目的:尿液碱化可预防接受大剂量甲氨蝶呤(HDMTX)的患者的肾毒性。虽然标准方法涉及静脉注射碳酸氢钠,替代口服碳酸氢盐方案在药物短缺和门诊治疗中至关重要.本研究旨在回顾这些方案的疗效和安全性。
方法:PubMed,WOS,使用PRISMA方案系统地搜索Scopus,以进行涉及人类受试者的相关研究,包括随机临床试验,回顾性,prospective,队列,病例报告,和案例系列研究。语言没有限制,时间,或年龄组。使用合格和合格的论文来提取疗效和安全性指标的数据,使用非随机干预研究中的偏倚风险(ROBINS-I)评估工具对最终相关记录进行质量评估.
结果:系统评价中纳入了12项研究,包括1212名参与者,来自8项研究的汇总数据用于荟萃分析。口服碳酸氢盐方案后,平均差异(MD)或比值比(OR)没有发现显着差异,除尿液pH值降至<7(MD:0.91,95%CI:0.32,1.5,P<0.05)和腹泻发生率(OR:2.92,95%CI:1.69,5.05,P<0.05)外。
结论:口服碳酸氢盐方案是碱化HDMTX尿液的安全有效方法,为IV方案提供可行且具有成本效益的替代方案。进一步的前瞻性多中心研究是必要的。系统审查注册标识符:CRD42023379666。
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.
RESULTS: 12 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).
CONCLUSIONS: 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.