Objective To screen the anti-Streptococcus pneumoniae (Spn) active ingredients in vitro from different polar parts of Pilea peltata,and to examine the combined antibacterial effect of the active ingredient and amoxicillin (AMX). Methods A 96-well plate microdilution method was used to determine the minimum inhibitory concentration (MIC) of different polar parts;the most active polar part was separated by preparative high-performance liquid chromatography,and the active ingredients were identified using spectral technology.The fractional inhibitory concentration (FIC) of active ingredients and AMX was determined by the 96-well plate chessboard microdilution method.The crystal violet method was used to investigate the effect of active ingredients on Spn biofilm.The effect of active ingredients on the appearance and morphology of Spn was investigated under the electron microscope. Results The MICs of the petroleum ether part,chloroform part,ethyl acetate part,n-butanol part,and water part were 1.000,1.000,0.500,1.000,and 2.000 mg·mL-1 respectively,among which the ethyl acetate part had the strongest antibacterial activity.Three compounds were isolated from ethyl acetate,namely 5,7,3',4'-tetramethoxyflavone 1,8-O-(p-coumaroyl)-1(10)E,4(5)E-humuladien-8-ol 2 and 1-O-p-coumaroyl copaborneol 3.These compounds were all isolated for the first time from Pilea peltate,their MICs against Spn were 200.000,50.000,and 25.000 μg·mL-1 respectively,and the compound 3 had the strongest antibacterial activity;the FIC value of AMX and compound 3 was 0.50,which had a synergistic antibacterial effect on Spn.Both AMX and compound 3 had inhibitory effects on Spn biofilm,but the biofilm inhibition rate of compound 3 (59.10±1.04%) was significantly lower than AMX (87.38±0.84)% (P<0.01);Moreover,there was no significant difference in biofilm inhibition rate between the combination of the two and AMX (P>0.05).The scanning electron microscope results showed that the bacterial cells in the compound 3 group had a smooth surface but varying degrees of depression.The surface of the bacterial cells in the AMX group and the AMX combined compound 3 group showed severe swelling and rupture. Conclusions Flavonoids and sesquiterpenoids are both the anti-Spn active components of Pilea peltate.Among them,sesquiterpenoids have more potent antibacterial activity,and their antibacterial action mechanism is related to inhibiting bacterial biofilms.Compound 3 and AMX have a synergistic antibacterial effect on Spn,but its mechanism of action is not by enhancing biofilm inhibition;although compound 3 cannot destroy the cell wall of Spn,it still has a negative impact on the appearance of the bacteria.
Organizational and institutional management plays a pivotal role in the pharmaceutical management of medical institutions.Strengthening management in this area significantly enhances the quality of medical services and promotes the standardization, refinement, and scientific management of hospitals at all levels and types.To achieve homogenization in organizational and institutional management, the Pharmaceutical Specialized Committee,Chinese Hospital Association compilation team adhered to principles of scientific, universality, instructiveness, and operability.After in-depth problem sorting, extensive opinion collection, and rigorous expert deliberation, we have formulated the first domestic group standard for regulating the organizational and institutional systems of pharmaceutical management in medical institutions.This article aims to detail the process of formulating this standard and to provide an in-depth analysis of its content, hoping to offer valuable advice and guidance for the construction of organizational and institutional management in pharmaceutical affairs for medical institutions of all levels and types.
Managing look-alike/sound-alike medications is important to medical institutions' pharmaceutical management and pharmacy services.Based on national policies and regulations,this standard focuses on the whole life cycle of look-alike/sound-alike medications in medical institutions.It is developed based on the principles of scientific validity,universality,guidance,and applicability,formed by sorting out problems,soliciting opinions,expert argumentation,and deliberation.It is the first group standard to standardize the management of look-alike/sound-alike medications.This paper introduced and analyzed the team composition,problem sorting and compilation process,and various elements of the standard in the process of formulating the standard,to provide a reference for medical institutions to use this standard.
Rescue vehicles and nursing unit drug stock are important in the clinical rescue process.Strengthening the management of rescue vehicles and nursing unit drug stock is conducive to ensuring the safety of clinical medication and improving the quality of medical services.Based on scientificity, universality, guidance, and operability principles, the standard preparation team revealed relevant national policy documents, domestic and foreign standards specifications, and literature.It sorted the key contents of rescue vehicles and base drug management.After several rounds of opinion collection and expert argumentation, the social organization standard Pharmacy administration and pharmacy practice in healthcare institutions—Part 3-7-3: Pharmaceutical supply services—Key drugs management—Rescue vehicle and nursing unit drug stock management was proved.The main content of the standard includes 10 elements from 3 key parts: basic requirements, management processes, and quality management and evaluation improvement, to provide guidance in allocating, storing, and managing rescue vehicles and nursing unit drug stock.
