Fasano Charles J, O'Malley Gerald, Dominici Paul, Aguilera Elizabeth, Latta Daniel R
Department of Emergency Medicine, Albert Einstein Medical Center, Philadelphia, PA 19141, USA.
Ann Emerg Med. 2008 Apr;51(4):400-6. doi: 10.1016/j.annemergmed.2007.06.493. Epub 2007 Aug 30.
This study is designed to test the hypothesis that the administration of octreotide acetate (Sandostatin; Novartis Pharmaceuticals) in addition to standard therapy will increase serum glucose level measured at serial intervals in patients presenting to the emergency department (ED) with sulfonylurea-induced hypoglycemia compared with standard therapy alone.
This study was a prospective, double-blind, placebo-controlled trial. All adult patients who presented to the ED with hypoglycemia (serum glucose level < or = 60 mg/dL) and were found to be taking a sulfonylurea or a combination of insulin and sulfonylurea were screened for participation in the study. Study participants were randomized to receive standard treatment (1 ampule of 50% dextrose intravenously and carbohydrates orally) and placebo (1 mL of 0.9% normal saline solution subcutaneously) or standard treatment plus 1 dose of octreotide 75 microg subcutaneously. Subsequent treatment interventions were at the discretion of the inpatient internal medicine service.
A total of 40 patients (18 placebo; 22 octreotide) were enrolled. The mean serum glucose measurement at presentation was placebo 35 mg/dL and octreotide 39 mg/dL. The mean glucose values for octreotide patients compared with placebo were consistently higher during the first 8 hours but showed no difference in subsequent hours. Mean glucose differences approached statistical significance from 1 to 3 hours and were significant from 4 to 8 hours after octreotide or placebo administration.
The addition of octreotide to standard therapy in hypoglycemic patients receiving treatment with a sulfonylurea increased serum glucose values for the first 8 hours after administration in our patients. Recurrent hypoglycemic episodes occurred less frequently in patients who received octreotide compared with those who received placebo.
本研究旨在验证以下假设:对于因磺脲类药物导致低血糖而就诊于急诊科(ED)的患者,在标准治疗基础上加用醋酸奥曲肽(善宁;诺华制药),与单纯标准治疗相比,能使连续测量的血清葡萄糖水平升高。
本研究为前瞻性、双盲、安慰剂对照试验。所有因低血糖(血清葡萄糖水平≤60mg/dL)就诊于急诊科且被发现正在服用磺脲类药物或胰岛素与磺脲类药物联合使用的成年患者均被筛选以参与本研究。研究参与者被随机分为接受标准治疗(静脉注射1安瓿50%葡萄糖并口服碳水化合物)和安慰剂(皮下注射1mL 0.9%生理盐水溶液)或标准治疗加1剂75μg皮下注射奥曲肽。后续治疗干预由住院内科服务自行决定。
共纳入40例患者(18例接受安慰剂;22例接受奥曲肽)。就诊时的平均血清葡萄糖测量值为安慰剂组35mg/dL,奥曲肽组39mg/dL。奥曲肽组患者的平均葡萄糖值在最初8小时内与安慰剂组相比持续较高,但在随后的时间里无差异。奥曲肽或安慰剂给药后,平均葡萄糖差异在1至3小时接近统计学显著性,在4至8小时具有显著性。
在接受磺脲类药物治疗的低血糖患者的标准治疗中加用奥曲肽,在给药后的最初8小时内可使我们患者的血清葡萄糖值升高。与接受安慰剂的患者相比,接受奥曲肽的患者低血糖复发事件发生频率较低。