中国科技论文统计源期刊 中文核心期刊
美国《化学文摘》《国际药学文摘》
《乌利希期刊指南》
WHO《西太平洋地区医学索引》来源期刊
日本科学技术振兴机构数据库（JST）
第七届湖北十大名刊提名奖
美国《化学文摘》《国际药学文摘》
《乌利希期刊指南》
WHO《西太平洋地区医学索引》来源期刊
日本科学技术振兴机构数据库（JST）
第七届湖北十大名刊提名奖
To promote the implementation of individualized pharmaceutical service for lamotrigine by hospital pharmacists,the Working Committee of Pharmacy Innovation Services of Chinese Pharmacists Association authorized the First Affiliated Hospital of University of Science and Technology of China to lead a multidisciplinary expert panel. This panel,comprising 63 specialists from diverse fields including pharmacy,medicine,hospital management,and methodology,developed the Expert Consensus on Individualized Pharmaceutical Service for the Antiepileptic Drug Lamotrigine (hereafter referred to as the Consensus). The Consensus was developed using the Delphi questionnaire methodology. Initially,the multi-disciplinary expert panel identified the prevalent issues in the clinical usage of lamotrigine and eatablished the framework. Subsequently,the writing committe conducted comprehensive literature reviews and evidence evaluations to draft the preliminary version based on China's current circumstances,clinical needs,and available research evidence. Finally,the Delphi method was reapplied to collect feedback from interdisciplinary specialists with extensive clinical practice. All opinions were systematically collated,analyzed,incorporated,and addressed through iterative revision until the Consensus was formed. The Consensus comprises 20 clinical recommendations across four key domains: the clinical applications of lamotrigine in epilepsy treatment,the plasma concentration monitoring of lamotrigine,the pharmacogenetic testing of lamotrigine,and individualized medication management of lamotrigine. This Consensus provides reference for hospital pharmacists to carry out individualized pharmaceutical services,including pharmaceutical care,medication recommendations,patient medication education,pharmaceutical follow-up,and home-based pharmaceutical services. It is of great significance for promoting scientific and rational drug use in clinical practice.
Objective To study the therapeutic effect of Baihuang Ganning mixture on mice with cholestatic hepatitis model induced by α-naphthalene isothiocyanate (ANIT),and to explore the mechanism by which Baihuang Ganning mixture improves cholestatic hepatitis. Methods A cholestatic hepatitis model was established in mice by intragastric administration of ANIT (60 mg·kg-1).Sixty mice were randomly divided into six groups (n=10):normal control group,model control group,the ursodeoxycholic acid group,and the high,medium,and low-dose of Baihuang Ganning mixture groups.Parameters including bile flow rate,serum biochemical indices (ALT,AST,T-BiL,D-BiL,ALP and TBA),histopathological changes in liver tissue,hepatic biochemical markers (MDA,NO,Na+-K+-ATPase and SOD),and expression levels of TGF-β1,P-Smad2,and P-Smad3 were evaluated. Results Serum biochemical analysis revealed that,compared to the model control group,the high and medium-dose Baihuang Ganning mixture groups exhibited significant reductions in ALT,AST,T-BiL,D-BiL,ALP,and TBA levels (P<0.01),along with increased bile flow rate (P<0.01).No significant changes were observed in the low-dose group.Histopathological examination demonstrated that high and medium-dose Baihuang Ganning mixture markedly alleviated ANIT-induced bile duct injury,cholestasis,and hepatocyte injury.Compared to the ursodeoxycholic acid group,high and medium-dose Baihuang Ganning mixture significantly reduced hepatic MDA and NO levels,enhanced Na+-K+-ATPase and SOD activities (P<0.01),and downregulated the expression of TGF-β1,P-Smad2,and P-Smad3. Conclusions Baihuang Ganning mixture significantly improved ANIT-induced cholestatic hepatitis in mice. Baihuang Ganning mixture can regulate the metabolism of bile acids,inhibit the proliferation and activation of hepatic stellate cells (HSC) and the synthesis of collagen,and delay the occurrence of cholestatic hepatitis by inhibiting the expression levels of TGF-β1,P-Smad2 and P-Smad3 proteins.
