Effect of heated povidone iodine solution on pain intensity and healing of chronic venous leg ulcer: a randomized controlled trial
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摘要:
目的 探讨加热聚维酮碘溶液对慢性下肢静脉性溃疡患者清创换药疼痛强度和溃疡愈合效果的影响。 方法 纳入2023年6月1日至2024年6月1日首次就诊于海军军医大学第一附属医院血管外科、烧伤科、整形外科门诊及病房的慢性下肢静脉性溃疡患者58例，随机分为加热组（使用38 ℃聚维酮碘溶液进行清创冲洗，n＝29）和常温组（使用24 ℃聚维酮碘溶液进行清创冲洗，n＝29）。比较两组患者一般基线资料，评估清创换药前后的疼痛强度、伤口床温度，并分析观察期间压疮愈合量表评分的变化及溃疡愈合率。 结果 两组间年龄、性别构成、吸烟史、BMI，清创前溃疡是否有渗出液和感染、溃疡持续时间、溃疡面积、压疮愈合量表评分，以及24 h镇痛药物使用情况等基线指标差异均无统计学意义（均P＞0.05）。换药清创前后两组疼痛强度差异均无统计学意义（均P＞0.05），清创时加热组患者的疼痛强度低于常温组（P＜0.05）。在冲洗前，两组伤口床温度差异无统计学意义（P＞0.05）；在冲洗后即刻和换药清创完成时，加热组的伤口床温度均高于常温组（P＜0.01、P＜0.05）。加热组患者在研究观察期间的压疮愈合量表评分存在低于常温组的趋势，且溃疡愈合率高于常温组（P＝0.033，HR＝0.452，95%CI 0.217~0.941）。 结论 在慢性下肢静脉性溃疡患者中，使用加热聚维酮碘溶液进行换药清创处理可以减轻患者换药清创时的疼痛强度，维持伤口床温度的稳定，促进溃疡愈合。 Abstract:Objective To investigate the effect of heated povidone iodine solution on pain intensity and ulcer healing in patients with chronic venous leg ulcer after debridement and dressing change. Methods A total of 58 patients with chronic venous leg ulcer who first visited outpatients and wards of Department of Cardiovascular Surgery, Department of Burns and Department of Plastic Surgery of The First Affiliated Hospital of Naval Medical University from Jun. 1, 2023, to Jun. 1, 2024 were enrolled and randomly assigned to heated group (using 38 ℃ povidone iodine solution for debridement and flushing, n＝29) or normal group (using 24 ℃ povidone iodine solution for debridement and flushing, n＝29). The general baseline data of the 2 groups were compared, the pain intensity and wound bed temperature before and after debridement and dressing change were evaluated, and the change of pressure ulcer scale score for healing during the observation period and ulcer healing rate were observed. Results There were no significant differences between the 2 groups in age, gender, smoking, body mass index, whether the ulcer exudates, infection, duration of ulcer, ulcer area, pressure ulcer scale score for healing or analgesic use within 24 h (all P > 0.05). There was no significant difference in pain intensity between the 2 groups before or after dressing change and debridement (both P > 0.05). The pain intensity during debridement