Objective To construct a more scientific and better standard system for pharmaceutical packaging materials to meet the needs of industrial development and supervision in the new situation Methods Entrust Shandong Institute of Medical Devices and Pharmaceutical Packaging Inspection to research the standard system under construction in pharmaceutical packaging materials and preparation manufacturing enterprises.The research was mainly based on questionnaires,supplemented by telephone research,and was carried out in two phases.Industry status,standard applicability,and sufficiency were key points of the implementation of implementing the new standard. Results Advice and suggestions for the current pharmaceutical packaging materials standard systems as well as the Shandong Province's industry state on the first stage.And advice and suggestions for the construction systems are collected in the second stage. Conclusion Through this investigation and analysis,enthusiasm and effectiveness of the participation of enterprises in the standardization work were increased.The necessity and feasibility of the improving the standard system were investigated and studied,which played a positive role in further improving the standard system.
Elderly diabetes has become a common disease,and China published Guidelines for the Diagnosis and Treatment of Diabetes in the Elderly in China in 2021.In the same year,in view of the changes on the latest medical evidence,The United States promulgated Standards for the Diagnosis and Treatment of Diabetes-2021,which updated the diagnosis and treatment of diabetes on the basis of the past.This article compares and interprets parts of the two guidelines on elderly diabetes in order to provide a reference for clinical decisions on the diagnosis and treatment of elderly diabetes.
Objective To study antidepressant effects of low dose ketamine (Ket) combined with butylphthalide (NBP) and its mechanism. Methods In vitro depression model of PC12 cell injury by corticosterone (CORT) was established. PC12 cell were divided into six groups,blank control grup,model control group(CORT 400 μmol·L-1),control group A(CORT 400 μmol·L-1+NBP 1 μmol·L-1), control group B(CORT 400 μmol·L-1+Ket 0.01 μmol·L-1),positive group(CORT 400 μmol·L-1+Ket 0.1 μmol·L-1), combined group(CORT 400 μmol·L-1+Ket 0.01 μmol·L-1+NBP 1 μmol·L-1).Cell viability was detected by a CCK-8 method. The morphological changes of neurons were observed by a fluorescence microscopy.Western blotting was used to evaluate the expression levels of p-ERK/ERK,BDNF and synapsin in injured cells.ICR mice were randomly divided into model control group,NBP group (30 mg·kg-1),Ket group (1 mg·kg-1) and combined group (NBP 30 mg·kg-1+Ket 1 mg·kg-1).Each group was administered separately.After 30 min from dosing,forced swimming test was used to evaluate the behavioral changes of mice. Results Compared with model control group,cell viabilities of model control group and combined group were (52.17±4.56)% and (75.39±4.64)%,synaptic neurons lengths were (64.53±12.14) μm and (89.12±24.53) μm,respectively.The neuronal length was significantly increased (all P<0.01),and the protein expression levels of p-ERK/ERK and BDNF in injured cells were significantly increased (all P<0.05),and the expression trend of synapsin protein was increased,but there was no statistical difference (P>0.05).In the acute depression mouse model experiment,the cumulative immobility times of the model control group and the combined group were (177.6±17.33) s and (119.90±41.45) s,respectively.Compared with the model control group,the cumulative immobility time of the combined group was significantly decreased (P<0.01). Conclusion NBP can enhance the antidepressant effect of low dose Ket,and its mechanism may be related to ERK-BDNF signaling pathway.
Objective To explore the mechanism of the Bushentongluo recipe in the treatment of osteoporosis in ovariectomized rats. Methods Postmenopausal osteoporosis rats were induced by an ovariectomy method.The model rats were randomly divided into model control group,high-dose Bushentongluo recipe group,low-dose Bushentongluo recipe group,and estrogen group,with 8 in each group.At the same time,the sham operation group was served as the control group.The rats were gavaged with corresponding drugs once per day for 12 weeks.After the treatment,samples were collected,and the biochemical blood indicators of propeptide of type I procollagen (PINP) and type I collagen carboxyl-terminal peptide beta special sequence (β-CTX) were detected.Bone mineral density (BMD) of all rats was tested.The protein expression of β-catenin,Wnt3a,and sclerostin and their mRNA in the femur were detected by Western blotting,immunohistochemistry,and RT-PCR. Results After the treatment,compared with the model control group,the bone mineral density increased in both Bushentongluo recipe groups.The levels of PINP in both Bushentongluo recipe groups were increased (P<0.01 or P<0.05) and β-CTX was decreased (P<0.01 or P<0.05).The immunohistochemical expression levels of Wnt3a and β-catenin in both Bushentongluo recipe groups were higher than those in the model control group (P<0.01),and the expression level of sclerostin and mRNA level were lower than that in the model control group (P<0.01). Conclusion The Bushentongluo recipe can inhibit the expression of sclerostin and regulate the increase of Wnt3a expression,thereby activating the Wnt/β-catenin signaling pathway and playing a role in the prevention and treatment of postmenopausal osteoporosis.