Objective To establish a high-performance liquid chromatography method to detect the purity of human epidermal growth factor (hEGF),to compare the stability of the products of different enterprises by purity results,and to provide technical support for improving quality control and unified monitoring of hEGF based on national drug sampling and testing. Methods Agilent 300SB C8 column(250 mm×4.6 mm,5 μm)was used.Mobile phase A was 7.5 mmol·L-1 sodium phosphate buffer (pH 6.8),and mobile phase B was acetonitrile,the column temperature was 30 ℃,the flow rate was 0.6 mL·min-1 with gradient elution,and the detector wavelength was set at 280 nm. Results The resolution between the main peak of hEGF and the adjacent impurity peak was more than 1.5,with a detection limit of 6 ng.This method has been successfully applied to determine the purity of the bulk and final products.The results showed that the purity of the final products decreased compared with the bulk.The maximum impurity that increased significantly was the deamidation impurity identified by the mass spectrometry. Conclusion Based on the typical sample of the full chain and multi-dosage form,the established method had good specificity and resolution for the preliminary identification and purity determination of hEGF bulk and final products.
Objective To evaluate the quality of propranolol hydrochloride tablets based on national drug sampling,to analyze existing quality issues and improve their quality standards,to provide references and suggestions for the production,quality control,and supervision of this product. Methods A comprehensive evaluation of 178 batches of sampled products was conducted using legal standards combined with exploratory research,including key quality indicators such as related substances,dissolution,content uniformity,content determination,in vitro dissolution profiles,and genotoxic impurity N-nitrosoproranolol.The quality of domestic propranolol hydrochloride tablets and the controllability of the current quality standards for product quality were assessed. Results According to the legal standard methods,the qualification rate of 178 batches of sampled products was 100%.Exploratory research revealed that the impurity levels of samples from six manufacturing enterprises were far below the limit requirements;however,differences existed in genotoxic impurity N-nitrosoproranolol and other aspects. Conclusions The overall quality of propranolol hydrochloride tablets is good,but the current standards need further improvement.It is recommended to add/revise the detection methods for related substances,content,and content uniformity,strictly control N-nitrosoproranolol,and urge enterprises to pay attention to the quality of excipients and the control of the preparation production process.
Objective To establish a high-throughput HPLC method for the simultaneous determination of 11 common antibacterial agents in acyclovir eye drops and to evaluate the quality and safety of the antibacterial agents in 42 batches of national drug inspection samples. Methods Gradient elution was performed on a Kromasil 100-5-C18 (4.6 mm×250 mm,5 μm) column with acetonitrile-5 mmol·L-1 ammonium acetate aqueous solution (containing 1% triethylamine,pH adjusted to 4.5 by acetic acid) as the mobile phase.The detection wavelength was 262 nm. Results Good linear relationships were obtained for 11 antibacterial agents (r≥0.999 9).The average recovery range was 98.2%-101.8%,and the RSD was 0.7%-2.7% (n=9).As revealed by the systematic analysis of 42 batches of national drug inspection samples,some batches of samples were detected with out-of-prescription antibacterial agents 4-hydroxybenzoic acid and ethylparaben,and the results were 0.02-49 μg·mL-1.This indicated that ethylparaben degradation and colinear production pollution were the two major risk sources. Conclusions The method is accurate,sensitive,and specific and can be used for the qualitative and quantitative detection of antibacterial agents in acyclovir eye drops.Besides,some products have degradation of antibacterial agents and incomplete cleaning during co-linear production.It is still essential to further reinforce product quality control.
