1.Three Janus kinase inhibitors in the treatment of rheumatoid arthritis:a rapid health technology assessment
Yu LI ; Xiaojun FENG ; Peng LYU ; Jingli ZHANG ; Tianlu SHI
Chinese Journal of Pharmacoepidemiology 2025;34(4):437-447
Objective To evaluate the efficacy,safety and economy of three Janus kinase inhibitors in the treatment of rheumatoid arthritis(RA)using a rapid health technology assessment method,and to provide a basis for drug access and rational clinical use.Methods PubMed,Cochrane Library,Embase,CNKI,WanFang Data databases and the official websites of foreign health technology assessment(HTA)institutions were searched electronically to collect HTA reports,systematic reviews/Meta-analysis and pharmacoeconomics studies of tofacitinib,baricitinib,and upadacitinib in the treatment of RA from inception to December 31,2024.Two reviewers independently screened the literature,extracted information and performed quality assessment of the included studies,and then performed descriptive analysis on the results.Results A total of 16 literature were included,including 12 systematic reviews/Meta-analysis and 4 pharmacoeconomic studies.In terms of efficacy,taking the American College of Rheumatology(ACR)evaluation criteria for symptom relief 20%(ACR20),ACR50,ACR70 and disease activity score 28(DAS28)<2.6 response rates as the efficacy indicators,upadacitinib 30 mg and upadacitinib 15 mg had better effectiveness in the treatment of RA patients.In terms of safety,the incidence of adverse drug events was the lowest in RA patients treated with 15 mg of upadacitinib.The incidence of serious adverse drug events in RA patients treated with tofacitinib 5 mg was the lowest.In terms of economy,compared with tofacitinib and baricitinib,upadacitinib 15 mg was the most economical.Conclusion Upadacitinib 15 mg has better efficacy,safety and economy in the treatment of RA patients.
2.Prevalence and associated risk factors of carotid plaque and artery stenosis in China: a population-based study.
Qingjia ZENG ; Chongyang ZHANG ; Xinyao LIU ; Shengmin YANG ; Muyuan MA ; Jia TANG ; Tianlu YIN ; Shanshan ZHAO ; Wenjun TU ; Hongpu HU
Frontiers of Medicine 2025;19(1):64-78
Stroke is a critical health issue in China, and carotid artery stenosis and plaque play key roles in its prevalence. Despite the acknowledged significance of this condition, detailed information regarding the prevalence of carotid artery stenosis and plaque across the Chinese population has been scarce. This study analyzed data from the China Stroke High-risk Population Screening and Intervention Program for 2020-2021, focusing on 194 878 Chinese adults aged 40 years and above. It assessed the prevalence of carotid artery stenosis and plaque and identified their associated risk factors. Results revealed a standardized prevalence of 0.40% for carotid artery stenosis and 36.27% for carotid plaque. Notably, the highest rates of stenosis were observed in north and south China at 0.61%, while southwestern China exhibited the highest plaque prevalence at 43.17%. Key risk factors included older age, male gender, hypertension, diabetes, stroke, smoking, and atrial fibrillation. This study highlights significant geographical and demographic disparities in the prevalence of these conditions, underlining the urgent need for targeted interventions and policy reforms. These measures are essential for reducing the incidence of stroke and improving patient outcomes, addressing this significant health challenge in China.