The pharmaceutical clinic benefits the physician clinic,which can effectively promote patients' rational drug use.In order to ensure the quality of pharmaceutical clinic service,the pharmaceutical clinic standard formulation team adhered to the principles of scientificity,versatility,guidance,and operability,sorted out essential management contents from three aspects of relevant national policies,relevant domestic and foreign standards and norms and literature analysis,and formulated this standard after several rounds of opinion solicitation and expert argumentation in combination with the actual working conditions.This paper interprets the key contents of the standard,including basic requirements,service process,quality management,and evaluation improvement,to provide guidance and reference for managers and pharmacists to understand the standard deeply and further improve the quality of pharmaceutical clinic work.
Medication consultant is a pharmaceutical service in which pharmacists apply pharmaceutical knowledge and clinical skills to provide medicant treatment and rational drug use to consultants.Standards of medication consultant was formulated based on the relevant national regulations and normative documents, combined with the requirements of hospital evaluation standards, industry experts' opinions, according to the scientific, universal, guiding and operable principles. The standards standardizes the basic requirements of medication consultation, consultation service process, and the whole process of quality management and evaluation improvement, it will be the basis for guiding clinical pharmacists to conduct medication consultations in medical institutions. This article is elaborating the formulation process of the standard of medication consultation and analyzing the key contents of the standard. It is helpful for pharmacists to comply with and implement of the requirements the standards of medication consultant in medication consultant practice.
The pharmaceutical services provided by clinical pharmacists in medical institutions can help to optimize the treatment effect and ensure the safety of patients' medication. Pharmaceutical ward round is one of the important contents of pharmaceutical services. The management standard of pharmacy ward round is made based on the whole process of pharmacy ward rounds, policies and regulations, and the principles of coordination, universality, applicability and consistency, as well as industry expert opinion. The management standard of pharmacy ward round standardizes the four links of essential requirements, preparation process, ward round process, quality management and evaluation improvement, which can become the basis for guiding clinical pharmacists to conduct pharmacy ward round in medical institutions. This article introduces and interprets the team composition, problem sorting and preparation process, and various elements of the standard, so as to provide a reference for the peers who use the standard.
Medication monitoring is one of the core contents for clinical pharmacists, which is closely related to rational use of medications by patients. The medication monitoring standards formulated is based on relevant national policies and regulations, accreditation standards for hospitals, expert opinions, the current situation and development trend of healthcare industry are of scientificity, general applicability, instructive guidance and practicality. They standarize basic requirements, service process, quality management, evaluation and improvement of medication monitoring, and can become the basis for guiding medical institutions to carry out medication monitoring. In order to facilitate understanding and the implementation of the standards, we describe the process of standards formulation and explain the key points of the standards.
The problem of bacterial resistance to antibiotics is becoming more and more serious,and effective antimicrobial management is an important way to prevent further deterioration of antibiotic resistance.With the release and implementation of Guidelines for the Clinical Application of Antibiotics in China (2015 Edition),the rational use of antibiotics has been regulated and guided in China.However,irrational clinical uses of antibiotics still exist in the clinic,such as the perioperative antimicrobial use in type Ⅰ incision operations.Meanwhile,it has been six years since the publication of Chinese Guidelines for the Clinical Application of Antibiotics (2015 Edition).During this period,many updated studies on the management for perioperative antimicrobial use in type Ⅰ incision operations emerged.Based on the principles of Guidelines for the Clinical Application of Antibacterial Drugs (2015 Edition),the evidence is analyzed and updated for the management of antibacterial drugs in the perioperative period of Type Ⅰ incision operations,and corresponding management cases are provided,which will provide a basis and reference for the standardized management of antibacterial drugs in the perioperative period of type Ⅰ incision operations.
