1.Evaluation of the efficacy and safety of dapagliflozin and empagliflozin in the treatment of patients with diabetic nephropathy based on real-world data
Chinese Journal of Pharmacoepidemiology 2025;34(7):734-742
Objective To investigate the efficacy,safety and influencing factors of the dapagliflozin and empagliflozin in the treatment of patients with diabetic nephropathy(DN)in the real world.Methods The data of patients with DN who received dapagliflozin or empagliflozin treatment at Nanjing Drum Tower Hospital from January 2020 to December 2024 were collected.Inverse probability of treatment weighting(IPTW)was used to balance the two groups of covariates,and the glycated hemoglobin(HbA1c),fasting blood glucose(FPG),postprandial blood glucose(2hPG),urine microalbumin(mAlb),urine microalbumin/creatinine ratio(UACR),estimated glomerular filtration rate(eGFR)and uric acid(UA)level were compared between the two groups before and after 6 months of treatment,and the progress of the disease and the occurrence of adverse reactions were recorded in follow-up.The Kaplan-Meier method and Log-rank test were used to analyze disease progression,and the Logistic regression model was used to analyze the influencing factors of adverse reactions in each group.Results A total of 305 patients were included,there was no statistically significant difference in baseline between the two groups after IPTW.After treatment,the levels of HbA1c,FPG,2hPG,mAlb and UACR of the two groups decreased significantly(P<0.05).And the 2hPG,eGFR and UA levels were better in the dapagliflozin group than in the empagliflozin group(P<0.05).There was no significant difference in the adverse reaction rate of the two groups(P>0.05).The median progression-free survival time of dapagliflozin group was 47 months,which was significantly higher than that of 35 months of empagliflozin treatment(P<0.05).Multivariate analysis results showed that diabetes course over 10 years,hyperuricemia,and vitamin D deficiency are risk factors for adverse reactions in the dapagliflozin group,and the combination of uric acid-lowering drugs was the risk factor for adverse reactions in the empagliflozin group.Conclusion Compared with empagliflozin,dapagliflozin demonstrates greater advantages in delaying the progression of DN,it can significantly reduce 2hPG and UA levels,and the safety of dapagliflozin is equivalent to empagliflozin.
2.Bibliometric analysis of researches on glucocorticoids use in systemic lupus erythematosus from 2004 to 2024
Jie BAI ; Liming DONG ; Zhihui SONG ; Jiawei WANG
Chinese Journal of Pharmacoepidemiology 2025;34(7):815-823
Objective To conduct a visual analysis of the research hotspots and trends of glucocorticoids in the treatment of systemic lupus erythematosus(SLE)both domestically and internationally.Methods The relevant literature from 2004 to 2024 on glucocorticoids use in SLE were retrieved in Web of Science,CNKI,WanFang Data and VIP databases.CiteSpace 6.3.R6 software was used to conduct bibliometric analysis of the number of publications,authors,research institutions,and keywords,and to draw knowledge maps.Results A total of 4,124 literature were retrieved,and 1,491 English literature and 593 Chinese literature were screened and included.The overall trend of English publications was increasing,while the number of Chinese publications declined in recent years.China is the most active country in this research field,but the research among authors and institutions was more dispersed.The results of keyword analysis showed that how to reduce the adverse reactions of glucocorticoids and special populations was the hotspots of research,with keywords such as"rheumatoid arthritis""damage""belimumab""children""pregnancy".Future research trends would be likely to focus on the assessment of treatment efficacy,prolonged remission,and reduction of disease-related injuries,with emergent keywords such as"validation""prolonged remission""treatment efficacy""renal function"Conclusion The use of glucocorticoids in the treatment of SLE continues to be the focus of the research,but with the increasing concern about adverse reactions,the research focus is gradually moving towards optimizing treatment regimens and exploring novel therapies.Future research needs to focus more on individualized treatment,long-term efficacy assessment and clinical application of emerging therapies.