in the heated group was lower than that in the normal group (P < 0.05). There was no significant difference in the temperature of wound bed before flushing between the 2 groups (P > 0.05). The temperature of wound bed in the heated group was significantly higher than that in the normal group immediately after flushing and at the end of debridement and dressing change (P < 0.01, P < 0.05). The pressure ulcer scale score for healing in the heated group showed a trend of being lower than that in the normal group during the observation period, and the ulcer healing rate was significantly higher than that in the normal group (P＝0.033, hazard ratio＝0.452, 95% confidence interval 0.217-0.941). Conclusion In patients with chronic venous leg ulcer, the use of heated povidone iodine solution can reduce the pain intensity during dressing change and debridement, maintain the stability of wound bed temperature, and promote the healing of ulcer. -
Keywords:
- lower extremity venous ulcer /
- povidone iodine /
- pain /
- wound healing /
- temperature /
- prognosis
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下肢静脉性溃疡（venous leg ulcer，VLU）是由持续或慢性静脉功能不全、静脉高压引起的下肢开放性皮肤损伤，占所有下肢慢性伤口的70%以上[1]。在中国，下肢慢性静脉功能不全的患病率为8.89%，其中VLU占1.5%[2]。VLU因伤口渗出的恶臭导致患者社交尴尬，严重影响患者的生活质量，但该病发病机制复杂、病程长、治疗难度大，2023年统计显示诊断和管理该疾病的花销约占西方国家年度医疗预算的2%[3]。
VLU的治疗选择包括药物治疗、压力治疗、外科治疗、溃疡创面处理等。对于VLU患者，应在仔细评估后，按照病情特点采用合适的方法或进行综合治疗，但所有治疗的基础都离不开溃疡创面的清洁与护理。临床实践中经常需要对溃疡创面进行冲洗，有研究评价了伤口敷料所用溶液的类型和清洁方法，发现除了冲洗溶液的选择外，冲洗液体的温度也很重要[4]。关于冲洗溶液的温度及其对伤口床温度、患者疼痛和舒适度影响的研究较少。聚维酮碘作为一种临床最常用的局部抗菌剂，虽然有研究显示其具有剂量依赖性的细胞毒性，但是由于具有广谱抗菌活性、鲜有耐药性、对生物膜的高效力、良好的耐受性和对过度炎症反应的作用，在VLU治疗中仍然有着重要作用。本研究旨在评估在VLU创面清创换药过程中，使用加热聚维酮碘溶液对患者疼痛程度、伤口床温度和溃疡愈合的影响。
1 资料和方法
1.1 研究设计
本研究为开放、随机、对照、比较性临床研究，分配比为1∶1。本研究根据《赫尔辛基宣言》规定进行，研究小组在首次接触患者时即邀请他们参加研究，同意入组的患者被告知相关研究程序并签署了知情同意书。共纳入来源于海军军医大学第一附属医院血管外科、烧伤科、整形外科门诊及病房的慢性VLU患者58例，患者首次就诊时间为2023年6月1日至2024年6月1日。随访观察截止到入组后3个月或溃疡愈合。
纳入标准：（1）年龄为18~80岁，性别不限；（2）诊断为慢性VLU（由医学专业人员使用下肢血管超声或根据静脉循环受损的临床体征诊断）且溃疡创面持续存在超过2周；（3）溃疡创面面积为2~50 cm2；（4）随机血糖≤11.1 mmol/L；（5）规范进行微粒化黄酮类药物治疗及压力治疗；（6）同意参加研究并完成相关知情同意书签署。
排除标准：（1）长期使用免疫抑制剂或糖皮质激素的患者；（2）有结核性溃疡、癌性溃疡、梅毒性溃疡或麻风性溃疡的患者；（3）伴有下肢动脉硬化闭塞症的患者；（4）患有严重肝病、肾病的患者（血白蛋白＜30 g/L）；（5）随访期间行外科手术或植皮治疗者；（6）已经参加其他临床研究的患者；（7）拒绝随访或完成问卷调查的患者。
1.2 样本量估计