Drug quality problems seriously threaten the life and health of patients,drug quality problems handling is an important part of pharmaceutical management in medical institutions,and strengthening the management of drug quality problems in medical institutions can provide a strong guarantee for drug safety of patients.This standard was compiled by the Pharmaceutical Affairs Commission of the Chinese Hospital Association,and the process included problems identification,framework development,manuscript writing,opinions gathering,expert argumentation and deliberation,and standards development.The standard regulates the basic requirements,coping strategies,quality control and continuous improvement of drug quality problems handling in medical institutions.This article elaborates on the methods and contents of formulating standards for drug quality problems handling,to provide reference and inspiration for medical institutions to carry out drug quality problems handling.
In surgical diagnosis and treatment,the perioperative period is a comprehensive diagnosis and treatment process,including the rational application of antibiotics,nutrition management,pain management,blood pressure,blood sugar management,and other processes.Perioperative pharmaceutical care has become one of the innovative fields of pharmaceutical care.In order to ensure the work and service quality of perioperative pharmaceutical care,the preparation team of perioperative pharmaceutical care standards takes scientific,universal,and practical principles as the basic principles,reviews the key points and difficulties from the three aspects of relevant national policy documents,relevant domestic and foreign standards and norms,and literature analysis,and combines the actual situation of perioperative pharmaceutical care.This pharmaceutical care standard was formulated after several rounds of opinion solicitation and expert argumentation.This paper analyzes the key contents of the standard,including the basic requirements,service process,quality control,and evaluation and improvement of perioperative pharmaceutical care,so as to provide reference suggestions for medical structure managers and pharmacists who carry out perioperative pharmaceutical care to deeply understand and practice this standard,so as to improve perioperative pharmaceutical care.
Hospital pharmacy research is significant in enhancing the level of rational drug use,improving the quality of pharmacy services,and promoting the improvement of drug treatment effects.To guarantee the standardization of hospital pharmacy research,the compilation team of “Hospital Pharmacy Research Standards” adheres to the principles of scientificity,universality,guidance,and operability,combs through the key management contents from three aspects,namely,relevant national policy documents,relevant domestic and international standards and norms,and literature analysis,combines with the actual working condition of hospital pharmacy research,and formulates the standards after several rounds of opinion collection and expert argumentation.This paper analyzes the key contents of the standard,including basic requirements,research process management,and research results management,to provide guidance and reference for hospital pharmacy researchers to understand the standard in-depth and further improve the standardization of hospital pharmacy research.
Objective To explore a standardized approach for indicating dosages in Chinese patent medicines (CPM) instructions. Methods A review of 1 378 classic formulas of traditional Chinese medicine in the 2020 edition of the Pharmacopoeia of the People's Republic of China (Chinese Pharmacopoeia) was conducted,focusing on three aspects: overdose,different dosage forms,and inclusion of toxic herbs.Approximately 50 representative formulas were selected,and their daily dosage of herbal pieces and the corresponding dosage of individual herbs were calculated.These results were then compared and analyzed against the dosages stipulated in the Chinese Pharmacopoeia. Results ①Overdose: Among the 1 378 reviewed formulas,146 (10.60%) were found to involve overdose.Specifically,eight formulas were identified as having an overdose of approximately 3 to 5 times the recommended dose,including Duanxueliu tablets and Zhixue Fumai mixture.②Dosage variations across dosage forms: Based on the conversion of the Ming-Qing dynasty dosage of one liang (Chinese traditional weight unit)to 36 g,the estimated daily dose per component of crude herbs in Yinqiao powder was close to the upper limit specified in the Chinese Pharmacopoeia.The total daily dose of crude herbs (75.60 g) was approximately five times that of the Yinqiao powder (15 g) listed in the Chinese Pharmacopoeia and three times that of the Japanese Kampo Yinqiao powder (23.868 g).Significant differences in dosage were observed among Yinqiao Jiedu preparations of different dosage forms.In terms of total daily dose of crude herbs,granules (52.50 g) had the highest dose,approximately 3-5 times that of tablets/capsules (11.20 g),soft capsules (13.44 g),and powders (15.00 g),but still 30% lower than the original prescription from ancient texts (75.6 g).Comparing the daily dose per component,granules fell within the Chinese Pharmacopoeia dose range,while tablets,capsules,soft capsules,and powders were all below the Chinese Pharmacopoeia dose.