1.Analysis on application of new anti-tumor drugs for respiratory system in 121 hospitals in China from 2019 to 2022
Yue XING ; Tong LIU ; Lu ZHONG ; Yao JIN ; Xue TENG
Chinese Journal of Pharmacoepidemiology 2025;34(1):27-34
Objective To investigating the usage and changing trend of new anti-tumor drugs for respiratory system of 121 hospitals after the implementation of relevant policies insurance negotiation in China from 2019 to 2022,explore the development tendency of new anti-tumor drugs in hospitals under the medical reform policy and provide references for the rational use and standardized management of new anti-tumor drugs.Methods Based on the anti-tumour drug for respiratory system varieties in the Guidelines for the Clinical Application of Novel Anti-tumour Drugs Version 2022,descriptive statistical analysis was applied to retrieve data on the use of new anti-tumour drugs for respiratory system in 121 hospitals from 2019 to 2022,and drug dosage form,amount,drug frequency(DDDs),average daily cost(DDC)and drug ranking ratio(B/A)were statistically analyzed.Results The number of users and the proportion of new anti-tumour drugs for respiratory system used in 121 hospitals in China showed a year-on-year increasing trend from 2019 to 2022.In different cities of China,the drug use amount of Guangzhou,Beijing,Hangzhou and Zhengzhou was relatively large.In terms of drug use,small-molecule targeted drugs were still the main new anti-tumor drugs,while macromolecule targeted drugs showed a downward trend,and immunotherapy drugs showed a gradual upward trend.In terms of the amount of use,the top drugs in the four years were ecitinib,aletinib,gefitinib and oxitinib.The small molecule targeted drugs included in the national insurance negotiations showed increasing use and a decreasing amount of money spent.The ranking of DDDs was basically stable,with fluctuations in individual varieties.The DDC values of small molecule targeted drugs had significantly decreased,while the DDC values of immunotherapy drugs were relatively high.From 2021 to 2022,the B/A value of the novel anti-tumor drugs was most respiratory tumors was close to 1,and the varieties located at 0.8 to 1.2 accounted for 61.5%of the total drugs.Conclusion At present,the selection of new anti-tumor drugs for respiratory system is still dominated by small molecule targeted drugs and the use of immunotherapy drugs is increasing.The synchronization of the amount and frequency of most drugs has increased.The adjustment of the medical insurance catalog and the implementation of policies such as national negotiation effectively promote the decrease of the amount of drug use and the improvement of drug trend.
2.Q-marker prediction analysis of Sanqi Shenfeng oral liquid based on fingerprint and network pharmacology
Liping FENG ; Weijun XIA ; Jinyu LI ; Dingqian ZHANG ; Ping REN ; Lihe LU
Chinese Journal of Pharmacoepidemiology 2025;34(1):35-46
Objective To establish the fingerprints and predict the quality markers of Sanqi Shenfeng oral liquid based on fingerprint and network pharmacology.Methods The fingerprints of 12 batches of Sanqi Shenfeng oral liquid were established by using HPLC,and their peaks were identified and assigned.The candidate components were selected by multiple statistical analysis methods such as similarity evaluation,hierarchical cluster analysis,principal component analysis and orthogonal partial least squares discrimination analysis(OPLS-DA).The"component-target-pathway"network diagram was constructed by network pharmacology,and the quality markers of Sanqi Shenfeng oral liquid were predicted.Results The 13 common peaks were identified from the established fingerprint.Compared with the reference material,eight common peaks were identified as 3(tetrahydroxystilbene glucoside),5(sodium benzoate),6(lobetyolin),7(notoginsenoside Ri),9(ginsenoside Rgi),10(ginsenoside Re),12(10-hydroxy-2-decenoic acid),13(ginsenoside Rb1).The similarity of 12 batches of Sanqi Shenfeng oral liquid samples was higher than 0.997,and 12 batches of samples were grouped into two categories.OPLS-DA analysis showed that peaks 2,3,4,7,9,10,11,12 were the main signature components affecting the quality of Sanqi Shenfeng oral liquid.Network pharmacology predicted that lobetyolin,notoginsenoside R1,ginsenoside Rg1,ginsenoside Rb1,ginsenoside Re and 10-hydroxy-2-decenoic acid were potential Q-markers of Sanqi Shenfeng oral liquid.The traditional functions are performed through STAT3/AKT1-Drp1,HIF-1 and PI3K-AKT signaling pathway.Conclusion The established fingerprint has good reproducibility,stability and feasibility.The six components have great influence on the quality of Sanqi Shenfeng oral liquid,which are transferable and traceable,and are closely related to the efficacy.They can be used as potential quality markers to provide a scientific basis for the quality control and evaluation of Sanqi Shenfeng oral liquid.
