Singh Sunita, Srivastava Niraj Kumar, Upadhyaya Amrita, Kumar Mrityunjay, Pawar Neeraj, Kapoor Rohit
Department of Paediatric Surgery, All India Institute of Medical Sciences, Raebareli, Uttar Pradesh, India.
Department of General Surgery, All India Institute of Medical Sciences, Raebareli, Uttar Pradesh, India.
J Indian Assoc Pediatr Surg. 2025 May-Jun;30(3):308-316. doi: 10.4103/jiaps.jiaps_256_24. Epub 2025 Apr 10.
To compare the efficacy of two topical agents in superficial infantile hemangioma (SIH).
A Randomised controlled trial was carried out with details as follows.
A prospective double-blinded, double-armed, randomized controlled trial.
Multidisciplinary unit from 2022 to 2024.
Children younger than 2 years with color Doppler-confirmed SIH (superficial to deep dermal fascia).
Randomization in treatment arm I: topical beta-blocker 0.5% timolol maleate (TTM) solution or treatment arm II: ultrapotent topical Steroid 0.05% clobetasol propionate ointment.
(1) reduction in area, (2) color change on visual analog scale (VAS), and (3) total VAS scores for color, size, and thickness. Each VAS parameter was rated from 0 to 3 (cumulative score 0-9).
Twenty patients were enrolled in each arm. Four patients in each group missed 96 weeks of follow up assessment but completed at least 9 months of treatment. In arm I, two patients were transitioned from TTM to oral propranolol due to rapid progression deep into the dermis. Arm I demonstrated a quicker improvement in color with a steeper reduction in area. The mean total VAS score on 9-point sales was comparable in both arms at 3 months, 6 months, 12 months, 18 months, and 24 months of treatment ( = 0.223, = 0.123, = 0.123, = 0.123, and = 0.103). At the end of the 96 week, both treatments achieved an excellent response ( = 0.634) with no rebound growth.
0.5%-TTM solution can be a first-line therapy for SIH due to its rapid onset of action and overall comparable efficacy in reducing SIH size. While clobetasol remains effective, its slower response may limit its utility.
比较两种局部用药治疗婴幼儿浅表性血管瘤（SIH）的疗效。
进行了一项随机对照试验，具体细节如下。
一项前瞻性双盲、双臂随机对照试验。
2022年至2024年的多学科科室。
年龄小于2岁、经彩色多普勒确诊为SIH（累及真皮浅层至深层筋膜）的儿童。
治疗组I随机使用局部β受体阻滞剂0.5%噻吗洛尔马来酸盐（TTM）溶液，治疗组II随机使用超强效局部类固醇0.05%丙酸氯倍他索软膏。
（1）面积缩小情况，（2）视觉模拟评分法（VAS）评估的颜色变化，以及（3）颜色、大小和厚度的VAS总评分。每个VAS参数的评分范围为0至3分（累计评分0至9分）。
每组纳入20例患者。每组有4例患者未进行96周的随访评估，但至少完成了9个月的治疗。在治疗组I中，有2例患者因病变迅速深入真皮而从TTM转换为口服普萘洛尔。治疗组I在颜色改善方面更快，面积缩小更明显。在治疗3个月、6个月、12个月、18个月和24个月时，两组9分制的平均VAS总评分相当（分别为=0.223、=0.123、=0.123、=0.123和=0.103）。在96周结束时，两种治疗方法均取得了良好的疗效（=0.634），且无复发增长。
0.5% - TTM溶液可作为SIH的一线治疗方法，因为其起效迅速，在缩小SIH大小方面总体疗效相当。虽然丙酸氯倍他索仍然有效，但其反应较慢可能会限制其应用。
