Martínez-de Jesús F R, Morales-Guzmán M, Castañeda M, Pérez-Morales A, García-Alonso J, Mendiola-Segura I
División de Cirugía, Centro Médico Nacional Adolfo Ruiz Cortines, Instituto Mexicano del Seguro Social, Veracruz, México.
Arch Med Res. 1997 Spring;28(1):95-9.
The objective of this study was to determine the efficacy of topically applied ketanserin for healing acceleration of diabetic foot ulcers. From August 1993 to September 1994, 140 NIDDM patients entered a randomized single-blind trial of topical ketanserin (Sufrexal, Janssen Pharmaceuticals; n = 69) vs. normal saline (labeled here as placebo; n = 71). All patients were subjected to surgical debridement of necrotic tissue and lavage with normal saline. Wounds were < 100 cm2 in area. Persons with NIDDM and foot ulcers Wagner 2 and 3 with a median of 8 (interquartile range 4-26) weeks duration were included. Ulcer area was measured at 0, 4, 8 and 12 weeks. The groups were similar in age, sex, years of diabetes duration, obesity, ulcer Wagner type, number of previous amputations and surgical debridements during this hospital stay. Average percent reduction in ulcer area at 12 weeks was 87% for ketanserin vs. 63% for placebo (p < 0.001). The regression equations for the least-squares fit to the area (y) against time (x) data points were y = 43.46-3.181x (r = -0.995) for ketanserin and y = 39.46-2.016x (r = -0.999) for placebo (p < 0.01). The 95% confidence limits for slopes were -3.181 +/- 0.98 and -2.016 +/- 0.15. Thus, average daily reduction in ulcer area was 4.5 mm2/day for ketanserin vs. 2.88 mm2/day for placebo. In conclusion, topical ketanserin significantly accelerated wound healing in diabetic neurotrophic foot ulcers when applied as part of a comprehensive healing program.
本研究的目的是确定局部应用酮色林对糖尿病足溃疡愈合加速的疗效。1993年8月至1994年9月，140例非胰岛素依赖型糖尿病（NIDDM）患者进入一项局部应用酮色林（苏发新，杨森制药公司；n = 69）与生理盐水（在此标记为安慰剂；n = 71）的随机单盲试验。所有患者均接受坏死组织的手术清创并用生理盐水冲洗。伤口面积<100 cm²。纳入患有NIDDM且足部溃疡为Wagner 2级和3级、病程中位数为8周（四分位间距4 - 26周）的患者。在0、4、8和12周时测量溃疡面积。两组在年龄、性别、糖尿病病程年数、肥胖程度、溃疡Wagner类型、本次住院期间既往截肢次数和手术清创次数方面相似。12周时，酮色林组溃疡面积平均减少百分比为87%，而安慰剂组为63%（p < 0.001）。根据面积（y）对时间（x）数据点进行最小二乘法拟合的回归方程，酮色林组为y = 43.46 - 3.181x（r = -0.995），安慰剂组为y = 39.46 - 2.016x（r = -0.999）（p < 0.01）。斜率的95%置信区间为-3.181 ± 0.98和-2.016 ± 0.15。因此，酮色林组溃疡面积平均每日减少4.5 mm²/天，而安慰剂组为2.88 mm²/天。总之，作为综合愈合方案的一部分应用时，局部应用酮色林可显著加速糖尿病神经营养性足溃疡的伤口愈合。
