Efficacy of collagenase ointment in treating deep partial-thickness burn wounds in infants and young children
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摘要:
目的 探讨胶原酶软膏治疗婴幼儿深Ⅱ度烧伤创面的效果。 方法 该研究为回顾性队列研究。2019年9月—2023年9月,中国医科大学附属第四医院收治40例符合入选标准的深Ⅱ度烧伤婴幼儿,其中男22例、女18例,年龄10~36个月。根据创面处理方式,将患儿分为行前期胶原酶软膏+后期凡士林油纱治疗的观察组（20例）和仅行凡士林油纱治疗的对照组（20例）。统计患儿创面坏死组织脱落时间、创面愈合时间；在每次换药时和治疗后每2天,采用新生儿婴儿疼痛量表（NIPS）、CRIES疼痛评分量表、儿童疼痛行为量表FLACC评估患儿疼痛情况,取多次测量的均值进行统计分析；统计在治疗开始后7 d内患儿不良症状持续时间,以及治疗期间患儿不良反应、创面感染发生情况与病原微生物检出情况。 结果 观察组患儿创面坏死组织脱落时间和创面愈合时间分别为（4.2±2.8）、（15.4±3.2）d,显著短于对照组的（8.3±1.5）、（22.8±2.1）d（均数差值分别为-4.2、-7.3 d,95%CI分别为-5.6~-2.7、-9.0~-5.6 d,t值分别为6.656、9.354,P值均<0.05）。协方差分析显示,在校正潜在混杂因素后,观察组患儿创面坏死组织脱落时间与创面愈合时间仍均显著短于对照组（均数差值分别为-4.1、-7.4 d,95%CI分别为-5.5~-2.7、-9.1~-5.7 d,F值分别为25.831、68.152,P<0.05）。每次换药时和治疗后每2天,2组患儿疼痛的NIPS、CRIES疼痛评分量表、FLACC评分比较,差异均无统计学意义（P>0.05）。在治疗开始后7 d内,观察组患儿不良症状持续时间为（2.0±0.7）d,显著短于对照组的（5.2±0.8）d（t=12.823,P<0.05）。治疗期间,观察组中发生不良反应、创面感染和检出病原微生物的患儿占比均低于对照组,但差异均无统计学意义（P>0.05）。 结论 胶原酶软膏能显著缩短婴幼儿深Ⅱ度烧伤创面坏死组织脱落时间和创面愈合时间,并缩短早期不良症状持续时间,尽管在降低疼痛评分和并发症发生率方面未显示显著优势,但其在临床应用中具有潜在价值。 Abstract:Objective To investigate the efficacy of collagenase ointment in treating deep partial-thickness burn wounds in infants and young children. Methods This study was a retrospective cohort study. From September 2019 to September 2023, 40 infants and young children with deep partial-thickness burns who met the inclusion criteria were admitted to the Fourth Affiliated Hospital of China Medical University. There were 22 males and 18 females, aged 10-36 months. According to the wound management method, the children were divided into observation group (n=20) treated with initial collagenase ointment followed by later vaseline gauze, and control group (n=20) treated with vaseline gauze alone. The wound necrotic tissue detachment time and wound healing time of pediatric patients were recorded. Pain of pediatric patients was assessed using the Neonatal Infant Pain Scale (NIPS), the CRIES pain score scale, and the children's pain behavior inventory FLACC during each dressing change and every 2 days after treatment, and the mean value of multiple measurements was used for statistical analysis. The duration of adverse symptoms of pediatric patients within 7 days after the start of treatment, as well as the occurrence of adverse reactions and wound infection, and detection of pathogenic microorganisms of pediatric patients during the treatment period were recorded. Results The wound necrotic tissue detachment time and wound healing time of pediatric patients in observation group were (4.2±2.8) and (15.4±3.2) d, respectively, which were significantly shorter than (8.3±1.5) and (22.8±2.1) d in control group (with mean differences of -4.2 and -7.3 d, respectively, 95% CI of -5.6--2.7 and -9.0--5.6 d, respectively, t values of 6.656 and 9.354, respectively, P values both <0.05). Analysis of covariance showed that after adjusting for potential confounding factors, the wound necrotic tissue detachment time and wound healing time of pediatric patients in observation group were still significantly shorter than those in control group (with mean differences of -4.1 and -7.4 d, respectively, 95% CI of -5.5--2.7 and -9.1--5.7 