Objective To evaluate the quality profile of losartan potassium tablets in China based on national drug sampling and testing,to assess their safety,efficacy,and potential quality risks,and to provide evidence for improving quality standards along with feasible regulatory recommendations. Method A comprehensive evaluation was conducted on 196 sampled batches using statutory standards combined with exploratory studies,including tests for related substances,moisture,nitrites,nitrosamine,and azide genotoxic impurities. Results The compliance rate under statutory standards was 100%.However,exploratory analyses identified variations in moisture and nitrite levels among products,although genotoxic impurities and related substances were either undetectable or well below regulatory limits. Conclusions Losartan potassium tablets demonstrate satisfactory quality,though existing standards require further refinement by adding moisture and nitrite specifications.
Objective To establish a method for the simultaneous determination of peimine,peiminine,and hupehenine in Juhong pills,to investigate the raw material usage of Fritillaria thunbergii Miq.,and to preliminarily develop a detection approach for identifying adulteration with Fritillaria hupehensis Hsiao et K.C.Hsia. Methods The high-performance liquid chromatography-triple quadruple mass spectrometry (HPLC-MS/MS) was performed on an Agilent Poroshell 120 SB C18 column (2.1 mm × 100 mm,2.7 μm) with a mobile phase consisting of acetonitrile-methanol (1:1) and 0.1% formic acid under gradient elution.The flow rate was set at 0.3 mL·min-1.The column temperature was maintained at 35 ℃,and the injection volume was 2 μL.Electrospray ionization (ESI) in positive ion mode and multiple reaction monitoring were employed to quantify the three components in 170 batches of Juhong pills.Simulated positive samples with varying adulteration ratios of Fritillaria hupehensis Hsiao et K.C.Hsia were prepared to establish a simple yet efficient detection limit for adulteration. Results Three components showed good linear correlation within their ranges (r≥0.997 5),and the averaged recoveries ranged from 92.0%-106.2%.A total of 61 batches were suspected of Fritillaria thunbergii Miq. adulteration with Fritillaria hupehensis Hsiao et K.C.Hsia in raw material inputs,with the peimine to peiminine ratio below 1.15.Among these samples,27 batches were large honey-bound pills with hupehenine levels of 2.636-9.939 μg·g-1;34 batches were water-honeyed pills showing significantly higher hupehenine contamination at 6.752-48.137 μg·g-1. Conclusion The established method is simple,reliable,and accurate for the quality control of Fritillaria thunbergii Miq. adulteration in Juhong pills without imposing significant additional costs.
Objective To establish a gas chromatography-mass spectrometry method for simultaneous determination of the contents of volatile components muscone,menthol,borneol,isoborneol,camphor,and carvone in Wuli Huichun pills,and to evaluate the quality of Wuli Huichun pills based on authenticity,effectiveness and safety. Methods The ethyl acetate extract was analyzed by HP-5MS capillary column (30 m×0.25 mm,0.25 μm) with temperature programming.The injection port temperature was set at 230 ℃,and the split ratio was set at 10:1.The carrier gas was high-purity helium gas.The injection port was in constant flow mode,with a carrier gas flow rate of 1.0 mL·min-1. The detector was a mass spectrometer with a triple quadrupole in series.The ion source was an electron bombardment source (EI) with a temperature of 250 ℃.The collision gas was argon.The temperature of the mass spectrometry transmission interface was 250 ℃.Scanning mode was SIM mode,with a solvent delay of 2 minutes. Results The linear relationships of the six components were good (r>0.999 0),the average recoveries were 93.57%-97.96%,and the RSD was 0.73%-2.5%. Conclusion The method is simple,accurate,and efficient,and can be used for the quality evaluation of Wuli Huichun pills.
