最新刊期
      卷 35 ， 期 21 ， 2024
      • YAO Xuefang,ZHANG Yan
        Vol. 35, Issue 21, Pages: 2577-2581(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.01
        摘要：OBJECTIVETo provide a reference for improving the drug patent linkage system.METHODSData on drug names， drug types， abbreviated new drug application （ANDA） acceptance numbers， registration classifications， and applicant names were obtained from the patent certifications and patent information disclosure modules of China’s patent information registration platform for marketed drugs. The data collection period was from July 4， 2021， to September 30， 2023. The analysis focused on the annual distribution of patent certifications for the ANDA varieties included in the statistics， the proportion of different registration classifications， the details of the type Ⅳ certifications， the remaining validity periods of the corresponding patents for the type Ⅲ certifications， and the number of manufacturers for the same variety.RESULTSAmong the ANDA varieties analyzed， type Ⅰ certifications predominated （accounting for 86.53%）， while types Ⅱ， Ⅲ and Ⅳ certifications each accounted for approximately 4% to 5%. In the three registration classifications， type Ⅰ certifications in registration classification 3 accounted for as high as 98.55%， and in registration classification 4， type Ⅰ certifications accounted for 79.65%， while types Ⅱ， Ⅲ and Ⅳ certifications each accounted for around 7%. In terms of the detailed type of the Ⅳ certifications， type Ⅳ of article 2 certifications had a large proportion （79.23%） and showed a slight upward trend， whereas the challenges of type Ⅳ of article 1 certifications were few. The remaining validity period of the patents corresponding to type Ⅲ certifications was excessively long， with a median of 18 months. The proportion of the same variety with fewer than 5 manufacturers was 36.44%， while those with more than or equal to 20 manufacturers accounted for 14.75%.CONCLUSIONSThe ANDA system in China has been orderly integrated with the drug patent linkage system in practice. It is recommended to optimize aspects such as patent certifications registration and objection mechanisms， the effective approval dates for ANDA with type Ⅲ certifications， and incentive measures for type Ⅳ of article 1 certifications， thereby further standardizing the ANDA process and guiding the high-quality development of generic drugs.  
        关键词：ANDA;patent certifications;trend analysis   
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        发布时间：2024-11-08
      • QIAO Ming,ZHU Yi,HU Junping,YANG Jianhua
        Vol. 35, Issue 21, Pages: 2582-2589(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.02
        摘要：OBJECTIVETo investigate the mechanism of Cistanche deserticola in the treatment of inflammatory bowel disease （IBD）.METHODSThe active components of C. deserticola were screened based on TCMSP and literature reports. The targets of active ingredients were obtained via Swiss Target Prediction platform. Then the disease targets were obtained by searching GeneCards and OMIM databases. PPI network and “drug-compound-disease-target” network were constructed. The core components and core targets were screened. GO and KEGG enrichment analyses were performed， and molecular docking verification was conducted for core targets and core components. The IBD mice model was established and divided into model group， positive control group （dexamethasone， 0.4 mg/kg） and C. deserticola extract group （100， 200， 400 mg/kg）； blank control group was set， with 8 mice in each group. Each group was given relevant medicine， once a day， for 7 consecutive days. Disease activity index （DAI） score and colon length were calculated， and the pathological morphology of the colon of mice was observed. The levels of inflammatory factors [interleukin-6 （IL-6）， IL-1β， IL-10， myeloperoxidase （MPO），tumor necrosis factor-α （TNF-α）] in colon tissue， and protein expressions of core targets were detected.RESULTSA total of 39 active ingredients and 232 potential targets of C. deserticola in the treatment of IBD were obtained. The treatment of IBD with C. deserticola might be related to core components such as quercetin， suchilactone， β-sitosterol and cistanoside H， and core targets such as TNF， AKT1， STAT3， EGFR and SRC. GO and KEGG pathway analysis predicted that the biological processes of C. deserticola in the treatment of IBD were mainly related to protein phosphorylation， and negative regulation of apoptosis， mainly involving PI3K/AKT and EGFR tyrosine kinase inhibitor resistance signaling pathways. The results of molecular docking showed that the binding energy between the core components and core target of C. deserticola was less than －4.7 kJ/mol. Animal experiment results showed that after intervention with C. deserticola extract， the body weight and colon length of mice significantly increased （P＜0.05 or P＜0.01）， while DAI decreased significantly （P＜0.05 or P＜0.01）. The congestion and edema of colon mucosa were significantly reduced， and the pathological score of colon tissue was significantly decreased （P＜0.05 or P＜0.01）； the levels of IL-6， IL-1β， MPO and TNF-α， as well as the protein expressions of PI3K， phosphorylated PI3K （p-PI3K）， EGFR， TNF-α， STAT3， phosphorylated STAT3 （p-STAT3）， AKT1， phosphorylated AKT1 （p-AKT1） and SRC in colon tissue were reduced significantly （P＜0.05 or P＜0.01）， while the level of IL-10 was significantly increased in model group （P＜0.01）.CONCLUSIONSC. deserticola may alleviate IBD by regulating the SRC/EGFR/PI3K/AKT signaling pathway.  
