment of dry eye disease. Methods A prospective randomized controlled clinical trial was performed on 60 patients diagnosed with dry eye at the ophthalmic clinic of a Grade A, Class Ⅲ hospital in Shanghai from June 2023 to September 2024. Specifically, patients were randomly divided into control group and study group. Patients in the control group were treated with sodium hyaluronate (0.3%) eye drops for six weeks; while in the study group, patients received the eye drops combined with the herbal self-heating steam eye mask mainly containing powders of Flos Buddlejae. Subsequently, comparisons and analysis were performed before and after treatment between the two groups in the clinical symptom questionnaire score traditional Chinese medicine (TCM syndrome score),the Chinese dry eye questionnaire score and determination of tear film fluorscein breakup time (FBUT), and curative effect. Results The quality control standard of the herbal powder in the self-heating steam eye mask was established through TLC and HPLC, and good heating behavior of the herbal self-heating steam eye mask was ascertained heating temperature (43±5)℃; heating duration (≥20 min), meeting requirements of the product quality control. After treatment for 6 weeks, FBUT was increased, while TCM syndrome score and the Chinese dry eye questionnaire score were both decreased in the study group (P<0.001). Besides, compared with the control group, TCM syndrome score and the Chinese dry eye questionnaire score were much lower, while the FBUT were higher in the study group (P<0.001). Moreover, the overall response rate in the study group (81.7%) was much better than that in the control group (25.9%). Conclusion The combination of sodium hyaluronate (0.3%) eye drops with herbal self-heating steam eye mask could be applied to the clinical treatment of dry eye disease due to its good clinical effects on relieving dry eye symptoms.
2.Integrating Transcriptomics and 3D Organoids to Investigate Mechanism of Periplaneta americana Extract Against Lung Adenocarcinoma
Qiong MA ; Chunxia HUANG ; Jiawei HE ; Yuting BAI ; Xingyue LIU ; Yuxuan XIONG ; Yang ZHONG ; Hengzhou LAI ; Yuling JIANG ; Xueke LI ; Qian WANG ; Yifeng REN ; Xi FU ; Funeng GENG ; Taoqing WU ; Ping XIAO ; Fengming YOU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(11):124-132
ObjectiveTo evaluate the antitumor activity of Periplaneta americana extract(PAE) against human-derived lung adenocarcinoma organoids(LUAD-PDOs) and to elucidate its potential mechanism based on transcriptomics. MethodsFresh tumor and adjacent normal tissues from patients with LUAD were collected to construct LUAD-PDOs and normal lung organoid(Nor-PDOs) models using 3D organoid culture technology. The effective intervention concentration of PAE was determined using the cell counting kit-8(CCK-8) assay. Experimental groups included the model group(LUAD-PDOs), normal group, model administration group(LUAD-PDOs+PAE), and normal administration group(Nor-PDOs+PAE). Hematoxylin-eosin(HE) staining was used to observe the pathological structures of PDOs, immunohistochemistry(IHC) was performed to detect the expressions of the proliferation marker Ki-67 and lung adenocarcinoma differentiation markers cytokeratin-7(CK-7) and Napsin A, TUNEL staining was applied to detect cell apoptosis. RNA sequencing(RNA-Seq) was conducted to identify differentially expressed genes(DEGs), followed by Gene Ontology(GO), Kyoto Encyclopedia of Genes and Genomes(KEGG), and Gene Set Enrichment Analysis(GSEA), alongside protein-protein interaction(PPI) network analysis to screen core mechanisms. Finally, key targets were validated by integrating external database analysis with immunofluorescence(IF). ResultsNor-PDOs and LUAD-PDOs that highly recapitulated the pathological characteristics of the primary tissues were successfully established. The CCK-8 assay determined that the effective intervention concentration of PAE was 16 g·L-1. Morphological observation showed that Nor-PDOs exhibited lumen-forming structures, whereas LUAD-PDOs displayed dense, solid structures. CCK-8 and TUNEL assays revealed that, compared with the model group, PAE intervention inhibited the proliferation of LUAD-PDOs and