作者：Emma Hitt, PhD 齣處：WebMD醫學新聞 　　August 14, 2009 — 美國食品藥物管理局（FDA）已經通知健康照護專業人員 使用特定不含葡萄糖糖類的病患使用GDH-P GDH-PQQ血糖測試試紙可能造成假性上升結果 - 趣味新聞網

發表日期 2009-08-29T06:18:10+08:00

     本帖最後由 lsc0019 於 2009-8-29 23:00 編輯

作者：Emma Hitt, PhD
齣處：WebMD醫學新聞

August 14, 2009 — 美國食品藥物管理局（FDA）已經通知健康照護專業人員，使用特定不含葡萄糖糖類的病患使用GDH-PQQ(glucose dehydrogenase pyrroloquinoline quinone)血糖測試試紙，會有血糖值假性升高的可能。

根據昨天一項由FDA安全性資訊與不良反應通報係統MedWatch所發布的警訊，GDH-PQQ檢測無法辨彆葡萄糖與其他糖類之差異，會使得血糖檢測的假性結果升高，這可能遮蓋顯著的低血糖且促使注射過多胰島素導緻嚴重的傷害或死亡。

從1997年開始，FDA接獲瞭13件與使用該試紙有關的死亡事件，其中麥芽糖或其他非葡萄糖糖類被認為扮演部分角色。即使FDA已經採取行動散佈有關使用該試紙風險的資訊，在這13件死亡事件中，自2008年仍有6件發生在健康照護機構。

在13位死亡病患中，其中10位因為腎髒衰竭接受腹膜透析而使用icodextrin腹膜透析液（Extraneal，Baxter），另外3位使用含有麥芽糖的物質。根據FDA公共衛生警訊，因為僞陽性結果，病患以假性升高的結果接受胰島素注射或輸注。使用該試紙的檢驗結果比相對應的實驗室檢驗值高15倍。

FDA宣稱，部分報告指齣，這些病例在死亡前發生嚴重傷害，例如低血糖、意識混亂、神經功能惡化、嚴重缺氧、腦部傷害以及昏迷。

FDA建議，使用乾擾試驗結果産品的病患、或是無法取得目前併用藥物資訊的病患，應該避免使用GDH-PQQ葡萄糖測試試紙。包括非葡萄糖類，會造成乾擾的産品包括icodextrin腹膜透析液、特定免疫球蛋白、abatacept（Orencia，Bristol-Myers Squibb）、tositumomab（Bexxar， GlaxoSmithKline）、任何包括或是會代謝成麥芽糖、半乳糖或木糖的産品。

許多試紙與相關儀器使用GDH-PQQ技術：ACCU-CHEK（Roche）、FreeStyle（Abbott Diabetes Care）、TRUEtest（Home Diagnostics）、CoZmonitor血糖檢測模組（供Deltec Cozmo胰島素幫浦使用，Smiths Medical MD），以及OmniPod胰島素處理係統（Insulet）。

根據FDA錶示，應該考慮在電腦醫囑開立係統、病患檔案、與病曆使用藥物交互作用警示，以提醒工作人員血糖假性上升的可能性。血糖儀的結果應該要由實驗室為基礎的血糖檢測結果確認。

更多資訊請查詢MedWatch網站。

有關於GDH-PQQ葡萄糖測試試紙的不良反應應該與MedWatch通報係統連係，緻電至1-800-FDA-1088或傳真到1-800-FDA-0178，綫上通報到 http://www.fda.gov/medwatch 或郵寄到5600 Fishers Lane, Rockville, Maryland 20852-9787。

GDH-PQQ Glucose Test Strips May Produce Falsely Elevated Results

By Emma Hitt, PhD
Medscape Medical News

August 14, 2009 — The US Food and Drug Administration (FDA) has notified healthcare professionals of the potential for falsely elevated blood glucose results with the use of glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ) glucose test strips in patients receiving products containing certain nonglucose sugars.

According to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program, the GDH-PQQ test cannot distinguish between glucose and other sugars and can "falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death."

Since 1997, the FDA has received reports of 13 deaths associated with the strips in which maltose or other nonglucose sugars were considered to play a role. Of these 13 deaths, 6 deaths in healthcare facilities took place since 2008, even though the FDA has taken steps to disseminate information about the risk.

Of the 13 patients who died, 10 were receiving icodextrin peritoneal dialysis solution (Extraneal, Baxter) for renal failure, and the other 3 were receiving substances containing maltose. As a result of the false-positive results, patients were treated with "insulin doses or insulin drips that were guided by falsely elevated results," according to an FDA Public Health Notification. Test results produced by the strips were up to 15 times higher than the corresponding laboratory results.

"Some reports indicated that serious patient injury, such as hypoglycemia, confusion, neurologic deterioration, severe hypoxia, brain damage, and coma occurred prior to death," the FDA states.

The FDA recommends that use of GDH-PQQ glucose test strips be avoided in patients who are receiving interfering products or from whom information regarding concomitant medication use cannot be obtained. Interfering products containing nonglucose sugars include icodextrin peritoneal dialysis solution, certain immunoglobulins, abatacept (Orencia, Bristol-Myers Squibb), tositumomab (Bexxar, GlaxoSmithKline), and any product containing or metabolized into maltose, galactose, or xylose.

Several test strips and associated monitors use GDH-PQQ methodology: ACCU-CHEK (Roche), FreeStyle (Abbott Diabetes Care), TRUEtest (Home Diagnostics), CoZmonitor blood glucose module (for use with the Deltec Cozmo insulin pump, Smiths Medical MD), and OmniPod insulin management system (Insulet).

According to the FDA, the use of drug interaction alerts should be considered in computer order entry systems, patient profiles, and charts to alert staff to the potential for falsely elevated glucose results. Glucose meter results should also be periodically verified with laboratory-based glucose assays.

More information is available on the MedWatch Web site.

Adverse events related to use of GDH-PQQ glucose test strips should be communicated to MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch , or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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