Wieman T J
Department of Surgery, University of Louisville, School of Medicine, Kentucky 40292, USA.
Am J Surg. 1998 Aug;176(2A Suppl):74S-79S. doi: 10.1016/s0002-9610(98)00185-8.
The results of four multicenter, randomized, placebo-controlled, parallel group studies of the efficacy of becaplermin gel are reviewed here. The four studies included a total of 922 patients, all of whom received a standardized regimen of good ulcer care. Patients were randomized to receive placebo gel, 30 or 100 microg/g becaplermin gel, or good ulcer care alone. In Studies 1 and 2, the incidence of complete healing was significantly higher in patients receiving becaplermin gel (30 microg/g, Study 1; 100 microg/g, Study 2) compared with that in patients receiving placebo gel. In Study 3, which was not powered for statistical analysis, the incidence of complete healing in patients treated with 100 microg/g becaplermin gel was approximately twice that of patients treated with good ulcer care alone. In Study 4, there was no significant difference in the incidence of complete healing in patients treated with becaplermin gel versus good ulcer care alone.
本文回顾了四项关于贝卡普勒明凝胶疗效的多中心、随机、安慰剂对照、平行组研究的结果。这四项研究共纳入922例患者，所有患者均接受标准化的良好溃疡护理方案。患者被随机分配接受安慰剂凝胶、30或100μg/g贝卡普勒明凝胶，或仅接受良好的溃疡护理。在研究1和研究2中，与接受安慰剂凝胶的患者相比，接受贝卡普勒明凝胶（研究1中为30μg/g，研究2中为100μg/g）的患者完全愈合的发生率显著更高。在研究3中，该研究未进行统计学分析的效能计算，接受100μg/g贝卡普勒明凝胶治疗的患者完全愈合的发生率约为仅接受良好溃疡护理治疗患者的两倍。在研究4中，接受贝卡普勒明凝胶治疗的患者与仅接受良好溃疡护理治疗的患者相比，完全愈合的发生率无显著差异。
