重组人血小板源生长因子凝胶剂治疗慢性糖尿病足溃疡的临床疗效及安全性评价  

Efficacy and safety of recombined platelet derived growth factor-BB on chronic diabetic foot ulcer

作　　者：袁戈恒[1] 郭晓蕙[1] 冉兴无[2] 薛耀明[3] 杨毅华[4] 苏本利[5] 文重远[6] 施秉银[7] 吕肖峰[8] 朱旅云[9] 杨静[1] 许樟荣[10] 张勇 赵敏 白雨 

机构地区：[1]北京大学第一医院内分泌科,北京100034 [2]四川大学华西医院内分泌科,成都610041 [3]南方医科大学南方医院内分泌科,广州510515 [4]汕头大学医学院第二附属医院内分泌科,广东汕头515041 [5]大连医科大学附属第二医院内分泌科,辽宁大连116023 [6]武汉大学人民医院内分泌科,武汉430060 [7]西安交通大学医学院第一附属医院内分泌科,西安710061 [8]中国人民解放军北京军区总医院内分泌科,北京100700 [9]中国人民解放军白求恩国际和平医院内分泌科,石家庄528000 [10]中国人民解放军第306医院糖尿病中心,北京100101 [11]天士力控股集团研究院临床医学中心,天津300410

出　　处：《中国临床药理学杂志》2015年第6期424-428,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价外用不同剂量的重组人血小板源生长因子凝胶剂治疗慢性糖尿病足溃疡的临床疗效和安全性。方法全国11个研究中心入组的213例慢性糖尿病足溃疡患者,随机分为3组,高剂量组(n=70)予以重组人血小板源生长因子凝胶剂(含重组人血小板源生长因子100μg·g-1)治疗;低剂量组(n=73)予以重组人血小板源生长因子凝胶剂(含重组人血小板源生长因子30μg·g-1)治疗;对照组(n=70)予以空白凝胶剂治疗。3组患者均每日用药1次,总用药周期最长20周。治疗前4周每周随访1次,4周以后每2周随访1次。观察20周试验期内的病人溃疡面积完全愈合百分率、目标溃疡完全愈合时间、溃疡面积缩小率和复发率和不良事件发生率。结果治疗20周内,全分析集中高、低剂量组和对照组目标溃疡完全愈合率分别为63.77%(44/69),50.68%(37/73)和44.93%(31/69)。高、低剂量组和对照组的中位完全愈合时间分别为5.65,4.90,4.70周。高、低剂量组和对照组4周溃疡面积缩小率分别为90.20%,89.00%和95.00%。高、低剂量组和对照组溃疡复发率分别为2.27%(1/44),2.70%(1/37)和0(0/31)。以上指标差异均无统计学意义(P>0.05)。本试验期间,高、低剂量组和对照组不良事件发生率分别为5.80%,2.74%,2.86%;高剂量组有1例与研究药物相关的不良事件,表现为用药部位轻度疼痛;高、低剂量组均未发生严重不良事件,对照组严重不良事件发生率为1.43%。结论 100μg·g-1重组人血小板源生长因子凝胶剂治疗慢性糖尿病足溃疡是安全有效的。Objective To evaluate efficacy and safety of different dosages of recombined platelet derived growth factor- BB（ r PDGF- BB） on chronic diabetic foot ulcer. Methods A total of 213 patients with chronic diabetic foot ulcer from 11 centers in China were enrolled and randomly divided into 3 groups after standard therapy： high dose group（ n = 70）,low dose group（ n = 73） and control group（ n = 70）. Patients in high dose group and low dose group were given recombined platelet derived growth factor 100 μg·g- 1and 30 μg·g- 1,po. And patients in control group were given blank gel,po. The longest duration was 20 weeks. After therapy,the patients were followed every week at first 4 weeks then every 2weeks since then. The data of duration of heal,the reduction area of ulcer,recurrence rate of ulcer and adverse events were recorded andcompared. Results During 20 weeks therapy,the ratio of heal were 63. 77%（ 44 /69）,50. 68%（ 37 /73）,44. 93%（ 31 /69） and the duration of heal were 5. 65,4. 90 and 4. 70 weeks in the high dose,low dose and control group,respectively（ P〈 0. 05）. The reduction area of ulcer were 90. 20%,89. 00%,95. 00% and recurrence rate of ulcer were 2. 27%（ 1 /44）,2. 70%（ 1 /37）,0（ 0 /31） in the high dose,low dose and control group（ P〈 0. 05）. The incidence of adverse reaction in high dose,low dose and control group were 5. 80%,2. 74% and 2. 86%. One patient in high dose group was reported local pain which was related with drug,and there was no severe adverse event found in high and low dose group. But the incidence of serious adverse reaction in the control group was 1. 43%. Conclusion High dose of r PDGF- BB（ 100 μg·g- 1） is effective and safe in treatment of chronic diabetic foot ulcer.

关 键 词：糖尿病足溃疡 重组人血小板源生长因子 临床试验 安全性 

分 类 号：R975.6[医药卫生—药品]