promoted apoptosis in LUAD cells, while showing no significant effect on the viability of Nor-PDOs. Transcriptomic analysis identified 719 DEGs that were significantly reversed after PAE intervention(347 up-regulated and 372 down-regulated)(P<0.05). GO enrichment analysis indicated that DEGs in the model administration group were significantly enriched in biological processes related to cell cycle regulation compared to the model group. KEGG pathway analysis revealed that PAE affected pathways related to proliferation and metabolism, including pathways in cancer and the p53 signaling pathway. GSEA further confirmed that PAE significantly enhanced the activity of the p53 signaling pathway(P<0.05). PPI network analysis indicated that breast cancer type 1 susceptibility protein(BRCA1) and checkpoint kinase 1(CHEK1) were the core down-regulated targets in the p53 pathway. IF verified the high expression of BRCA1 and CHEK1 in LUAD-PDOs and their significant downregulation after PAE intervention(P<0.05). Furthermore, survival analysis based on The Cancer Genome Atlas(TCGA) database indicated that low expression of BRCA1 and CHEK1 was significantly associated with prolonged overall survival in patients with LUAD(P<0.05). ConclusionPAE effectively inhibits proliferation of LUAD-PDOs and promotes their apoptosis, its anti-tumor mechanism is potentially associated with the activation of the p53 signaling pathway, with BRCA1 and CHEK1 genes likely serving as key downstream targets for the effects of PAE.
3.A blood management system from a systemic perspective: development of an integrated model from regional blood supply to clinical transfusion decision-making
Changtai ZHU ; Yunhua SUN ; Lanjun ZHANG ; Long HUANG ; Qinyun LI ; Heshan TANG ; Yan ZANG ; Junjie LIN ; Baohua QIAN
Chinese Journal of Blood Transfusion 2026;39(6):699-710
Objective: To address systemic challenges in the blood system, such as supply-demand imbalance, inefficient allocation, and inappropriate clinical use, while bridging gaps in current theories regarding the integration of social mobilization, institutional practice, and policy coordination. It sought to construct a system dynamics model spanning from macro to micro levels to analyze the blood management system holistically. Methods: Key variables were identified by a systematic literature search in both Chinese and English databases. An improved Delphi method was then employed to conduct expert consultations across different fields, leading to the selection and determination of core variable sets for each sub-model. Furthermore, by defining their logical relationships, a system dynamics model was constructed to systematically analyze the operation mechanism of the blood management system. Results: Four core sub-models were developed: 1) A macro "Dynamic Balance" model quantifying regional supply-demand equilibrium and inventory control; 2) a mobilization "Three-Layer Funnel" model analyzing how socio-cultural factors, service channels, and policy incentives influence donation behavior; 3) an institutional "Dual-Cycle Regulation" model revealing hospital blood usage is driven by both disease burden (demand cycle) and management practices (regulation cycle); and 4) an individual "Three-Layer Filter" model standardizing clinical transfusion decisions based on necessity, risk-benefit, and context. These were integrated into a "Multi-Layer Linkage and Feedback" model, elucidating bidirectional interactions among five levels: policy environment, regional supply, blood station mobilization, hospital application, and clinical decision-making. Conclusion: This study constructed a system dynamics model for blood management. By defining key variables and their logical relationships, it systematically analyzes the system′s operational mechanism. The integrated framework connects multiple levels—regional supply, voluntary donation, hospital blood use, and clinical decision-making—revealing their intrinsic linkages. Future efforts should employ systems thinking to synergistically enhance supply-side mobilization, demand-side management, systemic regulation, and decision standardization to build a safe, efficient, and sustainable blood security system.
