| Objective Through real-world research on the clinical application of voriconazole,we explore the effects of medication behavior and related factors on the efficacy,safety,and economy of the drug,with a view to providing a basis for rational clinical medication.Method 1.Cross-sectional study of medication behavior To establish a cross-sectional study on the prevention / treatment of invasive fungal infections with voriconazole in patients with hematological malignancies.According to the inclusion and exclusion criteria,the hospital electronic medical record system was used to collect medical record information of patients who were treated with voriconazole from May 1,2018 to July 31,2018.Describe the baseline data,disease status,treatment measures,clinical medication behavior,prognostic efficacy,the safety,and analyze the correlation between the specific cost and the total cost of hospitalization,use Epidate software for case data entry,and use SPSS22.0 software for statistical analysis,apply voriconazole to prevent / treat invasive fungi in patients with hematological malignancies.Descriptive analysis of infection medication behavior and possible clinical medication problems.2.Clinical efficacy and safety observation and research To establish an observational study on the prevention / treatment of invasive fungal infections with voriconazole in patients with hematological malignancies.According to the inclusion and exclusion criteria,the hospital electronic medical record system was used to collect medical record information of patients using voriconazole from August 1,2018 to December 31,2018,and analyze the clinical efficacy and safety of voriconazole under different treatment measures.Use Epidate software for case data entry,and use SPSS22.0 software for statistical analysis,and analyze the clinical efficacy and safety of voriconazole for the prevention / treatment of invasive fungal infections in patients with hematological malignancies.3.Prospective cohort study To establish a prospective cohort study on the prevention and treatment of invasive fungal infections with voriconazole in patients with hematological malignancies.According to the inclusion and exclusion criteria,the hospital electronic medical record system was used to collect the medical record information of patients using voriconazole injection from January 1,2019 to August 31,2019,according to the number of original drugs and generic drugs,combined antibacterial drugs,loading dose,and Three prospective cohort studies were established for analysis.Evaluate the clinical efficacy,safety and economy of patients.Use Epidate software for case data entry,and use SPSS22.0 software for statistical analysis,and analyze the clinical efficacy and safety of voriconazole injection for the prevention / treatment of invasive fungal infections in patients with hematological malignancies.4.Therapeutic Drug Monitoring To establish a surveillance study on the prevention and treatment of invasive fungal infections with voriconazole in patients with hematological malignancies.According to the inclusion and exclusion criteria,the hospital electronic medical record system was used to collect medical record information of patients receiving voriconazole injection from September 1,2019 to December 31,2019.The impact of the patient’s baseline data,medication status,and voriconazole injection blood concentration on its clinical efficacy and safety was analyzed.Use Epidate software for case data entry,and use SPSS22.0 software for statistical analysis,and analyze the blood concentration monitoring of voriconazole injection for the prevention / treatment of invasive fungal infections in patients with hematological malignancies.Results 1.Cross-sectional study of medication behavior There were 186 cases that met the inclusion exclusion criteria,including 93 male and female patients;aged 22-85 years old,with an average age of 60.42 ± 13.54 years old;a total of 98 patients were tested for fungi,the fungal submission rate was 52.69%,and the positive rate was 9.18 %;Out of 186 patients,a total of 104 patients used only voriconazole oral dosage,20 patients used only voriconazole injection dosage,62 patients mixed voriconazole injection dosage with oral dosage;134 patients took oral dosage for the first time.There were 52 cases of the first administration as an injection;a total of 166 patients had unreasonable medication,with an unreasonable rate of 89.24%.The main unreasonable medication behavior was the failure to give a loading dose;there were 142 cases of combined antibacterial drugs;drug costs are the main source of hospitalization costs and have a strong correlation.2.Clinical efficacy and safety observation and research There were 213 cases that met the inclusion and exclusion criteria.There was a significant difference in effective comparison between different medication purposes(P <0.05).After a pairwise comparison,it was found that there was a significant difference between preventive medicine and diagnosis-driven medication(P <0.05),bad There was no significant difference in the incidence of reaction(P> 0.05);in the diagnosis-driven medication,compared with the oral dosage of voriconazole,the first administration was voriconazole injection with higher clinical effectiveness,with a significant difference(P <0.05);Compared with voriconazole injection combined with 1-2 antibacterial drugs,3 or more antibacterial drugs have a higher incidence of adverse reactions,with a significant difference(P <0.05).In the application of oral dosage,the combination There was no significant difference between using 3 or more antibacterial drugs and 1-2 antibacterial drugs(P> 0.05).3.cohort study 3.1 The efficacy,safety and economic evaluation of the original research and imitation of voriconazole for the prevention / treatment of invasive fungal infection of hematological malignancies 266 cases met the inclusion and exclusion criteria,and 194 cases were included after matching by propensity