噻吗洛尔滴眼液外敷治疗中低风险婴儿血管瘤532例疗效及安全性评价

Efficacy Evaluation and Safety of Topical Timolol Maleate Eye Drops for Treating of 532 Patients with Middle and Low Risk Infantile Hemangiomas

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(χ^2=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。

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.