Objective To systematically evaluate the quality of Fengshiding capsules,to analyze existing problems based on national drug sampling and testing,and to offer references and suggestions for improving quality control and regulatory supervision of this product. Methods A total of 136 batches of Fengshiding capsules were subjected to standard quality tests and exploratory analyses.HPLC was used to establish the content determination of Angelica dahurica,Cynanchum paniculatum,and Glycyrrhizae Radix,as well as the limit test for anabasine in the preparation.Additionally,an UPLC method was also employed to establish the characteristic chromatogram of Fengshiding capsules.A screening method for artificial pigments was developed,and UPLC-MS/MS was used to detect the illegal addition of chemical drugs in Fengshiding capsules. Results All 136 batches of samples passed inspection according to the current quality standards.However,based on exploratory study evaluations,the content determination results of Cynanchum paniculatum,Angelica dahurica,and Glycyrrhiza Radix were below the proposed limits.The limit test for anabasine did not exceed the proposed threshold.Furthermore,the characteristic chromatograms revealed missing peaks in several samples,and some batches contained artificial pigments and residues of acetaminophen. Conclusions The overall quality of Fengshiding capsules is rated as “average”based on national drug sampling and testing.To enhance product quality,it is recommended to improve quality standards,ensure the use of high-quality raw herbal materials,promote stronger internal oversight by manufacturers,and intensify regulatory supervision.
Objective To mine and analyze signals of acute kidney injury (AKI) related to drugs,comprehensively summarize the potential risk drugs,and provide a reference for clinically safe medication. Methods The AKI reports from January 2004 to September 2023 in the US FDA Adverse Event Reporting System (FAERS) were retrieved.Disproportionality methods were used to explore the relationship between drugs and AKI,and demographic information,time to onset,and patient outcomes were analyzed. Results Out of 1 253 drugs,159 were identified as AKI signal drugs.Among these,there were 49 antimicrobial agents (30.82%),including 35 antibiotics and 14 antiviral agents;33 antineoplastic agents (20.75%);and 25 hypotensive agents (15.72%).Drug-related AKI occurred mostly in the elderly,and the male-to-female ratio was 124:100.The median time to onset for AKI related to antibiotics was ≤8 d,with the third quartile ≤21 d.Rivaroxaban and aspirin had higher proportions of death reports,with 33.03% and 31.44% respectively. Conclusions A multitude of drugs pose a risk for acute kidney injury,necessitating caution in their clinical application and the implementation of monitoring of renal function.The elderly are a high-risk group for drug-related AKI,and there are more males than females.For antibiotics,the first 21 days are the key monitoring period.For drugs that require long-term use,regular monitoring is necessary.
Objective To explore and evaluate the adverse drug events(ADE) signals of thromboembolic events induced by cisplatin and carboplatin,and to provide references for clinical safety and rational use of drugs. Methods The cisplatin- and carboplatin-related thromboembolic adverse events reports were collected from the U.S.FDA Adverse Event Reporting System (FAERS) database with the reporting time range from the first quarter of 2004 to the fourth quarter of 2023.Thromboembolic ADR signals were detected using the reporting odds ratio (ROR) method,the medicines and healthcare products regulatory agency (MHRA) method,and the Bayesian confidence propagation neural network (BCPNN) method at the SMQ level and preferred term (PT) level. Results A total of 1 959 cisplatin-related thromboembolism events and 2 524 carboplatin-related thromboembolism events were reported.In terms of gender composition,after excluding reports with unspecified gender,the ratio of male to female was 1.69:1 for cisplatin and 0.65:1 for carboplatin.For cisplatin,triple signals were generated at the “thromboembolic events” SMQ level as well as its sub-levels “venous thromboembolic events”,and dual signals were generated at the “arterial thromboembolic events” sub-level.However,for carboplatin,dual signals were generated at the “thromboembolic events” SMQ level,and three signals were generated only at the “venous thromboembolic events” sub-level.The PT hierarchy analysis of thromboembolic events revealed that except for “thrombotic microangiopathy” produced single signal,signals generated by cisplatin were all triple signals,among which “aortic thrombosis” (ROR 95%CI lower limit=72.59,IC-2SD=5.93) exhibited the strongest signal intensity.Different from cisplatin,except for “acute myocardial infarction”,“ischemic stroke”,and “cerebral infarction”,which generated dual signals,“aortic thrombosis”,which generated a single signal,all the other signals produced by carboplatin were triple signals.Additionally,“venous occlusive liver disease” (ROR 95% CI lower limit=11.58,IC-2SD=3.35) displayed the strongest signal intensity.Among various types of thromboembolic events,both cisplatin- and carboplatin-related “pulmonary embolism” and “deep vein thrombosis” were reported the highest number,ranking first and second,respectively. Conclusions In this study,cisplatin and carboplatin were proven to increase the risk of thromboembolic adverse events.Cisplatin was associated with potential risks of “venous thromboembolism” and “arterial thromboembolism”,while carboplatin was associated with “venous thromboembolism”.Therefore,attention should be paid to the above risks during clinical use.
