1.Mechanism of Xiezhuo Jiedu Prescription in Treatment of Ulcerative Colitis by Inhibiting Ferroptosis and Alleviating Intestinal Mucosal Injury Based on Nrf2/SLC7A11/GPX4 Signaling Pathway
Qiang CHUAI ; Wenjing ZHAI ; Sujie JIA ; Xiaomeng LANG ; Jie REN ; Xin KANG ; Shijie REN ; Xingchi LIU ; Xin LIU ; Xiaohong JIANG ; Jianping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(1):160-169
ObjectiveTo investigate the mechanism of Xiezhuo Jiedu prescription in the treatment of ulcerative colitis (UC) by inhibiting ferroptosis and alleviating intestinal mucosal injury based on the nuclear factor E2 related factor 2/solute carrier family 7 member/glutathione peroxidase 4 (Nrf2/SLC7A11/GPX4) signaling pathway. MethodsA total of 60 male SD rats were divided into a normal group, a model group, high- and low-dose Xiezhuo Jiedu prescription groups (26.64 and 13.32 g·kg-1, respectively), a ferroptosis inhibitor group (Ferrostatin-1, 0.005 g·kg-1), and a mesalazine group (0.27 g·kg-1), with 10 rats in each group. A UC rat model was established by intrarectal administration of trinitrobenzene sulfonic acid (TNBS)-ethanol. The normal group and the model group were intragastrically administered normal saline. The other groups were given intragastric administration according to the corresponding dosage for 7 d. The general condition, disease activity index (DAI) score, colon length, and mucosal injury index (CDMI) score were observed in each group. The pathological changes of colon tissue in each group were observed by hematoxylin-eosin (HE) staining. The intestinal mucosa and mitochondrial morphology in each group were observed by transmission electron microscopy. The expression levels of Occludin, Claudin-1, mucin 2 (MUC2), and E-cadherin in intestinal tissue were detected by immunofluorescence (IF). Enzyme-linked immunosorbent assay (ELISA) was used to detect the expression levels of serum tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-10 (IL-10) in each group, and a lactic acid assay kit or ELISA was employed to detect the expression levels of reactive oxygen species (ROS), ferrous ions (Fe2+), glutathione (GSH), malondialdehyde (MDA), 4-hydroxynonenal (4-HNE), diamine oxidase (DAO), and D-lactate (D-LA). Real-time quantitative polymerase chain reaction (Real-time PCR) was applied to detect the mRNA expression levels of Nrf2, SLC7A11, GPX4, Occludin, Claudin-1, MUC2, and E-cadherin in each group, and Western blot was adopted to detect the protein expression levels of Nrf2, p-Nrf2, SLC7A11, and GPX4 in each group. ResultsCompared with the normal group, rats in the model group exhibited listlessness, sluggish response, and mucopurulent and bloody stools. The model group also showed significantly increased DAI score, colon length, CDMI score, and expression levels of TNF-α, IL-6, ROS, Fe2+, MDA, 4-HNE, DAO, and D-LA (P<0.01). In addition, it presented significantly decreased IF values of Occludin, Claudin-1, MUC2, and E-cadherin and mRNA and protein expression levels of IL-10, GSH, Nrf2, p-Nrf2, SLC7A11, and GPX4 (P<0.01). There were different degrees of improvement in each administration group after treatment, and the improvement was the most significant in the high-dose Xiezhuo Jiedu prescription group (P<0.01). ConclusionXiezhuo Jiedu prescription may alleviate intestinal mucosal injury by inhibiting ferroptosis of intestinal epithelial cells via regulating the Nrf2/SLC7A11/GPX4 signaling pathway, thereby exhibiting efficacy in the treatment of UC.