Humans
;
China/epidemiology*
;
Male
;
Female
;
Prevalence
;
Middle Aged
;
Carotid Stenosis/epidemiology*
;
Risk Factors
;
Aged
;
Adult
;
Plaque, Atherosclerotic/epidemiology*
;
Stroke/epidemiology*
;
Aged, 80 and over
3.Effect of Diltiazem on Blood Concentration of Tacrolimus in Patients with Nephrotic Syndrome
Kuikui GENG ; Lei LAN ; Shengyu ZHANG ; Aizong SHEN ; Wei WU ; Tianlu SHI
Herald of Medicine 2025;44(2):287-292
Objective To analyze the effect of diltiazem on blood concentration of tacrolimus(TAC)retrospectively,and to provide reference for individual administration of tacrolimus in patients with nephrotic syndrome(NS).Methods The patients with NS who were treated in the outpatient/inpatient department of our hospital from January 2018 to December 2022 were collected,and the general information,combined drug use,blood drug concentration and other information of the patients were recorded.The patients were divided into two groups according to whether diltiazem was used or not:TAC group alone and TAC group combined with diltiazem.The effect of diltiazem on tacrolimus concentration was analyzed.Results A total of 45 patients with NS were included in this study,and 21 patients in the TAC group were treated with TAC alone.The mean blood concentration of TAC after medication was(5.77±2.87)ng·mL-1,which reached the effective therapeutic concentration range.The average blood concentration of TAC+Diltiazem group in the 24 patients was(2.90±1.29)ng·mL-1 before combined treatment,and increased to(5.74±2.46)ng·mL-1 after combined with diltiazem,with a growth rate of(127.34±119.57)%.The increase range was from 10%to 288%,and there was significant difference(P<0.05).According to the observation within 6 months after the combination of the two drugs,the average blood concentration of TAC continued to increase,especially in the 5th month after the administration of TAC,and the concentration tended to be stable after 5 months.By compare with the effect of diltiazem dosage on the blood concentration of TAC,90 mg·d-1 and 180 mg·d-1 had little difference in improving the blood concentration of TAC.At the same time,the combination of the two drugs did not cause adverse reactions.Conclusion A daily dose of 90 mg of Diltiazem can significantly increase the TAC blood concentration in patients with NS who cannot reach the effective therapeutic concentration with conventional doses.It can reach the effective clinical therapeutic concentration without increasing the dose of tacrolimus.The combination of the two drugs were generally safe and effective.
4.Three Janus kinase inhibitors in the treatment of rheumatoid arthritis:a rapid health technology assessment
Yu LI ; Xiaojun FENG ; Peng LYU ; Jingli ZHANG ; Tianlu SHI
Chinese Journal of Pharmacoepidemiology 2025;34(4):437-447
Objective To evaluate the efficacy,safety and economy of three Janus kinase inhibitors in the treatment of rheumatoid arthritis(RA)using a rapid health technology assessment method,and to provide a basis for drug access and rational clinical use.Methods PubMed,Cochrane Library,Embase,CNKI,WanFang Data databases and the official websites of foreign health technology assessment(HTA)institutions were searched electronically to collect HTA reports,systematic reviews/Meta-analysis and pharmacoeconomics studies of tofacitinib,baricitinib,and upadacitinib in the treatment of RA from inception to December 31,2024.Two reviewers independently screened the literature,extracted information and performed quality assessment of the included studies,and then performed descriptive analysis on the results.Results A total of 16 literature were included,including 12 systematic reviews/Meta-analysis and 4 pharmacoeconomic studies.In terms of efficacy,taking the American College of Rheumatology(ACR)evaluation criteria for symptom relief 20%(ACR20),ACR50,ACR70 and disease activity score 28(DAS28)<2.6 response rates as the efficacy indicators,upadacitinib 30 mg and upadacitinib 15 mg had better effectiveness in the treatment of RA patients.In terms of safety,the incidence of adverse drug events was the lowest in RA patients treated with 15 mg of upadacitinib.The incidence of serious adverse drug events in RA patients treated with tofacitinib 5 mg was the lowest.In terms of economy,compared with tofacitinib and baricitinib,upadacitinib 15 mg was the most economical.Conclusion Upadacitinib 15 mg has better efficacy,safety and economy in the treatment of RA patients.