4.Current Status and Optimization Strategies for Setting Objective Performance Criteria in Clinical Trials of Traditional Chinese Medicine
Jiaqi LAI ; Qian HUANG ; Xueyin CHEN ; Shaonan LIU ; Lihong YANG ; MIMAZHUOGA ; DAWA ; Zhijian LI ; Tuerxun WUFUER ; Xinfeng GUO
Journal of Traditional Chinese Medicine 2026;67(13):1461-1464
Current formulation of objective performance criteria (OPC) in traditional Chinese medicine (TCM) faces methodological challenges, including poor reporting quality, insufficient standardization of methods, limited comparability of study populations, and inadequate consideration of the genetic and environment particularities of ethnic minority populations. In response to these issues, this paper proposes optimization strategies for setting OPC in TCM, with particular attention to ethnic minority medicine. These include improving methodological techniques and statistical descriptions, ensuring transparency in meta-analyses and data sources; standardizing the estimation of point estimates and confidence intervals, and incorporating multidisciplinary expert consensus for value determination; introducing local real-world data from the same period, especially cohort study evidence, to compensate for the lack of high-quality randomized controlled trial data. Through process transparency and dynamic updating mechanisms, the credibility of OPC method can be enhanced, thereby providing methodological support for strengthening evidence-based research capacity in this field.
5.Randomized Controlled Study on Wenshen Yangxue Decoction Plus Endometrial Microstimulation for Polycystic Ovary Syndrome (PCOS) Infertility with Syndrome of Kidney-Yang Deficiency and Blood Stasis
Qianqian HUANG ; Qian HAN ; Mingwei XIN ; Junqin HE ; Jingshang WANG ; Xiaodan YIN ; Mengyuan LI ; Yanxiao YI ; Yanli TANG ; Yiting WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):181-190
ObjectiveTo evaluate the clinical efficacy and safety of Wenshen Yangxue decoction combined with endometrial microstimulation in the treatment of infertile patients with polycystic ovary syndrome (PCOS, syndrome of kidney-Yang deficiency and blood stasis). MethodsA randomized, positive-drug parallel-controlled, open-label clinical study was conducted. A total of 240 infertile PCOS patients with the syndrome of kidney-Yang deficiency and blood stasis who met the inclusion and exclusion criteria were randomly assigned into 4 groups, with 60 patients in each group. The control group was treated with clomiphene citrate (50-100 mg·d-¹, orally for 5-10 consecutive days) for ovulation induction. On the basis of the therapy in the control group, the Wenshen group was additionally treated with Wenshen Yangxue decoction (250 mL, warm oral administration, twice daily, in the morning and evening), and the stimulation group received endometrial microstimulation during the early follicular phase. The combined group was treated with clomiphene citrate plus Wenshen Yangxue decoction (at the same dosages as aforementioned) and endometrial microstimulation. The course of treatment for all the groups was 3 menstrual cycles. The pregnancy rate, ovulation status, sex hormone levels, glucose metabolism indicators, coagulation function, endometrial thickness, traditional Chinese medicine (TCM) symptom scores, and adverse reactions were observed in each group. ResultsA total of 239 patients were included in the final analysis, with 59 patients in the Wenshen group and 60 patients in each of the other three groups. The pregnancy rates were 43.3%(26/60) in the combined group and 32.2%(19/60) in the Wenshen group, both significantly higher than that (10%) in the control group (χ2=17.56,P<0.01). Compared with the control group, the combined and Wenshen groups had increased mature follicle rates (P<0.01), while the Wenshen group showed a decreased luteinization rate (P<0.05). All the groups exhibited significant reductions in TCM symptom scores after treatment, and the Wenshen and combined groups had lower scores than the control group (P<0.01). No statistically significant difference was found in the incidence of adverse events among the four groups, and all the adverse events were mild. ConclusionWenshen Yangxue decoction combined with endometrial microstimulation can alleviate the TCM symptoms of infertile PCOS patients with the syndrome of kidney-Yang deficiency and blood stasis, promote follicular maturation and ovulation, increase the cumulative pregnancy rate, and has good safety. It can provide new clinical evidence for the integrated traditional Chinese and Western medicine treatment of PCOS infertility.
