Shaikh Suhail A, Marini Bernard L, Hough Shannon M, Perissinotti Anthony J
Department of Pharmacy Services and Clinical Sciences, University of Michigan Health System, Ann Arbor, MI, USA.
J Oncol Pharm Pract. 2018 Apr;24(3):176-184. doi: 10.1177/1078155216687152. Epub 2017 Jan 11.
Purpose There is a lack of high-level evidence identifying meaningful outcomes and the optimal place in therapy of rasburicase in patients with, or at high risk for tumor lysis syndrome. The primary objective of this study was to evaluate and characterize outcomes resulting from an institution-specific guideline emphasizing supportive care, xanthine oxidase inhibitors, and lower doses of rasburicase. Methods In this retrospective chart review, we compared conservative rasburicase dosing, in accordance with newly developed UMHS tumor lysis syndrome guidelines, with aggressive rasburicase in adult patients (≥ 18 years of age) with hematological or solid tumor malignancies, and a uric acid level between 8 and 15 mg/dL. The primary efficacy outcome assessed the difference in the proportion of patients achieving a uric acid level <8 mg/dL within 48 h using a one-sided noninferiority test. The principle safety outcomes analyzed included incidence of acute kidney injury and hemodialysis requirement. Results One hundred sixty-one patients met inclusion criteria and were included in the study. Within 48 h of an elevated uric acid level, treatment was successful in 97.03% of patients in the conservative group, as compared with 98.33% in the aggressive group (difference, 1.3 percentage points; 95% confidence interval [CI], -3.33 to 5.93). Furthermore, there was no difference in the proportion of patients requiring hemodialysis (2.97% vs. 10.0%, p-value 0.079), or incidence of acute kidney injury (4.0% vs. 12.5%, p-value 1.00) between the treatment group and control group, respectively. Conclusions Conservative rasburicase use was noninferior to aggressive rasburicase use in patients with or at high risk for tumor lysis syndrome.
缺乏高级别证据来确定肿瘤溶解综合征患者或高危患者中瑞舒伐他汀有意义的治疗结局及最佳治疗时机。本研究的主要目的是评估并描述一项强调支持治疗、黄嘌呤氧化酶抑制剂及较低剂量瑞舒伐他汀的机构特定指南所产生的治疗结局。方法：在这项回顾性图表审查中，我们将根据新制定的密歇根大学医疗系统（UMHS）肿瘤溶解综合征指南进行的保守瑞舒伐他汀给药方案，与针对成年（≥18岁）血液系统或实体肿瘤恶性肿瘤且尿酸水平在8至15mg/dL之间的患者采用的积极瑞舒伐他汀给药方案进行比较。主要疗效结局采用单侧非劣效性检验评估48小时内尿酸水平<8mg/dL的患者比例差异。分析的主要安全性结局包括急性肾损伤的发生率和血液透析需求。结果：161例患者符合纳入标准并被纳入研究。在尿酸水平升高后的48小时内，保守组97.03%的患者治疗成功，积极组为98.33%（差异为1.3个百分点；95%置信区间[CI]，-3.33至5.93）。此外，治疗组和对照组之间需要血液透析的患者比例（2.97%对10.0%，p值0.079）或急性肾损伤的发生率（4.0%对12.5%，p值1.00）均无差异。结论：在肿瘤溶解综合征患者或高危患者中，保守使用瑞舒伐他汀并不劣于积极使用瑞舒伐他汀。