根据通过数字等级评定量表测量的疼痛强度估计样本量。依据既往的横断面研究，以静脉性溃疡患者在清创冲洗前后的疼痛强度作为参考[5]。在与对照组相比平均疼痛强度差异＞2分且置信水平为95%（α＝0.05）、统计功效为80%（β＝0.2）的情况下，所需的最小总样本量估计为50名参与者[6]。
1.3 研究程序
使用简单随机化方法将入组患者分为两组（加热组和常温组），除使用聚维酮碘温度不同外其余治疗均相同。加热组按照既往制定的方案，使用医用恒温保温箱将聚维酮碘溶液加热至38 ℃；在使用前，确保聚维酮碘溶液加热完毕并用红外线温度计（非接触式数字临床温度计）检查溶液的温度。常温组将在室温下使用的聚维酮碘溶液储存在清创室内，通过中央空调将室温稳定在约24 ℃，并通过室温温度计验证；同时在使用前以与加热组相同的方式检查温度。由同一研究人员评估所有溶液的温度。
完成患者随机分组后，由研究团队1名经过培训的伤口护理医师在护士的陪同下进行所有冲洗、清创操作。其间记录患者的疼痛评分及伤口床温度，并对入组患者进行压力治疗科普教育，整个治疗周期内患者均接受科学规范的弹性绷带压力治疗。
1.4 数据收集
在观察期间使用问卷调查方法完成数据收集，包括3个部分的内容：第一部分为患者一般基线资料调查，由患者入组时完成；第二部分主要涉及伤口床温度变化、溃疡相关变量、疼痛强度等，由进行清创操作的伤口护理医师完成；第三部分为随访周期内患者溃疡愈合的情况，由1名对分组不知情的研究人员填写。
1.5 结果变量
收集患者一般基线资料，如性别和年龄等。使用压疮愈合量表对静脉溃疡面积、渗出液情况及创面组织类型进行量化评分，评估伤口愈合情况[7-8]。同时评估溃疡持续时间、有无渗出液、有无感染、溃疡面积、清创冲洗前24 h内是否使用镇痛药等。
1.5.1 疼痛强度
在清创前、清创时、清创后即刻，使用0（无疼痛）~10（剧烈疼痛）数字等级评定量表评估患者的疼痛强度[9-10]。
1.5.2 伤口床温度
通过中央空调将清创室温度稳定在约24 ℃，并通过室温温度计验证。在第1周首次换药冲洗前、冲洗后即刻、清创换药完成时，用红外线温度计对伤口床温度进行测量。
1.5.3 溃疡愈合
溃疡愈合定义为溃疡创面完全闭合，并由1名对分组不知情的研究人员记录随访周期内患者的溃疡愈合情况，并通过观察创面有无持续1周的上皮化对结果予以验证。
1.6 统计学处理
使用Stata 17.0软件对数据进行分析。使用Shapiro-Wilk检验分析计量资料的正态性，当数据满足正态分布且方差齐性时以x±s表示，两组间比较采用独立样本t检验；当数据达不到正态分布的条件时以M（Q1，Q3）表示，两组间比较采用Mann-Whitney U检验；对于存在时间因素的变量分析采用双因素方差分析。计数资料以例数和百分数表示，组间比较采用χ2检验或Fisher确切概率法。采用生存曲线分析溃疡愈合率。检验水准（α）为0.05。
2 结果
2.1 基线资料
两组慢性VLU患者的年龄、性别构成、吸烟史及BMI等指标差异均无统计学意义（均P＞0.05），清创前溃疡相关指标（包括是否有渗出液、是否有感染、溃疡持续时间、溃疡面积、压疮愈合量表评分）及24 h内镇痛药物使用情况在两组间比较差异亦均无统计学意义（均P＞0.05）。见表 1。
表 1 慢性VLU患者的社会人口学和基线临床特征Table 1 Sociodemographic and baseline clinical characteristics of chronic VLU patientsN＝29 Variable Heated group Normal group Statistic P value Age/year, x±s 60.17±15.12 62.38±16.39 t＝0.534 0.596 Gender, n (%) χ2＝0.069 0.792 Male 16 (55.17) 15 (51.72) Female 13 (44.83) 14 (48.28) History of smoking, n (%) 8 (27.59) 9 (31.03) χ2＝0.083 0.773 BMI/(kg·m－2), x±s 29.39±4.31 30.29±6.39 t＝0.629 0.532 Exudate, n (%) 16 (55.17) 19 (65.52) χ2＝0.648 0.421 Infection, n (%) 18 (62.07) 16 (55.17) χ2＝0.284 0.594 Ulcer duration/week, M (Q1, Q3) 4.81 (3.19, 6.02) 5.14 (3.12, 6.29) U＝146.000 0.269 Ulcer area/cm2, M (Q1, Q3) 8.35 (3.69, 26.35) 6.39 (5.38, 28.72) U＝351.500 0.142 Pressure ulcer scale score for healing, x±s 11.69±3.94 13.29±4.69 t＝1.407 0.165 Use of analgesic drugs, n (%) 9 (31.03) 7 (24.14) χ2＝0.345 0.557 Heated group: The patients were treated with heated povidone iodine solution (38 ℃); Normal group: The patients were treated with room temperature povidone iodine solution (24 ℃). VLU: Venous leg ulcer; BMI: Body mass index. 2.2 疼痛强度变化
