外用噻吗洛尔治疗浅表婴幼儿血管瘤的近期疗效与安全性评价

Safety and short-term efficacy of timolol for the treatment of superficial infantile hemangiomas

目的评价外用噻吗洛尔治疗浅表婴幼儿血管瘤的近期疗效与安全性。方法2012年3月至2012年9月对109例浅表婴幼儿血管瘤根据家属自愿的原则分为治疗组（外涂噻吗洛尔滴眼液）89例和观察组20例。记录患儿的姓名、性别、年龄、瘤体部位、瘤体大小、颜色、质地的改变及不良反应等。由3名具有临床经验的专科医生结合图片等相关资料，对患儿用药前及用药后1周、3个月的疗效分别进行评价。疗效评定分为三级，I级（无效），Ⅱ级（控制生长），Ⅲ级（促进消退），有效率表示Ⅱ级和Ⅲ级病例数的总和占总体的百分比，消退率表示Ⅲ级病例数占总体的百分比。结果治疗组在涂药1周后大部分患儿可见瘤体颜色开始变暗、质地变软；涂药3个月时，Ⅲ级患儿达51例，其中完全消退或仅残留毛细血管扩张的有10例，Ⅱ级31例，I级7例。总体有效率为92．1％，消退率为57．3％。治疗3个月后患儿年龄6个月以内组和6个月以上组的有效率分别为93．6％和88．5％，差异无统计学意义（P〉0．05），而消退率分别为65．1％和38．5％，差异有统计学意义（P〈O．05）。所有患儿在治疗过程中均未发现全身或局部不良反应。观察组在3个月后I级13例（65％），Ⅱ级6例（30％），Ⅲ级1例（5％），有效率和消退率分别为35％和5％，明显低于治疗组，差异有统计学意义（P〈0．05）。结论外用噻吗洛尔对浅表婴幼儿血管瘤疗效明显，安全性较高，无全身或局部不良反应发生，可作为治疗6个月以内增生期浅表婴幼儿血管瘤的方法之一。

Objective To evaluate the safety and short-term efficacy of timolol for the treatment of superficial infantile hemangiomas. Methods From March 2012 to September 2012,109 infants with superficial hemangiomas were treated with topical application of Timolol eyedrops. Parents clinical data including gender, age, hemangioma position and size were retrospectively analyzed. The changes of hemangioma size,color, texture and side effects during treatment were also recorded. The therapeutic effects were evaluated 1 week, and 3 months after Timolol treatment by 3 independent physicians. The therapeutic effects were rated as： ineffective, the lesion continued growing; partly effective, the lesion stops growing, but had no regression in size, color and texture; effective, the lesion became smaller and softer. Results A total of 89 patients received Timolol treatment, and 20 patients were observed as controls. One week after treatment, hemangioma became softer and smaller. Three months after treatment,the overall response was ineffective in 7 patients （7. 90//oo）, partly effective in 31 （34. 8~）, and effective in 51 （57. 3%）. Ten patients＇ hemangioma completely disappeared. In the control group, the overall response was ineffective in 13 patients （65% ）, partly effective in 6 （30 %）, and effective in 1 （50%）. The regression rate and effectiveness of Timolol treated group were significantly better than those of the control group （P〈0. 05）. The percentage of patients with effective treatment was not significantly different between the 1-6 months group and the 7-12 months group （P〈0. 05）. The hemangioma regression rate of the 1-6 months group was significantly better than that of the 7-12 months group （P〈0. 05）. No side effects were observed. Conclusions Topical timolol is safe and effective for the treatment of superficial infantile hemangiomas.