1.Herbal Textual Research on Inulae Flos in Famous Classical Formulas
Caixia LIU ; Yue HAN ; Yanzhu MA ; Lei GAO ; Sheng WANG ; Yan YANG ; Wenchuan LUO ; Ling JIN ; Jing SHAO ; Zhijia CUI ; Zhilai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):210-221
In this paper, by referring to ancient and modern literature, the textual research of Inulae Flos has been conducted to clarify the name, origin, production area, quality evaluation, harvesting, processing and others, so as to provide reference and basis for the development and utilization of famous classical formulas containing this herb. After textual research, it could be verified that the medicinal use of Inulae Flos was first recorded in Shennong Bencaojing of the Han dynasty. In successive dynasties, Xuanfuhua has been taken as the official name, and it also has other alternative names such as Jinfeicao, Daogeng and Jinqianhua. The period before the Song and Yuan dynasties, the main origin of Inulae Flos was the Asteraceae plant Inula japonica, and from the Ming and Qing dynasties to the present, I. japonica and I. britannica are the primary source. In addition to the dominant basal species, there are also regional species such as I. linariifolia, I. helianthus-aquatili, and I. hupehensis. The earliest recorded production areas in ancient times were Henan, Hubei and other places, and the literature records that it has been distributed throughout the country since modern times. The medicinal part is its flower, the harvesting and processing method recorded in the past dynasties is mainly harvested in the fifth and ninth lunar months, and dried in the sun, and the modern harvesting is mostly harvested in summer and autumn when the flowers bloom, in order to remove impurities, dry in the shade or dry in the sun. In addition, the roots, whole herbs and aerial parts are used as medicinal materials. In ancient times, there were no records about the quality of Inulae Flos, and in modern times, it is generally believed that the quality of complete flower structure, small receptacles, large blooms, yellow petals, long filaments, many fluffs, no fragments, and no branches is better. Ancient processing methods primarily involved cleaning, steaming, and sun-drying, supplemented by techniques such as boiling, roasting, burning, simmering, stir-frying, and honey-processing. Modern processing focuses mainly on cleaning the stems and leaves before use. Regarding the medicinal properties, ancient texts describe it as salty and sweet in taste, slightly warm in nature, and mildly toxic. Modern studies characterize it as bitter, pungent, and salty in taste, with a slightly warm nature. Its therapeutic effects remain consistent across eras, including descending Qi, resolving phlegm, promoting diuresis, and stopping vomiting. Based on the research results, it is recommended that when developing famous classical formulas containing Inulae Flos, either I. japonica or I. britannica should be used as the medicinal source. Processing methods should follow formula requirements, where no processing instructions are specified, the raw products may be used after cleaning.
2.Herbal Textual Research on Inulae Flos in Famous Classical Formulas
Caixia LIU ; Yue HAN ; Yanzhu MA ; Lei GAO ; Sheng WANG ; Yan YANG ; Wenchuan LUO ; Ling JIN ; Jing SHAO ; Zhijia CUI ; Zhilai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):210-221
In this paper, by referring to ancient and modern literature, the textual research of Inulae Flos has been conducted to clarify the name, origin, production area, quality evaluation, harvesting, processing and others, so as to provide reference and basis for the development and utilization of famous classical formulas containing this herb. After textual research, it could be verified that the medicinal use of Inulae Flos was first recorded in Shennong Bencaojing of the Han dynasty. In successive dynasties, Xuanfuhua has been taken as the official name, and it also has other alternative names such as Jinfeicao, Daogeng and Jinqianhua. The period before the Song and Yuan dynasties, the main origin of Inulae Flos was the Asteraceae plant Inula japonica, and from the Ming and Qing dynasties to the present, I. japonica and I. britannica are the primary source. In addition to the dominant basal species, there are also regional species such as I. linariifolia, I. helianthus-aquatili, and I. hupehensis. The earliest recorded production areas in ancient times were Henan, Hubei and other places, and the literature records that it has been distributed throughout the country since modern times. The medicinal part is its flower, the harvesting and processing method recorded in the past dynasties is mainly harvested in the fifth and ninth lunar months, and dried in the sun, and the modern harvesting is mostly harvested in summer and autumn when the flowers bloom, in order to remove impurities, dry in the shade or dry in the sun. In addition, the roots, whole herbs and aerial parts are used as medicinal materials. In ancient times, there were no records about the quality of Inulae Flos, and in modern times, it is generally believed that the quality of complete flower structure, small receptacles, large blooms, yellow petals, long filaments, many fluffs, no fragments, and no branches is better. Ancient processing methods primarily involved cleaning, steaming, and sun-drying, supplemented by techniques such as boiling, roasting, burning, simmering, stir-frying, and honey-processing. Modern processing focuses mainly on cleaning the stems and leaves before use. Regarding the medicinal properties, ancient texts describe it as salty and sweet in taste, slightly warm in nature, and mildly toxic. Modern studies characterize it as bitter, pungent, and salty in taste, with a slightly warm nature. Its therapeutic effects remain consistent across eras, including descending Qi, resolving phlegm, promoting diuresis, and stopping vomiting. Based on the research results, it is recommended that when developing famous classical formulas containing Inulae Flos, either I. japonica or I. britannica should be used as the medicinal source. Processing methods should follow formula requirements, where no processing instructions are specified, the raw products may be used after cleaning.