2.Efficacy and safety of Babaodan Capsule in patients with chronic hepatitis B virus infection comorbid with gallbladder polyps
Qianqian NIU ; Huan CHEN ; Ying ZHENG ; Chunyan GOU ; Chen XU ; Li LI ; Xinxin WANG ; Jianping LIU ; Zhaolan LIU ; Xiuhui LI
Journal of Clinical Hepatology 2026;42(2):304-311
ObjectiveTo investigate the efficacy and safety of Babaodan Capsule (BBD) in the treatment of patients with chronic hepatitis B virus (HBV) infection with damp-heat in the liver and gallbladder comorbid with gallbladder polyps. MethodsA randomized, double-blinded, placebo-controlled single-center trial was conducted among 120 patients with chronic HBV infection who were admitted to Beijing YouAn Hospital, Capital Medical University, from August 2020 to April 2023, and they were divided into treatment group (BBD) and control group (placebo), with 60 patients in each group. The course of treatment was 24 weeks, and follow-up assessments were conducted every 4 weeks. The primary outcome measures were the number and maximum diameter of gallbladder polyps (assessed by ultrasound), and the secondary outcome measures included traditional Chinese medicine (TCM) syndrome score, blood lipid levels, and liver function parameters. The independent-samples t test or the Wilcoxon rank-sum test was used for comparison of continuous data between two groups, and the chi-square test or the Fisher’s exact test was used for comparison of categorical data between two groups; the Wilcoxon rank-sum test was used for comparison of ranked data between two groups; the generalized estimating equation was used to analyze repeated measures data. ResultsAfter 8 weeks of treatment, the treatment group had a significantly smaller diameter of polyps and a significantly lower number of polyps than the control group (Z=-1.76 and -1.80, both P<0.05), and after 24 weeks of treatment, the treatment group had a significantly higher polyp reduction rate than the control group (30.51% vs 10.91%, P<0.05). The subgroup analysis showed that patients receiving combined antiviral therapy, male patients, patients with a diameter of polyps of <5 mm, and patients with multiple polyps tended to achieve significantly greater benefits. At week 8 of treatment, the treatment group had a significantly better TCM syndrome score than the control group (Z=-2.35, P<0.05); after treatment, compared with the control group, the treatment group had a significantly greater increase in high-density lipoprotein (Z=-1.85, P<0.05) and significantly lower levels of alanine aminotransferase (Z=-2.06, P <0.05), aspartate aminotransferase (Z=-2.13, P<0.05), total bilirubin (Z=-2.12, P<0.05), and direct bilirubin (Z=-3.09, P<0.05). No serious adverse events were reported in either group. ConclusionBBD can effectively reduce the size of gallbladder polyps, improve TCM syndrome score, and reduce the level of bilirubin in patients with chronic HBV infection with damp-heat in the liver and gallbladder, with a favorable safety profile, and it may be more suitable for patients receiving combined antiviral therapy and specific subgroups (male patients, patients with a diameter of polyps of <5 mm, and patients with multiple polyps.
3.Analysis of Risk Factors and Establishment of Prediction Model for Turbidity Toxicity Accumulation Syndrome in Patients with Chronic Atrophic Gastritis
Yican WANG ; Chenggong ZHAO ; Pengli DU ; Jie WANG ; Yuxi GUO ; Haiyan BAI ; Yongli HUO ; Xiaomeng LANG ; Zheng ZHI ; Bolin LI ; Jianping LIU ; Yanru CAI ; Jianming JIANG ; Qian YANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):288-295
ObjectiveThis paper aims to explore the risk factors for chronic atrophic gastritis (CAG) with turbidity toxin accumulation syndrome and establish a prediction model. MethodsClinical data of 180 patients with CAG who participated in the "clinical study of Xianglian Huazhuo Particles blocking CAG cancer transformation" of Hebei Sheng Zhong Yi Yuan from July 2021 to March 2022 were collected. After confounding factors were controlled by propensity score matching, patients were divided into a training set (namely dev) and a validation set (namely vad) in a seven to three ratio. The risk factors for CAG with turbidity toxin accumulation syndrome in the training set were investigated by using univariate Logistic regression analysis and least absolute shrinkage and selection operator (namely Lasso) regression algorithms. Subsequently, a model, named model 1se, was developed by using the training set data to predict the risk factors for CAG with turbidity toxin accumulation syndrome. The accuracy of the prediction model was assessed by using various methods, including the receiver operating characteristic (ROC) curve, Hosmer-Lemeshow test (H-L), calibration plot, and decision curve analysis (DCA). ResultsAge, body mass index (BMI), family history of cancer, job and life satisfaction, yellow and greasy fur with slippery pulse, and heavy body sensation were independent risk factors of the model. The prediction model showed excellent predictive value for both the training and validation sets. ConclusionThe established prediction model for CAG with turbidity toxin accumulation syndrome has high discrimination and excellent calibration, which could provide an excellent clinical basis for disease diagnosis and individualized treatment of patients.