③Inclusion of toxic herbs: Among the 20 oral formulations containing Strychnos nux-vomica (Maqianzi) listed in the Chinese Pharmacopoeia,seven species exceeded the pharmacopoeial dose of 0.3-0.6 g per day.Notably,Shenjin Huoluo pill and Shufeng Dingtong pill exceeded the Chinese Pharmacopoeia dose by 1.5-2 times.The daily dose of strychnosine in Shenjin Huoluo pill was 21.3 mg,exceeding the toxic dose range of 5-10 mg. Conclusions The dosage indications in CPM instructions must adhere to a unified format,clearly stating the daily dose per component of crude herbs,the total daily dose of crude herbs,and the total number of administrations under the "Dosage and Administration" section.For instance,"Yinqiao Jiedu granules,with a total daily dose equivalent to 60 g of crude herbs taken in four doses (including: Flos Lonicerae 10.71 g,Fructus Forsythiae 10.71 g,Radix Platycodi 6.43 g,Herba Menthae Haplocalycis 6.43 g,Fructus Arctii 6.43 g,Semen Sojae Preparatum 5.36 g,Radix Glycyrrhizae 5.36 g,Herba Lophatheri 4.29 g,Herba Schizonepetae 4.29 g)." For CPM containing toxic herbs,dosage indications are even more crucial,such as specifying the daily dose of Maqianzi powder/processed Maqianzi and strychnosine in formulations containing this herb.
Objective The content of the relevant safety items in the instructions of Chinese patent medicines is "Not Clear" to provide a reliable reference for improving the safety and effectiveness of Chinese patent medicines. Methods Search the Chinese Pharmacopoeia 2020,National Essential Medicines List,Handbook of Selected Chinese Patent Drugs in Various Clinical Subjects,and Handbook of Modern Chinese Patent Drugs.Conduct random sampling according to Chinese patent medicines' different efficacy and dosage forms and collect complete basic information and versions.There are a total of 105 latest drug instructions.The safety information in each drug instruction is extracted and entered into Excel 2019.The annotations are summarized and statistically analyzed one by one. Results After summarizing,most instructions are marked with safety item information such as adverse events,contraindications,pharmacology,and toxicology.However,the degree of detail of each content varies greatly.Common problems include non-standard terminology description,content "avoiding the important and light,passing it off " or inconsistent content with the labeling,and insufficient clinical data research. Conclusions There is a severe lack of research content in the package insert of Chinese patent medicines,and it is still necessary to further strengthen the discussion and research on the mechanism of action of medicines to revise and improve the safety information of the instructions and ensure the safety of clinical use.
Objective Through the safety evaluation of Chinese patent medicines containing cinnabar,the correlation between the evaluation score and the content of drug instructions was analyzed.And the methods and suggestions for improving the label quality of Chinese patent medicines were proposed. Methods Establish a database of Chinese patent medicines and simple preparations containing cinnabar that meet the screening criteria in the 2020 edition of the Chinese Pharmacopoeia,and quantitatively score such Chinese patent medicines and simple preparations from the two first level dimensions of safety and toxicity characteristics of Chinese patent medicines and simple preparations,and at the same time,grade the level of safety evidence. Results From the perspective of safety evaluation dimension,Chinese patent medicines and simple preparations with relatively high safety score (safety score≥5 points) has a certain correlation with the content of adverse drug reactions clearly reported in the instructions of this kind of medicine,and 54.55% of the evidence risk of this kind of Chinese patent medicines and simple preparations is controllable,with good safety. From the perspective of the evaluation dimension of toxicity characteristics of Chinese patent medicines and simple preparations,the types of toxic ingredients in the compatibility of prescriptions and the scores of daily maximum dosage have certain guiding significance for clinical medication precautions. Conclusion For improving the adverse reaction information in the instructions of Chinese patent medicines and simple preparations containing cinnabar,and reminding the special population of drug use restrictions,it not only has an important impact on drug safety evaluation and grading,but also provides warning and reference for clinical and patient safety in drug use.