5.Effect of Diltiazem on Blood Concentration of Tacrolimus in Patients with Nephrotic Syndrome
Kuikui GENG ; Lei LAN ; Shengyu ZHANG ; Aizong SHEN ; Wei WU ; Tianlu SHI
Herald of Medicine 2025;44(2):287-292
Objective To analyze the effect of diltiazem on blood concentration of tacrolimus(TAC)retrospectively,and to provide reference for individual administration of tacrolimus in patients with nephrotic syndrome(NS).Methods The patients with NS who were treated in the outpatient/inpatient department of our hospital from January 2018 to December 2022 were collected,and the general information,combined drug use,blood drug concentration and other information of the patients were recorded.The patients were divided into two groups according to whether diltiazem was used or not:TAC group alone and TAC group combined with diltiazem.The effect of diltiazem on tacrolimus concentration was analyzed.Results A total of 45 patients with NS were included in this study,and 21 patients in the TAC group were treated with TAC alone.The mean blood concentration of TAC after medication was(5.77±2.87)ng·mL-1,which reached the effective therapeutic concentration range.The average blood concentration of TAC+Diltiazem group in the 24 patients was(2.90±1.29)ng·mL-1 before combined treatment,and increased to(5.74±2.46)ng·mL-1 after combined with diltiazem,with a growth rate of(127.34±119.57)%.The increase range was from 10%to 288%,and there was significant difference(P<0.05).According to the observation within 6 months after the combination of the two drugs,the average blood concentration of TAC continued to increase,especially in the 5th month after the administration of TAC,and the concentration tended to be stable after 5 months.By compare with the effect of diltiazem dosage on the blood concentration of TAC,90 mg·d-1 and 180 mg·d-1 had little difference in improving the blood concentration of TAC.At the same time,the combination of the two drugs did not cause adverse reactions.Conclusion A daily dose of 90 mg of Diltiazem can significantly increase the TAC blood concentration in patients with NS who cannot reach the effective therapeutic concentration with conventional doses.It can reach the effective clinical therapeutic concentration without increasing the dose of tacrolimus.The combination of the two drugs were generally safe and effective.
6.Clinical manifestation and influence factor analysis of coronavirus disease 2019 infection in inflammatory bowel disease patients: a multicenter cross-sectional study
Tianlu HUANG ; Chunyan PENG ; Jie LIANG ; Yan CHEN ; Mei WANG ; Chunhui OUYANG ; Xiaolei WANG ; Qingqing LI ; Honggang WANG ; Yue LI ; Wenjia LIU ; Yanping HAO ; Xiaoqi ZHANG
Chinese Journal of Inflammatory Bowel Diseases 2024;08(4):267-273
Objective:To investigate the changes in symptoms of inflammatory bowel disease (IBD) patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the coronavirus disease 2019 (COVID-19) pandemic, as well as the situation of IBD treatment medication use.Methods:A cross-sectional survey study method was used. A questionnaire survey was conducted on a voluntary sampling basis for IBD patients of multiple centers nationwide from December 1st to 31st 2022, collecting clinical data of patients diagnosed with COVID-19 through nucleic acid/antigen testing. Patients were divided into symptomatic exacerbation group and asymptomatic exacerbation group based on whether they felt an exacerbation of IBD symptoms including abdominal discomfort, increased bloody stool or the appearance of purulent bloody stool, increased frequency of diarrhea, etc. And the differences in age, gender, body mass index (BMI) , underlying disease conditions, SARS-CoV-2 vaccination status, IBD type, disease activity, COVID-19 symptoms, and treatment medication between the two groups were compared.Results:A total of 497 patients were included, 317 males and 180 females; age (35.27±11.54) years; 355 CD patients and 142 UC patients; more than 50% of patients exhibited respiratory system symptoms such as fever, muscle soreness, fatigue, cough, expectoration, nasal congestion, and some IBD patients exhibited digestive system symptoms and nervous system symptoms. The symptomatic exacerbation group consisted of 104 patients (20.93%) , and the asymptomatic exacerbation group consisted of 393 (79.07%) . There were no statistically significant differences in gender, age, BMI, underlying diseases, IBD type, and SARS-CoV-2 vaccine doses between the two groups (all P>0.05) . Compared with the asymptomatic exacerbation group, the proportion of patients in the disease active phase was higher [47.12% (49/104) vs. 24.68% (97/393) , P<0.001], and the proportion of patients using mesalazine/sulfasalazine was higher (35.58% vs. 23.41%, P = 0.012) , and the proportions of COVID-19 symptoms such as diarrhea, headache, and dizziness were all higher (all P<0.05) in the symptomatic exacerbation group. Among the 237 IBD patients using biologics, there was a statistically significant difference in the types of biologics used between the symptomatic and asymptomatic exacerbation groups (χ 2 = 9.351, P = 0.031) . Among the 240 patients using biologics, the proportion of delaying or interrupting the use of biologics was higher in symptomatic exacerbation group than that of the asymptomatic exacerbation group, and the difference was statistically significant [45.45% (20/44) vs. 23.98% (47/196) , χ 2 = 8.235, P = 0.004]. Among the 47 patients using immunosuppressants, there was no statistically significant difference in the proportion of stopping immunosuppressants between the symptomatic and asymptomatic exacerbation groups ( P = 0.263) . Conclusion:The main symptoms of IBD patients infected with COVID-19 are respiratory and systemic symptoms, and those in the active phase of the disease or those delaying or withdrawing biologics are more likely to experience an exacerbation of IBD symptoms during the infection.
