Watanabe K, Sekiya M, Ikeda S, Miyagawa M, Hashida K
Division of Internal Medicine, Minamiuwa Ehime Prefectural Hospital, Japan.
Am Heart J. 1996 Jul;132(1 Pt 1):23-9. doi: 10.1016/s0002-8703(96)90386-5.
This protocol was performed to elucidate the preventive effects of probucol on restenosis after percutaneous transluminal coronary angioplasty (PTCA). A total of 118 patients with 134 vessels undergoing successful PTCA was randomly and prospectively assigned to the probucol group (group P) or the control group (group C). The subjects consisted of 91 men and 27 women, with a mean age of 63.4 +/- 2.3 years. Sixty-six vessels of 59 patients in group P and 68 vessels of 59 patients in group C were evaluated by coronary angiography at 3 months after PTCA. Probucol (0.5 mg/day) was administered between >7 days before PTCA and 3 months after PTCA. The serum total cholesterol (TC) level and the formula low-density lipoprotein cholesterol (formula LDL-C) in group P decreased from 203.8 +/- 43.1 to 169.6 +/- 39.4 mg/dl and from 131.4 +/- 0.7 to 108.7 +/- 2.5 mg/dl, whereas in group C, the levels decreased only from 202.3 +/- 32.1 to 194.2 +/- 29.8 mg/dl and from 129.2 +/- 38.1 to 124.3 +/- 31.7 mg/dl, respectively. The restenosis rate was significantly lower in group P (19.7%; 13 of 66 vessels) than in group C (39.7%; 27 of 68 vessels; p < 0.05). In group P, the probucol blood concentration was significantly higher in the subjects without restenosis (31 +/- 9 microg/ml) than in those with restenosis (18 +/- 8 microg/ml; p < 0.01), but the serum TC and formula LDL-C levels were not significantly different between these two groups. In summary, long-term administration of probucol significantly reduces the incidence of restenosis after PTCA. it was suggested that the mechanism of this preventive effect was not reducing the serum TC or formula LDL-C levels, but rather an inhibitory action on smooth muscle cell proliferation.
本研究旨在阐明普罗布考对经皮腔内冠状动脉成形术(PTCA)后再狭窄的预防作用。118例患者的134支血管成功接受PTCA后,被随机、前瞻性地分为普罗布考组(P组)和对照组(C组)。研究对象包括91名男性和27名女性,平均年龄为63.4±2.3岁。PTCA术后3个月,对P组59例患者的66支血管和C组59例患者的68支血管进行冠状动脉造影评估。普罗布考(0.5mg/天)在PTCA术前>7天至术后3个月期间给药。P组血清总胆固醇(TC)水平和计算的低密度脂蛋白胆固醇(计算的LDL-C)水平分别从203.8±43.1降至169.6±39.4mg/dl和从131.4±0.7降至108.7±2.5mg/dl,而C组仅分别从202.3±32.1降至194.2±29.8mg/dl和从129.2±38.1降至124.3±31.7mg/dl。P组再狭窄率(19.7%;66支血管中的13支)显著低于C组(39.7%;68支血管中的27支;p<0.05)。在P组中,无再狭窄患者的普罗布考血药浓度(31±9μg/ml)显著高于有再狭窄患者(18±8μg/ml;p<0.01),但两组血清TC和计算的LDL-C水平无显著差异。总之,长期服用普罗布考可显著降低PTCA术后再狭窄的发生率。提示这种预防作用的机制不是降低血清TC或计算的LDL-C水平,而是对平滑肌细胞增殖的抑制作用。