score matching method.After a comparative analysis: the effective rate [97.94% vs 88.66%] of the two groups of patients was significantly different(P <0.05).There was no significant difference in the total incidence of adverse reactions [39.18% vs 42.27%] between the two groups(P> 0.05),including the incidence of abnormal liver function [38.14% vs 41.24%],and the incidence of visual impairment [0.00% vs 1.03%] There was no significant difference in the incidence of skin damage [1.03% vs 0.00%](P> 0.05).There was no significant difference in mortality between the two groups [2.06% vs 3.09%](P> 0.05).Economic evaluation shows that for each additional unit of clinical effectiveness,the hospitalization cost of the original drug patient increases by 5100.99 yuan,the drug cost increases by 2406.15 yuan,and the voriconazole cost increases by 1520.71 yuan.3.2 The efficacy,safety and economic evaluation of the amount of voriconazole injection combined with antibacterial drugs for the prevention / treatment of invasive fungal infections of hematological malignancies 354 cases met the inclusion and exclusion criteria,and 196 cases were included after matching by propensity score matching method.After a comparative analysis,there was no significant difference in the effective rate [81.44% vs 85.71%] between the two groups(P> 0.05).There was no significant difference in the total incidence of adverse reactions [39.80% vs 43.88%] between the two groups(P> 0.05),and there was no significant difference in the incidence of abnormal liver function [37.11% vs 43.88%](P> 0.05),skin The incidence of damage [4.08% vs 0.00%] was significantly different(P <0.05).The mortality rate of the two groups of patients [7.14% vs 1.02%] was significantly different(P <0.05).Economic evaluation shows that for every additional unit of clinical effectiveness,the cost of hospitalization for patients with 3 or more antibacterial drugs increases by 5,834.69 yuan,the cost of drugs increases by 3,758.32 yuan,and the cost of voriconazole increases by 522.10 yuan.3.3 The efficacy,safety and economic evaluation of the loading dose of voriconazole injection for the prevention / treatment of invasive fungal infection of hematological malignancies 371 cases met the inclusion and exclusion criteria,and 170 cases were included after matching by the propensity score matching method.After a comparative analysis,the effective rate [83.53% vs 90.59%] of the two groups of patients was not significantly different(P> 0.05).There was no significant difference in the total incidence of adverse reactions [44.71% vs 34.12%] between the two groups(P> 0.05),among which the incidence of abnormal liver function [42.35% vs 34.12%] and the incidence of visual impairment [2.35% vs 1.18%] There was no significant difference in the incidence of skin damage [1.18% vs 0.00%](P> 0.05).There was no significant difference in mortality between the two groups [2.35% vs 7.06%](P> 0.05).Economic evaluation shows that for every additional unit of clinical effectiveness,the hospitalization cost of patients who received a load dose increased by 2,358.42 yuan,the drug cost increased by 1,119.82 yuan,and the voriconazole cost increased by 305.54 yuan.4.Therapeutic Drug Monitoring Forty-one cases meeting the inclusion and exclusion criteria,the plasma concentration distribution of voriconazole injection ranged from 0.31 to 7.07 μg / ml,and the individualization difference was large.The blood drug concentration distribution range is: <0.5μ g / ml for 3 people,0.5 ~ 5μ g / ml for 35 people,> 5μg / ml for 3 people,and the blood drug concentration compliance rate is 85.36%.In terms of clinical efficacy,there is no significant difference between the standard group and the non-standard group(P> 0.05);in terms of safety,there is no significant difference in the incidence of total adverse reactions between the two groups(P> 0.05),of which,compared with the standard group The incidence of visual impairment in the non-compliance group was higher,with a significant difference(P <0.05).Conclusion 1.In the real-world treatment of voriconazole for the prevention / treatment of invasive fungal infections in patients with hematological malignancies,the medication situation is relatively complex,and there are medication behaviors in the selection of dosage form,dosage,combination of antibacterial drugs,route of administration,etc.in the treatment plan The difference is that the cost of drugs is the main source of hospitalization costs and has a strong correlation.2.Under different medication purposes,the clinical efficacy of voriconazole may be different.In the diagnosis-driven treatment,when the first administration is voriconazole injection,the clinical effect is better.The combination of voriconazole injection with 3 or more antibacterial drugs will increase its adverse reactions.Incidence rate.3.The clinical efficacy,safety and economy of voriconazole injection under different treatments 3.1 In terms of efficacy: the original voriconazole injection is superior to generic drugs;in terms of safety: there is no significant difference between the two;in terms of economics: the cost of hospitalization in the generic drug group is lower.3.2 In terms of efficacy: there is no significant difference between voriconazole injection combined with 3 or more antibacterial drugs and 1-2 antibacterial drugs;in terms of safety: the combination of 3 or more antibacterial drugs will increase the patient’s adverse effects Incidence rate;in economics: the cost of hospitalization in the combination of 1-2 antibacterial drugs is lower.3.3 In terms of efficacy and safety: there is no significant difference in the loading dose of voriconazole injection or not;in economics: the hospitalization cost of the group without loading dose is lower.4.The personalized blood concentration of voriconazole injection varies greatly.Patients should be monitored for changes in blood concentration. |
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