6.Randomized Controlled Study on Wenshen Yangxue Decoction Plus Endometrial Microstimulation for Polycystic Ovary Syndrome (PCOS) Infertility with Syndrome of Kidney-Yang Deficiency and Blood Stasis
Qianqian HUANG ; Qian HAN ; Mingwei XIN ; Junqin HE ; Jingshang WANG ; Xiaodan YIN ; Mengyuan LI ; Yanxiao YI ; Yanli TANG ; Yiting WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):181-190
ObjectiveTo evaluate the clinical efficacy and safety of Wenshen Yangxue decoction combined with endometrial microstimulation in the treatment of infertile patients with polycystic ovary syndrome (PCOS, syndrome of kidney-Yang deficiency and blood stasis). MethodsA randomized, positive-drug parallel-controlled, open-label clinical study was conducted. A total of 240 infertile PCOS patients with the syndrome of kidney-Yang deficiency and blood stasis who met the inclusion and exclusion criteria were randomly assigned into 4 groups, with 60 patients in each group. The control group was treated with clomiphene citrate (50-100 mg·d-¹, orally for 5-10 consecutive days) for ovulation induction. On the basis of the therapy in the control group, the Wenshen group was additionally treated with Wenshen Yangxue decoction (250 mL, warm oral administration, twice daily, in the morning and evening), and the stimulation group received endometrial microstimulation during the early follicular phase. The combined group was treated with clomiphene citrate plus Wenshen Yangxue decoction (at the same dosages as aforementioned) and endometrial microstimulation. The course of treatment for all the groups was 3 menstrual cycles. The pregnancy rate, ovulation status, sex hormone levels, glucose metabolism indicators, coagulation function, endometrial thickness, traditional Chinese medicine (TCM) symptom scores, and adverse reactions were observed in each group. ResultsA total of 239 patients were included in the final analysis, with 59 patients in the Wenshen group and 60 patients in each of the other three groups. The pregnancy rates were 43.3%(26/60) in the combined group and 32.2%(19/60) in the Wenshen group, both significantly higher than that (10%) in the control group (χ2=17.56,P<0.01). Compared with the control group, the combined and Wenshen groups had increased mature follicle rates (P<0.01), while the Wenshen group showed a decreased luteinization rate (P<0.05). All the groups exhibited significant reductions in TCM symptom scores after treatment, and the Wenshen and combined groups had lower scores than the control group (P<0.01). No statistically significant difference was found in the incidence of adverse events among the four groups, and all the adverse events were mild. ConclusionWenshen Yangxue decoction combined with endometrial microstimulation can alleviate the TCM symptoms of infertile PCOS patients with the syndrome of kidney-Yang deficiency and blood stasis, promote follicular maturation and ovulation, increase the cumulative pregnancy rate, and has good safety. It can provide new clinical evidence for the integrated traditional Chinese and Western medicine treatment of PCOS infertility.
7.Clinical characteristics and influencing factors of chronic obstructive pulmonary disease patients complicated with heart failure in Nanjing
Yumin ZHU ; Guoxin ZHANG ; Liping YIN ; Fan CHEN ; Bowen HUANG ; Qian LI
Journal of Public Health and Preventive Medicine 2025;36(4):64-68
Objective To analyze the clinical features of chronic obstructive pulmonary disease (COPD) patients with heart failure (HF) in Nanjing and explore the influencing factors. Methods A total of 773 COPD inpatients were selected from January 2021 to January 2024 in Nanjing Combined Hospital of Traditional Chinese and Western Medicine, Nanjing Qixia District Hospital, Nanjing Lishui District People's Hospital, Nanjing Pukou District Hospital of Traditional Chinese Medicine and Nanjing First Hospital., and were divided into 2 groups according to the presence or absence of combined HF. The general data and medical records of the two groups were compared, the clinical characteristics of COPD patients with HF were summarized, and the influencing factors of COPD patients with HF were analyzed by multivariate logistic regression. Results Among the 242 patients (31.31%) with COPD had HF, chronic paroxysmal dyspnea was the most common first symptom, 169 patients (69.83%) had left heart failure, 63 patients (30.17%) were diagnosed as right heart failure or global heart failure , 17 patients (7.02%) had myocardial infarction. Multivariate logistic regression analysis showed that the risk of HF was 1.678 times and 1.691times higher in COPD groups ≥ 50 years old and male COPD groups than in < 50 years old and female groups, respectively; the risk of HF was 1.491 times higher in COPD groups engaged in physical work than in physical work groups; the risk of HF was 1.447 times and 1.580 times higher in COPD groups with hypertension and coronary heart disease than in COPD groups without hypertension and coronary heart disease, respectively; the risk of HF was 1.859 times higher in COPD groups smoking>400 vial/year than in COPD groups≤400 vial/ year; the risk of HF was 1.757 times higher in COPD groups with acute exacerbation frequency≥2 times/year than in COPD groups<2 times/year; the above differences were statistically significant (P<0.05). Conclusion Attention should be paid to elderly, male and heavy physical work group of COPD patients. Active treatment of hypertension and coronary heart disease, effective tobacco control and reduction of the frequency of acute exacerbation are effective ways to reduce the risk of HF in COPD patients in Nanjing.
