1.Mechanisms of Qizhujianwei Granules in Blocking Malignant Progression of Gastric Intraepithelial Neoplasia
Yuling YU ; Yanmin WANG ; Siqi WANG ; Yateng SUN ; Yunhe WANG ; Yonghuang YAN ; Xinyu YANG ; Siqi HAN ; Yuhong SONG ; Yuhan WANG ; Cai ZHANG ; Zeqi SU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):143-151
ObjectiveTo investigate the effects of Qizhujianwei granules (QZJW) on abnormal proliferation and malignant transformation of gastric mucosal cells in rats with gastric intraepithelial neoplasia (GIN) and to explore the related mechanisms. MethodsA total of 80 SPF male Wistar rats were used. A GIN rat model was established using a four-factor comprehensive method consisting of methylnitronitrosoguanidine (MNNG), ranitidine, irregular feeding patterns, and sodium salicylate. Except for the normal group, after successful modeling, the rats were randomly divided according to body weight into a model group, a Moluodan group (0.55 g·kg-1), and a QZJW group (7.34 g·kg-1), with 12 rats in each group. All groups were treated for 8 weeks. The general characteristics of the rats and morphological changes of the gastric mucosa were observed. Histopathological changes of the gastric mucosa were examined by hematoxylin-eosin (HE) staining. Enzyme-linked immunosorbent assay (ELISA) was used to detect serum levels of pepsinogenⅠ (PGⅠ), pepsinogenⅡ (PGⅡ), and gastrin (G-17), as well as the expression level of transforming growth factor-β1 (TGF-β1) in gastric mucosal tissue, and the PGⅠ/PGⅡ ratio was calculated. Immunohistochemistry (IHC) was used to detect the localization and expression levels of proliferating cell nuclear antigen (Ki-67) and Vimentin in gastric mucosal tissue. Western blot analysis was used to determine the protein expression levels of Wnt family member 3A (Wnt3a), β-catenin, CyclinD1, proto-oncogene Cmyc, transforming growth factor-β receptor Ⅰ (TGFβRⅠ), intracellular signaling transducers Smad2/3, phosphorylated (p)-Smad2/3, twist family transcription factor (Twist1), and Vimentin in gastric mucosal tissue. ResultsCompared with the normal group, the model group showed characteristic changes including dim eyes, pale ears and claws, dark-red tongue, and reduced luster of the tail. The gastric mucosa appeared pale, with surface congestion and erosion. The gastric mucosal glands were disordered, the nuclear-to-cytoplasmic ratio increased, and local tumor cells were observed. Serum PGⅠ and PGⅡ levels and the PGⅠ/PGⅡ ratio were significantly decreased (P<0.01), while the level of G-17 was significantly increased (P<0.01). The protein expression levels of Ki-67, Wnt3a, β-catenin, CyclinD1, Cmyc, TGF-β1, TGFβRⅠ, Smad2/3, Twist1, and Vimentin in gastric mucosal tissue were significantly increased (P<0.05, P<0.01), whereas the ratio of p-Smad2/3 to Smad2/3 was significantly decreased (P<0.05). Compared with the model group, the general characteristics and gastric mucosal conditions of rats in the Moluodan group and the QZJW group were improved. HE staining showed that QZJW could effectively block the malignant progression of GIN. Serum PGⅠ and PGⅡ levels and the PGⅠ/PGⅡ ratio were significantly increased (P<0.05, P<0.01), while the level of G-17 was significantly decreased (P<0.01). The protein expression levels of Ki-67, Wnt3a, β-catenin, CyclinD1, Cmyc, TGF-β1, TGFβRⅠ, Smad2/3, Twist1, and Vimentin in gastric mucosal tissue were significantly decreased (P<0.05, P<0.01). ConclusionQZJW have a therapeutic effect on rats with GIN. The mechanism may involve inhibition of the Wnt/β-catenin signaling pathway to regulate the cell cycle and suppress abnormal cell proliferation. Meanwhile, it may inhibit epithelial-mesenchymal transition by suppressing the TGF-β1/Smad/Twist1 signaling pathway, thereby blocking the malignant progression of GIN.
