1.Interpretation of 2024 ESC guidelines for the management of elevated blood pressure and hypertension
Yu CHENG ; Yiheng ZHOU ; Yao LÜ ; ; Dongze LI ; Lidi LIU ; Peng ZHANG ; Rong YANG ; Yu JIA ; Rui ZENG ; Zhi WAN ; Xiaoyang LIAO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(01):31-40
The European Society of Cardiology (ESC) released the "2024 ESC guidelines for the management of elevated blood pressure and hypertension" on August 30, 2024. This guideline updates the 2018 "Guidelines for the management of arterial hypertension." One notable update is the introduction of the concept of "elevated blood pressure" (120-139/70-89 mm Hg). Additionally, a new systolic blood pressure target range of 120-129 mm Hg has been proposed for most patients receiving antihypertensive treatment. The guideline also includes numerous additions or revisions in areas such as non-pharmacological interventions and device-based treatments for hypertension. This article interprets the guideline's recommendations on definition and classification of elevated blood pressure and hypertension, and cardiovascular disease risk assessment, diagnosing hypertension and investigating underlying causes, preventing and treating elevated blood pressure and hypertension. We provide a comparison interpretation with the 2018 "Guidelines for the management of arterial hypertension" and the "2017 ACC/AHA guideline on the prevention, detection, evaluation, and management of high blood pressure in adults."
2.The effect of rutaecarpine on improving fatty liver and osteoporosis in MAFLD mice
Yu-hao ZHANG ; Yi-ning LI ; Xin-hai JIANG ; Wei-zhi WANG ; Shun-wang LI ; Ren SHENG ; Li-juan LEI ; Yu-yan ZHANG ; Jing-rui WANG ; Xin-wei WEI ; Yan-ni XU ; Yan LIN ; Lin TANG ; Shu-yi SI
Acta Pharmaceutica Sinica 2025;60(1):141-149
Metabolic-associated fatty liver disease (MAFLD) and osteoporosis (OP) are two very common metabolic diseases. A growing body of experimental evidence supports a pathophysiological link between MAFLD and OP. MAFLD is often associated with the development of OP. Rutaecarpine (RUT) is one of the main active components of Chinese medicine Euodiae Fructus. Our previous studies have demonstrated that RUT has lipid-lowering, anti-inflammatory and anti-atherosclerotic effects, and can improve the OP of rats. However, whether RUT can improve both fatty liver and OP symptoms of MAFLD mice at the same time remains to be investigated. In this study, we used C57BL/6 mice fed a high-fat diet (HFD) for 4 months to construct a MAFLD model, and gave the mice a low dose (5 mg·kg-1) and a high dose (15 mg·kg-1) of RUT by gavage for 4 weeks. The effects of RUT on liver steatosis and bone metabolism were then evaluated at the end of the experiment [this experiment was approved by the Experimental Animal Ethics Committee of Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences (approval number: IMB-20190124D303)]. The results showed that RUT treatment significantly reduced hepatic steatosis and lipid accumulation, and significantly reduced bone loss and promoted bone formation. In summary, this study shows that RUT has an effect of improving fatty liver and OP in MAFLD mice.
