1.Clinical evaluation of anlotinib in third-line treatment for advanced non-small cell lung cancer based on real-world data
Jian WU ; Peipei LI ; Yongfu ZHU ; Dongwei ZHANG ; Yongzhong WANG ; Hao CHEN
China Pharmacy 2025;36(12):1488-1494
OBJECTIVE To evaluate the clinical value of anlotinib in third-line treatment for patients with advanced non-small cell lung cancer (NSCLC) through real-world data. METHODS Clinical data of patients with advanced NSCLC who received treatment at the First Affiliated Hospital of Anhui University of Chinese Medicine from February 2021 to December 2024 were retrospectively collected. They were divided into anlotinib group (27 cases, receiving anlotinib therapy) and immunotherapy group (22 cases, receiving immunotherapy agents alone or in combination with chemotherapy drugs) according to treatment regimens. The progression-free survival (PFS) and overall survival (OS) of patients were compared between the two groups, and the occurrence of adverse drug reactions during the treatment period was recorded. Using a partitioned survival model, an economic evaluation of the two treatment regimens was conducted with a cost-utility analysis approach from the perspective of the healthcare system. RESULTS The median PFS and OS of patients in the anlotinib group were 5.93 months and 11.27 months, respectively; the median PFS and OS of patients in the immunotherapy group were 5.33 months and 9.77 months, respectively; the difference was not statistically significant (P>0.05). There was no statistical difference in the total incidence of adverse drug reactions and grade 3-4 serious adverse drug reactions between the two groups (P>0.05). Compared with the immunotherapy group, the incremental cost-effectiveness ratio of the anlotinib group was 1 806 724.60 yuan/quality-adjusted life year (QALY), which was significantly higher than three times China’s per capita gross domestic product in 2024 (287 247 yuan/QALY). CONCLUSIONS For third-line treatment of advanced NSCLC patients, the efficacy of anlotinib is no worse than that of immunotherapy alone or in combination with chemotherapy drugs, and the safety of the two groups is comparable. However, anlotinib is not cost-effective.
2.Improvement effect of ligustilide on rats with heart failure by regulating PKD1/HIF-1α/VEGF pathway
Lan ZHANG ; Yongxin WU ; Tao ZHANG ; Dongwei WANG
Journal of Jilin University(Medicine Edition) 2024;50(1):42-49
Objective:To discuss the effect of ligustilide on the cardiac function and angiogenesis in the rats with heart failure,and to clarify its regulatory effect on protein kinase D1(PKD1)/hypoxia-inducible factor-1α(HIF-1α)/vascular endothelial growth factor(VEGF)pathway.Methods:The SD rats were randomly divided into sham operation group,model group,ligustilide group,PKD1/HIF-1α/VEGF signaling pathway inhibitor CID755673(CID)group,and ligustilide+CID group.The heart failure rat model was established by ligation of the left anterior descending coronary artery.The rats in ligustilide group were injected intravenously with 20 mg·kg-1 ligustilide,the rats in CID group were injected intraperitoneally with 50 mg·kg-1 CID,and the rats in ligustilide+CID group were injected intraperitoneally with 50 mg·kg-1 CID followed by intravenous injection of 20 mg·kg-1 ligustilide,once per day for 4 consecutive weeks.The cardiac function indexes of the rats in various groups were detected by echocardiography;the percentages of myocardial infarction areas of the rats in various groups were detected by 2,3,5-triphenyltetrazolium chloride(TTC)staining;the pathomorphology of myocardium tissue of the rats in various groups was observed by HE staining;the expression levels of PKD1,HIF-1α,CD31,and VEGF mRNA and proteins in ischemic area of myocardium tissue of the rats in various groups were detected by real-time fluorescence quantitative PCR(RT-qPCR)and Western blotting methods.Results:Compared with sham operation group,the rats in model group and CID group had altered myocardial cell morphology,increased intercellular gaps,disorganized arrangement,visible muscle fiber breaks and inflammatory cell infiltration;the rats in ligustilide group and ligustilide+CID group had relatively orderly myocardial fiber arrangement,fewer myocardial fiber breaks and decreased number of inflammatory cells.Compared with sham operation group,the left ventricular ejection fraction(LVEF)and left ventricular fractional