TCT2008回顾：靶向肾脏治疗，保护肾脏功能效果良好
来源：医心网 发布时间：2008-10-31 13:56
From TCT 2008: Targeted Renal Therapy Shows Positive Effects in Protecting Kidney Function
要点：菲诺多泮预防手术或介入高风险患者的对比剂肾病
靶向肾脏治疗，是经皮将选择性多巴胺激动剂及血管扩张剂——菲诺多泮直接输入肾动脉，根据华盛顿TCT2008发表的一篇摘要，靶向肾脏治疗似乎可预防周围血管介入或者血管内主动脉瘤修复（EVAR）术后患者发生的造影剂肾病。
在会议报告的一个摘要中，该治疗似乎对冠脉旁路移植（CABG）患者具有保护作用。两组研究均由路易斯安那拉法叶、南方心血管研究所的David E. Allie博士发表。Allie博士及同事研究了靶向肾脏治疗，通过5-Fr Benephit输注系统直接给予菲诺多泮(Corlopam, Abbott Labs)。研究结果从Be-RITe注册研究得出，该研究是一项观察性多中心注册研究，进行了500多例靶向肾脏治疗。
经皮介入靶向治疗
在第一个研究中，88例患者进行周围血管介入术（74例）或者EVAR术（14例）。没有发生大血管通路或器械并发症，进行靶向肾脏治疗导管置入的时间从0.5分钟到8分钟不等（平均2.5分钟）。尽管Mehran评分预测CIN发生率为50%，但是大多数患者（89.8%）没有发生CIN（定义为血清肌酐比基础水平增加>25%）。9例患者（10.1%）发生CIN，其中7例患者两周内恢复正常，1例患者因容量过度负荷需要进行72小时透析。
“靶向肾脏治疗，对于周围血管介入和EVAR术后CIN高风险患者和肾功能恶化患者，是安全可行的预防CIN疗法。”研究者在摘要中写道。
试验从2005年10月进行到2007年7月。高风险患者接受靶向治疗，给予0.2-0.4 mcq/kg/min菲诺多泮。治疗时间从1到18个小时不等。研究者采用经股动脉和肱动脉入路方式。基线血清肌酐水平1.3～3.4 mg/dL，肌酐清除率是12～59 mL/min。
CABG靶向治疗
由Allie博士公布的第二项试验，评估了CABG围术期肾脏功能恶化高风险患者的靶向肾脏治疗效果。研究者对Be-RITe 注册研究中的64例CABG患者进行了靶向治疗，未发生围术期死亡或器械并发症。1例患者（1.5%）需要透析（预测率7.1%）。治疗后48小时，9例患者（14%）发生肾脏功能恶化（预测率40%），血清肌酐增加>25%。48小时肌酐清除率在57例患者中（89%）不变或有所改善。“心脏外科医生需要认识到，这种介入治疗可能会改善CABG结果。”研究者在摘要中报告说。
在研究中，患者于2005年5月到2007年4月间，给予0.2～0.4 mcq/kg/min菲诺多泮治疗。基线血清肌酐水平为1.7 ± 0.68 mg/dL，肌酐清除率为57.7 ± 31.9 cc/min，射血分数为39.7% ± 13.1%。靶向治疗持续时间为391.4分钟，CABG时间为267 ± 43.5分钟，心肌阻断时间为88.9 ± 35.6分钟。
Be-RITe 注册研究
Be-RITe回顾性注册研究，记录剂量、器械性能、临床结果和Benephit CV或Benephit PV输注系统引起的不良事件。FDA已经批准了这两种系统供内科医生专用于外周血管系统包括肾动脉输注。至今，FDA没有批准这两种系统用于治疗或预防CIN或其他疾病。
（source：www.tctmd.com）
（《医心评论》 刘瑞琦 翻译 陆卫 校对）
From TCT 2008: Targeted Renal Therapy Shows Positive Effects in Protecting Kidney Function
Key Points:
* Fenoldopam prevents contrast nephropathy in high-risk patients undergoing surgery or intervention.
By TCT Daily Staff
Percutaneous delivery of the selective dopamine agonist and vasodilating agent fenoldopam directly into the renal arteries, known as targeted renal therapy, appears to prevent contrast induced nephropathy (CIN) in patients undergoing peripheral vascular intervention or endovascular aortic aneurysm repair (EVAR), according to an abstract presented at TCT 2008 in Washington, DC.
In a separate abstract reported at the meeting, the therapy also appears to have a protective effect in patients having coronary artery bypass graft (CABG) surgery.
Both studies were presented by David E. Allie, MD, of the Cardiovascular Institute of the South in Lafayette, Louisiana. Allie and colleagues studied targeted renal therapy that involved direct infusions of fenoldopam (Corlopam, Abbott Labs) via the 5-Fr Benephit Infusion System (Flowmedica Inc.). Results were culled from the Be-RITe Registry, an observational multicenter registry with over 500 targeted renal therapy cases.
Targeted therapy for percutaneous interventions
In the first study, 88 patients underwent either peripheral intervention (n = 74) or EVAR (n = 14).
There were no major vascular access or device complications, and the time to targeted renal therapy catheter placement ranged from 0.5 to 8 minutes (mean, 2.5 minutes). The majority of patients (89.8%) did not develop CIN (defined as a >25% increase in serum creatinine), despite a Mehran score that predicted a 50% CIN rate. Nine patients (10.1%) developed CIN, of whom seven recovered within two weeks and one required 72 hours of dialysis for volume overload.
"Targeted renal therapy was found to be a safe and feasible therapy for CIN prevention during peripheral vascular intervention and EVAR in patients at high-risk for CIN and worsening renal insufficiency," the investigators write in the abstract.
This trial ran from October 2005 to July 2007. High-risk patients received targeted therapy with 0.2-0.4 mcq/kg/min of fenoldopam. Treatment times ranged from 1 to 18 hours. Researchers used femoral and brachial approaches. At baseline, serum creatinine levels were 1.3 to 3.4 mg/dL, and creatinine clearance was 12 to 59 mL/min.
Targeted therapy for CABG
The second trial presented by Allie assessed targeted renal therapy in CABG patients at high risk for worsening perioperative renal function.
The researchers performed targeted therapy in 64 CABG patients from the Be-RITe Registry, demonstrating no perioperative mortalities or device complications. One patient (1.5%) required dialysis (predicted rate = 7.1%). At 48 hours after treatment, nine patients (14%) had deteriorating renal function (predicted rate = 40%), defined as increasing serum creatinine >25%. Creatinine clearance was unchanged or improved in 57 patients (89%) at 48 hours.
"Cardiac surgeons need to be aware of this percutaneous therapy that has the potential to improve CABG outcomes," the investigators report in their abstract.
In the study, patients were treated between May 2005 and April 2007 with a dosage of 0.2 to 0.4 mcq/kg/min of fenoldopam. At baseline, serum creatinine levels were 1.7 ± 0.68 mg/dL, creatinine clearance was 57.7 ± 31.9 cc/min, and ejection fraction was 39.7% ± 13.1%. Targeted therapy duration was 391.4 minutes, CABG duration was 267 ± 43.5 minutes, and cross-clamp time was 88.9 ± 35.6 minutes.
The Be-RITe Registry
Be-RITe is a retrospective registry that is recording data on usage, device performance, clinical outcomes, and adverse events associated with either the Benephit CV or Benephit PV Infusion System. The FDA has approved both systems for the infusion of physician-specified agents in the peripheral vasculature, including the renal arteries. To date, the FDA has not approved the systems to treat or prevent CIN or any other condition.
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