        关键词：inflammatory bowel disease;network pharmacology;molecular docking;experimental verification   
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        发布时间：2024-11-08
      • ZHENG Linyu,ZHU Weihao,LUO Meimei,MEI Chunmei,LI Weidong,XU Lei,HUANG Yuyu
        Vol. 35, Issue 21, Pages: 2590-2595(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.03
        摘要：OBJECTIVETo investigate the changes in high performance liquid chromatography （HPLC） fingerprint spectra and nucleoside components between Pinelliae Rhizoma Praeparatum cum Zingibere et Alumine and its processed product Succus bambusae pinella preparata， providing a reference for the quality evaluation of the latter.METHODSHPLC fingerprint was established for 10 batches of Pinelliae Rhizoma Praeparatum cum Zingibere et Alumine and its processed product Succus bambusae pinella preparata following the Similarity Evaluation System of TCM Chromatographic Fingerprints （2012 Edition）. Hierarchical cluster analysis （HCA）， principal component analysis （PCA）， and orthogonal partial least squares-discriminant analysis （OPLS-DA） were conducted on their common peaks. The contents of four nucleoside components， hypoxanthine， uridine， adenine， and guanosine， in both Pinelliae Rhizoma Praeparatum cum Zingibere et Alumine and Succus bambusae pinella preparata were determined.RESULTSThe similarity between the fingerprints of the 10 batches of Pinelliae Rhizoma Praeparatum cum Zingibere et Alumine， Succus bambusae pinella preparata， and their corresponding reference fingerprints ranged from 0.851 to 0.990. A total of 10 common peaks were obtained for both samples， and 4 components were identified as hypoxanthine， uridine， adenine， and guanosine. The results of HCA， PCA and OPLS-DA showed that the samples of Pinelliae Rhizoma Praeparatum cum Zingibere et Alumine and Succus bambusae pinella preparata were clustered into separate categories， with OPLS-DA selecting 4 differential components between them， ranked by variable importance projection values as peak 8， peak 1， peak 6 （adenine） and peak 10. The content determination results showed that the average contents of hypoxanthine， uridine， adenine and guanosine in Succus bambusae pinella preparata declined by 15.90%， 12.00%， 26.04% and 22.18% compared to Pinelliae Rhizoma Praeparatum cum Zingibere et Alumine， respectively， with statistically significant differences in the contents of hypoxanthine， adenine and guanosine （P＜0.05 or P＜0.01）.CONCLUSIONSThe established fingerprint and content determination methods are simple to operate and have good repeatability， which are suitable for qualitative and quantitative analysis of Pinelliae Rhizoma Praeparatum cum Zingibere et Alumine and Succus bambusae pinella preparata. The average contents of the four nucleoside components decreased after the processing of Succus bambusae pinella preparata.  
        关键词：Pinelliae Rhizoma Praeparatum cum Zingibere et Alumine;fingerprint;content determination;nucleoside components;quality control   
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        发布时间：2024-11-08
      • TU Yujie,CAI Ying,CHENG Xueyi,SUN Jia,PAN Jie,LIU Chunhua,LI Yongjun,HUANG Yong,ZHENG Lin,LU Yuan
        Vol. 35, Issue 21, Pages: 2596-2602(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.04
        摘要：OBJECTIVETo investigate the mechanism by which Ginkgo flavone aglycone （GA） reduces the cardiotoxicity of doxorubicin （DOX） based on transcriptomics and proteomics.METHODSThirty-six mice were randomly assigned to control group （CON group， tail vein injection of equal volume of physiological saline every other day+daily intragastric administration of an equal volume of physiological saline）， DOX group （tail vein injection of 3 mg/kg DOX every other day）， and GDOX group （daily intragastric administration of 100 mg/kg GA+tail vein injection of 3 mg/kg DOX every other day）， with 12 mice in each group. The administration of drugs/physiological saline was continued for 15 days. Mouse heart tissues were collected for RNA-Seq transcriptomic sequencing and 4D-Label-free quantitative proteomic analysis to screen differentially expressed genes and proteins， which were then subjected to Kyoto encyclopedia of genes and genomes （KEGG） enrichment analysis. The expression levels of Apelin peptide （Apelin）， phosphatidylinositol 3-kinase （PI3K）， and protein kinase B （Akt） mRNA and protein in mouse heart tissues， as well as the phosphorylation levels of PI3K and Akt proteins， were verified. H9c2 cardiomyocytes were divided into control group （CON group）， DOX group （2 μmol/L）， and GDOX group （2 μg/mL GA+2 μmol/L DOX） to determine cell viability and the levels of key glycolytic substances in the cells.RESULTSSix common pathways were identified from transcriptomics and proteomics， including the Apelin signaling pathway， the PI3K-Akt signaling pathway， and insulin resistance. Among them， the Apelin and PI3K-Akt signaling pathways were the most enriched in terms of gene numbers. Target validation experiments showed that compared to the CON group， the relative expression of Apelin， PI3K and Akt mRNA and protein levels， as well as the phosphorylation levels of PI3K and Akt proteins， were significantly decreased in the DOX group （P＜0.05 or P＜0.01）. The relative expression of Apelin， PI3K and Akt mRNA and the phosphorylation levels of PI3K and Akt proteins were significantly increased in the GDOX group as compared with the DOX group （P＜0.05 or P＜0.01）. Cellular experiments indicated that compared to the CON group， cell viability in the DOX group was significantly decreased （P＜0.05）， the relative uptake of glucose and the relative production of pyruvate and lactate were significantly increased （P＜0.05）， and the relative production of ATP was significantly reduced （P＜0.05）. Compared to the DOX group， cell viability in the GDOX group was significantly increased （P＜0.05）， and the relative production of pyruvate and lactate was significantly reduced （P＜0.05）.CONCLUSIONSGA may alleviate DOX-induced cardiotoxicity by upregulating the mRNA and protein expression of Apelin， PI3K， and Akt in heart tissues， and regulating glycolytic processes.  
