Oral regimen for high dose methotrexate urine alkalinization: a systematic review and meta-analysis,DARU Journal of Pharmaceutical Sciences

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Oral regimen for high dose methotrexate urine alkalinization: a systematic review and meta-analysis
DARU Journal of Pharmaceutical Sciences ( IF 2.5 ) Pub Date : 2024-01-17 , DOI: 10.1007/s40199-023-00499-3
Romina Kaveh-Ahangaran ₁ , Mohammad Abdollahi _{2,

3} , Mohammad Vaezi ₁ , Amir Kasaeian _{1,

4,

5} , Zhalleh Bahlouli ₆ , Ghasem Janbabaei ₇ , Amirmahdi Mojtahedzadeh ₈ , Mojtaba Mojtahedzadeh ₆ , Shirin Djalalinia _{9,

10} , Bita Shahrami _{1,

6}

Affiliation

Hematology, Oncology, and Stem Cell Transplantation Research Center, Research Institute for Oncology, Hematology, and Cell Therapy, Tehran University of Medical Sciences, Tehran, Iran.
Department of Toxicology & Pharmacology, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Toxicology and Diseases Group (TDG), Pharmaceutical Sciences Research Center (PSRC), Tehran University of Medical Sciences, Tehran, Iran.
Digestive Diseases Research Center, Digestive Diseases Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Clinical Research Development Unit, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Department of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Hematologic Malignancies Research Center, Research Institute for Oncology, Hematology, and Cell Therapy, Tehran University of Medical Sciences, Tehran, Iran.
Faculty of Medicine, Semmelweis University, Budapest, Hungary.
Development of Research and Technology Center, Deputy of Research and Technology, Ministry of Health and Medical Education, Tehran, Iran.
Non-Communicable Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.

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).

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.

Graphical abstract

中文翻译：

高剂量甲氨蝶呤尿液碱化的口服方案：系统评价和荟萃分析

客观的

碱化尿液可预防接受大剂量甲氨蝶呤 (HDMTX) 治疗的患者出现肾毒性。虽然标准方法涉及静脉注射碳酸氢钠，但替代性口服碳酸氢盐治疗方案在药物短缺和门诊环境中至关重要。本研究旨在审查此类治疗方案的有效性和安全性。

方法

使用 PRISMA 协议系统地检索 PubMed、WOS 和 Scopus 中涉及人类受试者的相关研究，包括随机临床试验、回顾性、前瞻性、队列、病例报告和病例系列研究。没有语言、时间或年龄组的限制。使用合格和合格的论文来提取有效性和安全性指标的数据，并使用干预措施非随机研究中的偏倚风险（ROBINS-I）评估工具对最终相关记录进行质量评估。

结果

系统评价纳入了 12 项研究，共有 1212 名参与者，其中 8 项研究的汇总数据用于荟萃分析。口服碳酸氢盐治疗后，平均差 (MD) 或比值比 (OR) 没有显着差异，但尿液 pH 值降至 < 7 时除外（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）。