3.Effects of prescription pre-review system on rational drug use and off-label drug use management in outpatient and emergency department
Zhi GAO ; Lulu HAN ; Fang LIU ; Rui JIAO ; Wei ZHANG ; Yi ZHANG
China Pharmacy 2025;36(13):1666-1670
OBJECTIVE To explore the effects of prescription pre-review system on rational drug use and off-label drug use management in outpatient and emergency department. METHODS A retrospective analysis was conducted on outpatient and emergency department prescription data from three phases in our hospital: January to May 2023 (silent review phase, control group), June to October 2023 (systematic automatic review phase, intervention group 1), and November 2023 to March 2024 (phase combining systematic automatic review with centralized feedback from pharmacists to physicians regarding irrational prescriptions, intervention group 2). These phases followed the implementation of our hospital’s pre-prescription review software. Statistical analysis of the prompt rate of alert, rate of irrational prescriptions, registered the off-label drug use rate and false positive irrationality prescription rate were conducted. Meanwhile, the composition of irrational prescriptions was analyzed, and evidence- based evaluation of the off-label drug use proposed by clinicians was also conducted. RESULTS Compared with control group, the prompt rate of alert and the rate of irrational prescriptions in intervention group 1 were all decreased significantly after receiving pop-up notification, with statistically significant differences (P<0.05). With the help of system warning and the pharmacists feedback, the prompt rate of alert and the rate of irrational prescriptions declined further in the intervention group 2, but there was no statistically significant difference when compared with intervention group 1 (P>0.05). The main type of irrational drug use was improper administration routes. When comparing intervention group 1 with the control group, as well as intervention group 2 with intervention group 1, a significant decrease in the rate of improper administration routes was observed, with statistically significant differences (P<0.05). Compared with control group, there was no significant difference in the registered off-label drug use rate of intervention group 1 and intervention group 2 (P>0.05). The doctor’s awareness of off-label drug use registration increased due to the real-time alerts from the pre-prescription review software, along with the pharmacists’ regular summarization and feedback. Total 13 items registrations of off-label drug use were proposed by clinicians from June 2023 to March 2024, all of which were supported by evidence of varying levels; among them, 3 items received FDA approval, 4 items were included in the Micromedex database, and the remaining 6 items were supported by evidence from system reviews or randomized controlled trials. CONCLUSIONS Prescription pre-review system can improve the level of rational drug use and assist in the standardized management of off-label drug use.
4.Effects of scutellarin on endometrial carcinoma Ishikawa cells based on PI3K/Akt signaling pathway
Li-Li DAI ; Jing WANG ; Xu-Rui WEI ; Qing-Ya MA ; Na WANG ; Zhi-Xiang DU
The Chinese Journal of Clinical Pharmacology 2024;40(1):27-31
Objective To study the effects of scutellarin on endometrial carcinoma Ishikawa cells,and analyze the correlation between the effects and phosphatidyl inositol 3 kinase(PI3 K)/protein kinase B(Akt)signaling pathway.Methods Ishikawa cells were divided into blank group and experimental-L,-M,-H groups,each group was treated with complete medium containing 0,5,10 and 20 μmol·L-1 scutellarin,respectively.Cell viability,clonal formation ability,metastatic ability,invasion,apoptosis and protein expression were detected by cell counting kit-8(CCK-8),plate cloning,scratch,Transwell,flow cytometry and Western blot assay,respectively.Results The cell viability of blank group and experimental-L,-M,-H groups at 48 h were(100.00±0.00)%,(78.51±7.54)%,(52.93±4.91)%and(41.62±5.33)%;the clone formation rate were(100.00±0.00)%,(56.59±6.34)%,(35.23±4.62)%and(10.66±1.91)%;the scratch healing rate were(53.70±6.19)%,(40.59±4.75)%,(34.25±4.40)%and(15.78±2.14)%;the number of invasive cells were 189.70±14.06,106.82±12.67,84.37±8.13 and 53.74±6.78;the relative expression levels of matrixmetallo proteinase-2 were 0.96±0.10,0.73±0.06,0.68±0.08 and 0.42±0.05;tissue inhibitor of MMP-1(TIMP-1)were 0.35±0.04,0.51±0.05,0.74±0.08 and 1.20±0.14;the apoptosis rates were(4.21±0.53)%,(15.83±2.42)%,(22.72±3.85)%and(34.41±4.67)%;the relative expression levels of B cell lymphoma-2(Bcl-2)were 1.38±0.15,0.90±0.10,0.56±0.06 and 0.24±0.03;Bcl-2 associated X protein(Bax)were 0.31±0.02,0.44±0.04,0.93±0.11 and 1.26±0.14;the relative expression levels of PI3Kp85 were 0.67±0.05,0.42±0.04,0.36±0.02 and 0.28±0.03;phosphorylated Akt(p-Akt)were 0.78±0.06,0.53±0.04,0.46±0.05 and 0.42±0.03.Compared with the blank group,the above indexes in the experimental-L,-M,-H groups were statistically significant(P<0.05 or P<0.01).Conclusion Scutellarin can inhibit the proliferation,metastatic ability and invasion of endometrial carcinoma Ishikawa cells and promote apoptosis by regulating PI3K/Akt signaling pathway.