shortening(LVFS)of the rats in model group were decreased(P<0.05),the left ventricular end-systolic diameter(LVESD)and left ventricular end-diastolic diameter(LVEDD)were increased(P<0.05),and the expression levels of PKD1,HIF-1α,CD31,and VEGF mRNA and proteins in myocardium tissue were decreased(P<0.05).Compared with model group,the LVEF and LVFS of the rats in ligustilide group were increased(P<0.05),the LVESD and LVEDD were decreased(P<0.05),the percentage of myocardium infarction area was decreased(P<0.05),and the expression levels of PKD1,HIF-1α,CD31,and VEGF mRNA and proteins in myocardium tissue were increased(P<0.05);compared with model group,the LVEF and LVFS of the rats in CID group were decreased(P<0.05),the LVESD and LVEDD were increased(P<0.05),the percentage of myocardium infarction area was increased(P<0.05),and the expression levels of PKD1,HIF-1α,CD31,and VEGF mRNA and proteins in myocardium tissue were decreased(P<0.05);compared with ligustilide group,the LVEF and LVFS of the rats in ligustilide+CID group were decreased(P<0.05),the LVESD and LVEDD were increased(P<0.05),the percentage of myocardium infarction area was increased(P<0.05),and the expression levels of PKD1,HIF-1α,CD31,and VEGF mRNA and proteins in myocardium tissue were decreased(P<0.05);compared with CID group,the LVEF and LVFS of the rats in ligustilide+CID group were increased(P<0.05),the LVESD and LVEDD were decreased(P<0.05),the percentage of myocardium infarction area was decreased(P<0.05),and the expression levels of PKD1,HIF-1α,CD31,and VEGF mRNA and proteins in myocardium tissue were increased(P<0.05).Conclusion:Ligustilide can promote the angiogenesis,reduce the myocardium infarction area,and improve the cardiac function in the rats with heart failure;it works through activation of the PKD1/HIF-1α/VEGF pathway.
3.Progress on pharmaceutical characteristics of potassium-competitive acid blocker
Yaozhen WANG ; Can XU ; Shunli LV ; Jing TIAN ; Dongwei ZHANG
Journal of Pharmaceutical Practice and Service 2024;42(7):278-284
As a new class of acid inhibitors,potassium-competitive acid blocker(P-CAB)inhibits the conformational transition of H+,K+-ATPase with subsequent suppression of H+,K+exchanging by binding reversibly near the K+binding site of H+,K+-ATPase,which results in the inhibition of gastric acid secretion in a K+-competitive manner.The unique structure and novel mechanism of P-CAB contribute to the pharmaceutical characteristics superior to other PPIs,making it a new alternative for acid-related diseases(ARDs).Progress on pharmaceutical characteristics of P-CAB were reviewed in this paper.
4.Research on Determination Method of Particulate Matter in Drug Packaging Materials Based on the Pharmacopoeia of the People's Republic of China(2025 Edition)
Dongwei WANG ; Wenli LI ; Wei XIONG ; Jing ZHANG ; Lei CHEN ; Kai XU
Herald of Medicine 2024;43(11):1740-1744
Objective To establish and interpret of the Pharmacopoeia of the People's Republic of China(2025 Edition),to determine particulate matter in pharmaceutical packaging materials,and to provide further guidance and support for the later use of the standard.Methods By reviewing the existing problems in the use of Chinese pharmaceutical packaging materials standards(YBB standards)standards combined with the construction of new standard system for pharmaceutical packaging materials in the Pharmacopoeia of the People's Republic of China,also about the validation data of the pharmaceutical packaging materials,the scope、testing methods、requirements and the experimental parameters of the Pharmacopoeia of the People's Republic of China determination of particulate matter in pharmaceutical packaging materials are studied and interpreted in detail.Results Compared with the current YBB standard,the Pharmacopoeia of the People's Republic of China-determination of particulate matter in pharmaceutical packaging materials has solved the problems of incomplete application scope and unreasonable requirements and parameters in the YBB standard.Conclusion The content of the Pharmacopoeia of the People's Republic of China(2025 Edition)determination of the particulate matter in drug packaging materials method is more scientific、applicable and operable.This method can standardize the determination of a particulate matter in drug packaging materials and can also play a supporting role in the construction of the standard system to promote industrial development.
