Objective Urine alkalinization prevents nephrotoxicity in patients receiving high-dose
methotrexate (HDMTX). While the standard approach involves IV sodium bicarbonate,
alternative oral bicarbonate regimens are crucial in drug shortages and outpatient
settings. This study aims to review the efficacy and safety of such regimens.Methods
PubMed, WOS, and Scopus were systematically searched using the PRISMA protocol for
relevant studies involving human subjects, including randomized clinical trials, retrospective,
prospective, cohort, case reports, and case series studies. There were no restrictions
on language, time, or age group. Qualified and eligible papers were used to extract
data on efficacy and safety indicators, and the final relevant records were assessed
for quality using the Risk of Bias in Non-Randomized Studies-of Interventions (ROBINS-I)
assessment tool.Results12 studies with 1212 participants were included in the systematic
review, with pooled data from 8 studies used for meta-analysis. No significant differences
in mean differences (MDs) or odds ratio (OR) were found after the oral bicarbonate
regimen, except for when urine pH fell to < 7 (MD: 0.91, 95% CI: 0.32, 1.5, P < 0.05)
and the incidence of diarrhea (OR: 2.92, 95% CI: 1.69, 5.05, P < 0.05).Conclusion
An oral bicarbonate regimen is a safe and effective way to alkalize HDMTX urine, providing
a viable and cost-effective alternative to IV protocols. Further prospective multicenter
studies are necessary.Systematic review registration identifier: CRD42023379666.Conclusion
An oral bicarbonate regimen is a safe and effective way to alkalize HDMTX urine, providing
a viable and cost-effective alternative to IV protocols. Further prospective multicenter
studies are necessary.