5.Population pharmacokinetics of duloxetine in Chinese healthy subjects
Zhi-Wei HUANG ; Rui WANG ; Yi-Min YU ; Yan LI ; Yi-Feng SHEN ; Hua-Fang LI ; Yu-Mei WEI
The Chinese Journal of Clinical Pharmacology 2024;40(4):598-602
Objective To establish a population pharmacokinetic(PPK)model of duloxetine in Chinese subjects.Methods Based on the data of intensive sampling of duloxetine hydrochloride enteric coated tablets in 36 healthy subjects after single/multiple administrations,a PPK model of duloxetine was established using NONMEM software.The effects of gender,age,body weight,albumin,serum creatinine,glutamic pyruvic transaminase and dose on pharmacokinetic parameters were investigated by stepwise forward and backward methods.Model validation includes goodness of fit,visual prediction check and bootstrap.Results The PPK model of duloxetine was a one compartment model with first-order elimination and the absorption characteristics were described by the transit model,and the dose was a covariate of clearance.The inter-individual variability of clearance,volume of distribution,mean transit time and number of transit compartments were 54.71%,56.86%,27.30%and 87.71%,respectively.Conclusion The transit model more reasonably describes the absorption characteristics of duloxetine in Chinese subjects.
6.Bioequivalence study of buspirone hydrochloride tablets in Chinese healthy subjects
Ping LU ; Rui WANG ; Hui-Hui WU ; Hai-Yan LIU ; Ge-Fei HE ; Shun-Zhi ZHANG ; Wei WU
The Chinese Journal of Clinical Pharmacology 2024;40(5):723-727
Objective To study the pharmacokinetic characteristics of buspirone hydrochloride tablets in healthy adult populations under conditions of fasting and postprandial administration.Methods A single-center,randomized,three-cycle partially repeated crossover trial design was adopted,and 36 subjects were enrolled on fasting/postprandial,one tablet of the test preparation was taken in one cycle,one tablet of reference preparation(5 mg of buspirone tablets)was taken once in each of 2 cycles,the drug concentration of buspirone in plasma was determined by liquid chromatography-tandem mass spectrometry,and the pharmacokinetic parameters were calculated by WinNonlin software.Results Main pharmacokinetics of buspirone after oral administration of test and reference preparations in fasting group,the Cmax was(285.72±286.08)and(308.94±341.03)pg·mL-1;AUC0-t were(577.09±491.10)and(618.62±642.56)pg·mL-1·h;AUC0-∞ were(586.85±510.04)and(655.92±687.95)pg·mL-1·h;tmax was 0.75(0.33-4.00)and 0.75(0.33-1.75)h.Main pharmacokinetics of buspirone after oral administration of test and reference preparations in the postprandial group,the Cmax were(676.36±603.64)and(760.33±610.27)pg·mL-1;AUC0-t were(1 755.58±1 001.69)and(1 743.00±1 073.33)pg·h·mL-1;AUC0-∞ were(1 839.97±1 044.60)and(1 818.00±1 106.95)pg·mL-1·h;tmax was 1.25(0.25-4.50)and 1.00(0.25-3.50)h.The 90%confidence intervals of the AUC0-t and AUC0-∞ geometric mean ratios of the test preparation and the reference preparation in the fasting test and the postprandial test all fell between 80.00%and 125.00%,and the 95%upper confidence limit of of Cmax was ≤0 and geometric mean ratios point estimates fall between 80.00%and 125.00%.Conclusion Two kinds of buspirone hydrochloride are bioequivalent in Chinese healthy adult subject.
7.Research status on the mechanism of traditional Chinese medicine regulating TGF-β1/Smads signaling pathway to intervene liver fibrosis
Yong-Biao TAO ; Shi-Rui YANG ; Long-De WANG ; Ya-Na WU ; Zhi-Ming ZHANG ; Fu LI
The Chinese Journal of Clinical Pharmacology 2024;40(6):918-922
Hepatic fibrosis(HF)is a pathophysiological outcome of chronic liver injury and is characterized by excessive accumulation of extracellular matrix protein.A number of studies have confirmed that the signaling pathways formed by transforming growth factor-β1(TGF-β1)and its downstream Smad family play an important role in the occurrence and development of HF,and the traditional Chinese medicine(TCM)research targeting this pathway is currently a hot spot in the reversal of HF.Therefore,taking TGF-β1/Smads signaling pathway as the entry point,this paper reviewed the mechanism of action of TCM compound formula and single drug extract in intervening TGF-β1/Smad pathway and related factors upstream and downstream of the pathway to reverse HF in recent years,revealed the targeted therapeutic effect of TCM,and provided new strategies for clarifying the mechanism of TCM.