Objective To explore and analyze the adverse drug event (ADE) signals associated with pembrolizumab and to provide a reference for the real-world safety of drug use on elderly patients. Methods ADE reports of pembrolizumab in the general population and elderly population were collected from the FDA Adverse Event Reporting System (FAERS) for the period between January 1st,2019,and June 30th,2024.Multiple signal detection methods(ROR,PRR,MHRA) were employed for data mining.Classification and statistical analysis were performed using the System Organ Class (SOC) and Preferred Term (PT) from the MedDRA (Version 27.1) dictionary. Results A total of 966 signals were identified in the general population,spanning 24 SOCs,while 593 signals were detected in the elderly population,spanning 23 SOCs.Comparative visualization analysis of critical PTs under four major SOCs revealed no significant abnormal signals in elderly patients. Conclusion A comprehensive and multidimensional analysis of the ADE data from the FAERS database indicates that pembrolizumab appears to be relatively safe for use in elderly patients.
Objective To mine and analyze adverse drug events (ADEs) of novel agents for multi-drug-resistant tuberculosis (MDR-TB) based on the FDA Adverse Event Reporting System (FAERS) database,to explore the signals of ADEs,and to provide reference for clinical use. Methods The FAERS database was searched and extracted from Q1 of 2015 to Q4 of 2023,and the ADE reports about bedaquiline,delamanid,and pretomanid were collected.Data mining and analysis were carried out on relevant reports of the drug using the reporting odds ratio (ROR),proportional reporting ratio (PRR),medicines and healthcare products regulatory agency (MHRA),and the Bayesian confidence progressive neural network (BCPNN). Results The number of ADE reports for the target drugs bedaquiline,delamanid,and pretomanid were 2 477,1 630,and 173,respectively.ADE of the target drugs involved multiple organ systems.Positive signals detected by the ROR,PRR,MHRA,and BCPNN methods were 246,246,215,204 for bedaquiline;251,251,224,200 for delamanid;and 25,25,24,22 for pretomanid.Clinically significant high-risk signals include prolonged QT interval on ECG,anemia,liver toxicity,peripheral neuropathy,etc. Conclusions The signal mining of ADEs based on the FAERS database indicates that close attention should be paid to risks such as prolonged QT interval on ECG,anemia,liver toxicity,and peripheral neuropathy during the clinical use of bedaquiline,delamanid,and pretomanid.In addition,monitoring of new potential ADE signals (such as acute heart failure,respiratory failure,acute kidney injury,etc.) should be strengthened,and timely intervention measures should be taken to ensure medication safety.
In recent years,protein and polypeptide drugs have developed rapidly and have been widely used to treat cancer,hepatitis,and other diseases.The activity of proteins and polypeptides is closely related to their structure.Protein structures can be divided into four levels:primary,secondary,tertiary,and quaternary structures.The primary structure determines the advanced structure and biological functions of proteins.To ensure drug safety,it is necessary to carry out structural characterization and quality control.The advanced structure is the basis for proteins to express their functions and activities,and changes in spatial structure can lead to alterations in functions.This article reviews the progress of research on the primary and advanced structure characterization of proteins and polypeptides,including techniques such as reversed-phase high-performance liquid chromatography,Edman degradation,mass spectrometry,and spectroscopy.It aims to provide a reference for the structural characterization and quality control of other protein and polypeptide drug products.