3.Analysis of plasma metabonomic characteristics of type 2 diabetes mellitus patients with turbid toxin accumulation syndrome
Ziqi ZHAO ; Pai PANG ; Yue REN ; Bin WANG ; Yuntao MA ; Qianjing YANG ; Shentao WU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(1):34-42
Objective:
To explore the plasma metabonomic characteristics of patients with type 2 diabetes mellitus and turbid toxin accumulation syndrome.
Methods:
One hundred and three patients with type 2 diabetes mellitus and turbid toxin accumulation syndrome were enrolled from November 2023 to February 2024 in the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine and 54 healthy individuals were recruited. The general data of the two groups were analyzed, and the plasma metabolite content was detected using ultra-high performance liquid chromatography-Orbitrap mass spectrometry. Construct an orthogonal partial least squares discriminant analysis model to screen metabolites with significant intergroup changes. The variable importance in projection≥ 1, |log2FC|>1, and P<0.05 were used as the criteria for the screening of differential metabolites. Annotate differential metabolites using internal databases and the human metabolome database, and perform pathway analysis using MetaboAnalyst website.
Results:
There was no statistically significant difference in gender and age between the two groups.Seventeen potential differential metabolites were identified. The D-4′-phosphopantothenate, 2, 6-dichloroindophenol, 4-methylphenol, hypoxanthine, 11, 12-epoxyeicosatrienoic acids, oleamide, 3-phenyllactic acid contents were higher in patients with type 2 diabetes mellitus and turbid toxin accumulation syndrome than in healthy individuals(P<0.05); 3-anisic acid, 3-iodo-octadecanoic acid, mebendazole, β-alanine, citric acid, trans-aconitic acid, geranyl diphosphate, lysophosphatidylcholine(18∶2), phosphatidylethanolamine(18∶1), and caprolactam contents were lower in patients with type 2 diabetes mellitus and turbid toxin accumulation syndrome than in healthy individuals(P<0.05). Ten metabolic pathways were identified, including the key metabolic pantothenate and coenzyme A biosynthesis pathways.
Conclusion
Metabolic differences were observed between patients with type 2 diabetes mellitus and turbid toxin accumulation syndrome and healthy individuals, and the underlying mechanism may involve the pantothenate and coenzyme A biosynthesis pathways, jointly mediated by D-4′-phosphopantothenate and β-alanine.
4.Introduction of the main addition and revision of the Chinese Pharmacopoeia 2025 Edition(Volume Ⅱ)
ZHOU Yi ; WANG Zhijun ; YUE Zhihua ; CHENG Qilei ; YUE Ruiqi ; YANG Xi ; GUO Wei ; MA Shuangcheng
Drug Standards of China 2025;26(1):023-027
The Pharmacopeia of the People’s Republic of China 2025 Edition (referred to as the Chinese Pharmacopoeia 2025 Edition, ChP 2025) will be promulgated and implemented. This article introduces the process of development of ChP 2025 Edition (Volume Ⅱ), including the selection, the revision of general notices,the addition and revision of drug monographs, etc., and provides some analysis and examples to illustrate,which can facilitate the readers to understand and implement the ChP 2025 Edition (Volume Ⅱ).