        关键词：doxorubicin;cardiotoxicity;transcriptomics;proteomics;toxicity reduction mechanism   
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        发布时间：2024-11-08
      • ZHANG Guohui,ZHANG Haibo,CAO Dongsheng
        Vol. 35, Issue 21, Pages: 2603-2608(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.05
        摘要：OBJECTIVETo explore the mechanism by which casticin （CAS） promotes wound healing in superficial second-degree burned rats through phosphatidylinositol 3-kinase （PI3K）/protein kinase B （AKT）/mammalian target of rapamycin （mTOR） signaling pathway.METHODSRats were randomly assigned to a control group （physiological saline）， a model group （5% sodium carboxymethyl cellulose blank matrix）， low- and high-dose CAS groups （15 mL of CAS solution at concentrations of 30 and 60 mmol/L， respectively）， a high dose CAS plus LY294002 group [a mixture of 15 mL CAS solution （60 mmol/L） and PI3K inhibitor LY294002 solution （20 μmmol/L）]， and a positive control group （thick application of Jingwanhong ointment 0.5-1.0 cm）， with 15 rats in each group. Except for the control group， the other groups were subjected to a superficial second-degree burn rat model by igniting a mixture of burn fuel on the skin surface， and the administration was applied topically within two hours after the burn. After 28 days of administration， the wound healing rate of the burned rats was calculated， the histopathological changes in the central tissue of the rat’s burned wound were observed， and the levels of tumor necrosis factor α （TNF-α）， interleukin-1β （IL-1β）， IL-6， matrix metalloproteinase-2 （MMP-2）， MMP-9 and vascular endothelial growth factor （VEGF） in the serum of rat were detected. The phosphorylation levels of related proteins in the PI3K/AKT/mTOR signaling pathway in the burned tissue of the rats were also detected.RESULTSCompared with the control group， the rats in the model group showed epidermal and superficial dermal damage in skin tissue， poor healing status， inflammatory cell infiltration， and incomplete tissue structure. The levels of IL-6， IL-1β， TNF-α， MMP-2 and MMP-9 in the serum were significantly increased （P＜0.05）， and the levels of VEGF in the serum and the phosphorylation levels of PI3K， AKT， mTOR proteins in the central tissue of the burned wound were significantly decreased （P＜0.05）. Compared with the model group， the pathological changes and the levels of the above indicators in the serum and central tissue of the burned wound in the CAS low- and high-dose groups were significantly reversed （P＜0.05）， and the changes in the CAS high-dose group were significantly more pronounced than those in the CAS low-dose group （P＜0.05）. The addition of the PI3K inhibitor LY294002 could reverse the promoting effect of CAS on the wound healing of superficial second-degree burned rats （P＜0.05）.CONCLUSIONSCAS can promote the healing of superficial second-degree burned wounds in rats， and its mechanism of action may be related to the activation of the PI3K/AKT/mTOR signaling pathway.  
        关键词：superficial second-degree burn;wound healing;PI3K/AKT/mTOR signaling pathway   
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        发布时间：2024-11-08
      • JIN Juan,XIAO Li,PU Qian,ZHANG Hua,YU Lei
        Vol. 35, Issue 21, Pages: 2609-2615(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.06
        摘要：OBJECTIVETo explore the impact of placental polypeptide on the Runt-related transcription factor 3 （RUNX3）/Notch signaling pathway in rats with cyclophosphamide-induced premature ovarian failure （POF）， and its effects on ovarian function and oxidative stress.METHODSA POF rat model was induced by intraperitoneal injection of cyclophosphamide. Sixty POF rats of the model were randomly assigned to model group， low-dose （1 mg/kg） and high-dose （2 mg/kg） placental polypeptide groups， placental polypeptide plus empty vector group [placental polypeptide （2 mg/kg）， empty vector （1 μg）]， and placental polypeptide plus RUNX3 silencing group [placental polypeptide （2 mg/kg）， RUNX3 small interfering RNA （1 μg）]， with 12 rats in each group. Additionally， 12 healthy rats were selected as a control group. The intervention lasted for 4 weeks for all groups. After the final administration， the levels of sex hormones [estradiol （E2）， anti-Müllerian hormone （AMH）， follicle-stimulating hormone （FSH）] in rat serum and oxidative stress indicators [malondialdehyde （MDA）， superoxide dismutase （SOD）， catalase （CAT）， reactive oxygen species （ROS）] in ovarian tissue were measured. The pathology of rat ovarian tissue and apoptosis of ovarian granulosa cells were examined； the expression of apoptosis-related proteins [caspase-3， cleaved-caspase-3， B-cell lymphoma-2 （Bcl-2）， Bcl-2 associated X protein （Bax）] and RUNX3/Notch signaling pathway-related proteins in rat ovarian tissue were detected.RESULTSCompared with the model group， the low and high doses of placental polypeptide groups showed an increase in the number of normal follicles and a marked decrease in the number of atretic follicles， with significant increases in the serum levels of E2 and AMH， the ovarian tissue levels of SOD and CAT， as well as the expression levels of Bcl-2， RUNX3 and Notch1 proteins， and significant decreases in the serum FSH levels， the ovarian granulosa cell apoptosis rate， and the ovarian tissue levels of MDA and ROS， as well as the expression levels of cleaved-caspase-3， caspase-3 and Bax proteins （P＜0.05）； the changes in the high-dose group were significantly more pronounced （P＜0.05）. Compared with the high-dose placental polypeptide group and the placental polypeptide plus empty vector group， the placental polypeptide plus RUNX3 silencing group showed a decrease in the number of normal follicles and a significant reversal of the above indicators （P＜0.05）.CONCLUSIONSPlacental polypeptide may alleviate the symptoms of rats with POF by upregulating the RUNX3/Notch signaling pathway， improving sex hormone secretion， oxidative stress， ovarian granulosa cell apoptosis and ovarian function.  
        关键词：premature ovarian failure;Runt-related transcription factor 3;Notch;ovarian function;oxidative stress   
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        发布时间：2024-11-08
      • XIONG Rui,ZHANG Shipeng,LIU Hengxu,WANG Lu,LAI Xiaodan
        Vol. 35, Issue 21, Pages: 2616-2621(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.07
        摘要：OBJECTIVETo prepare Lonicerae japonicae flavonoids liposome membrane （LFLM）， and to study the mechanism of its anti-methicillin-resistant Staphylococcus aureus （MRSA）.METHODSL. japonicae flavonoids liposome （LFL） were prepared by ethanol injection with phospholipids and cholesterol as carriers. LFLM was prepared by loading LFL in mixed membranes of chitosan and polyvinyl alcohol. The particle size of LFL， polydispersity index （PDI） and release rate of LFLM were measured. A control group， LFLM low-concentration group （2.5 mg/mL）， LFLM-medium concentration group （5 mg/mL）， LFLM high-concentration group （10 mg/mL）， positive group （10 μg/mL vancomycin）， and combination therapy group （10 mg/mL LFLM and 10 μg/mL vancomycin） were set up. The effects of LFLM on MRSA colony formation and survival as well as the formation of MRSA biofilm were evaluated. The contents of K+， Mg2+， lactic dehydrogenase （LDH）， and alkaline phosphatase （AKP） in the supernatant of MRSA were determined. mRNA expressions of mecA and mecR1 in MRSA were determined.RESULTSThe particle size of LFL was （80.91±3.96） nm， and the PDI was 0.26±0.07. The release rate of LFLM was 55% within 12 h and 73% within 36 h. Compared with the control group， the number of MRSA colony formation decreased significantly in LFLM medium-concentration and high-concentration groups， and the positive group （P＜0.05）. The ratio of dead to live bacteria， biofilm inhibition rate， and the contents of K+， Mg2+， LDH and AKP were increased significantly （P＜0.05）， while the mRNA expressions of mecA and mecR1 were decreased significantly （P＜0.05）. The combination of LFLM and vancomycin further enhanced the anti-MRSA effect.CONCLUSIONSLFLM is prepared successfully in the study and has good drug release characteristics. LFLM can exert anti-MRSA activity by promoting cell wall and membrane damage， and suppressing the mRNA expression of mecA and mecR1.  