Objective To investigate the incidence and risk factors of post-operative infection after liver transplantation in children with biliary atresia(BA). Methods The clinical data of 42 children who received liver transplantation due to biliary atresia and the characteristics of perioperative infection from July to December 2020 were retrospectively analyzed.The nutritional risk score of children 1 week before surgery was evaluated using the screening tool for risk on nutritional status and Growth(STRONGkids).According to the antimicrobial agents used for prevention and the drug sensitivity results of bacterial culture,the characteristics of infection cases were summarized,and the data of all children before and after liver transplantation were analyzed by univariate analysis,and the variables of two groups were included in multivariate Logistic regression analysis to screen the risk factors of infection after liver transplantation in children with biliary atresia. Results Among 42 liver transplantation recipients,10(23.81%) were infected,and 3(23.08%) in the medium-risk nutrition group and 7(24.14%) in the high-risk nutrition group.Univariate analysis showed that there were statistically significant differences between the two groups in age ≤8 years at the time of operation,post-operative rejection,proportion of post-operative combined use of voliconazole and myctrophin against rejection,and probability of post-operative tacrolimus trough concentration exceeding the target concentration(P<0.05).The above variables were included in multivariate Logistic regression analysis,and the results showed that preoperative white blood cell,preoperative neutrophil percentage,and post-operative cholesterol were risk factors for post-operative infection in children with biliary atreia. Conclusion The high rate of infection in the high-risk group of preoperative malnutrition and the tacrolimus drug trough concentration repeatedly exceeding the target concentration are closely related to the infection after liver transplantation in children with biliary atresia.Nutritional intervention should be carried out for such children with preoperative malnutrition,and appropriate drugs should be given to prevent infection.
Objective Through the establishment of a multidisciplinary pharmacist team,graded pharmaceutical care is carried out,and an innovative model of clinical pharmacists implementing pharmacy monitoring is explored to promote pharmaceutical care among clinical pharmacists of different specialties. Methods A total of 175 patients were divided into an observation group (n=82) and a control group (n=93).Patients enrolled from January to September 2020 were included in the control group,in which a single clinical pharmacist performed pharmaceutical care without specifying the level and frequency of the pharmaceutical care.Patients enrolled from October 2020 to May 2021 were included in the observation group,in which a multi-disciplinary pharmacist team implemented graded pharmaceutical care.The therapeutic effect and rational drug use index between two groups were then compared. Results The effective rate of anti-infective treatment in the observation group (94.74%) was higher than that in the control group (86.21%),and the pre-albumin level at discharge [(26.35±7.61) g·L-1] was higher than that in the control group [(20.61±5.27) g·L-1],and the pain control rate (87.80%) was higher than that in the control group (74.19%).The cost of drug treatment in the observation group [(24 019.30±1 440.62) CNY] was lower than that in the control group [(25 764.90±1 299.54) CNY],and the antibiotics use intensity [45.10 DDDs/(100 person·days)] was lower than that in the control group [52.24 DDDs/(100 person·days)]. Conclusion The graded pharmaceutical care implemented by a multi-disciplinary pharmacist team can improve the treatment outcomes and optimize the expenditure structure of treatment costs.The innovative establishment of the graded pharmaceutical care model provides a reference for the standardized pharmaceutical care.
Objective To investigate influence factors of tacrolimus concentration in infants with cholestatic liver disease after liver transplantation and to provide a basis for individualized treatment. Methods According to the inclusion criteria,56 cases of liver transplantation in infants (≤ 12 months) with cholestatic liver disease in the liver transplantation center of Beijing Friendship Hospital were collected from January 2018 to December 2020 and retrospectively analyzed.The dosage and blood concentration of tacrolimus,clinical indicators before voriconazole,and 3,5 and 7 days after voriconazole administration,the dose and blood concentration of tacrolimus,and the dose and blood concentration of voriconazole were collected.Correlation among the blood concentration of tacrolimus,gender,clinical indexes,and combined voriconazole were analyzed. Results Gender and serum albumin concentration were significantly correlated with tacrolimus blood concentration (P<0.01).The dose of tacrolimus was decreased considerably after the combined use with voriconazole (P<0.01),and the standardized plasma concentration was significantly increased (P<0.01) after the combination with voriconazole,but the tacrolimus concentration had no significant change (P>0.05).The reduction of tacrolimus after voriconazole combination varies greatly among individuals,and there was no connection between the reduction of tacrolimus and voriconazole concentration. Conclusion There are significant individual differences in the effect of voriconazole on tacrolimus,and reducing the dose to 1/3 of the original dose in the instruction is not suitable to all infants.After the combination use of voriconazole and tacrolimus,blood concentration monitoring should be performed closely.The dosage should be adjusted in time to make the blood concentration reach the effective therapeutic range.