Endoplasmic reticulum stress (ERS) is associated with the pathophysiology of various lung diseases.Multiple experiments have confirmed that inhibiting ERS can alleviate inflammatory responses,improve lung function,and possess certain anti-infective effects.ERS inhibitors can positively impact the treatment of respiratory system diseases by targeting the unfolded protein response (UPR) in the ERS pathway and regulating the balance of calcium ions within the endoplasmic reticulum.Most current research on ERS inhibitors is still in the preclinical stage.This article thoroughly reviews the relevant reviews and various experimental research results on ERS in respiratory diseases,systematically examining the potential roles of the main branches of UPR,including inositol requiring enzyme 1 alpha (IRE 1α),protein kinase-like endoplasmic reticulum kinase (PERK),and activated transcription factor 6 (ATF6),as well as other ERS inhibitors in respiratory diseases.The aim is to promote clinical trial exploration of ERS inhibitors,with the hope of providing effective drug selection strategies for the treatment and symptom relief of respiratory diseases.
Objective Establishment of quality standards for Xiaoyan Muniziqi granules (XYMNZQG). Methods The qualitative identification of Cuscutae Semen and Dracocephalum moldavia in the preparation was carried out,and the content of hyperin and tilianin in the preparation was determined. Results The qualitative results of Cuscutae Semen and Dracocephalum moldavia in XYMNZQG were clear.The linear ranges of hyperin and tilianin were 11.932 2-95.457 6 μg·mL-1 (r=0.999 9) and 25.281 78-202.254 24 μg·mL-1 (r=0.999 4),respectively.The average recoveries were 99.11% and 99.52%,with RSDs of 0.47% and 0.72% (n=6). Conclusion The established quality control method is simple,reliable,and specific,and can be used for the quality control of XYMNZQG.
Objective To explore the prescription and preparation technology of compound Bupleurum suppository and draft its quality standard. Methods The volatile oil of Bupleurum was extracted by steam distillation,and the compound Bupleurum-based suppository was prepared by mixing the volatile oil with taurine using the melting method.The quality standard of the preparation was formulated according to the quality inspection items of the general rule 0107 of the Pharmacopoeia of the People's Republic of China (2020 Edition,Volume IV);The contents of n-hexanoic acid and n-heptanoic acid in the preparation were determined by gas chromatography-mass spectrometry (GC-MS).The content of taurine in the preparation was determined by high-performance liquid chromatography (HPLC). Results The optimized distillation time of the volatile oil was 1.5 h,The linear ranges of n-hexanoic acid,n-heptanoic acid and taurine are 23.175 0-115.875 0 μg·mL-1 (R2=0.999 4),4.590 0-68.850 0 μg·mL-1(R2=0.998 9) and 15-125 μg·mL-1(R2=0.999 6),respectively.The average recoveries are 99.83%,101.96%,98.89% with RSDs of 2.84%,1.36%,2.88%,respectively.The RSDs of precision,stability,and repeatability tests are less than 5%.The properties,mass difference,melting time,microbial limit,and stability assessment of the preparationwere all in accordance with the Pharmacopoeia of the People's Republic of China. Conclusion Compound Bupleurum suppository preparation technology is reasonable and feasible,which meets the quality standard.
Objective To study the physical and chemical stability of biapenem and parenteral nutrient solutions when they are used together through a Y-type infusion pathway,and to evaluate the rationality and feasibility of clinical compatibility. Methods Based on the actual clinical infusion rates of biapenem solution and parenteral nutrition solution in ICU,under room temperature and light conditions,simulate a Y-shaped pathway to mix biapenem solution and four types of parenteral nutrition solutions in three volume ratios (1:1,2:1,3:1),and collect the compatible solutions at 0,1,2,4,and 6 hours,observing the appearance,pH value,osmolality,insoluble particles,Zeta potential,particle size and the change of biapenem content of the compatible solution,to investigate the potential interaction between them. Results Within 6 hours,the appearance,pH value,osmotic pressure,insoluble particles,particle size,and Zeta potential did not significantly change.Compared with zero time,the content of the biapenem fluctuated between 93.68% and 100.86%,and there was no impurity peak interference in the chromatogram. Conclusion The physico-chemical properties of biapenem were stable within 6 hours under the condition of room temperature and no light exposure through Y-type infusion pathway and parenteral nutrient solutions.
