Department of Plastic and Reconstructive Surgery, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Eur J Pediatr. 2013 May;172(5):653-9. doi: 10.1007/s00431-012-1928-9. Epub 2013 Jan 23.
We aimed to assess the efficacy and safety of low-dose propranolol for treatment of infantile hemangiomas (IHs) in China. Our prospective study included data from 89 patients with IH, aged 1-12 months. Plasma renin activity, angiotensin II, and aldosterone were measured before initiation of propranolol therapy. Patients were administered propranolol (0.75-1 mg/kg/day) under close observation. The volume, texture, and color of lesions were used to evaluate efficacy. Safety endpoints included heart rate, systolic and diastolic blood pressures, alanine transaminase, aspartate transaminase, thyroid function tests, and fasting blood glucose. Adverse effects were recorded. Mean plasma angiotensin II concentration in patients with IH was higher than that in age-matched healthy children, whereas mean plasma renin activity was lower. Mean aldosterone level was higher at 1-3 months but lower at 4-12 months, than values reported previously. After propranolol therapy for 6 months, IH regression was classed as grade IV in 44 patients (49.4 %), grade III in 21 patients (23.6 %), and grade II in 24 patients (27.0 %); none were grade I. Mild adverse effects, including diarrhea, restless sleep, nausea, cold extremities, and hypoglycemia, occurred in 12 patients (13.5 %). Slight decreases in heart rate and blood pressure occurred in all patients (p < 0.05). The IHs of four patients (4.5 %) relapsed after treatment cessation at 4-5 months.
Low-dose propranolol is effective and safe for Chinese children with IH, and larger-scale studies are merited. Mechanisms underlying IH pathogenesis, and possible involvement of the renin-angiotensin-aldosterone system, deserve study.
评估小剂量普萘洛尔治疗中国婴幼儿血管瘤（IH）的疗效和安全性。
前瞻性研究纳入 89 例 112 月龄 IH 患儿，测定普萘洛尔治疗前患儿血浆肾素活性、血管紧张素Ⅱ和醛固酮水平。给予普萘洛尔（0.751 mg/kg/d）治疗，密切观察患儿。采用瘤体体积、质地和颜色变化评价疗效。安全性终点包括心率、收缩压和舒张压、丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、甲状腺功能和空腹血糖。记录不良反应。
IH 患儿平均血浆血管紧张素Ⅱ浓度高于同龄健康儿童，平均血浆肾素活性低于健康儿童。平均醛固酮水平在 13 个月时较高，412 个月时较低，与既往报道不同。普萘洛尔治疗 6 个月后，44 例（49.4%）患儿瘤体消退达Ⅳ级，21 例（23.6%）达Ⅲ级，24 例（27.0%）达Ⅱ级，无Ⅰ级患儿。12 例（13.5%）患儿出现腹泻、睡眠不安、恶心、四肢发冷和低血糖等轻微不良反应。所有患儿的心率和血压均有轻微下降（均 P<0.05）。4~5 个月停药后 4 例（4.5%）患儿 IH 复发。
小剂量普萘洛尔治疗中国婴幼儿 IH 安全有效，值得开展更大规模的研究。IH 发病机制的潜在机制，包括肾素-血管紧张素-醛固酮系统，值得进一步研究。
