A prospective randomized controlled study of different doses of oral propranolol in infantile hemangiomas

Abstract

Objective To study the efficacy of 1 mg·kg-1·d-1 and 2.0 mg·kg-1·d-1 of propranolol in the treatment of infantile hemangiomas, so as to provide an ideal dosage for clinical treatment. Methods From September 2015 to October 2016, there were 89 patients in accordance with the inclusion criteria of infantile hemangiomas. According to randomized and controlled principle, the patients were assigned to receive two propranolol regimens, Group A(n=45): propranolol at a dose of 1 mg·kg-1·d-1; Group B(n=44): propranolol at a dose of 2 mg·kg-1·d-1. 1 or 2 mg of propranolol base per kilogram per day, divided into two doses.The first dose was taken at 9, next at 15.The effective rate, cure rate and adverse effect rate were compared at the six months after treatment. The duration of the treatment was compared after 12 months′ treatment, and the recurrence rate was compared at the three months after being cured.The data were statistically processed with SPSS 22.0. The sample rate was compared with χ2 test, and the data were compared with t test. P<0.05 was statistically significant difference. Results Group A: Treatment for 6 months, 45 children were evaluated as follows: the effective rate was 91.1%(41/45), the cure rate was 60%(27/45). The incidence of adverse reactions was 13.3%(6/45). The cure rate of group A at 12 months was 86.7%(39/45). The duration of treatment was 7.6±2.7 months.The recurrence rate was 9.5%(4/42). Group B: Treatment for 6 months, 44 children were evaluated as follows: the effective rate was 90.9%(40/44), the cure rate was 72.7%(32/44). The incidence of adverse reactions was 15.9%(7/44). The cure rate of group B at 12 months was 88.6%(39/44). The duration of treatment was 6.2±1.9 months. The recurrence rate was 11.9%(5/42). The effective rate of the two groups at 6 months was not statistically significant(χ2=2.583, P=0.461). The cure rate of the two groups at 6 months was statistically significant(χ2=8.339, P=0.004). The incidence of adverse effects was not statistically significant(χ2=0.118, P=0.731). The cure rate of the two groups at 12 month was not statistically significant(χ2=0.080, P=0.778). The duration of treatment between the groups was statistically significant (t=0.290, P=0.009). The recurrence rate of the two groups after 3 months withdrawal was no statistical difference(χ2=0.124, P=0.724). Conclusions The propranolol doses at 1 mg·kg-1·d-1 and 2 mg·kg-1·d-1 in the treatment of infantile hemangiomas are safe and effective. The propranolol dose at 1 mg·kg-1·d-1 doesn′t decrease the effective and cure rate, not increase the recurrence rate in infantile hemangiomas. Low dose at 1 mg·kg-1·d-1 can be used as a common dose of propranolol in infantile hemangiomas. Key words: Infantile hemangiomas; Propranolol; Oral administration; Dose