2.Mechanisms of Qizhujianwei Granules in Blocking Malignant Progression of Gastric Intraepithelial Neoplasia
Yuling YU ; Yanmin WANG ; Siqi WANG ; Yateng SUN ; Yunhe WANG ; Yonghuang YAN ; Xinyu YANG ; Siqi HAN ; Yuhong SONG ; Yuhan WANG ; Cai ZHANG ; Zeqi SU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):143-151
ObjectiveTo investigate the effects of Qizhujianwei granules (QZJW) on abnormal proliferation and malignant transformation of gastric mucosal cells in rats with gastric intraepithelial neoplasia (GIN) and to explore the related mechanisms. MethodsA total of 80 SPF male Wistar rats were used. A GIN rat model was established using a four-factor comprehensive method consisting of methylnitronitrosoguanidine (MNNG), ranitidine, irregular feeding patterns, and sodium salicylate. Except for the normal group, after successful modeling, the rats were randomly divided according to body weight into a model group, a Moluodan group (0.55 g·kg-1), and a QZJW group (7.34 g·kg-1), with 12 rats in each group. All groups were treated for 8 weeks. The general characteristics of the rats and morphological changes of the gastric mucosa were observed. Histopathological changes of the gastric mucosa were examined by hematoxylin-eosin (HE) staining. Enzyme-linked immunosorbent assay (ELISA) was used to detect serum levels of pepsinogenⅠ (PGⅠ), pepsinogenⅡ (PGⅡ), and gastrin (G-17), as well as the expression level of transforming growth factor-β1 (TGF-β1) in gastric mucosal tissue, and the PGⅠ/PGⅡ ratio was calculated. Immunohistochemistry (IHC) was used to detect the localization and expression levels of proliferating cell nuclear antigen (Ki-67) and Vimentin in gastric mucosal tissue. Western blot analysis was used to determine the protein expression levels of Wnt family member 3A (Wnt3a), β-catenin, CyclinD1, proto-oncogene Cmyc, transforming growth factor-β receptor Ⅰ (TGFβRⅠ), intracellular signaling transducers Smad2/3, phosphorylated (p)-Smad2/3, twist family transcription factor (Twist1), and Vimentin in gastric mucosal tissue. ResultsCompared with the normal group, the model group showed characteristic changes including dim eyes, pale ears and claws, dark-red tongue, and reduced luster of the tail. The gastric mucosa appeared pale, with surface congestion and erosion. The gastric mucosal glands were disordered, the nuclear-to-cytoplasmic ratio increased, and local tumor cells were observed. Serum PGⅠ and PGⅡ levels and the PGⅠ/PGⅡ ratio were significantly decreased (P<0.01), while the level of G-17 was significantly increased (P<0.01). The protein expression levels of Ki-67, Wnt3a, β-catenin, CyclinD1, Cmyc, TGF-β1, TGFβRⅠ, Smad2/3, Twist1, and Vimentin in gastric mucosal tissue were significantly increased (P<0.05, P<0.01), whereas the ratio of p-Smad2/3 to Smad2/3 was significantly decreased (P<0.05). Compared with the model group, the general characteristics and gastric mucosal conditions of rats in the Moluodan group and the QZJW group were improved. HE staining showed that QZJW could effectively block the malignant progression of GIN. Serum PGⅠ and PGⅡ levels and the PGⅠ/PGⅡ ratio were significantly increased (P<0.05, P<0.01), while the level of G-17 was significantly decreased (P<0.01). The protein expression levels of Ki-67, Wnt3a, β-catenin, CyclinD1, Cmyc, TGF-β1, TGFβRⅠ, Smad2/3, Twist1, and Vimentin in gastric mucosal tissue were significantly decreased (P<0.05, P<0.01). ConclusionQZJW have a therapeutic effect on rats with GIN. The mechanism may involve inhibition of the Wnt/β-catenin signaling pathway to regulate the cell cycle and suppress abnormal cell proliferation. Meanwhile, it may inhibit epithelial-mesenchymal transition by suppressing the TGF-β1/Smad/Twist1 signaling pathway, thereby blocking the malignant progression of GIN.