5.Mechanism of Modified Shaofu Zhuyutang in Antagonising Ectopic Endometrial Tissue Fibrosis Based on Cellular Pyroptosis Mediated by TRL4/NF-κB/NLPR3 Signaling Pathway
Zuoliang ZHANG ; Jiaxing WANG ; Wanrun WANG ; Xiangyu LIN ; Bin YUE ; Zhirui ZHANG ; Yinan WANG ; Yaling YANG ; Dongqing WEI ; Cancan HUANG ; Quansheng WU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):19-28
ObjectiveTo investigate the mechanism of action of modified Shaofu Zhuyutang in antagonizing cellular pyroptosis and fibrosis in ectopic endometrial tissues of endometriosis through the Toll-like receptor 4/nuclear factor-κB/NOD-like receptor protein 3 (TRL4/NF-κB/NLPR3) signaling pathway. MethodsSeventy-two SPF-grade female SD rats were randomly divided into a sham-operated group (n = 12) and a modeling group (n = 60). The rats in the sham-operated group underwent a caesarean section, while the rats in the modeling group were used to establish an endometriosis model through the auto-transplantation method. After successful modeling, the animals were randomly divided into the model group, progesterone group (0.25 mg·kg-1), and modified Shaofu Zhuyutang low-, medium-, and high-dose groups (7.5, 15, 30 g·kg-1), with 12 animals in each group. After 4 weeks of drug administration, voluntary activity and heat pain latency were observed. The rats were sacrificed for tissue collection, and Masson staining were used to observe histopathological changes in the endometrial tissues. Enzyme-linked immunosorbent assay (ELISA) was used to measure serum levels of interleukin-18 (IL-18), interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), and transforming growth factor-β (TGF-β). Immunohistochemistry (IHC) was used to detect the protein expression area of tumor necrosis factor-related factor 6 (TRAF6) and NLPR3 in the endometrial tissues. Immunofluorescence (IF) was used to detect the relative fluorescence intensity of Caspase-1 and gasdermin D (GSDMD) in the endometrial tissues. Western blot was employed to measure the relative expression of TRL4, myeloid differentiation factor 88 (MyD88), TRAF6, NF-κB p65, phosphorylated NF-κB p65 (p-NF-κB p65), and NLPR3 proteins in endometrial tissues. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) was used to detect the mRNA expression of TRL4, MyD88, TRAF6, NF-κB, and NLPR3 in the endometrial tissues. ResultsCompared with the sham-operated group, rats in the model group showed reduced voluntary activity and shorter heat pain latency. Serum levels of IL-18, IL-1β, TNF-α, and TGF-β were elevated. The relative expression areas of TRAF6 and NLPR3 proteins were increased, and the relative fluorescence intensity of Caspase-1 and GSDMD was enhanced. The relative expression of TRL4, MyD88, TRAF6, NF-κB p65, p-NF-κB p65, and NLPR3 proteins, along with the expression of TRL4, MyD88, TRAF6, NF-κB, and NLPR3 mRNA, were significantly increased (P<0.01). Compared with the model group, rats in the progesterone group and the modified Shaofu Zhuyutang medium- and high-dose groups exhibited improved voluntary activity, longer heat pain latency, the fibrosis of endometrial tissue is alleviated. Serum levels of IL-18, IL-1β, TNF-α, and TGF-β were decreased. The relative expression areas of TRAF6 and NLPR3 proteins decreased, and the relative fluorescence intensity of Caspase-1 and GSDMD weakened. The relative expression of TRL4, MyD88, TRAF6, p-NF-κB p65, NLPR3 proteins, and TRL4, MyD88, TRAF6, NF-κB, and NLPR3 mRNA expression were reduced (P<0.05, P<0.01). ConclusionModified Shaofu Zhuyutang may play a therapeutic role in endometriosis by interfering with key proteins in the TRL4/NF-κB/NLPR3 signaling pathway, reducing NLRP3 inflammasome-induced cellular pyroptosis, antagonizing the fibrosis process in ectopic endometrial tissues, improving the inflammatory microenvironment in the pelvic cavity, and alleviating pain.