在随访观察期间，将每周的第1次清创换药操作设置为评估节点，在清创前、清创时、清创后即刻对疼痛强度进行评估，结果如图 1所示。在整个观察期间，清创前两组疼痛强度差异无统计学意义（均P＞0.05，图 1A），清创时加热组患者在各评估节点的疼痛强度均低于常温组（均P＜0.05，图 1B），清创后即刻两组患者的疼痛强度差异消失（均P＞0.05，图 1C）。
图 1 慢性VLU患者在不同阶段的疼痛强度Fig. 1 Pain intensity of patients with chronic VLU at different stagesA: Before debridement and dressing change; B: During debridement and dressing change; C: Immediately after debridement and dressing change. Heated group: The patients were treated with heated povidone iodine solution (38 ℃); Normal group: The patients were treated with room temperature povidone iodine solution (24 ℃). *P < 0.05 vs normal group at the same time point. n＝29, x±s. VLU: Venous leg ulcer.
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2.3 伤口床温度变化
在第1周首次换药冲洗前、冲洗后即刻、清创换药完成时3个时间点对伤口床温度进行测量，结果如图 2所示。在冲洗前，两组伤口床温度差异无统计学意义（P＞0.05）。在冲洗后即刻和清创换药完成时，加热组患者的伤口床温度均高于常温组，差异均有统计学意义（P＜0.01、P＜0.05）。
图 2 慢性VLU患者的伤口床温度变化趋势Fig. 2 Trend of temperature change in wound bed of chronic VLU patientsHeated group: The patients were treated with heated povidone iodine solution (38 ℃); Normal group: The patients were treated with room temperature povidone iodine solution (24 ℃).*P < 0.05, **P < 0.01 vs normal group at the same time point. n＝29, x±s. VLU: Venous leg ulcer.下载:
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2.4 压疮愈合量表评分
在随访观察期间，将每周的第1次操作设置为评估节点，记录两组患者压疮愈合量表评分变化趋势，结果如表 2所示。加热组患者的压疮愈合量表评分存在低于常温组患者的趋势。
表 2 慢性VLU患者的压疮愈合量表评分变化Table 2 Pressure ulcer scale for healing score of patients with chronic VLUn＝29, x±s Time/week Normal group Heated group t value P value 1 13.72±2.95 12.76±3.02 2.524 0.015 2 13.81±2.75 12.65±2.69 1.623 0.110 3 12.26±1.94 11.81±1.93 0.886 0.370 4 12.52±1.85 10.01±1.79 5.251 ＜0.001 5 11.56±1.68 9.75±1.87 3.886 ＜0.001 6 11.02±1.63 9.02±2.36 3.762 ＜0.001 7 9.53±1.52 8.93±1.46 1.533 0.131 8 8.62±1.89 8.56±1.72 0.126 0.900 9 9.88±0.98 8.49±1.95 3.430 0.001 10 8.77±1.59 6.97±2.06 3.725 ＜0.001 11 7.82±1.64 5.32±2.13 5.008 ＜0.001 12 7.53±1.53 4.72±1.96 6.086 ＜0.001 Heated group: The patients were treated with heated povidone iodine solution (38 ℃); Normal group: The patients were treated with room temperature povidone iodine solution (24 ℃). VLU: Venous leg ulcer. 2.5 溃疡愈合情况
