Clinical efficacy and influencing factors of different modes of continuous negative pressure wound therapy on venous ulcer wounds of lower limbs
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摘要: 目的 探讨不同模式持续负压伤口疗法(NPWT)对下肢静脉性溃疡创面的临床疗效并进行影响因素分析。 方法 2018年1月—2019年12月,江南大学附属医院收治53例符合入选标准的下肢静脉性溃疡患者,对其进行前瞻性随机对照研究。按随机数字表法将患者分为单一负压治疗组19例(男11例、女8例)、循环交替负压治疗组17例(男12例、女5例)和常规换药组17例(男10例、女7例),年龄分别为(47±11)、(49±10)、(47±10)岁。入院后,单一负压治疗组患者接受负压为-13.3 kPa单一负压模式持续NPWT,循环交替负压治疗组患者接受负压为-16.0~-10.7 kPa循环交替负压模式持续NPWT,常规换药组患者接受碘伏浸润的凡士林纱布换药治疗。治疗7、14 d,计算创面愈合率;治疗前及治疗7、14 d,采用经皮氧分压(TcPO2)测量仪检测创周TcPO2;治疗1、4、7、10、14 d,收集创面渗出液/引流液,采用pH计行pH值检测并记录渗出液/引流液量;治疗前及治疗7、14 d,采集静脉血,检测血清白细胞介素1β(IL-1β)、IL-6、肿瘤坏死因子α(TNF-α)、转化生长因子β1(TGF-β1)、血管内皮生长因子(VEGF)、碱性成纤维细胞生长因子(bFGF)水平;治疗前及治疗7、14 d,采集创面分泌物行细菌培养,分别采用视觉模拟评分法和汉密尔顿焦虑量表评定患者创面疼痛和焦虑程度;统计患者住院时间及治疗总费用。对数据进行重复测量方差分析、单因素方差分析、LSD检验、Kruskal-Wallis
H 检验、Mann-WhitneyU 检验、χ 2检验、Fisher确切概率法检验以及Bonferroni校正。根据治疗14 d创面愈合率,分创面愈合率≥70%的显著愈合和创面愈合率<70%的非显著愈合2个疗效评价等级,以此二分类的创面愈合率为因变量,以治疗前TcPO2、IL-1β、IL-6、TNF-α、TGF-β1、VEGF、bFGF水平与细菌检出情况、创面疼痛和焦虑程度及治疗1 d创面渗出液/引流液量和pH值为协变量,通过二分类多因素logistic回归分析,分析影响创面显著愈合的危险因素。 结果 (1)治疗7 d,单一负压治疗组患者创面愈合率为(33±10)%,明显高于常规换药组的(24±9)%(P <0.05);治疗14 d,单一负压治疗组、循环交替负压治疗组患者创面愈合率分别为(71±15)%、(66±18)%,均显著高于常规换药组的(45±19)%(P <0.01)。(2)与常规换药组比较,单一负压治疗组患者治疗14 d及循环交替负压治疗组患者治疗7、14 d创周TcPO2明显升高(P <0.05或P <0.01);单一负压治疗组患者治疗10、14 d及循环交替负压治疗组患者治疗7、14 d创面引流液pH值明显降低(P <0.05);单一负压治疗组患者治疗10、14 d及循环交替负压治疗组患者治疗7、10、14 d创面引流液的量明显减少(Z =-4.060、-4.954,-2.413、-4.085、-4.756,P <0.05或P <0.01);单一负压治疗组、循环交替负压治疗组患者治疗7、14 d血清IL-1β、IL-6、TNF-α水平显著降低(P <0.01),循环交替负压治疗组患者治疗14 d血清TGF-β1水平显著升高(P <0.05),单一负压治疗组、循环交替负压治疗组患者治疗14 d血清VEGF、bFGF水平显著升高(P <0.01);单一负压治疗组、循环交替负压治疗组患者治疗7、14 d创面分泌物细菌检出比例、创面疼痛及焦虑评分均显著降低(P <0.01)。负压治疗2组比较,除治疗7 d循环交替负压治疗组患者创面疼痛评分明显低于单一负压治疗组(P <0.01)外,前述其余指标均相近。(3)单一负压治疗组与循环交替负压治疗组患者住院时间相近(P >0.05),均显著短于常规换药组(P <0.01);3组患者治疗总费用相近(F =1.766,P >0.05)。(4)治疗前血清TNF-α与bFGF水平、创周TcPO2、创面疼痛程度为影响创面显著愈合的危险因素(比值比=1.109、0.950、1.140、2.169,95%置信区间=1.012~1.217、0.912~0.988、1.008~1.290、1.288~3.651,P <0.05或P <0.01)。 结论 临床应用单一负压模式和循环交替负压模式持续NPWT对下肢静脉性溃疡创面创基改善、提高愈合率均有积极的促进作用,但循环交替负压模式较单一负压模式更快改善创周TcPO2、更快降低创面pH值、更快减少渗液量、缓解疼痛效果更显著;治疗前血清TNF-α与bFGF水平、创周TcPO2、创面疼痛程度是影响创面显著愈合的危险因素。Abstract: Objective To explore the clinical efficacy of different modes of continuous negative pressure wound therapy (NPWT) on venous ulcer wounds of lower limbs, and to analyze the influencing factors. Methods From January 2018 to December 2019, 53 patients with venous ulcer of lower limbs who met the inclusion criteria and hospitalized in the Affiliated Hospital of Jiangnan University were recruited in this prospective randomized controlled study. According to the random number table, the patients were divided into single negative pressure therapy (SNPT) group (19 patients, 11 males and 8 females), cyclic alternating negative pressure therapy (CANPT) group (17 patients, 12 males and 5 females), and routine dressing change (RDC) group (17 patients, 10 males and 7 females), aged (47±11), (49±10), and (47±10) years respectively. After admission, patients in SNPT group were given continuous NPWT with the single negative pressure setting at -13.3 kPa, patients in CANPT group were also given continuous NPWT but with the cyclic alternating negative pressure setting from -16.0 to -10.7 kPa, while patients in RDC group were given dressing change with vaseline gauze soaked with iodophor. The wound healing rate was calculated on treatment day 7 and 14. Transcutaneous oxygen pressure (TcPO2) around the wound was detected by TcPO2 meter before treatment and on treatment day 7 and 14. The wound exudate/drainage fluid was collected on treatment day 1, 4, 7, 10, and 14, with the pH value measured using a pH meter, and the volume of exudate/drainage fluid recorded. Before treatment and on treatment day 7 and 14, venous blood was collected to detect the serum levels of interleukin 1β (IL-1β), IL-6, tumor necrosis factor α(TNF-α), transforming growth factor-β1 (TGF-β1), vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF). Before treatment and on treatment day 7 and 14, wound exudates were collected for bacterial culture, and Visual Analogue Scale and Hamilton Anxiety Scale were used