3.Optimization of Extraction Process and Material Basis Analysis of Modified Banxia Xiexintang
Yuling LIU ; Ruying TANG ; Dongxue ZHENG ; Qiling ZHANG ; Xinmin LIU ; Donghan BAI ; Longfei LIN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):129-139
ObjectiveTo optimize and validate the optimal sequential alcohol-water extraction process of modified Banxia Xiexintang(MBXT) based on pharmacodynamic evaluation, combined with the G1-entropy weight method and Box-Behnken response surface methodology, and to systematically and comprehensively analyze the material basis of this formula, providing a scientific basis for its quality control and industrial production. MethodsRats were randomly divided into the normal group, model group, metformin group, and MBXT water extraction, water extraction and ethanol precipitation, sequential ethanol-water extraction groups. Except for the normal group, a polycystic ovary syndrome with insulin resistance(PCOS-IR) model was established in all rats via a high-fat diet combined with letrozole induction. Enzyme-linked immunosorbent assay(ELISA) biochemical assay kits and hematoxylin-eosin(HE) staining were used to compare sex hormone levels in serum and ovarian histopathology, thereby screening extraction process routes. Based on this, a comprehensive score was constructed using the G1-entropy weight method based on the transfer rates of index components(berberine hydrochloride and baicalin) and the dry extract rate. Box-Behnken response surface methodology was then utilized to optimize the extraction process parameters. Finally, the chemical constituents of the sample from the optimal process were qualitatively analyzed by ultra-performance liquid chromatography-quadrupole-electrostatic field orbitrap mass spectrometry(UPLC-Q-Orbitrap-MS). ResultsPharmacodynamic findings revealed that compared with the normal group, serum testosterone(T) and luteinizing hormone(LH) levels were significantly elevated in the model group, while estradiol(E2) and follicle-stimulating hormone(FSH) levels were significantly decreased(P<0.01), with polycystic changes observed in ovarian tissues. Compared with the model group, all treatment groups significantly reversed the changes in sex hormone levels, with the sequential ethanol-water extraction group showing the optimal effect in improving the aforementioned indicators and pathological morphology, followed by subsequent process optimization. The optimized process involved adding 12 times the amount of 70% ethanol for extracting twice, each lasting 120 min, and adding 12 times the amount of water for extracting thrice, each lasting 90 min. Validation test results showed that under optimal process conditions, the average transfer rates of berberine hydrochloride and baicalin were 76.05% and 93.38%, respectively. MS analysis identified a total of 377 compounds, including 112 flavonoids, 41 terpenoids, 28 organic acids, 22 coumarins, and 8 alkaloids, while elucidating the cleavage patterns of key components. ConclusionThe optimized sequential ethanol-water extraction process is stable and feasible, effectively preserving the material basis of MBXT for treating PCOS-IR. It further clarifies the main chemical composition of this formula, providing a scientific basis for the development and quality control of its preparations.
4.Exploring Mechanism of Modified Banxia Xiexintang in Ameliorating Metabolic Disorders and Reproductive Function in PCOS-IR Rats Based on Metabolomics and Transcriptomics
Donghan BAI ; Ruying TANG ; Longfei LIN ; Yuling LIU ; Dongxue ZHENG ; Qiling ZHANG ; Xinmin LIU ; Hui LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):140-149
ObjectiveTo evaluate the therapeutic effects of modified Banxia Xiexintang(MBXT) on polycystic ovary syndrome with insulin resistance(PCOS-IR) rats and reveal its potential mechanisms based on the integrated analysis of transcriptomics and metabolomics. MethodsFemale SD rats were selected, and a PCOS-IR model was established by intragastric administration of letrozole combined with a high-fat diet for 21 days. The modeled rats were randomly divided into the model group, MBXT low-, medium-, and high-dose groups(6.62, 13.23, 26.46 g·kg-1), and metformin group(0.158 g·kg-1), with a normal group set up separately. After 14 days of administration, the estrous cycle was observed, ovarian morphology was