由生存曲线（图 3）可见，加热组患者的溃疡愈合率高于常温组（P＝0.033，HR＝0.452，95%CI 0.217~0.941）。
图 3 两组慢性VLU患者的溃疡愈合情况分析Fig. 3 Ulcer healing rate analysis of patients with chronic VLUHeated group: The patients were treated with heated povidone iodine solution (38 ℃); Normal group: The patients were treated with room temperature povidone iodine solution (24 ℃). VLU: Venous leg ulcer; HR: Hazard ratio; 95%CI: 95% confidence interval.下载:
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3 讨论
静脉性溃疡是慢性伤口最常见的病因[11]。慢性伤口的护理不仅造成了卫生服务的重大负担，还显著影响患者的生活质量[12]。既往多项多中心研究旨在解决慢性伤口患者更换敷料期间的疼痛问题[10, 13]。在本研究中，大多数患者在整个研究期间报告了轻度疼痛，27.6%（16/58）的患者需要在清创换药前24 h内服用镇痛药物。在临床实践中，能最大限度减轻疼痛的干预措施已成为慢性伤口患者护理的重要组成部分。
在临床其他操作过程中，对冲洗清洁溶液进行加热可以明显缓解患者的疼痛症状[14-15]，所以本研究假设使用加热的冲洗溶液可缓解患者更换辅料时的疼痛。在许多可用的抗菌剂中，基于碘载体的制剂如聚维酮碘在抗菌和伤口冲洗处置中一直很受欢迎，其具有广谱抗菌活性、穿透生物膜的能力、低耐药性、抗炎特性、低细胞毒性和良好的耐受性，而且在临床实践中也没有观察到其对伤口愈合有负面影响。
伤口床温度在伤口愈合过程中的重要性也正被临床研究者重视，甚至被认为是判断伤口愈合环境改善的一个新参数。既往研究证实，局部辐射加热显著增加局部皮肤血流量，并可能增强愈合伤口环境中的局部固有免疫[16]。更换辅料并使用冲洗液冲洗创面会使伤口床的平均温度下降约2 ℃，而恢复到冲洗前的温度大约需要23 min[17]。虽然目前关于伤口床温度变化的研究很少，对于慢性伤口床温度的正常范围也无共识[18]，但加热清洁溶液以减少敷料更换期间热损失的影响可能对伤口愈合有着重要作用。
在本研究中，当使用加热的聚维酮碘溶液冲洗时，伤口床温度可稳定在33~35 ℃，而使用常温聚维酮碘溶液冲洗时伤口床温度出现明显波动。先前研究已经证实，较高的伤口床温度与较好的压疮愈合量表评分呈正相关[19]。在本研究中，使用加热聚维酮碘溶液冲洗伤口的慢性VLU患者溃疡愈合率高于使用常温聚维酮碘溶液冲洗伤口的患者，与先前研究结果[19]相符。虽然间歇使用后监测到稳定的伤口床温度可能不足以持续影响伤口愈合，但使用加热聚维酮碘溶液冲洗后进行清创换药时血管舒张，以及对创面生物膜的破坏可能会给伤口愈合带来更大的益处。
由于慢性伤口患者需要隔天和长期更换敷料和换药处理，而敷料更换可能会带来疼痛和压力，因此提高患者舒适度是最基本的要求之一。虽然目前没有评估慢性伤口成人舒适度的量表，但本研究采用数字等级评定量表，将疼痛症状作为一种主观现象进行评估，结果也证实使用加热聚维酮碘溶液可以为慢性VLU的患者带来更好的舒适度。
综上所述，在慢性VLU患者中，使用加热聚维酮碘溶液进行换药清创处理可以维持伤口床温度的稳定，改善患者更换辅料时的舒适度，促进溃疡愈合。
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图 1 慢性VLU患者在不同阶段的疼痛强度
Fig. 1 Pain intensity of patients with chronic VLU at different stages
A: Before debridement and dressing change; B: During debridement and dressing change; C: Immediately after debridement and dressing change. Heated group: The patients were treated with heated povidone iodine solution (38 ℃); Normal group: The patients were treated with room temperature povidone iodine solution (24 ℃). *P < 0.05 vs normal group at the same time point. n＝29, x±s. VLU: Venous leg ulcer.