Objective To explore the problems arising from the safety content in the instructions of Chinese patent medicines containing bitter almonds and to make suggestions. Methods By searching the Chinese patent medicines containing bitter almonds in the "National Basic Medical Insurance,Work Injury Insurance and Maternity Insurance Drug List (2022)" of the Medication Assistant and Yaozhi Online,the article collated their primary functions,composition,adverse reactions,contraindications to medication,warnings,and precautions.The article entered the collected information into the Excel 2021 version,analyzed the summarized data,and made suggestions for the safety warning information in the instructions of Chinese patent medicines containing bitter almonds based on the results of the statistics. Results Among the 1 381 kinds of patent medicines listed in the "National Basic Medical Insurance,Work Injury Insurance,and Maternity Insurance Drug List (2022)",there are 67 varieties of Chinese patent medicines containing bitter almonds,and there were missing safety contents in the collected instructions.Among them,only five types were clearly labeled with specific contents of warnings,17 types were clearly labeled with adverse reactions,24 types were clearly labeled with contraindications,and 58 types were clearly labeled with precautions.However,in terms of the content of bitter almonds and prescription ratio,the maximum daily dosage of 2 out of 67 Chinese patent medicines containing bitter almonds exceeded the dosage of the Chinese Pharmacopoeia,and the prescription ratio of 14 Chinese patent medicines exceeded 10%;in terms of the combination and dosing,25 out of 67 Chinese patent medicines containing bitter almond were dosed with other poisonous traditional Chinese medicines,and the above medicines have high safety risks.The information on their safety should be increased,and their safety information should be increased. Conclusions The safety-related warnings in the instructions for Chinese patent medicines containing bitter almonds are not comprehensive enough.It is recommended to strengthen the management of the whole life cycle of drugs,increase the warnings of level 1 high-risk varieties,and improve adverse reactions,contraindications,and precautions according to the Technical Guiding Principles for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions (Trial).
Objective In this paper,the ethnic patent medicines (EPMs) in the Chinese Pharmacopeia,National Basic Medical Insurance,Employment Injury Insurance and Maternity Insurance Medicine List,and National Essential Medicine List (referred to as “one pharmacopeia and two lists”) were counted and analyzed. Methods The EPMs in “one pharmacopeia and two lists” were summarized,and the information of manufacturers,medicinal materials used in EPMs,and their current quality standards were collated,and their indicative function,adverse reactions,contraindications,and precautions were analyzed.The modern research level of the above EPMs was analyzed by searching relevant literature on CNKI and PubMed. Results A total of 142 EPMs in “one pharmacopeia and two lists” were included,and 68 of the EPMs had exclusive manufacturers and 98.75% of the medicinal materials had provincial-level or higher quality standards.There were issues such as the expression of indicative function in the instruction being mixed between medical terms,91.55% of the EPMs lacking sufficient information on adverse reactions,contraindications,and precautions,and modern basic research was weak. Conclusions In the development of EPMs,it is important to improve information on adverse reactions,contraindications,and precautions in the instructions.In expressing indicative function,it is necessary to avoid mixing medical terms,which is more conducive to the clinical promotion of EPMs.
Objective The quality of compound menthol nasal drops was reviewed and analyzed,and identified the bad trend in time.The improvement measures were formulated to improve the quality of the preparation. Methods Taking camphor and menthol in compound menthol nasal drops of Beijing Shijitan Hospital, Capital Medical University, as indicators,the quality of 30 batches of samples was retrospectively analyzed using the capacity sixpack report.The failure mode and effect analysis (FMEA) were applied to the prospective quality risk management. Results All 30 batches of compound menthol nasal drops met the quality standards,and the process was under control.However,there were potential risks in the process of menthol,so risk management was carried out and improvement measures are formulated. Conclusion The compound menthol nasal drops of the hospital have stable quality,and the quality of the medicine can be continuously ensured with improved processes.