3.Influencing factors of liver injury in breast cancer patients after chemotherapy:a Meta-analysis
Haiwei ZHANG ; Kai ZHOU ; Dongliang YANG ; Haixia ZHAO
Chinese Journal of Pharmacoepidemiology 2025;34(1):47-56
Objective To systematically review the risk factors for liver injury in breast cancer patients after chemotherapy.Methods PubMed,Cochrane Library,Embase,Web of Science,CNKI,SinoMed,WanFang Data and VIP databases were electronically searched to collect studies on the influential factors of liver injury in breast cancer patients from inception to March 31,2024.Two reviewers independently screened the literature,extracted data and evaluated the risk of bias of the included studies.Meta-analysis was performed by using RevMan 5.3 software.Results A total of 15 studies involving 6,486 patients were included.The results of Meta-analysis showed that hepatitis B virus infection[OR=2.41,95%CI(1.52,3.82),P<0.001],lymph node metastasis[OR=1.27,95%CI(1.05,1.55),P=0.02],hyperlipidemia[OR=1.58,95%CI(1.13,2.20)P=0.007],liver metastasis[OR=3.19,95%CI(2.11,4.84),P<0.001],tumor node metastasis(TNM)stage Ⅲ to Ⅳ[OR=1.49,95%CI(1.17,1.90),P<0.001],were risk factors for liver injury after breast cancer chemotherapy.Compared with other chemotherapy agents/regimens,the use of fluorouracil[OR=0.58,95%CI(0.42,0.80),P<0.001],cyclophosphamide[OR=0.65,95%CI(0.47,0.89),P=0.008],AC regimen[OR=0.38,95%CI(0.22,0.66),P<0.00 1]and neoadjuvant chemotherapy[OR=0.61,95%CI(0.43,0.88),P=0.007]were associated with a lower risk of liver injury,the use of paclitaxel drugs[OR=2.85,95%CI(2.31,3.52),P<0.001],intensive regimen[OR=3.48,95%CI(2.15,5.62),P<0.001],TAC regimen[OR=2.42,95%CI(1.38,4.24),P=0.002]increased the risk of liver injury.Tumor TNM stage I[OR=0.63,95%CI(0.51,0.78),P=0.001]were protective factors for liver injury after chemotherapy in breast cancer patients.Conclusion The current evidence shows that multiple factors influence the incidence of liver injury after breast cancer chemotherapy.Medical staff can formulate targeted chemotherapy programs according to the influencing factors and clinical characteristics to reduce the risk of liver injury after chemotherapy.
4.Study of the effect of Banxia Xiexin decoction on glucose and lipid metabolism and modulation of pancreatic sweet taste receptor signaling pathway in pre-diabetic rats
Chinese Journal of Pharmacoepidemiology 2025;34(2):182-190
Objective To investigate the ameliorative effect of Banxia Xiexin decoction(BXXXD)on the imbalance of glucose/lipid metabolism homeostasis in pre-diabetic rats as well as the modulation of pancreatic sweet taste receptor signaling pathway.Methods SD rats were fed a high-fat and high-sugar diet to establish a pre-diabetic model and randomly divided into BXXXD group(n=6)and the model group(n=6).An additional six SD rats were designated as the normal control group.Rats in the BXXXD group were administered BXXXD aqueous extract at 8 g·(kg·d)-1 by gavage for 4 weeks,while the model and normal control groups received an equivalent volume of distilled water for the same duration.Oral glucose tolerance tests(OGTT)were performed to evaluate glucose-handling capacity,with the time-glacose area under the curve(AUC)calculated.Serum insulin levels were measured via enzyme-linked immunosorbent assay(ELISA),and the homeostasis model assessment of insulin resistance(HOMA-IR)was used to determine the insulin resistance index.Blood lipid levels were analyzed using an automated biochemical analyzer.Protein expression levels of key molecules in the sweet taste receptor signaling pathway were detected by Western blotting.Results Compared with the normal control group,the model group exhibited significantly increased islet volume,elevated blood glucose levels at all time points during the OGTT,higher time-glucose AUC,elevated fasting insulin,HOMA-IR,60-min post-OGTT insulin,total cholesterol(TC),triglycerides(TG),and low-density lipoprotein cholesterol(LDL-C)levels(P<0.05).In contrast,high-density lipoprotein cholesterol(HDL-C),30-min post-OGTT insulin levels,and protein expression of TAS1R3,PLCβ2,and TRPM5 were significantly reduced(P<0.05).Compared with the model group,the BXXXD group showed significantly reduced islet volume,lower fasting blood glucose,30-and 60-min post-OGTT blood glucose,time-glucose AUC,fasting insulin,HOMA-IR,60-min post-OGTT insulin,TC,TG,and LDL-C levels(P<0.05).Conversely,HDL-C,30-min post-OGTT insulin levels,and protein expression of TAS1R3,PLCβ2,and TRPM5 were significantly elevated(P<0.05).Conclusion BXXXD may improve the homeostatic imbalance of glucose/lipid metabolism in prediabetes by modulating the pancreatic sweet taste receptor signaling pathway,which may provide a scientific basis to prevent and treat prediabetes by BXXXD.
