1.Pharmacoeconomic evaluation of glucagon-like peptide-1 receptor agonist combined with metformin in the treatment of type 2 diabetes mellitus
Tian YU ; Shaohua LIU ; Anhua WEI ; Jieru GUO ; Chengliang ZHANG ; Dong LIU ; Zhelong LIU
Chinese Journal of Pharmacoepidemiology 2024;33(4):388-401
Objective To evaluate the economic value of using glucagon-like peptide-1 receptor agonist(GLP-1RA)in combination with metformin for the treatment of type 2 diabetes mellitus(T2DM).Methods Based on 7 randomized controlled clinical trials(RCTs),Markov model was built to simulate the dynamic changes of metformin alone or combined with GLP-1RA in the treatment of T2DM patients without or with complications and death from the perspective of China's health system.Quality-adjusted life years(QALYs)was used as a health output indicator and 3 times China's per capita gross domestic product(GDP)in 2023 was set as the willingness-to-pay(WTP)threshold.The cycle was at the rate of 1 year and a total of 20 years cohort simulation in Markov model was applied to obtain long-term cost and effect of each treatment strategy.The incremental cost-utility ratio(ICUR)was analyzed as the primary evaluation indicator and the sensitivity of cost,utility and discount was performed to test the stability of the results.Results Compared with metformin alone,the ICUR of GLP-1RA including liraglutide,dulaglutide,exenatide,loxenatide,semaglutide combined with metformin were all below the WTP threshold,and the increased cost was acceptable.Extending the simulation time to 30 years or 50 years had no effect on results.The results of probability sensitivity analysis showed that the cost effect of semaglutide 0.5 mg combined with metformin had the highest probability of a cost-utility advantage of 99.7%among all the treatment strategies when WTP threshold was 3 times China's per capita GDP in 2023(268 074 yuan).Conclusion GLP-1RA,including liraglutide,dulaglutide,exenatide,lixisenatide,and semaglutide,at the regular recommended dose combined with metformin,would present higher cost-utility compared to metformin monotherapy.
2.Efficacy and safety of glucagon-like peptide 1 receptor agonists in the treatment of overweight or obese patients with type 2 diabetes:a Meta-analysis
Tian YU ; Shaohua LIU ; Anhua WEI ; Jieru GUO ; Chengliang ZHANG ; Dong LIU ; Zhelong LIU
Chinese Journal of Pharmacoepidemiology 2024;33(5):519-538
Objective To evaluate the efficacy and safety of glucagon-like peptide 1 receptor agonists(GLP-1RA)in type 2 diabetes mellitus(T2DM)patients with overweight or obese.Methods PubMed,Embase,Cochrane Library,Ovid,ClinicalTrial.gov,SinoMed,CNKI,WanFang Data and VIP databases were electronically searched to collect randomized controlled trials(RCTs)on the efficacy of GLP-1RA in the treatment of T2DM patients with overweight or obese from January 1,2005 to November 1,2023.Two researchers independently screened the literature,extracted data and evaluated the risk of bias of the included studies.R software was then used for meta-analysis.The level of evidence was assessed by using the GRADE system.Results A total of 71 RCTs were included,including 29 476 patients.The results of Meta-analysis showed that compared with other hypoglycemic drugs,GLP-1RA showed superior effects in improving HbAlc status(WMD=-0.55,95%CI-0.65 to-0.45,P<0.001)and weight loss(WMD=-2.61,95%CI-3.25 to-1.97,P<0.001),while the effect on fasting plasm glucose was time-dependent(within 16 weeks:WMD=0.25,95%CI-0.17 to 0.66,P=0.250;16 to 52 weeks:WMD=-0.06,95%CI-0.32 to 0.20,P=0.650;over 52 to 104 weeks:WMD=-1.67,95%CI-1.91 to-1.43,P<0.001).In terms of safety,the incidence of GLP-1RA's adverse reactions was higher than other hypoglycemic drugs(RR=1.11,95%CI 1.07 to 1.15,P<0.001);the incidence of hypoglycemia was lower with GLP-1RA than with insulin(RR=0.58,95%CI 0.48 to 0.71,P<0.001)and similar to oral hypoglycemic drugs(RR=0.83,95%CI 0.58 to 1.19,P=0.310).According to the GRADE assessment,only the certainty of the evidence for the results of the incidence of hypoglycemia was moderate,and the certainty of the evidence for the other results was low.Conclusion Current evidence shows that for T2DM patients with overweight or obese,GLP-1RA especially semaglutide,was more effective in lowering blood glucose,controlling body weight and reducing the occurrence of hypoglycemia than placebo,insulin and oral hypoglycemic drugs.