6.Mechanism of Wenyang Jieyu Prescription in Regulating Activation of Mouse Hippocampal Microglia Based on JAK2/STAT3 Signaling Pathway
Ying WANG ; Zihan GONG ; Wenqing LIANG ; Jingwen YANG ; Guangxin YUE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(8):88-96
ObjectiveTo explore the mechanism of the Wenyang Jieyu prescription in regulating depression-like behavior in mice after maternal-infant separation combined with secondary stress. MethodsAfter birth, the rats were randomly divided into blank (NC) group, maternal-infant separation (MS) group, restraint stress (RS) group, maternal-infant separation combined with restraint stress (MRS) group, Wenyang group, Jieyu group, Wenyang Jieyu (XSF) group, and minocycline group. Maternal-infant separation was performed on day 5 (PD5), followed by weaning at PD21 and prophylactic administration. The dose of Wenyang group, Xiaoyao group, XSF group and minocycline group were 5.85, 12.03, 16.71 g·kg-1 and 50 mg·kg-1, respectively. Restraint stress was applied on PD90. The model was evaluated using glucose, social interaction, open field, and O-maze behavior tests, as well as high-performance liquid chromatography to measure serotonin, dopamine, and other neurotransmitters. The expression level of ionized calcium-binding adaptor molecule-1 (Iba-1) protein, a marker of hippocampal microglia, was detected by immunohistochemistry. Protein expression levels of Janus kinase 2 (JAK2) and signal transducer and activator of transcription 3 (STAT3) in the hippocampus were analyzed by an automatic protein expression analysis system. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) was used to detect mRNA expression levels of M1 markers, JAK2/STAT3 pathway-related genes, and cytokines in hippocampal microglia in each group. ResultsCompared with the NC group, the MRS group exhibited depression-like behavior, with significantly decreased levels of neurotransmitters in the hippocampus (P<0.05, P<0.01), increased expression of Iba-1 (P<0.01), and elevated protein levels of JAK2 and STAT3 (P<0.05). The mRNA expression levels of CD68, CD11b, IL-1β, JAK2, and STAT3 were significantly increased (P<0.01), while IL-10 mRNA expression was significantly decreased (P<0.01). Compared with the MRS group, the XSF and minocycline groups showed some improvement in depression-like behavior. In these groups, the hippocampal neurotransmitter content was significantly increased (P<0.05, P<0.01), and Iba-1 expression was significantly decreased (P<0.01). The protein levels of JAK2 and STAT3 in the XSF group showed a downward trend. The mRNA expression levels of CD68, CD11b, JAK2, STAT3, and IL-1β in the hippocampus were significantly decreased in the XSF and minocycline groups (P<0.05, P<0.01), while IL-10 mRNA expression was significantly increased (P<0.05, P<0.01). ConclusionWenyang Jieyu prescription can regulate depression-like behavior in maternal-infant separation mice combined with secondary stress by inhibiting the polarization of hippocampal microglia to the M1 phenotype. The regulation of hippocampal microglia polarization by Wenyang Jieyu prescription may be associated with the JAK2/STAT3 pathway.
7.Five new triterpenoid saponins from the kernels of Momordica cochinchinensis
Ru DING ; Jia-qi WANG ; Yi-yang LUO ; Yong-long HAN ; Xiao-bo LI ; Meng-yue WANG
Acta Pharmaceutica Sinica 2025;60(2):442-448
Five saponins were isolated from the kernels of
8.Efficacy of Fufang Lingjiao Jiangya Pills with Different Proportions of Goat Horn Replacing Antelope Horn on Spontaneous Hypertensive Rats
Tengjian WANG ; Wanlu ZHAO ; Yang YU ; Yan LIU ; Kun CAO ; Zheyuan LIN ; Yue WU ; Lilan LUO ; Weizhi LAI ; Zhaohuan LOU ; Qiaoyan ZHANG ; Quanlong ZHANG ; Luping QIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):68-78
