计算机程序可改善术后胰岛素治疗

佛罗里达州棕榈滩——针对2,000多例患者的单中心研究显示，一款用于计算术后ICU患者最佳胰岛素剂量的在售计算机程序，可使患者高血糖事件发生率减半，低血糖事件发生率降低95%。

美国Carilion医院外科主任Christopher C. Baker博士在南方外科学会年会上报告称，该计算机程序还能大幅度减少护理人员的血糖检测次数，由应用该系统之前的7,495次/月降至4,072次/月。此外，术后患者医院获得性感染率也大幅下降。但Baker博士认为，这仅是一种时间上的关联，因为可能是同期其他治疗方面改善的结果。

德州大学外科教授David W. Herndon博士评论说：“人们对血糖控制系统敬而远之，因为NICE-SUGAR试验结果(N. Engl. J. Med. 2009;360:1283-97)显示，采用类似系统后低血糖事件增加。Carilion医院研究结果的重要性在于计算机支持系统可减少低血糖事件。如果真能做到这一点，他们就是胜利者。我们需要更好地控制ICU患者的血糖。”他认为，应通过前瞻性随机对照试验进一步证实该计算机程序的有效性，Baker博士同意这一建议。东卡罗莱纳大学外科教授兼主任Michael Rotondo博士称：“低血糖发生率的下降幅度之大令人难以置信。”他也期待前瞻性对照研究结果。

Carilion医院于2010年初在外科、创伤、神经创伤、心脏外科ICU以及心脏外科病情进展监护室5个外科ICU应用该计算机支持系统控制胰岛素剂量。Baker博士及其同事对上述5个病房应用计算机程序后(2010年7月~2011年12月)1,682例患者资料与此前(2009年7月~2009年12月)449例患者资料进行了对比研究。

研究者Sandy L. Fogel博士称，应用该程序后，护士抽取新近入住ICU患者的血样，并将血糖水平数据连同患者体重和血肌酐水平数据输入计算机，程序随即计算出最佳胰岛素输注剂量、输注速度以及下次采血时间。最初采血间隔为15~30分钟，但随着患者血糖得到控制(目标范围为70~150 mg/dl)，后续采血间隔越来越长。最终，采血间隔在6~8小时。

在6个月的历史对照期，护士抽取44,972份血样，平均7,495份/月，而应用计算机程序后的18个月内，抽取血样73,290份，平均4,072份/月。

应用计算机程序后，5个病房高血糖事件(定义为血糖水平>150 mg/dl)比应用前减少45%~57%，平均减少50%，差异有统计学意义。低血糖事件(定义为血糖水平<40 mg/dl)发生率由应用前的1%下降至0~0.12%(5个病房总发生率为0.05%)，相对减少95%，差异也具有统计学显著性。此外，17%的血糖检测结果介于60~69 mg/dl，3%低于60 mg/dl。

Carilion医院所使用的胰岛素剂量程序为Hospira公司上市的EndoTool。Baker博士、Herndon博士、Rotondo博士和 Fogel博士均无利益冲突披露。

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By: MITCHEL L. ZOLER, Clinical Endocrinology News Digital Network

PALM BEACH, FLA. – A commercially available computer program designed to calculate optimal insulin dosages for postsurgical ICU patients halved the rate of hyperglycemic episodes that patients experienced while dropping the rate of hypoglycemic events by 95% in a single-center, U.S. experience with a total of more than 2,000 patients.

The computer program also resulted in a dramatic reduction in the number of blood glucose measures the nursing staff performed, cutting testing down from 7,495 blood glucose measures/month before the system began to 4,072 blood measures/month once it was in place, Dr. Christopher C. Baker said at the annual meeting of the Southern Surgical Association.

An additional associated benefit was a substantial reduction in hospital-acquired infections in the postsurgery patients once computer-guided insulin dosing came online, but this was only a temporal association that may have also been driven by other improvements in patient management that happened at about the same time, said Dr. Baker, chairman of surgery at the Carilion Clinic in Roanoke, Va.

"People have shied away from glucose controls systems [like the one introduced at the Carilion Clinic] because the results from the NICE-SUGAR [Normoglycemia in Intensive Care Evaluation–Survival Using Glucose Algorithm Regulation] trial (N. Engl. J. Med. 2009;360:1283-97) showed that hypoglycemia episodes increase when you do this," commented Dr. David W. Herndon, professor of surgery at the University of Texas Medical branch in Galveston. "What is important in the Carilion results is that the computerized support system reduced hypoglycemia. If that can be done across the board, they might have a winner. We need to better control sugar in the ICU."

The next step is to prove the efficacy of this computer program in a prospective, randomized controlled trial, said Dr. Herndon, a suggestion that Dr. Baker also endorsed.

"The reduced incidence of hypoglycemia was incredibly impressive," commented Dr. Michael Rotondo, professor and chairman of surgery at East Carolina University in Greenville, N.C., who also called for results from a prospective, controlled study.

Surgeons at Carilion introduced the computerized support program for insulin dosing in early 2010 into five surgical intensive care departments: surgical ICU, trauma ICU, neurotrauma ICU, cardiac surgery ICU, and the cardiac surgery progressive care unit. Dr. Baker and his associates compared data collected on patients from all five units with the computerized system in place during July 2010-December 2011, a total of 1,682 patients treated using the computer program, with 449 patients treated in the five units during July 2009-December 2009, before use of the computer program started.

When using the program, nurses take an initial blood specimen from a patient newly arrived at the unit and enter the blood glucose level into the program along with the patient’s weight and blood creatinine level. The program then immediately calculates the appropriate bolus insulin dose, the insulin infusion rate, and the time to the next blood draw, said Dr. Sandy L. Fogel, a surgeon at Carilion who collaborated on the study. At first, the next blood draw is specified for about 15-30 minutes following the first, but subsequently the blood draws are directed to occur at longer and longer intervals as the patient’s blood glucose comes under control, within the target range of 70-150 mg/dL. Eventually, draws occur at 6-8 hour intervals, Dr. Fogel said.

During the 6-month historical control, nurses drew 44,972 blood specimens for glucose measurement, an average of 7,495/month, compared with 73,290 blood draws during the 18-month period with the program in place, an average of 4,072 blood specimens drawn/month.

During the 18 months with the program in use, hyperglycemic episodes, defined as a blood glucose level greater than 150 mg/dL, dropped by 45%-57% across the five units using the system compared with each unit’s historical control. Overall, hyperglycemic events fell by 50%, a statistically significant difference.

The incidence of hypoglycemic episodes, defined as a blood glucose level below 40 mg/dL, fell from a 1% rate during the historical control period, to rates that ranged from zero to 0.12% with the program in place, with an overall rate across all five units of 0.05%, a 95% relative decrease that was statistically significant.

The substantial decline in hypoglycemic episodes "was a surprise for us," Dr. Fogel said. In addition, out of all the blood measures performed using the computer program 17% had glucose levels of 60-69 mg/dL, and 3% were below 60 mg/dL. In short, the computer program "did not increase hypoglycemic episodes by any way you measure it," Dr. Fogel said.

The insulin-dosing program used at Carilion is the EndoTool, marketed by Hospira, Inc.

Dr. Baker, Dr. Herndon, Dr. Rotondo, and Dr. Fogel had no disclosures.