The object of this study was to analyze the curative effect and safety of propranolol combined with prednisone in the treatment of infantile hemangiomas (IHs). Forty-four children with IHs on the head and face at the proliferative phase admitted to Jinan Center Hospital Affiliated to Shandong University were randomly divided into two groups. Children in group A took orally propranolol 2 mg/kg/day in three divided doses combined with prednisone 2 mg/kg/day in two divided doses in the first two weeks; children in group B took orally propranolol alone, and the dose was the same as that in group A. The treatment time of the two groups was up to 6 months, and the clinical curative effect and the incidence rate of adverse reactions were compared between the two groups. In the comparison of the curative effect between two groups of children with the tumor size decrease as the evaluation index, the total effective rate of group A was 100%, which was better than that of group B (81.82%), and the results were significantly different (P<0.05). In the same comparison with the surface of hemangiomas becoming flat and the color becoming light as evaluation indexes, the total effective rates of group A were 95.45 and 100%, which was not significantly different (P>0.05) compared with those of group B (86.36 and 77.27%) with a significant difference. The treatment in group A was superior to that in group B in terms of the curative effect on IH children younger than 6 months and was effective for different types of IHs. In group A, adverse reactions included loss of appetite (n=1) and bronchial and upper respiratory tract infections (n=1); in group B, adverse reactions included crying at night (n=1), lowered heart rate (n=1) and loss of appetite (n=2). The incidence rate of adverse reactions was compared between the two groups, and the difference was not significant (P>0.05), indicating that the combination therapy did not aggravate adverse reactions, and adverse reactions in the two groups were less and not severe. In the treatment of IHs, propranolol combined with prednisone can significantly reduce the tumor volume at the proliferative phase and significantly improve the tumor color with a low incidence rate of adverse reactions in a mild degree. Children have high tolerance to this treatment method, and the treatment method is highly safe and of great significance in clinical practice.
PURPOSE: To evaluate the safety and efficacy of combined oral and topical beta blockers for the treatment of superficial periocular infantile hemangioma at the early proliferative stage.
METHODS: This was a randomized, controlled comparison trial involving 25 patients. Patients were randomly enrolled into two groups: the topical and systemic treatment and systemic treatment only groups. The topical and systemic treatment group was treated with oral propranolol (1 mg/kg per day initially, increased to 2 mg/kg per day gradually in 2 weeks) and timolol maleate 0.5% gel. The systemic treatment only group received oral propranolol (1 mg/kg per day initially, increased to 2 mg/kg per day gradually in 2 weeks) and simple eye ointment to be applied to the lesion. The Hemangioma Activity Score was used to record the proliferative activity of the hemangioma. The main outcomes of the study were the change in the hemangioma size, the proliferative activity, and the treatment side effects.
RESULTS: At the end of the treatment period, the Hemangioma Activity Score was significantly improved in both groups from their values before treatment. However, the score obtained after treatment was significantly better in the topical and systemic treatment group (P < .05). Regarding the response to treatment, 10 and 3 cases in the topical and systemic treatment and systemic treatment only groups, respectively, showed a good response, with a significant difference between the two groups (P < .50). There were no recorded serious local or systemic complications during treatment in either group.
CONCLUSIONS: The results from combining topical with oral beta blockers showed that topical beta blockers are of additive value in treating superficial periocular infantile hemangioma in the early proliferative stage. [J Pediatr Ophthalmol Strabismus. 2018;55(1):37-42.].
BACKGROUND/OBJECTIVE: To report our observations from a trial of the short-term effectiveness and safety of topical carteolol hydrochloride drops to treat infantile hemangiomas (IHs).
METHODS: From October 2012 to September 2015, the study recruited 349 children with superficial IHs. Participants were randomized to two groups: treatment (n = 224 who received 2% carteolol hydrochloride drops administered to the lesion surface twice daily) and observation (n = 125 who did not receive treatment). Therapy duration was 6 months.
RESULTS: The mean age at the beginning of treatment was 3.2 months. Treatment responses were categorized as class 1 (total regression), class 2 (partial regression or controlled growth), or class 3 (no response). Of infants receiving carteolol treatment, 10.7% (24 patients) were categorized as class 1, 72.3% (162 patients) as class 2, and 17.0% (38 patients) as class 3. Of infants in the observation group, 5.6% (7 patients) were categorized as class 1, 25.6% (32 patients) as class 2, and 68.8% (86 patients) as class 3. No adverse effects were noted during treatment.
CONCLUSION: Carteolol is an effective, safe topical treatment for superficial IHs. Carteolol may be used to treat proliferative superficial IHs, particularly in infants younger than 6 months.