to evaluate the degree of wound pain and anxiety of patients respectively. The length of hospital stay and the total treatment cost were counted. Analysis of variance for repeated measurement, one-way analysis of variance, least significant difference test, Kruskal WallisH test, Mann WhitneyU test, chi-square test, Fisher′s exact probability method test, and Bonferroni correction were used to analyze the data. According to the wound healing rate on treatment day 14, the efficiency of patients were divided into two grades of significant healing with wound healing rate≥70% and non significant healing with wound healing rate<70%. According to the two categories of wound healing rate as dependent variables, the levels of TcPO2, IL-1β, IL-6, TNF-α, TGF-β1, VEGF, bFGF levels and bacterial detection, wound pain and anxiety before treatment, wound exudate/drainage fluid volume and pH value on treatment day 1 were taken as covariates, and binary classification multifactor logistic regression analysis was used to analyze the risk factors of significant wound healing. Results (1) On treatment day 7, the wound healing rate of patients in SNPT group was (33±10) %, which was significantly higher than (24±9) % of RDC group (P <0.05). On treatment day 14, the wound healing rates of patients in SNPT group and CANPT group were (71±15)% and (66±18)%, respectively, which were significantly higher than (45±19)% of RDC group (P <0.01). (2) Compared with those of RDC group, the TcPO2 value around the wound of patients was significantly increased in SNPT group on treatment day 14 and in CANPT group on treatment day 7 and 14 (P <0.05 orP <0.01), the pH value of wound drainage fluid of patients was significantly decreased in SNPT group on treatment day 10 and 14 and in CANPT group on treatment day 7 and 14 (P <0.05), the volume of wound drainage fluid of patients was significantly reduced in SNPT group on treatment day 10 and 14 and in CANPT group on treatment day 7, 10, and 14 (Z =-4.060, -4.954, -2.413, -4.085, -4.756,P <0.05 orP <0.01), the serum levels of IL-1β, IL-6, and TNF-α of patients were significantly decreased in SNPT group and CANPT group on treatment day 7 and 14 (P <0.01), the serum level of TGF-β1 of patients was significantly increased in CANPT group on treatment day 14 (P <0.05), the serum levels of VEGF and bFGF were significantly increased in SNPT group and CANPT group on treatment day 14 (P <0.01), the bacteria detection proportion of wound exudate, wound pain, and anxiety scores of patients were significantly decreased in SNPT group and CANPT group on treatment day 7 and 14 (P <0.01). Compared between the negative pressure therapy two groups, except the wound pain score of patients in CANPT group was significantly lower than that in SNPT group (P <0.01) on treatment day 7, the other indicators mentioned above were similar. (3) The length of hospital stay of patients in SNPT group was similar to that in CANPT group (P >0.05), which were significantly shorter than the time in RDC group (P <0.01). The total treatment cost of patients among the three groups was similar (F =1.766,P >0.05). (4) Before treatment, the serum levels of TNF-α and bFGF, TcPO2 around the wound, and the degree of wound pain were risk factors for significant wound healing (odds ratio=1.109, 0.950, 1.140, 2.169, 95% confidence interval=1.012-1.217, 0.912-0.988, 1.008-1.290, 1.288-3.651,P <0.05 orP <0.01). Conclusions Clinical application of continuous NPWT under single negative pressure mode and cyclic alternating negative pressure mode has a positive effect on improving the wound base and healing rate of venous ulcer of lower limbs. But cyclic alternating negative pressure mode is significantly more effective than single negative pressure mode in improving TcPO2 around the wound, reducing wound pH value, reducing exudate volume and relieving pain. The serum levels of TNF-α and bFGF, TcPO2 around the wound and the degree of wound pain were the risk factors that affect the wound healing significantly.-
Key words:
- Negative-pressure wound therapy /
- Varicose ulcer /
- Wound healing /
- Chronic wound
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