        关键词：liposomes;membrane;Staphylococcus aureus;antibacterial   
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        发布时间：2024-11-08
      • XU Chunmeng,LIU Zhan,ZHANG Qianqian,LU Qi,DAI Yanpeng,ZHANG Xuelan,SHI Dianhua
        Vol. 35, Issue 21, Pages: 2622-2628(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.08
        摘要：OBJECTIVETo explore the changes in chemical compositions and the characteristics of “fried charcoal and saving properties” based on the carbon-frying process of Sophora japonica and its bud.METHODSThe slightly， moderately and heavily carbon-fried samples of S. japonica and its bud were prepared. The fingerprints of S. japonica， its bud and carbon-fried samples were established， and common peaks were identified. HPLC method was used to determine the contents of identified components and differential analysis was also performed； the differential components were screened by using chemometric methods， and their content ratios were used to characterize the “fried charcoal and saving properties” of S. japonica and its bud.RESULTSThere were 9 common peaks in the fingerprints of S. japonica and its carbon-fried samples， 8 common peaks in those of S. japonica bud and its carbon-fried samples. In the fingerprints of S. japonica and its bud， and their different fried products， 6 components were identified， such as rutin， kaempferol-3-O-rutinoside， isorhamnetin-3-O-rutinoside， quercetin， kaempferol， isorhamnetin. Among them， the contents of rutin， kaempferol-3-O-rutinoside and isorhamnetin-3-O-rutinoside were the highest in slightly carbon-fried samples of S. japonica bud， and the contents of quercetin and isorhamnetin were the highest in moderately carbon-fried samples of S. japonica bud， and the contents of kaempferol were higher in moderately and healily carbon-fried samples of S. japonica bud. The chemometric results showed that the variable importance projection values of rutin and quercetin were both greater than 1. The range of rutin-quercetin content ratio between 9.00-14.00 and 3.00-6.00 respectively could characterize “fried charcoal and saving properties” of S. japonica and its bud.CONCLUSIONSThere are significant differences in the chemical compositions of raw and fried products of S. japonica and its bud. Rutin and quercetin may be the differential components that affect their quality， and the ratio range of the two can be used to characterize the “fried charcoal and saving properties” of S. japonica and its bud in the future.  
        关键词：bud of Sophora japonica;carbon-fried;fingerprint;content determination;fried charcoal and saving properties   
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        发布时间：2024-11-08
      • CAO Dingya,WU Xiaojuan,FU Tingting,SONG Bing
        Vol. 35, Issue 21, Pages: 2629-2633(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.09
        摘要：OBJECTIVETo explore the ameliorative effect and mechanism of emodin on infectious preterm rats.METHODSThe infectious preterm rat model was established and divided into model group， emodin group （60 mg/kg， i.g.）， IKK activation group （2 μg pcDNA3.1-IKK recombinant plasmid via tail vein）， emodin+IKK activation group （i.g. 60 mg/kg emodin+2 μg pcDNA3.1-IKK recombinant plasmid via tail vein）， with 14 rats in each group. Another 14 pregnant female rats were set up as control group. Each group received corresponding intervention for 7 days. The muscle tension of the uterine muscle strip， and the indicator levels of serum inflammation [interleukin 1β （IL-1β）， IL-6， tumor necrosis factor α（TNF-α）] and oxidative stress [superoxide dismutase （SOD）， malondialdehyde （MDA）， catalase （CAT）] were detected； the pathological morphological changes of uterine tissue in rats were observed； the protein expressions of NOD-like receptor protein 3 （NLRP3）， cleaved-caspase-1 and IKK/IκB/NF-κB signaling pathway were detected.RESULTSCompared with control group， a large number of inflammatory cells infiltrated into the smooth muscle layer of uterus in model group with irregular cell distribution； the uterine muscle strip muscle tone， serum levels of IL-1β， IL-6， TNF-α and MDA， protein expressions of NLRP3， cleaved-caspase-1， IKK， IκB and NF-κB p65 in uterine tissue were significantly increased in model group， and the serum levels of SOD and CAT were significantly decreased （P＜0.05）. Compared with the model group， the infiltration of inflammatory cells in the uterine smooth muscle layer was reduced in the emodin group， and all quantitative indexes were significantly improved （P＜0.05）； the infiltration of inflammatory cells in the uterine smooth muscle layer was increased in IKK activation group， and all quantitative indexes further deteriorated （P＜0.05）. Activation of IKK could significantly reduce the improvement effect of emodin on the above indexes in infectious preterm rats （P＜0.05）.CONCLUSIONSEmodin can relieve inflammation and oxidative stress in infectious preterm rats by inhibiting the IKK/IκB/NF-κB signaling pathway， thus improving uterine smooth muscle contraction.  