Objective To perform an economic evaluation of ilaprazole in the treatment of patients with peptic ulcer bleeding and low-risk stigmata,and to provide a reference for drug selection. Methods From a societal perspective,we used decision analysis to evaluate the cost and effectiveness of ilaprazole and omeprazole in treating peptic ulcer bleeding patients during hospital stays.The probabilities of model nodes were taken from phase Ⅲ clinical trial research results,while cost data came from national medical insurance prices,published literature,and hospital databases.Sensitivity analysis and scenario analysis were performed to test the stability of the results. Results A cost minimization analysis was performed.Under the basic setting,the cost of the ilaprazole group was 4 038.99 yuan,and that of the omeprazole group was 3 837.61 yuan,which means that the cost of the ilaprazole group was 201.38 yuan higher.Sensitivity analysis showed that the results were stable.Scenario analysis showed that ilaprazole was more cost-effective than the innovator drug of omeprazole. Conclusion Ilaprazole was less economical than omeprazole in the treatment of peptic ulcer bleeding patients with low-risk stigmata.
Objective To evaluate drug-related problems (DRPs) and to analyze the influencing factors of patients undergoing video-assisted thoracoscopic surgery (VATS) before operation in thoracic surgery. Methods Clinical pharmacists used the Pharmaceutical Care Network Europe (PCNE) classification system (version 9.1) to analyze DRPs and influencing factors of patients who received VATS from March 1 to May 31,2023,and had at least one comorbidity. Results Out of 300 patients,174 were involved in a total of 200 DRPs. The most common category of DRPs is treatment safety (47.50%),followed by treatment effectiveness (46.00%) and others (6.50%).The most common cause of the problem is drug selection (33.83%),followed by other (33.33%) and patient cause (19.90%).367 interventions were conducted for DRPs,with the most interventions being at the drug level (55.86%),followed by the doctor level (39.24%) and the patient level (3.54%).In the end,96.00% of the intervention plan was accepted,and 86.50% of the problems were resolved.There were significant differences (P < 0.05) in the number of underlying diseases,medication varieties,body mass index (BMI),and length of hospital stay between the group with and without DRPs.The results of multivariate analysis showed that comorbidities,number of medication types,and BMI were independent risk factors for preoperative occurrence (or potential) of DRPs in VATS patients in thoracic surgery (OR>1,P<0.05). Conclusions Clinical pharmacists can effectively evaluate preoperative DRPs in patients undergoing VATS in thoracic surgery through the PCNE classification system.Comorbidities,number of medications,and BMI are influential factors for the occurrence of preoperative DRPs.Future clinical practice should focus on these risk factors to optimize treatment strategies and reduce the occurrence of DRPs.
Objective To analyze the distribution and drug resistance patterns of pathogenic bacteria in bile and blood cultures obtained from patients with biliary stones accompanied by acute biliary tract infection,to evaluate the clinical appropriateness of antibiotic use based on drug sensitivity results,and to provide evidence for empirical antibiotic treatment in such patients. Methods The clinical data of 161 patients with biliary calculi complicated by acute biliary tract infection who were admitted to the First People's Hospital of Neijiang from 2017 to 2023 were retrospectively analyzed.The results of microbial culture,drug sensitivity analysis,and patient characteristics were assessed to evaluate the appropriateness of clinical antimicrobial therapy. Results Among the 161 patients with positive cultures,212 strains of pathogenic bacteria were detected.The predominant pathogens were Escherichia coli,Klebsiella pneumoniae subspecies,and Enterococcus faecium.Age and underlying diseases significantly affected the distribution of Escherichia coli and Klebsiella pneumoniae subspecies.Within the gram-negative bacterial group,Escherichia coli and Klebsiella pneumoniae subspecies exhibited higher drug resistance to commonly used broad-spectrum penicillin,third-generation cephalosporin and quinolones but lower resistance rates to piperacillin and tazobactam;furthermore,elderly individuals aged ≥65 years showed higher resistance rates to ceftriaxone than those under age 65 while people with drug exposure history had higher ceftazidime resistance rates that were statistically significant.In contrast to Enterococcus faecalis which displayed low antimicrobial resistance rates for most drugs tested in this study,Enterococcus faecium demonstrated high levels of antibiotic resistance;however,both Enterococcus faecalis and Enterococcus faecium exhibited zero-resistance rates against vancomycin and tigecycline although this may be attributed to their small sample size in our study cohort.Finally,we found that empirical anti-infective drugs,as well as target anti-infective drugs,were not prescribed rationally among these patients due mainly to inappropriate combinations of antibiotics or incorrect dosages. Conclusions The predominant pathogens in patients with acute biliary tract infection are gram-negative bacteria,Gram-positive bacteria,and fungi;however,the potential involvement of anaerobic bacteria should not be overlooked.Vancomycin exhibits sensitivity against gram-positive bacteria,yet the overall rationality of antibiotic usage remains suboptimal.Enhanced clinical testing for pathogenic microorganisms is imperative in the management of biliary stones accompanied by acute biliary tract infection.In contrast,clinical pharmacists should provide comprehensive training on anti-infective drugs to clinicians to facilitate their judicious selection of antibiotics based on drug sensitivity results and prevent the emergence of multidrug-resistant bacteria.