examined by hematoxylin-eosin(HE) staining, and the levels of testosterone(T), estradiol(E2), follicle-stimulating hormone(FSH), and luteinizing hormone(LH) in serum were detected by enzyme-linked immunosorbent assay(ELISA). Serum metabolites and ovarian tissue gene expression were detected using ultra-performance liquid chromatography-quadrupole-electrostatic orbitrap mass spectrometry(UPLC-Q-Orbitrap-MS) and RNA-Seq technology, respectively, followed by multi-omics integrated analysis. ResultsPharmacodynamic findings revealed that all MBXT dose groups could reversed abnormal estrous cycles in PCOS-IR rats, improve polycystic ovarian lesions, and normalize dysregulated serum hormone levels(T, LH, E2, FS, P<0.05, P<0.01). Metabolomic analysis revealed that compared with the model group, MBXT reversed 278 differential metabolites such as estrone and S-formylglutathione, mainly involving pathways such as steroid hormone biosynthesis, glutathione metabolism, and lipid peroxidation regulation. Transcriptomic analysis identified 434 differentially expressed genes, and enrichment analysis revealed that MBXT significantly regulated lipid peroxidation defense systems, including glutathione metabolism, peroxisome function, and fatty acid metabolism, thereby intervening in ferroptosis processes. It also engaged in inflammation-related pathways such as the chemokine signaling pathway. Integrated analysis revealed that both metabolomics and transcriptomics co-enriched metabolic pathways associated with ferroptosis and fatty acid metabolism. And key Hub genes[such as Ras-related C3 botulinum toxin substrate 2 gene(Rac2) and Fas ligand gene(Faslg)] showed significant correlations with differential metabolites. ConclusionMBXT can effectively ameliorate reproductive dysfunction and metabolic disorders in PCOS-IR rats. Its mechanism may be related to remodeling the immune-metabolism network, particularly by regulating MHC-mediated immune responses, inhibiting local ovarian ferroptosis, and enhancing steroid hormone synthesis pathways.
5.Investigation on Mechanism of Modified Banxia Xiexintang in Improving Ovarian Dysfunction of PCOS-IR Rats by Inhibiting Ferroptosis via AMPK/FASN/GPX4 Signaling Pathway
Donghan BAI ; Ruying TANG ; Longfei LIN ; Yuling LIU ; Dongxue ZHENG ; Qiling ZHANG ; Xinmin LIU ; Hui LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):150-160
ObjectiveTo investigate the mechanism of modified Banxia Xiexintang(MBXT) in improving ovarian dysfunction in polycystic ovary syndrome with insulin resistance(PCOS-IR) rats by inhibiting ferroptosis through the adenosine monophosphate(AMP)-activated protein kinase(AMPK)/fatty acid synthase(FASN)/glutathione peroxidase 4(GPX4) signaling pathway. MethodsSeventy-six female SD rats were randomly divided into a normal group(n=13) and a modeling group(n=63). The modeling group established a PCOS-IR model by intragastric administration of letrozole combined with a high-fat diet for 21 days. After successful modeling, these rats were randomly divided into the model group, MBXT low-, medium-, and high-dose groups(6.62, 13.23, 26.46 g·kg-1), metformin group(0.158 g·kg-1), and high-dose of MBXT combined with ferroptosis inducer Erastin group(15 mg·kg-1), with 10 rats in each group. After 14 days of intervention, ovarian pathological morphology was observed by hematoxylin-eosin(HE) staining, the mitochondrial ultrastructure of granulosa cells was observed by transmission electron microscopy(TEM), ovarian reactive oxygen species(ROS) levels were detected by dihydroethidium(DHE) probe, biochemical methods were used to detect Fe2+, malondialdehyde(MDA), glutathione(GSH) and other indicators in ovarian tissues, serum sex hormone and insulin levels were measured by enzyme-linked immunosorbent assay(ELISA), and the protein expressions of AMPK, FASN, acyl-CoA synthetase long-chain family member 4(ACSL4), GPX4, and solute carrier family 7 member 11(SLC7A11) in ovarian tissues were detected by Western blot. ResultsCompared with the normal group, the model group showed polycystic changes in the ovaries, with atrophy of mitochondria in granulosa cells and increased membrane density. Serum levels of testosterone(T), luteinizing hormone(LH), and insulin were significantly increased(P<0.01). The levels of ROS, MDA, 4-hydroxynonenal(4-HNE), and Fe2+ in ovarian tissues were significantly