3.Research on signal mining of adverse event of minocycline based on FAERS database
Lu ZENG ; Lu WANG ; Anhua WEI ; Lumin ZHOU
Chinese Journal of Pharmacoepidemiology 2024;33(6):632-641
Objective To mine the adverse drug event(ADE)signals of minocycline,to provide a reference for clinical drug safety.Methods The reporting odds ratio(ROR)method,proportional report ratio(PRR)method,the Medicines and Healthcare Products Regulatory Agency(MHRA)method,and Bayesian confidence propagation neural network(BCPNN)method were used to analyze the ADE reports of minocycline based on U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)registration data from first quarter 2004 to fourth quarter 2023,and the signal distribution,signal intensity,gender and age differences,and mortality based on standard MedDRA query(SMQ)were analyzed.Results A total of 16 871 ADE cases of minocycline were screened,and 364 positive ADE signals were mapped to 27 system organ classification(SOC),the most involved SOC were systemic diseases and various reactions at the administration site,skin and subcutaneous tissue diseases,various neurological diseases,etc,and the strong signals with the higher number of ADE cases were drug reaction with eosinophilia and systemic symptoms(DRESS),polyarteritis nodosa and idiopathic intracranial hypertension,and compared to other drugs,the proportion of women with idiopathic intracranial hypertension caused by minocycline was higher(P<0.05).At the same time,29 cases of ADE in children under 8 years old were obtained,involving 10 SOC,206 deaths and 1 046 associated ADE-related cases,and there were 1 565 cases of hypersensitivity ADE,and 88 PT signals under the hypersensitivity SMQ.Among them,DRESS,urticaria,anti-neutral cytoplasm antibody-positive vasculitis,and facial edema were reported in high numbers and with strong signals.Conclusion The risk of hypersensitivity events and autoimmune diseases should be vigilant in the clinical use of minocycline,and ophthalmic monitoring could be performed especially in female patients if necessary.Attention should be paid to ADE collection and monitoring of minocycline in children under 8 years old.
4.Edaravone in the treatment of acute ischemic stroke:a rapid health technology assessment
Fang YU ; Lu ZENG ; Anhua WEI ; Xuepeng GONG ; Lu WANG
Chinese Journal of Pharmacoepidemiology 2024;33(10):1147-1155
Objective To rapidly evaluate the effectiveness,safety and economy of edaravone in treating acute ischemic stroke(AIS),and to provide the evidence-based basis for clinical decision-making.Methods PubMed,Embase,Web of Science,Cochrane Library,CNKI and WanFang Data databases and the official website of health technology assessment(HTA)agency were electronically searched to collect HTA reports,systematic reviews/Meta-analysis and pharmacoeconomic studies of edaravone in the treatment of AIS from the inception to October 1,2024.Two reviewers independently screened the literature,extracted data,evaluated the quality,summarized the results,and qualitatively described and analyzed the results.Results A total of 12 literature were included,involving 9 systematic reviews/Meta-analysis and 3 pharmacoeconomic studies.In terms of efficacy,edaravone alone or in combination with conventional therapy(alteplase,ozagrel)increased efficiency,improved short-term neurological deficit scores and improved patients'ability to perform activities of daily living compared with placebo or conventional therapy(alteplase,ozagrel)(P<0.05).There was no significant difference in the incidence of adverse reactions between edaravone and placebo,routine treatment,or other neuroprotectants(P>0.05).Combined with alteplase,it could reduce the incidence of intracranial hemorrhage compared to alteplase alone(P<0.05),with no statistically significant difference in all-cause mortality(P<0.05).Pharmacoeconomic studies showed that,edaravone does not have a cost-effectiveness advantage in the short term,but it may have a cost-effectiveness advantage from limited long-term studies.Conclusion Edaravone is effective and safe in the treatment of AIS,but there is limited research evidence and the conclusion still needs to be confirmed by further studies and clinical trials,and the economics need to be further evaluated.