d, respectively, F values of 25.831 and 68.152, respectively, P<0.05). During each dressing change and every 2 days after treatment, there were no statistically significant differences in the NIPS, CRIES pain score scale, and FLACC scores for pain between the two groups of pediatric patients (P>0.05). Within 7 days after the start of treatment, the duration of adverse symptoms of pediatric patients in observation group was (2.0±0.7) d, which was significantly shorter than (5.2±0.8) d in control group (t=12.823, P<0.05). During the treatment period, the proportions of pediatric patients with adverse reactions, wound infection, and detected pathogenic microorganisms in observation group were lower than those in control group, but the differences were not statistically significant (P>0.05). Conclusions Collagenase ointment can significantly shorten the necrotic tissue detachment time and wound healing time of deep partial-thickness burn wounds in infants and young children, and shorten the duration of early adverse symptoms. Although it did not show significant advantages in reducing pain scores or incidence of complication, it has potential value in clinical application. -
Key words:
- Child /
- Burns /
- Infants and young children /
- Deep partial-thickness /
- Microorganisms /
- Collagenase /
- Enzymatic debridement /
- Wound repair
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参考文献
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图 1 前期胶原酶软膏+后期凡士林油纱治疗例1患儿左大腿深Ⅱ度烫伤创面的效果。1A.伤后第3天,见大片黄白色坏死真皮组织；1B.伤后第4天,使用胶原酶治疗；1C.伤后第8天,坏死组织减少；1D.伤后第11天,偏浅的深Ⅱ度创面愈合,偏深的深Ⅱ度创面无感染；1E.伤后第20天,创面基本愈合；1F.伤后第24天,创面完全愈合；1G.伤后第56天,愈合皮肤无破溃
图 2 前期胶原酶软膏+后期凡士林油纱治疗例2患儿左上肢深Ⅱ度烫伤创面的效果。2A.伤后第2天,创面基底呈现黄色坏死真皮；2B.伤后第4天,清创削痂前；2C.伤后第10天,继续使用胶原酶；2D.伤后第13天,黄色坏死组织大部分已经脱落；2E.伤后第22天,创面基本愈合；2F.伤后第25天,创面完全愈合；2G.伤后第100天,创面愈合处少量瘢痕增生,呈红色且无破溃现象
Table 1. 2组深Ⅱ度烧伤婴幼儿一般资料比较
组别 例数 性别（例） 致伤原因（例） 年龄（月, 伤后入院时间（d, 深Ⅱ度烧伤面积（%TBSA, 烧伤总面积（%TBSA, 男 女 热液烫伤 热金属烫伤 对照组 20 13 7 16 4 19±5 1.78±0.28 2.6±0.6 6.8±2.2 观察组 20 9 11 17 3 17±8 1.80±0.53 2.6±0.5 7.2±1.9 统计量值 χ2=1.621 — t=0.836 t=0.115 t<0.001 t=0.559 P值 0.204 0.677 0.413 0.910 >0.999 0.583 注：TBSA为体表总面积；对照组患儿创面仅行凡士林油纱治疗,观察组患儿创面行前期胶原酶软膏+后期凡士林油纱治疗；“—”表示无此项 
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Table 2. 2组深Ⅱ度烧伤婴幼儿疗效指标比较（
组别 例数 创面坏死组织脱落时间（d） 创面愈合时间（d） 疼痛评分（分） NIPS评分 CRIES疼痛评分量表评分 儿童疼痛行为量表FLACC评分 对照组 20 8.3±1.5 22.8±2.1 3.6±1.4 6.3±2.1 5.4±1.9 观察组 20 4.2±2.8 15.4±3.2 3.3±1.2 6.0±1.7 5.1±1.5 均数差值（95%CI） -4.2（-5.6~-2.7） -7.3（-9.0~-5.6） -0.3（-1.2~0.6） -0.3（-1.6~1.0） -0.3（-1.0~1.1） t值 6.656 9.354 0.817 0.580 0.701 P值 <0.001 <0.001 0.424 0.568 0.492 注：对照组患儿创面仅行凡士林油纱治疗,观察组患儿创面行前期胶原酶软膏+后期凡士林油纱治疗；每次换药时和治疗后每2天进行1次疼痛评估,取多次测量的均值进行统计分析；NIPS为新生儿婴儿疼痛量表；CRIES为crying, requires oxygen, increased vital signs, expression, sleeplessness；FLACC为face, legs, activity, cry, consolability
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Table 3. 2组深Ⅱ度烧伤婴幼儿不良症状和不良反应及创面感染相关情况比较
组别 例数 不良症状持续时间（d, 不良反应（例） 创面感染（例） 病原微生物（例） 有 无 有 无 有 无 对照组 20 5.2±0.8 4 16 3 17 4 16 观察组 20 2.0±0.7 2 18 2 18 1 19 统计量值 t=12.823 — — — P值 <0.001 0.445 0.567 0.135 注：对照组患儿创面仅行凡士林油纱治疗,观察组患儿创面行前期胶原酶软膏+后期凡士林油纱治疗；不良症状持续时间为在治疗开始后7 d内的统计数据,其余指标均为治疗期间的统计数据；“—”表示无此项
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