        关键词：infectious preterm;IKK/IκB/NF-κB signaling pathway;uterine smooth muscle;inflammation;oxidative stress   
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        发布时间：2024-11-08
      • DENG Min,YU Hong,ZHOU Xiang,SUN Haidong
        Vol. 35, Issue 21, Pages: 2634-2639(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.10
        摘要：OBJECTIVETo investigate the effect of andrographolide （Andro） on the neuronal apoptosis in ischemic stroke （IS） rats by regulating the neuregulin-1 （Nrg-1）/epithelial growth factor receptor 4 （ErbB4） signaling pathway.METHODSThe IS rat model was established using the suture method. Sixty successfully modeled rats were randomly divided into model group （physiological saline）， Andro low-dose group （Andro-L group， 50 mg/kg）， Andro high-dose group （Andro-H group， 100 mg/kg）， and Andro-H+Dacomitinib group （100 mg/kg of Andro+7.5 mg/kg of Nrg-1/ErbB4 signaling pathway inhibitor Dacomitinib）， with 15 rats in each group. Another 15 rats were chosen as the sham group （physiological saline）. The rats were intragastrically administered medication/physiological saline once a day for 7 consecutive days. After medication， the neurological function of the rats was assessed； the levels of lactate dehydrogenase （LDH）， tumor necrosis factor-α （TNF-α）， interleukin-1β （IL-1β）， IL-10， and nerve growth factor （NGF） in the rat serum were detected； the infarct area of the rat brain was measured， and the pathological changes in the hippocampal tissue of the rats were observed. Moreover， the apoptosis rate of hippocampal neurons and the levels of malondialdehyde （MDA）， superoxide dismutase （SOD）， catalase （CAT）， matrix metalloproteinase-9 （MMP-9）， cleaved-caspase-3， Nrg-1 protein expressions and phosphorylated ErbB4 （p-ErbB4）/ErbB4 ratio in the hippocampal tissue were detected.RESULTSCompared with the model group， the Zea-Longa score， the escape latency， the serum LDH， TNF-α， IL-1β levels， the percentage of cerebral infarction area， the hippocampal neuron apoptosis rate， the MDA level and MMP-9， cleaved-caspase-3 protein expression levels in the hippocampal tissue in the Andro-L and Andro-H groups were significantly reduced/shortened （P＜0.05）. The dwelling time， the number of platform crossings， the serum IL-10， NGF levels， the CAT， SOD levels， the Nrg-1 protein expression level and p-ErbB4/ErbB4 ratio in the hippocampal tissue were significantly extended/increased （P＜0.05）； the degree of hippocampal neural tissue damage was significantly reduced. Dacomitinib could significantly weaken the improvement effect of high-dose Andro on neuronal injury in IS rats （P＜0.05）.CONCLUSIONSAndro can reduce the inflammatory response， oxidative stress， and hippocampal tissue damage in IS rats， and promote neurological function. Its mechanism of action may be related to the activation of Nrg-1/ErbB4 signaling pathway.  
        关键词：ischemic stroke;Nrg-1/ErbB4 signaling pathway;neuronal apoptosis;neurological function   
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        发布时间：2024-11-08
      • FENG Dalei,WANG Zhao,YANG Yingying,YANG Lei
        Vol. 35, Issue 21, Pages: 2640-2645(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.11
        摘要：OBJECTIVETo investigate the effect and possible mechanism of shikonin on neuroinflammation in sepsis-associated encephalopathy （SAE） rats by regulating the cyclic guanosine monophosphate-adenosine monophosphate synthase （cGAS）-stimulator of interferon gene （STING） signaling pathway.METHODSRats were randomly separated into SAE group， shikonin low-dose， medium-dose and high-dose groups （1.33， 2.66， 5.32 mg/kg）， high dose of shikonin+Roc A group （5.32 mg/kg shikonin+0.67 mg/kg cGAS-STING signaling pathway activator Roc A）， and control group， with 12 rats in each group. Except for the control group， SAE models were constructed in all other groups. After successful modeling， administration began once a day for 14 days. After administration， the Y-maze experiment and open-field experiment were applied to evaluate the learning and memory ability and anxiety state of rats， respectively. The pathological changes of neurons in the dentate gyrus （DG） of the hippocampus were observed. The number of CD86 and CD206 positive cells， the levels of interleukin-1β （IL-1β）， tumor necrosis factor-α （TNF-α）， IL-4 and IL-10， and the protein expressions of cGAS and STING were detected in the brain tissue of the hippocampus DG region.RESULTSCompared with the SAE group， the neuronal damage of rats in shikonin low-dose， medium-dose and high-dose groups were improved； the percentage of activity distance in the “new arm”， the duration of stay in the central area， walking distance， the number of intact neurons and CD206 positive cells in the brain tissue of the hippocampal DG area， and the levels of IL-4 and IL-10 increased/rised/prolonged significantly （P＜0.05）； the number of CD86 positive cells in the brain tissue of the hippocampal DG region， the levels of IL-1β and TNF-α， and protein expressions of cGAS and STING were significantly reduced/decreased/down-regulated （P＜0.05）， and the effect of shikonin was dose-dependent （P＜0.05）. Roc A could significantly reverse the improvement effect of high-dose shikonin on neuroinflammation in SAE rats （P＜0.05）.CONCLUSIONSShikonin can improve neuroinflammation in SAE rats by inhibiting cGAS-STING signaling pathway.  
        关键词：sepsis-associated encephalopathy;cGAS-STING signaling pathway;neuroinflammation   
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        发布时间：2024-11-08
      • ZHAO Danqi,LI Miao,SHI Zhengyuan,XU Xiqiao,WANG Shumei
        Vol. 35, Issue 21, Pages: 2646-2651(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.12
        摘要：OBJECTIVETo investigate the impact of the methionine synthase reductase （MTRR） rs10380 C＞T gene polymorphism on methotrexate （MTX） plasma concentration， adverse drug reaction， and prognosis in children with intracranial tumors.METHODSPeripheral blood was collected from children with intracranial tumors， and genomic DNA was extracted. The MTRR rs10380 C＞T genotype was analyzed using matrix-assisted laser desorption/ionization-time of flight-mass spectrometry. The association of the MTRR rs10380 C＞T gene polymorphism with the ratio of MTX plasma concentration to dose （C/D ratio）， adverse drug reaction， tumor recurrence， and metastasis was analyzed. Bioinformatics analysis was used to explore the association of the rs10380 genotype and MTRR gene expression and its possible mechanisms.RESULTSA total of 75 children were included in the study. The distribution frequencies of the wild-type CC genotype and C allele of rs10380 were 62.67% and 81.33%， respectively， while the distribution frequencies of the variant CT genotype and T allele were 37.33% and 18.67%， respectively， which were in accordance with Hardy-Weinberg equilibrium （P＞0.05）. The incidence of electrolyte disorders （51.06%） and tumor metastasis rate （57.45%） in children with the CC genotype were significantly higher than those with the CT genotype （P＜0.05）. No significant differences were observed in the 24-hour and 42-hour C/D ratios and recurrence rates between the two genotypes of children （P＞0.05）. Bioinformatics analysis showed that MTRR protein mainly works in conjunction with 10 proteins， including MMAA， and was involved in various biological processes such as sulfur amino acid biosynthesis.CONCLUSIONSThe MTRR rs10380 CC genotype may be a risk factor for electrolyte disorders and tumor metastasis in children with intracranial tumors after MTX chemotherapy.  
