| Background: Carbapenem antibacterial drugs are widely used in the treatment of patients with severe infections and are known as the last line of defense for Gram-negative bacterial infections,and with the rise in their clinical use,the resistance rate has also gradually increased,and the resistance of some bacteria to carbapenem antibacterial drugs has shown an outbreak trend.In order to strengthen the management of clinical application of antibacterial drugs and curb bacterial resistance,the National Health and Family Planning Commission issued the Notice on Further Strengthening the Management of Clinical Application of Antibacterial Drugs to Curb Bacterial Resistance on February 27,2017,which implemented special file management of carbapenem antibacterial drugs in various medical institutions and required strengthening the internal construction of special file management.Since the implementation of the special file management,the trend of drug resistance has been effectively curbed in most provinces,but the detection rate of drug-resistant bacteria still remains high in Henan Province.In order to clarify the reasons for the high detection rate of drug-resistant bacteria,it is of great practical significance to investigate the real clinical use of carbapenems in a medical institution in the region under the guidance of the national policy of implementing special file management.Objective: Under the guidance of the national implementation of special file management policies,the clinical use of carbapenems antibacterial drugs is improved,and the clinical application management strategy of carbapenems antibacterial drugs is improved,so as to provide evidence-based evidence and professional health technology assessment support for the rational use of such drugs.According to the "Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs(2021Trial)" on the workflow of comprehensive clinical evaluation of drugs.The comprehensive clinical evaluation of drugs needs to carry out scientific and standardized research from six dimensions: safety,effectiveness,economy,innovation,suitability and accessibility.To investigate the clinical use of carbapenems in a tertiary care hospital in Henan Province under the guidance of the national policy of special file management.Through investigating the rationality,economy,effectiveness of pharmacological management control measures and risk factors leading to drug-resistant bacterial infections in the clinical application of carbapenems in a tertiary care hospital in Henan Province,we investigated the implementation of the national policy of special file management in the hospital,provided reference for the rational,economic and scientific use of carbapenems in the clinical setting,and provided data support for the national management status of these drugs to formulate corresponding control measures.It also provides data support for the formulation of corresponding control measures for the current state of management of these drugs.Methods: The medical records of patients using carbapenem antibacterial drugs in a tertiary care hospital in Henan Province were used as the research object,and the clinical data of patients using carbapenem antibacterial drugs from January 1,2018 to December 31,2021 were collected,and the patient database was established with Excel,and literature research method,statistical analysis method,quantitative research method,and comparative analysis method were used to analyze the clinical We used literature research,statistical analysis,quantitative research and comparative analysis to analyze the rationality and economy of clinical application of carbapenems,the effectiveness of pharmacological management control measures and the risk factors leading to drug-resistant bacterial infections.1.Evaluation of the rationality of the clinical application of carbapenem antibacterial drugs:Establish the Evaluation Criteria and Scoring Rules for the Clinical Application of Carbapenem Antibacterial Drugs,and evaluate the rationality of drug indications,the rationality of drug process,the rationality of drug efficacy and management indexes.The SPSS 27.0 software was used to analyze and compare the differences in the rationality of drug use among departments and among the three carbapenem antibacterial drugs.2.Economic analysis of carbapenem antibacterial drugs: medical records meeting the inclusion criteria were screened,and the dosing information of patients with different dosing regimens was compiled in groups,and SPSS 27.0 software was used to analyze whether there were significant differences in the duration of dosing and clinical efficacy of each dosing regimen group.Cost-effectiveness analysis(CEA)was applied to calculate the cost-effectiveness ratio of each regimen group,and then analyze the differences in the economics of drug administration among the regimen groups.3.Evaluation of the effectiveness of pharmacological management control measures: Through the preliminary research,we understood the drug use situation in each department,trained the departments with prominent irrational drug use,set improvement goals by department and included the rational drug use in the performance assessment,conducted multidisciplinary treatment for difficult cases,and strengthened the comprehensive management of multiple departments,and after implementing the above control measures,we used SPSS 27.0 software to analyze and compare before and after pharmacological management After the implementation of the above control measures,SPSS 27.0 software was used to analyze whether there were significant differences in the rationality of application of carbapenems,medication effect and detection of drug-resistant bacteria,and then analyze the effectiveness of control measures.4.Risk factor analysis for carbapenem-resistant bacterial infections: medical records with positive bacterial detections in the patient database were screened and divided into carbapenem-sensitive and carbapenem-resistant groups based on their drug sensitivity test results.The risk factors that may lead to drug-resistant bacterial infections were assigned and