ObjectiveTo investigate the optimal ratio of goat horn replacing antelope horn in Fufang Lingjiao Jiangya pills and the blood pressure-lowering mechanism of this medicine. MethodsThe blood pressure-lowering efficacy of Fufang Lingjiao Jiangya pills with varying proportions of goat horn replacing antelope horn was evaluated on spontaneous hypertensive rats (SHR). In this experiment, 50 SHR rats were randomly grouped as follows: model (n=8), captopril (0.01 g·kg-1) (n=6), low-dose blank Fufang Lingjiao Jiangya pills (0.342 g·kg-1) (n=6), high-dose blank Fufang Lingjiao Jiangya pills (0.684 g·kg-1) (n=6), low-dose antelope horn-containing Fufang Lingjiao Jiangya pills (0.378 g·kg-1) (n=6), high-dose antelope horn-containing Fufang Lingjiao Jiangya pills (0.756 g·kg-1) (n=6), low-dose goat horn-containing Fufang Lingjiao Jiangya pills (0.378 g·kg-1) (n=6), and high-dose goat horn-containing Fufang Lingjiao Jiangya pills (0.756 g·kg-1) (n=6). Additionally, 8 WKY rats were used as the normal group. Drugs were administered by gavage for 4 weeks while an equal volume of distilled water was administered for the normal and model groups. Blood pressure was measured before administration, 3 h post administration, and biweekly thereafter. In the experiment for Fufang Lingjiao Jiangya pills with goat horn replacing antelope horn in different proportions, 48 SHR rats were randomly grouped as follows: model, blank Fufang Lingjiao Jiangya pills (0.684 g·kg-1), antelope horn-containing Fufang Lingjiao Jiangya pills (0.756 g·kg-1), 2× goat horn-containing Fufang Lingjiao Jiangya pills (0.824 g·kg-1), 4× goat horn Fufang Lingjiao Jiangya pills (0.969 g·kg-1), and 6× goat horn Fufang Lingjiao Jiangya pills (1.112 g·kg-1). The normal group included 8 WKY rats, and the normal group and model group received an equal volume of distilled water. The treatment lasted for 2 weeks, and blood pressure was recorded at various time points (pre-administration, 3 h post administration, and on days 4, 7, 10, and 14 of administration). Serum levels of angiotensin-converting enzyme (ACE), angiotensin Ⅱ(Ang Ⅱ), renin, and interleukin-6 (IL-6) were measured by enzyme-linked immunosorbent assay. Histopathological changes in the heart, kidney, and thoracic aorta were observed by hematoxylin-eosin staining. The protein levels of ACE2, angiotensin Ⅱ type 1 receptor (AT1R), and angiotensinogen (AGT) in the kidney tissue were determined by Western blot, while the expression of nuclear factor (NF)-κB p65 and Toll-like receptor 4 (TLR4) in the thoracic aorta tissue was assessed by immunohistochemistry. ResultsCompared with the model group, all treatment groups showed lowered blood pressure (P<0.05, P<0.01), and the 6× goat horn-containing Fufang Lingjiao Jiangya pills group showed consistent blood pressure-lowering effect with the antelope horn-containing Fufang Lingjiao Jiangya pills group. Compared with the normal group, the model group showed elevated serum levels of ACE, Ang Ⅱ, renin, and IL-6, while the elevations were declined in the Fufang Lingjiao Jiangya pills groups (P<0.05, P<0.01). Pathological changes in the heart, kidney, and thoracic aorta were alleviated in all the treatment groups, with the 6× goat horn- and antelope horn-containing Fufang Lingjiao Jiangya pills groups exhibited the best effect. Western blot and immunohistochemistry results showed that all the treatment groups exhibited down-regulated protein levels of AT1R, AGT, NF-κB p65, and TLR4 and up-regulated protein levels of ACE2 (P<0.05, P<0.01) compared with model group, with the 6×goat horn- and antelope horn-containing Fufang Lingjiao Jiangya pills groups showcasing the best effect. ConclusionReplacing antelope horn with 6×goat horn in Fufang Lingjiao Jiangya pills can achieve consistent blood pressure-lowering effect with the original prescription. The prescription may exert the effect by inhibiting the renin-angiotensin-aldosterone system (RAAS) and TLR4/NF-κB signaling pathways.