Objective To observe the effect of tripterygium wilfordii polyglycoside tablets combined with telmisartan on proteinuria and inflammatory indexes in patients with diabetic nephropathyA3. Methods 240 diabetes nephropathyA3' patients were were divided into control group and treatment group with each group were120 cases. On the basis of controlling blood glucose, the control group was given oral telmisartan tablets 80 mg, qd, for 4 months.On the basis of the control group, the treatment group was treated with tripterygium wilfordii polyglycoside tablets 20 mg,tid,changed to 10 mg, qd after oral administration for 3 months, and continued oral administration for 1 month.The curative effects and adverse reactions of the two groups were observated. The 24-hour urinary protein (24hUPE), urinary albumin / creatinine ratio (UACR), high-sensitivity C-reactive protein (hs CRP), serum interleukin-6 (IL-6), glomerular filtration rate (EGFR)and urinary albumin were compared between the two groups before and after treatment α1 microglobulin( α1M), urine β2 microglobulin( β2M). Results The total effective rate of the treatment group at 3 and 4 months of treatment (84.17% and 93.33%, respectively) were higher than that of the control group (62.50% and 61.67%, respectively) (P<0.05). The total effective rate of the treatment group at 4 months of treatment (93.33%) was higher than that of the treatment group at 3 months of treatment (84.17%) (P<0.05). 24hUPE, UACR, urine α1M,urine β2M, IL-6 and hs-CRP decreased after 3 and 4 months of treatment (P<0.05), and the decrease in the treatment group was better than that in the control group (P<0.05).There was no significant difference in the total incidence of adverse reactions between the treatment group and the control group (P>0.05). Conclusion Tripterygium wilfordii polyglycoside combined with telmisartan is more effective than telmisartan alone in patients with diabetic nephropathy A3 of multidisciplinary management, and can reduce proteinuria and inflammatory indicators.
Extracorporeal membrane pulmonary oxygenation (ECMO) is a cardiopulmonary bypass device used for patients with persistent respiratory and cardiac failure to extend time of cardiopulmonary support.Patients receiving ECMO usually are critically ill patients in ICU.Because of the frequent use of broad-spectrum antibiotics,compromised immune systems,and intubation,ECMO recipients are more vulnerable to be attacked by fungal invasion.Many kinds of antifungals are commonly used in clinic,and most are concentration-dependent drugs;the pharmacokinetics of those drugs is easily affected by ECMO.This article discusses the effect of ECMO on pharmacokinetics of antifungal drug,and hopes to provide a reference for the antifungal treatment for ECMO patients with fungal infection.
Diabetic nephropathy has a high incidence rate and severe harm.The clinical manifestations are characterized by persistent albuminuria or progressively decreased glomerular filtration rate (GFR).Finerenone is the third-generation of aldosterone receptor antagonist after spironolactone and eplerenone.On July 9,2021,the U.S.Food and Drug Administration approved the marketing application for finerenone to treat chronic kidney disease with type 2 diabetes.In February 2021,it was accepted by the Drug Evaluation Center of State Drug Administration of China.Clinical trials have shown that finerenone can bring both cardiac and renal benefits to patients with type 2 diabetic nephropathy with reasonable safety.It is expected to become one of the "troika" for the management of diabetic nephropathy along with renin-angiotensin system blockers and sodium-glucose co-transporter 2 inhibitors.
Objective To establish an ultra-performance liquid chromatography method(UPLC) for determination of 11-Oxomogroside Ⅴ,Mogroside Ⅴ,Siamenoside Ⅰ,Mogroside Ⅳ,Mogroside Ⅲ,Mogroside Ⅲe and Mogroside Ⅱe in Siraitiae Fructus. Methods The analysis was performed on a Waters BEH-C18 column (50 mm×2.1 mm,1.7 μm),with the mobile phase of acetonitrile-aqueous solution in gradient mode.The column temperature was 35 ℃.The flow rate was 0.3 mL·min-1.The injection volume was 1 μL.An ultraviolet detector setting at 203 nm was used for quantitative analysis.A mass spectrum detector in the selected ion monitoring model was used for qualitative analysis by monitoring ions of 1307.8,1309.8,1147.8,1147.8,985.7,985.7,and 823.7,respectively. Results 11-Oxomogroside Ⅴ,Mogroside Ⅴ,Siamenoside Ⅰ,Mogroside Ⅳ,Mogroside Ⅲ,Mogroside Ⅲe and Mogroside Ⅱe showed good linear relationships within the ranges of 0.50-20.10,5.03-201.20,0.51-20.24,0.52-20.63,0.51-20.22,0.51-20.56,0.50-19.92 μg·mL-1(r≥0.999),respectively.The average recoveries were 100.7%,98.4%,100.4%,99.0%,100.4%,99.2% and 99.2%,with RSD of 1.9%,1.0%,2.0%,1.9%,1.3%,0.8% and 2.1%,respectively. Qualitative results matched well with quantitative results. Conclusion The UPLC method is simple,accurate,and specific,which can be used to determine 11-Oxomogroside Ⅴ,Mogroside Ⅴ,Siamenoside Ⅰ,Mogroside Ⅳ,Mogroside Ⅲ,Mogroside Ⅲe and Mogroside Ⅱe in Siraitiae Fructus.