5.Choice of extraction media for Ni release risk evaluation on nickel-titanium alloys cardiovascular stents
Bin LIU ; Yang QIN ; Xiaoman ZHANG ; Changyan WU ; Dongwei WANG ; Wenli LI ; Cheng JIN ; Yunfan DONG ; Yiwei ZHAO ; Lili LIU ; Wei XIONG
International Journal of Biomedical Engineering 2024;47(2):156-161
Objective:To determine the content of the released nickel ion through the 7 extraction media to extract the Ni-Ti wires and to plot the curve of the released nickel ion so as to identify a leaching medium that can be substituted for blood for in vitro Ni release evaluation. Methods:The release of Ni through microwave digestion/inductively coupled plasma mass spectrometry (ICP-MS) in the goat serum was determined. Because of the high content of Ni release, it could be determined by diluting the extraction medium, and other extraction media could be determined directly. Ni release standard curves were plotted by the release amount and different time point variables. Though the different extraction media Ni release curves confirm the specificity of extraction media instead of blood.Results:By analyzing the Ni release curves of seven leaching media, it was found that none of these seven extraction media was suitable for the evaluation of Ni release in in vitro leaching media. Considering the safety of the leaching medium and the simplicity of preparation, hydrochloric acid solution was chosen as the leaching medium, but the concentration needed to be diluted accordingly. Finally, a hydrochloric acid solution was created as an alternative to blood for the in vitro study of Ni release from Ni-Ti alloy cardiovascular products, with a volume fraction of 0.005%. Conclusions:The in vitro leaching medium that can replace blood was found to be hydrochloric acid for the time being, but its concentration was too high, resulting in too much Ni release as well, which deviated from the actual situation. Therefore, the hydrochloric acid solution was diluted step by step, and the Ni release curve was examined until it was close to the clinical release level, and the actual concentration was determined, thus laying a solid foundation for the subsequent evaluation of the safety and risk.
6.Clinical Efficacy of Maiwei Yangfei Decoction in the Treatment of Idiopathic Pulmonary Fibrosis of Qi-Yin Deficiency Type
Dongwei ZHU ; Qi ZHAO ; Le BAI ; Tingyu PAN ; Jing WANG ; Shenhao GUO ; Yong XU ; Xianmei ZHOU
Journal of Nanjing University of Traditional Chinese Medicine 2024;40(9):962-969
OBJECTIVE To explore the therapeutic effect and safety of Maiwei Yangfei Decoction(MWYF)in the treatment of idiopathic pulmonary fibrosis of qi-yin deficiency type.METHODS A total of 58 patients with idiopathic pulmonary fibrosis of qi-yin deficiency type were randomly divided into an experimental group and a control group with 29 cases in each group according to a 1:1 ratio.Two cases dropped out of the experimental group and three cases dropped out of the control group.The control group received standardized treatment of Western medicine,and the experimental group received MWYF on the basis of the treatment of the control group.The treatment course of both groups was 3 months.The TCM syndrome score,lung function,6-minute walking distance(6MWD),transcutaneous blood oxygen saturation(SpO2),high-resolution computed tomography(HRCT)score,St.George's respir-atory questionnaire(SGRQ)score and serum sialoglycoprotein antigen(KL-6)level of the two groups were compared before and after treatment.Blood routine and liver and kidney function of the two groups were detected before and after treatment,and the occurrence of adverse reactions during treatment was recorded.RESULTS After treatment,the total score of TCM syndrome of the two groups was significantly improved(P<0.01),and the experimental group was better than the control group(P<0.01);the DLCO%of the experi-mental group increased(P<0.05),and the experimental group was higher than the control group(P<0.05).The experimental group showed significant improvement in 6MWD,HRCT grid shadow,SGRQ symptom score and total score,and serum KL-6 level(P<0.05,P<0.01),which was better than the control group(P<0.05,P<0.01).No serious adverse events occurred in either group dur-ing the treatment.CONCLUSION MWYF combined with standardized Western medicine treatment can effectively improve the clini-cal symptoms of patients with idiopathic pulmonary fibrosis of qi-yin deficiency type,reduce the expression level of serum KL-6,and has a definite effect and good safety.
