杨挺 李娣 浦洁

[摘要]目的：探究噻吗洛尔滴眼液持续外敷治疗中低度风险婴儿血管瘤的临床疗效及安全性。方法：选择2016年3月-2018年2月在无锡市儿童医院治疗的532例中低风险血管瘤患儿。根据家属自愿的原则分为实验组287例，对照组245例。实验组：皮损处噻吗洛尔滴眼液持续外敷1h，每日2次;对照组：皮损处噻吗洛尔滴眼液外敷20min，每日2次。每4周门诊复查，随访6个月～1年。将每例患儿治疗4个月的临床图片进行疗效评估，并记录局部皮肤不良反应。结果：根据Achauer疗效评定法判定临床疗效，Ⅱ级以上为有效。结果显示持续外敷1h有效率优于外敷20min，差异有统计学意义（χ2=31.4386，P<0.01）。局部皮肤不良反应包括红斑、脱皮、结痂，两组间比较无显著性差异。结论：噻吗洛尔滴眼液治疗中低度风险婴儿血管瘤安全、有效。

[关键词]婴儿血管瘤;噻吗洛尔;持续外敷;临床疗效;安全性

[中图分类号]R732.2    [文献标志码]A    [文章编号]1008-6455（2020）04-0041-03

Abstract： Objective  To study the clinical efficacy and safety of continuous topical application of timolol maleate eye drops in the treatment of middle and low risk infantile hemangiomas （IHs）. Methods  From March 2016 to February 2018， 532 children with middle and low risk IHs who were treated in Wuxi children's hospital were recruited. The subjects were divided into experimental group（287 patients） and control group（245 patients） according to the the principle of voluntary participation. In the experimental group， Timolol Maleate Eye Drops were continuously applied for 1 hour twice a day， while in the control group， Timolol Maleate Eye Drops were applied for 20 minutes twice a day. Follow-up visits were conducted every 4 weeks from 6 months to 1 year.  The clinical picture of each child after 4 months of treatment was evaluated and local skin adverse reactions were recorded. Results  The clinical efficacy was determined by the Achauer curative effect evaluation method. In this study， Level II or above was effective. The results showed that the effective rate of continuous external application for 1h was better than external application for 20min， and the difference was statistically significant（χ2=31.4386，P<0.01）. Local skin adverse reactions included erythema， desquamation and scab， and there was no significant difference between the two groups. Conclusion  Timolol Maleate Eye Drops appears to be an efficacy and safety drug in First Line Treatment of middle and low risk IHs， and our large sample study provides powerful evidence and experience for the continuous topical application of Timolol Maleate Eye Drops in the treatment of middle and low risk IHs.

Key words： infantile hemangiomas; timolol maleate; continuous external application; clinical efficacy; safety

嬰儿血管瘤（infantile hemangiomas，IH）是婴儿最常见的良性皮肤肿瘤[1-2]。该病主要病理特征为血管内皮细胞增殖，常于婴儿出生后不久出现，6个月龄内为快速生长期，6～12个月龄为稳定期，l岁后进入消退期。IH在早期可以有快速变化，可以看到小“充血性”或“擦伤样”斑片迅速演变成鲜红色肿瘤。在没有治疗干预的情况下，一般仅30%的IH会完全消退，而且无法估算完全消退时间、消退程度及是否会留有后遗症，这也是让家长感到惊慌的原因[3]。

IH在全身各部位均可发生，但最常见于头颈部（60%），其次为躯干（25%），再次为四肢（15%）。在女孩中比男孩更常见，从3：1到5：1不等[4]。IH治疗方法很多，但自口服普萘洛尔成功治疗IH以来，IH的治疗选择已大大改变。许多临床研究已证明普萘洛尔治疗的有效性和安全性，使得其成为中高风险IH的一线治疗方案[5]。……