8.Inhibitory effects of toosendanin on in vitro and in vivo growth of lung adenocarcinoma cells by regulating CDCA5 expression
Zhi-Cheng ZHANG ; Li-Xia SU ; Rui-Ling MENG ; Wen-Juan GUAN ; Hong-Qian LI
The Chinese Journal of Clinical Pharmacology 2024;40(7):994-998
Objective To investigate the inhibitory effect of toosendanin on the growth of lung adenocarcinoma cells in vitro and in vivo by regulating the expression of cell division cycle associated protein 5(CDCA5).Methods The expression of CDCA5 in different lung tissues was analyzed in TCGA database.The expression level of CDCA5 in BEAS-2B cells and A549 cells was detected by Western blot.The effect of different concentrations of toosendanin on the viability of A549 cells was determined by cell counting kit-8(CCK-8)assay.The A549 cells were randomly divided into 4 groups:control group(normal cells cultured normally),toosendanin group(normal cells cultured with 40 μmol·L-1 toosendanin),toosendanin+pcDNA group(cells transfected with pcDNA empty vector and cultured with 40 μmol·L-1 toosendanin),and toosendanin+CDCA5 group(cells transfected with CDCA5 overexpression vector and cultured with 40 μmol·L-1 toosendanin).After 48 h of cultivation,the proliferation and apoptosis of each group of cells were detected by CCK-8 and flow cytometry,and the expression of proliferation and apoptosis related proteins in each group of cells was detected by Western blot.The BALB/c nude mice were randomly divided into sh-NC and sh-CDCA5 stable transfected cell lines with nude mouse xenograft models.Daily intraperitoneal injection of 0.9%NaCl and 40μmol·L-1 toosendanin solution was given to observe and record the changes in tumor tissue volume and body mass.Results The results of CCK-8 showed that after 48 hours,the survival rates of A549 cells treated with 10,20,30,40,50,60 and 70 μmol·L-1 toosendanin were(80.74±8.71)%,(72.96±6.53)%,(61.01±4.86)%,(51.20±3.13)%,(42.10±5.94)%,(38.93±3.18)%and(33.48±2.94)%,respectively.Toosendanin significantly inhibited the proliferation of A549 cells.The proliferation rates of cells in the control group,toosendanin group,toosendanin+pcDNA group,and toosendanin+CDCA5 group were(100.00±4.19)%,(49.18±6.70)%,(55.75±5.74)%,and(77.66±7.48)%,respectively;the expression levels of CDCA5 protein were 1.08±0.11,0.44±0.04,0.43±0.05 and 0.99±0.10,respectively.The expression levels of CDCA5 protein in tumor tissues of nude mice in the sh-NC group,sh-CDCA5 group,toosendanin+sh-NC group,and toosendanin+sh-CDCA5 group were 1.04±0.14,0.42±0.04,0.56±0.08 and 0.32±0.04,respectively.Compared with the sh-NC group,the tumor blocks formed by nude mice in other groups were significantly smaller,and the tumor volume and weight were significantly lower(all P<0.05).Compared with the toosendanin+sh-NC group,the toosendanin+sh-CDCA5 group had more significant inhibitory effect on tumor formation,and the difference was statistically significant(P<0.05).Conclusion Toosendanin can inhibit the growth of lung adenocarcinoma cells in vitro and in vivo,which is mainly related to the inhibition of CDCA5 expression.