7.Attentional bias to aggressive words under self-threat priming in college students with different types of high self-esteem
Caibin DUAN ; Hui ZHOU ; Yu JIANG ; Hongyang ZHU ; Tong WANG ; Xinhui HUANG ; Dongwei JIAN
Chinese Mental Health Journal 2024;38(5):452-457
Objective:To investigate the characteristics of attention bias to aggressive information under self-threat priming in college students with different types of high self-esteem.Methods:A total of 650 college students were selected,and high self-esteem participants were selected through the Self Esteem Scale(SES).Then,43 partic-ipants were selected from different types of high self-esteem(fragile and safe)groups through the Implicit Associa-tion Test(IAT).Each group participated in Raven's Standard Progressive Matrices(SPM)with different difficulty levels to complete self-threat priming,and then completed the spatial cue experiment.When the cue was invalid,the attention bias was obtained according to the variation of the reaction time difference(RTI)between the subjects're-sponses to aggressive words and neutral words.Results:The RTI values of the fragile high self-esteem group were higher under high self-threat priming than that of the secure high self-esteem group(P<0.01).Under low self-threat priming,there was no significant difference in RTI values among different types of high self-esteem groups(P>0.05).Conclusion:Fragile high self-esteem group are more likely to develop attention bias towards aggressive words under high self-threat priming than that of secure high self-esteem group.
8.Applicability of H2 FPEF and HFA-PEFF Scores in Chinese Patients Suffering From Heart Failure With Preserved Ejection Fraction and Heart Failure With Preserved Ejection Fraction Complicated With Atrial Fibrillation
Xiaoyan JIA ; Lixiang LIU ; Dongwei WANG ; Xiwen MA ; Yongming LIU
Acta Academiae Medicinae Sinicae 2024;46(2):154-160
Objective To analyze the diagnostic values of H2FPEF and HFA-PEFF scores for heart failure with preserved ejection fraction(HFpEF)and HFpEF complicated with atrial fibrillation(HFpEF-AF)in Chinese patients and explore the related factors.Methods A cross-sectional study was conducted.A total of 835 consecutive HFpEF patients treated in the Department of Geriatric Cardiology,the First Hospital of Lanzhou Uni-versity from 2009 to 2020 were selected and assigned to a HFpEF-AF group(n =267)and a HFpEF group(n = 568)according to the presence of AF or not.HFA-PEFF and H2FPEF scores were used for retrospective diagnosis and the diagnostic consistency of the two scores was assessed.One hundred and thirty-six healthy volunteers with age and sex matching the patients during the same period were selected as healthy controls.The receiver operating characteristic(ROC)curves were established for H2FPEF and HFA-PEFF scores in diagnosing HFpEF-AF and HFpEF,on the basis of which the diagnostic performance of the two scores was evaluated.Results There was no difference in the HFA-PEFF score between the two groups(P =0.070).However,the HFpEF-AF group had higher mean H2FPEF score and higher proportion of patients with the score no less than 6 than the HFpEF group(P<0.001).According to the ROC curves,HFA-PEFF and H2FPEF scores demonstrated high perform-ance in diagnosing all HFpEF patients,with the area under the curve(AUC)of 0.892 and 0.922 and the opti-mal cut-offs of 4 and 4,respectively.The HFA-PEFF score showed similar performance in diagnosing HFpEF and HFpEF-AF,with the AUC of 0.899 and 0.911,respectively.The H2FPEF score had higher performance in di-agnosing HFpEF-AF(AUC of approximately 1.000)and low performance in diagnosing HFpEF(AUC of 0.885).Conclusions The HFA-PEFF score is applicable in the diagnosis of both HFpEF and HFpEF-AF.The H2FPEF score may underestimate HFpEF in Chinese patients,and its applicability in the Chinese patients with HFpEF alone remains to be investigated.