Objective To establish a method for rapid screening the adulterants of Atractylodis Rhizoma decoction pieces by fingerprint map and the determination of three active components,and to lay a foundation for the supervision and inspection of Atractylodis Rhizoma crude drug and decoction pieces. Methods The HPLC fingerprints of 58 batches of Atractylodis Rhizoma samples were established,and the contents of β-eudesmol,atractylodin and atractylon were determined simultaneously.The method of screening Atractylodis Rhizoma mixed counterfeits was established by calculating the ratio of fingerprint similarity and content determination.A total of 200 batches of Atractylodis Rhizoma pieces were analyzed by the similarity rate of fingerprints and ratio of content determination. Results A total of 192 batches of samples were identified as authentic Atractylodis Rhizoma pieces by fingerprint similarity (>0.90) and the ratio of Atractylon/Atractylodin (<2).A total of 8 batches of samples were identified as adulterants by fingerprint similarity (<0.90) and the ratio of atractylon/atractylodin (>200). Conclusion This method is sensitive, accurate and can quickly screen out the adulterants of Atractylodis Rhizoma pieces.It will provide a powerful technical support for the quality control of Atractylodis Rhizoma.
Objective To investigate the correlation of tacrolimus blood drug concentration and gene polymorphisms with the occurrence of post-transplantation diabetes mellitus (PTDM) with one year after renal transplantation. Methods The clinical data of 360 patients who received allogeneic renal transplantation and used tacrolimus + mycophenolic acid + glucocorticoid in the first people's hospital of Changzhou city from 2010 to 2020 were retrospectively analyzed.According to PTDM diagnostic criteria,the patients were divided into PTDM and non-PTDM groups.The blood drug concentrations of tacrolimus were collected,and genotypes of CYP3A5*3 (rs776746),POR*28(rs1057868),ABCB1 (rs1045642 and rs1128503),VDR ApaI (rs7975232),VDR BsmI (rs1544410),VDR FokI (rs2228570),and VDR Taq1 (rs731236) were determined by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP).The potential risk factors were initially screened by a single factor and then included in the logistic regression model for a multivariate analysis. Results PTDM occurred in 29 patients (8.05%) within one year after the operation.The tacrolimus blood drug concentrations in the PTDM group were significantly higher than those in the non-PTDM group at 7,14,21,28 days,and 6 months post-operatively (P<0.05),and there were no statistical differences in the C0 of tacrolimus between the two groups at 3 and 12 months postoperatively.Univariate analysis and multivariate analysis showed that age [OR 1.067,95% CI(1.018,1.118),P=0.007],BMI [OR1.192,95%CI(1.023,1.390),P=0.024],and blood concentration of tacrolimus at 28 days after operation [OR 1.470,95%CI(1.261,1.713),P<0.001] were the independent risk factors for PTDM within 1 year after the operation.There were no statistically significant differences in CYP3A5*3 (rs776746),POR*28 (rs1057868),ABCB1 (rs1045642 and rs1128503),VDR ApaI (rs7975232),VDR BsmI (rs1544410),VDR FokI (rs2228570),and VDR Taq1 (rs731236) genotypes between PTDM group and non-PTDM group. Conclusion The occurrence of PTDM after renal transplantation is related to factors such as age,BMI index,and tacrolimus blood concentration at the early stage after a renal transplantation.
Objective To explore the distribution of 5,10-methylenetetrahydrofolate reductase (MTHFR) 677 single nucleotide polymorphism of folate metabolism disorder-related gene locus in Han population in Hubei Province and to evaluate the folate metabolism ability of the Han population in Hubei Province. Methods Polymerase chain reaction (PCR) -chip hybridization technique was used to detect the gene polymorphisms of MTHFR C677T locus in 11830 healthy subjects and the differences in genotype distribution between sexes were counted. Results The genotype frequencies of CC,CT,and TT at MTHFR C677T locus in the Han population in Hubei Province were 36.83%,47.92%,and 15.25%,respectively.The proportion of MTHFR T677T genotype in males was higher than that in females,but the difference was not statistically significant.There was no significant difference in allele frequency of MTHFR C677T locus between males and females.There was no significant difference in genotype frequency between over 45 years old and under 45 years old.There was a significant difference in genotype frequency between women over 45 years old and women under 45 years old (P=0.033).There were substantial differences in homozygous mutation genotype (TT) between Han population in Hubei Province and Han population in Yunnan Province,Zhejiang Province,Guangdong Province,Henan Province,Jilin Province,and Beijing (P<0.05). Conclusion The distribution of MTHFR gene polymorphism in Han population in Hubei Province has evident regional specificity.The folate metabolism levels of different ages and sexes also show certain differences.The influence of MTHFR gene polymorphism should be considered when supplementing folate.