5.Clinical comprehensive evaluation of single-pill combination of perindopril and amlodipine for treatment of hypertension
Juan WU ; Xueyan TU ; Ping LONG ; Lu ZEGN ; Lu WANG ; Anhua WEI
Chinese Journal of Pharmacoepidemiology 2024;33(11):1265-1275
Objective To evaluate the clinical value of single-pill combination(SPC)of perindopril and amlodipine for the treatment of hypertension and provide reference for the selection and rational use in medical institutions.Methods A comprehensive clinical evaluation index system was established based on literature research and expert demonstration.Therefore,the safety,effectiveness,economy,innovation,suitability and accessibility of drugs were analyzed qualitatively and quantitatively.Results A total of 12 studies reported the outcome of perindopril and amlodipine SPC,including efficacy and safety.Perindopril amlodipine SPC was safe,and there was no significant difference in the incidence of adverse events during treatment compared with monotherapy,monotherapy combination or other antihypertensive SPC.In terms of effectiveness,perindopril and amlodipine SPC had clear antihypertensive effect,which could significantly reduce systolic blood pressure,diastolic blood pressure,pulse pressure difference and heart rate,and the blood pressure compliance rate of perindopril and amlodipine SPC was better than that of amlodipine or perindopril monotherapy group.Compared with other depressurized SPCs,it showed better or non-inferior effect.Perindopril amlodipine SPC,as a patented drug,has good innovation,high patient compliance,and has been included in China's medical insurance catalog,but the current medical institutions have a low supply rate,and drug prices and affordability are still at a relatively high level.Conclusion Perindopril amlodipine SPC has significant advantages in safety,effectiveness,suitability and innovation,but its economy and accessibility still need to be improved.
6.Therapy Updates of 2024 Guidelines for the Diagnosis and Treatment of Heart Failure in China
Juan WU ; Ping LONG ; Lu ZENG ; Lu WANG ; Xuepeng GONG ; Anhua WEI
Herald of Medicine 2024;43(11):1718-1722
Heart failure is a severe manifestation or advanced stage of various heart diseases,with high mortality and readmission rates.The 2024 guidelines for the diagnosis and treatment of heart failure,which are on the 2018 guidelines,combined with new evidence and China's national conditions,provide a comprehensive and systematic description and recommendation on the classification,diagnosis,prevention,treatment,comorbidity,and management of heart failure.This article reviewed the update of the therapeutic drugs section.
7.Rapid Health Technology Assessment of the Efficacy,Safety and Economics of Empagliflozin in the Treatment of Type 2 Diabetes Mellitus
Lu WANG ; Anhua WEI ; Lu ZENG ; Ling GUI ; Xuepeng GONG ; Dong LIU
Herald of Medicine 2023;42(12):1841-1849
Objective To rapidly evaluate the efficacy,safety and economics of empagliflozin in the treatment of type 2 diabetes mellitus(T2DM)and to provide evidence-based medical evidence for clinical decision.Methods PubMed,Embase,the Cochrane Library,CNKI,Wangfang,VIP database and major health technology assessment(HTA)websites were searched from the construction of the databases to Nov 30th,2022.Two researchers independently screened,extracted the data,evaluated the quality and analyzed the results according to inclusion and exclusion criteria.Results A total of 23 literatures were included,including 3 HTA reports,10 systematic review/Meta-analyses and 10 pharmacoeconomic studies.The results of efficacy showed that empagliflozin reduced HbA1c,blood pressure,body weight and all-cause mortality compared with the control group.Safety studies showed that empagliflozin was generally well tolerated,and significantly reduced MACEs and the relative risk of the renal primary outcomes,but increased the risk of genital infections and electrolyte abnormality compared with placebo and other oral antidiabetic drugs.The economic evaluation results showed that empagliflozin was more cost-effective in high risk patients with comorbid cardiovascular or kidney disease.Conclusion Empagliflozin is effective and safe in the treatment of T2DM,but the pharmacoeconomic studies focusing on chinese populations are urgently needed.
8.Effects of manual digitorum sensory stimulation on spasticity of fingers for stroke patients: a surface electromyography study
Yaxing TIAN ; Yongfeng HONG ; Xiuli KAN ; Xianshan SHEN ; Jing MAO ; Yan JIANG ; Ziyan HE ; Yu WU ; Wei HU ; Xiaoning SUN ; Shunyin HU
Chinese Journal of Rehabilitation Theory and Practice 2022;28(5):515-519
ObjectiveTo investigate the changes of surface electromyography (sEMG) of the flexors and extensors of the affected fingers after manual digitorum sensory stimulation (MDSS) in the hemiplegic patients after stroke. MethodsFrom April to August, 2020, 50 stroke patients in Department of Rehabilitation Medicine, the Second Hospital of Anhui Medical University accepted MDSS on the nail beds and the third knuckles of affected fingers, until the fingers extended actively. The tension of affected flexor pollicis brevis, flexor digitorum superficialis and extensor digitorum were assessed with modified Ashworth Scale (MAS) before and immediately after stimulation; while the root mean square (RMS) of sEMG of bilateral flexor pollicis brevis, flexor digitorum superficialis and extensor digitorum were recorded. ResultsThe MAS score of all the muscles decreased after stimulation (|Z| > 2.699, P < 0.01), while the RMS of affected extensor digitorum increased (t = -2.069, P < 0.05). Compared with the unaffected ones, RMS of affected flexor pollicis brevis and extensor digitorum decreased before and after stimulation (t > 2.450, P < 0.05). ConclusionMDSS may immediately relieve the spasm of flexors of hemiplegic fingers after stroke, which associates with the promoting muscle strength of the extensors.