3.Efficacy of oxycodone combined with midazolam as medication for ERCP under awake sedation
Yingying LI ; Chenxi FENG ; Anqiang FENG
Chinese Journal of Pharmacoepidemiology 2025;34(7):753-761
Objective To explore the efficacy and safety of oxycodone and midazolam for endoscopic retrograde cholangio-pancreatography(ERCP)under awake sedation.Methods Patients scheduled for elective ERCP in the department of gastroenterology of Xuzhou Central Hospital from January 2021 to December 2022 were prospectively recruited and randomly divided into the control group(pethidine combined with diazepam)and the experimental group(oxycodone combined with midazolam).Visual Analogue Scale(VAS)score,Ramsay Sedation Scale(RSS)score,heart rate(HR),respiratory rate(RR),blood oxygen saturation(SpO2),mean arterial pressure(MAP)and postoperative C-reactive protein and blood amylase levels were observed and compared between the two groups of patients before the procedure(T0),at the time of entry(T1),at the time of the opening of the endoscope into the duodenal papilla(T2),at the time of exit(T3).Additionally,incidence of adverse events,patient and endoscopist satisfaction were compared between the two groups.Results A total of 60 patients were included,30 in each group.The difference in the trends of VAS and RSS scores over time between the two groups was statistically significant(Ptime×treatment<0.05).Compared to the control group,the experimental group had lower VAS scores and higher RSS scores at T1,T2 and T3(P<0.05).The differences in SpO2 and MAP changes over time between the two groups were statistically significant(Ptime×treatment<0.05),with higher values observed in the experimental group at T1-T3(P<0.05).The incidence of pain,coughing and agitation in the experimental group was lower during the procedure(P<0.05).Both endoscopist and patient satisfaction were significantly higher in the experimental group(P<0.05).Conclusion Compared with pethidine combined with diazepam,oxcyodone combined with midazolam as a preoperative medication for awake sedation in ERCP treatment is more effective and safer.
4.Stomatitis caused by linagliptin tablet:a case report
Jie LI ; Xiaoyan LIU ; Yi HAN
Chinese Journal of Pharmacoepidemiology 2025;34(7):841-844
A 65-year-old male patient with type 2 diabetes developed who took linagliptin tablets for 6 months stomatitis liquid.After two weeks of treatment with triamcinolone oral ointment and Kangfuxin liquid,the symptoms did not improve.Clinical pharmacist consultation considered it to be caused by linagliptin tablets and advised the patient to discontinue linagliptin tablets,which was adopted by doctor.And,the patient was referred to the endocrinology department to adjust the glucose-lowering regimen.The oral lesions began to improve three days after discontinuation of the medication,and were completely healed at the third week of follow-up.The Naranjo's Assessment Scale was used to evaluate the association between linagliptin and stomatitis,with the result indicating'possibly related'.Stomatitis is a rare adverse reaction of linagliptin.Conventional local use of corticosteroids and mouthwashes may be ineffective,and timely discontinuation or reduction of the medication is necessary.This article may serve as a reference for clinical management of similar events.
5.Clinical study of lamotrigine combined with magnesium valproate in children with depressive episodes of bipolar disorder
Hai LIANG ; Feng ZHAO ; Huijuan CHEN ; Mengyu JIANG ; Panpan DI ; Miao YANG
Chinese Journal of Pharmacoepidemiology 2025;34(7):762-770
Objective To observe the efficacy,safety,and compliance of lamotrigine combined with magnesium valproate in treating children with depressive episodes of bipolar disorder,and to explore the effects on thyroid hormone levels,brain-derived neurotrophic factor(BDNF),C-reactive protein(CRP),interleukin-1(IL-1),interleukin-10(IL-10),tumor necrosis factor-α(TNF-α)and plasma concentration of valproate.Methods The children with bipolar disorder diagnosed from January 2023 to February 2025 were selected,and divided into the observation group and control group.The control group was treated with magnesium valproate tablets,and the observation group was added lamotrigine in addition to the treatment given to the control group.Both groups were treated continuously for 8 weeks.The clinical efficacy,the Hamilton Depression Scale-24(HAMD-24)score,Clinical Global Impression(CGI)assessment,thyroid hormone levels,BDNF,CRP,IL-1,IL-10 and TNF-α,daily average dose of magnesium valproate(D),blood concentration of valproate(C),C/D ratio,mean dosing interval(h),incidence of adverse reactions,and medication adherence and satisfaction scores in both groups was observed.Results A total of 100 children were included,50 in each group.After treatment,the total effective rate of the observation group was 98.00%which was significantly higher than that of the control group(84.00%)(P<0.05).The serum free triiodothyronine(FT3),free thyroxine(FT4),BDNF and IL-10 in both groups increased compared to the previous(P<0.05),while HAMD-24 score,CGI score,thyroid-stimulating hormone(TSH),CRP,IL-1 and TNF-α decreased(P<0.05),and all indicators in the observation group were better than those in the control group(P<0.05).Both groups had no serious or new adverse drug reactions,and the incidence of total adverse reactions,the difference in the incidence of total adverse reactions was not statistically significant(P>0.05).There was no statistically significant difference in valproic acid blood concentrations between the two groups of children(P>0.05).The medication compliance score and satisfaction score of the observation group were significantly higher than those of the control group(P<0.05).Conclusion Combination of lamotrigine with magnesium valproate in children with depressive episodes of bipolar disorder improves treatment effective and clinical symptoms,promotes a rise in thyroid hormone and BDNF as well as improves inflammatory factors and increases medication adherence and satisfaction in children with a better safety profile.