Objective To understand changes in the treatment cost of anti-Parkinson's disease drugs in clinic and to explore differences of the clinical efficacy and cost between monoamine oxidase B inhibitors (MAO-BI) and dopamine receptor agonists (DAs) in delaying the progression of Parkinson's disease. Methods The prescriptions of medicines for Parkinson's disease in outpatients of 30 hospitals in China from 2014 to 2019 were statistically analyzed,and the per capita yearly drug payment amount,per capita yearly drug intake,and average daily treatment cost of anti-Parkinson's disease drugs were summarized.In addition,the typical treatment schemes of two medications for delaying the progression of Parkinson's disease (DAs and MAO-BI) were analyzed for cost-effectiveness. Results A total of 8420 patients with Parkinson's disease were included in this study;prescription analysis results showed that the per capita yearly drug intake and the per capita yearly drug payment amount decreased by 14.0% and 18.2% from 2014 to 2019,respectively.On the other hand,the proportion of prescription payment and the ratio of drug selegiline intake increased by 268.8% and 317.2%,respectively,and the average daily treatment cost was 3.68 CNY/day.The results of the cost-effectiveness analysis showed that compared with the control group,the average time of adding the third class of drugs into the compound levodopa combined with the MAO-BI group was prolonged by 60.57 days,and the average daily treatment cost was reduced by 16.20 CNY per day (P<0.05). Conclusion The per capita treatment cost of anti-Parkinson's disease drugs in patients decreased continuously from 2014 to 2019,and the proportion of prescription payment and drug intake of MAO-BI are increasing.Meanwhile,the average daily treatment cost is decreasing.The addition of MAO-BI to the compound levodopa has apparent advantages over the addition of dopamine receptor agonists in delaying the use of the third anti-Parkinson's disease drug and reducing the average daily treatment cost.
Objective To analyze the risk factors of post-anesthesia induction hypotension (PIH) in patients undergoing general intravenous anesthesia with endotracheal intubation and to provide a theoretical basis for the prevention and treatment of patients at high risk of PIH. Methods The clinical data of 540 patients who underwent non-cardiac selective surgery with general intravenous anesthesia was retrospectively analyzed.Patients were divided into the PIH and the non-PIH groups according to whether PIH occurs.The univariate analyses and multivariate regression analyses were performed separately for patients with ASA physical status classification Ⅰ or Ⅱ and for patients with ASA classification Ⅲ or Ⅳ to screen for the independent risk factors of PIH. Results The overall incidence rate of PIH was 29.8%,and the incidence rates of PIH in patients with ASA classification Ⅲ or Ⅳ (46.9%) was higher than those in ASA classificationⅠ or Ⅱ patients (18.7%).According to the univariate analyses,opioid analgesics (sufentanil and fentanyl) were significantly correlated with PIH in ASA classification Ⅰ or Ⅱ patients (P<0.05),and the factors associated with PIH in ASA classification Ⅲ or Ⅳpatients were midazolam,intravenous anesthetics (etomidate,propofol,etomidate combined with propofol),and opioid analgesics (P<0.05).Binary logistic regression analysis identified two independent risk factors for PIH in ASA classification Ⅲ or Ⅳ patients,including midazolam and sufentanil (other than fentanyl).The model fit well,and the area under the receiver operating characteristic curve was 0.829,and the predictive sensitivity and specificity were 82% and 73.5%,respectively. Conclusion There was a higher occurrence of PIH in patients with ASA classification Ⅲ or Ⅳ,and the application of midazolam and sufentanil during anesthesia induction would further increase the risk of PIH.Therefore,the pre-anesthesia assessment of patients with ASA classification Ⅲ or Ⅳ should be strengthened,and preventive measures should be actively taken and anesthesia induction drugs should be scientifically and reasonably selected,so as to minimize or avoid the occurrence of PIH.