Objective A comprehensive evaluation of three kinds of closed triple therapy (fluticasone furoate,umeclidinium bromide and vilanterol trifenatate powder for inhalation,budesonide,glycopyrronium bromide and formoterol fumarate inhalation aerosol,beclometasone dipropionate,formoterol fumarate and glycopyrrolate inhalation aerosol)for stable maintenance treatment of chronic obstructive pulmonary disease (COPD) is conducted to provide reference for drug selection and rational clinical use in medical institutions. Methods Based on the Quick Guidelines for Drug Evaluation and Selection in Chinese Medical Institutions (Second Edition), this study collected drug instructions,clinical guidelines,and relevant literature from databases such as China National Knowledge Infrastructure (CNKI),Wanfang Database,VIP Database for Chinese Technical Periodicals(VIP),PubMed,Embase and Cochrane Library.Quantitative indicators were established to evaluate three inhalations that closed triple therapy formulations from five dimensions:effectiveness,pharmacological characteristics,safety,economy,and other attributes. Results The comprehensive scores of the formulations included in the evaluation are all above 80 points,among which the comprehensive score of fluticasone furoate,umeclidinium bromide and vilanterol trifenatate powder for inhalation is the highest at 89.2 points,followed by budesonide,glycopyrronium bromide and formoterol fumarate inhalation aerosol at 87.6 points,and the lowest score of beclometasone dipropionate,formoterol fumarate and glycopyrrolate inhalation aerosol at 82.9 points. Conclusions All three formulations have shown good clinical efficacy,and different triple formulations have different advantages in clinical treatment.Through the comprehensive evaluation of three types of inhalation triple preparations,it can provide a reference for drug selection in medical institutions,and provide a basis for clinical scientific,rational,safe,and personalized medication.
Objective To provide a reference for medication therapy management (MTM) of diabetic patients complicated with abnormal blood pressure fluctuation. Methods A 71-year-old female diabetic patient with combined hypertension and abnormal blood pressure fluctuations was referred by the doctor to the pharmacy clinic.The pharmacists provided MTM services through pharmacy inquiry,medication evaluation,medication reconciliation,drug use education,and pharmacy follow-up.They reconciliated the medication regimen based on plasma glucose levels and dynamic blood pressure rhythms. Results Through twelve times MTM services for fourteen weeks,the atherosclerotic cardiovascular disease (ASCVD) risk factors,including morning peak blood pressure,fasting plasma glucose (FPG),plasma glucose two hours post breakfast (P2hPG) and glycosylated hemoglobin (HbA1c),reduced from 163/115 mmHg,7.54 mmol·L-1,12.87 mmol·L-1 and 7.2% before MTM to 137/84 mmHg,6.42 mmol·L-1,8.79 mmol·L-1 and 6.4% after MTM services,and the trough blood pressure post breakfast raised from 86/64mmHg to 115/76 mmHg.The patient's plasma glucose and blood pressure were effectively managed and controlled,and the abnormal non-spoon-shaped hypertension rhythm changed to the normal spoon-shaped diurnal blood pressure rhythm,and the patient's dizziness symptoms disappeared after breakfast. Conclusion The hospital develops pharmacy clinics,where pharmacists provide MTM services for patients with chronic diseases such as hypertension and diabetes,promote clinical rational drug use,and improve the level of patient health management.
Objective To explore the pharmaceutical care clinical pharmacists provide for anti-infective therapy in patients undergoing continuous renal replacement therapy (CRRT) after lung transplantation. Methods The clinical pharmacist utilized a limited sampling strategy and participated in the entire anti-infective treatment process for an adult lung transplant recipient based on pharmacokinetic monitoring results.The CRRT duration was flexibly adjusted,the dosing regimen was optimized,and adverse drug reactions were monitored. Result The clinical pharmacist assisted the physician in optimizing the polymyxin B anti-infective therapy post-transplantation,leading to successful infection control and patient discharge. Conclusion Clinical pharmacists can conduct real-time drug concentration monitoring in lung transplant patients based on pharmacokinetic characteristics,develop individualized dosing regimens,and improve medication safety and efficacy during anti-infective therapy.
