Yao Chengcan, Yao Ping, Wu Hao, Zha Zhengang
College of Pharmacy, Jinan University, Guangzhou 510632, People's Republic of China.
Biomed Mater. 2006 Mar;1(1):33-7. doi: 10.1088/1748-6041/1/1/005. Epub 2006 Mar 15.
The objective of this study was to examine the safety and efficacy of topical application of recombinant basic fibroblast growth factor loaded on a kind of absorbable collagen sponge (rbFGF/ACS) in patients with chronic traumatic ulcers. This double-blind controlled trial included 58 patients with chronic traumatic ulcers. The patients were randomized into two groups. After debridement, the wounds were covered with rbFGF/ACS and then bound up with sterile gauze in the rbFGF/ACS group (n = 30), or bound up with petrolatum sterile gauze in the placebo group (n = 28). The complete closure of the wounds was assessed by photography. The wounds that failed to heal were defined as incomplete healing after 3 weeks. Compared with the placebo group, rbFGF/ACS significantly increased the incidence of complete wound closure by 68% (90.0% versus 53.6%, P = 0.0019) after 3 weeks and shortened the time to achieve complete wound closure by 24% (10.6 days versus 13.9 days, P = 0.0171). There was no difference in side effects between the two groups. rbFGF/ACS significantly increased the incidence of complete wound closure, shortened the complete healing time and improved the healing quality of chronic traumatic ulcers. The safety profile in the rbFGF/ACS group was similar to that in placebo group.
本研究的目的是探讨一种负载重组碱性成纤维细胞生长因子的可吸收胶原海绵(rbFGF/ACS)局部应用于慢性创伤性溃疡患者的安全性和有效性。这项双盲对照试验纳入了58例慢性创伤性溃疡患者。患者被随机分为两组。清创后,rbFGF/ACS组(n = 30)的伤口用rbFGF/ACS覆盖,然后用无菌纱布包扎,而安慰剂组(n = 28)用凡士林无菌纱布包扎。通过拍照评估伤口的完全闭合情况。3周后未愈合的伤口被定义为愈合不完全。与安慰剂组相比,rbFGF/ACS在3周后显著提高了伤口完全闭合的发生率68%(90.0%对53.6%,P = 0.0019),并将实现伤口完全闭合的时间缩短了24%(10.6天对13.9天,P = 0.0171)。两组之间的副作用没有差异。rbFGF/ACS显著提高了伤口完全闭合的发生率,缩短了完全愈合时间,改善了慢性创伤性溃疡的愈合质量。rbFGF/ACS组的安全性与安慰剂组相似。