Rigor prophylaxis in stage IV melanoma and renal cell carcinoma patients treated with high dose IL-2.

Rigor prophylaxis in stage IV melanoma and renal cell carcinoma patients treated with high dose IL-2.
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DOI:
10.1186/s12885-018-4810-y
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发表时间:
2018-10-20
期刊:
影响因子:
3.8
通讯作者:
Khong HT
Khong HT
中科院分区:
医学2区
文献类型:
--
作者:
Khong B;Lawson BO;Ma J;McGovern C;Van Atta JK;Ray A;Khong HT

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在白介素2(IL2)治疗转移性黑色素瘤和肾癌的过程中,强直是一个重要的不良事件。度冷丁一直是严格预防的支柱,但关于可能的替代方案的数据很少。对2009年5月至2016年10月在犹他州亨茨曼癌症研究所(HCI)接受IL2治疗的91名转移性肾细胞癌和黑色素瘤患者进行了严格预防的回顾性评估。42例患者服用了度冷丁,49例患者服用了曲马多。严格程度用按需(PRN)严格用药剂量的替代物列出,并用IL2剂量归一化。发热、低血压和肾功能不全的其他结果以二进制量表记录,并按周期归一化。采用单变量和多变量负二项模型进行统计分析。91名接受大剂量IL2治疗的患者被确认为转移性黑色素瘤或肾细胞癌。42名患者接受了度冷丁治疗,49名患者接受了曲马多的严寒预防。单因素负二项分析显示,发病率比(IRR):发热0.41(95%可信区间0.28-0.62,P值均<0.01); 0.001)、低血压(95%CI1.11~2.61,p值0.015)、肾功能不全(95%CI 0.35~0.98,p值0.041)、所有PRN药物的严重度(95%CI 0.79~1.28,p值0.964)、阿片类PRN药物的严谨性(95%CI 0.67~1.07,p值0.168)。多因素负二项分析显示:发热0.59(95%可信区间0.28~1.24,p值0.163),低血压0.93(95%可信区间0.43~2.03,p值0.864),肾功能不全1.1(95%可信区间0.52~2.32,p值0.807),每例肾功能不全0.92(95%可信区间0.67~1.26,p值0.604),阿片类药物引起的肾功能亢进(95%可信区间0.65~1.26,p值0.604)。P-值0.554)。单变量模型显示,度冷丁治疗前发热和肾功能不全的发生率显着降低,而曲马多的低血压发生率显着降低。然而,当控制人口统计学和其他治疗差异时,这些差异不再显著。
Rigors are a significant adverse event during interleukin-2 (IL2) therapy for metastatic melanoma and renal cell carcinoma. Meperidine has been a mainstay for rigor prophylaxis but there is a paucity of data regarding possible alternatives. Ninety one patients receiving IL2 therapy for metastatic renal cell carcinoma and melanoma at Huntsman Cancer institute (HCI), Utah from May 2009 to October 2016 were retrospectively evaluated for rigor prophylaxis. Forty two patients received meperidine and 49 received tramadol. Rigors were tabulated using the proxy of number of doses of as needed (PRN) rigor medications and normalized by IL2 doses. Other outcomes of fever, hypotension, and renal insufficiency were noted on a binary scale and normalized by cycles. Statistical analysis was performed utilizing univariate and multivariate negative binomial models. Ninety one patients were identified with metastatic melanoma or RCC who received high dose IL2 therapy. Forty two received meperidine and 49 received tramadol prophylaxis for rigors. Univariate negative binomial analysis shows incidence rate ratios (IRR): fever 0.41 (95% CI 0.28–0.62, p-value < 0.001), hypotension 1.7 (95% CI 1.11–2.61, p-value 0.015), renal insufficiency 0.58 (95% CI 0.35–0.98, p-value 0.041), rigors per all PRN meds 1.01 (95% CI 0.79–1.28, p-value 0.964), and rigors via opioid PRN meds 0.85 (95% CI 0.67–1.07, p-value 0.168). Multivariate negative binomial analysis shows IRR: fever 0.59 (95% CI 0.28–1.24, p-value 0.163), hypotension 0.93 (95% CI 0.43–2.03, p-value 0.864), renal insufficiency 1.1 (95% CI 0.52–2.32, p-value 0.807), rigors per al PRN meds 0.92 (95% CI 0.67–1.26, p-value 0.604), and rigors via opioid PRN 0.9 (95% CI 0.65–1.26, p-value 0.554). Univariate models indicated meperidine pre-treatment was associated with significantly lower rates of fever and renal insufficiency whereas tramadol was associated with significantly lower rate of hypotension. However, when controlled for demographics and other treatment differences, these differences were no longer significant.
DOI: 10.1200/jco.1995.13.3.688
发表时间: 1995-03-01
影响因子: 45.3
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发表时间: 1999-07-01
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