5.Current status analysis of anti-infection research by using the Bayesian method
Yiling LIU ; Jinglin LIU ; Zhenzhen LU ; Yingying WANG ; Qijing JIANG ; Bingzhe LI ; Luyan DAI ; Fanrong YAN ; Lihong HUANG
Chinese Journal of Pharmacoepidemiology 2025;34(1):69-77
Objective To analyze the application characteristics,trends,and special advantages of anti-infection research using the Bayesian method,and to provide methodological reference for the development of anti-infection research.Methods PubMed,CNKI and WanFang Data were electronically searched for the studies on anti-infection using Bayesian method published from January 1,2015 to November 21,2023.The relevant information of publication time,anti-infection type,sample size,Bayesian characteristics and Bayesian application pattern were analyzed descriptively and reviewed.Results A total of 86 studies were included,of which 41.9%were observational studies,only 7.0%were enterprise-initiated studies,and 48.8%were mentioning prior information studies.There was no domestic intervention study.The application characteristics and advantages of Bayesian method in intervention study,observational study and pharmacokinetic study are different.In intervention researches and observational researches,the application of Bayesian design decision and the application of Bayesian analysis and estimation accounts for 69.2%and 52.8%at most,respectively.Conclusions The Bayesian method is flexible,can be used for small sample sizes and complex model research,and can deal with uncertainty.In intervention studies in the field of anti-infection in China,the Bayesian method has not been applied widely.Only a handful of studies applying Bayesian method have been initiated by companies.In the future,it is still necessary to promote the advantages and application scenarios of Bayesian methods in the field of anti-infection research and strengthen the standardization of the application of Bayesian method.
6.Research progress on the application and safety of botulinum toxin type A during pregnancy
Chinese Journal of Pharmacoepidemiology 2025;34(2):216-223
Botulinum toxin type A has been widely used in disease treatment and cosmetic shaping.Women of childbearing age are the key population using botulinum toxin type A.Consultations about this drug are gradually increasing,but domestic reports on the application and safety during pregnancy are relatively rare.This study reviews the case reports of using botulinum toxin type A during pregnancy and before pregnancy,as well as pregnancy outcomes of botulinum toxin poisoning during pregnancy,discussing the safety and limitations of using botulinum toxin type A during pregnancy.The study showed when used in pregnancy at therapeutic doses,botulinum toxin type A has good effects on patients and can alleriate the patients'symptoms.Patients can avoid surgery or using drugs with lower safety during pregnancy.Exposure to botulinum toxin type A during pregnancy does not increase the incidence of fetal defects.Botulinum antitoxin should be given promptly to pregnant women with botulinum toxin type A poisoning.According to the current research data,it is suggested that botulinum toxin type A can be used as a therapeutic agent during pregnancy after fully informing patients of the risks of medication.
7.Visualization analysis of research hotspots of the economic burden of acute ischemic stroke
Yitong BAI ; Zhigang ZHAO ; Zhongjun GUAN
Chinese Journal of Pharmacoepidemiology 2025;34(1):78-85
Objective To analyze the hotspots and development trends of the economic burden of acute ischemic stroke,and to provide a reference for researchers in China to conduct related studies.Methods Web of Science Core Collection database was searched to collect relevant reviews or articles on the economic burden of acute ischemic stroke from January 1994 to December 2023.CiteSpace 6.1.R6 software was used to visualize the authors,countries/regions,research institutions,keywords,and co-cited references.Results A total of 1,162 articles were include.The United States was the country with highest number of publications and centrality.China ranked the second in publication volume,but its centrality ranking was relatively low.Among the top 10 institutions in terms of publication volume,6 were from the United States,and Capital Medical University was the only Chinese institution listed.The cost-effectiveness analysis of treatment plans,scientific management method,and the cost-effectiveness analysis of treatment plans were the main research topics.The past three years had focused primarily on the cost-effectiveness analysis of treatment plans.Conclusion The study of the economic burden of acute ischemic stroke has advanced rapidly in recent years,but there is still a significant gap between China and developed western countries such as the United States.Chinese researchers should research current hotspots,while also addressing the early foundation studies of these hotspots,providing beneficial conditions for conducting hotspot research.