7.Tenecteplase in the treatment of acute ischemic stroke:a rapid health technology assessment
Xiaomei DENG ; Huiting LI ; Peng MEN ; Zhetao ZHANG ; Jin ZHANG ; Tianlu SHI
China Pharmacy 2024;35(20):2541-2547
OBJECTIVE To assess the efficacy, safety and cost-effectiveness of tenecteplase in the treatment of acute ischemic stroke, and to provide a basis for clinical rational drug use and related decision-making. METHODS The related literature in the PubMed, the Cochrane Library, CNKI, Wanfang data and health technology assessment (HTA) databases were searched from the establishment of the database to June 30th, 2024. Systematic reviews/meta-analyses, pharmacoeconomic studies and HTA reports on tenecteplase in the treatment of acute ischemic stroke were collected. After data extraction and quality assessment, descriptive analysis of the included studies was carried out. RESULTS A total of 31 articles were included, involving 28 systematic reviews/ meta-analysis and 3 pharmacoeconomic studies. In terms of effectiveness, compared with alteplase, tenecteplase (0.25 mg/kg) could significantly increase the early neurological improvement; the 90 d excellent neurological recovery rate, 90 d good neurological recovery rate, and recanalization were not inferior to alteplase. For safety, compared with alteplase, tenecteplase did not increase the incidence of hemorrhage, symptomatic intracranial hemorrhage, 3-month mortality, or intracranial hemorrhage. In terms of cost-effectiveness, foreign research results showed that tenecteplase had economic advantages over alteplase. CONCLUSIONS Compared with alteplase, tenecteplase is effective and safe in the treatment of acute ischemic stroke, and it is cost-effective.
8.Ocular safety of intravitreal injection of a novel nanoparticle ciliary neurotrophic factor complex in cynomolgus macaques——a morphological evaluation
Tianlu ZHANG ; Yifan LIU ; Yin SHEN
Chinese Journal of Experimental Ophthalmology 2024;42(7):613-620
Objective:To evaluate the safety of a novel nanoparticle neurotrophic factor complex for intraocular application in non-human primates.Methods:Nanoparticles incorporated with ciliary neurotrophic factor (NP-CNTFs) were produced utilizing nanotechnology.Three adult male cynomolgus macaques were included and intravitreally injected with 10 μl NP-CNTFs at a concentration of 1 μg/μl into one of the two eyes, and these three eyes were designated as the NP-CNTFs group.The contralateral eyes received the same volume of phosphate buffered saline and were designated as the control group.Before the injection and on days 3 and 7 after the injection, routine clinical examinations of the anterior segment were performed to evaluate the ocular clinical symptoms such as conjunctival congestion, anterior chamber flare and cells.The fundus condition was observed by fundus photography.The morphological structure and thickness of retinas were detected by spectral domain-optical coherence tomography (SD-OCT).The use and care of animals were in accordance with the Guide for the Care and Use of Laboratory Animals issued by the National Institutes of Health and the standards of Association for Assessment and Accreditation of Laboratory Animal Care.The study protocol complied with the ethics of laboratory animal welfare and was approved by Hubei Topgene Biotechnology Co., Ltd.