elevated(P<0.01), while adenosine triphosphate(ATP), GSH, and reduced nicotinamide adenine dinucleotide phosphate (NADPH) levels were significantly decreased(P<0.01). The phosphorylation levels of AMPK and acetyl-CoA carboxylase (ACC), as well as the protein expressions of SLC7A11, GPX4, and ferroptosis suppressor protein 1(FSP1) were significantly downregulated(P<0.01), whereas the expressions of FASN, ACSL4, and nuclear receptor coactivator 4(NCOA4) were significantly upregulated(P<0.01). Compared with the model group, MBXT intervention at various doses improved the above pathological changes and biochemical indicators in a dose-dependent manner, with the high-dose group showing the most significant effect(P<0.01). Compared with the MBXT high-dose group, the high-dose of MBXT combined with ferroptosis inducer Erastin group restored ovarian ferroptosis characteristics in rats, with increased ROS and lipid peroxidation products, and altered expressions of key proteins(P<0.05, P<0.01). ConclusionMBXT can effectively improve ovarian function and metabolic disorders in PCOS-IR rats. Its mechanism may be related to activating the AMPK/ACC signaling pathway, downregulating FASN and ACSL4 to reduce lipid peroxidation substrates, and restoring glucose-6-phosphate dehydrogenase/phosphoglycerate dehydrogenase(G6PD/PHGDH) metabolic flux to enhance the GPX4/FSP1 antioxidant defense system, thereby inhibiting ferroptosis in ovarian granulosa cells.
6.Genetic Transformation for Medicinal Plants: A Review
Haoxiyu ZHANG ; Longfei LIN ; Yuan YUAN ; Yuling LIU ; Hui LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):323-330
Medicinal plants, with diverse species, high heterozygosity, and special breeding objectives, can be hardly bred with conventional hybridization techniques. Plant genetic transformation is highly selective and can specifically change the traits of plants, serving as an important technical means for the breeding of medicinal plants. The commonly used plant genetic transformation technologies include Agrobacterium-mediated transformation and particle bombardment. Agrobacterium-mediated transformation is the most widely used method, while it is not applicable to all medicinal plants due to the high specificity. Although not specific, particle bombardment is limited in application due to the low conversion efficiency and external force damage to cells and tissue. With the rise and development of nanotechnology, the emerging nanomaterial-mediated transformation has solved the problems of the above two technologies. However, limited by its late development, the mechanism of nanomaterial-mediated introduction of genetic materials into plant cells remains unclear, and thus this technology is rarely used in medicinal plants. This article summarizes the development status of several commonly used or emerging plant genetic transformation technologies such as Agrobacterium-mediated transformation, particle bombardment, and nanomaterial-mediated transformation, as well as their application in different medicinal plants. Furthermore, this article looks forward to the development trend of genetic transformation technologies for plants and their application prospects in medicinal plants and Chinese materia medica resources, aiming to provide new technical ideas for the genetic improvement and germplasm innovation of medicinal plants and inject new impetus into the sustainable development of Chinese materia medica resources.
7.Effect of traditional Chinese medicine on ICIs treatment based on regulation of intestinal flora
Hua ZHANG ; Shansi ZOU ; Yaling ZHANG ; Ranpei ZHU ; Xiaoqing LI ; Yuling ZHENG
Chinese Journal of Immunology 2025;41(3):760-766
With the advent of era of tumor immunotherapy,effect of intestinal flora in immunotherapy has attracted much attention.A large number of studies have confirmed the role of traditional Chinese medicine in regulating intestinal flora.Based on this,this paper discusses and summarizes the effect and mechanism of traditional Chinese medicine intervention on tumor immune checkpoint inhibitors(ICIs)treatment,providing a theoretical basis for in-depth understanding of the correlation between traditional Chinese medicine,intestinal flora and immunotherapy,and also providing new ideas for improving the efficacy of tumor immunotherapy and reducing immune-related adverse reactions.