8.Analysis of factors for international normalized ratio levels>3.0 in patients undergoing warfarin anticoagulation therapy after mechanical heart valve replacement
Shengmin ZHAO ; Bo FU ; Fengying ZHANG ; Weijie MA ; Shourui HUANG ; Qian LI ; Huan TAO ; Li DONG ; Jin CHEN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(05):655-662
Objective To investigate the factors influencing international normalized ratio (INR)>3.0 in patients undergoing warfarin anticoagulation therapy after mechanical heart valve replacement. Methods A retrospective analysis was performed on the clinical data of patients who underwent mechanical heart valve replacement surgery and received warfarin anticoagulation therapy at West China Hospital of Sichuan University from January 1, 2011 to June 30, 2022. Based on the discharge INR values, patients were divided into two groups: an INR≤3.0 group and an INR>3.0 group. The factors associated with INR>3.0 at the time of discharge were analyzed. Results A total of 8901 patients were enrolled, including 3409 males and 5492 females, with a median age of 49.3 (43.5, 55.6) years. The gender, body mass index (BMI), New York Heart Association (NYHA) cardiac function grading, INR, glutamic oxaloacetic transaminase, and preoperative prothrombin time (PT) were statistically different between the two groups (P<0.05). Multivariate logistic regression analysis revealed that lower BMI, preoperative PT>15 s, and mitral valve replacement were independent risk factors for INR>3.0 at discharge (P<0.05). Conclusion BMI, preoperative PT, and surgical site are factors influencing INR>3.0 at discharge in patients undergoing warfarin anticoagulation therapy after mechanical heart valve replacement. Special attention should be given to patients with lower BMI, longer preoperative PT, and mitral valve replacement to avoid excessive anticoagulation therapy.