(No.IACUC-2019-012).Results:The NP-CNTFs prepared in this study had a particle size of (317±3)nm, a polydispersity index of 0.042±0.015, and a zeta potential of (-38.9±0.7)mV, and exhibited relatively good stability, bioavailability, and biocompatibility.Clinical examinations revealed that the clinical manifestations of conjunctival congestion, anterior chamber flare and cells were slightly more obvious in the NP-CNTFs group at 3 days after injection compared to the control group, but basically returned to normal at 7 days after injection.The scores of anterior-segment clinical symptoms of the NP-CNTFs and control group were (2.67±0.88) and (1.00±0.58) at 3 days after injection, and (0.67±0.33) and (0.33±0.33) at 7 days after injection, respectively, with no statistical differences between them ( t=2.50, 1.00; both at P>0.05).Fundus photography showed normal fundus in both groups at 7 days after injection with no abnormal changes including vitreous opacity, vitreous hemorrhage, retinal hemorrhage or papilloedema.SD-OCT showed no significant histological changes in the retinas at 7 days after injection in both groups.The retinal nerve fiber layer thickness of the NP-CNTFs and control group were (107.67±0.88) and (111.00±3.22)μm, respectively, and the macular foveal thickness of the two groups were (255.67±2.03) and (254.67±3.84)μm, respectively, with no statistical differences between them ( t=1.43, 0.50; both at P>0.05). Conclusions:The complex NP-CNTFs shows good safety for intraocular application in cynomolgus macaques.
9.A Comparative Study on the Drugs in the Centralized Procurement List and the National Essential Medicine List of China
Xiaomei DENG ; Jin ZHANG ; Zhetao ZHANG ; Huiting LI ; Xiao LIU ; Yini MA ; Wenxin WU ; Tianlu SHI
Herald of Medicine 2024;43(7):1177-1180,后插1
Objective To compare and explore the differences between the eight batches of drugs in the centralized procurement list and the 2018 edition of the national essential medicine list,and to provide reference for updating and improving the national essential medicine list and the national centralized procurement list of drugs.Methods The category,generic name variety,specification,and other information of drugs included in the centralized drug procurement were collected and compared with the 2018 edition of the national essential medicine list,and the reasons for differences were analyzed.Results A proportion of 39%of centralized procurement drugs were listed in national essential medicines.Forty pharmacological classifications were not involved in the drugs of centralized procurement.Only anticoagulant and thrombolytic drugs with dual attributes accounted for a smaller variety proportion than the specification proportion.Conclusion There are some differences between the centralized procurement list and the 2018 edition of the national essential medicine list,which have some rationality,but also some problems to be solved.
10.Development and Analysis of Standards for Drugs Under Special Management
Kuikui GENG ; Ling JIANG ; Jiancun ZHEN ; Tianlu SHI ; Wei ZHANG ; Jin LU ; Jianqing WANG ; Xiaoyang LU ; Qianzhou LYU ; Zhiqing ZHANG ; Ying CHEN ; Hong XIA ; Qin GUANG ; Hongpeng BI
Herald of Medicine 2024;43(8):1217-1221
Drugs under special management include narcotic drugs,psychotropic drugs,toxic drugs for medical use,radiopharmaceuticals,and pharmaceutical precursor chemicals.Supervising and guiding the clinical use of drugs under special management is one of the important responsibilities of the Pharmaceutical Management and Drug Therapy Committee(Group)of medical institutions.The standard for drugs under special management is led by the Pharmaceutical Professional Committee of the China Hospital Association,which standardizes 16 key elements of organizational management,process management,and quality control management drugs under special management in medical institutions.It can guide the standardized implementation of Pharmaceuticals under special control work in various levels and types of medical institutions.This article elaborates on the methods and contents of formulating standards for Pharmaceuticals under special management,to provide reference and inspiration for medical institutions to carry out special drug drug management and daily related work.

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