Short-term curative effect and safety of propranolol combined with laser in the treatment of infantile hemangiomas was studied, so as to provide reference for clinical treatment. A total of 100 cases of infantile hemangiomas admitted to the Affiliated Hospital of Jining Medical University from October 2014 to June 2016 were selected into this study. According to the random number table method, they were divided into the control group and the observation group, with 50 cases in each group. The infant patients in the control group were treated with laser alone, and the infant patients in the observation group were treated with propranolol combined with laser. The healing time, the number of times of laser therapy, the short-term curative effect, the changes in serum inflammatory factors before and after treatment and the incidence of adverse reactions were compared between the two groups of infant patients. The healing time and the times of laser therapy of the infant patients in the observation group were less than those of the infant patients in the control group, and the differences were statistically significant (p<0.05). The short-term curative effect of the observation group (98%) was higher than that of the control group (82%), and the difference was statistically significant (p<0.05). The levels of serum inflammatory factors interleukin (IL)-2, IL-6 and IL-10 in the two groups of infant patients after treatment were lower than those before treatment, and the levels in the observation group were lower than those in the control group, and the differences were statistically significant (p<0.05). Propranolol combined with laser in the treatment of infantile hemangiomas has remar kable short-term curative effects. It can effectively reduce the levels of inflammatory factors, shorten the healing time and reduce the number of times of laser therapy. It is safe and worthy of clinical promotion.
<b>Importance: </b>There are limited data from randomized clinical trials comparing propranolol and steroid medication for treatment of infantile hemangioma (IH).<b>OBJECTIVE: </b>To determine the efficacy and safety of propranolol compared with steroid as a first-line treatment for IH.<b>Design, Setting, and Participants: </b>This randomized clinical noninferiority trial tested the efficacy and safety of propranolol vs steroid treatment for IH at a single academic hospital. All participants were diagnosed with IH between June 2013 and October 2014, had normal heart function, and had not been previously treated for IH.<b>INTERVENTIONS: </b>The participants were randomly assigned to either the propranolol group or the steroid group. In the propranolol group, the patients were admitted, observed for adverse effects for 3 days after treatment initiation, and then released and treated as outpatients for 16 weeks (2 mg/kg/d). In the steroid group, the patients were seen as outpatients from the beginning and were also treated for 16 weeks (2 mg/kg/d).<b>Main Outcomes and Measures: </b>The primary efficacy variable was the response to treatment at 16 weeks, which was evaluated by the hemangioma volume using magnetic resonance imaging before and at 16 weeks after treatment initiation. While comparing the effect of medication between the groups, we monitored the adverse effects of both drugs.<b>RESULTS: </b>A total of 34 patients (15 boys, 19 girls; mean age, 3.3 months; range, 0.3-8.2 months) were randomized to receive either propranolol or steroid treatment (17 in each treatment group). Guardians for 2 patients in the steroid group withdrew their consent, and 1 patient in the propranolol group did not complete the efficacy test. The intention-to-treat analysis, applying multiple imputations, found the treatment response rate in the propranolol group to be 95.65%, and that of the steroid group was 91.94%. Because the difference in response rate between the groups was 3.71%, propranolol was considered noninferior. We found that there was no difference between the groups in safety outcomes.<b>Conclusions and Relevance: </b>Our trial demonstrated that propranolol was not inferior to steroid with respect to therapeutic effects in IH.<b>Trial Registration: </b>clinicaltrials.gov Identifier: NCT01908972.
<b>BACKGROUND: </b>Renin-angiotensin system components have been demonstrated in the biology of infantile hemangioma (IH). Captopril, an angiotensin-converting enzyme inhibitor, is proposed as a therapeutic alternative to oral propranolol.<b>OBJECTIVES: </b>We sought to compare the benefit of propranolol and captopril in the treatment of IH, and to assess angiotensin-converting enzyme gene polymorphism in patients with IH and in control subjects.<b>METHODS: </b>Thirty patients with IH and 35 healthy control subjects were enrolled in this study. Patients were randomly assigned to treatment with either propranolol or captopril. Assessment was done clinically and by measurement of serum vascular endothelial growth factor and angiotensin II in patients and control subjects. Angiotensin-converting enzyme gene polymorphism was also studied.<b>RESULTS: </b>Clinical improvement was significantly better and faster in the patients treated with propranolol. Both groups showed reduced vascular endothelial growth factor and angiotensin II levels posttreatment, with a significantly higher percentage reduction in the propranolol-treated group. Cardiac side effects were reported only in the captopril-treated group. Baseline vascular endothelial growth factor level was significantly higher, and baseline angiotensin II level was significantly lower, in patients than control subjects.<b>Limitations: </b>We studied a relatively small number of patients and control subjects.<b>CONCLUSION: </b>Propranolol shows greater benefit than captopril in the treatment of IH.