9.Clinical characteristics of patients with listeriosis.
Chaoxia WEI ; Pengcheng ZHOU ; Qianqian YE ; Xun HUANG ; Chunhui LI ; Anhua WU
Journal of Central South University(Medical Sciences) 2021;46(3):257-262
OBJECTIVES:
To investigate the clinical characteristics of patients with listeriosis and to provide a basis for diagnosis, treatment, prevention and control of hospital infection.
METHODS:
A total of 10 inpatients, who suffered from the listeriosis in Xiangya Hospital, Central South University from January 2013 to June 2019, were retrospectively collected for this study. The characteristics of the patients' age, gander, basic information, case type, clinical manifestations, first consultation department, days of diagnosis, infection indicator, specimen type, results of drug sensitivity, treatment plan, hospital infection or not, outcome, follow-up data were analyzed.
RESULTS:
Two cases were pregnant women and other were non-pregnant adults among 10 patients with listeriosis. Among them, there were 3 cases with hospital acquired infection. The age of patient onset was 27-71 years old, and the time from onset to diagnosis was 5-36 days. Five cases had fever, and other 5 cases had not fever. There were headache, fatigue, local pain, and other specialized symptoms in the 10 patients.The white blood cell count,the neutrophil ratio, the inflammatory index C-reactive protein, the procalcitonin were all increased, and the erythrocyte sedimentation was accelerated in the 10 patients.All the patients were sensitive to ampicillin, penicillin G, meropenem, and compound sinomine.
CONCLUSIONS
Listeriosis often affects the patients with low immunity, which often leads to misdiagnosis or missed diagnosis in clinic.So early prevention, early diagnosis, and early treatment can reduce mortality; it is important for departments of nosocomial infection management to manage patients' diet for avoiding outbreaks of listeriosis in hospital.
Adult
;
Aged
;
Female
;
Humans
;
Listeria monocytogenes
;
Listeriosis/epidemiology*
;
Meropenem
;
Middle Aged
;
Pregnancy
;
Pregnancy Complications, Infectious
;
Retrospective Studies
10.Extraskeletal Ewing sarcoma of thyroid gland: A case report.
Weiyu ZHU ; Xinming YANG ; Junjie ZENG ; Minghui WEI ; Shuang WANG ; Wencheng LI
Journal of Central South University(Medical Sciences) 2021;46(5):558-564
Extraskeletal Ewing sarcoma is a rare event, and extraskeletal Ewing sarcoma of the thyroid gland is even rarer. It has non-specific clinical manifestation and difficulty in early diagnosis. The diagnosis mainly depends on histology and immunohistochemistry. It possesses the features of high malignancy, high rate of local recurrence, and distant metastasis. Currently, the aggressive multimodal treatment contains surgery, chemotherapy, and radiotherapy. This study presented a case of extraskeletal Ewing sarcoma arising in the thyroid gland of a 30-year-old woman, who presented with supraclavicular mass and sense of dysphagia obstruction in Department of Otolaryngology, Head and Neck Surgery, Second Xiangya Hospital, Central South University in 2018. Imaging studies demonstrated a cystic-solid mass in inferior of the left leaf of thyroid gland and in the posterior of the trachea and esophagus. The patient underwent localized tumor resection. The pathological diagnosis revealed that it was a small round cell tumor, and the immunohistochemistry results were considered to be extraskeletal Ewing sarcoma. Subsequently, the patient was given chemotherapy and local radiation therapy. There was no evidence of tumor recurrence or metastasis.
Adult
;
Combined Modality Therapy
;
Female
;
Humans
;
Immunohistochemistry
;
Neoplasm Recurrence, Local
;
Sarcoma, Ewing/therapy*
;
Thyroid Gland

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