8.Revision process of the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)
Jinan YAN ; Yunxiao WU ; Xiaolu NIE ; Houyu ZHAO ; Siyan ZHAN ; Feng SUN
Chinese Journal of Pharmacoepidemiology 2025;34(2):121-135
Pharmacoepidemiology is a scientific discipline that applies epidemiological principles and methods to study the utilization and effects of pharmaceuticals in populations.It plays a crucial role in promoting rational drug use and improving public health outcomes.High-quality pharmacoepidemiological research relies on rigorous methodological frameworks.Chinese Pharmaceutical Association(CPA)has officially initiated the development/revision of the of the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)in 2024.This revision project was supported by the Pharmacoepidemiology Committee of CPA,and was led by the Department of Epidemiology and Biostatistics at Peking University School of Public Health,which provided methodological guidance,in collaboration with multidisciplinary experts from across the country.Building on the experience of the 1st edition's development,the working group conducted a qualitative systematic review,to extract key information from global pharmacoepidemiology-related guidelines,laying the foundation for the development/revision proposals of the 2nd edition.Subsequently,through two rounds of Delphi method expert consultations and qualitative interviews,alongside extensive discussions within the working group,the draft revision of the guideline was created.Finally,through an expert consensus meeting using the Nominal Group Technique(NGT),a consensus was reached,resulting in a methodological guideline that integrates international perspectives with local applicability for pharmacoepidemiological research in China.The 2nd edition consists of 41 entries,including 8 primary entries,20 secondary entries,and 13 tertiary entries.It comprehensively covers key aspects such as study protocol development,study implementation,adverse event reporting,research report writing,and dissemination of study findings.Additionally,it addresses specific application scenarios and topics,as well as the application of artificial intelligence and real-world studies.
9.Myocardial infarction induced by penpulimab and anlotinib:a case report
Chunhui WANG ; Mengfei JIANG ; Wei WU ; Yuhong ZHOU
Chinese Journal of Pharmacoepidemiology 2025;34(2):231-235
A 71-year-old man with undifferentiated sarcoma was treated with palliative first-line regimen(epirubicin,anlotinib and penpulimab)for 6 cycles and maintained with anlotinib and penpulimab for 30 cycles.He was admitted to the hospital due to chest pain 25 months after the first treatment.The laboratory examination showed cardiac troponin T 1.26 ng·mL-1,N terminal pro B type natriuretic peptide 8,545 pg·mL-1,coronary computed tomography angiography(CTA)showed non-calcified plaque in the left proximal anterior descending branch,severe lumen stenosis,nearly complete occlusion.Emergency CTA was performed on the same day,showing 50%stenosis of the distal left main coronary artery(LMCA);95%stenosis of the left anterior descending(LAD)branch ostium,the LAD branch was medium-sized and showed no stenosis;50%stenosis of the left circumflex branch(LCx),and a cardiac stent was implanted into the LAD branch.The patient has recovered after coronary artery stent implantation.Naranjo's Assessment Scale was used to evaluate the association of suspected drugs,the acute myocardial infarction of this patient was likely associated with the combination of penpulimab and anlotinib.Myocardial infarction is a rare but severe adverse drug reaction of anti-tumor treatment.This article summarizes the related risks and treatment measures to provide a reference for clinical medication safety.
10.A case report of ischemic bowel disease caused by Shengxuexiaoban capsules
Cuilin XU ; Binbin LI ; Jing HU ; Naizhong HU ; Yanyan WANG
Chinese Journal of Pharmacoepidemiology 2025;34(2):236-240
A 76-year-old male patient with lung cancer developed thrombocytopenia due to chemotherapy.Three days after taking the Shengxuexiaoban capsules orally,he experienced abdominal pain and bloody stool and was admitted to the hospital.The blood test showed white blood cell count of 11.54×109·L-1,neutrophil percentage of 82.4%,platelet count of 93×109·L-1,and C-reactive protein level of 23.50 mg·L-1.Fecal occult blood test positive,and pathology indicatesd ischemic-like changes in the rectal mucosa.The patient was diagnosed with ischemic bowel disease.After treatment with fluid replacement and anti-infection,the patient's abdominal pain disappeared and his stool turned yellow.The Naranjo's Assessment Scale was used to evaluate the association between adverse effects of ischemic bowel disease and Shengxuexiaoban capsules,and the result was very likely related.This article analysed the clinical characteristics and drug treatment process of ischemic bowel disease caused by Shengxuexiaoban capsule through this case,aiming to provide references for the safe use of drugs in the clinically.

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