Abstract
Background and ObjectiveThe necessity of therapeutic drug monitoring (TDM) for vancomycin is controversial. The objective of the current review was to evaluate the available evidence for the necessity of TDM in patients given vancomycin to treat Gram-positive infections.MethodsMedline, Embase, Web of Sciences, the Cochrane Library and two Chinese literature databases (CNKI, CBM) were searched. Randomized controlled studies and observational studies that compared the clinical outcomes of TDM groups vs. non-TDM groups were included. Two reviewers independently extracted the data. The primary outcome was clinical efficacy of therapy. Secondary outcomes included vancomycin associated nephrotoxicity, duration of vancomycin therapy, length of hospital stay, and mortality. Meta-analysis was performed using the Mantel-Haenszel fixed effect method (FEM). Odds ratios (ORs) or weighted mean differences (WMD) with 95% confidence intervals (95%CIs) were calculated for categorical and continuous outcomes, respectively.ResultsOne randomized controlled trial (RCT) and five cohort studies were included in the meta-analysis. Compared with non-TDM groups, TDM groups had significantly higher rates of clinical efficacy (OR = 2.62, 95%CI 1.34–5.11 P = 0.005) and decreased rates of nephrotoxicity (OR = 0.25, 95%CI 0.13–0.48 P<0.0001). Subgroup analyses showed that TDM group had significantly higher rates of clinical efficacy in both cohort studies subgroup (OR = 3.04, 95%CI 1.34–6.90) and in Asian population subgroup (OR = 3.04, 95%CI 1.34–6.90). TDM group had significantly decreased rates of nephrotoxicity in all subgroup. There was no significant difference in duration of vancomycin therapy (WMD = −0.40, 95%CI −2.83–2.02 P = 0.74) or length of stay (WMD = −1.01, 95%CI −7.51-5.49 P = 0.76) between TDM and non-TDM groups. Subgroup analyses showed there were no differences in duration of vancomycin therapy. Only one study reported mortality rates.ConclusionsStudies to date show that TDM significantly increases the rate of clinical efficacy and decreases the rate of nephrotoxicity in patients treated with vancomycin.
Highlights
Vancomycin has been long considered the gold standard therapy for methicillin-resistant Staphylococcus aureus (MRSA) [1]
The search terms were the combination of text free terms and Medical Subject Headings (MeSH) terms as follow:(‘‘vancomycin’’MeSH) and (‘‘therapeutic drug monitoring’’ Odds ratios (ORs) ‘‘TDM’’ OR ‘‘drug monitoring’’ OR ‘‘therapeutic monitoring’’ OR ‘‘serum concentration monitoring’’ OR ‘‘therapeutic drug’’ OR ‘‘drug monitoring’’MeSH)
37 of the studies did not compare the clinical outcomes between the TDM group and the non-TDM group, 29 studies focused only on the pharmacokinetics or pharmacodynamics of vancomycin (n = 29), 4 studies were cost effectiveness studies, and the fulltext could not be obtained from 1 study even after contacting the corresponding author
Summary
Vancomycin has been long considered the gold standard therapy for methicillin-resistant Staphylococcus aureus (MRSA) [1]. The practice of routine monitoring serum vancomycin concentrations has been the subject of intense debate for many years [4,5,6,7,8,9]. This controversy has led many hospitals to not monitor vancomycin serum concentrations, especially in developing countries. The consensus review from the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists, as well as the consensus review from the Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring all recommended monitoring serum concentrations of vancomycin to minimize nephrotoxicity and maximize efficacy [10,11]. The objective of the current review was to evaluate the available evidence for the necessity of TDM in patients given vancomycin to treat Gram-positive infections
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