        关键词：methotrexate;methionine synthase reductase;genetic polymorphism;adverse reaction;prognosis   
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        发布时间：2024-11-08
      • JIANG Huanhuan,CHEN Dong,FU Aishuang,GE Yanlei,WANG Qiang,LI Shizi,SHEN Huiqin,LI Xia,WANG Yingcong,CHEN Yunfei
        Vol. 35, Issue 21, Pages: 2652-2657(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.13
        摘要：OBJECTIVETo explore the safety， effectiveness， and cost-effectiveness of elderly patients with sarcopenia receiving Shenling baizhu powder combined with nutrition and exercise intervention， providing a reference for rational clinical drug use.METHODSA total of 237 elderly sarcopenia patients were randomly assigned to an observation group （118 cases） and a control group （119 cases）. Both groups of patients received nutrition and exercise intervention； the observation group added Shenling baizhu powder （6 g each time， three times daily） on this basis. The safety， effectiveness， and cost-effectiveness of the two plans were compared after 3 months.RESULTSBoth groups of patients completed the follow-up. Before intervention， no significant difference was observed in skeletal muscle index （SMI）， grip strength， and 6-minute walk test （6MWT） speed between the two groups （P＞0.05）. After intervention， the grip strength of the patients in the observation group was significantly greater than that of the control group （25.05 kg vs. 23.18 kg， P＜0.01）； the treatment response rate of sarcopenia， SMI， and 6MWT speed were higher than those of the control group， but the differences were not statistically significant （P＞0.05）. The adverse reaction/event rate of the patients in the observation group was lower than that of the control group （14.41% vs. 16.81%， P＝0.611）， but the difference was not statistically significant. Compared with the control group’s plan， the cost of the observation group’s plan was higher （981.25 yuan vs. 913.94 yuan）， and the effect was better （effectiveness rate： 0.618 6 vs. 0.563 0）， with an incremental cost-effectiveness ratio of 1 210.61 yuan. The results of the sensitivity analysis were consistent with the cost-effectiveness analysis results.CONCLUSIONElderly patients with sarcopenia who receive Shenling baizhu powder combined with nutrition and exercise intervention can significantly strengthen grip strength without increasing the incidence of adverse reactions/events. Compared with the control group plan， the observation group needs to spend an additional 1 210.61 yuan for each additional effective patient with sarcopenia.  
        关键词：elderly;sarcopenia;nutrition support;exercise intervention;cost-effectiveness analysis   
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        发布时间：2024-11-08
      • CHEN Min,DAI Hongshan,JIANG Zhiwei,LI Shupei,YAO Miaoshi,SHU Yachun
        Vol. 35, Issue 21, Pages: 2658-2662(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.14
        摘要：OBJECTIVETo explore the safety， effectiveness and cost-effectiveness of a multimodal analgesic regimen in patients who underwent laparoscopic sleeve gastrectomy under the guidance of enhanced recovery after surgery principles.METHODSData from weight loss patients who underwent laparoscopic sleeve gastrectomy at our hospital were retrospectively collected. The trial group patients received a multimodal analgesic regimen， which included the use of 0.375% ropivacaine for local infiltration of the surgical incision before the end of surgery； intravenous infusion of flurbiprofen axetil 50 mg twice daily； intravenous infusion of methylprednisolone 40 mg once daily and oral administration of extended-release hydrocodone hydrochloride tablets 10 mg twice daily after surgery. The control group patients received a conventional analgesic regimen， which included intravenous infusion of flurbiprofen axetil 100 mg twice daily， with a daily dose twice that of the trial group； and intravenous injection of dexamethasone 5 mg once daily. Propensity score matching was used to balance the baseline data between the two groups. Then the pain scores during movement and at rest at 2， 12， 24 and 36 hours postoperatively， as well as the length of postoperative hospital stay， total length of hospital stay， time to first ambulation after surgery， adverse reactions during hospitalization， total drug costs， and costs of antimicrobial drugs during hospitalization were compared between the two groups.RESULTSThe trial group had significantly lower pain scores during movement at 2， 24 and 36 hours postoperatively， and at rest at 2， 12 and 24 hours postoperatively compared to the control group （P＜0.05）. The time to first ambulation after surgery， total length of hospital stay， and length of postoperative hospital stay were significantly shorter in the trial group compared to the control group （P＜0.05）. The incidence of shoulder and back soreness， and costs of antimicrobial drugs were significantly lower in the trial group compared to the control group （P＜0.05）. No statistically significant differences were observed in the total incidence of drug-related adverse reactions and total drug costs during hospitalization between the two groups （P＞0.05）.CONCLUSIONSThe multimodal analgesic regimen provides marked pain relief， demonstrates good safety profiles， and has a more economic advantage than the conventional analgesic regimen.  