Objective To conduct a multidimensional evaluation of brain cytoprotection agents used in the treatment of ischemic stroke,and to provide an evidence-based basis of medication selection and rational clinical use for medical institutions' decision-makers. Methods Based on the "Quick Guide to Drug Evaluation and Selection for Chinese Medical Institutions (Second Edition)" evaluation system,some scoring rules were adjusted.Referring to 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,seven brain cytoprotection agents were quantitatively scored from five dimensions: pharmacological characteristics,effectiveness,safety,economic aspects,and other attributes (insurance coverage,essential drugs,manufacturing enterprises). Results Overall,the evaluated drugs received low scores.The top three drugs were edaravone and dexborneol injection (63.15 points),urinary kallidinogenase injection (62.20 points),and butylphthalide injection (62.04 points). Citicoline injection had the lowest score due to unclear effectiveness (37.07 points). Conclusions Based on guideline recommendations,edaravone and dexborneol,urinary kallidinogenase,and butylphthalide,which scored above 60,are weakly recommended when no alternative medications are available in medical institutions.This study can be used as a reference for the selection of therapeutic drugs for ischemic stroke in medical institutions and offer a basis for rational clinical medication use.
Objective To analyze the clinical characteristics and treatment strategies for Nocardia brasiliensis infection. Methods A clinical pharmacist participated in the clinical diagnosis and treatment plan for a case of a membranous nephropathy patient infected with Nocardia brasiliensis, resulting in multiple infections in the lungs, eyes, and nervous system.They were involved in assessing the patient's infection symptoms and severity, as well as reviewing the literature to participate in developing and optimizing the clinical drug therapy regimen. Results Following infection with Nocardia brasiliensis, the patient developed lung, eye, and nervous system infections.The patient showed significant improvement after targeted treatment by clinical doctors and clinical pharmacists.At the 3-month outpatient follow-up, the patient's lung, eye, and lower limb nervous system had returned to normal. Conclusions Nocardia brasiliensis can colonize in various environments, and immunocompromised individuals are at risk of infection.Clinical diagnosis relies on metagenomic sequencing methods for identification.For mild to moderate infections, a combination of sulfamethoxazole/trimethoprim (TMP-SMX) can be used as monotherapy.Severe infections often require a combination of two or three antibiotic drugs(such as TMP-SMX, imipenem cilastatin, amikacin) for intravenous treatment for 3-6 weeks, and followed by oral therapy.The entire course of treatment typically lasts 3-6 months.Patients with timely and effective treatment usually have a better prognosis.
Objective To explore the identification of adverse reactions of type I diabetes during lung cancer treatment with cardonilimab and the pharmaceutical monitoring of patient's blood glucose management,and to accumulate experience for the prevention,treatment,and pharmaceutical services of related diseases. Methods The clinical pharmacist assisted doctors in judging adverse drug reactions and identifying suspicious drugs in a patient with lung cancer who developed type I diabetes.At the same time,the clinical pharmacist provided suggestions for clinical treatment by referring to clinical evidence,and providing medication education,pharmaceutical care,and long-term follow-up for the patient's blood glucose management. Results After intensive insulin therapy and dietary control,the patient's high glucose symptoms were relieved,and the blood glucose gradually stabilized.The patient continued to be challenged using cardonilimab immunotherapy,and the condition was stable. Conclusions Clinical pharmacists assist physicians in identifying adverse drug reactions on time and participate in the full process management of patient medication.They play an active therapeutic role in the medical team and reflect the value of pharmaceutical services.
