美國新澤西州的Hermayer KL博士今日發(fā)表在《臨床內分泌雜志》上的研究表明:不建議腎移植患者術后進行強化血糖控制治療。
研究人員對接受腎移植的患者進行了一項隨機對照試驗,將104例患者隨機分配到強化組或對照組,強化組接受靜脈胰島素治療IV(強化)治療,對照組接受標準皮下胰島素注射SC治療。強化組腎移植后3天接受強化IV胰島素治療[血糖(BG)為70~110mg/dl],對照組接受SC胰島素治療(BG =70~180mg/dl)。主要觀察指標的主要終點為移植物功能延遲恢復(DGF),次要終點為血糖控制、移植物存活和急性排斥反應。嚴重低血糖(BG=350mg/dl)的發(fā)生率是主要安全性結果指標。
研究結果顯示,104例患者中,有93例接受了腎移植:強化組44例,對照組49例。 強化治療組中8例表現(xiàn)出DGF,對照組為12例。研究共出現(xiàn)9例低血糖,其中強化治療組7例,對照組2例。此外,強化治療組有5例患者發(fā)生30次高血糖,對照組有12例患者至少有一次高血糖。共發(fā)生11例排異反應,強化治療組9例,對照組2例。
兩個治療組中,主要終點DGF無統(tǒng)計學差異??紤]血糖水平、排斥反應和移植物存活,強化治療組患者的排斥反應風險較高。
A Randomized Controlled Trial to Evaluate the Effect of Glycemic Control on Renal Transplantation Outcomes
Context: Outcomes from intensive glycemic control postrenal transplant have not been studied.
Objective: Our objective was to observe the optimal management of hyperglycemia in patients with diabetes or impaired glucose tolerance receiving renal transplantation.
Design, Setting, and Patients: We conducted a randomized controlled trial with patients undergoing renal transplantation randomized to either iv insulin therapy (intensive) or standard sc insulin therapy while the patients were admitted to the hospital.
Interventions: The study consisted of a 3-day postrenal transplant group treated with intensive iv insulin [blood glucose (BG) = 70–110 mg/dl] or a control group treated with sc insulin (BG = 70–180 mg/dl).
Main Outcome Measure: The primary endpoint was delayed graft function (DGF). Secondary endpoints were glycemic control, graft survival, and acute rejection episodes.
Results: A total of 104 patients were screened and randomized to either the intensive or control condition; however, the intention-to-treat analysis set consisted of only the 93 participants (n = 44 intensive, n = 49 control) that underwent a renal transplant. DGF was present in 18% (eight of 44) of the intensive group and 24% (12 of 49) of the control group (P = 0.46). The occurrence of severe hypoglycemia (BG < 40 mg/dl) and severe hyperglycemia (BG > 350 mg/dl) were the primary safety outcome measures. There were nine participants with hypoglycemia identified, seven of which (78%) were in the intensive treatment group (P = 0.08). There were 30 instances of hyperglycemia with five participants (11%) in the intensive group and 12 participants (24%) in the control group having at least one hyperglycemic event (P = 0.10). For the 11 rejection episodes, nine were in the intensive treatment group (P = 0.013).
Conclusions: The primary outcome measure of DGF was not statistically different for the two treatment groups. Regarding longer-term rejection and graft survival, the intensively treated participants were at higher risk for a rejection episode.