        关键词：laparoscopic sleeve gastrectomy;pain score;postoperative pain management   
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        发布时间：2024-11-08
      • LIU Hong,BAI Yu,WANG Xiaoyang,ZHANG Wensi,ZHANG Benjing,ZHANG Yanhua
        Vol. 35, Issue 21, Pages: 2663-2667(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.15
        摘要：OBJECTIVETo provide evidence for the safe clinical application of Trastuzumab for injection.METHODSReports of adverse drug reaction （ADR） related to Trastuzumab for injection submitted in Beijing from June 2018 to May 2023 were collected. Statistical analyses were performed using SPSS 25.0 software. The gender and age of patients with ADRs， outcome， types of cancer， and the time of onset， severity， affected organs/systems of ADRs were included for analyses. The univariate Logistic regression analysis was conducted on patient fever and ADR prognosis.RESULTSA total of 195 patients with 318 instances of ADRs were included in the study. Women （87.69%） and patients aged 60-69 （33.85%） were more likely to experience ADRs. Breast cancer dominated （86.67%） in terms of cancer types； in terms of outcomes， most patients （67.69%） showed improvement， and some patients （27.69%） achieved full recovery. Overall， 68.72% of ADRs mainly occurred on the day of medication， and 95.38% of ADRs were of “moderate” severity. The most affected organs/systems were general diseases and various reactions at the administration site （40.57%）， with chills （18.87%） and fever （18.24%） being the most common. Univariate Logistic regression analysis showed that fever mostly occurred within 1 day of medication （OR＝5.63， 95%CI was 2.26-14.02， P＜0.001）. The time of onset of ADR greater than 1 day was a risk factor for poor ADR prognosis （OR＝20.08， 95%CI was 2.45-164.43， P＝0.005）， mainly manifesting as bone marrow suppression and liver function abnormalities. Neutrophilia， cardiorespiratory arrest， and mixed liver damage were new ADRs not recorded in the drug’s instructions.CONCLUSIONWomen and patients aged ≥60 are high-risk groups for ADRs of Trastuzumab for injection. Chills and fever remain the most common ADRs of this drug， and these symptoms mostly occur within 1 day of medication， which have better prognoses. Close attention should be paid to the patient’s temperature changes on the day of drug infusion， with timely intervention. Regular monitoring of the patient’s hematological indicators is necessary to detect any bone marrow suppression and liver function abnormalities after medication.  
        关键词：adverse drug reaction;chill;fever;prognosis   
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        发布时间：2024-11-08
      • REN Xiangge,YU Xin,ZHANG Jiawei,ZHAO Peidong,ZHAI Wensheng
        Vol. 35, Issue 21, Pages: 2668-2675(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.16
        摘要：OBJECTIVETo evaluate the efficacy and safety of rituximab （RTX） in the treatment of children with refractory nephrotic syndrome （RNS） based on the real world by meta-analysis.METHODSA systematic search was conducted on CNKI， Wanfang， VIP， PubMed， Embase， Web of Science， the Cochrane Library， and CINAHL databases to strictly screen the literature and evaluate their quality. A meta-analysis was performed on the extracted literature data using R 4.2.2 and RStudio software.RESULTSA total of 26 real-world studies were included in this study， involving 996 children with steroid-dependent nephrotic syndrome/frequente-relapse nephrotic syndrome （SDNS/FRNS） and 205 children with steroid-resistant nephrotic syndrome （SRNS）. The results of the meta-analysis showed that the complete remission （CR） rate of RTX treatment for RNS was 46% （95%CI： 37%-56%）， the partial remission （PR） rate was 22% （95%CI： 14%-31%）， and the discontinuation rate was 35% （95%CI： 25%-44%）. The results of subgroup analysis showed that the CR rate of RTX treatment in SDNS/FRNS children was 49% （95%CI： 37%-62%）， PR rate was 25% （95%CI： 0-50%）， discontinuation rate was 41% （95%CI： 29%-52%）； the CR rate in SRNS children was 42% （95%CI： 27%-56%）， PR rate was 22%（95%CI： 12%-32%）， discontinuation rate was 21% （95%CI： 4%-38%）. The recurrence rate in children with SDNS/FRNS was 39% （95%CI： 21%-57%） within 1 year or less， 18% （95%CI： 18%-98%） in 2 years and more. As for safety， the majority of adverse reactions were mild infusion reactions， with an incidence of 13% （95%CI： 8%-22%）. Sensitivity analysis suggested that the results were robust. There was publication bias in mild infusion reaction rate.CONCLUSIONSRTX is effective and safe in the treatment of RNS in children.  
        关键词：frequente-relapse;steroid-dependent;steroid-resistant;real world;children   
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        发布时间：2024-11-08
      • ZHENG Zihui,ZHAO Zinan,GAO Feng,LI Wenying,YUAN Han,ZHANG Baige,YANG Liping,JIN Pengfei
        Vol. 35, Issue 21, Pages: 2676-2683(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.17
        摘要：OBJECTIVETo conduct rapid health technology assessment （HTA） of ulinastatin （UTI）， and to evaluate the efficacy， safety and cost-effectiveness of UTI in the treatment of acute pancreatitis （AP）.METHODSRetrieved from PubMed， Embase， the Cochrane Library， CNKI， Wanfang database， CBM and official websites of HTA institutions， the systematic review （SR）/meta-analysis， economic evaluation and HTA reports of UTI in the treatment of AP were collected from the inception to Apr. 2024. Two researchers independently conducted screening， quality evaluation and data extraction according to the admission and exclusion criteria， and descriptive analysis was adopted to analyze and summarize the data.RESULTSA total of 19 studies were included， involving 15 SR/meta-analysis and 4 economic studies， and no HTA report was retrieved. In the treatment of AP， UTI showed clear advantages over conventional treatment alone in terms of improving the overall effective rate， shortening the recovery time of amylase， reducing the time required to relieve abdominal pain and distension， lowering the mortality rate， and decreasing the average hospital stay. Compared to other positive drugs （carbendate mesylate， octreotide， somatostatin， etc.）， its efficacy is similar， with a favorable safety profile. As far as the current research was concerned， UTI had obvious economic advantages over other positive drugs.CONCLUSIONSUTI is safe and effective in the treatment of AP， and has economic advantages.  