Objective To provide a home care pharmacy for a patient with severe heart failure and diuretic resistance,and to provide a reference for healthcare pharmacists to carry out home care pharmacy practice. Methods As part of the family physician team,clinical pharmacists performed home care pharmacy practice on a patient with severe heart failure and diuretic resistance.This involved providing an assessment of medication regimen,medication reorganization,medication education,medication counseling,popularization of medical knowledge,management of the home medicine box,and guidance on a healthy lifestyle.Meanwhile,online and offline methods were adopted to conduct regular follow-up visits to the patient. Results The patient's medication adherence was dramatically improved,the symptoms of heart failure were improved,and no adverse reactions occurred. Conclusion Clinical pharmacists' home care pharmacy practice contributes to improving patients' diseases,reducing the risk of adverse drug reactions and potential medication errors,and promoting safe and rational drug use for patients.
Objective To detect the adverse drug reaction (ADR) signals of tetracycline representative drugs (tetracycline,minocycline,tigecycline,and doxycycline) in children,and to provide reference for safe clinical medication. Methods A total of 34 quarters of ADE report data related to four tetracyclines from the first quarter of 2015 to the second quarter of 2023 in the US FDA Adverse Event Reporting System (FAERS)were collected and grouped according to the age of minor children.The report odds ratio (ROR) method and the comprehensive standard method (MHRA) were used for signal mining. Results A total of 367 461 reports were retrieved from the FAERS database for all minor children under 18 years old.There were 43,583,40 and 501 reports related to tetracycline,minocycline,tigecycline and doxycycline,respectively.A total of 280 ADE signals were detected after deduplication,involving 22 system organ classifications.Tetracycline was concentrated in the gastrointestinal system and various nervous systems.Minocycline was mainly in the hepatobiliary system,endocrine system,and subcutaneous and subcutaneous tissue diseases.Tigecycline was involved in the gastrointestinal system,systemic diseases and various reactive diseases at the administration site,Doxycycline was concentrated in the gastrointestinal system,mental illness,skin and subcutaneous tissue diseases.And it was found that psychosis was not involved in adverse reactions.Adverse reactions not included in the instructions include blindness and papilledema caused by minocycline,hypertriglyceridemia and acute pancreatitis caused by tigecycline,Bell's palsy,growth retardation,blindness,depression,suicidal thoughts and anxiety caused by doxycycline. Conclusions In different age groups of minor children,there are some differences in ADR among the four tetracycline drugs.ADR should be strictly monitored when using tetracycline drugs in all children.While paying attention to the effects of these drugs on children's teeth and bones,other ADE should also be vigilant,such as Jarisch-Herxheimer reaction,acne,thyroiditis,headache.The newly discovered involvement of systemic organs and AE can provide a reference for improving the adverse reactions of tetracycline-representative drugs to ensure the treatment safety of patients.
A male patient,51 years old,was diagnosed as follows: ① type 2 diabetes mellitus;② grade 2 hypertension (extremely high risk).To improve circulation,the patient was administered pentoxifylline injection 0.2 g mixed with 250 mL of 0.9% sodium chloride injection via an intravenous drip,once daily (qd).After 4 days of treatment,liver function tests showed the following results: alanine aminotransferase (ALT) at 2 390.80 U·L-1,aspartate aminotransferase (AST) at 948.28 U·L-1,and gamma-glutamyltransferase (GGT) at 517.81 U·L-1.It was highly probable that pentoxifylline caused abnormally elevated liver enzymes,with a clear drug-related association.After discontinuing pentoxifylline injection and initiating liver-protecting and enzyme-lowering treatment,the liver function indicators gradually improved.Enhanced monitoring during the clinical use of pentoxifylline is essential to ensure patient safety.
Objective To explore the effect of home-based pharmaceutical care for patients with stable chronic obstructive pulmonary diseases(COPD)based on a digital remote management applet. Methods A total of 237 patients with stable COPD from a hospital pharmaceutical outpatient service from March 2022 to March 2023 were divided into a control group,a home visit group,and a remote management group according to the random number table method.Patients in the home visit and remote management groups received home-based pharmaceutical interventions such as health science popularization,medication consultation,medication guidance,effect evaluation of pharmacotherapy,prescription simplification,and reorganization.Such interventions were not provided in the control group.Regular follow-up was performed for 12 months. Results After a pharmaceutical intervention,the operating scores of the inhalation device and medication compliance scores of the home visit and remote management groups were significantly better than the control group (P<0.05).The improvement in medication compliance was greater in the remote management group than in the home visit group (54.3% vs. 44.6%).In the three groups between enrollment and 12 months follow-up,CAT scores decreased by 0.78,6.16,and 7.30 points in the control group,home visit group,and remote management group,respectively.The mean scores of SGRQ symptom decreased by 1.19,4.24,and 6.10 points,the mean activity scores decreased by 1.65,3.56,4.80 points,the impact mean score decreased by 1.08,4.19,5.16 points,and the mean score of the total score decreased by 1.29,4.00,4.80 points in the control group,home visit group,and remote management group,respectively.The remote management group showed dia better decline in CAT score and SGRQ score than the home visit group,and there were significant differences between the two groups compared with the control group after intervention (P<0.05). Conclusions Digital remote management of home-based pharmaceutical care mode can effectively improve medication compliance,operation accuracy of inhalation devices,clinical symptoms,and the patient quality of life.This is an effective and efficient pharmaceutical care mode for the long-term home medication management of stable COPD patients.
