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Abstract：
BACKGROUND: High-dose methotrexate is used to treat a variety of malignancies. Methotrexate-associated supportive care and the threshold methotrexate level for the discontinuation of supportive care are not consistent among studies. We evaluated the implementation of high-dose methotrexate administration guidelines, which raised the standard threshold methotrexate level for the discontinuation of supportive care from <0.05 to <0.1 µmol.
METHODS: A single-center, observational analysis of patients receiving high-dose methotrexate from 1 January 2015 to 31 May 2017 was conducted. The primary endpoint was time from the start of the methotrexate infusion until the discontinuation of the sodium bicarbonate infusion, before and after guideline implementation.
RESULTS: Fifty-two patients met the inclusion criteria, which comprised of a total of 136 individual methotrexate doses and were included in the retrospective analysis. Twenty-four patients were included in the prospective analysis, which comprised a total of 46 individual methotrexate doses. The primary endpoint, time until discontinuation of the sodium bicarbonate infusion, was a median of 97.7 h in the retrospective group versus 73.2 h in the prospective group (p = 0.098). Secondary endpoints also favored patients in the prospective group, including hours of hospitalization, number of methotrexate levels checked, weight gained during admission, and adherence to the guideline.
CONCLUSIONS: Among patients who received high-dose methotrexate, implementation of a guideline using a methotrexate threshold of <0.1 µmol was able to significantly decrease the time to discontinuation of supportive care and subsequently may lead to early hospital discharge given that we did not show a statistical significance.
METHODS: A single-center, observational analysis of patients receiving high-dose methotrexate from 1 January 2015 to 31 May 2017 was conducted. The primary endpoint was time from the start of the methotrexate infusion until the discontinuation of the sodium bicarbonate infusion, before and after guideline implementation.
RESULTS: Fifty-two patients met the inclusion criteria, which comprised of a total of 136 individual methotrexate doses and were included in the retrospective analysis. Twenty-four patients were included in the prospective analysis, which comprised a total of 46 individual methotrexate doses. The primary endpoint, time until discontinuation of the sodium bicarbonate infusion, was a median of 97.7 h in the retrospective group versus 73.2 h in the prospective group (p = 0.098). Secondary endpoints also favored patients in the prospective group, including hours of hospitalization, number of methotrexate levels checked, weight gained during admission, and adherence to the guideline.
CONCLUSIONS: Among patients who received high-dose methotrexate, implementation of a guideline using a methotrexate threshold of <0.1 µmol was able to significantly decrease the time to discontinuation of supportive care and subsequently may lead to early hospital discharge given that we did not show a statistical significance.
摘要：
背景：大剂量甲氨蝶呤用于治疗多种恶性肿瘤。甲氨蝶呤相关的支持治疗和停止支持治疗的阈值甲氨蝶呤水平在研究中并不一致。我们评估了大剂量甲氨蝶呤给药指南的实施情况，将停止支持治疗的标准阈值甲氨蝶呤水平从<0.05提高到<0.1µmol。
方法：单中心，对2015年1月1日至2017年5月31日接受大剂量甲氨蝶呤治疗的患者进行观察性分析.主要终点是从开始输注甲氨蝶呤到停止碳酸氢钠输注的时间，在指南实施之前和之后。
结果：52例患者符合纳入标准，其中包括总共136个单独的甲氨蝶呤剂量,并包括在回顾性分析中.24名患者被纳入前瞻性分析，其中包括总共46个单独的甲氨蝶呤剂量。主端点，时间直到停止碳酸氢钠输注，在回顾性组中的中位数为97.7h,在前瞻性组中为73.2h(p=0.098).次要终点也有利于前瞻性组中的患者，包括住院时间,检查甲氨蝶呤水平的数量，入院时体重增加,并遵守准则。
结论：在接受大剂量甲氨蝶呤的患者中，实施使用甲氨蝶呤阈值<0.1µmol的指南能够显著缩短停止支持治疗的时间,并且由于我们没有显示统计学意义,因此可能导致早期出院.
方法：单中心，对2015年1月1日至2017年5月31日接受大剂量甲氨蝶呤治疗的患者进行观察性分析.主要终点是从开始输注甲氨蝶呤到停止碳酸氢钠输注的时间，在指南实施之前和之后。
结果：52例患者符合纳入标准，其中包括总共136个单独的甲氨蝶呤剂量,并包括在回顾性分析中.24名患者被纳入前瞻性分析，其中包括总共46个单独的甲氨蝶呤剂量。主端点，时间直到停止碳酸氢钠输注，在回顾性组中的中位数为97.7h,在前瞻性组中为73.2h(p=0.098).次要终点也有利于前瞻性组中的患者，包括住院时间,检查甲氨蝶呤水平的数量，入院时体重增加,并遵守准则。
结论：在接受大剂量甲氨蝶呤的患者中，实施使用甲氨蝶呤阈值<0.1µmol的指南能够显著缩短停止支持治疗的时间,并且由于我们没有显示统计学意义,因此可能导致早期出院.