9.A study of drugs related to contraindications in children in the 2020 edition of the Chinese Pharmacopoeia
Yu YANG ; Rui-Ling ZHAO ; Xin-Wen XU ; Zhi-Gang ZHAO
The Chinese Journal of Clinical Pharmacology 2024;40(9):1355-1359
Objective The varieties of chemical drugs prohibited for children in the 2020 edition of Chinese Pharmacopoeia were analyzed.Provide a technical basis for the development of a list of drugs prohibited by children.This is requirement of China's Children's Development Program(2021-2030).Methods Drug inserts are collected through websites such as"PharmaIntelligence",from which information on children's prohibitions is extracted,and drugs with consistent information on children's prohibitions are analyzed in the instructions of different manufacturers.Results Among the 1 741 kinds of chemicals,there are a total of 240 drugs with consistent information on the prohibition of children in the instructions of different manufacturers,of which 113 are labeled"prohibited"for children of different ages,53 are"not suitable"for children of different ages,38 are"not recommended""for children of different ages,and 36 are labeled with other children's prohibition related information.According to the classification of the clinical drug instructions involving 21 categories.Including anti-infective drugs(77),nonsteroidal anti-inflammatory drugs and anti-gout drugs(28),nervous system drugs(20),psychotropic drugs(16),digestive system drugs(16),endocrine system drugs(16),etc.Conclusion Children are at a special stage of growth and development,and the pharmacological and toxicological characteristics of drugs in children are different from those in adults.The risk-benefit ratio of drugs used in children needs continuous research to provide more detailed evidence for drug use and ensure the safety of drug use in children.
10.Efficacy of roxallistat combined with polysaccharide iron complex and Shengxuening in the treatment of maintenance hemodialysis renal anemia with poor recombinant human erythropoietin
Rui-Feng CHEN ; Pei YU ; Zhi-Ting WANG ; Yan LI ; Rui-Xian ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(12):1704-1708
Objective To investigate the efficacy of roxallistat combined with polysaccharide iron complex and Shengxuening in the treatment of maintenance hemodialysis renal anemia with poor recombinant human erythropoiesis.Methods Maintenance hemodialysis renal anemia patients with poor recombinant human erythropoietin effect were divided into control group and treatment group according to random number table method.The control group took roxallistat orally with a body weight of>60 kg,120 mg each time,3 times a week,and 45-60 kg with 100 mg each time,3 times a week;oral polysaccharide iron complex,300 mg each time,once a day.The treatment group was given Shengxuening orally based on the control group,0.25-0.50 g each time,3 times a day.Both groups were treated for 3 months.The clinical efficacy,inflammatory factors,iron metabolism,renal function,anemia index,traditional Chinese medicine symptom score and adverse drug reaction were compared between the two groups.Results In the control group,34 cases were enrolled,1 case fell off,and finally 33 cases were included in the analysis.In the treatment group,35 cases were enrolled,1 case was shed,and 34 cases were finally included in the analysis.After treatment,the total effective rate of treatment group and control group was 97.06%(33 cases/34 cases)and 81.82%(27 cases/33 cases),respectively,and the difference was statistically significant(P<0.05).After treatment,the nuclear transcription factor kappa B(NK-κB)in treatment group and control group were(24.09±3.06)and(35.23±4.11)ng·L-1;interferon gamma(IFN-γ)were(41.39±4.13)and(50.10±5.27)ng·L-1;transferrin saturation(TAST)were(38.62±5.91)%and(31.16±4.73)%;serum ferritin(SF)were(28.13±5.77)and(22.47±4.65)μmol·L-1;serum iron(SI)were(15.66±3.76)and(13.19±2.94)μmol·L-1;urinary protein excretion rate(24 h UPE)were(1.85±0.41)and(2.91±0.62)g·24 h-1;blood urea nitrogen(BUN)were(5.16±0.67)and(6.89±0.97)mmol·L-1;hemoglobin(Hb)were(91.38±11.23)and(83.19±8.54)g·L-1;hematocrit(Hct)were(29.01±7.40)%and(24.56±5.69)%;main disease score were(5.29±1.05)and(7.15±1.53)scores;the secondary scores were(3.11±0.46)and(4.98±0.77)scores;the total scores were(8.40±1.49)and(12.13±2.30)scores,with statistical significance(all P<0.05).The total incidence of adverse drug reactions in treatment group and control group were 14.71%and 9.09%,with no statistical significance(P>0.05).Conclusion Roxallistat combined with polysaccharide and iron complex and Shengxuening have good therapeutic effect in the treatment of maintenance hemodialysis renal anemia with poor recombinant human erythropoietin effect;it can reduce inflammation,regulate iron metabolism,improve renal function,and reduce adverse drug reactions.

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