8.Research on the transdermal delivery of triptolide encapsulated in hyaluronic acid-phospholipid micelles for the treatment of psoriasis
Xiaoli WANG ; Xiangyi LIU ; Xiaohui NING ; Zhenhai ZHANG ; Yuling WANG ; Yu BAO ; Huixia LYU ; Peiwei ZHU
Journal of China Pharmaceutical University 2025;56(6):719-728
Psoriasis, a chronic, immune-mediated inflammatory disease characterized by hyperproliferation of keratinocytes, is difficult to cure and prone to relapse, often leading to systemic damage. Triptolide (TPL) can modulate cutaneous immune responses and inflammation, yet its therapeutic window is narrow with significant toxicity. To enhance skin targeting and retention of TPL while reducing systemic absorption and toxicity, a TPL/hyaluronic acid/phospholipid polymeric micelle (TPL/HA-DOPE) was constructed via HA's targeting of the CD44 receptor on skin cells. The prepared TPL/HA-DOPE exhibited a uniform spherical morphology with particle size of (130.4±1.23) nm, drug loading capacity of (19.74±0.084) %, and encapsulation efficiency of (85.53±1.34) %. Transdermal permeation studies in vitro and in vivo demonstrated that TPL/HA-DOPE not only enhanced uptake in HaCaT cells but also exhibited excellent skin retention. In a murine model of psoriasis, the TPL/HA-DOPE gel at the dose of 50 μg/(kg•d) showed the most significant improvement in erythema, scaling, and epidermal thickening. Histological analysis confirmed that TPL/HA-DOPE markedly reduced stratum corneum thickness, epidermal hyperplasia, and inflammatory cell infiltration. Ki67 immunostaining proved that its anti-inflammatory mechanism might be achieved by reducing the number of Ki67-positive cells and lowering the levels of inflammatory factors IL-6 and TNF-α. The above results demonstrate that HA-DOPE as a drug delivery carrier for the treatment of psoriasis-like skin diseases has high value of scientific research and good prospects for clinical application.
9.Analysis of the mechanism of Zangjiangzhi capsule in the treatment of hyperlipidemia based on its ingredients identified by UHPLC-Q-Exactive-Orbitrap-MS
Changting He ; Yuling Zhao ; Yongchun Huang ; Yudong Su ; Shoude Zhang
Journal of Traditional Chinese Medical Sciences 2025;2025(1):44-55
Objective:
To explore the mechanism of action of Zangjiangzhi capsule (ZJZC) in treating hyperlipidemia (HLP).
Methods:
The components of ZJZC were analyzed and identified using ultra-high performance liquid chromatography with Q-Exactive Orbitrap tandem mass spectrometry (UHPLC-Q-Exactive-Orbitrap-MS/MS). Network pharmacology analysis was used to explore the mechanism of action of ZJZC in HLP treatment. The SwissTargetPrediction database was used to predict compound targets, and GeneCards, DisGeNet, OMIM, and DRUGBANK databases were used to identify HLP-related targets. Protein–protein interaction diagrams were constructed using the STRING database. The targets were subjected to gene ontology and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analysis. The “herb-ingredient-target” network was visualized using Cytoscape. Preliminary validation was performed using molecular docking and enzyme-linked immunosorbent assay.
Results:
Ninety compounds were identified in ZJZC, including 34 flavonoids, 12 phenols, 10 terpenoids, 10 alkaloids, 8 organic acids, 8 anthraquinones, and 9 other compounds. In total, 904 targets were identified for these compounds. Among them, 158 targets intersected with the HLP target network. Network pharmacology analysis showed that MAPK1, PPAR-α, RXRA, HSP90AA1, PIK3R1, AKT1, PIK3CA, IL6, TNF, and ESR1 are the key targets of action. KEGG enrichment analysis identified 164 pathways. Among these, the AGE-RAGE signaling pathway in diabetic complications, lipid and atherosclerosis pathways, regulation of lipids in adipocytes, and insulin resistance are related to HLP. Molecular docking showed good affinity between the key targets and ingredients. Further, ZJZC treatment in mice resulted in lower expression of MAPK1 protein and increased expression of PPAR-α protein, which have been shown to be strongly associated with HLP.
Conclusions
This study showed that ZJZC contains various active ingredients and can modulate multiple targets and pathways associated with HLP, providing evidence at the molecular level for its clinical application in the treatment of HLP.