coded,including age(years),gender,comorbid chronic diseases,long-term bed rest or history of admission in the last 2 months,days of hospitalization,combination of antibacterial drugs,glucocorticoids,surgery,ICU admission,mechanical ventilation and indwelling catheter,etc.The risk factors were analyzed by chi-square test and binary logistic regression analysis,and correlations were drawn Conclusion.Results:1.Analysis of the reasonable rate of drug use: the reasonable rate of "drug indications" in the hospital was 94.64%,among which the indications for serious infections caused by sensitive multi-drug-resistant Gram-negative bacilli(G-)were 54.62%,"severe infections with mixed bacteria The rate of compliance with the indications for " severe infection with mixed bacteria " was 38.37%,and there was no " moderate to severe infection in immunodeficient patients of unknown etiology "," Carbapenem-Resistant The compliance rate of "Carbapenem-Resistant Enterobacteriaceae(CRE)bacterial infection" was 1.57%;the reasonable rate of "medication process" was 74.92%,of which the compliance rate of "drug species selection" was 98.18%.The compliance rate of "drug selection" was98.18%,"dosage and combination" was 79.21%,"route of administration" was 99.67%,and "drug interaction" was 96%."The compliance rate of " management indicators " was 27.31%,of which the compliance rate of " prescribing authority " was 45.96%,and the compliance rate of " consultation The compliance rate of "prescription authority" indication was 45.96%,"consultation" indication was 64.44%,"laboratory test" indication was 82.43%,"medication result" treatment efficiency was 79.70%,and no adverse reaction was reported.The reasonable rate of each rational drug use index in the hospital is increasing year by year,among which the reasonable rate of "management index" is increasing more,but the overall reasonable rate is low.There is no significant difference in the rational rate of three kinds of carbapenems,and the rational rate of different departments is different.2.Economic analysis of carbapenems: Using cost-effectiveness analysis,the Cost-Effectiveness Ratio(CER)was calculated for each group,with the smallest C/E value of imipenem cistatin sodium injection 1g Q12 h in group 1,and the control group with the lowest efficiency,and the smallest ΔC/ΔE value of meropenem for injection 0.5g Q8 h in group 7.value was the smallest.The results of sensitivity analysis were the same,the model stability was good and the results were credible.3.Evaluation of the effectiveness of pharmacy management control measures: comparison of rational drug use indicators in each year from 2018 to 2021: P < 0.05 for indications,dosage and dispensing,prescribing authority,consultation,and efficacy assessment,with significant differences;comparison of rational drug use indicators in each year from 2018 to 2020 before pharmacy management:P < 0.05 for prescribing authority and consultation,with significant differences;pharmacy Comparison of the rationality of medication indicators before and after pharmacy management in 2018-2020 and 2021: P <0.05 for indications,dosage and dispensing,prescribing authority,consultation,and efficacy assessment,with significant differences;no significant differences in the data of drug-resistant bacteria detection in each year.In conclusion,pharmacological management can significantly improve the rational rate of indications and drug usage and dosage,and improve the clinical efficacy of such drugs,and pharmacological management did not significantly improve the detection rate of drug-resistant bacteria.4.Analysis of risk factors for carbapenem-resistant bacterial infections: days of hospitalization(P=0.008,OR=1.009),comorbid chronic diseases(P=0.002,OR=2.322),history of prolonged bed rest or admission in the last 2 months(P=0.005,OR=2.079),combination of antimicrobial drugs(P<0.001,OR=3.903),combination of glucose corticosteroids(P=0.001,OR=2.171),surgery(P=0.038,OR=1.752),ICU admission(P<0.001,OR=2.425),and mechanical ventilation(P=0.006,OR=1.968)as risk factors for carbapenem-resistant bacterial infections,in order of the magnitude of the OR of the risk factors for infection,causing drug-resistant The influence of the risk factors in order of influence was: combined application of antimicrobial drugs > admission to ICU > combined chronic diseases > combined glucocorticoids > long-term bed rest or history of admission in the last 2 months > mechanical ventilation >surgery > days of hospitalization.Conclusions:1.The overall rational rate of carbapenem antimicrobial drug use in the hospital is low,and the main factors affecting the rational rate are unreasonable management indicators(prescribing authority and consultation).The application process of this class of drugs should be standardized,the prescribing authority of special use class antimicrobial drugs should be strictly limited,and the management of the clinical application of carbapenem antimicrobial drugs should be strengthened.2.There is no significant difference in the reasonable rate of indications and therapeutic efficiency of the three carbapenems.Using pharmacoeconomic methods,we can screen out the more cost-effective drug treatment regimens,and at the same time combine pharmacokinetic theory to select the most economical,safe and effective treatment regimen.3.The implementation of pharmacological management control measures in hospitals can improve the rational rate of clinical application and therapeutic efficiency of carbapenem antimicrobial drugs,but it has no significant effect on the detection rate of drug-resistant bacteria,Therefore,we should continue to strengthen the cooperation with the departments concerned,such as the hospital-acquired,laboratory and other departments,to jointly develop preventive and control measures for multi-drug-resistant bacteria,to stop the spread of drug-resistant bacteria in medical institutions,to reduce the incidence of hospital-acquired drug-resistant bacteria,and to reduce the detection rate of drug-resistant bacteria in medical institutions. |
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