Nishimura M, Sasaki T, Ohishi A, Oishi M, Kono S, Totani Y, Kato Y, Noto Y, Misaki S, Higashi K, Shimada F, Wakasugi H, Inoue K, Hoshiyama Y, Yamada K
Department of Internal Medicine, Sakura National Hospital, Chiba, Japan.
Clin Nephrol. 2001 Aug;56(2):96-103.
A multicenter prospective clinical trial was carried out in 9 National Hospitals in Japan to elucidate the time-dependent change in urinary Type IV collagen excretion rate of Type II diabetes mellitus (DM) patients, and to investigate whether an angiotensin-converting enzyme inhibitor (ACE-I) or probucol is effective in preventing progression of renal involvement of diabetics by evaluating urinary Type IV collagen excretion.
Normo- and microalbuminuric patients with Type II DM were recruited. Patients were assigned to either the control (n = 88), ACE-I (n = 43) or probucol (n = 37) group and treated for 24 months. Besides albumin excretion rate (AER), urinary Type IV collagen excretion rate was also measured.
Although, AER, urinary N-acetyl-beta-D-glucosaminidase and beta2-microglobulin excretion rates in the control group did not vary over 24 months, urinary Type IV collagen excretion rate in the control group increased time-dependently (p < 0.01 vs baseline at 18 months and p < 0.005 vs baseline at 24 months). In the ACE-I and probucol groups, time-dependent increases in urinary Type IV collagen excretion rates were not observed. In the ACE-I group, the urinary Type IV collagen excretion rate was significantly lower than that in the control group at 24 months (p < 0.05). In the probucol group, the urinary Type IV collagen excretion rate was significantly lower than that in the control group at 6 months (p < 0.05). In the ACE-I group, AER decreased significantly compared with baseline at 18 months (p < 0.05) and at 24 months (p < 0.005).
ACE-I has a beneficial effect and probucol may have a beneficial effect in preventing the progression of early diabetic nephropathy. Measurement of the urinary Type IV collagen excretion rate in combination with AER would be useful for the management of early renal involvement in Type II DM.
在日本9家国立医院开展了一项多中心前瞻性临床试验，以阐明2型糖尿病（DM）患者尿IV型胶原排泄率的时间依赖性变化，并通过评估尿IV型胶原排泄来研究血管紧张素转换酶抑制剂（ACE-I）或普罗布考是否能有效预防糖尿病患者肾脏病变的进展。
招募了II型糖尿病的正常白蛋白尿和微量白蛋白尿患者。患者被分为对照组（n = 88）、ACE-I组（n = 43）或普罗布考组（n = 37），并接受24个月的治疗。除了白蛋白排泄率（AER）外，还测量了尿IV型胶原排泄率。
虽然对照组的AER、尿N-乙酰-β-D-氨基葡萄糖苷酶和β2-微球蛋白排泄率在24个月内没有变化，但对照组的尿IV型胶原排泄率随时间增加（与18个月时的基线相比p < 0.01，与24个月时的基线相比p < 0.005）。在ACE-I组和普罗布考组中，未观察到尿IV型胶原排泄率随时间增加。在ACE-I组中，24个月时尿IV型胶原排泄率显著低于对照组（p < 0.05）。在普罗布考组中，6个月时尿IV型胶原排泄率显著低于对照组（p < 0.05）。 在ACE-I组中，与基线相比，18个月时AER显著降低（p < 0.05），24个月时也显著降低（p < 0.005）。
ACE-I在预防早期糖尿病肾病进展方面具有有益作用，普罗布考可能也有有益作用。联合测量尿IV型胶原排泄率和AER将有助于II型糖尿病早期肾脏病变的管理。