4.Analysis of Risk Factors and Establishment of Prediction Model for Turbidity Toxicity Accumulation Syndrome in Patients with Chronic Atrophic Gastritis
Yican WANG ; Chenggong ZHAO ; Pengli DU ; Jie WANG ; Yuxi GUO ; Haiyan BAI ; Yongli HUO ; Xiaomeng LANG ; Zheng ZHI ; Bolin LI ; Jianping LIU ; Yanru CAI ; Jianming JIANG ; Qian YANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):288-295
ObjectiveThis paper aims to explore the risk factors for chronic atrophic gastritis (CAG) with turbidity toxin accumulation syndrome and establish a prediction model. MethodsClinical data of 180 patients with CAG who participated in the "clinical study of Xianglian Huazhuo Particles blocking CAG cancer transformation" of Hebei Sheng Zhong Yi Yuan from July 2021 to March 2022 were collected. After confounding factors were controlled by propensity score matching, patients were divided into a training set (namely dev) and a validation set (namely vad) in a seven to three ratio. The risk factors for CAG with turbidity toxin accumulation syndrome in the training set were investigated by using univariate Logistic regression analysis and least absolute shrinkage and selection operator (namely Lasso) regression algorithms. Subsequently, a model, named model 1se, was developed by using the training set data to predict the risk factors for CAG with turbidity toxin accumulation syndrome. The accuracy of the prediction model was assessed by using various methods, including the receiver operating characteristic (ROC) curve, Hosmer-Lemeshow test (H-L), calibration plot, and decision curve analysis (DCA). ResultsAge, body mass index (BMI), family history of cancer, job and life satisfaction, yellow and greasy fur with slippery pulse, and heavy body sensation were independent risk factors of the model. The prediction model showed excellent predictive value for both the training and validation sets. ConclusionThe established prediction model for CAG with turbidity toxin accumulation syndrome has high discrimination and excellent calibration, which could provide an excellent clinical basis for disease diagnosis and individualized treatment of patients.
5.Evaluation of CARIFS Score and Negative Antigen Conversion Rate of Qingxuan Daozhi Formula in Treatment of Influenza in Children (Heat Accumulation in Lung and Stomach Syndrome):A Multi-center Randomized Controlled Clinical Study
Jing WANG ; Liqun WU ; Tiegang LIU ; Yongning CAO ; Jing QIU ; Jing LI ; Huaqing TAN ; Ying ZHANG ; Xulei GOU ; Jia WANG ; Jing LI ; Haipeng CHEN ; Xueying QIN ; Yuanshuo TIAN ; Yang WANG ; Chen BAI ; Zhendong WANG ; Qianqian LI ; He YU ; Xueyan MA ; Fei DONG ; Lin JIANG ; Yingqi XU ; Jianping LIU ; Xiaohong GU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(13):188-196
ObjectiveThis paper aims to observe the syndrome improvement and negative antigen conversion rate of Qingxuan Daozhi formula in the treatment of influenza in children (heat accumulation in the lung and stomach syndrome). MethodsThrough a multi-center randomized controlled methodology design,confirmed influenza cases were collected from October 2022 to April 2023 in the pediatrics department of eight hospitals,such as Dongfang Hospital of Beijing University of Chinese Medicine. A total of 180 children with influenza and heat accumulation in the lung and stomach syndrome conforming to the standard were recruited through the clinic. The sick children meeting the inclusion criteria were randomly divided into groups by a block-randomized method. The children in the experimental group were treated with Qingxuan Daozhi formula for five days,and those in the control group were treated with Oseltamivir Phosphate Granules for five days. The primary efficacy indicator was the negative conversion rate of influenza antigen detection. Secondary efficacy indicators were the Canadian acute respiratory illness and flu scale (CARIFS) and the incidence of complications,severe cases, and critical cases. Follow-up observation was conducted on the day of enrollment,48 hours after medication,72 hours after medication, and (6+1) d after medication. ResultsOne hundred and eighty participants were randomly assigned to the experimental group (90 cases) or the control group (90 cases). All participants were followed up during the study. Comparison of influenza antigen detection results in the primary efficacy indicators showed that the average time of negative influenza antigen conversion in the experimental group was (5.29±1.25) d,and that in the control group was (5.40±1.68) d,without a statistically significant difference. After five days of intervention,52 cases in the experimental group and 51 cases in the control group converted to negative,without a statistically significant difference. CARIFS score results in the secondary efficacy indicators showed that during 72 hours after intervention,there were statistically significant differences between the experimental group and the control group in three dimensions, including headache,muscle soreness, and the need for extra care (P<0.05). On the (6+1) days after the intervention,the differences in both the experimental group and the control group were statistically significant in 10 dimensions, including sore throat,bad sleep,uncomfortable feeling,poor spirit and fatigue,crying more than usual,the need for extra care,symptom,function,influence on parents,and total score (P<0.05). The comparison results within the group in the dimensional scores of symptom, function, and influence on parents,as well as the CARIFS total score showed that with the delay of follow-up time,scores of both groups decreased significantly,with a statistically significant difference (P<0.01). Inter-group comparison results showed that the mean score of the experimental group was higher than that of the control group at the time of enrollment. With the progress of intervention,the score of the experimental group was significantly decreased compared with that of the control group. At the end of follow-up,the mean score of the experimental group was lower than that of the control group,with no statistically significant difference. In terms of the incidence of complications,severe cases, and critical cases, there were no complications,severe cases, and critical cases in the two groups,without a statistically significant difference. ConclusionThe symptom improvement effect and negative antigen conversion rate of Qingxuan Daozhi formula in the treatment of influenza in children (heat accumulation in the lung and stomach syndrome) are not inferior to Oseltamivir Phosphate granules, and children's acceptance is better. It can be more widely used in clinical treatment of influenza in children (heat accumulation in the lung and stomach syndrome).
6.A panel study on association of short-term air pollution exposure and peripheral blood microparticles in healthy adults
Bin ZHANG ; Xinghou HE ; Jiahui LIU ; Xuyang SHAN ; Yan FANG ; Huiying XU ; Erlu ZHAO ; Shengcong LIU ; Hongbing XU ; Jianping LI ; Wei HUANG
Journal of Environmental and Occupational Medicine 2026;43(1):1-7
Background Microparticles (MPs) are one of the main medium of inflammatory reaction with an important role in atherosclerotic progression. Studies on association of air pollution exposure and levels of peripheral blood MPs are limited among human. Objective To evaluate the effects of short-term exposure to air pollution on levels of peripheral blood MPs. Method A panel of 73 healthy adults was followed with 4 repeated follow-ups in Beijing, China, from November 2014 to January 2016. During each visit, we collected questionnaire information, fasting venous blood, urine, and exposures to fine particulate matter (PM2.5), black carbon, nitric oxide, nitrogen dioxide, nitrogen oxide, sulfur dioxide, carbon monoxide, and ozone. We used linear mixed-effect models to analyze associations of air pollution exposure with levels of total MPs (TMPs) and MPs derived from various cells. Stratified analysis was conducted by levels of C-reactive protein (CRP) and malondialdehyde (MDA). Results The results showed significant associations between air pollution exposure and peripheral blood TMPs at 2 h-6 d prior to the follow-ups (P<0.05), while no statistical associations were found for MPs derived from different cell types. Significant increases in TMPs of 7.8% (95%CI: 0.7%, 15.3%) and 14.3% (95%CI: 2.8%, 27.2%) were observed with each interquartile range (IQR) increase in PM2.5 (IQR=64.9 μg·m−3) at prior 18 h and NO (IQR=40.5 μg·m−3) at prior 48 h. Among participants with low levels of CRP and MDA, significantly positive associations were observed between air pollution exposure and levels of TMPs (P<0.05). Conclusion Short-term exposure to air pollution is significantly associated with increased levels of circulating MPs in healthy adults, and in people with lower systemic inflammation, peripheral blood MPs levels are more easily affected after exposure to air pollutants.
