CAJ | 학술논문

目的：评价富血小板凝胶(PRG)应用于难愈性糖尿病足溃疡的有效性和安全性。方法自2013年6月1日至2014年9月1日共纳入62例难愈性糖尿病足溃疡患者，采用完全随机化法分为PRG组和标准组。两组均给予基础治疗和创面常规治疗。PRG组则在创面常规治疗基础上，根据创面体积采血制备PRG并敷于创面；两组均在入组后3 d、以后每周更换一次敷料并观察创面情况直至愈合或12周末。采用t检验、u检验、χ2检验比较两组的基线数据及愈合效果、Kaplan?Meier生存分析比较两组随时间变化的愈合率、Cox回归分析筛选影响愈合的因素。结果 PRG组的愈合效果(分为无效、有效、显效、痊愈)明显好于标准组(u=－3.081，P<0.05)；其总有效率(显效+痊愈)及愈合率明显要高(分别为96.8%比71.0%，93.5%比61.3%，χ2=9.226、7.631，均P<0.05)；两组的Kaplan?Meier时间愈合曲线的比较差异有统计学意义(P<0.05)；PRG组的愈合时间显著短于标准组[26(21～35)比60(43～84) d，Z=－5.073，P<0.05]。Cox回归分析显示：凝胶治疗、ABI、治疗前体积有统计学意义(B=2.552、2.982、－0.343，RR=12.836、19.725、－0.343，均P<0.05)。PRG组与标准组的住院时间及住院费用的比较差异均无统计学意义（均P>0.05）。观察过程中，未见与凝胶治疗相关的严重不良反应发生。结论PRG应用于难愈性糖尿病足溃疡的疗效优于标准组，不增加住院费用，有良好的安全性。
목적：평개부혈소판응효(PRG)응용우난유성당뇨병족궤양적유효성화안전성。방법자2013년6월1일지2014년9월1일공납입62례난유성당뇨병족궤양환자，채용완전수궤화법분위PRG조화표준조。량조균급여기출치료화창면상규치료。PRG조칙재창면상규치료기출상，근거창면체적채혈제비PRG병부우창면；량조균재입조후3 d、이후매주경환일차부료병관찰창면정황직지유합혹12주말。채용t검험、u검험、χ2검험비교량조적기선수거급유합효과、Kaplan?Meier생존분석비교량조수시간변화적유합솔、Cox회귀분석사선영향유합적인소。결과 PRG조적유합효과(분위무효、유효、현효、전유)명현호우표준조(u=－3.081，P<0.05)；기총유효솔(현효+전유)급유합솔명현요고(분별위96.8%비71.0%，93.5%비61.3%，χ2=9.226、7.631，균P<0.05)；량조적Kaplan?Meier시간유합곡선적비교차이유통계학의의(P<0.05)；PRG조적유합시간현저단우표준조[26(21～35)비60(43～84) d，Z=－5.073，P<0.05]。Cox회귀분석현시：응효치료、ABI、치료전체적유통계학의의(B=2.552、2.982、－0.343，RR=12.836、19.725、－0.343，균P<0.05)。PRG조여표준조적주원시간급주원비용적비교차이균무통계학의의（균P>0.05）。관찰과정중，미견여응효치료상관적엄중불량반응발생。결론PRG응용우난유성당뇨병족궤양적료효우우표준조，불증가주원비용，유량호적안전성。
Objetive To evaluate the efficacy and safety of platelet?rich gel(PRG) in the treatment of the refractory diabetic foot ulcers. Methods A total of Sixty?two patients with refractory diabetic foot ulcer were recruited, from June 1, 2013 to September 1, 2014. All patients were randomly assigned into the conventional group(n=31) and PRG group(n=31) by the method of random number generator. Both groups were treated with general support and wound managed as usual. Wound treatments were same for two groups such as off?loading, debridement, dressing change, improvement of blood perfusion and anti?infection if necessary. The wounds of PRG group were treated with PRG according to wound volume to extract blood,and then covered with petrolatum gauze,after completely cleaning and regular treatment. Wounds were observed 3 days after enrollment, and every week until healed completely or in the end of 12 weeks observing period. The t,u and χ2 tests were used for comparing baseline data and healing efficacy.Kaplan?Meier survival analysis was used for comparing cumulative ulcer healing rate over time between two groups, Cox regression analysis was used for screening the factors influencing healing. Results The healing efficacy (including poor, better, good and completely healing) in PRG group is better than conventional group(u=-3.081, P<0.05). The total effective rate (percentage of good and completely healing) (96.8%vs 71.0%,χ2=9.226, P<0.05)and completely healing rate (93.5% vs 61.3%, χ2=7.631,P<0.05) of PRG group were significantly higher than those of conventional group. The comparison of Kaplan?Meier healing time curve between PRG group and conventional group was statistically significant (P<0.05). Compared with conventional group, median of healing time was shorter in PRG group (26(21?35) vs 60(43?84) d, Z=-5.073, P<0.05). Cox regression analysis of these two groups showed that the PRG treatment, ABI, baseline ulcer volume were statistically different(B=2.552,2.982,-0.343,RR=12.836,19.725,-0.343,all P<0.05). The hospital stay and medical cost between PRG group and conventional group were no statistically significant(all P>0.05). During the observation period,there was no serious adverse events associated with PRG treatment. Conclusions PRG treatment is effective, safe in treating the refractory diabetic foot ulcers, and significantly promotes ulcer healing without increasing economic burden in hospital.