复方桐叶烧伤油治疗新鲜中、小面积Ⅱ度烧烫伤的多中心临床研究

Multi-center Clinical Study of Compound Folium Paulownieae Burn Oil for Fresh Medium and Small Area Second Degree Burn

目的评价复方桐叶烧伤油治疗新鲜中、小面积Ⅱ度烧烫伤的临床疗效和安全性。方法采用配对或区组随机、双盲、阳性药平行对照、多中心临床研究方法,共观察了新鲜中、小面积Ⅱ度烧烫伤病例259例,其中试验组130例,外涂复方桐叶烧伤油;对照组129例,外涂复方虎杖烧伤油。结果对新鲜中、小面积Ⅱ度烧烫伤的治疗,试验组总有效率100%,愈显率为98.36%;对照组总有效率为98.36%,愈显率为60.00%;两组比较差异有显著性(P<0.05)。结论复方桐叶烧伤油治疗新鲜中、小面积Ⅱ度烧烫伤具有明显的临床疗效,且未发现明显的不良反应。

Objective To evaluate the clinical efficacy and safety of the treatment of fresh medium and small area second degree burn with Compound Folium Paulownieae Burn Oil（ CFPBO ）. Methods A randomized, double-blind, positive parallel controlled, muhi-center clinical trial was carried out in 259 patients. Of them, 130 patients in trial group took CFPBO, and 129 in the control group took Compound Rhizoma Polygoni Cuspidati Burn Oil. Results For the treatment of fresh medium and small area second degree burn, the total effective rate was 100 %, and cure and markedly effective rate was 98.36 % in the trial group; in the control group, the total effective rate was 98.36 %, and cure and markedly effective rate was 60 %, the difference being statistically significant between the two groups（P 〈 0.05）. Conclusion CFPBO is safe and effective in the treatment of fresh medium and small area second degree burn, and has no obvious adverse reaction.