Objective To construct a surgical pharmaceutical risk management index system and then to enhance surgical pharmaceutical service quality. Methods Literature research and consulting pharmaceutical experts were used to collect relevant data and construct initial scale items.The Delphi expert consultation method was used to revise and improve indicators with 20 experts, after 2 rounds of inquiry improvement. The analytic hierarchy process (AHP) was used to calculate the weight of each indicator,finally forming the surgical pharmaceutical risk management index system. Results The final construction of the scale entries includes four dimensions,14 second-grade indexes,and 71 third-grade indexes.The questionnaire response rates were 100.00%,while the authority coefficient of experts was 0.832. In the consultation,the harmony coefficients of the first,second,and third indicators were 0.743,0.491,and 0.277,respectively.The AHP was used to determine the weights of indicators,and the result passed the consistency test.The professional factors and pharmacist factors of the first indicators are large in weight. Conclusion The constructed surgical pharmaceutical risk management index system is scientific and practical,which can provide a reference for the clinical work of surgeons and maximize the risk of avoidance.
Objective To investigate and analyze the construction and management status of drug clinical trial institutions in Jiangxi Province,and to provide a reference for institutions' standardized management and development. Methods The registered drug clinical trial institutions in Jiangxi Province were selected as the research objects in the "Drug and Medical Device Clinical Trial Institution Filing Management Information System",and the public data were retrieved.Questionnaires were sent to the registered medical institutions as "Questionnaire Star" to collect the questionnaire data.The data on the construction and management of drug clinical trial institutions were analyzed descriptively from multiple dimensions. Results By December 2023,52 drug clinical trial institutions and one vaccine clinical trial institution had been registered in Jiangxi Province.The organization and management structure,personnel composition,hardware,and software of the registration institutions met the basic requirements for conducting drug clinical trials.In recent years,the number of drug clinical trial record institutions and the number of projects to undertake has increased year by year,and the management ability and comprehensive strength of clinical trial institutions have been continuously enhanced,and there is still a big gap compared with the developed areas of the pharmaceutical industry. Conclusion There is unbalanced regional development,uneven ability of different institutions to undertake projects,a low level of clinical trial information management,and the comprehensive ability of clinical trials needs to be improved in Jiangxi Province.
Objective To explore the impact of gender factors in participant selection during bioequivalence studies,and to provide insights for improving the screening success rate in subsequent trials. Methods A retrospective study was conducted to summarize the screening information of healthy subjects in the bioequivalence study conducted in the Phase I Clinical Trial Laboratory of the Affiliated Hospital of Xiangnan University from July 2021 to July 2023.The number of failed screening cases in different stages of screening for each project was counted,and the influence of gender factors on subject screening was analyzed. Results A total of 32 bioequivalence studies involving 2 794 subjects,including 1 816 males and 978 females,were included in the study.The proportion of males was higher in vital signs and BMI abnormalities,and the proportion of females was higher in ECG abnormalities and active withdrawal,and the pass rate was lower in males than in females (40.0% vs. 45.8%),and the existence of the two was statistically significant (P<0.05).The results of PCA showed that the distribution of data in males was more dispersed,and the distribution of data in females was centralized,and the two could be clearly differentiated.Binary logistic regression analysis showed significant differences between males and females in laboratory test screening failures and BMI (P<0.05).Further analysis showed that the screening failure rates of blood biochemistry,urine routine,coagulation function and blood transfusion were higher in males than in females,but the screening failure rates of blood routine were lower than those of females. Conclusions Gender is an important influencing factor in the screening process of bioequivalence studies.Including subjects with appropriate gender ratios can help improve enrollment speed and reduce clinical trial costs.