Plasma Concentration,efficacy,safety And Economic Evaluation Of Domestic And Imported Vancomycin For The Treatment Of Infection With Resistant Gram-positive Cocci

Objective:To compare the plasma concentration,clinical efficacy,safety and economics of imported vancomycin（Vancoci）and domestic vancomycin（Laikexin）for the treatment of infection caused by resistant gram-positive cocci and evaluate the differences,pros and cons between them.Then providing support data for the choice of rational medication in clinic.Methods:97 patients with resistant gram-positive cocci were selected from January 2018 to February 2019 as study subjects.According to the patient’s clinical symptoms,pathogenic examination and laboratory test results,the patients were randomly treated with Vancocin（n=50）or Laikexin（n=47）after diagnosis was confirmed.A combination of other antibiotics was decided by the doctor according to the patient’s clinical symptoms.Following multiple dosing mean steady state,author determined the trough concentration of blood sample which was collected within 30 minutes before administration.The course of treatment was drug withdrawal and study endpoint was 7 days after drug withdrawal.The clinical symptoms,laboratory tests and microbiological tests was evaluated and compared in both group.The plasma concentration,efficacy,safety and economical efficiency of the both group ware observed.Results:PartⅠTo compare the efficiency of treatment with Vancocin and Laikexin.（1）The response rates of Vancocin group and Laikexin group were 80.0% and 78.7%respectively after 7 days of medication administration.（2）The clinical effective rate,bacterial clearance rate,clearing time and comprehensive therapeutic effect rate of the Vancocin group were equal to the Laikexin group.The Vancocin group got the clinical effective rate 97.6%,and the Laikexin group 86.9%.The bacterial clearance rate and clearing time in both group were 84.0%,87.2%and 8.77±6.67 days,10.40±7.69 days,respectively.Comprehensive therapeutic effect rate was 84.0%vs 83.0%.There were no significant difference between the two groups（P>0.05）.PartⅡThe comparison result of plasma concentration of Vancocin group and Laikexin group（1）The means of plasma concentration was 15.62±7.72 mg·L^-1,15.28±8.28 mg·L^-1,the standard-reaching rate was 66.0%,63.8%（p>0.05）in two groups.Plasma concentration maybe not suitable as an efficacy prediction of vancomycin for child patients.（2）The standard-reaching rate of plasma concentration of children（25.0%³3.3%）was significantly lower than other age groups（83.3%¹00.0%）（p>0.05）in two groups.PartⅢThe result showed that incidence of adverse reactions of the two groups were 6.0%and 6.23%（p>0.05）,respectively.The main manifestations were nephrotoxicity,hematological toxicity and drug fever.Nephrotoxicity may be correlatived with high plasma concentration.PartⅣThe average cost of vancomycin﹙8714.24±5413.73﹚vs﹙3716.58±2247.53﹚yuan of two groups was significantly different（p<0.001）,but the average costs of antibacterial agents﹙10983.52±9146.83﹚vs﹙10480.80±11137.17﹚yuan was no statistical difference（p>0.05）.The cost-effectiveness ratio of Laikexin economics was higher than Vancocin when they are as a Single Agent（81.93 VS 44.62）.However,when the combination is treated,the two antibiotics were economically equivalent（130.75 VS 126.27）.Conclusions:Vancocin and Laikexin can rapid eliminate the bacterial for patients with drug-resistant Gram-positive coccus infection.The standard-reaching rate of plasma concentration,response rate,effective and adverse reaction of Vancocin are equal to that of Laikexin.It should not be maked a difference because of efficacy.Laikexin economics is higher than Vancocin when they are as a Single Agent,However,when the combination is treated,the two antibiotics are economically equivalent.