9.Sishenwan Restores Intestinal Barrier in Rat Model of Diarrhea-predominant Irritable Bowel Syndrome Due to Spleen-kidney Yang Deficiency by Regulating Intestinal Flora and Short-chain Fatty Acids
Qian ZHANG ; Siqi LI ; HUYUNLIAN ; Na WEN ; Chaoqun HUANG ; Binbin LIU ; Chengxia SU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):80-89
ObjectiveTo investigate the effect and mechanism of Sishenwan in restoring the intestinal barrier function in the rat model of diarrhea-predominant irritable bowel syndrome (IBS-D) due to spleen-kidney Yang deficiency based on intestinal flora and short-chain fatty acids. MethodsAfter the delivery of 10 SPF-grade pregnant rats, 4 male suckling rats were kept in each litter for the experiment. The male suckling rats were randomly allocated into blank, model, low-dose (3.51 g·kg-1) Sishenwan, high-dose (7.02 g·kg-1) Sishenwan, and Peifeikang (0.54 g·kg-1) groups, with 8 rats in each group. The blank group was fed conventionally, and the other groups were subjected to mother-child separation and Sennae Folium gavage (1 g·mL-1, 10 mL·kg-1) for the modeling of IBS-D due to spleen-kidney Yang deficiency. After the modeling was completed, the rats in Sishenwan groups were administrated with the corresponding dose of Sishenwan decoction by gavage, and the Peifeikang group with bifidobacterium triple live powder+normal saline suspension. The blank and model groups were treated with an equal volume of normal saline by gavage. The general conditions and fecal characteristics of rats were observed. After 2 weeks of administration, the rats were anesthetized for sample collection. The pathological changes of the colon tissue in rats were observed by hematoxylin-eosin staining. Enzyme-linked immunosorbent assay was employed to measure the levels of transforming growth factor-beta (TGF-β), interleukin-10 (IL-10), and interleukin-22 (IL-22). Immumohistochemical staining (IHC) was performed to detect the positive expression of zonula occludens-1 (ZO-1) and occludin in the colon tissue. Western blot was employed to determine the protein levels of ZO-1 and occludin in the colon tissue of rats, and 16S rRNA gene sequencing was performed for intestinal flora. Gas chromatography-mass spectrometry was employed to determine the content of short-chain fatty acids (SCFAs) in the cecum contents of rats. ResultsThe colon tissue in the blank group presented a clear structure, neat glands, and no inflammatory cell infiltration. In the model group, the colon tissue showcased a disorganized structure, irregular arrangement of glands, and inflammatory cell infiltration. Compared with the model group, the low-dose and high-dose Sishenwan groups and the Peifeikang group exhibited an intact colon tissue structure, regular arrangement of glands, and reduced inflammatory cell infiltration. Compared with the blank group, the modeling lowered the levels of TGF-β, IL-10, and IL-22 in the serum (P<0.01), down-regulated the protein levels of ZO-1 and occludin in the colon tissue (P<0.01), and decreased the content of acetic acid and propionic acid and increased the content of butyric acid in cecum contents (P<0.05). Compared with the model group, low-dose and high-dose Sishenwan raised the levels of TGF-β, IL-10, and IL-22 in the serum (P<0.05, P<0.01), and Peifeikang elevated the levels of TGF-β and IL-10 in the serum (P<0.01). High-dose Sishenwan and Peifeikang up-regulated the protein levels of ZO-1 and occludin (P<0.05, P<0.01), increased the content of acetic acid and propionic acid in cecum contents (P<0.05), and decreased the content of butyric acid (P<0.05). The 16S rRNA gene sequencing results showed that the intestinal flora structure of the model group changed compared with that of the blank group. Compared with the model group, Sishenwan and Peifeikang increased the relative abundance of Lachnospiraceae, Muribaculaceae, Akkermansiaceae, Ligilactobacillus, UBA3282, Akkermansia, and Corynebacterium while reducing the relative abundance of Oscillospiraceae, Desulfovibrionaceae, Lactobacillus, Romboutsia, and Desulfovibrio. They can restore the intestinal flora structure similar to that in the blank group. ConclusionSishenwan can alleviate diarrhea symptoms and colonic mucosal inflammation, increase the expression of tight junction proteins in the colonic mucosa, and strengthen the intestinal barrier in IBS-D rats with the syndrome of spleen-kidney Yang deficiency. The mechanism of action may be related to optimizing the structure and balance of intestinal flora and regulating the SCFAs, and the effect of high-dose Sishenwan is obvious.