Objective Analyzing the clinical characteristics of vancomycin blood drug concentration in neutropenia patients and exploring possible influencing factors provides a reference for the rational application of vancomycin in neutropenia. Methods This study retrospectively collected the basic information and main clinical indicators of neutropenia patients who received intravenous vancomycin from the First Affiliated Hospital of China Medical University from January 1,2013 to March 31,2021. The correlation analysis of all indicators was conducted using Spearman.Furthermore,Kruskal-Wallis H test was used to compare the differences of various detection indexes among the subtreatment concentration group (vancomycin serum trough concentration <10 mg·L-1),treatment concentration group (vancomycin serum trough concentration 10-20 mg·L-1) and ultra-treatment concentration group (vancomycin serum trough concentration >20 mg·L-1). Results A total of 83 patients were included in this study. The correlation analysis showed a positive correlation between vancomycin serum trough concentration and age,white blood cell count,red blood cell count,hemoglobin concentration,total bilirubin,serum creatinine concentration,and serum urea nitrogen (P<0.05) and a negative correlation between serum vancomycin concentration and granulocyte count,granulocyte ratio,total protein creatinine clearance and glomerular filtration rate (P<0.05).The Kruskal-Wallis H test showed that age and serum creatinine concentrations in the subtherapeutic concentrations group of patients were significantly lower than in the treatment and hypertherapeutic concentration groups,and creatinine clearance and estimated glomerular filtration rates were significantly higher than in the treatment and hypertherapeutic concentration groups. White blood cell count,red blood cell count,hemoglobin concentration,total bilirubin and serum urea nitrogen in the subtherapeutic concentrations were significantly lower than in the supertreated group.Further analysis showed that the serum trough concentration of vancomycin increased significantly with the increase of age and total bilirubin concentration,but decreased significantly with the increase of creatinine clearance. Conclusion The blood concentration of vancomycin is difficult to reach the standard in neutropenia patients,in clinical application of vancomycin antiinfection treatment,more attention should be paid to age,creatinine clearance rate,total bilirubin and drug combination,combined with the treatment drug monitoring (TDM) to adjust the regimen,to improve the vancomycin serum concentration compliance rate in patients with granulocyte deficiency and improve their clinical anti-infection efficiency.
Objective Bibliometric and visual analysis of medication reconciliation literature was conducted to provide a reference for its implementation and study for domestic pharmacists. Methods “Web of Science” (WOS) database with “Medication Reconciliation” was searched.The bibliometrics method was applied to analyze the number of articles published per year,countries,authors,institutions,and journals.CiteSpace software was used to detect citation prominences,and VOSviewer was used to visually cluster keywords to analyze research status and development trend. Results A total of 300 medication reconciliation associated articles were included.The first record began in 2003.The United States published the largest number related articles and had the closest cooperation and communication with other countries,and the number of articles far exceeded that of other countries.Brigham and Women's Hospital was the institution with the most publication volumes,and US scholar Schnipper JL was the author with the most publications and International Journal of Clinical Pharmacy was the journal with the most publications.A total of 10 prominent citations were detected,and 4 related research clusters were found by a keyword cluster analysis.In addition to the elderly patients,patients with cardiovascular diseases,and patients with more concurrent drugs,and recently,cancer patients have also became objects of medication reconciliation and attracted much attention,becoming a new research hotspot. Conclusion The research on medication reconciliation in our country is still in the development stage.We should learn from the advanced experience of other countries,make use of electronic information technology,pay more attention to transition links such as hospital admission and discharge,and provide medication reconciliation to more patient groups.Medication reconciliation and related research needs to be further enhanced in China.
The ethical review should commit throughout the whole process of clinical trials.Even the clinical trials which approved by the ethics committee initial review may still have a variety of problems in the process of implement,the continuing review of the ethics committee will help to reduce the risk of implementation process.The ethical continuing review still has many deficiencies,such as initiative and lack of timeliness,ethical review reportis not standard,the regulations and policies are insufficient,etc.Combination with the construction of information platform for clinical trials,we tried to putforward the solving measures for the ethical continuing review,which expect to make ethical continuing review work truly timely,effective and high quality,in order to improve the quality of clinical trials,and to protect the safety and rights of the subjects.