9.Interventional Effect and Metabolomics Analysis of Linderae Radix on Fibrosis of Rats with Intrauterine Adhesions
Jing YAN ; Dun YANG ; Dongwei GUO ; Yajing WANG ; Liangli LIU ; Tianyang JIA ; Mingxia XIE
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(15):142-151
ObjectiveTo investigate the pharmacological effect and metabolic mechanism of Linderae Radix on the intrauterine adhesion (IUA) rat model. MethodAn IUA rat model was induced by mechanical injury and infection. Molecular biology and pharmacology techniques were employed to evaluate the inhibitory effect of Linderae Radix extract (LAE) on fibrosis in IUA. Serum metabolomics analysis based on gas chromatography-mass spectrometry (GC-MS) was conducted to explore the metabolic regulation mechanism of LAE. ResultAnimal experiments showed that LAE significantly improved the morphology and structural damage of uterine tissue cells in the IUA rat model, promoted endometrial proliferation, vascular regeneration, and morphological recovery, inhibited the mRNA expression of transforming growth factor-β1 (TGF-β1), Smad2, and Smad3, and increased the expression of Smad7 mRNA to suppress fibrosis. Additionally, LAE significantly suppressed the levels of estrogen (E2), follicle-stimulating hormone (FSH), luteinizing hormone (LH), and tumor necrosis factor-α (TNF-α) expression (P<0.01), thereby improving the uterine microenvironment. Metabolomics analysis revealed significant metabolic abnormalities in the serum of IUA rats compared with the results in the normal group, and nine differential metabolites were identified. LAE effectively ameliorated these metabolic abnormalities, primarily by influencing six differential metabolites, including five shared metabolites among the nine identified markers: L-aspartic acid, L-pyroglutamic acid, L-serine, glucose, and L-norvaline. Pathway enrichment analysis indicated that the aminoacyl-tRNA biosynthesis pathway was the main affecting mechanism. ConclusionIn combination with the pharmacological research results, LAE effectively improved uterine damage and inhibited fibrosis in the IUA rat model. Its mechanism may involve the inhibition of the aminoacyl-tRNA biosynthesis pathway and the improvement of the microenvironment.
10.Semimonthly Table of Contents Application of health technology assessment in 4 European countries and its enlightenment to China
Dongwei YE ; Li WANG ; Shuwen LIU
China Pharmacy 2022;33(1):1-6
OBJECTIVE To provide referen ce for improving the application of health technology assessment (HTA) in decision-making for health insurance drugs in China. METHODS The application of HTA in decision-making for health insurance drugs in Britain ,France,Germany and Sweden were sorted out and analyzed from two aspects :the establishment of HTA institutions and the process of HTA. The suggestions for improvement were put forward ,combined with the implementation of HTA in China. RESULTS & CONCLUSIONS Britain,France,Germany and Sweden have set up special HTA institutions ,which perform their respective duties and cooperate closely. During the implementation of HTA ,the above four countries have set different value assessment criteria to screen drugs with “high cost performance ”,all stakeholders actively participate ,make the evaluation results and decisions public ,set up objection handling links ,open a rapid evaluation channel to improve the accessibility of drugs ,and re-evaluate the drugs included in the reimbursement list to ensure the sustainability of medical insurance. It is suggested that China should combine the national conditions ,strengthen the cooperation of HTA institutions ,focus on talent training and comprehensive value assessment criteria , promote stakeholder ’s participation , improve the transparency of decision-making,and improve the implementation procedures of HTA in China.

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