10.Sishenwan Restores Intestinal Barrier in Rat Model of Diarrhea-predominant Irritable Bowel Syndrome Due to Spleen-kidney Yang Deficiency by Regulating Intestinal Flora and Short-chain Fatty Acids
Qian ZHANG ; Siqi LI ; HUYUNLIAN ; Na WEN ; Chaoqun HUANG ; Binbin LIU ; Chengxia SU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):80-89
ObjectiveTo investigate the effect and mechanism of Sishenwan in restoring the intestinal barrier function in the rat model of diarrhea-predominant irritable bowel syndrome (IBS-D) due to spleen-kidney Yang deficiency based on intestinal flora and short-chain fatty acids. MethodsAfter the delivery of 10 SPF-grade pregnant rats, 4 male suckling rats were kept in each litter for the experiment. The male suckling rats were randomly allocated into blank, model, low-dose (3.51 g·kg-1) Sishenwan, high-dose (7.02 g·kg-1) Sishenwan, and Peifeikang (0.54 g·kg-1) groups, with 8 rats in each group. The blank group was fed conventionally, and the other groups were subjected to mother-child separation and Sennae Folium gavage (1 g·mL-1, 10 mL·kg-1) for the modeling of IBS-D due to spleen-kidney Yang deficiency. After the modeling was completed, the rats in Sishenwan groups were administrated with the corresponding dose of Sishenwan decoction by gavage, and the Peifeikang group with bifidobacterium triple live powder+normal saline suspension. The blank and model groups were treated with an equal volume of normal saline by gavage. The general conditions and fecal characteristics of rats were observed. After 2 weeks of administration, the rats were anesthetized for sample collection. The pathological changes of the colon tissue in rats were observed by hematoxylin-eosin staining. Enzyme-linked immunosorbent assay was employed to measure the levels of transforming growth factor-beta (TGF-β), interleukin-10 (IL-10), and interleukin-22 (IL-22). Immumohistochemical staining (IHC) was performed to detect the positive expression of zonula occludens-1 (ZO-1) and occludin in the colon tissue. Western blot was employed to determine the protein levels of ZO-1 and occludin in the colon tissue of rats, and 16S rRNA gene sequencing was performed for intestinal flora. Gas chromatography-mass spectrometry was employed to determine the content of short-chain fatty acids (SCFAs) in the cecum contents of rats. ResultsThe colon tissue in the blank group presented a clear structure, neat glands, and no inflammatory cell infiltration. In the model group, the colon tissue showcased a disorganized structure, irregular arrangement of glands, and inflammatory cell infiltration. Compared with the model group, the low-dose and high-dose Sishenwan groups and the Peifeikang group exhibited an intact colon tissue structure, regular arrangement of glands, and reduced inflammatory cell infiltration. Compared with the blank group, the modeling lowered the levels of TGF-β, IL-10, and IL-22 in the serum (P<0.01), down-regulated the protein levels of ZO-1 and occludin in the colon tissue (P<0.01), and decreased the content of acetic acid and propionic acid and increased the content of butyric acid in cecum contents (P<0.05). Compared with the model group, low-dose and high-dose Sishenwan raised the levels of TGF-β, IL-10, and IL-22 in the serum (P<0.05, P<0.01), and Peifeikang elevated the levels of TGF-β and IL-10 in the serum (P<0.01). High-dose Sishenwan and Peifeikang up-regulated the protein levels of ZO-1 and occludin (P<0.05, P<0.01), increased the content of acetic acid and propionic acid in cecum contents (P<0.05), and decreased the content of butyric acid (P<0.05). The 16S rRNA gene sequencing results showed that the intestinal flora structure of the model group changed compared with that of the blank group. Compared with the model group, Sishenwan and Peifeikang increased the relative abundance of Lachnospiraceae, Muribaculaceae, Akkermansiaceae, Ligilactobacillus, UBA3282, Akkermansia, and Corynebacterium while reducing the relative abundance of Oscillospiraceae, Desulfovibrionaceae, Lactobacillus, Romboutsia, and Desulfovibrio. They can restore the intestinal flora structure similar to that in the blank group. ConclusionSishenwan can alleviate diarrhea symptoms and colonic mucosal inflammation, increase the expression of tight junction proteins in the colonic mucosa, and strengthen the intestinal barrier in IBS-D rats with the syndrome of spleen-kidney Yang deficiency. The mechanism of action may be related to optimizing the structure and balance of intestinal flora and regulating the SCFAs, and the effect of high-dose Sishenwan is obvious.


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