7.Advantages,Challenges,and Implementation Pathways of Natural Experiments in Evaluating the Efficacy of Traditional Chinese Medicine
Rihe LIU ; Tingxiu LIU ; Kai LIU ; Yuan SUN ; Xiaohan ZHANG ; Jianping LIU ; Zhaolan LIU
Journal of Traditional Chinese Medicine 2026;67(14):1491-1496
A natural experiment is a causal inference study design grounded in real-world research. Its core concept is to use quasi-random variation in exposure generated by external factors to evaluate the effects of interventions or exposures on outcomes. It is particularly suitable for research settings in which randomized controlled trials (RCTs) are infeasible or ethically constrained, and it combines causal inference capacity with relatively strong external validity. This article provides an overview of the definition, key features, and current application status of natural experiments, and proposes the application scenarios for applying natural experiment strategies to the evaluation of therapeutic effects in traditional Chinese medicine (TCM), including policy implementation or policy change evaluation, assessment of variations in clinical practice within hospitals, and evaluation of differences in resource allocation across regions or institutions. The design pathway includes starting from clinical or policy-related TCM questions, systematically collecting relevant data, performing statistical modeling and effect estimation, and interpreting effect estimates in the context of clinical practice. It further analyzes the advantages and challenges of using natural experiments in TCM.
8.Advantages,Challenges,and Implementation Pathways of Natural Experiments in Evaluating the Efficacy of Traditional Chinese Medicine
Rihe LIU ; Tingxiu LIU ; Kai LIU ; Yuan SUN ; Xiaohan ZHANG ; Jianping LIU ; Zhaolan LIU
Journal of Traditional Chinese Medicine 2026;67(14):1491-1496
A natural experiment is a causal inference study design grounded in real-world research. Its core concept is to use quasi-random variation in exposure generated by external factors to evaluate the effects of interventions or exposures on outcomes. It is particularly suitable for research settings in which randomized controlled trials (RCTs) are infeasible or ethically constrained, and it combines causal inference capacity with relatively strong external validity. This article provides an overview of the definition, key features, and current application status of natural experiments, and proposes the application scenarios for applying natural experiment strategies to the evaluation of therapeutic effects in traditional Chinese medicine (TCM), including policy implementation or policy change evaluation, assessment of variations in clinical practice within hospitals, and evaluation of differences in resource allocation across regions or institutions. The design pathway includes starting from clinical or policy-related TCM questions, systematically collecting relevant data, performing statistical modeling and effect estimation, and interpreting effect estimates in the context of clinical practice. It further analyzes the advantages and challenges of using natural experiments in TCM.
