Mohan V Krishna
Bharat Biotech International Limited, Genome Valley, Shameerpet (M), Hyderabad 500078, A.P., India.
Diabetes Res Clin Pract. 2007 Dec;78(3):405-11. doi: 10.1016/j.diabres.2007.06.004. Epub 2007 Jul 25.
Recombinant human epidermal growth factor (REGEN-D 150), which was cloned and over expressed in E. coli, has shown enhanced healing of chronic diabetic foot ulcers (DFU) by significantly reducing the duration of healing in addition to providing excellent quality of wound healing and reepithelization. Post-marketing surveillance (PMS) study of REGEN-D 150 in 135 patients of DFU in India was compared with Phase III clinical trial data of REGEN-D 150 in India. Statistical analysis of study data determined that the empirical survival probability distribution, in terms of non-healing of ulcers, was lowest in the case of PMS study, better than that for Phase III; more DFU patients were healed in PMS study. Percentage of patients cured in any given week (e.g., in week 10) is above 90% in PMS study, as compared to 69% in Phase III clinical trial; this percentage was around 18% for the control group with placebo in the Phase III trial. The average wound healing time was significantly lower in PMS study, 4.8 weeks, while it was 9 weeks in Phase III clinical trials while the average wound healing with REGEN-D 150 was found to be 86% in this study. REGEN-D 150 has been found to result in healthy granulation and stimulate epithelization, thus leading to final wound closure. The PMS study has established the efficacy of REGEN-D 150 in faster healing of diabetic foot ulcers.
重组人表皮生长因子(REGEN-D 150)在大肠杆菌中克隆并过量表达,除了能提供出色的伤口愈合和再上皮化质量外,还通过显著缩短愈合时间,显示出对慢性糖尿病足溃疡(DFU)有促进愈合的作用。对印度135例DFU患者进行的REGEN-D 150上市后监测(PMS)研究与REGEN-D 150在印度的III期临床试验数据进行了比较。研究数据的统计分析确定,就溃疡不愈合而言,PMS研究中的经验生存概率分布最低,优于III期临床试验;PMS研究中有更多的DFU患者愈合。在PMS研究中,任何给定周(例如第10周)治愈的患者百分比高于90%,而在III期临床试验中为69%;在III期试验中,使用安慰剂的对照组这一百分比约为18%。PMS研究中的平均伤口愈合时间显著更短,为4.8周,而III期临床试验中为9周,且在本研究中发现使用REGEN-D 150的平均伤口愈合率为86%。已发现REGEN-D 150可形成健康的肉芽组织并刺激上皮形成,从而导致伤口最终闭合。PMS研究证实了REGEN-D 150在更快治愈糖尿病足溃疡方面的疗效。