        关键词：acute pancreatitis;efficacy;safety;cost-effectiveness;rapid health technology assessment;evidence-based evaluation   
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        发布时间：2024-11-08
      • CHEN Juanjuan,WANG Song,WANG Yanfang,YAO Mingjie,DU Shuzhang,CHEN Baozhan
        Vol. 35, Issue 21, Pages: 2684-2689(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.18
        摘要：OBJECTIVETo construct an evaluation index system for the effectiveness of cough and wheeze pharmaceutical care clinic （CWPC） among asthma patients， and to provide assessment tools and a theoretical basis for improving the control level of asthma patients and standardizing pharmaceutical care.METHODSLiterature analysis and semi-structured interviews were used to establish the evaluation index system for the effectiveness of CWPC among asthma patients. Delphi method was used to conduct two rounds of expert correspondence consultation， and the index weights were determined by the analytic hierarchy process. The reliability and validity of the constructed index system were analyzed by questionnaire.RESULTSTotally 29 experts from three disciplines of medicine， pharmacy and nursing were selected from the third-grade class A hospitals in Henan province. After two rounds of expert correspondence consultation， the effectiveness evaluation index system of CWPC asthma patients （including 9 sub-dimensions， such as lung function， symptoms； 35 measurement items， such as wheezing and respiratory rate） was finally determined from three core dimensions of structure level， function level and literacy management level， and the weight value of each dimension index was determined. The results of the reliability and validity analysis confirmed the scientific rationality of the index system.CONCLUSIONSThe constructed CWPC effectiveness evaluation index system for asthma patients has a high degree of recognition， reliability and validity， and can be used as a measurement tool for the effectiveness evaluation of asthma patients.  
        关键词：asthmatic patients;effectiveness;index system;reliability and validity   
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        发布时间：2024-11-08
      • DU Chunhui,WAN Yongli,YANG Xiaojiao,ZHOU Jin,WANG Jianbo,ZHAO Zhenyu
        Vol. 35, Issue 21, Pages: 2690-2696(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.19
        摘要：OBJECTIVETo establish a clinical pharmaceutical pathway of anti-infective therapy for high-risk populations of antibiotic-associated encephalopathy （AAE）， and analyze its application effects.METHODSClinical pharmacists developed the “AAE High-Risk Population Screening Form” and “Antibiotic AAE Risk Comparison Form” based on literature and expert opinions， and established the “Clinical Pharmaceutical Pathway of Anti-infective Treatment for AAE High-Risk Population” in our hospital. A prospective， non-randomized controlled study was conducted from May 2023 to April 2024， including 50 cases in the observation group and 50 cases in the control group among patients with pulmonary infections admitted to the Dept. of Internal Medicine in our hospital. The observation group was involved in the development of an anti-infective treatment following the clinical pharmaceutical pathway by clinical pharmacists， while the control group received routine anti-infective treatment by clinical physicians. The occurrence of AAE， the rational antibiotic drug use， and the effectiveness of initial anti-infective treatment in the two groups were observed， and the intervention measures and outcomes of AAE cases were summarized.RESULTSThe anti-infective treatment clinical pharmaceutical pathway for AAE high-risk population was preliminarily established in our hospital. The analysis of the application effects showed that there was 1 case of AAE in the observation group and 8 cases in the control group， with a significantly lower incidence of AAE in the observation group than in the control group； the rational antibiotic drug use and the effectiveness of initial anti-infective treatment in the observation group were both significantly superior to those in the control group （P＜0.05）. Drug withdrawal and dressing change were the preferred effective intervention measures for AAE， and encephalopathy treatment drugs could be used as auxiliary measures for symptom relief. Timely and effective intervention was conducive to rapid symptom relief， with a total improvement rate of AAE of 88.89%.CONCLUSIONSThe anti-infective treatment clinical pharmaceutical pathway for AAE high-risk population can effectively prevent the occurrence of AAE as well as contribute to promoting rational drug use and the effectiveness of initial anti-infection plans and strengthening treatment outcomes.  
        关键词：clinical pharmaceutical pathway;anti-infection;neurotoxicity;personalized medication;rational drug use;high-risk population screening   
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        发布时间：2024-11-08
      • LIU Zhu,WANG Jiawei,FANG Yijun,PENG Jinchan,LI Liqun,XIE Sheng
        Vol. 35, Issue 21, Pages: 2697-2702(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.20
        摘要：epsis is a life-threatening organ dysfunction caused by infection. Janus kinase/signal transducer and activator of transcription （JAK/STAT） signaling pathway plays a key role in the regulation of inflammatory response， oxidative stress and apoptosis. Some traditional Chinese medicine monomers， such as flavonoids （such as taxifolin）， alkaloids （such as sinomenine）， and stilbenes （such as piceatannol） can exert anti-inflammatory， anti-oxidation， and inhibition of apoptosis by regulating the JAK/STAT signaling pathway， which is helpful to improve sepsis. Traditional Chinese medicine compounds （such as Zuojinfang） and traditional Chinese medicine injections （such as Astragalus injection， Xuebijing injection） can also inhibit inflammation， protect organ function， and reduce sepsis-related damage by regulating JAK/STAT signaling pathway. Although traditional Chinese medicine has shown great potential in the prevention and treatment of sepsis， the current research mainly focuses on in vitro and animal models， and more relative clinical researches need to be conducted.  
        关键词：sepsis;JAK/STAT signaling pathway;inflammatory response   
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        发布时间：2024-11-08
      • JIANG Tingting,Wang Yunyun,Wu Xiangxiang,ZENG Huahui,Zhu Xin
        Vol. 35, Issue 21, Pages: 2703-2708(2024) DOI: 10.6039/j.issn.1001-0408.2024.21.21
        摘要：Progesterone is currently the first-line drug for clinical treatment and prevention of threatened abortion and habitual abortion. However， due to its special chemical structure， its solubility is low， which limits its clinical application. Therefore， the new technology and new dosage form of progesterone solubilization preparation is an important direction of its research and development. In this paper， the research progress of progesterone solubilization preparation technology in recent years is reviewed. It is found that the water solubility of progesterone can be enhanced by solid dispersion technology， inclusion technology， micronization， nanocrystallization （ including nanosuspensions， polymer micelles， nanoparticles， etc. ）， liposome technology， self-emulsification， cocrystal technology， and 3D printing. Eight technologies are used to increase the solubility of progesterone， improve its bioavailability and reduce its toxic and side effects， to serve the clinic better.  
        关键词：preparation method;solubility;bioavailability;solubility-enhancing formulation technology   
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