9.Analysis of Pharmacodynamic Material Basis, Mechanisms, and Efficacy-related Quality Markers of Puerariae Lobatae Radix and Puerariae Thomsonii Radix with Different Therapeutic Effect
Xiaowei MENG ; Zhenzhen YANG ; Wenting WU ; Ronghua LIU ; Yongmei GUAN ; Hui OUYANG ; Liping HUANG ; Yaqi WANG ; Qiong LI ; Huanhuan DONG ; Jianping GONG ; Weifeng ZHU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(18):269-281
Puerariae Lobatae Radix and Puerariae Thomsonii Radix are the dried roots of Pueraria lobata and Pueraria thomsonii of the Leguminosae family, respectively. Since their separate inclusion in the 2005 edition of Pharmacopoeia of the People's Republic of China, the two herbs have been individually recorded. Although they share the same functions and indications, the required content of puerarin differs by a factor of up to eightfold between them. The current quality standard relies solely on a single indicator, puerarin, which fails to reflect the correlation between chemical constituents and core therapeutic effects. This has resulted in prominent issues of mixed use in clinical practice and production, thereby constraining the high-quality development of the industry. Modern research has demonstrated that Puerariae Lobatae Radix contains a comprehensive range and higher content of isoflavonoid constituents, while Puerariae Thomsonii Radix is rich in starch and polysaccharides. Puerariae Lobatae Radix exhibits stronger effects in antipyresis, cardiovascular and cerebrovascular protection, and central analgesia, while Puerariae Thomsonii Radix demonstrates greater advantages in anti-inflammation, hypoglycemia, and peripheral analgesia. Based on this, the chemical material bases of Puerariae Lobatae Radix and Puerariae Thomsonii Radix at both the macromolecule and micromolecule levels were systematically reviewed and compared. The pharmacodynamic material bases and mechanisms of action underlying their three core therapeutic effects, namely "relieving exterior syndrome and clearing heat", "promoting fluid production to quench thirst", and "dredging channels and activating collaterals", were summarized. The most highly correlated common metabolic pathway shared by both herbs for these three therapeutic effects is the arachidonic acid metabolic pathway, and their common core target is prostaglandin-endoperoxide synthase 2 (PTGS2). This review provided clinical application recommendations based on the therapeutic differences between the two herbs, elucidated the scientific connotation of their "same origin but different effects", and, grounded in the quality marker (Q-Marker), proposed the concept of efficacy-related Q-Marker based on "substance-efficacy-syndrome" association, as well as a novel strategy for efficacy-oriented quality evaluation. Preliminary screening of quality markers associated with different therapeutic effects was also conducted. This study aims to provide critical scientific evidence for the precise clinical application of Puerariae Lobatae Radix and Puerariae Thomsonii Radix, the improvement of quality standards, and the high-quality development of the industry.
10.Pharmaceutical services for patients with CTLA-4 haploid deficiency and severe malnutrition
Di LIU ; Jianping CAO ; Hong YU ; Taofeng JIANG ; Xiaobin MENG
China Pharmacy 2026;37(15):2045-2050
OBJECTIVE To provide a reference for clinical pharmacists to participate in the treatment of rare and complex cases of CTLA-4 haploid deficiency combined with severe malnutrition. METHODS The clinical pharmacist participated in the diagnosis and treatment of a complex case of CTLA-4 haploid deficiency with severe malnutrition, type 1 diabetes, blood coagulation abnormalities with gastrointestinal bleeding and virus infection, assisted the doctor to develop an individualized parenteral nutrition program, and dynamically adjusted the ratio of glucose and insulin (from 3.9∶1 to 15.6∶1). When patient had severe coagulation abnormalities and gastrointestinal bleeding, the clinical pharmacist recommended discontinuing fat emulsion and switching to glucose amino acid dual energy supply; when the patient had a high fever accompanied by a sudden drop in platelets, the clinical pharmacist recommended to improve the second-generation sequencing of plasma metagenomics. Based on positive results for both EB virus and cytomegalovirus, the clinical pharmacist recommended to discontinue meropenem and switch to ganciclovir for antiviral treatment; when the patient experienced systemic itching and mental excitement, the clinical pharmacist quickly diagnosed as an adverse reaction of ganciclovir and recommended to switch to acyclovir for antiviral treatment. The clinical pharmacist simultaneously carried out parenteral nutrition medication education, and standardized infusion speed, and continuously monitored bleeding-related indicators. RESULTS The physician adopted the advice of the clinical pharmacist. After comprehensive intervention, the patient’s body temperature returned to normal, gastrointestinal bleeding stopped, coagulation indicators significantly improved, blood sugar control reached the standard, and the condition improved and the patient was discharged. CONCLUSIONS Clinical pharmacists rely on comprehensive pharmaceutical services to balance the benefits and risks of treatment for rare and complex cases. They play a key role in individualized nutrition planning, refined blood glucose control, infection identification and anti-infection optimization, and identification and treatment of adverse drug reactions to ensure patient medication safety and efficacy.

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