小剂量普萘洛尔口服治疗婴儿血管瘤的近期疗效与安全性评价

Treatment of infantile hemangiomas with low-dose propranolol ： evaluation of short-term efficacy and safety

目的评价小剂量普萘洛尔口服治疗婴儿血管瘤的近期疗效与安全性。方法2008年10月至2009年5月，共58例血管瘤患儿在山东省临沂市肿瘤医院和上海交通大学医学院附属第九人民医院接受并完成普萘洛尔治疗。男19例，女39例；年龄1～12个月，平均4个月；血管瘤大小为1．5cm×1．0cm～18．0cm×5．0cm，浅表血管瘤27例，深部血管瘤9例，混合型血管瘤22例；病变位于头颈部41例，四肢和躯干12例，阴唇2例，肛周、会阴、阴囊各1例。普萘洛尔1．0～1．5mg／kg，每天1次顿服，连续服用。住院治疗7～10d后，出院连续服药，每2周复诊，动态观察和记录血管瘤大小、质地、颜色变化，观察并随时处理治疗过程中出现的不良反应。按4级评分法对近期疗效进行评价。结果服药后24h，所有患儿瘤体张力均有不同程度减小，颜色开始变淡，体积开始缩小，5～7d内变化最显著。服药2个月者7例，3个月者22例，4个月者21例，5个月者8例。随访5—9个月，疗效评定为Ⅳ级（优）者10例（17．2％），Ⅲ级（好）35例（60．4％），Ⅱ级（中）12例（20．7％），I级（差）1例（1．7％）。深部血管瘤的疗效显著优于浅表型血管瘤（P〈0．05），但不同部位血管瘤之间疗效差异无统计学意义（P〉0．05）。主要不良反应为心率减慢（100％），腹泻（37例，63．8％）和睡眠改变（21例，30．2％），均未造成严重影响，经对症处理，全部恢复正常。结论普萘洛尔小剂量121服治疗婴儿血管瘤近期疗效良好，不良反应轻微，可作为婴儿血管瘤的一线治疗药物。

Objective To evaluate the short-term efficacy and safety of propranolol in the treatment of infantile hemangiomas. Methods Between October 2008 and May 2009, oral propranolol was applied to 58 infants with heamngiomas at a dose of 1.0 - 1.5 mg per kilogram of body weight per day in Linyi, Shandong and Shanghai. There were 19 males and 39 females 1 to 12 months old with a mean age of 4 months. The primary tumor size was 1.5cm×1.0cm～18.0cm×5.0cm. Twenty-seven were superficial, nine deep-seated and 22 mixed. The tumors were located in head and neck （ n = 41 ） , trunk and extremities （ n = 12 ） , labium vulvae （ n = 2 ） , perianal region （ n = 1 ） , perineum （ n = 1 ） and scrotum （ n = 1 ）. The patients were hospitalized for 7 to 10 days, continued medication at home and revisited every 2 weeks. The changes of tumor size, texture and color were monitored and recorded at a regular interval. The adverse effects after medication were observed and managed accordingly. The short-term results were evaluated using a 4-point scale system. Results At 24 hours post-medication, all the tumors decreased in density, color and size. The changes became conspicuous within 5 to 7 days. Seven patients had medication for 2 months, 22 for 3 months, 21 for 4 months and 8 for 5 months. The follow-up period was 5 to 9 months. The overall response was scale I （poor） in 1 patient （ 1.7% ） , scale Ⅱ/ （moderate） in 12 patients （20. 7% ） , scale Ⅲ（good） in 35 patients （60. 4% ） and scale Ⅳ （excellent） in 10 patients （ 17.2% ）.Statistical analysis showed that the treatment response for deep-seated hemangiomas was significantly better than that for superficial hemangiomas （ P 〈 O. 05 ）, but no significant difference was found among different primary sites （P 〉0. 05）. The main adverse effects were bradycardia （100%）, diarrhea （63.8%） and sleep change （30. 2% ） , which resolved after expectant treatment without any significant sequel. No serious adverse effect was observed. Conclusions Oral propranolol treatment at a low dose is a safe and effective regimen for infantile proliferating hemangiomas. And it can be used as the first-line therapeutic modality. The short-term efficacy is excellent while the side effects are minimal.