9.Bufei Tongbi Decoction Inhibits Pulmonary Fibrosis in Diabetic Rats via TGF-β1/p-Smad3 Signaling Pathway
Gang WANG ; Rensong YUE ; Qiyue YANG ; Dan ZHANG ; Xin CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(10):176-184
ObjectiveTo study the effect of Bufei Tongbi decoction on pulmonary fibrosis in diabetic rats via the transforming growth factor-β1 (TGF-β1)/phosphorylated Smad family member 3 (p-Smad3) signaling pathway. MethodsStreptozotocin (60 mg·kg-1) and bleomycin (24.80 U·kg-1) were used to prepare the rat model of diabetes with pulmonary fibrosis by intratracheal injection. Sixty rats were randomly assigned into blank, model, low-, medium-, and high-dose (3.98, 7.95, and 15.90 g·kg-1, respectively) Bufei Tongbi decoction, and pirfenidone (0.36 mg·kg-1) groups (n=10). The successfully modeled rats in each group were administrated with corresponding agents once per day for four consecutive weeks. After drug administration, fasting blood glucose and lung function indicators were measured. Chemical immunoassay was employed to determine the serum levels of hydroxyproline (Hyp), hyaluronic acid (HA), and laminin (LN). The lung index was determined by the wet and dry methods. The pathological changes in the lung tissue were observed by hematoxylin-eosin (HE) staining, and the degree of fibrosis was detected by Masson staining. The mRNA and protein levels of TGF-β1, p-Smad3, Smad3, α-smooth muscle actin (α-SMA), collagen type Ⅰ alpha 1 (Col1A1), and fibronectin were determined by PCR and Western blotting, respectively. ResultsCompared with the blank group, the model group showed alveolar septa thickening, obvious thickening of the basement membrane of pulmonary blood vessels, severe destruction of the alveolar structure, structural disarrangement of the lung parenchyma, and an increase in the proportion of inflammatory cell infiltration in the lung tissue, together with a large amount of blue collagen deposition and a large amount of collagen fibroplasia in the bronchial wall, vessel wall, interstitium, and alveolar wall, which indicated severe fibrosis. Bufei Tongbi decoction groups and the pirfenidone group showed lower fasting blood glucose level (P<0.05) and higher forced vital capacity (FVC), cytoplasmic dynein (Cydn), FEV0.3/FEV ratio, and lung index (P<0.05) than the model group. Moreover, these groups demonstrated alleviated lung fibrosis, elevated Hyp, HA, and LN levels, down-regulated mRNA levels of α-SMA, Col1A1, and fibronectin, and down-regulated protein levels of TGF-β1, Smad3, p-Smad3, α-SMA, Col1A1, and fibronectin (P<0.05). ConclusionBufei Tongbi decoction can inhibit pulmonary fibrosis in diabetic rats by inhibiting the TGF-β1/p-Smad3 signaling pathway.
10.Effects of Modified Guomin Decoction (加味过敏煎) on Traditional Chinese Medicine Syndromes and Quality of Life in Patients with Mild to Moderate Atopic Dermatitis of Heart Fire and Spleen Deficiency Pattern:A Randomized,Double-Blind,Placebo-Controlled Trial
Jing NIE ; Rui PANG ; Lingjiao QIAN ; Hua SU ; Yuanwen LI ; Xinyuan WANG ; Jingxiao WANG ; Yi YANG ; Yunong WANG ; Yue LI ; Panpan ZHANG
Journal of Traditional Chinese Medicine 2025;66(10):1031-1037
ObjectiveTo observe the clinical efficacy and safety of Modified Guomin Decoction (加味过敏煎, MGD) in patients with mild to moderate atopic dermatitis (AD) of the traditional Chinese medicine (TCM) pattern of heart fire and spleen deficiency, and to explore its possible mechanisms. MethodsIn this randomized, double-blind, placebo-controlled study, 72 patients with mild to moderate AD and the TCM pattern of heart fire and spleen deficiency were randomly divided into a treatment group and a control group, with 36 cases in each group. The treatment group received oral MGD granules combined with topical vitamin E emulsion, while the control group received oral placebo granules combined with topical vitamin E treatment. Both groups were treated twice daily for 4 weeks. Clinical efficacy, TCM syndrome scores, Visual Analogue Scale (VAS) for pruritus, Dermatology Life Quality Index (DLQI) scores, Scoring Atopic Dermatitis (SCORAD) and serum biomarkers, including interleukin-33 (IL-33), interleukin-1β (IL-1β), immunoglobulin E (IgE), and tumor necrosis factor-α (TNF-α) were compared before and after treatment. Safety indexes was also assessed. ResultsThe total clinical effective rates were 77.78% (28/36) in the treatment group and 38.89% (14/36) in the control group, with cure rates of 19.44% (7/36) and 2.78% (1/36), respectively. The treatment group showed significantly better clinical outcomes compared to the control group (P<0.05). The treatment group exhibited significant reductions in total TCM syndrome scores, including erythema, edema, papules, scaling, lichenification, pruritus, irritability, insomnia, abdominal distension, and fatigue scores, as well as reductions in VAS, DLQI, SCORAD, and serum IgE and IL-33 levels (P<0.05 or P<0.01). Compared to the control group, the treatment group had significantly better improvements in all indicators except for insomnia (P<0.05). No adverse events occurred in either group. ConclusionMGD is effective and safe in treating mild to moderate AD patients with heart fire and spleen deficiency pattern. It significantly alleviates pruritus, improves TCM syndromes and quality of life, and enhances clinical efficacy, possibly through modulation of immune responses.


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