Objective To optimize the information management process of outpatient narcotic drugs and the first category psychotropic drugs (anesthesia drugs) in hospitals,and to reduce the time and cost of patients' visits,and to improve the efficiency of medical staff,so as to provide a reference for managing outpatient anesthesia drugs in domestic hospitals. Methods Based on the process reengineering theory,ASME was used to analyze the outpatient anesthetic and psychotropic medicine acquisition process,and the process of using anesthetic drugs for outpatients was modified by ECRSI. Results The process of obtaining outpatient anesthetic drugs in the sample hospital has been optimized,and the archiving of paper medical records of outpatient anesthetic drugs has been cancelled,and an electronic medical record system has been established.The intelligent management system for rational clinical use of drugs has been jointly developed,and the prescription of anesthetic drugs has achieved 100% priority review.Anesthesia and psychotropic medicine medication knowledge database were established,and individualized patient medication education was carried out.Patients have more than three ways to learn about precautions for the use of narcotic drugs. Conclusion Through process reengineering,the sample hospital has established an outpatient information-based anesthesia prescription management system to ensure patients' safe and timely medication,and it provides a reference for the management of anesthetic drugs and psychotropic drugs in hospitals under the same category.
Objective To probe into processing biological samples after testing in drug clinical trial protocols and informed consent form (ICF),and to standardize the description of biological samples processing,in order to ensure the standardization of drug clinical trials and protect the rights and interests of subjects. Methods The drug clinical trial projects approved by a hospital drug clinical trial institution from June 2017 to April 2021 were collected.The sponsors,specialty,trial stages,trial plans,processing expression and description position of biological samples involved in clinical trial protocols and ICF after testing were collated and summarized. Results A total of 64 clinical trial projects were collected,of which foreign-funded (including joint ventures) projects accounted for 59.4%.Domestic and foreign-funded enterprises had no significant difference in the description of preservation and destruction of biological samples after testing (P>0.05),and more than 50% of the biological samples were not mentioned for preservation and destruction.In the study protocols and ICF,98.4% and 95.3% of biological samples processing were not mentioned in local hospital laboratory after testing,respectively.In comparison,73.7% and 56.2% of the biological samples processing were described in the item of "management of biological samples" in the study protocol and ICF,respectively. Conclusion There are limitations in the description of the part for post-testing biological samples in the clinical trial protocols and ICF.A column should be set up to clearly state the final processing methods,such as preserving and destroying the remaining biological samples after testing.The drug clinical trial institutions,ethics committees,and other regulatory authorities of hospitals should strengthen the risk control of the description of biological samples processing and strictly review them.
Objective To investigate the cognitive status and pharmaceutical demand of the national centralized drug procurement policy (abbreviated as the “centralized procurement policy”) for physicians and patients at two Grade-A tertiary hospitals in different regions,and to provide a reference for decision-maker to improve the level of pharmaceutical services. Methods The questionnaire survey method was used to investigate the cognitive status of the centralized procurement policy and pharmaceutical demand of physicians and patients at two Grade-A tertiary hospitals in Suzhou and Hulunbuir.The research contents included basic information about physicians and patients,the policy awareness,the evaluation of the policy,the influence of the policy on drug use behavior,and the pharmaceutical demand. Results ①Physicians and patients interviewed in Suzhou completed 543 and 1260 valid questionnaires,respectively,while 209 physicians and 1183 patients completed valid questionnaires in Hulunbuir;②The awareness rates on the policy of physicians and patients at two Grade-A tertiary hospitals were 79.39% and 61.60%, respectively,of which the awareness rates of physicians (82.87%) and patients (66.19%) in Suzhou were significantly higher than those in Hulunbuir physicians (70.33%) and patients (56.72%) (P<0.05);③67.00% of physicians and 59.60% of patients were satisfied with the treatment effect of national centralized purchasing drugs (abbreviated as “NCPDs”),and 62.65% of physicians were satisfied with the safety of NCPDs.77.55% of physicians and 79.14% of patients thought that NCPDs were well equipped,and 72.53% of physicians and 71.96% of patients felt that NCPDs was reasonable and patients benefited greatly.67.84% of physicians and 81.59% of patients advocated the priority to use NCPDs;④80.90 % of physicians prioritized to choose NCPDs when prescribing for patients,and 69.24% of patients would actively choose NCPDs in the same kind of drugs;⑤the pharmaceutical demand of physicians at two Grade-A tertiary hospitals in both regions mainly included providing policy training (80.23%),formulating the Centralized Drug Prescription Collection or Quick Examination Manual (82.58%),making the information prompt at the doctor's workstation (76.05%),feedbacking the prescription comments (64.15%),and so on;the pharmaceutical demand of the patients include science education (85.78%) and medication guidance (71.43%). Conclusion Physicians are highly aware of the centralized procurement policy in two regions,while patients have a relatively low awareness of the policy;physicians and patients have a variety of ways to know the policy;among physicians and patients who know the policy,most physicians and patients have positive feedbacks on the evaluation of the policy,and drug use behavior is more affected by the policy;both physicians and patients have high pharmaceutical demands from pharmacists.