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中高剂量顺铂化疗的短期水化治疗效果:SHORTCIS 试验。

Efficacy of Short Hydration for Intermediate to High-Dose Cisplatin-Based Chemotherapy for Outpatients: SHORTCIS Trial.

机构信息

Division of Medical Oncology, Department of Internal Medicine, Buddhasothorn Hospital, Chachoengsao, Thailand.

出版信息

Asian Pac J Cancer Prev. 2022 Oct 1;23(10):3323-3330. doi: 10.31557/APJCP.2022.23.10.3323.

DOI:10.31557/APJCP.2022.23.10.3323
PMID:36308355
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9924323/
Abstract

OBJECTIVE

Supporting data exists concerning short hydration to prevent cisplatin-induced nephrotoxicity. However, only a few studies exist. Further, data remains limited, comprising mostly retrospective data. Therefore, the study would like to evaluate the efficacy of short hydration using a prospective cohort study.

MATERIALS AND METHODS

This is a prospective cohort non-randomized controlled study in patients receiving intermediate to high doses of cisplatin. Short hydration was set as the intervention arm, while conventional hydration was set as the controlled arm. The consecutive estimates glomerular filtration rates (eGFR) were compared at baseline, Week 3, Week 6, Week 9, Week 12, and Week 15 for both groups by using multilevel regression analysis with the random-effects model with double adjustment (propensity score and confounding adjustment) was used. The trial was registered with the Thai Registry of Clinical Trials, SHORTCIS ThaiClinicalTrials.org, number TCTR20210128002.

RESULTS

30 patients were registered. 14 were assigned to a short hydration group, while 16 were assigned to a conventional hydration group. The levels of consecutive eGFR of the group receiving short hydration were stable (regression coefficients 0.05), while the levels of consecutive eGFR of the group receiving conventional hydration were declined (regression coefficients -1.94). The multilevel regression analysis of consecutive eGFR between conventional group and short hydration group when adjusted for random-effects parameters and double adjustment were significantly different (p-value = 0.001). When analyzing the relationship of received short hydration, it could significantly reduce the risk of nephrotoxicity as well, i.e. acute kidney injury (odds ratio 0.06, 95%CI 0.003, 0.990, p-value 0.049).

CONCLUSION

Short hydration was more efficient for preventing nephrotoxicity than conventional hydration protocols in patients receiving intermediate to high doses of cisplatin.

摘要

目的

有支持性数据表明,短期水化可预防顺铂引起的肾毒性。然而,仅有少数研究存在,且数据仍然有限,主要是回顾性数据。因此,本研究希望通过前瞻性队列研究来评估短期水化的疗效。

材料和方法

这是一项在接受中高剂量顺铂治疗的患者中进行的前瞻性队列非随机对照研究。短期水化作为干预组,常规水化作为对照组。使用具有双调整(倾向评分和混杂因素调整)的随机效应模型的多层回归分析比较两组患者在基线、第 3 周、第 6 周、第 9 周、第 12 周和第 15 周的连续估计肾小球滤过率(eGFR)。该试验在泰国临床试验注册中心(Thai Registry of Clinical Trials)注册,注册号为 SHORTCIS ThaiClinicalTrials.org,编号为 TCTR20210128002。

结果

共登记了 30 例患者,其中 14 例被分配到短期水化组,16 例被分配到常规水化组。接受短期水化的患者的连续 eGFR 水平稳定(回归系数 0.05),而接受常规水化的患者的连续 eGFR 水平下降(回归系数-1.94)。对随机效应参数和双调整进行调整后,常规组和短期水化组的连续 eGFR 的多层回归分析结果有显著差异(p 值=0.001)。分析接受短期水化与肾毒性的关系时,发现短期水化还能显著降低急性肾损伤的风险(比值比 0.06,95%CI 0.003,0.990,p 值=0.049)。

结论

在接受中高剂量顺铂治疗的患者中,与常规水化方案相比,短期水化更能有效地预防肾毒性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4379/9924323/0cfbb691cde2/APJCP-23-3323-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4379/9924323/1132f1243ca7/APJCP-23-3323-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4379/9924323/3ed3d8df1513/APJCP-23-3323-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4379/9924323/30222bdbbfcc/APJCP-23-3323-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4379/9924323/0cfbb691cde2/APJCP-23-3323-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4379/9924323/1132f1243ca7/APJCP-23-3323-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4379/9924323/3ed3d8df1513/APJCP-23-3323-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4379/9924323/30222bdbbfcc/APJCP-23-3323-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4379/9924323/0cfbb691cde2/APJCP-23-3323-g004.jpg

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