6.Severe acute liver injury induced by tolvaptan:a case report
Kexin WANG ; Erxia SHI ; Zhongyan ZHOU ; Xuan HE
Chinese Journal of Pharmacoepidemiology 2025;34(7):830-834
A 66-year-old man was admitted with acute left heart failure and hyponatremia.On the first day of admission,15 mg tolvaptan tablets were given orally.On the second day of admission,alanine transaminase and aspartate transaminase were significantly increased to 916.76 U·L-1 and 1 857.1 U·L-1,respectively,which met the diagnostic criteria of severe acute liver injury.The drug was immediately stopped and hepatoprotective therapy was given,and on the 10th day of admission,the patient's liver function improved significantly,and on the 12th day of admission,the patient was discharged after his condition stabilised.The results of the correlation evaluation indicated that the development of acute liver injury in this patient is likely related to tolvaptan.This article discusses the mechanism,time of occurrence,population and treatment of tolvaptan-induced liver function injury,suggesting that clinical use of tolvaptan should be highly vigilant for acute liver function injury and routine monitoring of patients' liver function to ensure the safe use of the drug.
7.A case report of acute kidney injury caused by semaglutide in combination with multiple medications
Jiamei GU ; Chenquan TANG ; Yi JIANG ; Hao YIN ; Chen FENG ; Yi XUE
Chinese Journal of Pharmacoepidemiology 2025;34(7):835-840
A 53-year-old female patient with type 2 diabetes mellitus,hypertension,and hyperlipidemia,on long-term therapy with metformin,gliclazide,dapagliflozin,sacubitril/valsartan,lercanidipine,and atorvastatin,was initiated on semaglutide due to obesity and suboptimal glycemic control.Patient using semaglutide 0.25 mg and 0.5 mg without adverse effects,and developed gastric discomfort after adjusting dose to 0.75 mg.She remained on this dose for 7 weeks.Upon further dose escalation to 1 mg,she experienced persistent nausea,vomiting,and diarrhea.Fifteen days later,she was admitted to the hospital with impaired consciousness.Laboratory findings revealed blood urea nitrogen of 35.4 mmol·L-1 and serum creatinine of 825 μmol·L-1.The patient was diagnosed with acute kidney injury(AKI),which was considered related to semaglutide,metformin,dapagliflozin,and sacubitril/valsartan.All medications were discontinued.Following symptomatic treatment including fluid resuscitation,volume expansion,and hemodialysis,the patient's renal function gradually recovered.The association between AKI and semaglutide,metformin,dapagliflozin,and sacubitril/valsartan was evaluated using the Naranjo's Assesment Scale,the results were all"probable".This case highlighted that clinical use of semaglutide requires careful consideration of concomitant medications and vigilance for renal impairment.In the event of AKI,prompt assessment,discontinuation of medications with potential renal impairment and symptomatic management were necessary to ensure safe medication administration.