Objective To preliminarily describe the current situation of chronic disease drug continuity between community hospitals and the Affiliated Hospital of Qingdao University in the medical alliance,to explore the key points for further improving the connection between upper and lower-level hospitals in the medical alliance,and to improve the drug supply guarantee and the ability of pharmaceutical services of primary medical institutions. Methods The nine community hospitals within the medical alliance centered on the Affiliated Hospital of Qingdao University were taken as the research subjects to investigate the medication continuity between the community hospitals and the core hospital in terms of cardiovascular diseases,diabetes,and respiratory system diseases before and after the medical alliance. Results Before the integration of medical alliances,the drug linkage rate for cardiovascular diseases,diabetes,and respiratory system diseases in community hospitals and core hospitals was relatively low.After the integration of medical alliances,the average drug linkage rate for the three chronic diseases significantly increased,all exceeding 60%.At the same time,the drug catalog in community hospitals was streamlined,reducing the phenomenon of one drug having multiple specifications.There is a significant difference in the number of drug varieties provided by different community hospitals for the three chronic diseases. Conclusion The medical alliance with the Affiliated Hospital of Qingdao University as the core promotes the up-down linkage of drug treatment in community hospitals,simplifies the drug catalog of primary medical structure,and facilitates the treatment and prescription of chronic patients.
Objective To investigate the status and developmental trends of clinical trials for weight control drugs in China,and to provide data support for sponsors,researchers,and regulatory authorities. Methods The drug clinical trial registration and information platform of the National Medical Products Administration was utilized to search for registered clinical trials of weight control drugs from November 2012 to June 2024.The search employed "overweight", "obesity", and "weight loss" as keywords.The information collected included project registration time,drug name,dosage form,drug classification,indications,trial staging,study progress,design type,lead unit,and sponsor.Microsoft Office Excel software was employed for data entry,organization,and extraction. Results A total of 95 registered clinical trials of weight control drugs were identified,comprising 40 domestic multicenter trials,47 domestic single-center trials,and 8 international multicenter trials.Regarding trial phasing,46 (48.4%) were phase I clinical trials,17 (17.9%) were phase II clinical trials,19 (20.0%) were phase III clinical trials,and 13 (13.7%) were bioequivalence trials.The drug categorization encompassed 22 chemical drugs,20 biological products,and 1 traditional Chinese medicine/natural drug.Concerning drug dosage forms,there were 32 items of injectable dosage forms,8 items of tablets,2 items of capsules,and 1 item of chewable tablets. Conclusions Registered clinical trials for weight-loss medications in China are predominantly concentrated in regions with developed medical resources.Injectable biologics constitute most test drugs,with most drugs in the early stages of research and development.The examination of the safety and efficacy of these drugs remains to be substantiated,and it is anticipated that a considerable period will elapse before their approval and market introduction.
Objective To analyze the projects of the Management Science Department of the National Natural Science Foundation of China (NSFC) funded to hospital pharmacists from 2013 to 2024,providing references for hospital pharmacists to apply for such projects. Methods Websites such as the National Natural Science Foundation Big Data Knowledge Service Management Portal,MedSci,and LetPub were retrieved,supplemented by manual retrieval.Relevant projects with hospital pharmacists as the project leaders were screened out,and keywords such as the research topic,research theory/model,and research type of the projects were extracted for analysis. Results From 2013 to 2024,40 projects of the Management Science Department of the NSFC were given to hospital pharmacists as project leaders,and both the number of projects and the proportion of funding showed an upward trend.The awarded projects mostly demonstrated the relevance of national macro-pharmaceutical policies and were matched with corresponding management theories/models based on the research content.The research themes and research objects were diverse,and the research types were mainly model construction and pattern construction. Conclusion Pharmacists should closely follow the direction of national policies,seek research inspirations in their daily work,and enhance the learning of management research methods,guiding and regulating research through management theories.
