Dailey G E, Boden G H, Creech R H, Johnson D G, Gleason R E, Kennedy F P, Weinrauch L A, Weir M, D'Elia J A
Scripps Clinic, San Diego, CA 92037, USA.
Metabolism. 2000 Nov;49(11):1491-5. doi: 10.1053/meta.2000.17700.
The purpose of this study was to assess the effects of pulsatile intravenous insulin therapy (PIVIT) on the progression of diabetic nephropathy in patients with type 1 diabetes mellitus (DM). This 18-month multicenter, prospective, controlled study involved 49 type 1 DM patients with nephropathy who were following the Diabetes Control and Complications Trial (DCCT) intensive therapy (IT) regimen. Of these, 26 patients formed the control group (C), which continued on IT, while 23 patients formed the treatment group (T) and underwent, in addition to IT, weekly PIVIT. Blood pressure in all patients was maintained below 140/90 mm Hg on antihypertensive medication, preferentially using angiotensin-converting enzyme (ACE) inhibitors. All study patients were seen in the clinic weekly for 18 months, had monthly glycohemoglobin (HbA1c), and every 3 months, 24-hour urinary protein excretion and creatinine clearance (CrCl) determinations. The HbA1c levels declined from 8.61% +/- 0.33% to 7.68% +/- 0.31% (P = .0028) in the T group and from 9.13% +/- 0.36% to 8.19% +/- 0.33% (P = .0015) in the C group during the study period. CrCl declined significantly in both groups, as expected, but the rate of CrCl decline in the T group (2.21 +/- 1.62 mL/min/yr) was significantly less than in the C group (7.69 +/- 1.88 mL/min/yr, P = .0343). We conclude that when PIVIT is added to IT in type 1 DM patients with overt nephropathy, it appears to markedly reduce the progression of diabetic nephropathy. The effect appears independent of ACE inhibitor therapy, blood pressure, or glycemic control.
本研究的目的是评估脉冲式静脉注射胰岛素疗法（PIVIT）对1型糖尿病（DM）患者糖尿病肾病进展的影响。这项为期18个月的多中心、前瞻性对照研究纳入了49例遵循糖尿病控制与并发症试验（DCCT）强化治疗（IT）方案的1型糖尿病肾病患者。其中，26例患者组成对照组（C），继续接受IT治疗；23例患者组成治疗组（T），除IT治疗外，每周接受PIVIT治疗。所有患者通过使用降压药物（优先使用血管紧张素转换酶（ACE）抑制剂）将血压维持在140/90 mmHg以下。所有研究患者在18个月内每周到诊所就诊，每月检测糖化血红蛋白（HbA1c），每3个月测定24小时尿蛋白排泄量和肌酐清除率（CrCl）。在研究期间，T组的HbA1c水平从8.61%±0.33%降至7.68%±0.31%（P = 0.0028），C组从9.13%±0.36%降至8.19%±0.33%（P = 0.0015）。正如预期的那样，两组的CrCl均显著下降，但T组CrCl下降率（2.21±1.62 mL/min/年）明显低于C组（7.69±1.88 mL/min/年，P = 0.0343）。我们得出结论，在有明显肾病的1型糖尿病患者中，当在IT基础上加用PIVIT时，似乎能显著降低糖尿病肾病的进展。这种效果似乎独立于ACE抑制剂治疗、血压或血糖控制。