8.Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)and their series interpretation(7):selection of control groups
Qinxi TIAN ; Siyan ZHAN ; Feng SUN ; Zhirong YANG
Chinese Journal of Pharmacoepidemiology 2025;34(7):725-733
The selection of an appropriate control group is a critical component of pharmacoepidemiologic research.This article provides an interpretation of the control selection methods outlined in the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition).According to the 2nd edition,studies are categorized into interventional and non-interventional research.In interventional research,control group options include placebo controls,no-treatment controls,active controls,and dose-response controls.For non-interventional research,the gold standard design is the active comparator new user(ACNU)design.When the ACNU design is not feasible,alternative control group strategies should be selected based on the research objective,data sources,exposure characteristics,and potential confounding.These alternatives may include non-user comparators,prevalent user comparators,self-controlled comparators,and external controls.Finally,this article compares the applicability,strengths,and limitations of various control group types.It aims to provide methodological guidance for the scientific selection of control groups in pharmacoepidemiologic studies and to support the conduct of high-quality research.
9.Development and application of a rapid identification algorithm for cutaneous lupus erythematosus and its subtypes based on medical insurance databases
Yutong WANG ; Xianglong MENG ; Yu PAN ; Chen WEI ; Hui JIN ; Shengfeng WANG
Chinese Journal of Pharmacoepidemiology 2025;34(7):743-752
Objective To develop and validate data extraction and patient identification algorithms for cutaneous lupus erythematosus(CLE)and its two subtypes,discoid lupus erythematosus(DLE)and subacute cutaneous lupus erythematosus(SCLE),and to enable high-efficiency patient identification in large-scale electronic health databases.Methods This study utilized data from the 2013-2017 National Insurance Claims for Epidemiological Research(NICER)to construct data extraction and rapid patient identification algorithms.The manual verification results were used as gold standard to assess the sensitivity and specificity of the algorithms.Additionally,the basic characteristics of the identified patients were analyzed.Results Initially,standardized expressions were developed based on medical terminology and diagnostic codes.These were further refined with input from clinicians to include potential synonyms and common misspellings,improving the preliminary screening expressions.Through iterative verification by clinicians and data management engineers,a final disease-specific screening algorithm was established.The developed extraction and identification algorithms for all 3 targeted disease demonstrated strong performance,with sensitivity values of 0.985,1.000,and 0.991,and specificity values of 0.997,0.999,and 0.998 for CLE,DLE,and SCLE,respectively.A total of 34,554 CLE cases,including 2,879 DLE cases,and 623 SCLE cases were identified between 2013 and 2017,with a higher prevalence among females than males.Conclusion This study developed and validated an identification algorithm for CLE patients based on medical insurance databases,demonstrating high performance.The proposed algorithm provides a methodological framework and empirical evidence for designing and optimizing big data-driven rapid patient identification algorithms in dermatology research.
10.Efficacy and safety of dose-optimization strategies for CDK4/6 inhibitors in HR+/HER2-advanced breast cancer:a Meta-analysis
Yating ZHENG ; Songling LIU ; Liyan ZHOU
Chinese Journal of Pharmacoepidemiology 2025;34(7):795-805
Objective To systematically review the efficacy and safety of reduced versus standard doses of CDK4/6 inhibitors in patients with HR+/HER2-advanced breast cancer.Methods PubMed,Web of Science,Cochrane Library,Embase,CNKI,WanFang Data,VIP,databases were electronically searched to collect randomized controlled trials(RCTs)on HR+/HER2-advanced breast cancer patients treated with reduction of CDK4/6 inhibitor dose and standard dose from inception to April 1,2025.Two reviewers independently screened the literature,extracted data,and assessed the risk of bias of the included studies.Meta-analysis was performed using RevMan 5.1 software.Results A total of 14 RCTs involving 4,958 patients were included.The results of Meta-analysis showed that there was no statistically significant difference in PFS[HR=1.01,95%CI(0.92,1.11),P=0.81]and OS[HR=0.78,95%CI(0.52,1.18),P=0.25]in the dose-reduced group and the standard dose group,while ORR[RR=0.83,95%CI(0.71,0.96),P=0.01]and incidence of grade 3 and above neutropenia[RR=0.42,95%CI(0.21,0.85),P=0.02]in the dose-reduced group were significantly better than those in the standard dose group.Conclusions Current evidence shows that the dose reduction of CDK4/6 inhibitors can considerably reduce the incidence of grade 3 and above neutropenia without affecting PFS and OS.

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