Sun Haojie, Yang Chengxin, Liu Xuekui, Liang Jun, Geng Houfa
Xuzhou Central Hospital, Xuzhou Clinical School of Xuzhou Medical University, The Affiliated XuZhou Hospital of Medical College of Southeast University, Xuzhou, Jiangsu, China.
Xuzhou Medical University, Xuzhou, Jiangsu, China.
Int J Low Extrem Wounds. 2023 May 18:15347346231176917. doi: 10.1177/15347346231176917.
This study was to evaluate the efficacy of (Kangfuxin Liquid) relative to normal saline when applied in negative-pressure wound therapy (NPWT) with instillation for facilitating diabetic foot ulcers (DFUs) healing. Eighty patients with Wagner grades 3 or 4 DFUs were enrolled in this retrospective study. Based on the treatment type, patients were equally assigned to either (i) an NPWT with Kangfuxin liquid instillation group (NPWT-K) or (ii) an NPWT with normal saline instillation group (NPWT-I). The primary study outcome was the wound healing rate and Kaplan-Meier survival estimate was used to examine the cumulative wound healing rate, while the secondary outcomes were the amputation rate, inpatient days, duration of antibiotic treatments, reinfection rate, new ulcer formation rate, readmission rate, and changes in the inflammatory markers (such as ESR, CRP, and PCT) and serum growth factors (including VEGF, EGF, and bFGF). The 12-week wound healing rate (31 of 40[77.5%] vs 22 of 40[55.0%], = .033) and the cumulative wound healing rate was higher in the NPWT-K group than in the NPWT-I group ( = .004). The wound healing time was shorter in the NPWT-K group (55 days [95% CI 50-60]) than in the NPWT-K group (64 days [95% CI 59-69], = .016). Patients who received NPWT-K had fewer inpatient days and duration of antibiotic treatment and faced lower reinfection and readmission rates ( < .05). After 1 week of treatment, the ESR, CRP, and PCT levels in the blood were lower in the NPWT-K group than in the NPWT-I group ( < .05), while the VEGF, EGF, and bFGF levels in the NPWT-K group were higher than those in the NPWT-I group ( < .001). The present study showed that NPWT with Kangfuxin liquid instillation was effective and showed significantly accelerated DFUs healing. Thus, Kangfuxin liquid is an effective instillation solution for use in the treatment of DFUs with NPWT.
本研究旨在评估康复新液在负压伤口治疗(NPWT)中用于促进糖尿病足溃疡(DFU)愈合时相对于生理盐水的疗效。80例Wagner分级为3级或4级的DFU患者纳入本回顾性研究。根据治疗类型,患者被平均分配到以下两组之一:(i)康复新液滴注的NPWT组(NPWT-K)或(ii)生理盐水滴注的NPWT组(NPWT-I)。主要研究结局为伤口愈合率,采用Kaplan-Meier生存估计来检验累积伤口愈合率,次要结局为截肢率、住院天数、抗生素治疗时长、再感染率、新溃疡形成率、再入院率以及炎症标志物(如血沉、C反应蛋白和降钙素原)和血清生长因子(包括血管内皮生长因子、表皮生长因子和成纤维细胞生长因子)的变化。NPWT-K组的12周伤口愈合率(40例中的31例[77.5%]对比40例中的22例[55.0%],P = 0.033)和累积伤口愈合率高于NPWT-I组(P = 0.004)。NPWT-K组的伤口愈合时间短于NPWT-I组(55天[95%置信区间50 - 60]对比64天[95%置信区间59 - 69],P = 0.016)。接受NPWT-K治疗患者的住院天数和抗生素治疗时长更少,且再感染和再入院率更低(P < 0.05)。治疗1周后,NPWT-K组血液中的血沉、C反应蛋白和降钙素原水平低于NPWT-I组(P < 0.05),而NPWT-K组的血管内皮生长因子、表皮生长因子和成纤维细胞生长因子水平高于NPWT-I组(P < 0.001)。本研究表明,康复新液滴注的NPWT有效且显著加速了DFU的愈合。因此,康复新液是用于NPWT治疗DFU的一种有效滴注溶液。