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图 2 慢性VLU患者的伤口床温度变化趋势
Fig. 2 Trend of temperature change in wound bed of chronic VLU patients
Heated group: The patients were treated with heated povidone iodine solution (38 ℃); Normal group: The patients were treated with room temperature povidone iodine solution (24 ℃).*P < 0.05, **P < 0.01 vs normal group at the same time point. n＝29, x±s. VLU: Venous leg ulcer.
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图 3 两组慢性VLU患者的溃疡愈合情况分析
Fig. 3 Ulcer healing rate analysis of patients with chronic VLU
Heated group: The patients were treated with heated povidone iodine solution (38 ℃); Normal group: The patients were treated with room temperature povidone iodine solution (24 ℃). VLU: Venous leg ulcer; HR: Hazard ratio; 95%CI: 95% confidence interval.
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表 1 慢性VLU患者的社会人口学和基线临床特征
Table 1 Sociodemographic and baseline clinical characteristics of chronic VLU patients
N＝29 Variable Heated group Normal group Statistic P value Age/year, x±s 60.17±15.12 62.38±16.39 t＝0.534 0.596 Gender, n (%) χ2＝0.069 0.792 Male 16 (55.17) 15 (51.72) Female 13 (44.83) 14 (48.28) History of smoking, n (%) 8 (27.59) 9 (31.03) χ2＝0.083 0.773 BMI/(kg·m－2), x±s 29.39±4.31 30.29±6.39 t＝0.629 0.532 Exudate, n (%) 16 (55.17) 19 (65.52) χ2＝0.648 0.421 Infection, n (%) 18 (62.07) 16 (55.17) χ2＝0.284 0.594 Ulcer duration/week, M (Q1, Q3) 4.81 (3.19, 6.02) 5.14 (3.12, 6.29) U＝146.000 0.269 Ulcer area/cm2, M (Q1, Q3) 8.35 (3.69, 26.35) 6.39 (5.38, 28.72) U＝351.500 0.142 Pressure ulcer scale score for healing, x±s 11.69±3.94 13.29±4.69 t＝1.407 0.165 Use of analgesic drugs, n (%) 9 (31.03) 7 (24.14) χ2＝0.345 0.557 Heated group: The patients were treated with heated povidone iodine solution (38 ℃); Normal group: The patients were treated with room temperature povidone iodine solution (24 ℃). VLU: Venous leg ulcer; BMI: Body mass index. 表 2 慢性VLU患者的压疮愈合量表评分变化
Table 2 Pressure ulcer scale for healing score of patients with chronic VLU
n＝29, x±s Time/week Normal group Heated group t value P value 1 13.72±2.95 12.76±3.02 2.524 0.015 2 13.81±2.75 12.65±2.69 1.623 0.110 3 12.26±1.94 11.81±1.93 0.886 0.370 4 12.52±1.85 10.01±1.79 5.251 ＜0.001 5 11.56±1.68 9.75±1.87 3.886 ＜0.001 6 11.02±1.63 9.02±2.36 3.762 ＜0.001 7 9.53±1.52 8.93±1.46 1.533 0.131 8 8.62±1.89 8.56±1.72 0.126 0.900 9 9.88±0.98 8.49±1.95 3.430 0.001 10 8.77±1.59 6.97±2.06 3.725 ＜0.001 11 7.82±1.64 5.32±2.13 5.008 ＜0.001 12 7.53±1.53 4.72±1.96 6.086 ＜0.001 Heated group: The patients were treated with heated povidone iodine solution (38 ℃); Normal group: The patients were treated with room temperature povidone iodine solution (24 ℃). VLU: Venous leg ulcer. -
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