10.Multi-center clinical study on the efficacy and safety of combined lienal polypeptide injection therapy in children with Mycoplasma pneumoniae pneumonia
Qi CHENG ; Yunxiao SHANG ; Han ZHANG ; Jiujun LI ; Ning CHEN ; Lishen SHAN ; Nan YANG ; Lihua NING ; Xuemei BAI ; Jianhua LIU ; Yuling HAN ; Jichun WANG ; Jing LI ; Yong FENG ; Liyun LIU ; Li CHEN ; Si LIU ; Qinzhen ZHANG ; Jia ZHENG ; Fengchao LI ; Sukun LU ; Yun ZHANG ; Xiaoyi CHAI
International Journal of Pediatrics 2025;52(3):204-210
Objective:To observe the efficacy and safety of combined lienal polypeptide injection therapy in the treatment of Mycoplasma pneumoniae pneumonia(MPP)in children aged 3 to 14 years old in multiple clinical centers.Methods:A randomized,controlled,multi-center clinical study design was adopted.A total of 240 hospitalized children aged 3 to 14 years old with MPP from 7 hospitals from September 1,2023 to January 31,2024 were included.According to the severity of pneumonia,they were divided into the mild MPP group with 80 cases and the severe MPP/refractory MPP(SMPP/RMPP)group with 160 cases,and then randomly divided into the control group and the experimental group at a ratio of 1 ∶1,using the random number table method.After screening,subjects entered a treatment period of 5 to 7 days.The control group was treated with azithromycin,while the experimental group was treated with azithromycin plus lienal polypeptide injection .The recovery of lung CT,length of hospital stay,duration of fever,cough score,whether mild cases developed into severe or refractory cases,duration of hormone use,use of intravenous immunoglobulin(IVIG),bronchoscopy treatment,and immune function were observed between the two groups to evaluate the efficacy of lienal polypeptide injection.Adverse events after medication,vital signs,blood routine,urine routine,liver function,myocardial enzymes,renal function,and electrocardiogram were observed to evaluate the safety. Results:A total of 231 subjects have completed the trial in the 7 hospitals,including 118 cases in the experimental group and 113 cases in the control group.Main observation index:the rate of lung CT aggravation in the experimental group was lower than that in the control group(2.6% vs 15.3%, P<0.01),and the difference was statistically significant.Secondary indexes:there were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and immunoglobulin between the two groups(all P>0.05).However,the rate of cases of plastic bronchitis(PB)found under bronchoscopy in the experimental group was lower than that in the control group(0 vs 18.8%, P=0.03),and the difference was statistically significant.Among the mild MPP(72 cases),there were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and the improvement rate of lung CT between the two groups(all P>0.05).However,compared with the control group,the rate of cases developing into SMPP/RMPP in the experimental group was less(24.3% vs 48.6%, P=0.03),and the difference in IgG before and after treatment was small[0.53(-0.04,1.18)g/L vs 1.33(0.48,2.25)g/L, P=0.01].Among the SMPP/RMPP cases(159 cases),the rate of cases of PB found under bronchoscopy in the experimental group was less than that in the control group(0 vs 20%, P=0.04),and the rate of cases with aggravated lung CT in the experimental group was less than that in the control group(1.3% vs 19.5%, P<0.01),and the improvement rate of lung CT in the experimental group was higher than that in the control group(88.8% vs 75.3%, P=0.03),with statistically significant differences.There were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and immunoglobulin between the two groups(all P>0.05).Two cases in the experimental group developed rashes,which improved after the drug was discontinued.There were no serious adverse reactions such as abnormal vital signs like dyspnea and cyanosis due to the use of lienal polypeptide injection.There were no obvious changes in blood routine,liver function,myocardial enzymes,renal function,electrocardiogram,and urine routine values before and after medication compared with the baseline. Conclusion:The combined use of lienal polypeptide injection in the treatment of MPP in children can reduce the probability of the transformation from mild cases to SMPP/RMPP,reduce the rate of aggravation of the image findings,promote the absorption of lung inflammation,reduce the rate of PB found under bronchoscopy,and has good safety.


Result Analysis
Print
Save
E-mail